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 Prevalence of Chronic Diseases Drives Growth in the North America Biosimilars Market

The increasing aging population, coupled with changing social behaviors and the widespread adoption of sedentary lifestyles due to rapid urbanization, is contributing to the rising incidence of obesity and chronic illnesses such as diabetes. Twin studies have also confirmed a genetic component to several chronic conditions, including cardiovascular diseases (CVDs), diabetes, obesity, Alzheimer’s disease (AD), and depression. According to the National Council on Aging, approximately 80% of Americans aged 65 and older suffer from at least one chronic condition, while 68% live with two or more. Similarly, the Centers for Disease Control and Prevention (CDC) reported in 2020 that nearly 60% of U.S. adults had at least one chronic disease, and 40% were managing two or more.

Cardiovascular conditions—including atherosclerosis, angina, and myocardial infarction—are among the leading causes of death globally, often linked to fast-paced, unhealthy lifestyles. The World Health Organization (WHO) attributes roughly 17.9 million deaths per year to CVDs, making them the leading global cause of mortality. Diabetes, another major chronic disease with no definitive cure, can cause severe complications such as heart attacks, strokes, kidney failure, amputations, vision loss, and nerve damage. According to the International Diabetes Federation (IDF), diabetes cases in North America are projected to rise from 46 million in 2017 to 62 million by 2045. Globally, the number of people with diabetes is expected to increase from 425 million in 2017 to 629 million by 2045—an estimated 35% growth market over the forecast period.

North America Biosimilars Market Overview

Autoimmune diseases are also on the rise in North America. As of 2019, over 24 million Americans were living with autoimmune disorders, according to the NIH Autoimmune Diseases Coordinating Committee. Additionally, about 8 million individuals have auto-antibodies—biomarkers that signal a predisposition to autoimmune diseases. A 2020 study by the Clinical Research Branch of the National Institute of Environmental Health Sciences (NIEHS) reported a marked increase in antinuclear antibodies (ANA)—the most prevalent marker of autoimmunity—across a diverse segment of the U.S. population, including males, non-Hispanic whites, adults over 50, and adolescents.

In the U.S., biosimilars are playing a critical role in managing chronic and autoimmune conditions, as well as certain cancers and kidney diseases. According to Cardinal Health, the FDA has approved 33 biosimilars to date, with 21 currently available on the market. Of these, 17 are used for cancer treatments, three target autoimmune diseases, and one is approved for diabetes management. This growing adoption of biosimilars reflects their increasing importance in meeting the treatment demands of a population facing a surge in chronic health conditions.

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