North America Biosimilars Market Regional Analysis and Industry Growth by Forecast to 2028

The North America Biosimilars Market is expected to grow from US$ 7,115.74 million in 2022 to US$ 47,746.80 million by 2028. It is estimated to grow at a CAGR of 37.3% from 2022 to 2028.

Rising Chronic Disease Burden Fuels Growth in North America Biosimilars Market

The North America Biosimilars Market growing aging population, shifting social behaviors, and increasing adoption of sedentary lifestyles—driven by rapid urbanization—are contributing to higher rates of obesity and chronic diseases such as diabetes. Genetic factors also play a significant role, with studies linking hereditary traits to conditions like cardiovascular disease (CVD), diabetes, obesity, Alzheimer’s, and depression. According to the National Council on Aging, 80% of adults aged 65 and older have at least one chronic condition, while 68% suffer from two or more. The Centers for Disease Control and Prevention (CDC) reports that in 2020, nearly 60% of U.S. adults had at least one chronic disease, and 40% had two or more.

Cardiovascular diseases—including atherosclerosis, angina pectoris, and acute myocardial infarction—remain leading causes of death globally, exacerbated by high-stress lifestyles. The World Health Organization (WHO) estimates that CVDs account for 17.9 million deaths annually. Meanwhile, diabetes, a chronic and incurable condition, leads to severe complications such as heart attacks, strokes, kidney failure, amputations, vision loss, and nerve damage. The International Diabetes Federation (IDF) projects that diabetes cases in North America will rise from 46 million in 2017 to 62 million by 2045. Globally, the number of people with diabetes is expected to surge from 425 million in 2017 to 629 million by 2045—a 35% increase North America Biosimilars Market.

North America Biosimilars Market Segments Covered

North America Biosimilars Market By Disease Indication

• Cancer
• Diabetes
• Autoimmune Diseases
• Other Diseases

North America Biosimilars Market By Drug Class

• Granulocyte Colony-Stimulating Factors
• Human Growth Hormone
• Insulin
• TNF Blockers & Monoclonal Antibodies
• Erythropoietin-Stimulating Agents

North America Biosimilars Market By Route of Administration

• Intravenous
• Subcutaneous

North America Biosimilars Market By End User

• Hospitals
• Speciality Clinics
• Homecare

North America Biosimilars Market Regions and Countries Covered

North America

• US
• Canada
• Mexico

North America Biosimilars Market leaders and key company profiles

• Amgen Inc
• Celltrion Inc
• Sanofi SA
• Biocon Ltd
• Coherus BioSciences Inc
• Eli Lilly and Co
• Sandoz AG
• Teva Pharmaceutical Industries Ltd
• Pfizer Inc
• Dr. Reddy’s Laboratories Ltd

North America Biosimilars Market Overview

Autoimmune diseases are also on the rise, with the NIH Autoimmune Diseases Coordinating Committee reporting that over 24 million Americans were affected in 2019. Additionally, 8 million individuals carry auto-antibodies, indicating heightened risk. Research from the National Institute of Environmental Health Sciences (NIEHS) reveals a notable increase in antinuclear antibodies (ANA), a key autoimmune biomarker, particularly among males, non-Hispanic whites, adults over 50, and adolescents.

Biosimilars in the U.S. are increasingly used to treat cancers, kidney diseases, diabetes, and autoimmune disorders like rheumatoid arthritis and Crohn’s disease. According to Cardinal Health, the FDA has approved 33 biosimilars, with 21 currently available in the market. Of these, 17 target cancer-related treatments, three address autoimmune conditions, and one is used for diabetes management.

Strategic Insights for the North America Biosimilars Market

To navigate the evolving biosimilars landscape, stakeholders must leverage data-driven insights to identify emerging trends, assess competitive dynamics, and uncover regional opportunities. Key strategic considerations include:

1. Market Differentiation – Companies should explore underserved segments or develop unique value propositions to stand out in a competitive market.
2. Data-Driven Forecasting – Advanced analytics can help predict market shifts, enabling proactive decision-making for manufacturers, investors, and healthcare providers.
3. Future-Readiness – A forward-looking approach is critical to anticipating regulatory changes, pricing pressures, and evolving patient needs.
4. Targeted Expansion – Identifying high-growth therapeutic areas, such as oncology and autoimmune diseases, can drive long-term success.

By adopting these strategies, industry players can optimize profitability, enhance market positioning, and capitalize on the expanding demand for biosimilars in North America. Whether through innovation, strategic partnerships, or data-backed investments, stakeholders must remain agile to thrive in this dynamic sector.

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Author’s Bio:

Suryakant Gadekar

Senior Market Research Expert at Business Market Insights