Novel Drug Reconstitution Systems: Emerging Options for the Reconstitution of Lyophilized Drugs

Lyophilization of Pharmaceuticals and Drug Reconstitution In 2018, seven out of ten top-selling prescription medicines were biologics. The liquid formulations of biologics are not much stable and tend to loose efficacy with time due to the changes in their pharmacokinetic and pharmacodynamic properties. Therefore, lyophilization of such drugs is essential before their storage. Around 50%

Squamous Non-Small Cell Lung Cancer Market: Current Scenario and Future Trends

Close to 1.8 million fatalities reported in 2020 were observed to be associated with lung cancer, which is believed to be one of the most aggressive forms of carcinoma, globally. One of the primary reasons for the high mortality rate associated with this condition is anticipated to be late diagnosis, which eventually results in delayed

Pharmaceutical Contract Manufacturing and The Rising Adoption of Sophisticated Processes

Recent developments in pharmacology and biotechnology have been able to drive significant advances and innovation in understanding the root causes of various diseases; this has further aided in the discovery and development of more targeted treatment strategies. It is worth noting that such advances in the healthcare industry have made pharmaceutical development and contract manufacturing

Remote Patient Monitoring: A Paradigm Shift in Healthcare System

The development of the concept of remote patient monitoring (RPM) started nearly 200 years ago in 1800s. However, it wasn’t until the introduction of cloud computing, that the domain evolved at a significant pace. In fact, RPM solutions are gradually being integrated into mainstream healthcare systems; specifically, during the COVID-19 induced lockdown, such advanced tools

Clinical Trial Planning and Design Services Market: What Does the Future Hold?

Over the years, clinical research has undergone an evolutionary change, in terms of cost of research, technology used, and duration of the study. It is worth highlighting that clinical research involves two major steps, namely study design and study reporting. Further, study design involves three key steps, theoretical design, data collection design and statistical analysis

Pharmaceutical Contract Manufacturing: The Solution to Production of Complex Substances

The inherent expertise of CMOs and CDMOs is believed to be capable of enabling reduction in the time-to-market a product, significant cost-benefits, as well as access to larger production capacities and novel technologies.  It is worth mentioning that there has been substantial merger and acquisition activity in the pharmaceutical contract manufacturing market in the past

Display Library Technologies: Where do we stand?

Over time, a variety of methods / approaches have been developed for the generation of viable therapeutic leads. These include the hybridoma technology, B-cell cloning, transgenic animal-based techniques, in vitro display methods (using phages, ribosomes, mRNA, and cDNA) and cell surface display methods (involving mammalian, yeast, and bacterial cells). Despite being responsible for the development

Target Protein Degradation – Transformative Approach to Selectively Eliminate Disease-Causing Protein

Targeted protein degradation is an emerging therapeutic modality that has the potential to enable the treatment of difficult-to-treat diseases. While conventional medicines, such as small molecule inhibitors and monoclonal antibodies, address fewer than 20% of the proteome, TPD offers a unique means to tap into the rest of the vast, unexplored proteome. Through TPD, a

Nothing Ventured, Nothing Gain: Bringing to Light The Continuous Manufacturing Equipment Providers

Over the years, several industries have implemented evolutionary changes in their respective manufacturing processes. One to the most rewarding advancements in this direction, is process automation. In pharmaceutical manufacturing, the automation of various aspects of the production process has led to the establishment of the continuous manufacturing paradigm. However, the transition to continuous manufacturing is

Polycystic Ovary Syndrome (PCOS)

Polycystic Ovary Syndrome is a condition in which the ovaries produce abnormal amount of androgens (males sex hormones), higher than the amount usually present in a woman with normal ovaries. The ovaries develop fluid filled sacs, known as follicles, which contain an immature egg. However, in polycystic ovary syndrome, none of the eggs mature and

Cell Line Development and Characterization: An Ocean of Opportunities for Service Providers

The growing pipeline of monoclonal antibodies, vaccines, enzymes, biosimilars and other therapeutic proteins have created an ever- increasing demand for highly- productive and stable cell lines. Many of the recombinant biotherapeutic products, produced in cellular systems, have been translated into commercial successes; these include ALPROLIX®, ELOCTATE® and ELAPRASE®.  Given their impact on the overall quality

Modular Facilities: A Paradigm Shift in Pharmaceutical Facility Design

The concept of modular building has long been employed in other sectors, but it has only recently acquired traction in the pharmaceutical business over the last two to three decades. Modular construction is a process wherein factory-produced, pre-engineered building units, which are constructed offsite under controlled plant conditions, are assembled on site to construct the

Intracellular delivery technologies – solution to undruggable targets

Over time, advances in molecular biology and pharmacological chemistry have enabled the identification of biological targets localized in the subcellular space, and development of therapeutic leads against them. In fact, there are several clinical conditions, which were previously considered undruggable since the traditional small molecule-based interventions were unable to penetrate the selectively permeable cell membrane.

Antibody Purification: A Deeper Look into Service Providers Landscape

Over time, several innovative technologies have been developed to support the designing and manufacturing of various types of antibody products; however, the aforementioned processes are characterized by high costs and technical complexities, especially during the production and downstream processing steps. Therefore, it is challenging for new entrants and companies with limited resources and capital, to

Antisense Oligonucleotides – The Revolutionizing Modalities in the Field of Gene Silencing

Oligonucleotide (commonly referred to as oligos), are short single stranded DNA or RNA molecules, typically containing 15-20 nucleotide residues.[1],[2] In the modern biopharmaceuticals and biotechnology, the applications of these molecules are vast, including (but not limited to) genetic testing, fundamental biomolecular research, and forensic analysis. Oligonucleotides are a diverse class of therapeutics that are divided

Non-Invasive Diagnostics for Fibrotic Disease Market: A Step Towards Painless and Specific Detection of Fibrosis

Advances in the field of biotechnology have enabled the development of several minimally invasive / non-invasive approaches for diagnosis of fibrotic diseases which include imaging diagnostics and biomarker-based assays. Among the biomarker-based tests, liquid biopsy (based on the analysis of biofluids such as blood, urine and / or plasma), a relatively new concept, has emerged

Targeting the STING Pathway

Stimulator of interferon genes or STING, discovered by the laboratory of Glen N Barber in 2008, is one of the signaling proteins that is responsible for the transcription of genes associated with the innate immunity of an individual. Amidst the recent COVID-19 pandemic, it has become even more essential to strengthen the immune system. The

Virtual Clinical Trials: The Present And Future Of Pharmaceutical Research

The lack of patient centricity in traditional clinical trials is known to inhibit trial sponsors to retain enough patients, which is critical to successfully complete safety and efficacy evaluations of novel therapeutic interventions on predetermined completion dates. In addition, the lack of participant compliance in clinical trials often leads to massive delays which are known

Biopharmaceutical Contract Research Organizations: Fueling the research of novel biologics

Biologics, often referred to as biopharmaceuticals or large molecules, are manufactured in the biological system, such as microorganisms, plants, or animal cells. Biologics represent one of the fastest growing segments of the pharmaceutical industry. This can be attributed to the rapid pace of innovation in this field, driven by the need for effective and personalized

Outlook for the contract manufacturing industry following the growing biologics pipeline

The recent years have portrayed the renaissance in the domain of biologics, as pharmaceutical industry has once again gained attention towards the production of bioproducts. In fact, in 2019, a total of 28 biopharmaceutical products (including monoclonal antibodies, recombinant proteins and gene therapies) were approved in the US. Further, over 8,000 biological pharmaceutical products are

Digital Biomarkers: Is Efficient Remote Monitoring of COVID-19 Patients Primary Reason for Incessant Rise in Demand?

Biomarkers or biological markers are distinctive physiological features in an individual, which can be detected and quantified in order to gain insights about health and disease. On the other hand, digital biomarkers are defined as digital means that are employed to collect data about these unique biomarkers. These are combination of hardware and software features,

Artificial Intelligence in Drug Discovery – Could help Reduce Significant Capital and Time Required

Drug discovery is a complex process which involves significant utilization of time and resources. As per several sources, on an average, the entire drug development process (from initial proof-of-concept to commercial launch) takes around 10-15 years and capital investments worth USD 4-10 billion to develop a drug from concept to commercial launch. The early stages

mRNA: the Higgs boson of modern medicine?

