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Biosimilars & Biologics Market 2025 | $1.77T Growth, Biocon & Sandoz Acquisitions, FDA & EMA Regulatory Boost

08-11-2025 03:31 PM CET | Health & Medicine

Press release from: DataM Intelligence 4Market Research LLP

Biosimilars and Biologics Market

Biosimilars and Biologics Market

The Biosimilars and Biologics Market is projected to reach approximately US$1,773.77 billion by 2033, growing at a compound annual growth rate (CAGR) of 14.4% between 2025 and 2033, according to DataM Intelligence. This rapid growth reflects rising demand for cost-effective biologic therapies and expanding product pipelines driven by innovation and patent expirations.

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Notable Alliances and Mergers Steering Market Growth in 2025

In 2025, Biocon Biologics significantly strengthened its position in the biosimilars sector by acquiring Viatris' expansive biosimilar portfolio for $3.34 billion, boosting its global reach and pipeline of complex biologics. Meanwhile, Sandoz announced the acquisition of Just Evotec Biologics' development and manufacturing facilities in Toulouse, France, for about $300 million, enhancing its capacity with state-of-the-art automated technology to meet growing biosimilar demand worldwide.

Innovative Technological Advancements Reshaping the Market in 2025

• Regulatory Streamlining: Regulatory agencies like the FDA and EMA are harmonizing and accelerating approval pathways, enabling faster market entry and improving global patient access to biosimilars.
• Patent Expirations Driving Growth: The expiry of patents on key biologics, including monoclonal antibodies for oncology, autoimmune diseases, and diabetes, is fueling a rapid increase in biosimilar development and launches.
• Technological Advancements: Ongoing improvements in bioprocessing, analytical techniques, and manufacturing methods are ensuring that biosimilar products meet high-quality standards.
• Product Innovation: New subcutaneous formulations, long-acting biologics, and combination products are being introduced to enhance patient convenience, treatment adherence, and safety profiles.
• Asia-Pacific Growth Hub: The Asia-Pacific region, particularly China and India, is emerging as a major biosimilar manufacturing and consumption hub due to favorable regulations, growing healthcare investments, and large patient populations.

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Regional Market Catalysts for Biosimilars and Biologics in 2025

The United States biosimilars market growth is propelled by patent expirations of blockbuster biologics like Humira and Enbrel, increasing demand for affordable chronic disease treatments, and proactive FDA regulatory support encouraging faster approvals. Oncology remains the fastest-growing therapeutic segment.

In Japan, the biosimilars and biologics market is rapidly expanding due to strong healthcare investments, an aging population, and supportive government policies that align with global regulatory standards. Collaborative research and increasing awareness among healthcare providers also contribute to steady market growth.

Emerging Opportunities, Growth Drivers, and Leading Competitors

The biosimilars and biologics market holds growing opportunities in developing biosimilars for high-value monoclonal antibodies, reducing manufacturing complexities and costs, and entering new therapeutic areas and geographic regions. Key players driving innovation and market expansion include Amgen, Pfizer, Merck, Biogen, Coherus BioSciences, Sandoz, Chugai Pharmaceutical, Takeda Pharmaceutical, Fuji Pharma, Kyowa Kirin, and JCR Pharmaceuticals. The overall market momentum is fueled by patent expiries, increased chronic disease prevalence, and a rising demand for cost-effective, safe, and efficacious biologic alternatives.

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Contact Person: Sai Kiran
Email: Sai.k@datamintelligence.com
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DataM Intelligence is a leading market research and consulting firm committed to providing end-to-end business solutions, from in-depth research and analysis to strategic advisory. We combine proprietary insights, evolving market trends, and the latest industry developments to deliver timely, impact-driven strategies tailored to each client's unique needs. Our services include both syndicated and custom market reports, as well as hands-on consulting, all backed by a robust research methodology. With a library of over 6,300 reports spanning 40+ industries, we have supported more than 200 organizations across 50+ countries with accurate data, detailed market intelligence, and actionable guidance enabling informed decisions and long-term growth.

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