The Future Of Healthcare: Wearable Injectors Unveiled

In the continuous evolving landscape of healthcare, wearable injectors have emerged as transformative devices with the potential to redefine patient care. These innovative instruments combine precision, convenience, and patient-centered design to revolutionize drug delivery. In this detailed blog, we will delve deeply into the world of wearable injectors, exploring their underlying technology, advantages, limitations, diverse

Cannabis Testing / Hemp Testing: Unlocking the Future Opportunities in Healthcare

Cannabis testing belongs to a class of flowering plants famous for its psychoactive properties and recreational uses. Cannabis sativa is the most widely used variety of the plant; other forms such as Cannabis indica and Cannabis ruderalis are also popular in different regions.  In earlier times, cannabis was used primarily for recreational purposes, however, medical

Advancements In Automation Of Manufacturing Processes: Key Value Driver For Escalated Interest In The Cell Therapy Domain

Cell therapies are based on the premise that the patient’s own cells (autologous), or those from a healthy donor (allogeneic), can be genetically re-programmed to combat various diseases. In this form of therapy, patients are injected with living and intact human cells that are deemed to be capable of providing therapeutic benefit. It is important

Cryomacs Freezing Bags – A Critical Component in the Successful Delivery of Biological Samples and Therapies

Owing to the ability to preserve a wide variety of elements for such a long period of time, including cells, tissues, blood and DNA, cryopreservation has emerged as a key focus area for stakeholders in the biopharmaceutical industry. It is worth mentioning that it is extremely difficult to store biological components, such as stem cells

The Future of Drug Delivery: Exploring Large Volume Wearable Injectors

With the increasing global population, the incidence rates of several chronic disease indications, such as diabetes, heart disorders, neurological disorders and oncological disorders, are on the rise. Therefore, medical technology is rapidly evolving, enabling more advanced and patient-friendly methods of drug delivery. In the pursuit of creating patient-centric healthcare solutions, the medical industry has witnessed

Conjugation and Labeling of Molecules: A Burgeoning Approach in Therapeutics Development and Molecular Imaging

Conjugation is the process of formation of a single, stable hybrid, wherein one of the entities is a molecule, such as protein, antibody, peptide and small molecule. These molecules can be conjugated with various modalities, such as haptens, enzymes, isotopes, fluorescent tags, carrier proteins, polymers, particle conjugates and photoreactive molecules. Bioconjugation is a subset of

How Can Quantum Computing Technology Help In Pharmaceutical R&D?

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

Companion Diagnostics Services: Future of Outsourcing

In the recent years, service industry has become a fast-growing segment in the overall healthcare domain – thanks to the steady increase in demand for contract research organizations (CROs) and contract manufacturing organizations. The need to focus on developing more efficient interventions, within stipulated timelines and budget constrains is the key driver for outsourcing operations

Breaking the Waves: How Blue Ocean Strategy in Healthcare Can Propel Pharma / Biotech Companies to Success

In the fiercely competitive landscape of the pharma and biotech industries, standing out from the crowd is crucial for success. One strategy that has gained traction in recent years is the Blue Ocean Strategy. By charting new waters and creating uncontested market spaces, companies can differentiate themselves and unlock unprecedented growth opportunities. In this blog

Nutrigenomics: The Future of Personalized Nutrition

Recent advances in DNA sequencing technologies have led to significant developments in healthcare-focused research on precision medicine and diagnostics. Given the recent shift from the one-size-fits-all model to a more personalized mode of treatment, there has been a growing interest for identification and adoption of novel techniques. According to a study, around 20,000 genes are

Digital Biomanufacturing – Current Scenario and Future Trends

Breakthroughs in the biotechnology industry, over the last few decades, has provided a considerable boost to the overall development landscape of biopharmaceutical drugs. In 2022, a milestone was witnessed when the number of approvals received by biologics narrowly outpaced those reported by small molecules. Further, in the same year, nearly half of the biologic approvals

Biopharmaceutical Contract Manufacturing: Transforming Promise into Reality

Over the last few decades, the development landscape of small molecule drugs has been significantly impacted by various biotechnology breakthroughs. Further, with the advent of novel technologies, biologics have made a significant impact in the pharmaceutical domain, delivering ground-breaking treatment for a myriad of disease indications, including immunological, oncological and rare disorders. In this context,

Cell Therapy Consumables Industry: Current Scenario and Future Trends

Cell therapy is the therapeutic approach which involves the injection of healthy cells in the human body, in order to replace the diseased / non-functioning cells to regulate certain functions. Driven by the benefits offered by cellular therapies and recent approvals by regulatory authorities, the demand for such therapies has increased considerably. This trend has

Cell Therapy and Gene Therapy Contract Research Organizations: The Next Growth Opportunity

Over the years, cell and gene therapies (CGT) and other advanced therapy medicinal products (ATMPs) have managed to capture the interest of both drug developers and healthcare investors. Their popularity can be attributed to various factors, such as minimal side effects, clinical efficacy and their personalized nature. However, there are several complexities associated with the

Novel Spectrometry Platforms: Key Advancements

Spectrometry is an analytical technique that is used to analyze the fundamental components of a radiation or ion beam’s spectrum. There are two main divisions of spectrometry, which involve the use of electromagnetic radiation and ionization (also known as mass spectrometry), respectively. The former division of spectrometry uses electromagnetic radiation from different regions of an

