Drug Discovery

Biomedical research is an evolutionary process involving a wide array of research experiments focused on studying diseases and their treatment options; biospecimens are credited as critical components of this process, starting from drug development to clinical trials and epidemiological investigations. Further, in the field of precision medicine, biospecimens act as a link between the biology of a patient and the development of customized therapy. However, procurement and storage of a high quali

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It is a well-known fact that development of a novel therapeutic intervention is both a time and cost intensive process. In fact, several reports have indicated that it can take around 10 years for a prescription medicine to transition from the discovery stage to the market, requiring investments worth over USD 2.5 billion. It is worth mentioning that clinical trials form an integral part of the overall drug development process, as they enable both innovators and regulators to assess the safety a

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Small molecule drugs account for nearly 90% of the contemporary therapeutics pipeline. In 2020, the US FDA’s Center for Drug Evaluation and Research approved 35 small molecule drugs, representing 66% of the total number of new molecular entities (NMEs) clearing regulatory review in the same year.  It is worth highlighting that the process of drug development, beginning from the discovery of a pharmacological lead to the commercialization of a clinically validated product, takes around

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Biologics are one of the fastest growing classes of therapeutics in the pharmaceutical industry. However, the development of such large molecule drugs is inherently complex, involving elaborate target selection and validation, hit generation, lead selection / optimization and characterization protocols. Of the aforementioned steps, hit (potential drug candidates against validated biological targets) generation is a highly resource-intensive process. In fact, it is estimated that an average of 18

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Given the various advantages of biologics, such as high specificity for their intended molecular targets, ability to treat a myriad of disease indications, and patient friendly toxicity profiles, the demand for such interventions is high. In 2020 alone, more than 20 biopharmaceutical products (including monoclonal antibodies, recombinant proteins and gene therapies) were approved in the US. Amidst the COVID-19 pandemic, the biopharmaceutical industry has witnessed considerable growth, with sever

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The process of drug development and manufacturing is estimated to take around 10-15 years. In addition, according to a study published in the Journal of the American Medical Association, it was estimated that approximately USD 1.3 billion in capital investment is required in progressing a single pharmacological lead from the bench to the market. It is also worth highlighting that close to 90% of pharmaceutical product candidates fail to make it past the clinical stage of development. This h

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The development of a novel molecular entity for pharmacological use, is  not only complex but also cost intensive. It requires close to 10 years and over USD 2.5 billion in capital investment, for a prescription therapeutic to traverse from the bench to the market. It is worth highlighting that a significant proportion (40%) of the pharmaceutical R&D budget in the US is spent on clinical research, evaluating the safety and efficacy of novel therapeutic interventions in human subjects. C

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Over the years, the biopharmaceutical market has grown into a promising, high value vertical within the overall pharmaceutical industry. In fact, nearly 29% and 25% of the total number of novel drugs approved by the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) in 2018 and 2019, respectively, were biologics. As a result, the pipeline of biologics and biosimilars is growing at a commendable pace. Given that the development and manufacturing of such therapies

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The “Epidermolysis Bullosa 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 Epidermolysis Bullosa.   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 addition

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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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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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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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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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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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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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[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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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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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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[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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Targeted protein degradation is a revolutionary pharmacological concept that presents viable drug development opportunities and is anticipated to introduce a new paradigm in modern therapeutic interventions. Due to various reasons, conventional drugs / therapies have been limited in terms of their capability to target certain proteins of pathological significance. Presently, medical researchers engaged in the development of bifunctional protein degrader-based interventions claim that this upcomi

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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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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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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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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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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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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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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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Alzheimer’s disease is a progressive neurological disorder characterized by the death of brain cells, eventually leading to memory loss, cognitive dysfunction and dementia. Accounting for 60-70% cases of dementia, Alzheimer’s disease is known to be the sixth leading cause of death in the US. Presently, more than 6 million Americans of all ages are living with Alzheimer's and this number is projected to reach around 13 million by 2050. In 2020, the healthcare burden associated wit

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Clinical trials are a fundamental requirement for evaluating the safety and efficacy of novel therapeutic interventions. Owing to the involvement of several different stakeholders and given the inherent complexity of the process, these trials are prone to delays, and only 10% of the pharmacological leads that are evaluated, eventually enter the market. Clinical research is also capital intensive; it is estimated that, in the US alone, 40% of the pharma R&D budget is spent on conducting clini

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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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Given their ability to treat a wide range of clinical conditions, including oncological disorders, cardiovascular disorders, genetic disorders, ophthalmic diseases and orthopedic disorders, advanced therapy medicinal products (ATMPs) have revolutionized the delivery of healthcare. Presently, over 30 cell and gene therapies have received marketing approval, while around 1,000 therapeutic leads are under evaluation. Considering the advantages of ATMPs, and their ability to address the underlying c

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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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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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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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  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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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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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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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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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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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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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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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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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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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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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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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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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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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 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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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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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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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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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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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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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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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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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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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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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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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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