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Biosimilar pipeline analysis refers to products created to be similar to an already approved biological medicine (the originator). Biosimilars provide alternatives to patients by expanding access to critical biological therapies. With biologics development becoming more sophisticated, biosimilar drugs can now be developed with comparable safety and efficacy as their reference products. The growing prevalence of chronic diseases globally has fueled the demand for cost-effective biopharmaceuticals.
The global biosimilar pipeline analysis market is estimated to be valued at US$ 29.4 billion in 2024 and is expected to exhibit a CAGR of 17% over the forecast period 2023 to 2030.
Key Takeaways
Key players operating in the biosimilar pipeline analysis market include Pfizer Inc. (AC. Hospira). Some key companies are focusing on expanding their product portfolios by developing biosimilars for various conditions.
The market presents significant opportunities due to patent expiries of blockbuster biologics and the growing demand for affordable therapies. Technological advancements such as improved analytics and manufacturing techniques have enabled the development of complex biosimilar drugs.
Market Drivers
One of the major drivers fueling the biosimilar pipeline analysis market growth is the patent expiry of biologic drugs. As patent protections expire, companies can develop biosimilars of the reference product and market them at lower costs. This provides affordable treatment options and promotes competition in the market. The increasing research focus on developing biosimilars targeting high revenue indications like oncology, immunology, and endocrinology is further driving the demand.
Current Challenges in Biosimilar Pipeline Analysis Market
The biosimilar pipeline analysis market is facing various challenges currently due to stringent regulations by the health authorities and increased pressure from branded biologics manufacturers. High development costs and extensive clinical trials are required to establish biosimilarity, which increases financial risk for biosimilar developers. Moreover, the perceptions of physicians and patients regarding interchangeability of biosimilars with reference products also pose a challenge. Patent litigations initiated by innovator companies delay the approval and launch of competing biosimilars. Lack of incentives and support policies from governments in some countries further affect market growth.
SWOT Analysis
Strength: The market is witnessing continuous expansion due to rising demand for affordable biologics and patent expiration of major biologic drugs. Growing prevalence of chronic diseases will propel the demand for biosimilars.
Weakness: Developing biosimilars requires huge R&D investments and time consuming clinical trials. Biosimilars also face negative perception and lack of confidence among physicians and patients.
Opportunity: Emerging Asian and Latin American countries with large patient pools present lucrative business opportunities. Favorable policies and pricing regulations by some governments promote biosimilar adoption.
Threats: Intense competition among existing players may lead to price wars. Innovator companies aggressively defending their product patents pose regulatory and legal challenges for biosimilar developers.
Geographical Regions with High Market Concentration
The biosimilar pipeline analysis market in North America and Europe accounts for over 65% of the global market value currently. Presence of major pharmaceutical players and established regulatory guidelines support the high market concentration in these regions. The US market alone represents around 30% share owing to presence of many Phase 3 pipeline assets and favorable reimbursement system.
Fastest Growing Geographical Region
Asia Pacific region is poised to be the fastest growing market for biosimilar pipeline analysis during the forecast period. This is attributed to increasing healthcare spending, huge patient population, and growing adoption of affordable biosimilars in China, India and other Asian countries. Favorable regulatory framework and marketing exclusivity incentives provided by governments in the region further boost new market entrants.
*Note:
- Source: Coherent Market Insights, Public sources, Desk research
- We have leveraged AI tools to mine information and compile it