Messenger RNA (mRNA) is a single-stranded molecule, which is complementary to the DNA strands of a gene. It plays a prominent role in the process of protein synthesis, wherein mRNA is responsible for transferring genetic information from DNA to ribosomes, a specialized structure, or organelle, which decodes genetic information into a protein. In the last

Advancing Healthcare Delivery via Artificial Intelligence

Artificial Intelligence have demonstrated intelligent behavior through their ability to learn, communicate with its users and solve complex problems using highly sophisticated algorithms. AI-driven technologies have continued to evolve rapidly, with several industries increasingly deploying such solutions across key aspects of value chain. Furthermore, AI is also made with same idea of making tasks simpler

Antibody Drug Conjugates (ADCs): A Deeper Look into Contract Manufacturing Landscape

Antibody Drug Conjugates (ADCs) known as the 21st Century Magic Bullets, have emerged as a promising class of targeted therapies being developed for the treatment of cancer. Two decades ago, in the year 2000, the domain witnessed the approval of first ADC known as Mylotarg®, by the US FDA.  This was followed by the successful

Single-Cell Sequencing: The New Era of Gene Expression Analysis

For developing an improved understanding of the interactions of individual cells within their microenvironment, advanced molecular probing solutions are being used by researchers across the globe. In this context, high-throughput single-cell analysis, has emerged as a powerful analytical technique for studying individual cells, enabling researchers to study gene expression at single cell resolution. Single-cell sequencing

Harnessing The Power of Real World Evidence to Fight COVID-19 Pandemic

With the ongoing pandemic of COVID-19, there is long wait for the vaccine to be approved. Even after the vaccine gets approved, there is no assurance of the complete eradication of virus. There will still be percentage of people who contract the illness. Therefore, it is very important to trace and detect the treatments in

Microbial Contract Manufacturing: Growing Microbial-Based Biologics Pipeline Boosts The Market

The recent years have portrayed the renaissance in the domain of microbial fermentation, as microbial biopharma industry has once again gained attention towards the production of biologics using microbial expression system. The modification and innovation in the microbial expression systems for the production of various biologics have side-lined some of the earlier concerns associated with

REAL-WORLD EVIDENCE: THE GAME CHANGER IN DRUG DEVELOPMENT

While the definition of real world evidence is still evolving, most proponents associate it with data that is derived from medical practice among heterogeneous sets of patients in the real world setting. It is the integration of data gathered from various sources, such as EHRs, medical charts, patient claims and billing activities, product and disease

Are Handheld Ultrasound Imaging Devices a True Revolution in Diagnostic Imaging Domain?

Advancements in the field of disease diagnostics have led to development of point-of-care medical imaging devices; handheld ultrasound scanners have emerged as a novel solution to cater to unmet need in this domain. These handheld ultrasound imaging devices are the lightest portable ultrasound devices, which permit patient diagnosis from a single transducer and transmit images

Digital Therapeutics: Key Concepts and Regulations to Tackle COVID-19 Pandemic

Digital therapeutics are clinically validated applications / software / online programs that have demonstrated the capability to facilitate positive outcomes when used in the prevention / treatment / management of diseases / clinical conditions. These therapeutics are designed to engage patients in personalized treatment or disease prevention programs, through mediating behavioral or psychological modifications, providing

Inhaled and Intranasal Drug Delivery: A Deeper Look into Service Providers Landscape

The techniques used for the drug delivery are found to be have an enormous impact on the efficacy of the treatment. In fact, the slow progression of the efficacy, has suggested the need of different approaches for the effective delivery of drug to the target area, along with the optimal bioavailability. Over the years, several

Targeted Drug Delivery Devices: An Attractive Option for Improving the Efficacy of Biologics

The gradual shift of healthcare industry towards the development of biologics is a well-known fact. Owing to this shift, there are over 1,000 cell and gene therapies which are being developed for the treatment of various disorders, majority of them being oncological disorders, cardiovascular disorders and neurological disorders.  Additionally, over the last decade, multiple immunotherapies

Single-Use Bioreactors on Rescue for COVID-19 Research

The development of single-use bioreactors started nearly 40 years ago in 1980s. It was around this time that the bio-processors began to use plastic film bags to culture cells, which were initially designed for food storage and culture media containment. Moreover, incremental evolution of the concept of disposable technologies have facilitated various advancements in development

Nuclear Medicines And Radiopharmaceuticals: Redefining The Use Of Radioactivity In Modern Day Healthcare

Fostered by partnerships between national laboratories, academia, and the pharmaceutical industry, the field of nuclear medicines and radiopharmaceuticals has evolved over the past few decades, in parallel with advances in imaging instrumentation, radionuclide production, and radiopharmaceutical development. Nuclear reactors and particle accelerators are presently used to produce a wide array of radionuclides for diagnostic and

Will the Renascence of Microbial Manufacturing be Impacted by the Pandemic?

Since the discovery of recombinant DNA technology, several types of microbes have been established as a versatile biomolecule expression system. This can be attributed to the ease of handling of microbial cell lines, which are considered less fragile (compared to cells of higher eukaryotes); rendering them a popular choice for manufacturing operations. Moreover, incremental evolution

Drug Repurposing – A Deeper Look into Service Providers Market

Over the past decade, several scientific and technological breakthroughs in the drug repurposing industry have resulted in an accelerated pace of research and innovation within this domain. Further, the demand for effective repurposed therapies in the on-going war with the pandemic, is on the rise. However, one of the primary challenges faced by this industry

Outsourcing: An Attractive Option For Antibody Production

In recent years, contract manufacturers have become an integral part of the overall biopharmaceutical market. This trend is also gaining popularity within the antibody therapeutics market, as developers are increasingly outsourcing their antibody production requirements to contract service providers. This can be attributed to the fact that employing such third-party service providers offers various advantages,

Large Volume Wearable Injectors: A breakthrough to simplify Chronic Disease Management

The last few years have witnessed a rising incidence of chronic illnesses across the globe. Long term clinical conditions, such as neurological disorders, cardiovascular disorders, chronic pain and oncological disorders, have been shown to impose a significant burden on the modern healthcare system and those who suffer from such diseases. It is reported that about

Significant Potential of Gut Flora: Human Microbiome

Human Microbiome Therapies are Viable Alternatives to Antibiotics, with Substantial Therapeutic Potential The term microorganisms was perceived to be synonymous to harmful, disease causing agents, until the discovery of certain beneficial microbial colonies in the human system. Currently, humans and a variety of species of bacteria, yeast and protozoa, are known to co-exist in mutually

The Evolving Dynamics of Large Volume Wearable Injectors Market

The field of self-injection devices has witnessed a lot of innovation in the recent years. Specifically, , large volume wearable injectors are certainly a boon due to their ability to address challenges associated with the administration of high volume formulations, viscous drug solutions and cater to frequent dosing requirements of patients suffering from chronic health

Medical Device CROs – The next Growth Opportunity

Over the past decade, numerous scientific and technological breakthroughs in the medical device industry have resulted in an accelerated pace of research and innovation within this domain. Further, the demand for high quality and efficient medical devices, driven by a growing geriatric population and increasing incidence of various chronic clinical conditions, is on the rise.

Fill / Finish Services Industry: Impact of the Swelling Biopharmaceutical Pipelines

Biopharmaceuticals represent the most rapidly growing and high-value segment of the pharmaceutical industry. Growing at an annualized rate of ~12%, the industry stands tall with more than 5,000 biologics in development and over 300 FDA approved biologics, since 2002. Biologic drug development is characterized by high quality standards and a rapidly growing demand for novel

In Vitro ADME Testing Services: Emerging Opportunities for Service Providers

According to the US Food and Drug Administration (USFDA), less than 10% of investigational new drug (IND) candidates progress beyond the submission of a new drug application (NDA); this implies that majority of the drug / therapy candidates fail to reach the market owing to unacceptable safety and efficacy profiles and the problems associated with

Increasing Prevalence of Chronic Diseases- Driving the Demand for Self-Administration Devices, Like Autoinjectors

Over the last decade, autoinjectors have emerged as a promising therapeutic commodity for safe administration of parenteral therapies. Patients who suffer from chronic diseases, such as diabetes, rheumatoid arthritis and multiple sclerosis, often require frequent dosing of medication which poses significant inconvenience to them for visiting proper healthcare centers. Hence, autoinjector devices enable such patients

Peptide APIs – A Deeper Look Into Contract Manufacturing Market

The recent years have portrayed the renaissance of peptide APIs, as pharma industry has once again turned its attention towards the potential of therapeutic peptides. Adoption of peptides as therapeutic agents have side-lined some of the earlier concerns associated with them, such as bioavailability, and has led to manufacturing of high-quality peptides in a larger