Organ-on-Chip: Rising Need of Products and Technologies

The process of drug development and safety testing is extremely expensive and time-consuming. Animal testing is a vital part of drug development process, which is beneficial for researchers in understanding the cause, diagnosis, and treatment of various medical conditions. However, there are several concerns over the validity of animal research; drugs that seem to be safe

RNA Sequencing Service Providers: Growth Opportunities

Genome sequencing has historically been classified into DNA sequencing and RNA sequencing. DNA sequencing generates data that is very robust, reproducible, insightful, and can be applied to genes having different expression level by selecting genomic region. Inspite of several developments made to increase the efficiency of DNA sequencing even further, there are certain challenges associated

Market Landscape of Blockchain in Healthcare: The growing use of the technology in Drug Discovery and Clinical Trials

In recent years, blockchain has garnered significant interest of researchers, as well as industry players, as it has proven to be a versatile tool for decentralized monetary transactions and data exchange in various industries, such as banking, cyber security, supply chain management, government and healthcare. Several stakeholders in healthcare have adopted blockchain for various operations,

mRNA: A New Era in Biopharmaceutical Contract Manufacturing Market

mRNA has completely revolutionized the field of medicine and significantly influenced the study and treatment of human diseases. The success of COVID-19 vaccines paved the path for mRNA-based drug products. Safety, efficacy and rapid production of mRNA drives the interest in this domain. However, synthesis and manufacturing of mRNA is fraught with several challenges as

Transforming Biomanufacturing: Potential of Cell Free Systems

Overview of Cell Free Systems Cell-free systems are ­in-vitro platforms which allow occurrence of biochemical reactions in the absence of living cells. These expression systems utilize bio machinery harvested from the lysate of disrupted cells for the manufacturing of a wide array of macromolecular and small molecule products. Biomanufacturing utilizing cell free systems is an

Manufacturing Execution Systems: A Necessity for Healthcare Industry

Like any other industry, the healthcare industry is drastically growing in its way. Thus, manufacturers need to update themselves with the new technologies and tools to stay relevant and competitive with the current market trends. Manufacturing execution systems (MES) play a crucial role in achieving long term competitive advantages in the healthcare industry. MES is

Novel Antibody Therapies: Addressing Unmet Needs for Oncological Disorders

Antibodies are key components of the immune system that bind to specific markers on cells or tissues, thereby offering first line of defense against multiple disorders. The novel antibody therapies include different classes of antibodies, that are responsible for killing or inhibiting disease-causing agents. These therapies target proteins that are expressed on the surface of

Manufacturing Execution Systems: A Step Towards Smart Manufacturing in Healthcare Sector

The continuously growing demand for healthcare products and present economic environment drives the need for adoption of automated tool and technologies in order to improve manufacturing, process, increase throughput reduce cycle time, maintain quality and to get the best out of the available resources to eliminate unnecessary production costs. It is worth mentioning that in

Novel Antibody Therapies: Current Scenario and Future Potential

Novel antibody therapies are chimeric proteins having antibodies attached lethal effector molecules. Currently, six of these therapies are commercially available, while around 140 molecules are under development majorly for oncological disorders. Multiple novel antibody formats have been engineered to enhance therapeutic efficacy. This has opened a new target space for the development of antibody therapeutics

Liposome: A Novel Drug Delivery System

Introduction to Liposome Liposome was initially identified and described as swollen phospholipid systems, called Banghasomes, by British hematologist Alec D. Bangham, in 1961 at the Babraham Institute, University of Cambridge. Later, the structural description of liposomes was revealed as small systems constituting one or more closed phospholipid bilayers. The liposomal vesicles are considered as either

Transformation of Biopharmaceuticals Manufacturing Through Single-use Bioreactors

Recently, in the biopharmaceutical industry an increasing demand for quality biologics has been observed, where Single-Use-Systems (SUSs) Bioreactors have emerged as one of the most prominent and reliable solution for biomanufacturing. Disposable bioreactors have transformed the process of conventional biomanufacturing, and their adoption is increasing rapidly for production of various biologics, such as antibody, recombinant proteins,

Medical Device Coating and Surface Modification Technologies: Current Market Landscape and Emerging Opportunities

Over the past 50 years, the medical device industry has seen several notable developments. In fact, the use of biomedical devices, such as medical implants, surgical instruments, and prostheses has increased substantially over the time. Every year, millions of individuals undergo surgeries and implantations. Cardioverter defibrillators, prosthetic hips and knees, contact lenses, and cardiac pacemakers

Cell Free System market: Current Landscape, Growth Opportunities and Future Market Outlook

In recent years, cell free systems / cell free expression systems have emerged as a promising alternative for the conventional cell-based biomanufacturing process. It is a well-known fact that traditional biomanufacturing is a complex process that requires living cells and specific conditions in order to maintain proper homeostasis for cell growth. Moreover, cell based biomanufacturing

Next Generation Biomanufacturing – The Upcoming Era of Digital Transformation

Upon realizing the potential of digital biomanufacturing over traditional processes, players are actively undertaking initiatives to adopt advanced platforms to drive operational excellence, visibility, control and synchronization in bioprocessing. Industry 4.0: An amalgamation of physical equipment and smart software Digital biomanufacturing offers real-time process optimization based on factors, such as anticipated product quality and batch

Antiviral Drugs: The Unmet Requirement in the Pharmaceutical Space

Over the past few years, a number of antiviral drugs targeting a myriad of infectious diseases, including human immunodeficiency virus (HIV) infection, hepatitis, herpes simplex virus (HSV) infection, cytomegalovirus (CMV) infection, influenza, coronavirus infection (COVID-19) and others, have received approvals from various regulatory authorities, globally. However, it is important to note that, currently, the approved

Key Trends in Non-Viral Transfection Market

In order to manipulate the cells, genetic material / nucleic acid is artificially introduced into the cells by using specific carriers / vectors. This process is known as transfection. It does not use viral components for transfection and are aimed at circumventing the challenges, such as inflammation, immunogenicity and non-specific transduction, associated with viral vectors.

