Research Insights

Presently, the world is witnessing a radical change in the way industrial operations are conducted. Technological advances have now enabled a number of simple and complex processes to be automated. In addition, growth in adoption of the concept of internet of things has led to the generation of large volumes real-time data, which require advanced machine-learning techniques for analysis. Collectively, the aforementioned developments have initiated a new phase in the current industrial revolution

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The “Staphylococcus Aureus Pneumonia Market: Pipeline Review, Developer Landscape and Competitive Insights, 2020-2030” report features an extensive study on the marketed, clinical and preclinical molecules available / being developed for the treatment of Staphylococcal pneumonia. This report provides an in-depth analysis of the product pipeline and developer companies, highlighting the current treatment practices, emerging drugs, and market share of the individual therapies. In ad

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Since the discovery of the means to artificially synthesize radioisotopes (early 1930s), they were almost immediately adopted for healthcare applications, by the mid-1940s. Presently, a variety of diagnostic and therapeutic techniques are based on the use of such substances, commonly referred to as radiopharmaceuticals. Despite their inherent toxicity, nuclear medicine is considered an important part of modern healthcare, with applications spanning across a number of therapeutic areas, including

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Novel drug / therapy development is a complex and capital intensive process characterized by several challenges and setbacks. A prominent concern reported by innovators is attrition (close to 90%) of candidate drugs / therapies owing to various reasons, in addition to therapeutic efficacy and safety. Moreover, it is estimated that a new drug takes anywhere between 10-12 years to progress from the bench to market. Given the increasing global population and rising incidence of various types o

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Over the years, advances in cell biology and pharmacology have led to the development of a variety of advanced biologics, which experts believe, possess the potential to address several unmet needs associated with the treatment of different types of diseases. Currently, there are more than 1,000 cell and gene therapies under development; most of which are being developed for the treatment of oncological disorders, cardiovascular disorders and neurological disorders. Additionally, over the last d

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With close to 80 monoclonal antibodies approved till date, and over 550 molecules in the clinical pipeline, antibody based pharmacological interventions have become an important part of the biopharmaceutical industry. In fact, they are presently estimated to constitute the largest class of biologics in the industry. Examples of recently approved monoclonal antibody products include (in reverse chronological order) Adakveo® (November 2019), Beovu® (October 2019), SKYRIZI™ (April 201

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Chronic disorders, such as arthritis, diabetes, cancer, obesity and heart disease, are considered to be the leading causes of death and disability across the world. Specifically, the global prevalence of diabetes is estimated to be more than 300 million adults by 2025. According to the WHO, more than 450 million people are presently suffering from some form of mental health disorder (such as anxiety and depression), and / or neurological disorder. The rise in number of patients suffering from su

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Depression is one of the most common chronic neurological conditions in modern society. It is estimated that over 250 million people, across all age groups, suffer from some form of depression, worldwide. Moreover, this condition along with other mental health disorders are estimated to be responsible for productivity associated losses worth over USD 1 trillion, every year, at the global level. In fact, the US reported a sharp increase (~20%) in number of prescriptions for antidepressants and an

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The process of successfully developing a novel therapeutic intervention is both time and cost intensive. In fact, it is estimated that a prescription drug requires around 10 years and over USD 2.5 billion in capital investment, before reaching the market. In this process, clinical trials are a crucial requirement, enabling both innovators and regulators to assess the efficacy of a candidate drug and establish whether it is safe for use in humans. It is estimated that nearly 50% of the total time

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The ‘Multi-drug Resistant Tuberculosis Market, 2020-2030’ report features comprehensive insights about the current market landscape consisting of several industry stakeholders engaged in developing disease modifying interventions, drug products and therapies that have been developed / are being developed for the treatment of condition as well as the market trends across various geographical regions (North America, Europe and Asia-Pacific).  This report provides an informed op

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Proteins are complex biomolecules that are involved in a number of essential functions in living organisms. Proteome profiling refers to the large-scale, high-throughput analysis of biological samples for the detection, identification, and functional characterization of resident proteins. The process includes the study of polypeptide structure, expression, function, protein-protein interactions, and post translational modifications (PTMs). With the growing prominence of peptide-based therapeutic

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In pharmaceutical manufacturing, the use of certain hazardous chemical reactions has been shown to enable developers to optimize existing production processes, as well as improve yields. In other words, certain chemical reactions, which are generally regarded as harmful, offer a more direct route to the end product, requiring fewer raw materials and involving a limited number of side reactions. As a result, the number of process steps are essentially reduced, when compared to using conventional

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Advent of smartphones coupled to the easy accessibility of information on the internet, has rendered it crucial for companies to establish a digital presence. As opposed to traditional strategies, digital marketing is not only cost effective but offers several ancillary benefits, such as targeted outreach and data driven output. In fact, a recent study stated that digital advertising is expected to account for around 50% of the overall global advertisement spend by 2021. However, the adopti

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Harnessing the naturally evolved, medicinal functions of gut bacteria in order to achieve desired clinical outcomes / benefits is the core principle behind the rapidly growing field of microbiome therapeutics. In fact, in recent years, promising insights from microbiome focused research has been the cause of much enthusiasm within the medical science community, offering a novel perspective related to personalized medicine. This particular class of products exists at the interface of naturopathi

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Our estimates suggest that the global digital twin market is likely to be worth USD 5.1 billion in 2020 and this value is projected to reach USD 115.1 billion by 2035, growing at an estimated CAGR of 23.2%. A digital twin is the digital replica of the physical entity of the product, processes, places or human. The concept of the digital twin technology was first introduced by NASA in 2010. The aforementioned organization used digital twin technology for developing a highly detailed simulation mo

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Since the discovery of ultrasound, the field of medical imaging has evolved significantly, offering non-invasive means for physicians to accurately visualize almost all major organ systems for diagnostic purposes. However, conventional medical imaging solutions are severely limited in terms of mobility, throughput and are usually dependent on stationary power sources. As a result, they are impractical in situations characterized by low physician / pathologist to patient ratios. There is, th

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Since the approval and launch of cell and gene therapy products, such as Zolgensma® (2019), ZYNTEGLO™ (2019), Luxturna® (2017), KYMRIAH® (2017) and YESCARTA® (2017), there has been a significant increase in demand for viral vectors. Experts believe that the number of such therapies is likely to double over the next couple of years. It is also worth mentioning that this particular field of medical research received close to USD 10 billion in funding in 2019. Currently, over

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Chronic diseases, such as diabetes, cardiovascular disorders, neurological disorders, autoimmune disorders and various types of cancer, are known to be the leading causes of death and disability across the world.  The clinical conditions associated with these diseases affect patients’ overall quality of life.  In fact, according to the World Health Organization (WHO), over 50% of the global population is currently estimated to be suffering from at least one chronic disease.  

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Electric Vehicle (EV) charging station can be described as an electric vehicle supply equipment (EVSE), which is part of an infrastructure responsible for supplying electric energy for recharging plug-in electric vehicles. The global EV charging infrastructure market is projected to reach USD 140.0 billion by 2030, growing at an estimated CAGR of 31.2%. The rapid pace of growth expected to be witnessed within this industry can be attributed to the constant innovation and R&D efforts bei

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Vaccines are versatile preventive formulations that have, so far, enabled the global eradication of smallpox (1980) and polio (2015), which are both debilitating viral diseases. According to the WHO, currently, global vaccination coverage is nearly 85%. This is believed to be responsible for preventing close to three million deaths, which would have otherwise been caused by infectious diseases, such as chickenpox, diphtheria, measles, pneumonia, tetanus, and tuberculosis. In fact, recent immuniz

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According to the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), at present, there are close to 175,000 types of medical devices available in the US. In fact, since 2019, the USFDA has approved close to 55 medical devices. Further, over 7,000 medical device focused clinical trials have been registered worldwide. In this context, our estimates suggest that total revenues from global sales of medical devices is likely to be around USD 450 billion in 2020. Th

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Chronic conditions, such as arthritis, cancer, diabetes, and heart disease are known to affect approximately 133 million Americans, representing over 40% of the total US population. This number is projected to grow to 157 million by the end of 2020. In addition, nearly 20 million Americans are estimated to suffer from some form of neurological disorder. Such conditions are generally characterized by a variety of complex symptoms, such as seizures, chronic pain and sleep disorders, for which medi

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Biologics represent one of the fastest growing classes of therapeutic molecules in modern healthcare. As per an article published in January 2020, the annual global biologics market is expected to be approximately USD 380 billion by 2024, representing a relatively higher growth rate (~8%) compared to conventional pharmaceuticals. Considering the necessity to bypass gastric metabolism, biologics are mostly designed for administration via parenteral routes. In fact, majority of such therapies are

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China represents nearly 18% of the global population. Studies indicate that the Chinese pharmaceutical market is the second largest in terms of annual pharmaceutical revenues, and is estimated to generate more than 10% of the global sales. Till date, over 25 biologics and biosimilar products have been approved in China. In addition, close to 1,000 clinical trials, investigating a variety of biologics and biosimilars for treating a diverse range of diseases, are presently underway in this region.

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[COVID-19 SERIES] New coronavirus (COVID-19) is a previously unidentified strain of coronavirus, that first emerged in the Chinese city of Wuhan in December 2019. The virus belongs to the same family as the virus that causes severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). On 30th January 2020, the World Health Organization (WHO) declared the coronavirus outbreak as a global health emergency. In fact, the virus is estimated to have infected more than 45,

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Small molecule drugs represent nearly 90% of pharmaceutical products available in the market. In fact, in 2019, the FDA’s Center for Drug Evaluation and Research approved 48 drugs, of which, 67% were small molecules. However, drug development and manufacturing is a cost intensive process, and is, at times, characterized by the need for advanced capabilities and specialized facilities, which are not possible for all developer companies to build in-house. This has compelled many of the small

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Over the years, advances in stem cell biology and regenerative medicine have enabled the discovery and development of a number of stem cell-based therapies. In fact, many believe that such interventions possess the potential to address several unmet needs related to the treatment of a wide range of diseases. Stem cell-based treatments are known for their ability to replace damaged cells and tissues, thereby, effectively reversing the adverse physiological effects they cause. However, challenges,

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According to a study conducted by the World Health Organization (WHO), diseases that affect the central nervous system (CNS), such as Alzheimer’s disease, brain cancer, multiple sclerosis. Parkinson’s disease and stroke, are characterized by a significant unmet need for effective treatment options. In 2019, it was reported that nearly 1.5 billion people suffer from some form of disorder affecting the CNS across the globe. In fact, the incidence of CNS disorders is anticipated to

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Drug discovery and development is a complex and tedious process that requires a significant amount of resources and capital investment (~USD 2.6 billion). In fact, on an average, the journey from the establishment of initial proof-of-concept to commercial launch, is estimated to take around 10-12 years. However, only a small fraction of early stage therapeutic candidates are able to make it past preclinical testing, into clinical evaluation. Further, even fewer clinical stage candidates are even