Increasing Rate of Drug Failure has Prompted the Drug Developers to Rely on CROs offering In Vitro ADME Testing Services for their Outsourcing Requirements

It is 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 on R&D initiatives in the pharmaceutical / biotechnology sector has increased from around USD 128 billion in 2008 to USD 165 billion in 2018. Moreover, only a small

Targeted Protein Degradation is Anticipated to Become a Major Therapeutic Modality in the Coming Decade

The targeted protein degradation approach is believed to possess the potential to unlock the undruggable proteome, which was traditionally considered to be inaccessible. Compared to conventional inhibition strategies, degradation offers several benefits, which include the opportunity to completely remove aberrant proteins and associated systemic malfunctions. As a result, targeted protein degradation-based therapeutics have generated enthusiasm

Rising Popularity of Drug Targeting Synthetically Lethal Targets Fuels the Battle of PARP Inhibitors for Treatment of Advanced Cancer Indications

Cancer is considered to be the second leading cause of mortality, after cardiovascular diseases, accounting for every sixth reported death in the world. The International Agency for Research on Cancer (IARC) states that the number of new cancer cases is expected to grow to 27.5 million across the globe, by 2040. Experimental evidence has shown

Targeted Protein Degradation – Defining a New Frontier in the Field of Medicine

The concept of targeted protein degradation presents revolutionary drug development opportunities and is anticipated to bring about a paradigm shift in modern healthcare. While conventional medicines, such as small molecule inhibitors and monoclonal antibodies, address fewer than 20% of the proteome, targeted protein degradation offers a unique means to tap into the rest of the

In Silico / Computer-Aided Drug Discovery Service Providers for Large Molecules

Over time, the complexities associated with drug discovery have increased, especially in case of large molecule drugs, which are inherently more complex than conventional small molecules. As a result, an increase in the overall research and development (R&D) expenditure in the pharmaceutical / biotechnology sector has been witnessed. In addition to the complexities involved, the

Computational / In Silico Drug Discovery: A Boon in Disguise for Faster Drug Discovery Operations Amidst COVID-19

The COVID-19 pandemic is predicted to throw the global economy into recession, with loss of trillions of dollars. The pharmaceutical industry cannot escape the brunt of the circumstances as well. In fact, according to a survey, 95% of healthcare industry professionals are worried about the impact the pandemic is likely to have on the industry. So far,

Next Generation Immune Checkpoint Inhibitors and Stimulators: Another Big Opportunity

There is an urgent unmet need for developing innovative and effective cancer therapeutics for the treatment of patients with late-stage and refractory cancer. Amidst the widespread initiatives to develop more targeted anti-cancer therapies, immune checkpoint inhibitors emerged as a highly specific and potent option to eradicate tumor cells with minimal side effects. Once the body

Favorable Demand Dynamics within the Ophthalmic Drugs Contract Manufacturing Market

In the past two decades, advances in optometry, along with an increased understanding of human eye and vision care, have led scientists to develop innovative treatment methods in order to treat eye disorders and to overcome the limitations offered by conventional medical practices. The current ophthalmic diseases treatment landscape is characterized by a number of

Outsourcing has become a popular trend in ophthalmic drug development domai

Owing to various reasons, such as growing manufacturing demand, need for specialized facilities, equipment and operational expertise, and high costs of development associated with certain drugs / therapies, a number of innovator companies have demonstrated a preference to outsource certain aspects of ophthalmic drug development and production operations to contract service providers. Over 240 companies

Microbiome-based Live Biotherapeutics Contract Manufacturing: Rising Opportunities for Specialized CMOs / CDMOs

What is the current development pipeline of microbiome-based live biotherapeutics? With over 85 products under preclinical and clinical development, the current development pipeline of microbiome-based live biotherapeutics has several promising candidates, which are anticipated to get commercialized over the next few years. Hence, the demand for R&D and manufacturing services for such products is anticipated

RISE OF ANTIBODY DRUG CONJUGATES WITH THE RECENT APPROVALS

Antibody drug conjugates (ADCs) have captured the attention of both large and small pharmaceutical companies, and academic / research institutions, for more than a decade. For the past few years, several failures of clinical trials were blamed for the lack of interest of some companies in this therapeutic approach. However, after a decade-long dribble of

Needle-free Injection System: A light bearer in the fight against the thick darkness of COVID-19

The apocalyptic images of the COVID-19 induced locked-down world are heart wrenching. All healthcare related domains are being created at a rapid rate. Around the world, the coronavirus pandemic is overstretching health services and reportedly more than 40 companies have boosted their R&D efforts to hit the bulls eye and deliver the much awaited vaccines

CRISPR Can be a Solution to Address the COVID-19 Pandemic

As we know, COVID-19 is causing large scale loss of life and severe human suffering. With the pandemic spreading across the globe, researchers are racing against the clock to develop diagnostic tools, vaccines and treatments. Recently, WHO has launched a Solidarity clinical trial to assess relative effectiveness of four potential drugs against COVID-19. Further, there

Growing Pipeline of Microbiome-based Live Biotherapeutics Fuels the Manufacturing Demand

Live biotherapeutics are fragile bacteria, which require ideal conditions of heat, moisture and pH of products, to survive and prevent premature germination. In fact, manufacturing is presently one of the biggest bottlenecks in this domain; manufacturing such products is both technically challenging and financially demanding. One of the biggest challenges in the development of a

Growing Oligonucleotide-based Drugs Pipeline Escalates Manufacturing Demand

As therapeutic agents, oligonucleotides are known to be associated with several unique features, such as high selectivity and potency (similar to biologics), and differentiated pharmacology, which further augment their drug-like properties. At present, eight oligonucleotide-based drugs are available in the market, namely (in reverse chronological order of year of approval) GIVLAARI™ (2019), ONPATTRO® (2018), TEGSEDI™

Response to COVID-19 Pandemic with Oligonucleotides

Never before, scientists say, the universal community of researchers have put a halt to all other ongoing research and have urgently focused towards swiftly evolving health emergency. In the past few months, scientists have been repurposing their research efforts towards contributing to the global effort in response to COVID-19 pandemic. For the purpose of mitigating

How COVID-19 Poses a Sharp Challenge on China Biopharmaceutical Contract Manufacturing Market?

China, epicenter of the COVID-19, is the world’s second largest pharmaceutical market and accounts for 20 % of the global output of APIs. With over 25 biologics and biosimilar products approved till date and close to 1,000 clinical trials, investigating a variety of biologics and biosimilars, being underway in this region, China’s biopharma market is

Neoantigen Targeted Therapies Pave the Way to Personalized Anti-cancer Therapy

Neoantigen Targeted Therapies Pave the Way to Personalized Anti-cancer Therapy There is an urgent unmet need for developing innovative and effective cancer therapeutics for the treatment of patients with late-stage and refractory cancer. Amidst the widespread initiatives to develop more targeted anti-cancer therapies, immunotherapy emerged as a highly specific and potent option to eradicate tumor

The Future of Manufacturing: Collaborative Robots in the Factories

The world has experienced a radical change with the advancements in technologies and systems that aid daily activities. Particularly, automation has played an important role in increasing the productivity and quality of the production process in various industries. Within the automation industry, robots have already been established; however, one of the fastest-growing segment of robotics

COVID 19 and Vaccines: How Big Will be the Impact on Prefilled Syringes Market?

Coronavirus(COVID 19) is spreading around the world, with 2.6 million global active cases[TB1] . Till date, there are no approved treatments for COVID-19. However, multiple pharmaceutical companies are doing research at breakneck speed to develop therapeutics and preventive vaccines against this novel coronavirus. The pharma industry is hoping to compress the development timelines to get a

COVID-19: Drugwatch – 6 April 2020

To date, there are no approved treatments for COVID-19. However, the pharmaceutical industry is abuzz with activity as medical researchers strive to develop a cure, and possibly a vaccine, for the illness caused by the novel coronavirus. In this article, we have attempted to explore some of the more popular treatments / preventive measures that

COVID-19: Where are we today?

