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Research Insights

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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