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.

North America’s Biosimilars Market: Key Insights

Autoimmune diseases are also on the rise in the region. According to the NIH Autoimmune Diseases Coordinating Committee, over 24 million Americans had autoimmune conditions in 2019, with an additional 8 million carrying auto-antibodies—indicating a heightened risk of developing such diseases. Research from the National Institute of Environmental Health Sciences (NIEHS) highlights a notable increase in antinuclear antibodies (ANA), a key biomarker for autoimmunity, particularly among males, non-Hispanic whites, adults over 50, and adolescents.

Biosimilars have emerged as a critical treatment option for chronic and autoimmune diseases, including cancer, kidney disease, diabetes, rheumatoid arthritis, and Crohn’s disease. In the U.S., the FDA has approved 33 biosimilars, with 21 currently available on the market growth. Among these, 17 are used in cancer treatments, three target autoimmune conditions, and one is prescribed for diabetes management. This expanding biosimilars market reflects the growing demand for cost-effective alternatives to biologic therapies in managing chronic diseases.

Rising Chronic Disease Burden Fuels Growth in North America's Biosimilars Market

The growing aging population, shifting social behaviors, and increasing adoption of sedentary lifestyles due to rapid urbanization are contributing to higher rates of obesity and chronic diseases such as diabetes. Genetic factors also play a key role, with studies linking conditions like cardiovascular disease (CVD), diabetes, obesity, Alzheimer’s disease, and depression to hereditary causes. 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—are among the leading causes of death globally, driven by increasingly hectic lifestyles. The World Health Organization (WHO) estimates that CVDs account for approximately 17.9 million deaths annually. Meanwhile, diabetes, a chronic and incurable disease, can lead 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, reflecting a 35% increase.

North America Biosimilars Market Segmentation (2022)

North America biosimilars market By Disease Indication

• Cancer (Largest market share in 2022)
• Diabetes
• Autoimmune Diseases
• Other Disease Indications

North America biosimilars market By Drug Class

• Granulocyte Colony-Stimulating Factors (G-CSFs) (Largest share)
• Human Growth Hormone
• Insulin
• TNF Blockers & Monoclonal Antibodies
• Erythropoietin-Stimulating Agents
• Others

North America biosimilars market By Route of Administration

• Intravenous (IV) (Dominant segment)
• Subcutaneous
• Others

North America biosimilars market By End User

• Hospitals (Leading segment)
• Specialty Clinics
• Homecare
• Others

North America biosimilars market By Country

• United States (US) (Market leader in 2022)
• Canada
• Mexico

North America biosimilars market Key Players

Major companies operating in the North America biosimilars market include:

• 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 Key Insights

• Cancer was the leading disease indication, reflecting high demand for oncology biosimilars.
• G-CSFs (e.g., used for chemotherapy-induced neutropenia) dominated the drug class segment.
• Intravenous administration was most common, aligning with hospital-based treatments.
• Hospitals were the primary end users, driven by infrastructure for biologic administration.
• The US held the largest share due to favorable regulations (e.g., FDA approvals) and high biosimilar adoption.

North America biosimilars market Growth Drivers

1. Cost savings over biologics.
2. Patent expirations of blockbuster biologics (e.g., Humira, Neulasta).
3. Government initiatives promoting biosimilar use (e.g., US FDA’s Biosimilars Action Plan).
4. Rising chronic diseases (cancer, diabetes, autoimmune disorders).

North America biosimilars market Strategic Insights

Strategic insights for the North America Biosimilars provides data-driven analysis of the industry landscape, including current trends, key players, and regional nuances. These insights offer actionable recommendations, enabling readers to differentiate themselves from competitors by identifying untapped segments or developing unique value propositions. Leveraging data analytics, these insights help industry players anticipate the market shifts, whether investors, manufacturers, or other stakeholders. A future-oriented perspective is essential, helping stakeholders anticipate market shifts and position themselves for long-term success in this dynamic region. Ultimately, effective strategic insights empower readers to make informed decisions that drive profitability and achieve their business objectives within the market.

North America biosimilars market Regional Insights

The geographic scope of the North America Biosimilars refers to the specific areas in which a business operates and competes. Understanding local distinctions, such as diverse consumer preferences (e.g., demand for specific plug types or battery backup durations), varying economic conditions, and regulatory environments, is crucial for tailoring strategies to specific markets. Businesses can expand their reach by identifying underserved areas or adapting their offerings to meet local demands. A clear market focus allows for more effective resource allocation, targeted marketing campaigns, and better positioning against local competitors, ultimately driving growth in those targeted areas.

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Author’s Bio:

Suryakant Gadekar

Senior Market Research Expert at Business Market Insights