Research Insights

On an average, around 50 drugs are approved by the US Food and Drug Administration (US FDA) annually. Further, studies indicate that more than 100,000 tons of pharmaceutical products are consumed globally per year. In addition, over the next five years, the global pharmaceutical market is projected to grow at a CAGR of 4.7%, with global drug sales anticipated to raise revenues worth USD 1.5 trillion in 2023. This continuously growing pipeline of pharmaceutical drug products has inadvertently led

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Over the past few years, a number of advanced vaccines targeting a myriad of disease indications have received approval from various regulatory authorities. Post the onset of COVID-19, there has been a surge in the demand for viral vaccines. In fact, it is estimated that more than 4.5 billion people, across the globe, have received at least a single dose of COVID-19 vaccine. In other words, around 60% of the global population has been vaccinated against COVID-19. However, as the global populatio

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

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Currently, biologics represent one of the fastest growing classes of the pharmaceutical industry. In fact, the US Food and Drug Administration (USFDA) has approved more than 630 biologic products till date, while over 8,000 such drug candidates are being evaluated in clinical studies. Primarily, biologic candidates are being designed for delivery via the parenteral route. However, this route is associated with the need for frequent medication, administered by a professional, in clinics or hospit

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Since the approval of Orthoclone OKT3, a murine monoclonal antibody against T cell expressed CD3 (for the treatment of acute transplant rejection) in 1986, antibody therapeutics have evolved into a prominent class of therapeutics. These therapeutics have high target specificities and favorable safety profiles. Currently, close to 100 monoclonal antibodies have been approved while more than 500 molecules are being evaluated in clinical trials. Some of the recently approved monoclonal antibody the

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Exosomes are extracellular vesicles that play an important role in cell-to-cell communication and act as carriers of circulating nucleic acids, lipids and proteins in body. Over time, various research studies have demonstrated the potential of exosomes in disease diagnosis and drug delivery applications, owing to their ability to act as biomarkers for various diseases and transport important functional elements. Given the various benefits, exosomes have gained significant interest in the biophar

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First introduced in 1950s, the flow cytometry technique has gained significant attention in the past few decades. This can be attributed to the fact that flow cytometry has been demonstrated to be capable of overcoming various challenges associated with conventional analytical techniques, such as western blotting and immunohistochemistry. The key concerns related to traditional approaches include low specificity and sensitivity, time and cost intensive procedures, higher chances of producing fal

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Given the advancement of several promising microbiome-based live biotherapeutic products through clinical pipeline, this upcoming therapeutic segment is anticipated to become one of the fastest growing markets within the pharmaceutical industry in the coming years. Specifically, in 2020, around 575 IND applications were filed for such therapies, targeting a myriad of diseases indications, including autoimmune, gastrointestinal, infectious, metabolic and oncological disorders, indicating remarkab

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Over the past few years, the prevalence of neurological disorders has increased at an annualized rate of 10.9%. Further, the mortality associated with such diseases is projected to account for 12.2% of the global death rate, in 2030. In this context, several research initiatives are underway to identify an approach that allows effective delivery of the target medication directly into the brain. One key challenge currently faced by researchers is the presence of the complex blood brain barrier (B

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Cancer is one of the leading causes of death, worldwide. In 2020 alone, over 19 million new cases of the disease (affecting different organs) and close 10 million associated fatalities, were reported worldwide. Over the next couple of decades, experts believe that the global cancer burden is likely to increase by almost 50%. Currently, a variety of therapeutic measures are available for the treatment of different types of cancers; of these, surgery, chemotherapy, and radiation therapy, are consi

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The global healthcare sector has been overtly reluctant to embrace technology. This may partially be due to the failure of early digitization efforts, which were fraught with challenges and turned out to be more of a liability rather than a path forward. In fact, according to a study, clinicians ended up spending more than twice as much time on administrative work (49%), such as updating electronic medical records, than on seeing patients (27%). The delivery of modern healthcare services is, the

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Since the approval of the first protein / peptide-based therapy (recombinant human insulin) in 1982, there has been a substantial increase in the R&D initiatives focused on such products. Earlier, majority of the biologics were administered subcutaneously. However, with the technological advancements in delivery formulations, oral delivery of therapeutic interventions   has gained significant traction, prompting stakeholders to leverage their expertise in the development of orally admin

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Over the years, the popularity of biologics has led to an evident shift in the focus of pharmaceutical companies, from traditional interventions towards more complex and advanced pharmacological interventions, such as peptide therapeutics. Since the discovery of insulin, the peptide therapeutics market has evolved significantly. Presently, over 80 peptide-based drugs are available in the market for the treatment of an array of diseases, including cancer, chronic pain, diabetes, HIV infection, mu

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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 under clinical investigation worldwide. Given the evident benefits of biologics over small molecule drugs (including high e

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Packaging is considered a critical aspect of pharmaceutical manufacturing. It is, therefore, imperative for drug manufacturers to ensure that formulations enclosed in primary containers are safe for consumption / administration. Despite being well established, there are several concerns associated with the drug packaging process, such as the risk of contamination, filling errors (inaccurate dose dispensation), complex packaging systems, integrity related concerns (pores, cracks and scratches) of

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It is a well-known fact that clinical trials form an integral part of the overall drug development process, enabling innovators to assess safety and efficacy of their drug candidates / devices. These studies account for around 50% of the total time and capital invested in the development process. However, the conduct of trials is often fraught with several challenges, including scientific and operational complexity, concerns associated with recruitment and retention of suitable patients, issues

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Isolation of the first site-specific restriction enzyme, Hind II, in the 1970s, became one of the breakthrough advances in biotechnology. This led to the discovery of various methods for manipulating living creatures at the genomic level, thereby, opening up a slew of new possibilities in basic and applied life sciences domain. Soon after, in the 1980s, the US FDA authorized human insulin, marketed under the brand name HUMULIN®, as the world's first genetically modified medication. With

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Over the past few years, protein-based therapeutics, including peptides, hormones, vaccines, monoclonal antibodies, blood factors and therapeutic enzymes, have gained a lot of attention from clinical researchers engaged in the field of drug development. The success of these therapeutics can be attributed to the various clinical benefits offered by such products, such as high target specificity, low toxicity and favorable safety profiles. It is worth mentioning that, at present, the protein / pep

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