Biosimilars are biological medical products which are the identical copies of the original products. Biosimilars are also termed as subsequent entry biologic or follow-on biologic. Biosimilars are expected to possess active properties, similar to that of officially approved original product at present. Biosimilars 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. In 2010, The Food and Drug Administration (FDA) has gained the authority to approve biosimilars as a part of Patient Protection and Affordable Care Act. The approval process is based on thorough demonstration of similarity and comparability with the existing approved product. 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.
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Patent expiry of blockbuster drugs and increasing government initiatives for biosimilars promotion drives the growth of biosimilars market
The key factors driving the growth of biosimilars market are the increasing demand due to their cost-effectiveness, rising geriatric population, growing pressure to curtail healthcare expenditure, increasing government support and initiatives to develop and promote biosimilars, strategic collaborations to enhance productivity and clinical trial activities for biosimilars. According to the American Health and Drug Benefits in 2013, the average biosimilars sale was more than U.S. $1 billion annually. For instance the global sales was projected to be around U.S. $7.19 billion for Remicade (infliximab) and U.S. $5.98 billion for Avastin (bevacizumab), leading to the higher approval by the doctors and patients of biosimilars globally. Also, the early phase of biosimilars market, easy entry, high growth opportunity, agreement for improved reimbursements with insurance companies are further driving the biosimilars market. The expiry and termination of numerous blockbuster pharmaceuticals drugs like Humira, Enbrel and Remicade in the next 5 to 10 years is the primary driver providing significant opportunity for new players to enter the market.
Cost effective potential of biosimilars is the primary factor expected to boost the biosimilars market in Asia Pacific
Regional segmentation of the biosimilars market by Coherent Market Insights comprises North America, Europe, Asia-Pacific, Latin America and Middle East and Africa. The first FDA approval biosimilar in 2015, Sandoz’s Zarxio has marked a promising hit of the biosimilars market across North America. According to the American Society of Health-System Pharmacists survey in 2013, about 99% of 214 surveyed pharmacy directors reported at least one oncologic drug shortage with the consequences of adopting the distribution of biosimilars to meet the rising demands. Also, the demand for biosimilars is expected to gather momentum in North America owing to the rising prevalence of cancers, autoimmune diseases, kidney failures and growth hormone deficiency and increasing approval rates by FDA. The treatment for various diseases including diabetes, rheumatoid arthritis and types of cancers are anticipated to become affordable in developing countries like China and India, thus providing opportunities for major players in the Asia Pacific biosimilar market to expand during the forecast period. Additionally, the Asia-Pacific market is expected to witness higher growth owing to economic biopharmaceuticals or the low- cost of biosimilars, high adoption rate and consistent guidelines issued by the regulatory authority.
The increase in product extensions integrated with technological innovations is expected to intensify the competitive environment within manufacturers
Key players operating in the biosimilars market include Sandoz International GmbH, Apotex, Biocon, Zydus Cadila Healthcare, Celltrion and Pfizer. The leading manufacturers are focusing on outsourcing the production of biosimilar products with strategic collaborations to replace the existing expensive drugs. For instance, in August 2016, the FDA approval by Sandoz for the biosimilar Erelzi, used for treating multiple inflammatory diseases such as rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis and juvenile idiopathic arthritis. The other prominent vendors include Hexal, Accord Healthcare, Harvest Moon Pharmaceuticals, Eli Lilly and Teva Pharmaceuticals.
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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,Immunomodulators,.
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,Oncology,Blood Disorders,Growth Hormone Deficiency Diseases,Infectious Diseases,Others,.