The global biopharmaceutical industry has come a long way since its first product, biosynthetic human insulin (trade name ‘Humulin’), which was approved in 1982. Biopharmaceuticals a...
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The global biopharmaceutical industry has come a long way since its first product, biosynthetic human insulin (trade name ‘Humulin’), which was approved in 1982. Biopharmaceuticals are drugs produced using biotechnology, used for medical purposes such as therapeutics and in vivo diagnostics. These may either be derived from genetically altered bacteria or fungi (called as biotech drugs), or may come from blood and blood plasma products (referred to as biologics). Biopharmaceuticals comprise of a diverse group of products including proteins, peptides, antibodies, nucleic acids, whole cells, viral particles, and vaccines. Today, there are more than three hundred biopharmaceutical products which have been approved for use and many more in late stages of clinical development. These drugs are highly specific, efficient and tailored for use in the prevention and healing of a number of life-threatening diseases.
Biopharmaceuticals have been acting as a refuge to the pharmaceutical industry which, under mounting economic pressures, has embraced biopharmaceuticals as a means to maintain flow in its drying product pipelines. The demand for these products is the greatest in complex areas where conventional pharmaceutical drugs have been less successful. The rising R&D costs, low productivity and generic competition have greatly hampered the pharmaceuticals business, and the sluggish rate of innovation has generated a high demand for biotechnology-based product development.
Research shows that an ageing population and the associated increase in incidence of diseases have opened up significant opportunities for biopharmaceutical manufacturers. Cancer, central nervous system disorders, cardiovascular diseases, autoimmune diseases, inflammatory diseases, diabetes, hormone/enzyme replacement, respiratory diseases, and infectious diseases are the major therapeutic areas likely to see significant biopharmaceutical product launches in the coming years. Oncology is one crucial focus of major biopharmaceutical projects globally, and due to the disease characteristics it can safely be assumed that anti-cancer biopharmaceuticals will be important catalysts for market growth in the coming years. Increased regulatory approval rate for these products is also expected to help drive growth of this market. Advances in diagnostics coupled with biopharmaceuticals will enable increased emphasis on personalized medicines, thereby directing developments in this area. Moreover, enhanced use of modern technologies such as genomics, cellomics, toxicogenomics, and pharmacogenomics will help derive advances in this sector.
The US biopharmaceuticals market, which accounts for more than half of the global biopharmaceutical market, is further expected to experience growth. This could be due to various reasons like the launch of new products, sanction of novel indications for existing drugs and therapies, and a rapid increase in the aged population. The five major markets in Europe include the UK, Germany, France, Italy and Spain, accounting for a major share of the global biopharmaceutical market. Emerging markets such as India, China and Eastern European countries are also likely to witness strong growth in the coming years. Conventional pharmaceutical players such as Johnson & Johnson, Sanofi-Aventis, Eli Lilly & Co., and Novo Nordisk are some of the key companies capitalizing on biopharmaceuticals. Pharmaceutical companies are forming important alliances with less recognized biotechnology companies at various stages of the drug lifecycle, which is considerably driving technical innovation and overall market growth.
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