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Recent advances in the manufacturing technologies have prompted pharmaceutical companies to shift from the traditional multi-step, batch manufacturing processes to faster, and relatively more efficient continuous manufacturing.  Continuous manufacturing, also known as continuous flow chemistry, is an advanced manufacturing technology, which drives operations in a continuous manner (24×7) in one facility, without hold times.  The concept was first described in the 1700s, in relati

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Over the last few years, the exponential growth in the pipeline of nucleic acid based therapies has led to the escalating interest of pharmaceutical industry in this domain. Presently, more than 2,000 trials evaluating different types of gene therapies are underway. Moreover, according to experts at the US FDA, around 40 new gene therapies are likely to be approved by 2022. In this context, it is worth highlighting that viral vectors are a crucial element in gene therapy development and manufact

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Oligonucleotides have a wide range of applications in medical science. In basic research and diagnostics, these are indispensable to contemporary molecular testing and analytical protocols (such as the polymerase chain reaction (PCR), and DNA sequencing), genomic library construction and artificial gene synthesis. In fact, amid the ongoing coronavirus pandemic, several oligonucleotide manufacturers have started offering critical oligonucleotide chemistries, controls and components for the delive

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Since the establishment of the therapeutic relevance of insulin in the early 1920s, peptide therapeutics have come a long way. Presently, there are over 60 peptide-based drugs available in the market. Specifically, these products represent one of the earliest classes of biologics and have, so far, demonstrated significant potential in the treatment of a variety of metabolic and oncological disorders. Examples of popular, marketed therapeutic peptides include Victoza®, LUPRON DEPOT®, Zola

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Cancer is known to be one of the leading causes of death worldwide, accounting for 0.6 million deaths in 2019, in the US alone. The World Health Organization has estimated the number of new cancer cases to rise by 70% over the next 20 years, across the globe. Conventional treatment options, such as chemotherapy, surgery and radiation therapy, are still considered as the current standard of care. However, their efficacy is severely limited, especially when it comes to treating late-stag

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Among drug delivery devices, prefilled syringes represent one of the fastest growing primary packaging formats, which are also designed for dose administration. In fact, over the past ten years, there has been an evident increase in the development of parenteral drugs (especially with the introduction of several classes of biologics), which has resulted in an increased consumption of prefilled syringes, by approximately three fold.  The sustained preference for such products can be attribut

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Over the past few years, peptides (including oligopeptides, polypeptides and synthetic peptides) and macrocycle-based pharmacological interventions have gained a lot of attention from clinical researchers; drug development efforts focused on such molecules have significantly increased. This can be attributed to the benefits offered by the aforementioned drug classes, which include high target specificity, low toxicity and favorable safety profiles. ,   In fact, more than 60 peptide-based th

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Highly potent active pharmaceutical ingredients (HPAPIs), which include cytotoxic APIs, are drug substances that can exhibit biological activity at approximately 150 μg per kilogram of body weight, with a therapeutic dose of or below 10 mg. Owing to the widespread applications associated with these compounds, HPAPIs have emerged as one of the key areas of interest to researchers and manufacturers across the globe. As compared to conventional therapeutic products, highly potent compounds offer

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The process of drug development, beginning from the discovery of a pharmacological lead to its commercial launch, is estimated to take around 10-15 years, involving capital investments in the range of USD 4-10 billion. ,   Moreover, it is well-known that only a small proportion of leads, which are selected for further investigation during the initial stages of research, are actually translated into product candidates for clinical research studies. Over time, the complexities of drug discove

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The global smart lighting market was $xx billion in 2019 and is expected to reach $ 80.9 billion by 2030, growing at an estimated CAGR of 13.6% during the forecast period. Smart lighting is the lighting solution, which is controlled by the apps that are run on mobile phones or on laptops or on personal computers. With the help of these apps, the lighting lamp can automatically switch on or switch off according to the preset time or automatically, according to the time of the day.

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Personalized medicine has brought about a paradigm shift within the healthcare sector. However, therapies tailored to specific disease-related molecular signatures require appropriate companion diagnostics in order to make physicians aware of patients’ unique genetic profiles, enabling them to make informed treatment related decisions. In fact, a clinical study of nearly 200 unique pharmacological interventions, which were evaluated across more than 670 clinical trials, suggests that the l

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According to the WHO, in 2020, nearly 75% of fatalities that are estimated to be reported across the globe, are likely to be caused due to  diseases, such as chronic stroke disease, diabetes, cancer, heart disease, and certain mental health conditions.  In addition, as per a report published by the Center for Managing Chronic Disease, University of Michigan, more than 50% of the global population was estimated to be living with some form of chronic illness.  The rising prevalence

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Low bioavailability is one of the primary concerns associated with marketed drugs; in fact, various studies indicate that around 40% of available drugs are poorly bioavailable / soluble. As the drug developers shift their focus towards development of lipophilic drug compounds, the issue with aqueous solubility / bioavailability of the drugs is likely to increase further. It is estimated that around 90% of NCEs belong to BCS class II and IV, which are known to be associated with low solubili

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Since the approval of Orthoclone OKT3® in 1986, monoclonal antibodies have become an important part of modern healthcare practices. In fact, several experts consider monoclonal antibodies to be the backbone of the biopharmaceutical industry. It is worth noting that, till date, more than 100 therapeutic monoclonal antibodies have been approved across different geographies; recent approvals include (in reverse chronological order) Adakveo® (November 2019), Beovu® (October 2019), SKYRIZ

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The human body is known to harbor numerous communities of microbes, including both beneficial and harmful species, which are collectively referred to as the microbiota. Likewise, the ecological system of commensal, symbiotic, and perhaps pathogenic microorganisms that reside within a host system is called the microbiome.  Research insights, generated primarily  from the Human Microbiome Project (2009) and other independent studies, have demonstrated that an imbalance in the microbiome

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Ophthalmic diseases, such as age-related macular degeneration, cataract, diabetic retinopathy, dry eye and glaucoma, are considered among the leading causes of vision loss across the globe. According to the World Health Organization’s report published in 2019, at least 2.2 billion individuals in the world are reported to be visually impaired. In fact, blindness caused due to multiple reasons, is projected to increase to 75 million affected individuals by 2020. Moreover, current estimates i

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The first monoclonal antibody, Orthoclone OKT3®, was approved in 1986 by the FDA. Since then, a number of antibody therapeutics (more than 100) have been marketed for the treatment of patients suffering from various disease indications, primarily malignant tumors and other rare disorders. Despite the success, these drugs are associated with several limitations, such as increased patient resistance and a general lack of understanding of in vivo mechanisms of action. The aforementioned challen

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More than 40% of the US population is estimated to be suffering from some form of a chronic health condition. According to the US National Health Council, over 75% of the nation’s healthcare expenditure is on the treatment of chronic diseases, such as diabetes. The major share of expenses incurred by patients living with a chronic disorder is driven by the frequent need to medicate, which may require repeated visits to hospitals / out-patient clinics. Over time, a variety of solutions enab

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The concept of targeted protein degradation presents revolutionary drug development opportunities and is anticipated to bring about a paradigm shift in modern healthcare. Owing to various reasons, conventional pharmacological interventions have been severely restricted in terms of accessing protein targets of pathological significance. However, researchers engaged in developing bifunctional protein degrader-based interventions claim that this upcoming class of medicinal compounds possess the cap

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The process of drug development, beginning from the discovery of a molecule to its commercial launch, takes around 10-15 years and capital investments worth USD 4-10 billion. It is a well-known fact that only a small proportion of molecules, which are selected for further investigation during the initial stages of research, are actually translated into product candidates. Given the complexities involved in the drug discovery process, the overall research and development (R&D) expenditur

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Till date, more than 20 cell-based therapies have been approved (recent examples include Zynteglo® (2019), Alofisel® (2018), YESCARTA® (2017) and Kymriah® (2017)), while over 500 product candidates are under development. In fact, there are over 1,000 active clinical studies of cell therapies, worldwide. Over the last few years, such therapies have garnered significant attention within the biopharmaceutical industry. Several companies and venture capital funds / investors have alr

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According to experts in the healthcare industry, one in three adults are estimated to be suffering from some type of chronic clinical condition, such as multiple sclerosis, diabetes, rheumatoid arthritis and cardiovascular diseases. Chronic clinical conditions are considered to be among the leading causes of death and disability across the world.  Typically, in such cases, individuals are required to medicate on a daily basis. In addition to the cost of medication, such individuals are also

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[COVID-19 SERIES] Advances in DNA sequencing technologies have led to significant developments in a variety of healthcare-focused research fields, such as precision medicine and diagnostics. Particularly, the impact of next generation sequencing (NGS) methods, enabling whole genome and whole exome sequencing, has been the most profound. This high throughput, parallel genome sequencing technology has greatly reduced the overall cost and time investment. In fact, compared to the Human Genome

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The global colocation datacenter market was $XX billion in 2019 and is expected to reach $170.6 billion by 2030, growing at an estimated CAGR of 13.6% during the forecast period. A colocation data center or the multi-tenant data centers are generally, operated by third parties. A collocation data center service provider provides, mainly, infrastructure, cooling, bandwidth, whereas, the client provides storage and servers. The data center facility is either leased by the room or cabinets. The gro

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With six approved drugs, namely POLIVY™ (2019), LUMOXITI™ (2018), BESPONSA® (2017), MYLOTARG™ (2017, reapproval), KADCYLA® (2013) and ADCETRIS® (2011), and more than 200 in the pipeline (clinical / preclinical stages), antibody drug conjugates (ADCs) are now recognized as a potent class of targeted therapeutics. The success of this relatively novel class of therapeutics is attributed to the ability of lead molecules to specifically identify and eliminate disease ass

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According to the World Bank, more than 50,000 different types of medical devices are currently being used on a daily basis in healthcare facilities across the globe. In 2018, the global medical devices market was estimated to have reached a net worth of approximately USD 450 billion.  It is also worth noting that, since in the same year, the USFDA approved over 130 medical devices. ,   However, a relatively large proportion of developers lack the resources and technical expertise requi

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[COVID-19 SERIES] According to experts, the global vaccines market is anticipated to generate revenues worth USD 100 billion by 2025. Data presented by the WHO indicates that the current global vaccination coverage is nearly 85%; this is believed to be responsible for preventing close to three million deaths from diseases, such as diphtheria, tetanus, whooping cough and measles. Recent global immunization records indicate that more than 115 million children were immunized against diphtheria

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Cancer is known to be one of the leading causes of death worldwide. In 2019, 0.6 million deaths due to cancer are estimated in the US alone. Moreover, the World Health Organization has estimated the number of new cancer cases to rise by 70% over the next 20 years.  One of the primary reasons for the high mortality associated with this condition is believed to be late diagnosis. This results in delayed treatment, which severely compromises chances of survival. For many years, tissue biopsy h