Deep Learning-based Interoperability: Advanced Neural Networks Mimicking the Human Brain

Artificial intelligence is the ability of a system to think like humans, discover the meaning, and execute the tasks. Recent advancements in the AI domain (e.g. deep learning, machine learning) have contributed to an invariable increase in the popularity of this technology across several industries, having impacted the healthcare industry at a significant scale. Machine

mRNA Therapeutics and mRNA Vaccines Industry: Current Scenario and Future Trends

Messenger ribonucleic acid (mRNA) is a single-stranded molecule that is complementary to a gene’s DNA. It is important in the process of protein synthesis because mRNA is responsible for transferring genetic information from DNA to ribosomes, which then decodes the genetic information into a protein. In the last few years, researchers have become interested in

Novel Cell Cytometers: Need of the Hour

The domain of novel cell cytometers has attracted much attention of within the global biopharmaceutical industry in recent years. This popularity can be attributed mainly to the need of these tools to address the rising prevalence of chronic disease conditions. Cell cytometers allow for the simultaneous characterization of cells from a mixed population, thereby helping

Patient Recruitment – Key Determinant of Successful Clinical Trials

Clinical trials are a fundamental requirement for evaluating the safety and efficacy of novel therapeutic interventions. Initiating a clinical trial is a complex and time-consuming process, involving suitable planning and execution. In addition, there are several other challenges, including inefficiencies related to data handling, and difficulties associated with patient enrollment and retainment, which further complicates

Exploring AI-based Digital Pathology

How is AI being used in Digital Pathology? Digital pathology is a transformative technology that has enabled pathologists to make the shift from visual inspection of tissue samples to automated image analysis. With the advent of AI, pathologists are now benefiting from computerized image analysis software that can draw conclusions and deliver diagnoses in a

NFC Tags and RFID Smart Labels for Pharmaceutical and Healthcare Industry: Lets trace medicines from its origin

Traditionally, text and images were printed on pharmaceutical products to convey important information. In recent years, the use of smart labels allows the developer to convey a greater amount of information about the product to the consumers, without the need for additional packaging space. It is worth noting that smart labels contain a transponder code

Introduction To Exosome Therapeutics

In  recent years, therapies utilizing extracellular vesicles have garnered significant attention among the industry stakeholders for the treatment of diverse target indication, primarily owing to the various benefits offered by them, including target specificity, enhanced tissue regeneration, and reduced inflammation and chronic pain. Over time, various research studies have demonstrated the potential of exosomes (membrane

Unlocking the Potential of Digital Twins in Healthcare: Benefits, Challenges and Opportunities

The application of digital twins in healthcare has the potential to revolutionize patient care, improve clinical outcomes, and reduce costs. Digital twins, or virtual replicas of physical objects and environments, are being used in many different industries, and healthcare is no exception. In healthcare, these can be used to provide better patient monitoring, improve remote

Investment Opportunities in Women’s Digital Health

Digital health is a broad term that refers to the utilization of communication and information technologies to manage, track, and improve the overall healthcare delivery system. Owing to the potential of digital technology to optimize patient healthcare and the development of pharmaceuticals, the digital healthcare industry has witnessed significant rise in investments in the past

Genotoxicity Testing: Unlocking the Future Safety Assessment Opportunities

Genotoxicity testing refers to the evaluation of detrimental effects of chemical or physical agents on the genetic processes and related hereditary material of living cells. On the other hand, mutagenicity is the process of inducing irreversible and transmissible alterations in the genetic material of organisms either spontaneously or through mutagenic activity. Disruption of the integrity

Adeno-Associated Viral Vectors: Unlocking the Future Opportunities

Given the potential of gene therapies in targeting the underlying cause of a disease at cellular level,  the demand for such therapies has increased considerably over the past few years. Currently, more than 285 gene therapies are being evaluated in different phases of clinical development. Further, various gene therapy developers have raised more than USD 10 billion

Modular Construction – Retrofitting Conventional Buildings

Shifting construction away from traditional sites and into factories could dramatically change the way we build. Will off-site builds bolster construction this time around? Over the years, construction has straggled behind other sectors in terms of efficiency. Off-site builds or modular construction is a powerful way to reform construction business saving more time, labor, cost

Long-Acting Drug Delivery: A Novel Pharmacological Strategy to Deliver Therapeutic Modalities

Over the last two decades, the pharmaceutical industry has observed a paradigm shift from conventional drug delivery strategies to the long-acting drug delivery (LADD) of products to treat several disease indications, such as ophthalmic disorders, oncological disorders, neurological disorders and infectious diseases. LADD has emerged as the novel and advanced drug delivery system which manipulate

Digital Therapies: The “Digital Pills” of current generation

As per United Nation’s report, the current global population stands at around 8 billion and expected to reach 9 billion by the end of 2030. This increase in population is accompanied with a rise in the incidence of several chronic disease indications. In fact, as per a report published by National Association of Chronic Disease

