Dubai, UAE – January 12, 2026 — Kings Research today announced the release of its latest market intelligence study, “Global Biosimilar Monoclonal Antibody Market: Size, Share, Trends & Forecast 2025–2032.” The report delivers an in-depth assessment of market evolution, covering growth drivers, segmentation, regional performance, and competitive developments shaping the biosimilars landscape.
According to Kings Research, the global biosimilar monoclonal antibody market was valued at USD 10.71 billion in 2024 and is projected to grow from USD 12.44 billion in 2025 to USD 40.77 billion by 2032, registering a CAGR of 18.48% during the forecast period. The expansion is fueled by increasing adoption of cost-effective biologic alternatives across oncology, autoimmune, and inflammatory disease treatments.
Biosimilars are highly similar to approved reference monoclonal antibodies, offering comparable safety and efficacy at lower costs. They improve patient access while reducing financial strain, especially as biologic drugs account for only 5% of prescriptions but roughly 51% of total U.S. drug spending.
These therapies have generated around USD 56 billion in U.S. healthcare savings since 2015 and are typically priced nearly 50% lower than reference biologics. Globally, biosimilars can cost up to 60% less than originator biologics, expanding access to treatments for cancer and autoimmune diseases.
Kings Research identifies the following growth accelerators:
1. Patent Expirations of Blockbuster Biologics:
The expiration of patents for leading monoclonal antibodies continues to open pathways for biosimilar approvals. This trend is already reflected in regulatory outcomes, with 76 FDA-approved biosimilars currently available, intensifying competition and accelerating market entry (Source: www.hhs.gov).
2. Regulatory Support for Biosimilars:
Regulatory agencies such as the U.S. FDA and the European Medicines Agency have implemented streamlined biosimilar approval frameworks to improve clarity, confidence, and adoption. Despite this progress, biosimilars still account for less than 20% of the U.S. biologics market share, indicating substantial headroom for growth as regulatory confidence translates into broader clinical uptake.
3. Rising Cancer and Autoimmune Disease Burden:
The increasing global prevalence of cancer and autoimmune disorders continues to drive sustained demand for monoclonal antibody-based therapies. The World Health Organization reports that biosimilar versions of trastuzumab alone have already been authorized in at least 65 countries, demonstrating the role of biosimilars in expanding access to life-saving oncology treatments worldwide.
4. Healthcare Cost Containment Initiatives:
Governments and public payers are actively promoting biosimilar adoption to reduce biologics-related spending. U.S. federal health agencies emphasize biosimilars as a central component of national drug-pricing and affordability strategies, given their demonstrated ability to deliver tens of billions of dollars in cumulative healthcare savings.
5. Manufacturing and Process Innovation:
Advances in bioprocessing technologies, analytical characterization, and large-scale biologics manufacturing are improving production efficiency and supply reliability for biosimilar manufacturers, supporting broader regulatory approvals and sustained market expansion across both developed and emerging healthcare systems.
For pharmaceutical executives, payers, and healthcare stakeholders, the biosimilar monoclonal antibody market offers significant advantages:
- Cost Efficiency: Lower-priced alternatives to originator biologics reduce treatment and reimbursement costs.
- Expanded Patient Access: Improved affordability increases therapy reach across emerging and developed markets.
- Portfolio Diversification: Enables pharmaceutical companies to strengthen biologics pipelines with lower R&D risk.
- Healthcare Sustainability: Supports long-term cost control in oncology and chronic disease management.
- Competitive Differentiation: Early market entry and scale provide pricing and formulary advantages.
Regional Outlook
- North America: The largest market, driven by strong regulatory frameworks, high biologics utilization, and increasing payer acceptance of biosimilars.
- Asia-Pacific: The fastest-growing region, supported by expanding biologics manufacturing capacity, rising disease burden, and government-led initiatives to improve access to affordable biologic therapies.
Competitive Landscape
The market is characterized by strategic partnerships, product launches, and global expansion initiatives. Key players include Biocon Limited, CELLTRION INC., Sandoz, Samsung, Pfizer Inc., Amgen Inc., Viatris Inc., Dr. Reddy’s Laboratories Ltd., Coherus Oncology, Formycon AG, Alvotech, Teva Pharmaceutical Industries Ltd., Boehringer Ingelheim International GmbH, F. Hoffmann-La Roche Ltd, and Enzene Biosciences.
The full Kings Research report provides detailed insights across therapeutic area, route of administration, end-user segmentation, and competitive benchmarking. To request a sample, access the complete report, or explore tailored consulting services, please visit https://www.kingsresearch.com/report/biosimilar-monoclonal-antibody-market-3007.
About Kings Research
Kings Research is a global provider of syndicated market research and strategic consulting services, supporting organizations in identifying growth opportunities, navigating regulatory landscapes, and making data-driven business decisions.
All market data are sourced from Kings Research proprietary analysis, validated against credible regulatory and public sources. Examples cited include the U.S. Food and Drug Administration (FDA.gov), European Medicines Agency (ema.europa.eu), World Health Organization (who.int), and peer-reviewed biomedical research publications.