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Advanced therapy medicinal products, such as cell and gene therapies, have revolutionized healthcare practices. The introduction of such treatment options has led to a paradigm shift in drug development, production and consumption. Moreover, such therapies have actually enabled healthcare providers to treat several difficult-to-treat clinical conditions. In the past two decades, more than 30 such therapy products have been approved; recent approvals include Zolgensma® (2019), RECELL® Sys

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The concept of RNA interference (RNAi) was identified in the 1980s. It is based on the selective silencing of specific sequences of mRNA, thereby, inhibiting the ability to translate into disease causing proteins. This phenomenon was first demonstrated in the petunia flower and later studied in C. elegans. Interestingly, the discovery was awarded the Nobel Prize in 2006. Even though the technique was discovered less than two decades ago, RNAi has had a significant impact within the pharmaceutica

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The 1970s witnessed the introduction of one of the most revolutionary advances in biotechnology, when Hamilton Smith (a molecular biologist at Johns Hopkins University School of Medicine) purified the first site-specific restriction enzyme, called Hind II. This development enabled the scientific community to devise the means to manipulate living organisms at the genetic level, opening up a plethora of opportunities in fundamental and applied life science research. Soon after, in the 1980s, the U

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[COVID-19 SERIES] Chronic clinical conditions, such as diabetes, cardiovascular disorders, certain types of neurological disorders, and cancer, are considered to be among the leading causes of death and disability across the world. The Center for Managing Chronic Disease at the University of Michigan recently reported that over 50% of the global population is suffering from some form of chronic disease. Despite significant advances in drug / therapy development for the treatment o

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In 2018, it was estimated that the availability of low-cost, generic versions of pharmaceutical interventions saved nearly USD 1.6 trillion in healthcare costs in the US over the last decade.  Given the cost benefits offered, generic medicines usually have high adoption rates. Moreover, upcoming patent expiries of several blockbuster drugs, such as LYRICA®, Cialis®, Advair® and Sensipar®, have intensified the interest of several drug manufacturers in the development of gener

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Over the last 12 months, the pharmaceutical industry reported a year-on-year increment of nearly 75% in funding to support the development of various cell and gene therapies. In fact, close to USD 5 billion has been invested into research on gene-based therapies in the previous two decades. Interestingly, over 2,600 clinical studies have been initiated in this field of research, since 1989. The aforementioned numbers are indicative of the rapid pace of development in this upcoming segment o

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The global automotive lithium-ion battery market was $17.4 billion in 2019 and is expected to reach $95.3 billion by 2030, growing at an estimated CAGR of 17.1 % during the forecast period. Lithium-ion batteries are advanced rechargeable batteries that are used in portable consumer electronic products and in electric vehicles, such as e-bikes, e-rickshaws, and e-cars. In the last few years, lithium-ion batteries have been able to effectively penetrate into the automotive market due to its long l

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As of August, over 30 medical devices were approved by the US FDA alone, in 2019.  Given recent technological advances and the increasing complexity of such products, the need for proper medical device labels has become a concern that is being addressed by both label manufacturers and regulators. In this context, it is worth highlighting that more than 10% of product recalls observed in this market are attributed to medical device labeling related issues. Labels ensure that a product is use

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Advances in the fields of cell biology and regenerative medicine have led to the development of a variety of stem cell-based therapies for many cardiovascular, oncological, metabolic and musculoskeletal disorders. Driven by the revenues generated from stem cell therapies, the regenerative medicine market is anticipated to generate revenues worth USD 100 billion by 2030. With a promising pipeline of over 200 stem cell therapy candidates, it has become essential for developers to scale up the prod

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With six approved and marketed drugs, namely POLIVY™ (2019), LUMOXITI™ (2018), BESPONSA® (2017), MYLOTARG™ (2017, reapproval), KADCYLA® (2013) and ADCETRIS® (2011), antibody drug conjugates (ADCs) have become recognized as a potent class of targeted therapeutic agents catering to oncology and hematological diseases markets. The success of such conjugated products can be attributed to their ability to effectively identify and eliminate disease associated cells /

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Since the approval of the first therapy, Genedicine® in 2003, the gene therapy domain has evolved significantly. Specifically, in 2019, three gene therapies, namely Zolgensma® (US), Zynteglo™ (Europe) and Beperminogene Perplasmid (Japan), have received approval / conditional approval, leading to a marked upward surge in the interest in this field. In fact, the growing popularity can be correlated to the substantial increase (more than 90%) in the number of patents that have been fi

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CAR-T cell therapies are based on the principle of harnessing the innate potential of the immune system to selectively target and destroy diseased cells. Encouraging clinical results reported across several completed and ongoing trials, coupled to lucrative financing, have inspired many biopharmaceutical developers and academic research groups to focus their efforts on this relatively novel class of cell-based immunotherapies. With two approved products, namely KYMRIAH® (Novartis) and YESCAR

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Cancer is known to be one of the leading causes of death worldwide. In the US, 0.6 million deaths (https://www.cancer.gov/about-cancer/understanding/statistics) were reported to have been caused due to cancer in 2018 alone. Further, according to the International Agency for Research on Cancer (IARC), close to 17 million new cancer cases were reported in 2018, worldwide. By 2040, it is estimated that the aforementioned number is likely to grow to 27.5 million.  It is worth mentioning that in

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Advances in the fields of cell biology and regenerative medicine have led to the development of various cell-based therapies, which, developers claim, possess the potential to treat a variety of clinical conditions. In 2018, it was reported that there were more than 1,000 clinical trials of such therapies, being conducted across the globe by over 900 industry players. Moreover, the total investment in the aforementioned clinical research efforts was estimated to be around USD 13 billion. Given t

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Mitochondrial diseases are characterized by chronic, genetic and progressive medical symptoms that arise due to inherited or spontaneous mutations in mitochondrial DNA (a small, circular, double-stranded with ~16,500 base pairs that exists outside of the nucleus), or in some cases, nuclear DNA, which adversely alter the function of mitochondria. Such clinical conditions are rare and are known to affect multiple parts of the body, including neurons and nerves, kidneys, heart, liver, eyes, ears, a

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Although the healthcare industry relies on patient to take medications responsibly, in 2017, close to 18 million individuals were reported to have misused prescription drugs, in the US. In fact, data from a National Survey on Drug Use and Health conducted in the same year, showed that an estimated 2 million Americans misused prescription pain relievers for the first time in the previous year. Moreover, the same study reported 1.5 million people abusing tranquilizers, over 1 million abusing presc

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[COVID-19 SERIES] The global vaccines market is anticipated to generate revenues worth USD 100 billion by 2025. According to the WHO, the global vaccination rate is nearly 85%, demonstrating the high clinical demand for vaccines.  In addition to meeting the growing demand for vaccines, the developers of these pharmacological interventions are also plagued by high costs of development and complex production protocols. Given that vaccine manufacturing requires highly regulated, state-of-

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The cancer therapeutics market is considered to be one of the most active segments within the pharmaceutical industry. In the past five years, the USFDA has approved more than 100 drugs for the treatment of different types of cancer. However, there is still a pressing need for more specific and potent drugs / therapies to combat this complex, life threatening clinical condition. It is also worth highlighting that, in the coming years, the number of cancer patients is anticipated to increase

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Natural killer (NK) cells, or killer (K) cells, represent an important subset of cellular mediators of the innate immune system. These cells are known to be instrumental in containing viral infections and regulating tumor development, while the adaptive immune system generates an antigen-specific response.  Technically, they are classified as group I innate lymphocytes. Although they share a common progenitor, NK cells are very different from B-lymphocytes and T-lymphocytes,  and do no

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Recent advances in data science technology solutions, such as Internet of Things, machine learning, artificial intelligence and real world evidence-based solutions, have enabled medical device developers to digitize and automate a number of product development and manufacturing processes. In 2020, the global medical devices market is estimated to reach a net worth of approximately USD 430 billion.  However, most developers lack adequate resources and the necessary expertise to manufacture m

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Cancer is known to be one of the leading causes of death worldwide, accounting for 0.6 million deaths in 2018, in the US alone.  The World Health Organization has estimated the number of new cancer cases, reported across the globe, to rise by 70% over the next 20 years.  Conventional treatment options, such as chemotherapy, surgery and radiation therapy, continue to demonstrate limited efficacy in late-stage cancers. Moreover, the non-specific and highly toxic nature of chemotherapy an

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Biologics constitute a majority of the top selling drugs and presently represent one of the fastest growing segments of the overall pharmaceutical industry. In fact, since the launch of recombinant protein-based therapies around three decades earlier, the overall biologics market has grown at an annualized rate of over 12%. It is also worth highlighting that more than 5,000 biopharmaceutical product candidates are currently under development.  Despite the fact that biopharmaceuticals offer

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Pharmaceutical packaging plays a crucial role in ensuring the sterility and quality of a drug product, while also providing information related to its identity and, in certain cases, dosing instructions. Primary packaging material, owing to the fact that it is in immediate contact with the drug / therapy formulation, is considered to be extremely important when it comes to preserving the stability, efficacy and safety of the packaged drug product. Further, given the growing complexity of modern

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Over the last couple of decades, the healthcare market has witnessed the entry of several advanced and effective treatment options for cancer; these include a variety of targeted therapies, immunotherapies and certain anti-cancer vaccines as well. However, clinical cancer research is still plagued by high failure rates, various drug / therapy-related limitations, and treatment-based adverse effects, some of which have proven to be fatal. A prominent concern is associated with deciding the type o

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The process of developing novel and effective healthcare products is both cost and time intensive. Studies suggest that each prescription drug requires around 10 years and over USD 2.5 billion in working capital before it reaches the market. Further, it is estimated that, in the US, 40% of the pharma industry’s R&D budget is spent solely on conducting clinical trials.  In addition to excessive capital requirement, clinical research is fraught with various other challenges, such as

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Depression is a chronic medical condition characterized by a persistent feeling of sadness and lack of interest in external stimuli. It is a commonly diagnosed mental health disorder and is considered among the leading causes of disability across the globe. It has been estimated that over 300 million people (considering all age groups) suffer from depression worldwide. Further, depression and other depressive disorders are projected to be responsible for an economic burden of up to USD 210 billi

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The introduction of personalized medicine has brought about a paradigm shift within the healthcare sector. Over the years, many cases have been identified where conventional treatment options have failed to demonstrate any therapeutic benefit. It is estimated that nearly 50% of prescribed drugs / therapies fail to show adequate clinical benefits. In fact, adverse drug-related reactions / side effects are reported to be the fourth leading cause of death in the US.  To mitigate challenges ass