Medical Device Coatings and Modification Technologies

Over the past 50 years, the medical device industry has seen several notable developments. In fact, according to the World Health Organization (WHO), presently, around two million medical devices are available across the globe. Further, since 2020, the Food and Drug Administration (FDA) has approved 125 medical devices. The growing demand for complex medical devices,

The Future of Dentistry: Dental 3D Printing

3D printing, also known as additive manufacturing, is a method of producing 3-dimensional objects layer-by-layer, using a computer aided design. Owing to its ability to print complex models using a wide range of materials, 3D printing has applications across various industries, including dental, aerospace, automotive, healthcare, food, fashion, mechanical engineering and other manufacturing industries.  In

Bioavailability Enhancement Technologies

A study conducted on terminated drug development projects revealed that majority of the drug candidates fail in early drug development phases, due to the problems associated with their pharmacokinetic profiles, ADME (distribution, metabolism, absorption and excretion) properties and toxicity-related issues. Moreover, it is a well-established fact that the systemic / local absorption and distribution of

Liposomes Development: Service Providers Landscape

In recent years, liposomes have garnered significant interest of researchers, as well as industry players, owing to their potential in diagnosis and treatment of various diseases, with a focus on delivering drugs and genetic material. Liposomes are small, artificial and lipid-based bilayered spherical vesicles, which are created spontaneously by hydrated phospholipids. Owing to their ability

mRNA Synthesis: ManufacturingProcess of Modern Revolutionary Molecule

Messenger ribonucleic acid (mRNA) is a single-stranded molecule, which carries coding sequence and plays a prominent role in protein synthesis. It transfers genetic information form to DNA to ribosomes, a specialized structure, or organelle, which decodes genetic information into a protein. Structure of mRNA Post the onset of the COVID-19 pandemic mRNA has emerged as

TIL Therapies: A New Paradigm in Cancer Treatment

Modified tumor-infiltrating lymphocytes or TIL therapies have emerged as a viable and potent option to selectively eradicate the tumor population, with minimal side effects. Till date, several clinical trials have demonstrated the efficacy and therapeutic superiority (over conventional treatment options) of TIL-based therapies. Their tumor-cell killing efficiency is attributed to the fact that they are

Viral Clearance and Viral Testing Services

Considering the rising demand for biologics, innovators in the biopharmaceutical industry are constantly exploring avenues that would enable them to overcome the existing technical and operational challenges related to viral-clearance and testing for timely approval of biologics. Outsourcing the viral-clearance and viral testing studies has emerged as a promising alternative for most of the manufacturers.

Artificial Intelligence (AI) In Oncology: Current Scenario And Future Potential

In the last decade, the popularity of AI has grown invariably. Specifically, it has made a considerable impact in the medical sector and oncologic treatment as well, due to a surge in electronic data, breakthroughs in technological infrastructure and groundbreaking research in deep learning neural networks. AI has demonstrated potential in improving tumor imaging diagnosis

Rising Demand for Medical Devices CROs

Over the past decade, numerous scientific and technological breakthroughs in the medical device CROs industry have resulted in an accelerated pace of research and innovation within this domain. Further, the demand for advanced and minimally invasive medical devices has been augmented due to the increase in expenditure on healthcare. However, one of the primary challenges

SARM1 Inhibitors: A Novel Approach Against Neurodegenerative Disorders

Presently, several industry and non-industry stakeholders are evaluating SARM1 inhibitors as potential therapeutic agents for the treatment of neurological disorders across various preclinical studies and early stages of clinical development, worldwide. Given the encouraging research outcomes, the players in this domain have received more than USD 10 million in grants, since 2014, from the various

TCR Therapies: An Emerging Therapeutic Modality

Modified T-cell receptors or TCR therapies is an emerging class of adoptive therapy that employs genetically modified lymphocytes to target specific tumor markers. Structurally, TCR is a heterodimer comprising of two different polypeptide chains, namely the α-chain and β-chain. TCR therapies’ tumor-cell killing efficacy may be primarily attributed to the fact that they are pre-sensitized

Cell Therapy – The Revolutionary Therapeutic Modality: All Set To Obliterate Oncological Disorders

The American Society of Gene and Cell Therapy (ASGCT) defines cell therapy as a therapeutic modality that involves the administration of either normal or modified cells to patients for the treatment of various diseases. In this form of therapy, patients are injected with living and intact human cells that are deemed to be capable of

Applications of Blockchain in Various Sectors: An Introduction

Introduction and Applications of Blockchain The term blockchain refers to the way it stores transaction data in blocks that are linked to form a chain. This technology is also known as Distributed Ledger Technology. Since every entry is stored as a block on the chain, the length of the chain increases as more transactions are

Intracellular Drug Delivery – Future Potential

Healthcare treatment is important for those having fatal diseases and so is the precision treatment in almost every case. One of such disease which has squabbled the entire humanity and accounts for the highest number of death rates globally is cancer. It’s a disease wherein the body’s abnormal cells grow uncontrollably and spread to other

Antiviral Drugs Development: Are we Prepared for the Next Viral Pandemic?