Comparison with other communicable diseases According to worldometers.info, as of 5 April 2020 (5:30 PM GMT), the total number of COVID-19 cases rose to over a million, with a reported mortality rate of 5%. Further, a comparison with certain other communicable disease-related deaths (Figure below) presents a worrisome situation. As of 5-April 2020, the novel

Fragment-based Drug Discovery – A Boon in Disguise to get a Breakthrough Drug Against Covid-19

With over 855,000 cases and 42,000 deaths, the novel coronavirus has taken its toll on humanity. The pandemic is predicted to throw the global economy into recession, with loss of trillions of dollars. The pharmaceutical industry cannot escape the brunt of the circumstances as well. In fact, according to a survey, 95% of healthcare industry

COVID-19 Impact on Cell and Gene Therapy Manufacturing Market

With close to half-million infections and the economy showing signs of the 2008 financial crisis, COVID-19 has impacted several industries. Government institutes and industry players have announced various steps to deal with the ongoing situation. In this article, we will highlight the developments in the cell and gene therapy manufacturing industry amid the ongoing COVID-19

Continuous Manufacturing: Solution to Pharmaceutical Manufacturing Industry’s COVID-19 Concerns

The ongoing COVID-19 crisis has put the pharmaceutical manufacturing supply chain under close scrutiny. The overdependence of the US on China and India to meet its API demand has been the talk of the town. However, with the number of infected cases in the US surpassing that of China, the focus has shifted from discussing

COVID-19 Impact on Gene Therapy Market

In a recent press release, bluebird bio, one of the leading gene therapy developers, announced that COVID-19 has delayed the EU launch and US filing of the company’s gene therapy candidate Zynteglo (LentiGlobin). The company now expects to dose the first commercial patient with Zynteglo in Germany in the second half of 2020. Earlier, the company had

Contraband in the Clinical Trials -A saga of the great apes, who went on to ban the nature

To err is human, to rectify divine, this irony perhaps holds truer for cannabis than any other domain. After using cannabis in multiple forms for at least 10,000 years, a series of events, including spread of misinformation, anti-Mexican sentiment and fear led to the ban of nature a.k.a. cannabis. The US implemented Marijuana Tax Act

Immuno-Oncology Biomarker: Benchmarking Big Pharma Activity

Over the past few years, therapeutic advancements in conventional treatment paradigms have led to an increase in survival among cancer patients. Recent developments in the field of immuno-oncology, such as the introduction of several cancer vaccines, adoptive T-cell therapies, and checkpoint inhibition therapies, have demonstrated significant potential, and some of the aforementioned therapies have already

Microbiome Contract Manufacturing: Time to Push the Increase Capacity Button

The interest in the trillions of microbiome present in the human body has attracted a lot of research effort in the microbiome domain. The first such effort at a large scale was The Human Microbiome Project, conducted by the National Institutes of Health in the United States, which characterized the microbial communities at five major

Cell Therapy and The Rise of Novel Technologies

Roots Analysis has actively tracked the developments in the field of cell therapy and gene therapies. The team has focused on identifying the key challenges that are hampering the growth of these revolutionary therapies. To identify the challenges, the team has interviewed several stakeholders involved in cell therapy development and manufacturing. In addition, a recent

Is genomics revolution all fun and games? How blockchain can calm data security nerves!

Have you had your genomics sequenced? If you asked this question a few years ago, people would have thought you were crazy. However, today, genetic tests are up for sale in supermarkets! Fifteen years ago, the first ever Human Genome Project was carried out, which took more than 13 years to complete. This (Human Genome

Catalent’s Shopping List: Hinting Towards a One-Stop Cell & Gene Therapy CMO in Making

There appear to be no Monday blues for Catalent as the company announces the acquisition of MaSTherCell Global, a technology-focused cell and gene therapy contract development and manufacturing organization. Following its last year’s acquisition of Paragon Bioservices (a leading viral vector developer), Catalent’s recent acquisition has extended the company’s leadership in this already crowded space.

CMO, CMO Everywhere, Not a Single One That Fits: The Reality of Biopharma Contract Manufacturing Market

I was recently involved in a discussion with the global outsourcing manager of one of the big pharma companies. The premise of the discussion was around the criteria that big Biopharma Contract players follow for choosing a supplier for their products. One key question that came up in the discussion was whether one-stop-shops are really

Targeted Protein Degradation Market: Riding on the Popularity of PROTAC, Market is set to Grow Exponentially

Over the years, the drug hunters have tried to target the tens of thousands of proteins responsible for sickness and health. But a vast majority of them have remained out of reach. While, the scientific evolution has led to the development of potent and selective small-molecule inhibitors of protein function, but still, multiple targets of

Evolution of Cancer Diagnostics: Rise of Novel Non-Invasive Methods

Cancer diagnosis, today, employs a mix of invasive and non-invasive strategies. Invasive cancer diagnostic methods are generally expensive and uncomfortable. Biopsies have been the gold standard to determine the clinicopathological characteristics of cancer tissues for many years. The procedure is very uncomfortable and painful for patients and in many cases, the results are known to

CAR-T Pipeline Update: Autolus Therapeutics Presents Preclinical Data on AUT06NG

Autolus Therapeutics, a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer, presented pre-clinical data on AUTO6NG, the company’s next-generation GD2-targeting CAR (chimeric antigen receptor) T cell therapy, at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC). What did the results highlight: The results demonstrated the utility

Microbiome Research Update: New Study Uncovers Role of Bacteria in Bowel Cancer

Dr. Kaitlin, from the University of Bristol, speaking at the 2019 NCRI Cancer Conference, confirmed that they have discovered evidence of the presence of an unclassified type of bacteria from the bacterial group named ‘Bacteroidales’ increased the chances of bowel cancer by 2 to 15 percent.  The researchers employed the technique known as Mendelian randomization to

New Research in ALS – Mitoautophagy Responsible for Development of Early Stages of Neurodegeneration

Researchers at Northwestern Medicine have discovered a new phenomenon in the brain that could explain the development of early stages of neurodegeneration seen in diseases such as ALS, which affects voluntary muscle movement such as walking and talking Mitoautophagy. What is the discovery: The researchers have invented a new term to describe the discovery: Mitoautophagy,

FDA Approves Celgene’s REBLOZYL® for the Treatment of Anemia

The U.S. Food and Drug Administration (FDA) has approved Celgene’s REBLOZYL® (luspatercept-aamt) for the treatment of anemia in adult patients with beta-thalassemia who require regular red blood cell (RBC) transfusions. What is Beta-thalassemia: Beta-thalassemia is a blood disorder that reduces the body’s production of hemoglobin. Low levels of hemoglobin lead to a shortage of mature red blood cells and a lack of oxygen in

CAR-T Pipeline Update: Celgene posts pivotal data ahead of FDA filing

Celgene has recently published positive data from a pivotal trial (NCT02631044) of its CAR-T therapy. As per the reports, the data look competitive against Gilead’s Yescarta and Novartis’ Kymriah, leading analysts to predict Celgene will win FDA approval next year. This is a big news for the overall CAR-T pipeline. As per the reported data, the

New Real-World Data Unveiled at ACAAI Indicates Comparable Clinical Practice Logistics to Implement Oral Immunotherapy and Environmental Allergy Shots

In a recent press release by Aimmune Therapeutics, the company reported that the Clinical Practice logistical needs for implementing oral immunotherapy (OIT) for food allergies, such as peanut allergy, into clinical practice are comparable to those for subcutaneous immunotherapy (SCIT) for environmental allergies. These data were presented at the American College of Asthma, Allergy and Immunology

Party Like Celebrities: American Gene Technologies Hosts a Red Carpet Event to Celebrate IND Submission

On November 6, 2018, American Gene Technologies (AGT) announced that it will host a red carpet event to celebrate a significant milestone in the company’s 11-year history of scientific research in cell and gene therapy. Last month, the company successfully submitted its Investigational New Drug (IND) application to the Food & Drug Administration (FDA) to

T-Cell Therapies Funding Update: Tmunity Raises $75 Million in Series B Funding

On 31st October 2019, Tmunity Therapeutics, a private biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T cell Therapies, announced the closing of $75 million Series B financing. Who were the key investors: The financing was led by Andreessen Horowitz (also known as “a16z”). Joining the Series B

Avantgen Enters a Strategic Collaboration Agreement for its NK Cell Engager Technology

On 7 November 2019, AvantGen, a biotechnology company with its array of technology platforms for antibody discovery, optimization, and novel NK cell engager generation, announced a strategic agreement with an undisclosed biopharmaceutical company for the purpose of generating multiple novel bi-specific NK cell engaging therapeutic antibody product candidates. Under the terms of the agreement, AvantGen

CARsgen anti-BCMA CAR T Therapy Receives RMAT Designation

On 28 October 2019, CARsgen Therapeutics, a clinical-stage biopharma company, announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational CT053 CAR-T cell therapy. What is CT-053: CT053 is a fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cell therapy for the treatment of relapsed and/or refractory multiple

Genome Editing Services Market Snapshot

The rising demand for genome editing services has resulted in the rise of several players with a wide range of capabilities. Currently, there are close to 80 players that claim to offer CRISPR based genome diting services. To get more insights about the market, check out the detailed report here.

