North America Biosimilars Market Size & Outlook, 2026-2033
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North America biosimilars market highlights
- The North America biosimilars market generated a revenue of USD 16,852.8 thousand in 2025.
- The market is expected to grow at a CAGR of 18% from 2026 to 2033.
- In terms of segment, monoclonal antibodies (mabs) was the largest revenue generating drug class in 2025.
- Insulin & Analogues is the most lucrative drug class segment registering the fastest growth during the forecast period.
- Country-wise, Mexico is expected to register the highest CAGR from 2026 to 2033.
North America data book summary
| Market revenue in 2025 | USD 16,852.8 thousand |
| Market revenue in 2033 | USD 62,494.5 thousand |
| Growth rate | 18% (CAGR from 2026 to 2033) |
| Largest segment | Monoclonal antibodies (mabs) |
| Fastest growing segment | Insulin & Analogues |
| Historical data covered | 2021 - 2024 |
| Base year for estimation | 2025 |
| Forecast period covered | 2026 - 2033 |
| Quantitative units | Revenue in USD thousand |
| Market segmentation | Monoclonal Antibodies (mAbs), Growth Factors & Hematopoietic Agents, Insulin & Analogues, Osteoporosis / Bone Metabolism Agents, Others Drug Class |
| Key market players worldwide | Amgen Inc, Roche, Sandoz Group AG ADR, Dr. Reddy’s Laboratories, Teva Pharmaceutical Industries Ltd, Pfizer Inc, Samsung Bioepis, Biocon, Viatris Inc, Celltrion Healthcare, AbbVie Inc |
Other key industry trends
- In terms of revenue, North America region accounted for 42.6% of the global biosimilars market in 2025.
- Globally, North America is projected to lead the regional market in terms of revenue in 2033.
- Asia Pacific is the fastest growing regional market and is projected to reach USD 33,695.2 thousand by 2033.
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Biosimilars Market Scope
Biosimilars Market Companies
| Name | Profile | # Employees | HQ | Website |
|---|---|---|---|---|
| Sandoz Group AG ADR | View profile | - | - | - |
| Biocon | View profile | 10001+ | Bangalore, Karnataka, India, Asia | http://www.biocon.com |
| Samsung Bioepis | View profile | 501-1000 | Incheon, Inch'on-jikhalsi, South Korea, Asia | https://www.samsungbioepis.com |
| Celltrion Healthcare | View profile | 51-100 | Incheon, Inch'on-jikhalsi, South Korea, Asia | http://www.celltrionhealthcare.com/ |
| Viatris Inc | View profile | 38000 | 1000 Mylan Boulevard, Canonsburg, PA, United States, 15317 | https://www.viatris.com |
| Roche | View profile | 10001+ | Basel, Basel-Stadt, Switzerland, Europe | http://www.roche.com |
| Dr. Reddy’s Laboratories | View profile | 10001+ | Hyderabad, Andhra Pradesh, India, Asia | http://www.drreddys.com/ |
| Pfizer Inc | View profile | 88000 | 66 Hudson Boulevard East, New York, NY, United States, 10001-2192 | https://www.pfizer.com |
| AbbVie Inc | View profile | 50000 | 1 North Waukegan Road, North Chicago, IL, United States, 60064-6400 | http://www.abbvieinvestor.com |
| Amgen Inc | View profile | 26700 | One Amgen Center Drive, Thousand Oaks, CA, United States, 91320-1799 | https://www.amgen.com |
| Teva Pharmaceutical Industries Ltd | View profile | 37851 | 124 Dvora HaNevi’a Street, Tel Aviv, Israel, 6944020 | https://www.tevapharm.com |
North America biosimilars market outlook
The databook is designed to serve as a comprehensive guide to navigating this sector. The databook focuses on market statistics denoted in the form of revenue and y-o-y growth and CAGR across the globe and regions. A detailed competitive and opportunity analyses related to biosimilars market will help companies and investors design strategic landscapes.
Monoclonal antibodies (mabs) was the largest segment with a revenue share of 52.26% in 2025. Horizon Databook has segmented the North America biosimilars market based on monoclonal antibodies (mabs), growth factors & hematopoietic agents, insulin & analogues, osteoporosis / bone metabolism agents, others drug class covering the revenue growth of each sub-segment from 2021 to 2033.
North America is expected to witness high CAGR during the forecast period, due to rising efforts from manufacturers to tap growth opportunities in U.S. and Canada. The U.S. biosimilar regulatory pathway was established in March 2009, and since then the region has gained significant momentum, presenting new opportunities and challenges.
Rise in the number of approvals is anticipated to boost the adoption of biosimilars in the near future in the region. For instance, in December 2019, Amgen received FDA approval for AVSOLA (infliximabaxxq).
The biosimilar was approved for all the indications of chronic inflammatory conditions. Total healthcare costs have increased due to high-prices patented pharmaceutical drugs, especially biologics.
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Target buyers of North America biosimilars market databook
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Our clientele includes a mix of biosimilars market companies, investment firms, advisory firms & academic institutions.
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30% of our revenue is generated working with investment firms and helping them identify viable opportunity areas.
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Approximately 65% of our revenue is generated working with competitive intelligence & market intelligence teams of market participants (manufacturers, service providers, etc.).
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The rest of the revenue is generated working with academic and research not-for-profit institutes. We do our bit of pro-bono by working with these institutions at subsidized rates.
Horizon Databook provides a detailed overview of continent-level data and insights on the North America biosimilars market , including forecasts for subscribers. This continent databook contains high-level insights into North America biosimilars market from 2021 to 2033, including revenue numbers, major trends, and company profiles.
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North America biosimilars market size, by country, 2021-2033 (US$K)
North America Biosimilars Market Outlook Share, 2025 & 2033 (US$K)
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