Infectious diseases are known to be one of the top 10 leading causes of deaths, worldwide. In-fact, more than 40 million people are affected by various types of infectious diseases annually. Further, it has been around three years since the COVID-19 pandemic hit the world, and yet, shows no signs of disappearing. An article published

Exploring How Artificial Intelligence Is Transforming Digital Pathology

How is AI being used in Digital Pathology? Digital pathology is a transformative technology that has enabled pathologists to make the shift from visual inspection of tissue samples to automated image analysis. With the advent of AI, pathologists are now benefiting from computerized image analysis software that can draw conclusions and deliver diagnoses in a

At-home Self-testing: A Giant Leap Towards Transformation in Diagnostic Sector

In the health industry, digitization has evolved over time with numerous advances to ensure that everyone has equitable access to health products and medical specialists.  At-home Self-testing has the ability to improve health equity and accelerate progress toward universal health coverage, and it has the capacity to alter health care. Self-testing alternatives provide individuals and

SARM1: A Potential Therapeutic Target For Neurodegenerative Diseases

Neurological disorders are considered the second leading cause of death and the primary cause of long-term disability, worldwide. In fact, over 6.5 million neurological disorder related deaths are reported annually, globally. Further, according to a report published by the United Nation (UN), close to 1 billion people, across the globe, suffer from various types of

Advancements in Automation of Processes: Key Value Driver for Escalated Interest in Cell Therapies Manufacturing Domain

Considering the vast potential of cell therapies in the treatment of rare disorders and sufficient body of evidence validating the clinical benefits / therapeutic potential of this complex class of biologic drugs, cell therapies have garnered considerable attention of players engaged in the healthcare industry, in the past few years. The focus of stakeholders has

CAR-T Cell Therapy: Addressing Key Unmet Needs Across Various Oncological Indications

Amidst the active initiatives undertaken to develop more targeted anti-cancer therapies, CAR-T therapies have emerged as a promising option, given their ability to eradicate tumor cells from the body with minimal treatment-related side effects. Further, CAR-T cell therapy, relatively recent addition to the gamut of anticancer interventions, has demonstrated significant promise. Overall, this highly specific

Rising Need of Organ on a Chip Products And Technologies

The process of drug development and safety testing is extremely expensive and time-consuming. Animal testing is a vital part of drug development process, which is beneficial for researchers in understanding the cause, diagnosis, and treatment of various medical conditions. However, there are several concerns over the validity of animal research; drugs that seem to be

Antibody Drug Conjugates Market: The Future of Novel Therapies

Antibody drug conjugates (ADCs) are an upcoming class of targeted therapeutic agents that have garnered the attention of pharmaceutical companies, and academic / research institutions across the world. Fundamentally, these complex biotherapeutic entities represent the combination of the target specificity of an antibody and the therapeutic features of a chemotherapy / cytotoxic drug. Such conjugates

Spatial Genomics, Transcriptomics and Proteomics Solutions – An Amelioration of Tissue Analytics

Recent advances in multi-omics approaches, including genomics, transcriptomics, proteomics, metabolomics, cytometry and imaging, in combination with bioinformatics and biostatistics, have been translated into several popular bioanalytical platforms, such as next-generation sequencing (NGS), single-cell analysis, flow cytometry and mass spectrometry. These platforms, although widely adopted, require tissue fixation and are therefore not capable of providing fundamental

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

Is Blue Ocean Strategy The Silver Bullet For Emerging Teleradiology Players to Achieve A Breakthrough In This Highly Competitive Market?

Blue ocean strategy, a concept first introduced in 2004, by W Chan Kim, and Renee Mauborgne in their bestselling book of the same name, talks about how to achieve a breakthrough in a highly saturated market by focusing on creating a new uncontested market. Blue ocean strategy is a systematic approach that helps emerging service

Women’s Digital Health: A New Era of Female Healthcare

Women’s digital health involves the initiatives taken by industry stakeholders and researchers, which include technological remedies, such as mobile apps, software, wearable devices and diagnostic tools that exclusively aid in improving female health and wellness. Since it is primarily focused on women’s healthcare, it is termed as Female Technology or FemTech. The term “FemTech” was

Sustainable, biodegradable and Eco- Friendly Packaging: A Paradigm Shift in Healthcare Packaging

What is Sustainability and Why is Sustainability Important? The term sustainability is derived from the Latin word sustinere, which means to hold or support. Sustainable packaging is defined as packaging that is safe for individuals, as well as the environment, while meeting all requirements for performance, cost and ease of fabrication. Further, the product should be specially

Single-use Technology: A Step Towards Future Transformation

Over the past decade, the biopharmaceutical industry has witnessed several advancements in terms of bioprocessing. Bioprocess technology is one of the integral parts of biotechnology that deals with different biological processes involving living or competent cells to get value added products at the end of the process. Recently, an increasing demand for various efficient technology

Continuous Manufacturing:  A Magic Bullet to Meet the Demand for Pharmaceutical Products

Over the last few decades, the pharmaceutical industry has been using batch processes for production of pharmaceutical products, which is a multi-phase process. However, the surge in the demand for drugs due to COVID-19 has led the pharmaceutical industry to shift on to a more agile and flexible technique- continuous, which is a single flow

Metabolomics: An Emerging yet Powerful Tool in Clinical Research and Development

Scientific fields involved in high throughput measurement of biological molecules are referred with the suffix-omics including, transcriptomics, genomics, proteomics and metabolomics. Genomics is the study of genetic material within a cell, and transcriptomics is the study of gene activity in different cells. Likewise, metabolomics refers to the study of byproducts of metabolism. Although, metabolomics is

Subcutaneous Biologics: The Unmet Requirement in the Pharmaceutical Space

Over the years, the incidence and prevalence of chronic diseases, have increased significantly. Presently, the recommended treatment options for such clinical conditions are mostly biologics, which need to be administered via parenteral routes to ensure maximum therapeutic benefit. Given the inherent requirement for frequent medication, patients suffering from such long-lasting clinical conditions generally end up