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Over the years, the biopharmaceutical market has grown into a prominent and promising segment of the overall pharmaceutical industry. Characterized by a number of blockbuster therapies (Humira,  Rituxan,  Lantus,  Avastin,  Herceptin  and Remicade ) and a robust pipeline of product / therapy candidates, the market is poised for significant growth in the coming years. It is worth mentioning that much of the anticipated success of the biopharmaceutical market is dependent

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Chronic disorders, such as diabetes, cancer, heart disease, obesity, and certain types of mental health problems, are considered among the leading causes of death and disability across the globe. According to a report published by the Center for Managing Chronic Disease at the University of Michigan in 2018, more than 50% of the global population lives with some form of chronic illness. In 2018, the global prevalence of diabetes (considered to be one of the fastest-growing clinical conditions) w

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According to a study conducted by the International Osteoporosis Foundation (IOF), more than 200 million individuals around the world suffer from osteoporosis. In fact, a total of 8.9 million fractures per year are attributed to osteoporosis, implying that an osteoporotic fracture (of the hip, knee, spine, shoulder, or wrist) occurs after every three seconds. The annual socioeconomic burden associated with this condition is estimated to be around USD 19 billion and EUR 37 billion, in the US and

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Alzheimer’s disease is a neurodegenerative condition characterized by progressive memory loss, cognitive dysfunction anddementia. Currently, it is the most commonly reported neurodegenerative disorder across the world, and the sixth leading cause of death in the US. It was estimated that, in 2018, nearly 5.7 million Americans (considering all age groups) were living with Alzheimer’s disease. During the same year, Alzheimer’s disease and other dementias were projected

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Cardiovascular disorders and metabolic disorders are considered to be amongst the leading causes of death worldwide. In fact, approximately one-third of the annual number of deaths across the globe are attributed to cardiovascular disorders.  In the US, the annual economic burden associated with these disorders is estimated to be over USD 500 billion. According to a study conducted by RTI International for the American Heart Association, the prevalence of cardiovascular diseases is expected

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[COVID-19 SERIES] Clinical trials represent an arduous step in the drug development process and are crucial to understanding the safety and efficacy profiles of novel therapeutic interventions. As these trials are prone to delays, and can even fail altogether, they impose an immense financial pressure on sponsors. Amongst several known challenges, patient recruitment is considered to be one of the rate limiting steps when it comes to getting drugs to the market. It is estimated that 80% of clini

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For more than five decades, contact lenses have primarily been used to correct vision-related disorders. The existence of several unmet needs in the field of ophthalmology, recent technological advances and the availability of new biomaterials, have substantially expanded the range of potential application areas for contact lenses. It is estimated that close to 2.4 million eye injuries occur every year in the US. In order to cater to this demand, a myriad of therapeutic contact lenses have been

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Given their high target specificity and limited toxicity compared to small molecule drugs, biotherapeutics have revolutionized treatment paradigms across a myriad of clinical conditions, including metabolic disorders, cancers, neurological disorders and autoimmune disorders. In fact, the extent of growth of such therapies can be gauged from the fact that more than 300 biopharmaceuticals have been approved between 2002 and 2018. In 2018, over 15 biological license applications (BLA) received

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The early stages of drug discovery research, which include the identification of a relevant biological target and a viable lead compound with therapeutic potential, play a crucial role in the overall success of a drug candidate in both preclinical and clinical studies. It is also important to note that the process of drug discovery is extremely demanding, both in terms of capital and time. In fact, the overall amount spent in R&D initiatives in the pharmaceutical / biotechnology sector has i

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Chronic kidney disease (CKD) is characterized by progressive loss of kidney function over a period of time. In most patients suffering from CKD, symptoms (such as swollen ankles, blood in urine and foamy urine) are rarely observed until kidney function has declined by 75%. It is worth highlighting that over 90% of the patients suffering from reduced kidney function are unaware of their medical condition.In the US, 15% of adults are reported to be suffering from mild or severe forms of CKD.In fac

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The success of the Human Genome Project resulted in the generation of large volumes of genomic data, which is extensively used in biotechnology and medical research. Further, advancements in high throughput gene sequencing technologies have enabled scientists to expedite the genome sequencing process, and achieve significant cost benefits as well. In fact, it is estimated that, by 2025, around 15% of the world’s population will have had their genomes sequenced, resulting in the generation

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Poor adherence to prescribed medications is a growing concern in the healthcare industry and is believed to be associated with negative health outcomes, inflated medical expenses, loss in productivity and, in certain cases, proves fatal as well. It has been estimated that, of the ~4 billion annual prescriptions filled by the retailers in the US, approximately 50% are not taken by patients in accordance to physicians’ instructions. According to the US Centers for Disease Control and Pr

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In the recent past, cell and gene therapies have emerged as promising treatment options for a myriad of complex clinical conditions, including cancers and inherited disorders. Currently, more than 25 such advanced therapy medicinal products are available in the market; examples of recently approved therapies include Alofisel (2018), LUXTURNA™ (2017), YESCARTA™ (2017), Kymriah™ (2017) and INVOSSA™ (2017). In addition, over 500 cell and gene therapy candidates are bein

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The process of developing new and disruptive medical products involves heavy investments, both in terms of time and cost. Estimates suggest that each prescription drug requires an average of about 10 years and over USD 2.5 billion in working capital before it gets commercialized. In order to gain regulatory approval and establish standards for the safety and efficacy of these products, randomized clinical trials (RCTs) are conducted; these account for a staggering 40% of the pharmaceutical indus

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Pharmaceutical packaging plays a key role in ensuring the sterility and quality of a drug product, while providing information related to its identity and, in certain cases, dosing instructions as well. Primary packaging, owing to the fact that it is in direct contact with the drug / therapy, is considered to be critical to the preservation of the product’s stability, efficacy and safety. Further, given the growing complexity of modern pharmacological interventions, especially biologics, i

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The origins of the cold chain for transportation of temperature sensitive products can be traced back to 1797, when British fishermen first used natural ice to preserve their fish stock.Presently, a wide variety of pharmaceutical products, such as biologics, vaccines, human organs for transplantation and certain conventional pharmacological interventions as well, are temperature sensitive and require freezing / cryogenic holding temperatures for transport. In fact, over 95% of all approved biolo

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Harmful chemicals / contaminants from primary packaging have often been shown to migrate into pharmaceutical products, threatening the safety of several patients who use these products. For instance, in 2010, McNeil Consumer Healthcare was compelled to recall more than 500 lots of Tylenol, Motrin, Benadryl and Zyrtec upon being made aware of the presence of an antifungal chemical, called 2, 4, 6-tribromoanisole (which is used to chemically treat shipping pallets), in the aforementioned product f

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Antibody drug conjugates (ADCs) are one of the most popular classes of targeted therapeutic agents and have captured the attention of both large and small pharmaceutical companies, and academic / research institutions across the world. Fundamentally, these complex biotherapeutic entities represent the combination of the target specificity of an antibody and the cytotoxic potential of a chemotherapy drug; such conjugates are believed to be more efficient and effective in specifically identifying

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The National Academy of Medicine indicates that as many as 100 million people in the US suffer from some form of pain, which has been shown to be associated with a socioeconomic burden of around USD 600 billion per year, in treatment costs and lost productivity. Further, it has been estimated that nearly 1 million people in America suffer from Parkinson’s disease, with approximately 60,000 new patients being diagnosed every year.Over the past few decades, the prevalence of such chronic dis

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Chronic pain refers to the psychophysiological response to an underlying clinical condition, which is observed to persist for a duration greater than six months and is generally unresponsive to multiple treatment regimens. It is estimated that more than 1.5 billion individuals across the world suffer from this type of pain. Some of the most common physiological conditions that are characterized by a chronic sensation of pain include migraine, lower back pain, pain associated with cancer, arthrit

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Amidst the current initiatives to develop more targeted anti-cancer therapies, chimeric antigen receptor T-cell (CAR-T) therapy has emerged as a potent and viable therapeutic intervention to eradicate tumor cells, with minimal side effects. It is based on the principle of harnessing the innate potential of the immune system to target and destroy diseased cells. There are certain key characteristics that render CAR-T cells suitable for use as effective therapeutic tools; these include target spec

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Cell-based therapies have gained significant attention in the overall biopharmaceutical industry. The personalized nature of these treatment options render them highly specific and, according to a number of clinical studies, safe and efficacious. Such therapies are considered to possess the potential to address various unmet medical needs associated with the treatment of several types of physiological disorders and clinical conditions. A number of pharmaceutical companies and investors have alre

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The early stages of research related to drug discovery, including the identification of a relevant biological target and a viable lead compound, play a crucial role in the overall success of a drug candidate in preclinical and clinical studies. It is also worth noting that the process of drug discovery is extremely demanding, both in terms of capital requirements and time. Moreover, there is always a high risk of failure associated with R&D programs and, considering the increasing regulatory

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Biologics constitute a majority of the top selling drugs of today and also represent one of the fastest growing segments of the overall pharmaceutical industry. In fact, the share of biologics in the overall pharmaceutical market has increased from 16% in 2006 to over 25% in 2017.Having reported over 70% increase in revenues over the past 5-6 years, the market for biologically derived products is currently estimated to be worth more than USD 200 billion.Despite their clinical and commercial succ

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Parkinson’s disease is a chronic disorder that gradually leads to progressive deterioration of motor functions due to loss of dopamine-producing brain cells. It is presently the second most common neurodegenerative disease (after Alzheimer’s disease) and is characterized by symptoms such as shaking, rigidity, difficulty in walking / movement, and several other cognitive and behavioral problems. Parkinson’s disease is known to affect 1-2 per 1,000 individuals and has been shown

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Over the years, the self-injection devices market has grown into a promising segment of the pharmaceutical industry. The domain is presently characterized by the presence of advanced technology platforms and innovative devices, offering a variety of user-friendly drug delivery solutions. One of the major driving forces behind the growth in this field is the rising incidence of chronic clinical conditions, such as rheumatoid arthritis, multiple sclerosis and diabetes. Although various pharmacolog

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Cancer therapeutics continues to be one of the most active segments, in terms of drug development efforts, within the pharmaceutical industry. In fact, in the past five years, USFDA has approved more than 70 drugs for the treatment of different types of cancer. However, there is still a pressing need to develop more specific and potent therapeutics to combat this complex, life threatening clinical condition. According to the National Institutes of Health, the economic burden of cancer care in th

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Batteries are considered amongst the most remarkable man-made inventions in history and have been the focus of intense investigation by both scientists and engineers across the globe. Evolving from the primitive Voltaic Pile (the first electrical battery created in 1799), which used zinc and copper electrodes and brine-soaked paper as an electrolyte, a wide range of batteries are now available in the market. Amongst these, lithium-ion (Li-ion) batteries have long been considered a breakthrough i

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The origins of spray drying can be traced back to 1872, when the first patent related to the technique was registered in the US. The first commercial use of this form of drying was reported in the 1920s when powdered milk was introduced into the market. Spray drying, which is already established in the food and chemical sector, is also considered to be a rapid, cost-effective, and scalable process for the production of dry powder formulations of pharmacological material. Owing to characteristics

