North America Biosimilars Market Size & Outlook, 2026-2033
Global Market
Related Markets
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.
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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Publish Date: Nov 05, 2025
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Biosimilars Market Scope
Biosimilars Market Companies
| Name | Profile | # Employees | HQ | Website |
|---|---|---|---|---|
| Teva Pharmaceutical Industries Ltd | View profile | 37,851 | 124 Dvora HaNevi’a Street, Tel Aviv, Israel, 6944020 | www.tevapharm.com |
| Amgen Inc | View profile | 26,700 | One Amgen Center Drive, Thousand Oaks, CA, United States, 91320-1799 | www.amgen.com |
| AbbVie Inc | View profile | 50,000 | 1 North Waukegan Road, North Chicago, IL, United States, 60064-6400 | www.abbvieinvestor.com |
| Pfizer Inc | View profile | 88,000 | 66 Hudson Boulevard East, New York, NY, United States, 10001-2192 | www.pfizer.com |
| Dr. Reddy’s Laboratories | View profile | 10001+ | Hyderabad, Andhra Pradesh, India, Asia | www.drreddys.com/ |
| Roche | View profile | 10001+ | Basel, Basel-Stadt, Switzerland, Europe | www.roche.com |
| Viatris Inc | View profile | 38,000 | 1000 Mylan Boulevard, Canonsburg, PA, United States, 15317 | www.viatris.com |
| Celltrion Healthcare | View profile | 51-100 | Incheon, Inch'on-jikhalsi, South Korea, Asia | www.celltrionhealthcare.com/ |
| Samsung Bioepis | View profile | 501-1000 | Incheon, Inch'on-jikhalsi, South Korea, Asia | www.samsungbioepis.com |
| Biocon | View profile | 10001+ | Bangalore, Karnataka, India, Asia | www.biocon.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 Outlook 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.
- North America Biosimilars Market Drug Class Outlook (Revenue, USD Thousand , 2021-2033)
- Monoclonal Antibodies (mAbs)
- Growth Factors & Hematopoietic Agents
- Insulin & Analogues
- Osteoporosis / Bone Metabolism Agents
- Others
- North America Biosimilars Market Indication Outlook (Revenue, USD Thousand , 2021-2033)
- Autoimmune Disorders (RA, IBD, Psoriasis, Ankylosing Spondylitis)
- Oncology (Breast, Colorectal, Lymphoma, Lung, Gastric)
- Diabetes Mellitus (Type 1 & Type 2)
- Ophthalmic Disorders (Wet AMD, DME, RVO)
- Hematologic / Rare Blood Disorders
- Others
- North America Biosimilars Market End Use Outlook (Revenue, USD Thousand , 2021-2033)
- Hospitals
- Specialty Pharmacies
- Online & Retail Channels
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Horizon Databook provides a detailed overview of continent-level data and insights on the North America Biosimilars Market Outlook, including forecasts for subscribers. This continent databook contains high-level insights into North America Biosimilars Market Outlook from 2021 to 2033, including revenue numbers, major trends, and company profiles.
North America Biosimilars Market, 2021-2033 (US$K)
North America biosimilars market statistics, by drug class, 2021-2033 (USD Thousand)
