Biologics are drugs in the form of genetically engineered proteins, derived from human genes. As per the US FDA, biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. The biologic drugs are derived from a variety of natural sources such as humans, animals, or microorganisms and consist of products, such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Advanced biotechnology techniques and complex processes are used to manufacture biologics. They are at the forefront of biomedical research.
Drivers for the biologics market include big brand name drugs losing patent extensions, growing incidence of chronic diseases and their diagnoses across the globe, increased availability of advanced diagnostics, rising government initiatives in healthcare and growing technological advancements in research and development across the globe by big drug makers to sustain competition and invest in incremental innovation. Other factors increasing the demand for biologic drugs include rising regulatory convergence and better access to healthcare for all nations.
Restraints for the market include difficulty in manufacturing, as the drugs are highly complex in nature. They must be processed under tightly controlled conditions/controls, maintained throughout the production process. This type of atmosphere and quality control procedures are not easily available in less developed nations. Environmental contamination needs to be eliminated from the manufacturing process. Further, biologics are extremely susceptible to light, heat conditions, and need extremely good refrigeration processes, which is not available uniformly throughout the world.
Biologics market is at risk over the forthcoming years due to leading biologic drugs expected to lose exclusivity over the next seven years. The patented biologic drugs are expected to be replaced by biosimilar drugs. Competition is expected to be limited in the market as the drugs are expected to be formed using various types of innovative technologies. Increasing geriatric population, early onset of ageing, increasing awareness for technologically advanced medical procedures and drugs, higher spending power, and rising incidence of chronic diseases such as cancer, rheumatoid arthritis, etc. are expected to drive the market growth of biologic drugs.
Depending on geographic regions, biologic drug market is segmented into seven key regions: North America, South America, Eastern Europe, Western Europe, Asia Pacific, Japan, and Middle East & Africa.
In terms of geography, North America and Europe dominate the market, followed by Asia-Pacific. However, rising technological advancement in healthcare and systematic drug review process will drive the markets over North America, Japan and other regions. Europe currently dominates the biosimilars market driven by technically advanced healthcare infrastructure and high patient awareness & regulatory harmonization. Increasing funding for development of biologics available through public-private partnerships, availability of high-quality research infrastructure and innovative strategies developed by drug makers to restrict entry of new players are factors expected to contribute to market growth of biologics over the forecast period. Emerging markets include Eastern European countries followed by countries in Eastern Africa. Rising disease incidences in these countries is expected to prove favorable for the growth of the biologics market.
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Some of the key players in biologics market are Unilife Corporation, Retractable Technologies, Inc., Smiths Medicals, Becton, Dickinson & Company, Smiths Medical, Terumo Corporation, Pfizer Inc. (AC. Hospira), Roche Diagnostics, AstraZeneca, Bayer AG, Genzyme, GSK Biologicals, Lundbeck, Novartis AG, and Merck KGaA.