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Genetically modified therapies have emerged as a promising treatment option for various diseases (primarily ones that currently have no cure), including cancers, inherited disorders and certain viral infections. These therapies have demonstrated the potential to treat chronic indications, such as Alzheimer’s disease, Parkinson’s disease and rheumatoid arthritis, as well. Gene therapies, and other therapies that require genetic modification, involve the introduction of therapeutic DNA

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  Cancer is known to be one of the leading causes of death worldwide, accounting for 0.6 million deaths in 2017 in the US alone. The World Health Organization states that the number of new cancer cases globally is expected to rise by 70% in the coming 20 years. Although cancer therapeutics continue to be one of the most active areas in terms of drug development, there is still a significant unmet need in this domain. Conventional cancer treatments, such as chemotherapy, surgery and radia

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Protein and peptide-based therapeutics have been in use for more than three decades since the approval of recombinant human insulin, the first protein therapy, in 1982. Earlier, most biologic drugs were delivered through the subcutaneous route. However, over time, advances in delivery formulations have enabled the development of orally administrable versions of therapeutic proteins / peptides. Owing to numerous compelling reasons, the concept of oral delivery has gained significant traction. The

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The present pipeline of pharmaceutical products is increasingly complex and requires specialized facilities, equipment and operational expertise. Small molecule drugs account for nearly 90% of the therapeutics in the pharmaceutical market. In fact, in 2017, FDA’s Center for Drug Evaluation and Research approved 34 small molecule drugs; this represents an annual growth of nearly 56%, signifying the growing importance of contract manufacturing in the overall pharmaceutical industry. The cost

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The concept of gene transfer into mammalian cells can be traced back to the 1920s. However, the first gene therapy, Gendicine® , was only approved in 2003 in China; since then, the domain has evolved significantly. The year 2017 was particularly eventful; despite the withdrawal of Glybera from the European market in early 2017, the latter half of the year witnessed the approval of two gene therapies, namely Invossa™ and Luxturna™. In fact, Luxturna™ became the first gene th

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With growing electricity consumption, the peak electricity demand is expected to increase manifold by 2050. It is believed that, owing to their intelligence features, smart grids have the potential to reduce the projected peak demand increases by up to 24% across some of the major regions of the world. This is because sensors in smart grids can detect peak load in advance and divert surplus supply from low demand areas to meet the peak requirements in a particular region.Moreover, with countries

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According to the Forum of International Respiratory Societies, around 4 million individuals die each year due to chronic respiratory diseases. The World Health Organization (WHO) estimates the global prevalence of two of the most common chronic respiratory diseases, namely asthma and chronic obstructive pulmonary disease (COPD), to be around 335 million and 400 million patients respectively. Specifically, COPD is currently known to be the fourth leading cause of death worldwide. According to the

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The digital revolution has transformed the way businesses operate across the globe. However, digitally stored information is prone to hacking and manipulation by cyber criminals. The concern is validated by the fact that more than 5.1 million records are compromised due to data breaches every day. In 2016, close to 1,800 incidents of data breaches were reported across all the industries; in total, almost 1.4 billion data records were lost or stolen. The year 2017 also witnessed several cyberatta

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According to the World Health Organization, close to 250 million individuals, including 36 million blind people, presently suffer from some form of vision impairment. Further, a recent study published in September 2017 estimates that the number of blind people is likely to increase to 38.5 million, by 2020, and to 115 million, by 2050. Current projections also indicate that, in the US alone, the total economic burden related to vision loss is expected to reach approximately USD 715 billion by 20

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Cancer stem cells (CSCs) are known to be rare, immortal cells within a tumor that can both self-renew and differentiate into several cell types that form the tumor mass. Over time, the development of CSCs has been shown to be associated with several signaling pathways, which regulate the survival and proliferation of these cells. Presently, a number of initiatives are underway to explore specific targets that can be used to selectively eliminate cancer stem cells and, thereby, confer therapeutic

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3D printing has garnered significant attention within the healthcare industry. The concept of 3D bioprinting was conceived in the late 1990s; since then, various industry stakeholders and academicians have undertaken several initiatives in order to further develop / improve this technology for a variety of applications. Organovo was the first company to enter the 3D bioprinting space by printing functional blood vessels in 2010. The company now offers 3D printed kidney and liver tissue models. T

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Monoclonal antibodies have been in use for more than two decades. The first product candidate was launched in 1986; since then, they have been used for the treatment of a myriad of diseases, including cancer, inflammatory diseases and infectious diseases. However, despite their clinical and commercial successes, these therapies are known to have certain drawbacks that have had an impact on their overall efficacy, thereby, limiting their therapeutic potential. These drawbacks are related to their

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Since the first approval of MYLOTARG™ in 2000 and its subsequent withdrawal in the year 2010, the ADC market has evolved considerably. In the last seven years, the market has witnessed an increasing interest from drug developers and healthcare investors alike. Post the commercialization of ADCETRIS® in 2011 and KADCYLA® in 2013, there was a temporary, but evident, decline in the popularity of ADCs. This was attributed to the fact that no new ADC candidates were approved after 2013

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Cross contamination and cell line misidentification are some of the major concerns associated with the use of cell lines. According to published literature, cell lines used for scientific experiments are either misidentified or contaminated in approximately 15-25% cases. The use of such cell lines yields unreliable and irreproducible results, and leads to significant delays in research time lines and financial losses. The detrimental impact of using incorrect / misidentified cell lines poses a s

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The business strategies and operational processes in the pharmaceutical industry have regularly evolved over time. Over the past few years, there has been an increased pressure on drug manufacturers to optimize drug development costs and speed up the drug development process. Specifically, with the rise of personalized therapies and orphan drugs, manufacturers are now expected to produce significantly low volumes of a wide range of drugs owing to the patient specific nature of such therapies. In

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A number of research efforts in drug discovery are being directed towards the introduction of in vitro testing models that replicate the in vivo microenvironment and provide physiologically relevant insights. Cell culture monolayers or 2D cell cultures are known to harbor differences in morphology, growth rate, function, viability and the overall behavior, as compared to those in natural environment. However, it has been realized that 3D cell cultures facilitate cell interaction with the surroun

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A number of monoclonal antibodies (more than 70) have already been approved for use in humans. These therapeutic products, which target a particular epitope on an antigen, have become a popular and robust treatment option for various diseases. However, despite the success of antibody therapeutics, there are several limitations associated with the use of mono-specific antibodies. It has been reported that certain patients treated using these therapeutic modalities have failed to respond, or have

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First discovered in 1975, monoclonal antibodies are considered to be one of the fastest growing therapy segments in the biopharmaceutical industry. In the year 2016, Humira, a monoclonal antibody, generated revenues worth more than USD 16 billion to become the highest selling drug. With a strong development pipeline and high clinical success rate, the market continues to witness increasing adoption of antibody based therapies and products. The growing industry has faced / continues to face se

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Microbiome therapeutics represent a new frontier in the field of medicine. The human microbiome is characterized by more than 100 trillion commensal, symbiotic and pathogenic microorganisms that colonize the gut, mouth, skin and various other parts of the body. Majority of these microorganisms benefit humans by supplementing them with traits that they do not otherwise possess; these include the capability to metabolize complex carbohydrates and prevention of growth of pathogens. However, some of

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The growing pipeline of biological drugs has resulted in a continuous increase in the demand for different types of cell lines. More than 650 biologics have been approved till date, and over 1,500 are under clinical development. Additionally, the loss of patent exclusivity of several biologics in the coming years is likely to be followed by the entry of numerous biosimilars as many companies compete to grab a share of already established drug markets. The importance of cell lines in other areas,

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The renewable energy industry has witnessed an unprecedented growth in the last few years, owing to the increasing energy demand and concerted efforts to prevent environmental damage. Factors, such as increasing population, advances in technology, rapid industrialization in emerging markets (such as China and India), rising standard of living, and globalization are driving the global demand. In fact, the global economy is predicted to grow three folds between now and 2050; this is anticipated to

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The early stages of research related to drug discovery, including the identification of a relevant target and a viable lead compound, play a crucial role in the overall success of a drug in preclinical and / or clinical studies. The process of drug discovery is extremely demanding, both in terms of capital expenses and time. Moreover, there is always a high risk of failure associated with R&D programs and, given the increasing regulatory stringency, the approval of new drugs has become signi

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The rising demand of personalized medicines to provide targeted treatment options has encouraged pharmaceutical companies to shift their focus from small molecules to discovery and development of biologics, particularly antibody based therapeutics. Antibodies, because of several advantages such as high specificity and targeted approach, are increasingly becoming crucial for the treatment of a number of diseases. In fact, since 2015, more than 20 antibodies have been approved by the USFDA. The gr

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It has been estimated that close to 131 million babies are born each year across the globe. Of these, approximately 7.9 million are born with birth defects. In fact, more than 7,000 genetic disorders have been identified so far and the number is rising.Genetic testing solutions that enable early detection of genetic abnormalities in fetuses and newborns are important to ensure that the person does not face complications later in life. With the emergence of innovative diagnostic and screening tec

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Over the years, the biopharmaceutical market has grown into a prominent and promising segment of the overall pharmaceutical industry. Characterized by a number of blockbuster therapies (HUMIRA, RITUXAN, Lantus, Avastin, Herceptin and REMICADE) and a robust pipeline of product / therapy candidates, the market is poised for significant growth in the coming years. It is worth mentioning that much of the anticipated success of the biopharmaceutical market is dependent on new biologics, which ar

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Cancer is an extremely complex disease and medical science is still struggling to figure out the reasons and factors that influence the disease origin, propagation, spread (metastasis) and relapse. In 2017, a total of 1.7 million new cancer cases are estimated to be diagnosed in the US alone; during the same time period, close to 0.6 million patients are estimated to die due to cancer. The high cancer mortality rate is primarily due to delay in detection of the disease. Therefore, in addition to

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It is predicted that the global economy will increase by three-folds between now and 2050. This, in turn, is likely to result in increased energy demands.According to Enerdata Energy Statistical Yearbook 2016, electricity demand has more than doubled between 1990 and 2015 to reach 20,568 TWh. This demand is projected to grow even further; in fact, by 2035, the growth is expected to be in the range of 69% to 81%. As the global economy aims for energy security, renewable energy sources such as sol

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Cancer metabolism is based on the principle that cancer cells, as compared to normal cells, have different metabolic activities in order to support their enhanced energy and anabolic requirements. The pioneering discovery by Otto Warburg in the middle of the 20th century led to the observation that metabolic activity in tumor tissues leads to a ten-fold increase in production of lactate (from glucose) under aerobic conditions. This revelation generated a significant interest and led industry sta

