Biosimilar is a type of biological product that is almost identical to the original product, which has undergone patent expiration. Development and validation of biosimilars are an important part of the overall production process. Regulation for biosimilar drugs plays an important role in maintaining the efficiency and balance between original and biosimilar drugs. There are various authorities such as U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), which regulate the development and commercialization of biosimilars. Biosimilar drugs are available at relatively low prices as compared to patented drugs without compromising on efficacy.
Biosimilar has a complex structure, multi-layer manufacturing and immunogenicity risk due to which they require unique regulatory pathways for introduction in the market. Biosimilar ensures treatment of diseases considered to be incurable such as cancer and autoimmune disorders, they are developed independently and have same mechanism of action as patented drugs for the specific disease. There are different stages involved in the development of biosimilars such as product development, process development, clinical trial and regulatory approval and review.
Biosimilar pipeline analysis market taxonomy:
By Product Type
Patent expiration and low pricing is expected to fuel the biosimilar pipeline analysis market
Biosimilar market is under the initial phase of development, they are used for the treatment of various disorders such as autoimmune disease, cancer as per National Institute of Health 2012 report, there were more than 23.5 million people living with autoimmune disease in the U.S. and low pricing of biosimilar drugs make them affordable for people. The same mechanism of action provides effective treatment for disease along with increased awareness among people are expected to fuel the growth of biosimilar pipeline market. Various companies and their R&D departments such as Pfizer Inc., Zydus Cadila are involved in the development of biosimilar, which is under clinical trial. Pfizer’s biosimilar clinical stage pipeline includes five monoclonal antibodies fare under clinical trial phase I and phase 3 which will be used for the treatment of autoimmune disease and oncology.
There are various patented drugs available in the market, with certain drugs such as Adalimumab, the high cost of these drugs directed the biosimilar market. There are few drugs, which are under the last phase of clinical trial are BI695502 developed by Boehringer Ingelheim, PF- 06439535 by Pfizer, Biosimilar bevacizumab by Biocon, and FKB238 by Kyowa Pharmaceutical Industry Co. Increased R&D is expected to support the growth of biosimilar pipeline analysis market. There is a need for complex infrastructure in the development of biosimilar and lengthy process of clinical trial and approval are the major challenges faced by biosimilar pipeline analysis market.
Developed regions are expected to support the growth of biosimilar pipeline analysis market
Global biosimilar pipeline analysis market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East and Africa. Europe is expected to dominate the biosimilar pipeline analysis market due to technological advancements in healthcare facilities and regulatory affiliation. Asia Pacific is expected to closely follow Europe in terms of growth due to increased prevalence of autoimmune disease, cancer, unmet clinical needs of people, and large price conscious population of emerging economies. North America market is expected to grow significantly due to high R&D investments, which supports the growth of biosimilar pipeline analysis market in near future.
Key players of biosimilar pipeline analysis market
There are various players present across the world and competing with each other extensively in the market to attain maximum share. Companies are also involved in R&D to increase the biosimilar pipeline. Some key players are Biocon, Pfizer Inc., F. Hoffmann-La Roche Ltd, Amgen Inc., Kyowa Pharmaceutical Industry Co. Ltd, Boehringer Ingelheim GmbH, AstraZeneca, Novartis AG, and Merck & Co.
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