Biosimilars and Follow-on Biologics Market: Introduction
- Biosimilars are medicinal products that contain biological active substances that have been shown to be similar to existing approved biological drugs (so-called "reference medicinal products") in terms of quality, biological activity, safety, and efficacy. A comprehensive comparability exercise is used to demonstrate the resemblance to the reference medicinal products.
- Follow-on biologics are medications obtained primarily from biological sources such as bacteria and yeast. Small molecules, such as human insulin or erythropoietin, or complex compounds, such as monoclonal antibodies, can make up biosimilar pharmaceuticals. Given the loss of exclusivity for branded pharmaceuticals, biosimilars are gaining traction.
Key Drivers, Restrains, and Opportunities of Global Biosimilars and Follow-on Biologics Market
- Monoclonal antibodies (mAbs), insulin, erythropoietin (EPO), interferons, growth hormones, and fertility hormones are the key therapeutic areas with high revenue potential in the market. Recent changes in FDA’s approach to biosimilars have favored the expansion of the global biosimilars and follow-on biologics market.
- Increase in research on follow-on insulin has attracted sizable research investments by biopharmaceutical companies. However, commercialization of biosimilars into routine clinical practice is implausible. The pace of commercialization of biosimilars is reliant on better regulatory and pricing structures. Increase in incidence of diseases across the world and better access to health care for all drive demand for biosimilar drugs.
- Restrictions in developing and registering biosimilar pharmaceuticals and the complexity of manufacturing procedures restrain the global market. Drugs are difficult to verify and must adhere to stringent rules. Moreover, drugs differ from each other in terms of raw materials and manufacturing processes, which is likely to hamper the development of biosimilars in the near future.
- The COVID-19 pandemic has had a significant impact on the global economy at different levels, including the healthcare industry. The global market is likely to witness a steep decline in sales of biosimilars and follow-on biologics during the lockdown period due to the shutdown of manufacturing units, acute shortages in raw materials, and a lack of potential workforce. Production and supply chain activities have faced significant disruptions due to the pandemic. However, the market is expected to recover gradually, providing attractive sales opportunities in several regions in the near future.
Europe to Capture Major Share of Global Biosimilars and Follow-on Biologics Market
- Europe is anticipated to account for major share of the global biosimilars and follow-on biologics market during the forecast period. The region's dominance is attributed to the technologically advanced health care infrastructure, strong patient awareness, and regulatory harmonization in the region. Increase in investment in biosimilar drug development, availability of high quality research infrastructure, and drug companies' strategies to prevent new players from entering the market.
- The biosimilars and follow-on biologics market in Asia Pacific is likely to grow at a rapid pace during the forecast period owing to rise in prevalence of chronic diseases. This is attributed to the prevalence of chronic diseases and improving health infrastructure in this region. In developing countries, collaboration with domestic players is a major opportunity for biosimilars. Several companies, such as Amgen and Novartis, are collaborating with businesses in Asia in order to gain access to the biopharmaceutical market.
Key Players Operating in Global Biosimilars and Follow-on Biologics Market
The global biosimilars and follow-on biologics market is highly competitive and mature due to the participation and presence of large number of established as well as new players.
Major players operating in the global biosimilars and follow-on biologics market are:
- Novartis AG
- Pfizer, Inc.
- Amgen, Inc.
- Coherus Biosciences, Inc.
- Dr. Reddy’s Laboratories
- Biocon Limited
- Mylan NV (Viatris, Inc.)
- Roche Diagnostics
- Merck KGaA
- Samsung Bioepis Co., Ltd.
- Other Prominent Players
Global Biosimilars and Follow-on Biologics Market: Research Scope
Global Biosimilars and Follow-on Biologics Market, by Type
- Human Growth Hormone
- Monoclonal Antibodies
- Granulocyte-Colony Stimulating Factor
Global Biosimilars and Follow-on Biologics Market, by Application
- Blood Disorders
- Oncology Diseases
- Chronic & Autoimmune Diseases
- Growth Hormone Deficiencies
Global Biosimilars and Follow-on Biologics Market, by Region
- North America
- Rest of Europe
- Asia Pacific
- Australia & New Zealand
- Rest of Asia Pacific
- Latin America
- Rest of Latin America
- Middle East & Africa
- GCC Countries
- South Africa
- Rest of Middle East & Africa