Biosimilars are biopharmaceutical drug having active components, which are similar to one that has previously been licensed. They are identical copies of the original products and can be manufactured only when the patent for the original innovator product expires. Biologics or biosimilars are sensitive to changes in manufacturing process due to the higher molecular complexity.
Biosimilars are generally derived from living cells of plants, animals, yeast, bacteria and viruses, through genetic engineering processes including controlled gene expression and recombinant DNA technology. In 2010, the Food and Drug Administration (FDA) approved biosimilars as a part of Patient Protection and Affordable Care Act. The approval process is based on thorough demonstration of similarity and comparability with existing approved product.
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Patent expiry of drugs and increasing government initiatives for biosimilars to drive growth of the biosimilars market
Increasing demand for cost-effective drugs, increasing number of geriatric population, high healthcare expenditure, increasing government support and initiatives to develop and promote biosimilars, strategic collaborations to enhance productivity and clinical trial for development of biosimilars are major factors driving growth of the market. According to the American Health and Drug Benefits in 2013, an estimated sale of biosimilars was more than US$ 1 billion annually. For instance, global sales of biosimilars was projected to reach US$ 7.19 billion for Remicade (infliximab) and US$ 5.98 billion for Avastin (bevacizumab), owing to high adoption of biosimilar drugs by doctors and patients. Furthermore, expiry and termination of pharmaceuticals drugs such as Humira, Enbrel and Remicade is providing significant opportunity for new players to enter the market.
Biosimilars Market Taxonomy
The global biosimilars market is segmented on the basis of product type, manufacturing type, application, end user, and geography.
On the basis of product type, the global biosimilars market is segmented into:
- Monoclonal Antibodies
- Recombinant Hormones
- Anti-Inflammatory Agents
- Recombinant Growth Stimulators
On the basis of by manufacturing type, the global biosimilars market is segmented into:
- In-house Manufacturing
- Contract Manufacturing Organizations
On the basis of application, the global biosimilars market is segmented into:
- Chronic & Autoimmune Diseases
- Blood Disorders
- Growth Hormone Deficiency Diseases
- Infectious Diseases
Availability of biosimilar drugs at cost effective rate is expected to boost growth of biosimilars market in Asia Pacific
Regional segmentation of the biosimilars market by Coherent Market Insights comprises North America, Europe, Asia Pacific, Latin America, Middle East, and Africa. The first biosimilar, Sandoz’s Zarxio was approved by FDA in 2015 for sale in North America. According to the American Society of Health-System Pharmacists survey in 2013, around 99% of 214 surveyed pharmacy directors reported shortage of at least one oncologic drug with distribution of biosimilars. Also, biosimilars market in North America region is expected to gain significant traction, owing to increasing prevalence of cancer, autoimmune diseases, kidney failures, and growth hormone deficiency. Biosimilar drugs provide cost effective treatment options for various diseases such as diabetes, rheumatoid arthritis and cancer, thus providing opportunities for growth of market in China and India. Furthermore, biosimilars market in Asia Pacific region is expected to witness higher growth, availability of cost effective biosimilars, high adoption rate, and consistent guidelines issued by regulatory bodies.
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Key players operating in the biosimilars market include Sandoz International GmbH, Apotex, Biocon, Zydus Cadila Healthcare, Celltrion, Pfizer, Hexal, Accord Healthcare, Harvest Moon Pharmaceuticals, Eli Lilly, and Teva Pharmaceuticals. Leading manufacturers are focusing on outsourcing the production of biosimilar drugs with strategic collaborations to replace existing drugs. For instance, in August 2016, the FDA approved Sandoz for the biosimilar Erelzi for treatment of multiple inflammatory diseases such as rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis and juvenile idiopathic arthritis.