The Global Biosimilars Market Growth Accelerated by Increased Demand for Biosimilars

 

Biosimilars Market

The global biosimilars industry represents a class of therapeutic biological products that are similar versions of originator biologics. Biosimilars offer comparable efficacy and safety to their reference biologic products and play an important role in increasing patient access to lifesaving medicines by lowering healthcare costs through competition. Key products in this market include filgrastim, infliximab, and insulin glargine biosimilars, which are used for treating various conditions like cancer, diabetes, rheumatoid arthritis.

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 2024-2031, as highlighted in a new report published by Coherent Market Insights.

 

Market Dynamics:

One of the major drivers propelling the growth of the biosimilars market is the patent expiry of major blockbuster biologics. For instance, the patent of immunosuppressants Enbrel and Humira expired in 2022, thereby opening significant opportunities for biosimilar versions of these drugs. This is allowing several biosimilar manufacturers to replicate important biologic drugs at a fraction of the price of original drugs. Additionally, increasing investments by biosimilar manufacturers to expedite biosimilar development and approval processes is also fueling market growth. For instance, U.S. regulatory bodies like the FDA have introduced various initiatives to facilitate the development and approval of high-quality biosimilars to meet the increasing healthcare needs. This helps reduce overall healthcare expenditure and expands access to vital medications, especially in developing regions.

 

SWOT Analysis

 

Strength: Biosimilars can help lower drug costs for patients, thereby increasing access to treatment. They are expected to be significantly cheaper than their reference biologic drugs. Biosimilars development requires lower investment compared to innovative biologics as they can rely on prior FDA approval of the reference product.

 

Weakness: Intellectual property protections and regulatory exclusivities for reference biologics create market entry barriers for biosimilars. Clinical trials need to show biosimilarity rather than product in and out itself which requires considerable investment.

 

Opportunity: The patent expiration of major biologics like Humira, Rituxan, and other blockbuster drugs will open significant opportunities for biosimilars to enter the market. Successful development and adoption of biosimilars can help reduce healthcare expenditure considerably.

 

Threats: Pharmaceutical companies invest heavily in new formulations, indications, or combinations for reference products to extend their market exclusivity which may delay biosimilars entry. Concerns around interchangeability, production process complexity and immunogenicity risks pose challenges.

 

 

Key Takeaways

 

The Global Biosimilars Market Size is expected to witness high growth over the forecast period of 2024 to 2031. The market size is projected to reach US$ 60.16 Mn by 2031 from US$ 33.87 Mn in 2024, growing at a CAGR of 5.9%.

 

Regional analysis: Europe dominates currently with the highest biosimilars market share owing to established regulatory approval pathway and favourable pricing & reimbursement mechanisms. However, Asia Pacific region is expected to offer lucrative growth opportunities during the forecast period driven by initiatives to make healthcare more affordable and expanding patient pool in emerging economies like China and India.

 

Key players:Key players operating in the biosimilars market 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).


Get More Insights Here

https://www.newsanalyticspro.com/biosimilars-market-size-share-growth-outlook-2023/

https://coolbio.org/virtual-reality-is-changing-the-face-of-gaming-industry/

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