More than 50 Large Volume Wearable Injectors are Available / Under Development

Over time, both drug developers and medical device Injectors manufacturers, have entered into strategic alliances to combine their respective expertise and develop appropriate drug-device combination products. Presently, multiple such combinations, facilitating easy delivery of both insulin and non-insulin drugs, in large volumes, are either already available in the market or under development. Check out more

ADCs Pipeline Update: Avacta Partners with ADC Therapeutics

On November 1, 2019, Avacta Group and ADC Therapeutics have announced a collaboration agreement for the development of novel drug candidates. What is the objective of the collaboration: The partnership will aim at the development of drugs combining ADC Therapeutics’ pyrrolobenzodiazepine-based cytotoxic warheads with Avacta’s Affimer targeting platform. What are the financial terms of the agreement: The detailed

ADCs Pipeline Update: Daiichi Sankyo Initiates Clinical Trial

On October 31, 2019, Daiichi Sankyo and Sarah Cannon Research Institute announced the dosing of the first patient in a first-in-human phase 1/2 study (NCT04145622) evaluating DS-7300. What is DS-7300: DS-7300 is an investigational B7-H3 targeting antibody-drug conjugate (ADC). What is B7-H3: It is a Type I transmembrane protein belonging to the B7 family, which includes immune checkpoint

ADCs Pipeline Update: Sutro Biopharma Presents Encouraging Data in Patients with Advanced Ovarian Cancer

Sutro Biopharma, a California based, clinical-stage company, announced initial safety data in ovarian cancer patients from its ongoing phase I study (NCT03748186) of STRO-002. The drug is a folate receptor alpha (FolRα)-targeting antibody-drug conjugate (ADC) and potent anti-tumor activity in preclinical endometrial cancer patient-derived xenograft (PDX) models. The data are being presented at the AACR-NCI-EORTC Molecular Targets

ADCs Pipeline Update: Femtogenix Presents Novel Data on ADCs Containing Reduced Potency Payloads

Femtogenix, a UK based biotechnology company developing the next generation of DNA-interactive Antibody Drug Conjugate (ADC) payloads, announced data demonstrating the potent efficacy and favorable toxicity profile of a reduced potency analog from its Pyridinobenzodiazepine (PDD) ADC payload platform in solid tumor models. The presented data demonstrated that Femtogenix’s reduced potency payload has a favorable

Antibody Drug Conjugates Market Update: Ambrx and NovoCodex Collaborate

Ambrx and NovoCodex Biopharmaceuticals announced that they have formed a second collaboration to develop and commercialize Ambrx’s internally developed site-specific antibody drug conjugates (ADCs). What is the focus of the agreement: Under the agreement, Ambrx and NovoCodex will join forces to continue the development of ARX305, an Ambrx enabled ADC for the treatment of CD70

Cell Therapy Manufacturing Market Update: Compal and University to set up GTP lab

The Compal Group’s Raypal Biomedical and Kaohsiung Medical University Chung-Ho Memorial Hospital on October 22 signed an MoU to jointly set up a GTP (good tissue practice) cellular laboratory in Kaohsiung City, southern Taiwan. What are the key capabilities of Raypal: Founded in 2016, Raypal specializes in R&D of immunocyte and immunotherapy, stem cell and

Cell Therapy Pipeline Update: Talaris Therapeutics Announces Initiation of Phase 3 Clinical Trial

Talaris Therapeutics, a late-clinical stage biotechnology company based in Boston, MA and Louisville, KY, announced the initiation of FREEDOM-1 (NCT03995901), the company’s Phase 3 clinical trial of FCR001 in living donor kidney transplant (LDKT) recipients. What is the objective of the trial: This pivotal trial will evaluate the safety and efficacy of a single dose of FCR001,

Gene Therapy Pipeline Update: Orchard Therapeutics Presents Data on Metachromatic Leukodystrophy

Orchard Therapeutics, a commercial-stage biopharmaceutical company, announced initial results from a clinical trial (NCT03392987) with a cryopreserved formulation of OTL-200, gene therapy in development for the treatment of metachromatic leukodystrophy (MLD). Get the details of the results here. What is OTL-200: OTL-200 is autologous CD34+ cells transduced with a lentiviral vector containing human arylsulfatase A (ARSA) complementary deoxyribonucleic

Cell Therapy Market Update: MaxCyte Advances Phase I Clinical Trial of Lead mRNA-based Cell Therapy

MaxCyte, the global Cell Therapy, and life sciences company, announced the initiation of dosing in the third cohort of patients of MaxCyte’s Phase I clinical trial (NCT03608618) with the next higher cell dose of MCY-M11. The dose-escalation trial is evaluating the safety and tolerability, as well as preliminary efficacy, of MCY-M11 administered intraperitoneally across a series

Genome Editing Market Update: Intellia Therapeutics Presents Data at the 2019 Annual Congress of the European Society of Gene and Cell Therapy

Intellia Therapeutics, one of the leading genome editing company focused on the development of curative therapeutics using CRISPR/Cas9 technology is presenting one oral presentation and four poster presentations at the 27th Annual Congress of the European Society of Gene and Cell Therapy (ESGCT) meeting taking place October 22-25, 2019, in Barcelona, Spain. Get a complete

Gene Therapy Pipeline Update: Adverum Biotechnologies Doses First Patient for Wet AMD

Adverum Biotechnologies, a clinical-stage gene therapy company developing drugs to teated rare ocular diseases, announced that the first patient was dosed in the third cohort (n=9) of the ongoing OPTIC phase 1 clinical trial (NCT03748784) for ADVM-022 for the treatment of neovascular or wet age-related macular degeneration (wet AMD). What is ADVM-022: ADVM-022 utilizes a propriety

Gene Therapy Pipeline Update: AVROBIO Receives Orphan-Drug Designation

AVROBIO, a US-based company, developing lentiviral-based gene therapies, has announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation for the Company’s investigational gene therapy, AVR-RD-02, for the treatment of Gaucher disease. What is AVR-RD-02: AVR-RD-02 consists of the patient’s own hematopoietic stem cells, genetically modified to express glucocerebrosidase (GCase), the enzyme that is deficient

Cell Therapy Manufacturing Update: United Therapeutics Receives Permit

As per recent news coverage, United Therapeutics has received a permit for $9.5 million build-out of its cell therapy facility on the second floor of Mayo Clinic’s Discovery and Innovation Building. What is the area of the facility:  The facility will have a total of 21,843-square-foot space. What are the capabilities at the facility:  The facility will house

Gene Therapy Funding Update: With a Promise of $100 Million in Funding, US Government Bets Big on Gene Therapy

In a recent press announcement, The U.S. National Institutes of Health (NIH) has agreed to invest in the development of Gene Therapy in an attempt to cure HIV and sickle cell diseases. The program, for which NIH will partner with The Bill & Melinda Gates Foundation, will involve funding of $100 million each over the next

Cell and Gene Therapy Technology Update: ReNeuron Presents Positive Data

ReNeuron, the UK based, clinical-stage stem cell therapeutics company, announced that new data relating to its CTX stem cell platform will be presented today at the 27th Annual Congress of the European Society of Gene and Cell Therapy (ESGCT). Dr. Steve Pells, Principal Investigator at ReNeuron, will present new data showing the phenotypic stability and scalability

Gene Therapy Pipeline Update: AGTC Presents Promising Data of its AAV Vectors for Ocular Gene Therapy

Applied Genetic Technologies Corporation (AGTC), a clinical-stage biotechnology company, developing transformational genetic therapies for patients suffering from rare and debilitating diseases, announced new data from non-clinical studies evaluating the effect of pre-existing anti-AAV antibodies on the transduction and expression efficiency of AAV vectors. According to the company’s CSO, Preexisting immunity to AAV remains a challenge for

Gene Therapy Pipeline Update: Rocket Pharmaceuticals Receives IND Clearance for Gene Therapy for Pyruvate Kinase Deficiency

