Biosimilar Pipeline AnalysisMarket – Dynamics
BiosimilarMarket is under the initial phase of development, they are used for thetreatment of various disorders such as autoimmune disease, cancer as perNational Institute of Health 2012 report, there were more than 23.5 millionpeople living with autoimmune disease in the U.S. and low pricing of biosimilardrugs make them affordable for people. High prevalence of various types ofcancers and the need for affordable and effective treatment are the majorfactors driving growth of the biosimilar pipeline analysis market. According tothe Centre for Disease Control (CDC), around 14.1 million people were diagnosedwith 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.
Biosimilar is a type ofbiological product that is almost identical to the original product, which hasundergone patent expiration. Development and validation of biosimilars are animportant part of the overall production process. Regulation for biosimilardrugs plays an important role in maintaining the efficiency and balance betweenoriginal and biosimilar drugs. There are various authorities such as U.S. Foodand Drug Administration (FDA) and European Medicines Agency (EMA), whichregulate the development and commercialization of biosimilars. Biosimilar drugsare available at relatively low prices as compared to patented drugs without compromisingon efficacy.
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Biosimilar has a complexstructure, multi-layer manufacturing and immunogenicity risk due to which theyrequire unique regulatory pathways for introduction in the market. Biosimilarensures treatment of diseases considered to be incurable such as cancer andautoimmune disorders, they are developed independently and have same mechanismof action as patented drugs for the specific disease. There are differentstages involved in the development of biosimilars such as product development,process development, clinical trial and regulatory approval and review.
Rising approval of biosimilars isexpected to propel the market growth over the forecast period. As of January2020, around 26 biosimilars has received U.S. Food and Drug Administration(FDA) approvals. In December, 2019, Amgen Inc., received U.S. Food and DrugAdministration (FDA) approval for Avsola (infliximab-axxq) a biosimilar ofRemicade, indicated for the treatment of Crohn disease, ulcerative colitis,rheumatoid arthritis and other conditions.
Various other companies such asPfizer Inc., Mylan, Merck, Amgen, Zydus Cadila are involved in the developmentof biosimilars. Currently Amgen Inc. has 2 biosimilars at the clinical stagepipeline which includes ABP 798, ABP 959 which will be used for the treatmentof non-Hodgkins Lymphoma, Paroxysmal nocturnal hemoglobinuria and rheumatoidarthritis.
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There are various patentedbiologics available in the market, but at a cost much higher that isinaccessible to general population. This directed the need for biosimilarsmarket. There is a need for complex infrastructure in the development ofbiosimilar and lengthy process of clinical trial and approval are the majorchallenges faced by biosimilar pipeline analysis market.
Biosimilar Pipeline AnalysisMarket – Regional Insights
Global biosimilar pipelineanalysis market is segmented into North America, Latin America, Europe, AsiaPacific, Middle East and Africa. Europe is expected to dominate the biosimilarpipeline analysis market due to technological advancements in healthcarefacilities and regulatory affiliation. Asia Pacific is expected to closelyfollow Europe in terms of growth due to increased prevalence of autoimmunedisease, cancer, unmet clinical needs of people, and large price conscious populationof emerging economies.
North America market is expectedto grow significantly due to rising product approvals and high R&Dinvestments, which supports the growth of biosimilar pipeline analysis marketin near future. For instance, in June 2019, Pfizer Inc., received U.S. Food andDrug Administration approval for ZIRABEV (bevacizumab-bvzr) it is thebiosimilar to Avastin, indicated for the treatment of metastatic colorectalcancer, recurrent or metastatic non-squamous non-small cell lung cancer,recurrent or metastatic cervical cancer.
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