Biosimilar Market Industry Size to Reach USD 112.59 Billion by 2032, At a CAGR of 17.4% To Forecast 2025-2032

Biosimilar Market was estimated at USD 31.20 Bn in 2024 and is expected to grow at a CAGR of 17.4% from 2025 to 2032, reaching nearly USD 112.59 Bn by 2032.

LOS ANGELS, CA, UNITED STATES, August 22, 2025 /EINPresswire.com/ -- Stellar Market Research examines the growth rate of the Biosimilar Market during the forecasted period 2025-2032

The Biosimilar Market is projected to grow at a CAGR of approximately 17.4% over the forecast period. The Biosimilar Market was valued at USD 31.20 billion in 2024 and is expected to reach USD 112.59 billion by 2032. The biosimilar market revolves around the expiry of patents for biologics, the growing number of chronic diseases, the need for cost savings, support from regulators, acceptance by physicians, demand from emerging markets, biotech R&D, and strategic collaborations in the industry.

Biosimilar Market Overview

The biosimilar market is becoming a more significant player as healthcare facilities look for cheaper solutions that are biologics of high cost. The use of biosimilars for cancer, immunological, and hormone diseases has become more frequent due to the influence of decline in the patents and the increase in chronic diseases. Their adoption is growing in Europe, North America, and the Asia-Pacific region, all of which are benefiting from the changes in regulations. Some of the main players in the industry are putting their money into the development and collaborations. Although regulatory difficulties and the acceptance of the prescribers are among the obstacles, the biosimilars are changing the scene in the availability of the most advanced biologic therapies that save lives globally.

To know the most attractive segments, click here for a free sample of the report: https://www.stellarmr.com/report/req_sample/biosimilar-market/2759

Biosimilar Market Dynamics

Drivers

Patent Expiry of Biologics

Patent expiration of biologics that block the market, such as Humira, Enbrel, and Herceptin, has unveiled markets for biosimilars, which in turn raises competition and makes prices go down. The launches of the U.S. Humira biosimilar and the FDA approvals are among the latest indicators of this transition. Although the patent litigations have postponed several entries, the settlements are now facilitating the pace of biosimilar availability, which enhances the patients' access and makes healthcare worldwide more innovative.

Increased Physician and Patient Acceptance

The disbelief at the start about the efficiency and safety of biosimilars has now almost disappeared with the mounting clinical evidence and the data from the everyday use that show similar performance to the original biologics. Besides the trust that the regulators have placed in the safety and efficacy of biosimilars and the education effort by the medical societies, physicians, and patients are now more confident of them, hence higher use of biosimilars, greater patient access, and important savings for the healthcare system worldwide.

Advances in Biomanufacturing Technology

Biomanufacturing innovations single-use bioreactors, continuous manufacturing, and AI-powered process optimization, have enhanced the quality, uniformity, and scale of biosimilar production. Such improvements reduce expenses, accelerate the product development phase, and contribute efficient supply of manufacturers to the global market. Industrial progress of this nature, propelled by FDA policies and exemplified by Amgen and Samsung Bioepis investments, is among the key factors behind the biosimilar market expansion.

Restrain

Limited Awareness and Education

One of the major factors behind the slow acceptance of biosimilars is the limited knowledge and understanding of healthcare providers and patients. As a result, these groups suspect biosimilars and assume them to be unsafe and ineffective. Regulatory bodies like the FDA and EMA, along with patient advocacy organizations, are developing educational programs and digital resources to advance knowledge, establish confidence, and promote usage that would ensure patient access and health system savings.

Innovations and Developments

Technological innovation is a key factor propelling the Biosimilar Market forward. Notable advancements include:

Advanced Cell Line Engineering: CRISPR combined with different gene-editing methods has not only revolutionized the development of cell lines but also has upgraded the proteins produced for biosimilars in both quantity and quality.

Single-Use and Continuous Manufacturing: The implementation of single-use bioreactors and continuous production systems has contributed to the possibility of cutting the risk of contamination, lowering the costs, and increasing the scalability.

Biosimilar Market Segmentation

By Product Type

By Product Type, the Biosimilar Market is further segmented into Monoclonal Antibodies, Insulin, Growth Hormones, and Others. The biosimilar market is led by monoclonal antibodies, which are in high demand for the treatment of cancer and autoimmune diseases, with the expiry of patents and the confirmed efficacy being the main reasons. New FDA approvals and the market entry of Humira biosimilars are intensifying the rivalry. Besides this, the strategic investments and large-scale acceptance of Europe are propelling the growth not only by spreading access to patients but also by lowering healthcare expenses worldwide.

Biosimilar Market Regional Analysis

North America: The biosimilar market is dominated by North America which is mainly attributed to high healthcare expenditure, the expiry of patents on leading biologics such as Humira, supportive FDA regulations, the increasing acceptance of biosimilars by physicians, the investments in advanced manufacturing, and the incentives provided by payers which are the main factors responsible for the fast adoption of biosimilars and the market growth.

Europe: Europe is the second-leading biosimilar market due to early EMA regulation, strong adoption, government support, and high physician confidence resulted in this growth. Strict pricing and a smaller market size have affected commercial growth and overall revenue, but despite this, biosimilar usage in Europe remains high.

Asia-Pacific: Asia-Pacific ranks third in the biosimilar market due to strong local manufacturing, rising demand, the implementation of supportive regulations, and the global expansion by companies such as Biocon.

To know the most attractive segments, click here for a free sample of the report: https://www.stellarmr.com/report/req_sample/biosimilar-market/2759

Recent Developments:

Ustekinumab Biosimilar Launch: Opened the U.S. market with a substantial discount, more than 80% lower than the wholesale acquisition cost (WAC) of Stelara. The FDA and EMA are two regulatory agencies that are investigating a simplified development process that may lead to the exclusion of the standard clinical efficacy trials for some biosimilars.

Biosimilar Market Competitive Landscape

The global and regional players in the Biosimilar Market concentrate on developing and enhancing their capabilities, resulting in fierce competition. Notable players include:

Amgen (United States)
Pfizer (United States)
Biogen (United States)
Coherus Biosciences (United States)
Sorrento Therapeutics (United States)
Momenta Pharmaceuticals (United States)
Sandoz (Switzerland)
STADA Arzneimittel (Germany)
Fresenius Kabi (Germany)
BioNTech (Germany)
Novartis (Switzerland)

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About Stellar Market Research:

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