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The number of biopharmaceuticals being developed and manufactured has increased significantly in recent years. This is evident from the fact that over 10 novel biologics have been approved annually by FDA over the last three years; this represents around 30% of the total novel drugs approved during this time period. Currently, more than 50% of the drugs in clinical pipeline comprise of biologics. It is worth highlighting that most of these products are not stable as aqueous formulations, making

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B-cell maturation antigen (BCMA), an important biomarker of the B-cells, has emerged as a promising therapeutic target for the treatment of multiple myeloma and other hematological malignancies. The antigen is universally expressed on the surface of multiple myeloma cells. The research focus shifted towards BCMA targeted therapies in 2004, when the role of BCMA was first indicated in the progression of multiple myeloma. It is the second most common type (13%) of all hematological malignancies. T

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The use of live cells for therapeutic purposes can be traced back to 1968, when patients were first successfully treated with allogeneic human hematopoietic stem cell transplants. This practice has now become an integral part of clinical procedures in the space of bone marrow regeneration and organ transplantation. Cell-based therapies are an emerging segment of the overall biopharmaceutical industry. Post the approval of first cell-based therapy, Carticel, in 1997 in the US, the field has rapid

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Deep learning is a novel machine learning technique that can be used to generate relevant insights from large volumes of data. The term Deep Learning was coined in 2006 by Geoffrey Hinton to refer to algorithms that enable computers to analyze objects and text in videos and images. Fundamentally, deep learning algorithms are designed to analyze and use large volumes of data to improve the capabilities of machines. Companies, such as Google, Amazon, Facebook, LinkedIn, IBM and Netflix, are alread

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Drug delivery systems optimized to provide flexibility in dosing regimen, reduce the number of hospital visits, decrease dependence on healthcare professionals and enhance adherence to the therapeutic regimen have become the preferred choice of drug administration. The large scale adoption of prefilled syringes, the first ready-to-use injection device to be marketed, demonstrated the growing interest in the concept of such convenient drug delivery systems. In addition, several pen-injectors and

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Lupus is a serious, potentially fatal, autoimmune disease that attacks healthy tissue. The different types of the disease covered in the tracker include systemic lupus erythematosus (SLE), discoid lupus erythematosus (DLE), cutaneous lupus erythematosus (CLE), lupus nephritis and lupus vulgaris. Several drugs, including anti-inflammatory drugs (aspirin and acetaminophen), non-steroidal anti-inflammatory drugs (NSAIDs) (ibuprofen, naproxen, indomethacin, nabumetone and celecoxib), corticostero

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The concept of immunotherapies dates back to the 18th century; however, since inception, the field has evolved tremendously and is currently cited as one of the most rapidly growing segments of the pharmaceutical industry. Harnessing immune system components for developing therapeutic solutions has demonstrated significant clinical benefit for various diseases areas, specifically against a number of oncological indications. Immunotherapeutics have gradually gained a strong foothold in the pharma

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Injectable drug delivery systems have traversed a long way from conventional syringes with vials to prefilled syringes, autoinjectors, pen injectors and needle free systems. These modern devices have become preferred devices for parenteral administration of drugs. Specifically, the demand for prefilled syringes has been rising strongly over the past several years. A growing number of healthcare facilities are now adopting this format for delivering drugs. The popularity of prefilled syringes is

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Rheumatoid Arthritis (RA) is an autoimmune, inflammatory disorder wherein various components of the immune system begin to attack the body’s own cells and tissues. The disease is characterized by pain and swelling in and around the joints. It is a systemic disease and is known to affect several joints at the same time or different joints at different times. Hence, it is also termed as migratory or flitting polyarthritis. It has been estimated that RA affects over 1% of the world population

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Since the discovery of penicillin in 1948, antibiotics have emerged as a crucial class of pharmacological interventions responsible for treating several infectious conditions. In addition, antibiotics are also used for prophylactic purposes in patients who have undergone surgery, or immunocompromised patients (cancer patients undergoing chemotherapy). However, the inappropriate use of antibiotics, both in healthcare and food production, has rapidly accelerated an evolutionary response of antibio

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The ubiquitin proteasome system (UPS) is one of the key protein degradation pathway involved in the control of protein homeostasis and turnover that mediates the regulation of several cellular processes. The UPS consists of two separate consecutive steps, ubiquitination and proteasomal degradation. Due to its involvement in multiple metabolic and regulatory functions, the UPS is considered as a vital part of the cellular machinery controlling protein homeostasis. Targeting specific components of

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The discovery of the second messengers, cAMP and cGMP, in 1958 led to a deeper understanding of the signal transduction processes behind physiological stimulation and response. Later, the identification of phosphodiesterases (PDEs) and the establishment of their role in diseases led to the development of drugs targeting this class of enzymes. PDEs are a complex superfamily of metallophosphohydrolase enzymes that regulate the activity of second messengers. The superfamily consists of 11 different

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Gene therapy has emerged as a promising treatment option for various diseases (primarily the ones that currently have no cure) including cancers, inherited disorders and some viral infections. Gene therapies and genetically modified therapies involve the introduction of therapeutic DNA (gene of interest) into the patient’s body. There have been a number of successful trials in several systems showing the efficient transfer and expression of a variety of human genes into target cells. This

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Cancer is an extremely complex disease and medical science is still trying to understand the numerous factors responsible for its origin, propagation, spread (metastasis) and relapse. In 2016, an estimated 1.7 million new cancer cases were reported in the US alone. Furthermore, as projected by the World Health Organization (WHO), the annual incidence of cancer worldwide is expected to rise to 24 million by 2035. Currently, there is a huge unmet need for advanced and efficient treatment intervent

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Owing to the indispensable need of every individual to remain healthy, the healthcare sector has been a key element in the overall growth of society and economy. With the ever increasing global population that currently stands at 7.4 billion, healthcare management is a primary challenge as more and more people become aware about fitness and health. In order to address this challenge, the industry is obligated to revise, restructure and improve its services and methodologies. The trend has recent

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An imbalance in the production and / or drainage of aqueous humor within the eye is known to lead to an increase in intraocular pressure (IOP). Acutely elevated IOP, a condition broadly known as ocular hypertension, may either lead to the expulsion of ocular contents through a traumatic opening or result in a number of clinical conditions / disorders including glaucoma. Currently available treatment options include ocular hypotensive medications, laser therapy and surgical interventions. However

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Epigenetics is defined as a heritable change in the gene expression and its activity without alteration in the DNA sequence. The different epigenetic mechanisms through which gene expression can be modulated primarily include histone modification, DNA methylation, alteration of chromatin architecture and involvement of small-interfering or non-coding RNAs. Enzymes such as histone acetyltransferases (HATs), histone methyltransferases (HMTs), histone deacetylases (HDACs) and histone demethylases (

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Diabetes, considered to be the most common metabolic disorder in humans, is ranked among the top ten fatal diseases in the US. The increasing incidence, growing prevalence and the progressive nature of the disease has spurred several pharmaceutical companies to develop novel approaches / therapies to provide better treatment options for diabetic patients worldwide. While insulin supplements and insulin based therapies represent a major portion of the anti-diabetic drugs market, non-insulin thera

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Oncology market, for decades, has been pillared on three areas: Surgery, Radiation Therapy and Chemotherapy. Immuno-oncology, especially immune checkpoint inhibitors, has recently gained traction from several stakeholders. Immune checkpoints are molecules that regulate (stimulate or inactivate) the immune cells. Yervoy (an anti CTLA-4 inhibitor) was the first immune checkpoint inhibitor that was made commercially available in 2011 for treatment of patients suffering from unresectable or metastat

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After years of research tracing back to the 18th century, a gamut of novel therapies namely, CAR-T, TCR and TIL therapies, have finally reached a point of maturity. These promising therapeutic strategies, developed under the banner of T-cell immunotherapies, are set to hit the market in the near future.T-cells, also named as the soldiers of the immune system, are featured with specificity and functionally combat infections, cancerous cells and other foreign entities. High therapeutic potential a

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Vaccines have always been viewed as a low-margin business characterized by high entry barriers. Developmental and production related complexities, combined with significant fixed costs and stringent regulatory standards,have limited competition among vaccine manufacturers. In addition, these complexities have also restricted innovation in this space to a great extent. However, recent advances in biotechnology and biomanufacturing have resulted in the development of advanced technologies capable

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As defined by the National Nanotechnology Initiative, nanotechnology is the branch of science that deals with materials smaller than 100 nanometers. Nanomedicines are nano-sized particles that help in the diagnosis, treatment and monitoring of therapeutic agents. The discovery of several nanocarriers such as polymers, proteins, micelles, dendrimers, liposomes, emulsions, nanoparticles, each with a unique structure, has provided the drug developers with options to improve the pharmacokinetics and

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DNA is the repository of genetic information in all living cells. Genomic integrity and stability are amongst the key considerations for effective and coordinated biological function. However, DNA is not inert. Cells are continuously exposed to several endogenous and exogenous insults that often cause DNA damage. Despite its role in cellular signalling, ROS, a by-product of mitochondrial respiration, is known to cause severe oxidative DNA damage. Lesions in genomic DNA may also be caused by hydr

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With the rising trend towards self-injection devices and rapidly growing pipeline of the biologics / biosimilars, autoinjectors have recently emerged as an important class of medical devices. Compared to conventional delivery systems, these devices automate the process of delivering drugs through subcutaneous or intramuscular routes. Autoinjectors are primarily spring-driven systems and use fillable / prefilled syringes or cartridges as primary containers. Due to their numerous benefits includin

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Developed through introduction of modifications in monoclonal antibodies (mAbs), antibody based therapeutics are gaining increased attention from both large and small pharmaceutical companies. The Y-arm of the antibody is known as Fab, comprising a constant and a variable domain from each light and heavy chain. The variable domain (Fv) within the Fab region is responsible for target specificity and binding affinity whereas the base of the antibody, known as the fragment crystallizable (Fc) regio

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The human immune system is comprised of a number of different types of specialized molecules and cells that are involved in complex interactions and activities to facilitate an immune response. Immunotherapies exploit the body's innate potential to specifically target a particular molecular antigen and mount an efficient immune response against the cells bearing the diseased signature. Currently, four major types of immunotherapies (classified by product class) targeting the CD19 antigen are

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Bispecific antibodies (bsAbs) are artificial antibodies created by joining together two monoclonal antibodies (or parts) that target different epitopes.The resulting antibody has binding affinities for two or three different epitopes concurrently. Various technology platforms have been used for bsAbs production over the years. These platforms are based on the concepts of chemical crosslinking, hybrid hybridomas, with the latest being recombinant techniques. Different binding sites can be expl

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With the rising demand for targeted therapies, high potency compounds such as high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become the key focus of researchers and manufacturers worldwide. HPAPIs, which include cytotoxic APIs, are drug substances that are formulated to manufacture high potency drug products. Cytotoxic drugs are a category of highly potent drug products and, due to their increased utility in the treatment of cancer indications, have gained wide

