by Biosimilars are biopharmaceutical drugs that are highly similar to an existing approved biological drug. Biosimilars offer advantages of reduced costs and greater accessibility of treatments to patients. The need for biosimilars arises due to the high costs of biologics and patent expiry of top-selling biologics.
The Global Biosimilars Market is estimated to be valued at US$ 33.87 Mn in 2024 and is expected to exhibit a CAGR of 5.9% over the forecast period 2024 to 2031.
Key Takeaways
Key players operating in the biosimilars are U.S. Environmental Protection Agency (EPA), European Chemicals Agency (ECHA), Food and Drug Administration (FDA), Ministry of Environment, Forest and Climate Change (India), National Health Commission (China), Canadian Food Inspection Agency (CFIA), National Institute for Health and Welfare (THL) (Finland), Federal Institute for Risk Assessment (BfR) (Germany), National Institute of Food and Drug Safety Evaluation (KFDA) (South Korea), Ministry of Ecology and Environment (China), Environment Agency (United Kingdom), Ministry of Health, Labour and Welfare (Japan), Australian Government Department of Agriculture, Water and the Environment, Health Canada, Ministry of Health (Brazil).
Key opportunities in the biosimilars market include approvals of new biosimilar products by regulatory agencies, patent expiry of major biologics enabling biosimilar approvals, and increasing healthcare expenditure in developing markets. Technological advancements have enabled development of highly similar biosimilars closely matching the structure, safety, and efficacy of reference biologics.
Market Drivers
The key driver for the Biosimilars Market Demand is the increasing healthcare expenditure. Rising income levels and growing elderly population are increasing the burden of healthcare costs globally. Biosimilars prove more affordable alternatives to reference biologics and help save significant healthcare costs. This is expected to boost the demand for biosimilars over the forecast period. Entry of new players due to patent expiry of major biologics also supports the growth of the biosimilars market. Approval of new biosimilar products expands treatment options available to patients.
Challenges in Biosimilars Market
The biosimilars market faces several challenges related to manufacturing complexities, lengthy approval process and intellectual property barriers. Developing a biosimilar requires high capital investment and specialized manufacturing capabilities due to the large molecular size and complexity of biological molecules. The approval process is also very long as it involves extensive comparability testing between the biosimilar and reference molecule to prove similarity. patent thickets covering innovative biologics also limit biosimilar approvals. However, gradual patent expiries of major biologics will help expand market opportunities for biosimilars in the coming years.
SWOT Analysis
Strength: Biosimilars offer cost savings of 20-30% compared to reference biologics. They expand treatment access in cancers and chronic diseases.
Weakness: High R&D costs and regulatory risks. Biosimilars face market access barriers in some regions.
Opportunity: Patent expiry of major biologics like Rituximab, Trastuzumab, Infliximab opens large markets. Emerging economies offer high growth potential.
Threats: Intense competition from reference biologics and other biosimilars limits pricing flexibility. Regulatory delays can impact returns on investment.
Geographical Regions
North America currently dominates the biosimilars market, accounting for over 35% of the global market share in 2024, driven by the US. The US is a major market owing to favorable regulations and upcoming patent expiries. Europe is another key region, led by countries like Germany, UK and France. The European market is well established with the presence of major biosimilars of infliximab, insulin and erythropoietin.
Fastest Growing Region
Asia Pacific region is poised to exhibit the highest CAGR of around 9% during the forecast period. Key country markets including India, China, South Korea and Japan are witnessing increased uptake of biosimilars to expand treatment access and contain healthcare costs. Favorable regulations, rising healthcare investments and large patient pools present significant growth opportunities in Asia Pacific biosimilars market.
