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 – Dynamics
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. High prevalence of various types of cancers and the need for affordable and effective treatment are the major factors driving growth of the biosimilar pipeline analysis market. According to the Centre for Disease Control (CDC), around 14.1 million people were diagnosed with cancer in 2012, in the U.S., resulting in around 8.2 million fatalities. Around 19.3 million new cases of cancer are projected to be diagnosed by 2025. Similarly according to the data published by World Health Organization (WHO), cancer accounted for 8.8 million of deaths worldwide in 2015.
Rising approval of biosimilars is expected to propel the market growth over the forecast period. As of January 2020, around 26 biosimilars has received U.S. Food and Drug Administration (FDA) approvals. In December, 2019, Amgen Inc., received U.S. Food and Drug Administration (FDA) approval for Avsola (infliximab-axxq) a biosimilar of Remicade, indicated for the treatment of Crohn disease, ulcerative colitis, rheumatoid arthritis and other conditions.
Various other companies such as Pfizer Inc., Mylan, Merck, Amgen, Zydus Cadila are involved in the development of biosimilars. Currently Amgen Inc. has 2 biosimilars at the clinical stage pipeline which includes ABP 798, ABP 959 which will be used for the treatment of non-Hodgkins Lymphoma, Paroxysmal nocturnal hemoglobinuria and rheumatoid arthritis.
There are various patented biologics available in the market, but at a cost much higher that is inaccessible to general population. This directed the need for biosimilars 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.
Biosimilar Pipeline Analysis Market – Regional Insights
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 rising product approvals and high R&D investments, which supports the growth of biosimilar pipeline analysis market in near future. For instance, in June 2019, Pfizer Inc., received U.S. Food and Drug Administration approval for ZIRABEV (bevacizumab-bvzr) it is the biosimilar to Avastin, indicated for the treatment of metastatic colorectal cancer, recurrent or metastatic non-squamous non-small cell lung cancer, recurrent or metastatic cervical cancer.
Biosimilar Pipeline Analysis Market Taxonomy:
By Product Type:
Key players in the biosimilar pipeline analysis market:
Some of the key players operating in the biosimilar pipeline analysis market includes Biocon, Pfizer Inc., F. Hoffmann-La Roche Ltd, Amgen Inc., Kyowa Pharmaceutical Industry Co. Ltd, Boehringer Ingelheim GmbH, AstraZeneca, Novartis AG, and Merck & Co.