Biosimilars Market worth US$72.29 billion by 2035 with 7.5% CAGR | MarketsandMarkets™
DELRAY BEACH, Fla., June 17, 2025 /PRNewswire/ -- The global Biosimilars Market, valued at US$32.75 billion in 2024 stood at US$35.04 billion in 2025 and is projected to advance at a resilient CAGR of 7.5% from 2025 to 2035, culminating in a forecasted valuation of US$72.29 billion by the end of the period. This growth is driven by several key factors, including a rising number of regulatory approvals and product launches, the patent expiries of major biologics, and the increasing prevalence of chronic diseases that require effective and affordable treatment options. Furthermore, cost containment pressures in global healthcare systems and a surge in R&D collaborations among biopharma companies have significantly accelerated biosimilar development and commercialization. Notably, the first biosimilar version of the blockbuster GLP-1 agonist Semaglutide is projected to launch in China by 2026, and it is anticipated to contribute to approximately 25% of the global biosimilars market share by 2035, underscoring its transformative impact on the market landscape. However, the intricacies involved in the manufacturing processes of biosimilars may present challenges that could impede market expansion throughout the forecast period.
Download PDF Brochure: https://www.marketsandmarkets.com/pdfdownloadNew.asp?id=40
Browse in-depth TOC on "Biosimilars Market"
420 - Tables
58 - Figures
391 - Pages
By indication, the escalating global burden of cancer, coupled with the high costs associated with biologic therapies, has positioned oncology as the leading segment in the biosimilars market. These biologic medications offer a cost-effective alternative to reference products, thereby improving patient access to crucial treatments. The heightened investment in R&D within oncology has established biosimilars as a strategic option for healthcare systems aiming to enhance treatment affordability. The primary biosimilars utilized for oncological treatments include trastuzumab, bevacizumab, rituximab, filgrastim, epoetin alfa, and denosumab. Ongoing regulatory approvals continue to expand this market segment, while sustained research initiatives and collaborative endeavors are poised to augment market development further.
By Drug Class, Infliximab, rituximab, adalimumab, trastuzumab, pembrolizumab, dupilumab, ustekinumab, risankizumab, and other monoclonal antibodies are biologic therapeutics for managing autoimmune diseases, malignancies, chronic conditions, and infectious diseases. These agents are engineered through recombinant DNA (rDNA) technology, enabling them to selectively target specific antigens or cellular receptors, which enhances their therapeutic efficacy and specificity. The introduction of biosimilars for these established mAbs has the potential to significantly reduce healthcare expenditures while improving patient access to vital therapies. Moreover, with the patent expirations of several prominent mAbs, the subsequent surge in market competition is expected to drive down prices and generate increased pharmaceutical interest in mAb development. Given their affordability and versatility across oncology and autoimmune therapy, mAb biosimilars are poised to play a pivotal role in shaping the future landscape of therapeutic options.
By geography, the European market has emerged as the leading contributor to the biosimilar sector, driven by pro-biosimilar governmental policies, heightened investments in research and development, and an increasing disease burden. Key suppliers in this arena include France, Italy, Spain, Germany, and the UK. The European Medicines Agency (EMA) has approved 132 biosimilars across various therapeutic classes, enhancing patient access, lowering treatment costs, and expediting market entry. This approval encompasses a range of biologics, including insulin, TNF inhibitors, VEGF inhibitors, and monoclonal antibodies. Notably, in February 2025, the European Commission approved YESINTEK, Biocon Biologics' biosimilar of ustekinumab, underscoring Europe's commitment to improving access to biologic therapies and reinforcing its leadership position in the global biosimilars landscape.
Request Sample Pages : https://www.marketsandmarkets.com/requestsampleNew.asp?id=40
Key players in the biosimilars market include Sandoz Group AG (Switzerland), Pfizer Inc. (US), Amgen Inc. (US), Celltrion, Inc. (South Korea), Biocon (India), Dr. Reddy's Laboratories Ltd. (India), Eli Lilly and Company (US), Teva Pharmaceutical Industries Ltd. (Israel), Fresenius Kabi AG (Germany), and STADA Arzneimittel AG (Germany).
Biocon (India):
In March 2025, Biocon entered into a strategic collaboration with Civica, Inc. to manufacture and market insulin Aspart in the US jointly. As per the agreement, Biocon will provide the drug substance for insulin Aspart, while Civica will handle the downstream processes, including drug development, clinical trials, and the production of the final drug product. This partnership aims to bring biosimilars to the US market, leveraging both companies' strengths in biopharmaceutical development and commercialization. In February 2025, Dr. Reddy's collaborated with Shanghai Henlius Biotech (China) to commercialize HLX15 (daratumumab), a biosimilar candidate to Darzalex and Darzalex Faspro, in the US and Europe.
Sandoz Group AG (Switzerland)
Sandoz Group AG, a prominent player in the biosimilars sector, has strategically concentrated on launching first-to-market products for high-value biologics, exemplified by its offerings Pyzchiva (ustekinumab) and Tyruko (natalizumab). In addition to its commitment to innovative product launches, Sandoz has enhanced its capabilities in manufacturing, technology, and production capacity. A key development in this arena occurred in May 2023, when Sandoz partnered with Just-Evotec Biologics, a CDMO specializing in continuous biomanufacturing; this collaboration develops and manufactures multiple biosimilars, thereby advancing Sandoz's pipeline to a robust total of 24 assets.
For more information, Inquire Now!
Related Reports:
Monoclonal Antibody Therapeutics Market
Drug Discovery Services Market
Biologics Safety Testing Market
Pharmaceutical Drug Delivery Market
Get access to the latest updates on Biosimilars Companies and Biosimilars Market Size
About MarketsandMarkets™:
MarketsandMarkets™ has been recognized as one of America's Best Management Consulting Firms by Forbes, as per their recent report.
MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. With the widest lens on emerging technologies, we are proficient in co-creating supernormal growth for clients across the globe.
Today, 80% of Fortune 2000 companies rely on MarketsandMarkets, and 90 of the top 100 companies in each sector trust us to accelerate their revenue growth. With a global clientele of over 13,000 organizations, we help businesses thrive in a disruptive ecosystem.
The B2B economy is witnessing the emergence of $25 trillion in new revenue streams that are replacing existing ones within this decade. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines – TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing.
Built on the 'GIVE Growth' principle, we collaborate with several Forbes Global 2000 B2B companies to keep them future-ready. Our insights and strategies are powered by industry experts, cutting-edge AI, and our Market Intelligence Cloud, KnowledgeStore™, which integrates research and provides ecosystem-wide visibility into revenue shifts.
To find out more, visit www.MarketsandMarkets™.com or follow us on Twitter, LinkedIn and Facebook.
Contact:
Mr. Rohan Salgarkar
MarketsandMarkets™ INC.
1615 South Congress Ave.
Suite 103, Delray Beach, FL 33445
USA: +1-888-600-6441
Email: sales@marketsandmarkets.com
Visit Our Website: https://www.marketsandmarkets.com/
Logo: https://mma.prnewswire.com/media/1868219/MarketsandMarkets_Logo.jpg
Share this article