Exosomes Manufacturing: A Deeper Look into Service Providers Market

Over the years, applications of exosomes in therapeutics have undergone an evolutionary change, in terms of cost of research, technology used, and duration of the study. Moreover, various startups and small firms have entered into collaborations in order to advance their innovations and offer specialized research expertise, services and technologies. In order to promote the

Biopharmaceutical Excipient Manufacturing – Current Scenario and Future Trends

Over the years, the rising popularity of biologics has led to a paradigm shift in the healthcare industry. In the last decade alone, the annual number of approvals of biopharmaceuticals (including monoclonal antibodies, recombinant proteins, vaccines and gene therapies), by the US FDA, have steadily risen. In fact, over 8,000 biological pharmaceutical products are currently

Biopharmaceutical Excipient Manufacturing Market: Current Scenario and Future Potential

Over the years, the rising popularity of biologics has led to a paradigm shift in the healthcare industry. In the last decade alone, the annual number of approvals of biopharmaceuticals (including monoclonal antibodies, recombinant proteins, vaccines, and gene therapies), by the US FDA, have steadily risen. In fact, over 8,000 biological pharmaceutical products are currently

Complement Therapeutics: The Clinical Antidote for Complement-Associated Diseases

Complement System:  Key Component of Immune System Complement system was discovered in 19th century as a part of immune system responsible for tissue repair and homeostasis, thereby providing first line of defense against multiple infections. This complete process is in association with a complex and highly regulated assembly of proteins which involve several soluble and

Next Generation Complement Therapeutics: Potential Life-Changing Therapies for Multiple Rare Disorders

Since the approval of Soliris® in 2007, an anti-C5 antibody, the field of complement drug discovery has gained significant attention. Currently, nine complement therapeutics are commercially available, while around 190 molecules are under development for various disease indications. Some of the complement therapeutics, namely Berinert®, Cinryze®, ORLADEYO®, Ruconest® and TAKHZYRO® were approved for the treatment

Oral Protein / Peptide-based Drugs: Addressing Key Unmet Needs Across Disease Indications

Orally administrable protein / peptide-based therapeutics offer several advantages including, effective treatment of numerous clinical conditions and degenerative disorders. Interestingly, recent advances in this domain have led to the development of several treatment strategies that, according to developers, exhibit the necessary capabilities to overcome challenges posed by traditional oral protein formulations  and peptide-based therapies. One of

Intranasal Therapeutics and Drug Delivery Systems: The Perfect Alternative to Conventional Route of Administration

The intranasal route of administration is widely accepted as effective and non-invasive option for the local and systemic delivery of several types of active pharmaceutical ingredients (API). Majority of such formulations are designed to treat chronic obstructive pulmonary disorders (COPD), asthma and other respiratory diseases. Interestingly, over the past few years, drug developers focused on

Container Closure Integrity Testing: A Necessity for Pharmaceutical Industry

Over the past few years, the pharmaceutical industry is growing a tremendous pace. Considering patient’s health and safety, the drug products are expected to be free from microbial contamination and should be safe for use throughout the drug’s life cycle. Therefore, several quality checks are performed to ensure product’s sterility and stability. One of the

Accelerating Oligonucleotide Demand: A Force Driving The Contract Manufacturing Market

Since the approval of the first antisense therapy in 1998, oligonucleotides have been in light for their capabilities as therapeutic agents. Oligonucleotides are short synthetic nucleotide chains with immense potential in the diagnosis and treatment of a myriad of disease indications. In addition to therapeutics, these complex molecules act as a significant resource in various

Next Generation Sequencing (NGS) Library Preparation Kits: Revolutionizing the Field of Genetic Sciences

NGS has emerged as an evolutionary technology in modern biotechnology and healthcare research, enabling researchers to develop a better understanding of the cause and consequences of disease. Over the past few years, several companies have started offering a diverse range of genome sequencing products and services using various second and third generation sequencing technologies. Presently,

Rising Need of Autoinjectors

With the increasing global population, the incidence rates of several chronic disease indications, such as diabetes, anaphylaxis, rheumatoid arthritis and psoriasis, are on the rise. This has led to a rise in the demand for effective treatment options for patients suffering from these diseases. Further, in order to improve the quality of life in these

Next Generation Sequencing (NGS) Library Preparation Kits Market: Current Scenario and Future Potential

Since the introduction of a gene sequencing method by Frederick Sanger in 1977, the field of genomic data collection and analysis has evolved significantly. Advancement in DNA sequencing technologies have resulted in noteworthy developments in various healthcare-related research fields, such as diagnostics and personalized medicine. However, the conventional nucleotide library preparation process has several challenges,

Growing Demand for Oligonucleotides Proposes Shedload of Opportunities for Contract Manufacturers

In the 20th century, major research went into discovery of a therapeutic class with the primary purpose of interfering with the RNA expression linked to disease causing proteins, nowadays classified as oligonucleotides. These short, single-stranded DNA or RNA molecules have various applications in biopharmaceutical and biotechnology industries including, genetic testing, basic research, forensic analysis and

MYELOID CELL TARGETING THERAPEUTICS: BUDDING THERAPY AGAINST CANCER

Myeloid cells represent a group of cells containing granulocytes, monocytes, macrophages, mast cells and dendritic cells, which play a key role in innate immunity. These cells are found in abundance in the tumor microenvironment and inflamed areas. The tumor recruits and modulates endogenous myeloid cells to tumor-associated macrophages, dendritic cells, myeloid-derived suppressor cells and neutrophils,

