Biosimilars are biotherapeutic products that are highly similar to currently approved biological reference products. Biosimilars demonstrate no clinically meaningful differences between the biosimilar product and the approved reference biologic product in terms of safety, purity, and potency. The high cost associated with the development of biologics as well as patent expiries of biologic drugs has increased the demand for biosimilars globally.

The global Biosimilar Pipeline Analysis Market is estimated to be valued at US$ 29.4 Bn in 2023 and is expected to exhibit a CAGR of 17% over the forecast period 2023 to 2030, as highlighted in a new report published by Coherent Market Insights.

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Market key trends:

The biosimilar pipeline analysis involves RD, regulatory approval, manufacturing and commercialization process. Government initiatives to increase the adoption of biosimilars and reduce healthcare expenditure have accelerated the development and approval process of biosimilars. In addition, the growing demand for cost-effective treatment alternatives has increased the global spending on biosimilar clinical trials. Biosimilar developers are currently focusing on therapeutic areas of oncology, diabetes, autoimmune diseases and growth hormone deficiencies. Monoclonal antibodies are also gaining traction as key biosimilar drug classes due to patent expiries of blockbuster biologics in coming years.
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Porter’s Analysis

Threat of new entrants: High capital requirement for RD and clinical trials poses a barrier for new entrants in the biosimilar market.
Bargaining power of buyers: Large pharmaceutical companies and wholesalers have significant bargaining power over smaller biosimilar manufacturers.
Bargaining power of suppliers: Few biologics manufacturers control key drug supplies, granting them strong influence over pricing.
Threat of new substitutes: Biosimilars for widely used biologics ensure a consistent market, though novel biological therapies pose a future threat.
Competitive rivalry: Frequent patent litigations between biologics and biosimilar makers intensify competition in the biosimilar market.

Key Takeaways

The global biosimilar pipeline analysis market is expected to witness high growth, exhibiting a CAGR of 17% over the forecast period, due to increasing biosimilar approvals and launches. The market size for 2023 is estimated to reach US$ 29.4 Bn.

Regional analysis: North America dominates the global market currently owing to high adoption of biosimilars. However, Asia Pacific is anticipated to achieve the fastest growth over the forecast period due to rising healthcare expenditure, increasing generics market and improving regulatory guidelines in the region.

Key players operating in the biosimilar pipeline analysis market are Pfizer Inc. (AC. Hospira). They are focusing on expanding their biosimilar portfolio through strategic collaborations to strengthen their market position.