Rocket Pharmaceuticals, a New York-based, clinical-stage company, developing first-in-class gene therapies for rare and devastating inherited diseases announced clearance of Investigational New Drug (IND) by the FDA for RP-L301 gene therapy. RP-L301 is a lentiviral vector (LVV)-based gene therapy for the treatment of Pyruvate Kinase Deficiency (PKD), a genetic rare disease. Last month, the company received

Gene Therapy Pipeline Update: Homology Medicines Presents Data Demonstrating Preclinical Proof-of-Concept

Homology Medicines, a company using proprietary gene editing and gene therapy platform announced the presentation of preclinical data supporting its investigational gene therapy programs for the treatment of metachromatic leukodystrophy (MLD) and phenylketonuria (PKU) at the American Society of Human Genetics (ASHG) 2019 Meeting. The presented preclinical data showed the results from studies conducted in

Alzheimer’s Pipeline Update: Biogen Takes a U-Turn on Failed Drug; Approval in Sight

In one of the most drastic shifts in fortune in the pharmaceutical industry, Biogen has decided to submit its previously failed Alzheimer’s drug for approval. According to the company, The Phase 3 EMERGE (NCT02484547) study met its primary endpoint showing a significant reduction in clinical decline, and Biogen believes that results from a subset of patients

Cell Therapy Manufacturing Update: Merck Becomes the First to Introduce Acoustic Technology

With its acquisition of FloDesign Sonics earlier this month, Merck/MilliporeSigma has become the first company to introduce acoustic technology in cell therapy manufacturing. The acquisition of FloDesign Sonics is a strategic fit for Merck, strengthening its ability alongside to manufacture cell-based therapies for patients. What is Acoustic Cell Processing: Acoustic cell processing is a disruptive technology that allows

Plasmid DNA Manufacturing Market Update: Cytovance®Introduces Integrated Single-Use Platform

In the ongoing shift of biologics manufacturers to single-use systems, Cytovance®, a leading biopharmaceutical CDMO, announced the addition of an integrated single-use platform for the manufacturing of plasmid DNA (pDNA) at their facilities in Oklahoma City, OK. According to the company, two grades are available (Critical Reagent Grade™, CGMP-grade) in lot sizes from 1g to 50g,

Gene Therapy Market Update: Researchers Deliver a Cure for Epidermolysis Bullosa (EB)

In a recent news update, a team of Irish gene therapy researchers announced a breakthrough in the search for a cure for one of the worst strands of the incredibly painful skin disease, EB (epidermolysis bullosa). According to the researchers, the incredibly painful genetic condition, which affects approximately 300 people in Ireland, is caused by a

Technological Evolution of ADC Conjugation Platforms

Last week, I wrote an article on the key innovators in ADC therapeutics space,Technological highlighting the key winners at the 6th World ADC Awards. One of the winners, that has really impressed several drug developers in this space, is Zymeworks. The company has its proprietary conjugation Technological platform, ZymeLink™, which offers site-specificity and customization of

Gene Therapy Market: Big Pharma Bets Big

Last week, I came across an interesting article by Andrew Dunn titled Sanofi investing in gene therapy as R&D focus turns toward rare disease. The article caught my attention because in June, this year, Sanofi scaled back its four-year-old gene therapy alliance with Voyager Therapeutics, for the second time. If we just look at the news titles,

Super Generics Market: The Untapped Gold Mine

The Super Generics industry has enjoyed a remarkable run over the past two decades. The vast healthcare cost-saving potential of these therapies has accelerated their adoption and proven the immense potential that generics have to reach wider patient segments. The problems arrive: While the generics market is highly attractive, the increasing competition in this domain

Growing Cell and Gene Therapy Market: Vector Manufacturers Make Merry

Cell and Gene Therapy are the new entrants in the pharma Superstar Club. They are selling tickets faster than a Queen’s concert in the 1980s. In fact, as per the Alliance of Regenerative Medicine’s recent findings, there has been more than 75% year on year increment in funding to support the development of various cell and gene therapies.

Synthetic Lethality Market: Riding on the ESMO 2019 Success of PARP Inhibitors

After a strong showdown at ESMO 2019, both GSK and AstraZeneca have reignited the fight of small molecule anti-cancer drugs against the industry’s brawny immunotherapy push. Leading this fight is poly(ADP-ribose) polymerase (PARP) inhibitor, one of the leading synthetic lethality targets. These better than expected results at ESMO further validate the potential of synthetic lethality

Abuse Deterrent Formulation Technologies: Combating Prescription Drug Abuse

Although the healthcare industry relies on the 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

Natural Killer Cell Therapies: Pipeline Review

Natural killer (NK) Cell Therapies , 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. Several studies have demonstrated the various benefits of NK

Vaccine Contract Manufacturing: Current Landscape and Future Potential

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

Neoantigen Targeted Therapies: Mapping the Future Growth Potential

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. Recent developments in genomic analysis and advances in bioinformatics have enabled the

Biologics Fill / Finish Services: Current Landscape, Growth Opportunities and Future Market Outlook

According to a recent CDMO survey, about 54% respondents claimed to have collaborated with a contract service provider for clinical and commercial-scale product development projects. Specifically, fill / finish is the final step in the production process and is considered among the most crucial stages of drug product manufacturing. Biologic drug products require special procedures

Elastomeric Closures for Parenteral Containers: Current Market Landscape and Future Growth Opportunities

The use of elastomeric materials, along with various types of coatings (such as FluoroTec® and Teflon®) have emerged as a promising alternative to conventional, non-coated closures used for primary packaging containers, which were prone to leaching and shedding of particulate contaminants. The advantages of using elastomeric materials in manufacturing container closures are many, including low

Cancer Biomarkers Market: Focus on TMB, MSI / MMR and TILs Testing

Advances in biotechnology have enabled the development of several high throughput tools, which have led to the establishment of better biomarkers based on genome / exome profiles. Novel biomarkers, such as tumour mutation burden (TMB), microsatellite instability (MSI) / mismatch repair (MMR) deficiency, tumour infiltrating lymphocytes (TILs) and certain others, are presently being investigated across

Novel Clinical Trial Service Providers: Focus on RWD, Virtual Trials, Adaptive, Umbrella and Basket Designs

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. Estimates suggest that nearly 85% of Novel Clinical trials fail

The Emergence of Encapsulated Cell Therapies and Affiliated Technologies

Extensive research on  Cell Therapies encapsulation strategies have enabled the development of a variety of technologies capable of confining therapeutic entities within biocompatible matrices / carriers. Since 2013, over 3,000 patents have been published related to the aforementioned type of therapy, indicating the rapid pace of R&D activities in this domain. I have highlighted below

Bone Cement Delivery Systems: Current Landscape, Growth Opportunities and Future Market Outlook

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. The annual socioeconomic burden associated with this condition is estimated to be around USD 19 billion and EUR 37

Cybersecurity in Healthcare: The Impending Threat

Organizations, in the process of collating and storing huge volumes of data on digital platforms, end up placing themselves at enormous risk of losing valuable information to cybercriminals. Estimated annual losses attributed to cyberattacks committed globally, amount to over USD 100 billion. The year 2017 witnessed several cyberattacks; notable examples include WannaCry and NotPetya ransomware

Alzheimer’s Disease Market: Pipeline Review, Developer Landscape and Competitive Insights

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 Market and other dementias were projected to be responsible for a healthcare burden amounting to USD 277 billion, in the US. Despite extensive research aimed at comprehending the etiopathogenesis of

Stem Cell Therapies: Upcoming Opportunities in Cardiovascular and Metabolic Disorders (CVMD)

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.  Likewise, a significant proportion of the global population suffers from diabetes or some form of metabolism related clinical condition. As per

Patient Recruitment: Market Landscape and Opportunities for Contract Service Providers

It is estimated that 80% of clinical trials do not meet their designated patient enrolment deadlines. In addition, retaining patients is also a matter of concern, considering that the approximate dropout rate across clinical studies is around 30%. Delays in product launch, due to inability of the sponsors to recruit / retain patients, are highly

Next Generation Contact Lenses and Visual Prosthesis: Rising Popularity to Drive a Multibillion Dollar Market

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 also worth highlighting that Visual Prosthetics,

