The Global Biosimilars Market Growth Accelerated by Increased Demand for Biosimilars
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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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