Bringing in Light Genome Editing Techniques: ZFN, TALEN and Meganucleases

Presently, there are several companies and universities, which are exploring the potential of different gene editing technologies beyond CRISPR for basic research, and the development of gene editing solutions. With the development of a variety of versatile DNA modulation technologies such as include zinc-finger nucleases (ZFNs), TAL effector nucleases (TALENs), engineered endonucleases / meganucleases (EMNs)

ADC Payload / Warheads and Rise in its Demand

With six approved drugs, namely POLIVY™ (2019), LUMOXITI™ (2018), BESPONSA® (2017), MYLOTARG™ (2017, reapproval), KADCYLA® (2013) and ADCETRIS® (2011), and more than 300 candidates in the pipeline (clinical / preclinical stages), antibody drug conjugates (ADCs) have emerged as a promising class of therapeutics for the treatment of various disease indications. Over time, medical researchers have

Myeloid cell targeting therapeutics: Budding therapy against cancer

Myeloid cells represent a group of cells containing granulocytes, monocytes, macrophages, mast cells and dendritic cells, which play a key role in innate immunity. These cells are found in abundance in the tumor microenvironment and inflamed areas. The tumor recruits and modulates endogenous myeloid cells to tumor-associated macrophages, dendritic cells, myeloid-derived suppressor cells and neutrophils,

Site management organizations: A deeper look into clinical trial site management landscape

Clinical trials form an integral part of the overall drug development process, enabling the necessary evaluation of the safety and efficacy of a drug candidate. Studies suggest that around 40% of the total investment made for the development of drug candidate is dedicated to clinical trials; this is equivalent to an expenditure of USD 78

At-Home Blood Collection: New Era of Diagnosis and Testing

In the era of COVID-19, where the world is looking for point of care treatment, in order to avoid maintain physical distance. Post the onset of COVID-19 pandemic, there has been a decline in number of patients visiting laboratories for sample collection and testing. To avoid risk of infections, patients have postponed their routine tests

Myeloid Cell Targeting Therapies: Budding Therapy Against Cancer

The global cancer burden is increasing rapidly with over 19 million new cancer cases and 10 million deaths reported in the year 2020. Given the rising prevalence, researchers have made significant efforts in discovering new approaches for the treatment of oncological diseases. With several programs having entered the clinical stages, myeloid cell targeting therapies have

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Classification of Regulatory T-Cell Therapies The Regulatory T-Cell Therapies (Tregs) are a mature subpopulation of T-cells that play a critical role in mediating immunological tolerance to self-antigens and suppress immune responses that are harmful to the host, thereby, enabling homeostasis. These mainly develop in thymus from CD4+ thymocytes and are mainly of three types: natural

Site Management Organizations (SMOs): A Trending Term in the Clinical Trial Domain

Innovators in the pharmaceutical industry are constantly developing ways to improve the process of conducting clinical trials and managing research sites. Amidst other alternatives, outsourcing various trial operations to a specialized service provider, such as site management organizations (SMOs), has emerged as a viable option for various developers. The advantages of engaging such specialized service

DNA DATA STORAGE: RESEARCH LANDSCAPE AND FUTURE PROSPECTS

DNA data storage involves encoding and decoding binary data to and from synthesized strands of DNA. It offers generous, long-lasting, and stable data storage solution with orders of magnitude relatively higher than current storage mediums. Owing to the numerous benefits offered by DNA data storage as compared to other mediums, it is anticipated that this

HER2 Targeting Therapies Market: A Deeper Look into Therapy Developer Landscape and Future Opportunities

The epidermal growth factor receptor (EGFR is a tumor resistance biomarker which plays an essential role in the differentiation and proliferation upon activation through the binding of one of its ligands. A non-ligand-binding member of EGFR family, HER2 exerts its activity through heterodimerisation along with its other family members. HER2 is a transmembrane growth factor

THE RISING REALM: BIOPRESERVATION MEDIA INDUSTRY

Biopreservation is the exclusive biological approach designated for the preservation of cells, tissues and organs ex-vivo for the purpose of storage, shipment and transportation. Biopreservation media is one of the most crucial entity in conferring effectiveness. The selection of the type of media depends upon the considerable time duration desired for the storage, type of

Cell and Gene Therapy Bioassay – A Prerequisite for the ATMPs Development

Bioassay – A Prerequisite for the Cell and Gene Therapy Development Over the past few years, investigational new drug (IND) filings for cell and gene therapy product have significantly increased. In fact, from year 2016 to 2020 more than 300 IND filing for cell and gene therapy product have been recorded, indicating that several developers

Rising Need of Large Volume Wearable Injectors

With the increasing global population, the incidence rates of several chronic disease indications, such as diabetes, heart disorders, neurological disorders and oncological disorders, are on the rise. This has led to a rise in the demand for effective treatment options for patients suffering from these diseases. Further, in order to improve the quality of life

Pharmaceutical Vials Witnessing High Demand Due to COVID-19 Pandemic

Over the years, advances in drug / therapy development processes have led the pharmaceutical industry to gradually shift from a one-drug treats all model to a more personalized approach of treatment. The growing complexity of modern pharmacological interventions, such as monoclonal antibodies, and cell and gene therapies, has further prompted the drug developers to develop

Fc Fusion Therapeutics – A New Approach to Drug Therapy

Since the approval of Enbrel®, CD4-Fc fusion protein (for the treatment of rheumatoid arthritis) in 1998, Fc fusion therapies have evolved into a prominent class of therapeutics.[1] Currently, 13 Fc fusion drugs are commercially available, while around 50 molecules are under development for various disease indications. Some of the Fc fusion therapeutics including  Arcalyst® (recurrent pericarditis,

