North America accounted for the largest share, accounting for approximately 30% of the global market, in 2017
NEW YORK, Sept. 3, 2019 /PRNewswire/ -- Market Overview
In the recent years, several blockbuster biologic drugs of major pharmaceuticals companies, such as Remicade, Rituxan, Herceptin, Enbrel, Lantus, and others expired. In the coming decade, there would be a rise in the patent expiration of several existing biological drugs, such as Erbitux, Avastin, Orencia, and others, which would provide an opportunity for many innovator companies as well as generic manufacturers to offer services, specially tailored toward biosimilars. In addition, factors, such as cost effectiveness nature of biosimilars, rising acceptance and adoption by various stakeholders with the need of diversification in technology and business models, growing prevelence of chronic diseases are expected to drive the global biosimilar market. At the same time, with factors, such as lack of definitive standards for approval and adequate profitability, given the greater risk with concerns regarding substitutability and interchangeability, many companies are discouraged from investing in this market, thus impeding the growth of the market studied.
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Scope of the Report
A biosimilar is a biologic that is "similar" to another biologic medicine (known as a reference product) which is already licensed by the U.S. Food and Drug Administration (FDA). Biosimilars are highly similar to the reference product in terms of safety, purity and potency, but may have minor differences in clinically inactive components. In approving biosimilars, the FDA may require that manufacturers conduct a clinical study (or studies) sufficient to establish safety, purity or potency in one or more uses for which the reference product is licensed and the biosimilar seeks licensure.
Key Market Trends
Oncology segment holds the major share in global bio similar market
Applications segment of the market is segmented as Blood disorders, Growth hormonal deficiency, Chronic and autoimmune disorders, Oncology, Others. The oncology segment is dominating the global market for biosimilars in terms of revenue owing to the high prevalence of cancer including lung, liver, colorectal, stomach, breast, and blood cancer. According to the National Cancer Institute (NCI) report, it was estimated that 1,735,350 new cases of cancer are diagnosed in the US in 2018, and 609,640 people will die from the disease. Amelita, Amgen's version of Humira is the first adalimumab biosimilar to be approved by the US FDA in September 2016. Two European versions, named Amgevita and Solymbic, were recommended in the European Union (EU) in January 2017.
North America to dominate the growth of biosimilar market
North America accounted for the largest share, accounting for approximately 30% of the global market, in 2017. The North American segment of the market studied is majorly driven by the presence of many large research laboratories, such as Sandoz, Amgen, Teva Pharmaceutical, and others. According to a recent report, more than 40 biosimilars are under development, including approximately 20 biosimilars ready to be released into the market, and a significant number of biosimilars are in the pipeline. Owing to the immense economic developments and booming biotechnology companies in the region, Asia-Pacific is also expected to record robust growth over the forecast period. Furthermore, factors such as high demand for the low-cost therapeutics and treatments, high prevelance and incidence of various chronic diseases, increase in R&D expenditures by the market players in the emerging economies such as India, South Korea and China are also propelling the growth of biosimilars market in Asia Pacific region.
Competitive Landscape
There is massive competition in the Biosimilar market. With the presence of many domestic and also international market players. Most of the market players are adopting various growth strategies such as acquisitions, partnerships, new product launches to survive in the market. For instance,
- In, 2018 Mylan NV launched Hulio(TM), a biosimilar to AbbVie's Humira® (adalimumab), across major markets in Europe.
- In October 2018, Sandoz, a Novartis division in biosimilars, recieved US Food and Drug Administration (FDA) approval for its biosimilar, HyrimozTM (adalimumab-adaz) for treatment of rheumatoid arthritis, juvenile idiopathic arthritis in patients four years of age and older.
- In Nov 2018, Teva recieved FDA Approval of HERZUMA® (trastuzumab-pkrb), a Biosimilar to HERCEPTIN®, for the Treatment of HER2-Overexpressing Breast Cancer for Certain Indications
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