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The biopharmaceutical industry has been witnessing a significant paradigm shift in R&D outsourcing over the last few years. Specialty CROs have emerged as credible players in the market to overcome the shortcomings of full service / traditional CROs. Often, these full service providers offer a wider portfolio of services but fail to align their efforts to meet the requirements of sponsors, primarily the smaller biotech organisations / start-ups. Specialty CROs, on the other hand, specialize

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Peptide therapeutics, due to their numerous advantages such as high selectivity, stability, efficacy, safety, bioavailability and tolerability offer a number of benefits over other therapeutic classes. In addition, peptides (when compared to proteins) are much smaller in size and can be easily synthesized, optimized and evaluated as viable therapeutic solutions for a number of diseases. These highly favourable and intrinsic characteristics of peptides have caused an evident shift in the interest

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The term “microbiota” refers to specific clusters of commensal, symbiotic and pathogenic microorganisms that reside in various regions on and within the human body. The human microbiome is involved in various functions that are essential to lead a healthy life. Majority of the microorganisms benefit humans by supplementing them with traits that they would otherwise not possess. These include metabolism of complex carbohydrates, renewal of gut epithelial cells and prevention of growth

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The ADC market is being driven by the sales of ADCETRIS® and KADCYLA®, the only two commercially available drugs. It is a relatively new concept with respect to technology, although the individual molecules that form ADCs have been used since long. This new class of therapeutics has witnessed a strong acceptance from both big and small pharmaceutical companies as they try to fill gaps in their respective oncology pipelines. There has been a healthy growth in the number of pipeline molecu

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Discovered less than two decades ago, RNAi has made its presence felt in all spheres of the pharmaceutical industry. RNAi is a natural post-transcriptional process of gene silencing involving short strands of nucleic acids. It is a regulatory process that cells utilise to silence and/or inhibit gene expression through the destruction of specific mRNA molecules. One of the major advantages of RNAi is that it enables sequence specific knockdown of a target gene. Indications, such as age-related ma

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Infusion pumps are a class of drug delivery devices that have found wide adoption across different application areas. Their popularity can be attributed to their reliable, user friendly features and ergonomic design. The market has a wide array of different types of infusion pumps (volumetric, syringe, implantable, elastomeric, ambulatory and others); combined, they offer a large range of infusion volume, flow rate, occlusion alarm pressure range and many other technical parameters that can be a

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Biopharmaceuticals is currently one of the fastest growing segments in the pharmaceutical industry. They have a vital use in the treatment of chronic diseases and also result in high profit margins for the drug developers. There are several therapeutic areas for which biopharmaceuticals are being investigated; these include oncology, metabolic disorders, viral infections, genetic disorders and immunological disorders. Biotherapeutics (both approved and under investigation) include monoclonal ant

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Cancer is an extremely complex disease and medical science is still struggling to figure out the reasons and factors influencing the disease origin, propagation, spread (metastasis) and relapse. In addition to satisfying the unmet market need for advanced and efficient treatment interventions, cancer prevention, early detection and management is extremely important. The high cancer mortality rate is primarily due to delay in detection of the disease.Early diagnosis and screening makes it possibl

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WHO has stated that the number of new cancer cases is expected to rise by 70% in the coming two decades. In the US alone, over one million people are diagnosed with cancer each year. Although cancer therapeutics continues to be one of the most active areas in terms of drug development, there is still a significant unmet need. Specifically, immuno-oncology has been gradually nurtured by researchers over the last several years. Post an evident shift towards the development of therapeutics targetin

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NASH or Non-Alcoholic Steatohepatitis refers to a chronic liver disorder characterized by accretion of fat (lipid droplets), along with inflammation and degeneration of hepatocytes. In other words, it can be defined as significant steatohepatitis not caused due to alcohol, drugs, toxins, infectious agents or other identifiable exogenous causes. NASH is often accompanied with a high possibility of cirrhosis, a condition in which the liver functions are changed, leading to liver insufficiency. Alt

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Advances in genetic engineering and cloning techniques have allowed isolation and expression of heterologous and recombinant proteins for research, therapeutic and industrial uses. Large scale applications such as enzyme, antibody or vaccine production require high amounts of protein. This demands that the system producing protein must be easy to culture, allow rapid cell growth and provide good yield. Various expression systems based on the machinery of bacteria, yeast, insect or mammalian cell

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Antibody Drug Conjugates (ADCs) are a new class of therapeutic drugs consisting of a cytotoxic drug linked to a monoclonal antibody. These novel conjugates are believed to be very effective and efficient in treatment of a disease. However, manufacturing such highly potent toxic molecules is accompanied with several known and unknown challenges. In-house manufacturing of ADCs is rare primarily because of the complex nature of these molecules. Their manufacturing requires both clean room biolog

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Characterised by increased utility in chronic diseases and capital intensive manufacturing, the global biopharmaceutical market is expanding robustly. As the demand for biologics is increasing continuously, manufacturers are on the lookout for novel strategies that will help them attain maximum returns on investment.Derived from biological elements, biologic medications have transformed the treatment paradigm of life threatening, debilitating diseases. However, such drugs come at staggering pric

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Cancer is known to be one of the leading causes of death worldwide. The field of oncology is vast and comprises several indications, including some rare / orphan forms. Although oncology continues to be one of the most active areas in terms of drug development, there is still a significant unmet need. The focus of drug developers is gradually moving towards immunotherapeutics, which make use of the body’s own immune system or its components to fight cancer. It is a relatively new concept,

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The problem of counterfeit products has been a common challenge to all the industries across the globe. However, when it comes to the pharmaceutical industry, the issue primarily revolves around the health of patients rather than revenue losses in the industry. Counterfeit drugs create substantial public health hazards and cause crucial safety concerns. Falsified or substandard drugs can lead to adverse reactions / side effects and consequently lead to the death of a patient. The major challe

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Injectable drug delivery systems have traversed a long way from conventional syringes with vials to prefilled syringes, auto-injectors, pen injectors and needle free systems. These modern devices have become preferred devices for parenteral administration of drugs, mainly used for treatment of chronic conditions requiring patients to self-administer medication several times a week. The origins of prefilled syringes can be traced back to early 1980s when Sanofi and Rhone Poulenc-Rorer (Sanofi-

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The concept of growing tissues outside their natural system in an artificially created microenvironment is known as tissue culturing. It is a common tool for developing model systems that are useful for studying the basic human molecular and cell biology metabolisms. Cell culturing was first initiated in flat plastic or glass dishes as 2D cell culturing. Since then, all the tissue engineering, stem cell, molecular biology work is being carried out on the widely popular petri dishes. However, the

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Given the intricacy of the anatomy and physiology of the eye, it is quite challenging to deliver an ophthalmic drug effectively to a specific ocular site. Several barriers have to be overcome for a successful ocular drug delivery. These include dilution of a drug by tears, clearance of a drug by the lymphatic system of conjunctiva and drug permeation issues with respect to the cornea, sclera and choroid. Approximately 95% of the drug, in topical eye drops, is lost due to the aforementioned barri

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Several people across the globe suffer from different neurological disorders. However, the drugs currently available in the market provide only symptomatic relief and do not treat the root cause. This is because of their inability to penetrate across the blood brain barrier (BBB). BBB is a highly selective permeable membrane which allows the entry of only specific molecules, across it, into the brain. The widening gap between the demand of effective treatments and supply of BBB permeable drugs i

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Characterized by a rapidly expanding product pipeline and a capital intensive manufacturing business, the biopharmaceutical market is witnessing a growing trend towards contract manufacturing. In addition to serving as a cost-cutting tool, contract manufacturing provides several other advantages to biopharmaceutical companies including technical expertise, operational efficiency, regulatory support and the ability to focus on core competencies.Spanning multiple operations withinthe wider manufac

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Over decades, the oncology market has been led by surgery, chemotherapy and radiotherapy. The non-specificity of chemotherapy/radiotherapy and limitations of surgery has expanded the focus of many pharmaceutical companies to improve these treatments as well as discover novel cancer therapies with minimum toxic effects. Targeted cancer therapy is an upcoming area gaining strong foothold in the industry and has already become the focus of a number of pharmaceutical companies. Different types of

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The service oriented and dynamic nature of the healthcare industry has led to the discovery of a plethora of treatment options for a wide range of ailments.However, there are certain diseases, termed as rare, that continue to remain untreated and neglected. Rare / orphan diseases, as the name suggests, are those diseases which are relatively infrequent in occurrence. Many orphan diseases are life-threatening and progressive in nature. Absence of potential treatment regimes catering to these dise

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Amongst the increasing financial pressures and the need to reduce cost and improve efficiencies, the pharmaceutical industry has witnessed a paradigm shift from vertically integrated business model to a network of suppliers. As such, contract manufacturing has evolved as one of the integral components of the pharmaceutical market. Started initially as a one-off activity, contract manufacturing has evolved into a dynamic business model; currently most prevalent in manufacturing, outsourcing is st

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Several disorders that arise inside the body are a result of either a direct genetic aberration or a dysfunctional/non-functional protein. The attempt to use nucleic acids to correct or delete the genes causing a particular disease is known as gene therapy. Although gene therapy has not contributed significantly to the global pharmaceutical market yet, it is anticipated to grow at a fast pace over the next decade. Gendicine, developed by SiBiono GeneTech, was the foremost gene therapy that en

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Owing to their complexity and instability, proteins and peptides are mostly injected by intravenous or subcutaneous routes. Amongst the various modes of administration, oral delivery is the more preferred route. Although very convenient, there are many challenges which hinder this route of administration. These include enzymatic and pH-dependent degradation of the amino acid based drugs in the gastrointestinal tract, low epithelial permeability and instability during formation. As a result, prot

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Oral drug delivery technologies form an integral part of the pharmaceutical industry. From the conventional tablets / capsules to modern-day fast disintegrating and rapidly acting tablets / films, the market has come a long way. Lower bioavailability of oral solid drugs, inconvenience of administering injections, inaccurate dosing by liquid formulations have turned the focus of pharmaceutical companies to develop novel oral dosage forms that eliminate several known limitations. In addition, dysp

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Amongst various efforts to ensure efficient drug delivery, subcutaneous administration has emerged as one of the most promising approaches to deliver viscous biologic drugs in a patient friendly format. Owing to its numerous compelling advantages, the concept has gained huge traction in recent years. The flexibility and convenience of subcutaneous administration over other routes of delivery, along with the increasing trend of self-medication, are some of the key factors contributing to the expa

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In today’s pharmaceutical market, many drugs are supplied in powdered formulation because of their lower shelf life in liquid formulation. The drugs are formulated into powdered form by various processes such as lyophilisation or spray drying; these drugs are then reformulated into liquid form by mixing with a suitable diluent at the time of administration. The overall market of drug reconstitution systems is characterised by the presence of around 50 devices (both conventional and novel).