Pharmaceutical Vials Market: Current Scenario and Future Trends

Primary packaging material (e.g. Pharmaceutical Vials) plays a crucial role in preserving the stability, efficacy and safety of the drug as it is in direct contact with the packaged therapeutic. Additionally, primary packaging material assists in maintaining the sterility and quality of a drug product, while also providing information related to its identity and, in

ADC Therapeutics – Alternative to Traditional Anticancer Therapies

Antibody-drug conjugates (ADCs) are an upcoming class of targeted therapeutic agents that have captured the attention of both large and small pharmaceutical companies, and academic / research institutions from all across the world. Fundamentally, these complex biotherapeutic entities demonstrate the combination of target specificity of an antibody and therapeutic features of a chemotherapy / cytotoxic

Glycoengineered Antibodies and Fc Protein – Virtue of enhanced effector functions

With close to 100 approved monoclonal antibodies, and over 550 molecules in the clinical pipeline, antibody based pharmacological interventions have become one of the fast growing segment of the biopharmaceutical industry.[1] In fact, these interventions are anticipated to generate a cumulative sales of USD 300 billion by 2025.[2] Further, within the antibody therapeutics industry, engineered

Antibody Drug Conjugates – A Potential Tool Against Cancer

Over the years, various technological advancements, such as antibody engineering for site-specific conjugation and enhanced pharmacokinetic and pharmacodynamic properties, have paved the way for antibody drug conjugates (ADCs) to be recognized as potent therapies targeting a wide range of indications, including solid tumors and hematological malignancies. ADC Therapeutics are engineered therapies comprised of monoclonal antibodies

Sustainable Packaging: Paramount for Pharmaceutical Sector

Sustainable Packaging in pharmaceutical industry plays a crucial role in ensuring the sterility and quality of a drug product, while it also provides information related to its identity and, in certain cases, dosing instructions. Pharmaceutical packaging is typically carried out under Packagingcontrolled conditions; specifically, for therapeutics that are designed for parenteral administration, fill / finish

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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

Cell Therapy Packaging – Importance and Future Perspective

Over the years, the pharmaceutical industry has witnessed several advancements in drug development. It has gradually shifted from a one-drug treats all model to a more personalized approach of treatment, which involves the use of personalized cell therapies for various disease indications. This shift has led to an evident change in the pharmaceutical packaging domain

Progressive Supranuclear Palsy (PSP): A Tough Nut to Crack

Since John Steele, John Richardson, and Jerzy Olszewski first described Progressive Supranuclear Palsy (PSP) in 1964, the neuroscience community has been on the lookout to find a “miracle molecule” or an “elixir” that can cure patients diagnosed with this debilitating disease. With more than 2,000 research studies published so far, the domain has garnered significant

Teleradiology: The Need of The Hour During COVID-19 Pandemic

Teleradiology is a branch of telemedicine that uses telecommunication systems for the transmission of radiological images from one location to another. Additionally, it helps the radiologists to interpret various types of images, such as computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), ultrasound, and X-rays, remotely. As of late, teleradiology has piqued

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In the era of digitalization where the world is looking forward towards automating their manufacturing process, the bioprocess industry took a while to adopt the automation technology. The biopharmaceutical industry came across several obstacles while adopting the automated technology. Examples of which include, complexity of the processes and delicacy of the living cells and organisms

Novel Drug Reconstitution Systems: Opportunities in Accurate Reconstitution and Drug Delivery

The novel drug reconstitution systems have emerged as a promising alternative to traditional methods of reconstitution, adding significant value to the storage and transfer of lyophilized therapeutics. These systems enhance the portability, efficiency and optimum delivery of the lyophilized drugs and have the potential to reduce the number of steps significantly, which enable the dilution

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

ADC Manufacturing: How Are the Contract Manufacturers Supporting the Growing Demand

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 antibody-drug

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

Cell Therapy Manufacturing: Here are the Key Innovations

Last week, during our weekly industry update sessions, our prime focus was to understand the recent innovations in the field of cell therapy manufacturing. We were also looking out for players that are driving these innovations. To start with, the first news that caught our attention was Novartis’ decision to sidestep Europe travel ban to

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.

Vector Manufacturing Market: Opinion Leaders Highlight Key Concerns

The growing pipeline of cell and gene therapies has led to an increase in demand for high-quality gene delivery vehicles and, therefore, has created significant opportunities for companies with expertise in manufacturing viral and non-viral vectors. In an article published last year, I discussed the growing cell and gene therapy market and how it has

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

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 editing services. To get more insights about the market, check out the detailed report market report – Genome Editing Services.

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

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,

10 Key Facts About ADC Market

Global Antibody Drug Conjugates ADC market is expanding and is estimated to be around USD 7.72 billion in 2023. The compound annual growth rate of ADC market is estimated to be 9.50% in the coming decade. Roots Analysis has been publishing multiple articles and key insights pack for ADC market growing potential to keep the

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

Biopharmaceutical CMO: The Growing Need

Over the years, the biopharmaceutical market has grown into a prominent and promising segment of the overall pharmaceutical industry. Owing to the growing number of start-ups that are engaged in R&D of novel biologics, there is significant opportunity for the biopharmaceutical CMOs in this domain. It is worth highlighting that, since 2000, more than 115

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