Drug Delivery Technologies: Emerging Paradigms Shaping the Future of Biologics

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

Large Volume Wearable Injectors: The Goldrush Continues

The self-injection devices market is currently characterized by the presence of a myriad of advanced and innovative drug delivery solutions, equipped with a variety of user-friendly features. Notable examples of such products include prefilled syringes, reusable and disposable pen injectors, autoinjectors and large volume wearable injectors. Large volume wearable injectors are capable of drug delivery

Genomic Data Management: Opportunities for Blockchain Platform Providers

It is estimated that, by 2025, around 15% of the world’s population will have had their genomes sequenced, resulting in the generation of several zettabytes of data. However, currently, there are not many reliable and secure data management resources that offer secure storage, seamless exchange of information, and a reliable transaction platform, for large volumes

Drug Adherence Enhancement: Novel Approaches to Drive Future Growth

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 Prevention (CDC), failure to comply to prescribed treatment regimens has been identified as the cause of

The Rise of Cell and Gene Therapy CROs

Over 500 cell and gene therapy candidates are being investigated in different stages of clinical development across various geographies. In fact, in the past five years alone, more than 1,000 clinical trials, that are currently active, were initiated to evaluate the potential of these therapies across multiple therapeutic indications. Due to several development challenges, such

The Rise of Medical Device CROs

According to the World Bank, more than 50,000 different types of Medical Device are currently being used every day in health care facilities worldwide.  In 2018, the global medical devices market is estimated to reach a net worth of approximately USD 450 billion. However, a relatively larger proportion of device developers lack the required internal

Pre-Sterilized / Ready-to-Use (RTU) Primary Packaging: Current Market Landscape and Future Growth Opportunities

The use of ready-to-use (RTU), or pre-sterilized / pre-treated, container-closure systems have emerged as a promising alternative to conventional primary packaging, adding significant value to streamline pharmaceutical fill / finish operations. These packaging components eliminate multiple steps in the overall fill / finish process (mainly washing, sterilizing and preparing containers), thereby, helping improve operational efficiencies

Cold Chain Logistics for Healthcare: Emerging Opportunities in Cell Therapies, Vaccines and Human Organs

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. In fact, over 95% of all approved biologics and 90% of all vaccines are cold chain dependent.  Stakeholders in this segment have designed

Extractables and Leachables Testing: Emerging Opportunities for Service Providers

During drug product manufacturing and fill / finish, it is important to consider not only the impurity profiles of the drugs, but also identify potential sources of contamination in the containers / packaging material used. due to high variability in the type of impurities (organic (volatile, non-volatile or semi- volatile compounds) or inorganic (metals or

ADC Manufacturing: Current Landscape, Growth Opportunities and Future Market Outlook

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. Owing to the fact that these novel conjugates are highly potent toxic molecules, their manufacturing requires elaborate technical capabilities, along

Neurostimulation Devices: Competitive Landscape, Market Evolution and Opportunity Areas

Extensive research in the field of Neurostimulation has demonstrated the potential of this technique in providing therapeutic relief to a number of patients, who have developed resistance to conventional medication. Since the introduction of the first neurostimulation therapy in 1960s, their numerous observed benefits, such as reversible and minimally invasive nature of the procedures (to

Antibody Discovery: The Rise of Services and Platform Providers

Owing to several beneficial features, such as high specificity, and a favorable safety profile, antibody Discovery based pharmacological interventions, with 79 molecules approved till date and over 200 molecules in the preclinical / discovery stages, presently represent the largest class of biologics. The discovery of antibodies is a long, arduous and cost intensive process. As

Non-Opioids Chronic Pain Management Drugs and Devices: Future Roadmap to USD 10 Billion+ Opportunity

Owing to the rapid onset of their medicinal effect, which offers immediate relief with high efficacy, opioids are still considered to be one of the most widely used pharmacological interventions for the management of moderate to severe forms of pain. However, these drugs are known to induce a euphoric state upon intake, often causing patients

CAR-T: The Future Roadmap of The USD 15 Billion+ Opportunity

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 radiation therapy, have demonstrated very limited efficacy in late-stage cancers. Amidst the current initiatives to develop more targeted anti-cancer therapies,

Cell Therapy Manufacturing: The USD 8 Billion+ Growth Opportunity

Cell Therapy 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. Around 20 such therapies have been approved so far; recent approvals include Alofisel® (2018), YESCARTA® (2017) and Kymriah® (2017). It is also

The Meteoric Rise of Digital Therapeutic, Monitoring and Diagnostic Solutions

Chronic disorders, such as diabetes, heart disease, obesity, mental health problems and insomnia, are considered to be the leading causes of death and disability across the world.  According to a 2018 report published by the Center for Managing Chronic Disease at the University of Michigan, more than 50% of the global population currently lives with

Autoinjectors: Technological Evolution, Current Opportunities and Key Future Growth Areas

Since the introduction of the first autoinjector device in 1980s, their numerous benefits, such as ease-of-use, reduced chances of dosing errors, integrated safety mechanisms, and almost negligible risk of needlestick injuries, have been widely recognized among consumers and healthcare service providers. Autoinjectors are also considered to be potential life cycle management tool. Drugs nearing patent

New Frontiers in Cancer Therapies: Focus on Transcription Factors, GTPases, Phosphatases and GPCRs, 2018-2030

Cancer Therapies continues to be one of the most active segments within the pharmaceutical industry. However, certain biological targets have long eluded drug development efforts. One such target is Ras family, which has been identified to play a critical role in oncogenesis. Scientific literature suggests that the RAS gene is mutated across about 30% of

Bioavailability Enhancement: Current Market Landscape and Future Opportunities

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 be

Next Generation Batteries: Mapping the Future Potential

In contrast to the conventional Li-ion batteries, next-generation product chemistries, which include lithium polymer, solid-state, thin film and printed batteries, have been proven to be safe under abusive conditions, demonstrated significant improvements in terms of overall performance, and are environmental-friendly. Moreover, owing to their flexible form factor, it is believed that these batteries can offer

Viral Vectors and Plasmid DNA Manufacturing: Current Landscape and Opportunity Areas

Over the last few decades, various Viral Vectors and non-viral vectors have been developed, optimized and standardized for introduction of therapeutic DNA / gene of interest into a patient’s body / cells. Currently, the most popular viral vectors, on the basis of their use in active clinical trials, are those based on AAV, adenovirus, lentivirus

Pharmaceutical Spray Drying: Current Market Landscape and Future Growth Opportunities

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, such as reproducibility and its continuous mode of operation, the technique has become very popular in the pharmaceutical and

T-Cell Immunotherapies: The Goldrush Continues

Amidst the current initiatives to develop more targeted anti-cancer therapies, immunotherapy has emerged as a highly potent option 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. It encompasses several treatment approaches, such as monoclonal

The Growing Importance of Oral Proteins and Peptides

Oral Proteins 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

Pharmaceutical Contract Manufacturing: Current Market Landscape and Future Opportunities

 The present pipeline of pharmaceutical products is becoming increasingly complex and requires specialized facilities, equipment and operational expertise. In addition, the costs associated with acquiring manufacturing capabilities are exorbitant and, therefore, it is difficult for companies with limited finances and capacity constraints to succeed by themselves. Over the years, the contract manufacturing market has grown

Gene Therapies: Mapping the Future Growth Potential

The first gene therapy, Gendicine®, was only approved in 2003 in China; since then, the domain has evolved significantly. The ‘Gene Therapy Market (2nd Edition), 2018-2030’ report provides an extensive study on the current market landscape of gene therapies, with a prime focus on gene augmentation based therapies and oncolytic viral therapies, featuring an elaborate discussion on the

Novel Drugs and Smart Devices for Respiratory Disorders: Mapping the Future Potential

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. According to the data provided by the WHO, more than 3 million people die annually from COPD. Asthma, on

Cybersecurity in Healthcare: A Must Have in Today’s Digital World

The healthcare industry has been amongst the prime targets for hackers over the last several years. In 2017, the healthcare industry had been compromised a number of times, representing 25% of the total number of breaches worldwide. Across these instances, around 31 million records were compromised, stolen or lost. In order to overcome these challenges,

Back of the Eye Disorders: The Emergence of Novel Drugs and Delivery Technologies

The current treatment landscape for back of the eye disorders is characterized by the presence of blockbuster Novel Drugs, such as Lucentis® and Eylea®, and various other therapeutic options. Despite the success of these therapies, their invasive mode of administration, high dosage frequency and other drug related side effects, are some of the drawbacks that

Cancer Stem Cell Therapies: Mapping the Future Growth Potential

The objective of the ongoing R&D in this domain is to develop novel CSC directed treatments that can combat complications, such as off-target toxicities and disease relapse, associated with the current standard of care treatments. The ‘Cancer Stem Cell Therapies Market, 2017-2030’ report examines the current landscape and the future outlook of the growing pipeline of products

3D Bioprinting: What Lies Ahead?

