Biosimilars Market Outlook, Scope & Overview:
Industry reports indicate that the global biosimilars market was valued at USD 29.51 billion in 2023 and is projected to reach USD 108.8 billion by 2031, growing at a CAGR of 17.7% over the forecast period 2024-2031.
Regulatory Approvals and Patent Expirations to Drive Growth of Global Biosimilars Market
The increasing adoption of biosimilars will continue to influence global market revenues. Healthcare systems are turning to biosimilars as a cost-effective alternative to biologics, with the potential to significantly reduce healthcare expenditures and improve patient access to essential therapies.
As a product segment, monoclonal antibodies (mAbs) currently hold a significant share of the global biosimilars market. This segment is anticipated to grow at a year-over-year rate of 17.7% in 2024 over 2023 and reach USD 108.8 billion in revenues by 2031. The upcoming patent expirations of major biologic drugs and the increasing number of biosimilar approvals are expected to drive market growth.
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Biosimilars Market – Market Dynamics
Drivers:
The biosimilars market is experiencing significant growth due to the rising prevalence of chronic diseases, the increasing demand for cost-effective biologic therapies, and the expanding number of biosimilar products entering the market. Regulatory bodies in major regions, such as the FDA in the United States and the EMA in Europe, are actively supporting the development and approval of biosimilars, further driving their adoption. Additionally, the growing acceptance of biosimilars by healthcare providers and patients, along with initiatives to promote biosimilar usage, is contributing to market expansion.
Restraints:
Despite the strong growth potential, challenges such as stringent regulatory requirements, high development costs, and the complexity of manufacturing biosimilars are hindering their widespread adoption. Additionally, patent litigations, brand loyalty towards original biologics, and the need for extensive clinical trials to demonstrate biosimilarity pose additional challenges to market growth. Furthermore, the lack of awareness and education about biosimilars among healthcare professionals and patients can also limit market expansion.
Biosimilars Market – Market Outlook
The proven benefits of biosimilars in reducing healthcare costs, increasing access to biologic treatments, and improving patient outcomes have contributed to the market's growth. Biosimilars are expected to witness increased adoption across major markets, including North America, Europe, and Asia Pacific, driven by favorable regulatory frameworks, growing healthcare expenditures, and the rising focus on biologic treatments for chronic diseases.
Global Biosimilars Market
The rise in demand for biosimilars in developed and emerging markets is expected to drive market growth over the forecast period. North America currently holds a significant market share in the global biosimilars market, with the US being a key contributor to market revenues. Europe and Asia Pacific regions are also experiencing rapid adoption of biosimilars, supported by increasing biosimilar approvals, patent expirations, and initiatives to enhance biosimilar uptake.
Key Players in the Biosimilars Market
Leading companies in the biosimilars market include Pfizer Inc., Novartis AG (Sandoz), Amgen Inc., and Biocon Limited. These companies are at the forefront of developing and commercializing biosimilar products for various therapeutic areas, including oncology, immunology, and endocrinology.
In conclusion, the global biosimilars market is poised for substantial growth over the forecast period, driven by increasing regulatory support, patent expirations of major biologics, and the expanding adoption of biosimilars across diverse therapeutic areas.
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