Biosimilars are biologic medications designed to be similar to an existing FDA approved reference biologic product. Biosimilars are meant to provide affordable alternatives to expensive biologic therapies after biological patents expire. Biosimilars improve patient access to lifesaving therapies in areas such as oncology, immunology and hematology. The global biosimilars market is estimated to be valued at US$ 29.4 Bn in 2023 and is expected to exhibit a CAGR of 5.9% over the forecast period 2023 to 2030, as highlighted in a new report published by Coherent Market Insights.

Market Dynamics:
One of the major driver fueling the growth of the biosimilars market is the increasing patent expiry of blockbuster biologics. Between 2018 to 2024, biologics such as AbbVie's Humira, Pfizer's Neupogen, Genentech's Rituxan, and Johnson & Johnson's Remicade with a combined sales value of over $35 billion will go off-patent, opening the gateway for biosimilars entry. The emergence of biosimilars also represents considerable cost savings compared to reference biologics which are highly priced. According to the European Commission, biosimilars have the potential to save European healthcare systems nearly €100 billion between 2014-2020 as a result of lower average medicine prices. This cost saving along with improved access to treatment are expected to drive the future adoption of biosimilars over the forecast period.

SWOT Analysis
Strength: Biosimilars are nearly identical copies of original biologic drugs and provide more treatment options at lower costs compared to reference biologics. Biosimilars can treat various chronic diseases by mimicking the pharmacological effects of original biologics. With established manufacturing processes, biosimilars can gain quick regulatory approvals.

Weakness: Developing biosimilars require huge capital investments and specialized research expertise due to complexity in replicating biologic molecules. Biosimilars may face patent litigations from reference drug companies which can delay market entry. Limited substitutability and interchangeability provisions restrict automatic substitution of biosimilars for prescribed reference biologics in some regions.

Opportunity: Patent expiry of major biologic drugs provide opportunities to introduce affordable biosimilar versions, increasing patient access to treatments. Growing prevalence of chronic diseases worldwide will augment the demand for cost-effective biologics and biosimilars. Favorable regulatory guidelines and incentive programs in several countries promote biosimilars usage.

Threats: Unfavorable pricing policies and limited reimbursement coverage pose challenges in biosimilars commercialization. Heightened competition from emerging biosimilars players may erode brands and compress margins. Adverse drug reactions and immunogenicity issues attributed to biosimilars can harm market reputation and future sales. Stringent pharmacovigilance requirements increase regulatory compliances cost burden.

Key Takeaways
Global Biosimilars Market Size is expected to witness high growth over the forecast period of 2023-2030. The market size is estimated to reach US$ 29.4 Bn by 2024, expanding at a CAGR of 5.9% through 2030.

Regional analysis - Europe dominates currently due to an established regulatory framework and incentive programs supporting biosimilar approvals and usage. However, the Asia Pacific region is expected to offer lucrative opportunities with emerging biosimilars industries in China, India and South Korea. Favorable regulatory guidelines and rising healthcare spending will accelerate biosimilars market growth in Asia Pacific region during the forecast period.

Key players - Key players operating in the biosimilars market include U.S. Environmental Protection Agency (EPA), European Chemicals Agency (ECHA), Food and Drug Administration (FDA), and Ministry of Health, Labour and Welfare (MHLW). These regulatory agencies play a critical role in establishing guidelines and approving biosimilars.

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