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The concept of bispecific antibodies is increasingly gaining traction in the pharma industry owing to several therapeutic advantages and their potential to address challenges known with the monoclonal antibody based therapies. Bispecific antibodies are artificial antibodies created by joining together two monoclonal antibodies (or parts) that target different epitopes. The resulting antibody has binding affinities for two or three different epitopes concurrently. The market is still in its in

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The focus of drug developers is gradually moving towards immunotherapeutics, which make use of the body’s own immune system or its components to fight cancer. It is a relatively new concept, with the only success being targeted antibody based therapeutics (including monoclonal and conjugated antibodies). These antibody based drugs are passive immunotherapeutics. There has been a surge of interest in other classes of active immunotherapeutics including cell based therapies such as Dendritic

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Cancer is known to be one of the leading causes of death worldwide. The field of oncology is vast and comprises several indications, including some rare / orphan forms. Although oncology continues to be one of the most active areas in terms of drug development, there is still a significant unmet need. The focus of drug developers is gradually moving towards immunotherapeutics, which make use of the body’s own immune system or its components to fight cancer. It is a relatively new concept,

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A significant proportion of the world’s population is suffering from otologic diseases. Absence of any disease modifying drugs is a big unmet need in the market. The current treatment of inner ear diseases is primarily based on counselling, electric and magnetic nerve stimulations. At the same time, there is a growing off-label use of drugs for symptomatic relief. Cochlear implants, brainstem implants and hearing aids are other commonly available options to the patients to overcome hearing

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Transdermal delivery via microneedles is increasingly gaining traction as one of the more promising drug delivery technologies. Microneedles are of a few hundred microns in size, capable of creating transient pores across the skin by penetrating the stratum corneum layer to deliver molecules. These needles are not big enough to reach the nerve-rich regions of the skin; as a result, the drug delivery is perceived as completely painless and devoid of bleeding. Drugs, vaccines, proteins, peptides a

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With increasing awareness about occupational safety and growing concern on the prevention of needlestick injury, safety injection devices have gained increased attention from the manufacturers and healthcare professionals worldwide. The accelerated emergence of regulatory controls over the past few years have further ensured that manufacturers come up with modifications in the product design and integrated safety controls to meet the requirements. Safety injection devices, which include safet

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The injectable drug delivery market holds significant potential for the future. From the conventional syringes with vials and painful needles to the modern-day pre-filled syringes, pen-injectors, needle free injectors and auto-injectors, the market has come a long way. The rising prevalence of chronic diseases is one of the key factors driving the companies to develop systems that allow patients to self-administer drugs. Taking the concept of self-injectors to a new stratum, ‘Large volume

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Worldwide statistics indicate that there is a high cholesterol burden despite the presence of many cholesterol-lowering drugs in the market. Out of all the available options, statins have been ubiquitously prescribed over the last 25 years. Researchers have concluded that reduction of plasma LDL cholesterol (LDLC) is the cornerstone of assessing heart risk. Irrespective of baseline cholesterol concentration, each mmol/L LDLC reduction translates to cardiovascular risk reduction by one-fifth. Alt

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Diabetes is a chronic disease growing at an alarming rate across the globe. Over 382 million people are estimated to be currently suffering from the disease; the number is likely to increase to 592 million by 2035. With a very high prevalence, especially in some regions such as China and India, an increasing proportion of diabetic patients are likely to benefit from more efficient and accurate diagnostic tests in the future. Furthermore, an efficient measurement of the condition can help lowe

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With the rising demand for targeted therapies, high potency compounds such as high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become the key focus of researchers and manufacturers worldwide. HPAPIs, which include cytotoxic APIs, are drug substances that are formulated to manufacture high potency drug products. Cytotoxic drugs are a category of highly potent drug products and, due to their increased utility in the treatment of cancer indications, have gained wide

...read more

Antibody drug conjugates (ADCs) are a new class of therapeutic agents, gaining increasing attention from both large and small pharmaceutical companies. Generally addressed as the marriage of an antibody with a toxic drug / chemotherapy drug, these conjugates are believed to be more efficient and effective in the treatment of a disease. The ADC market is still in its infancy. At present, Adcetris and Kadcyla are the only two marketed drugs. However, there are several ADCs under development, wi

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Prefilled syringes are gaining strong acceptance in the market as drug delivery systems for injectable drugs. They have become a preferred device for parenteral administration of drugs, mainly used for treatment of chronic conditions requiring patients to self-administer medication several times a week. The origins of these syringes can be traced back to early 1980s when Sanofi and Rhone Poulenc-Rorer (Sanofi-Aventis) introduced syringes as drug delivery devices for heparins in Europe. Prefil

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The concept of ‘spray drying’ started in late 19th century in the food and chemical industry. Within pharmaceutical industry, spray drying found its use initially for the production of APIs. The technology has not been used as widely for commercial drug formulations yet. We have come across only limited examples of marketed drugs for which spray drying is used for developing the commercial batches. The future growth in the market will primarily be driven by aseptic spray drying, whic

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With an influx of new technologies and increasing awareness about personalized medicine, the pharmaceutical industry has steadily started to adopt a more customized drug development model. The concept of companion diagnostics holds huge potential for pharma companies as well as medical community. This new approach to medication is expected to transform healthcare by improving treatment outcomes, eliminating adverse reactions and reducing cost and time barriers associated with the conventional me

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Targeted therapeutics is fast emerging as the key focus area in biopharmaceutical industry. Oral targeted therapeutics has attracted many drug developers due to the ease of administration it offers to patients (especially pediatric and geriatric patients). In the case of leukemia, current marketed oral drugs include Gleevec, Tasigna, Sprycel, Bosulif, Imbruvica and Iclusig. The high price of these drugs still remains a major constraint to the market growth. Further, as leukemia accounts for a

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With nearly 300 million dry eye sufferers worldwide, dry eye represents one of the largest ophthalmic indications. It is also known as keratoconjunctivitis sicca. To date, there is no cure for dry eye syndrome, but there are treatments to control its symptoms. The prevalence of dry eye syndrome primarily increases with age, and has an estimated incidence of 15% in persons over the age of 65 years. A greater risk of acquiring dry eye is also experienced by females, with postmenopausal women being

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There is widespread optimism that the single-use bioreactors market is likely to continue its double digit growth in the future. The concept of “single-use technology”, which started in 1970s with the use of vials and pipettes, has emerged rapidly over the last decade. Today, this term surrounds a wide range of primarily plastic disposable technologies that are suitable for a wide variety of scales, from upscale bioprocessing to final formulation and filling. These can be found in va

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Given the intricacy of the anatomy and physiology of the eye, it is quite challenging to deliver an ophthalmic drug effectively to a specific ocular site. Several barriers have to be overcome for successful ocular drug delivery. For example, dilution of a drug by tears, clearance of a drug by the lymphatic system of conjunctiva, drug permeation issues with respect to the cornea, sclera, choroid etc. Accordingly, different drug delivery systems have been devised for controlled release of drugs to

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The 3D printing industry has come a long way over the last many years; the technology has the potential of revolutionising the way things occur currently. Many industries have already benefitted from multiple advancements in this field, resulting in improved and more efficient processes worldwide. A quick look at www.3dprintingchannel.com suggests that 3D printing has multi-faceted dimensions; the technology has recently been used in varied industries such as automotive, medical, business, indus

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The concept of Antibody drug conjugates (ADCs) is simple - a cytotoxic / chemotherapy drug is delivered to the target tissue through linking it with a monoclonal antibody. However, the practical challenge of manufacturing such complex and highly toxic molecules is huge. The multi-component aspect of ADCs deems it necessary to have both biologic and high-potency facilities. Despite the fact that this new class of therapeutic agents is gaining increased attention from both small and large pharm

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The injectable drug delivery market holds significant potential for the future. From the conventional syringes with vials and painful needles to the modern-day pre-filled syringes, pen-injectors, needle free injectors and auto-injectors, the injectable drug delivery devices market has come a long way. Taking the concept of self-injectors to a new stratum, ‘Bolus Injectors’ have surfaced recently. Also known as non-insulin patch pumps, these devices not only offer a range of benefits

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Antibody based therapeutics are the fastest growing segment of the drugs and biologics market. There are 30 approved antibody based therapeutics available in the US and European markets since the launch of first anti-CD3 antibody, Orthoclone Okt3, in 1986. A bispecific antibody is a second generation immunotherapy, an upgraded version of monoclonal antibody improved in structure and functionality. The conjugated artificial antibodies are formed by physically putting together two monoclonal an

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Engineered antibodies are antibody based therapeutics, which are gaining increasing attention from both large and small pharmaceutical companies. Developed through introduction of modifications in monoclonal antibodies, the aim is to develop antibodies with improved efficacy. Research done in the last decade to develop engineered antibodies has yielded a rich knowledge base on how to develop and market these next generation antibodies. These therapeutic antibodies seem to be more promising, w

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Antibody Drug Conjugates (ADC) are a new class of biologic therapeutics. These are complex molecules comprising of an antibody linked to few cytotoxin molecules through linker technology. This class of biologics is attracting the attention of drug developers, with several large and small companies entering the market through collaboration and licensing agreements with technology providers. The ADC market is still in its infancy. So far, three ADCs have received market approval. However, the f

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Prefilled syringes are gaining strong acceptance in the market as drug delivery systems for injectable drugs. They have become a preferred device for parenteral administration of drugs, mainly used for treatment of chronic conditions requiring patients to self-administer medication several times a week. The rising demand for prefilled syringes is driving the manufacturers to introduce improvements in technology related to the material of prefilled syringes, and lubrication technology to reduc

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Targeted therapeutics and companion diagnostics are the pillars of personalised medicine. Personalised medicine is a genome-based therapeutic approach that aims to adopt customised treatment for each individual. It uses aspects of genetic testing for checking potential abnormalities and tailoring the treatment so as to make it as individualised as the disease itself. Targeted drugs have been fast to overshadow the traditional drugs, which favour the concept of one-size-fits-all. This has prim

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Alzheimer’s disease is a neurodegenerative disease of the brain which leads to loss of memory and cognitive functions. With ageing world population, the number of patients suffering from Alzheimer’s disease is expected to increase in the future. There is a huge unmet need in the market owing to lack of effective, disease-modifying drugs. Alzheimer’s treatment is a high risk, high reward market. Drugs currently available in the market have reached maturity; patents of leading

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Neurostimulation devices are gaining acceptance as therapy alternative for certain chronic conditions such as pain. These devices have also found use in management of movement disorders including Parkinson’s disease and epilepsy. The currently available neurostimulators mainly focus on spinal cord stimulation (SCS), deep brain stimulation (DBS), vagus nerve stimulation (VNS) and sacral nerve stimulation (SNS). The market is still niche, with limited number of devices available in the ma

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