The current applications of 3D bioprinted products cater to various requirements within the pharmaceutical industry for clinical testing of therapeutic drugs. The ‘3D Bioprinting: Technologies, Products and Key Application Areas, (2nd Edition), 2018-2035’ report provides a comprehensive study on the current market landscape of the 3D bioprinting industry, featuring an elaborate discussion on the future potential of this evolving market. Some of

Non-Antibody Protein Scaffolds: A Niche but Highly Promising Opportunity Area

Amongst other novel formats, non-antibody protein scaffolds have emerged as viable alternatives to conventional therapies, having the capability to address the existing challenges associated with classical antibody based therapies. The ‘Non-Antibody Protein Scaffolds: Drugs and Diagnostics Market, 2017-2030’ report provides a comprehensive study of the current market landscape of non-antibody protein scaffolds, and related drugs and diagnostics, featuring an

Antibody Drug Conjugates: Riding on the Second Growth Wave

While there are close to 200 ADCs in various stages of development, the market field is currently going through a gradual transition, shifting from relying on conventional technologies to newer approaches for generating ADCs. The ‘Antibody Drug Conjugates Market (4th Edition), 2017-2030’ report provides a comprehensive study on the current landscape of ADCs, featuring an elaborate discussion

Biopharmaceutical Contract Manufacturing: Transforming Promise into Reality

The development and manufacturing processes for biologics are complex, and usually require advanced capabilities and specialized expertise. This has led many stakeholders in the biopharmaceutical industry to outsource significant parts of their business operations to contract service providers. The ‘Biopharmaceutical Contract Manufacturing Market (2nd edition), 2017 – 2027’ report provides an extensive study of the contract manufacturing

Antibody Discovery: The Rise of Services and Platform Providers

The rising demand for 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. The ‘Antibody Discovery: Services and Platforms, 2017-2027’ report provides an extensive study on the current market landscape and future outlook of the antibody discovery service and

Modular Facilities in Pharma / Biotech: An Evolutionary Leap Forward

Modular facilities have demonstrated tremendous potential in several fields; specifically, the shorter time taken to establish such facilities has a significant impact on expediting various operational processes. The ‘Modular Facilities in the Pharma / Biotechnology Industry, 2017-2030’ report provides an extensive study on the current market landscape and future outlook of modular facility manufacturers that

3D Cell Cultures: A Multi-Billion Dollar Growth Opportunity

The use of advanced 3D cell culture techniques in in vitro studies is seen to have the capability to overcome several challenges associated with 2D systems. The ‘3D Cell Cultures: Products, Technologies and Key Application Areas (2nd Edition), 2017-2030’ report features an extensive study on the various scaffold-based and scaffold-free 3D culture systems. Some of

Bispecific Antibodies: Current Landscape, Market Trends and Future Outlook

Bispecific antibodies have demonstrated the capability to address the existing challenges associated with monoclonal antibodies, such as high manufacturing costs, limited applicability in assays and the general lack of understanding of precise in vivo mechanisms of action. The ‘Bispecific Antibody Therapeutics Market (3rd Edition), 2017-2030’ report provides a comprehensive study of the current landscape of bispecific antibodies, featuring an

Deep Learning: Opportunities in Drug Discovery and Diagnostics

Deep learning is a novel machine learning technique that can be used to generate relevant insights from large volumes of data. The applications of the technology are being explored across a variety of areas. The ‘Deep Learning: Drug Discovery and Diagnostics Market, 2017-2035′ report examines the current landscape and future outlook of the growing market of deep learning

Liquid Biopsy: Will It Be The Future Gold Standard?

Invasive cancer diagnostic methods, such as tissue biopsies, have been the gold standard to determine the clinicopathological characteristics of cancer tissues for many years. The procedure is not only cost-intensive but is also a traumatic experience for the patients. The ‘Non-Invasive Cancer Diagnostics Market (2nd Edition), 2017-2030’ report provides an extensive study on liquid biopsy kits / assays

Cell Therapy Manufacturing: A Niche but Rapidly Growing Multi-Billion Dollar Industry

Post the approval of first cell-based therapy, Carticel®, in 1997 in the US, the field has rapidly advanced and a number of such therapies are currently under development. The ‘Cell Therapy Manufacturing Market, 2017-2027’ report provides an extensive study of the rapidly growing market of cell therapy manufacturing and focuses both on contract manufacturers and cell therapy

Large Volume Wearable Injectors: The Goldrush Continues

The large scale adoption of prefilled syringes demonstrated the growing interest in the concept of such convenient drug delivery systems. Large volume wearable injectors are advanced versions of the existing self-injection devices. The ‘Large Volume Wearable Injectors Market (3rd Edition), 2017-2027′ report features an extensive study of the current landscape and the likely future evolution of this category

Antibody Humanization and Affinity Maturation: Current Market Landscape and Opportunity Areas

Certain steps of antibody drug discovery require advanced expertise, and companies offering these specialized services have attracted significant attention of drug / therapy developers. Two such specific services are to reduce antibody immunogenicity (humanization) and enhance its affinity (affinity maturation). The ‘Antibody Humanization and Affinity Maturation: Services and Platforms, 2017-2030’ report provides a comprehensive view on the current landscape and the

Cell Line Development: A Gold Mine for Service Providers

Owing to their use in the manufacturing of biologics and biosimilars, and various application areas, such as drug screening, gene functional studies, cell-based assay development, diagnostics and tissue engineering, there is growing demand for different types of cell lines. The ‘Cell Line Development Services Market, 2017 – 2027’ report provides an extensive study of the rapidly growing market

Microbiome Therapeutics and Diagnostics: Unlocking the Future Potential

Microbiome therapeutics represent a new frontier in the field of medicine. Currently, there are many probiotics, prebiotics, and medical foods and supplements that are commercially available, and several drug / therapy candidates that claim to be capable of modifying / manipulating the microbiome in order to provide therapeutic benefits. The ‘Microbiome Therapeutics and Diagnostics Market (2nd Edition), 2017-2030’ report provides a

T-Cell Immunotherapy: The Next Big Thing in Immunotherapeutics

The concept of immunotherapies dates back to the 18th century; however, since its inception, the field has evolved tremendously and is currently cited as one of the most rapidly growing segments of the pharmaceutical industry. Post the early success of immune checkpoint inhibitors, T-cell immunotherapy has emerged as another innovative and potent arm of this market.

Anti-Counterfeiting Technologies in Healthcare

In order to effectively combat the problems related to counterfeit medicines, several companies have come up with innovative technologies to provide the necessary tools to manufacturers, healthcare professionals and patients to authenticate pharmaceutical products. These technologies can be broadly classified under two categories, namely Authentication Technologies and Track & Trace Technologies. Authentication technologies are further

Cancer Stem Cells: A Step Closer to the Cure

The discovery of cancer stems cells (CSCs) may have revolutionized the field of cancer research in a manner similar to how the “germ theory of disease” altered the way medical science looked maladies in general.  Before the germ theory, disease and sicknesses were attributed to be manifestations of bad omens and evil spirits. The discovery of

Genome Editing: Future Potential and Ethical Concerns

Scientists around the word are debating the scientific and ethical possibilities of using powerful gene editing tools, such as the CRISPR/Cas9 system, to treat heritable diseases in human embryos. In 1987, the discovery of Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)/CRISPR-associated (Cas) genes in single celled prokaryotic systems revolutionized genetic engineering. Initially thought to be

Social Media in Pharmaceutical Marketing

The importance of the pharmaceutical industry as a global sector is undeniable. In 2014, pharmaceutical sales reached a milestone of USD 1 trillion. Apart from discovering and developing innovative healthcare solutions, pharmaceutical companies also need to market and promote their products to remain profitable. It is worth mentioning that the sales and distribution of pharmaceutical

Generic Drugs: Rising Opportunity for Indian Pharmaceutical Players

India is en route to becoming a powerful and dynamic nation. Numerous initiatives undertaken by both the private and public sectors have been launched to revolutionize the way the nation operates. Prominent examples include the smart cities initiative, introduction of high speed trains, and the extensive efforts by the current Prime Minister, Mr. Narendra Modi,