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 Diseases Fueling North America Biosimilars Market
The North America biosimilars market is experiencing significant market growth, primarily driven by the increasing prevalence of chronic diseases across the region. This surge in chronic conditions is linked to a combination of factors, including an aging population, evolving social behaviors, and the widespread adoption of sedentary lifestyles spurred by accelerating urbanization. These factors contribute to a rise in obesity and various chronic ailments like diabetes. Genetic predispositions also play a role, with twin studies highlighting the link between genes and conditions such as cardiovascular diseases (CVDs), diabetes, obesity, Alzheimer's disease (AD), and depression.
The Growing Burden of Chronic Illnesses
The statistics paint a clear picture of the escalating health challenge. The National Council on Aging, Inc., reports that a striking 80% of adults aged 65 and older have at least one chronic condition, and 68% contend with two or more. The Centers for Disease Control and Prevention (CDC) further indicates that in 2020, nearly 6 out of 10 people in the US suffered from at least one chronic disease, with 4 out of 10 having two or more.
Cardiovascular diseases, including atherosclerosis, angina pectoris, and acute myocardial infarction, are a leading cause of global mortality, often exacerbated by hectic lifestyles. The World Health Organization (WHO) identifies CVDs as the number one cause of death worldwide, accounting for an estimated 17.9 million deaths annually.
Diabetes, a severe chronic condition with no functional cure, leads to various complications and increases the risk of premature death. These complications can include heart attack, stroke, kidney failure, leg amputation, vision loss, and nerve damage. The International Diabetes Federation (IDF) projects a significant rise in diabetes cases in North America, from 46 million in 2017 to an estimated 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, representing a 35% increase in disease prevalence during this forecast period.
Autoimmune Diseases and the Role of Biosimilars
Autoimmune diseases are also on the rise, contributing to the demand for biosimilars. In 2019, the NIH Autoimmune Diseases Coordinating Committee reported that over 24 million Americans suffered from autoimmune diseases, with an additional 8 million having auto-antibodies, which indicate a risk of developing these conditions. The reasons behind this increase are not fully understood, but a 2020 study by the Clinical Research Branch at the National Institute of Environmental Health Sciences (NIEHS) revealed a significant increase in the prevalence of antinuclear antibodies (ANA), a common biomarker for autoimmunity, across various demographics in the US.
In the US, biosimilars are crucial for treating patients with various conditions, including cancers, kidney diseases, diabetes, and autoimmune diseases like rheumatoid arthritis and Crohn's disease. According to Cardinal Health, the FDA has approved a total of 33 biosimilars in the US, with 21 currently commercially available. Of these, 17 are utilized for cancer treatments, three for autoimmune conditions, and one for diabetes.
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
- Cost savings over biologics.
- Patent expirations of blockbuster biologics (e.g., Humira, Neulasta).
- Government initiatives promoting biosimilar use (e.g., US FDA’s Biosimilars Action Plan).
- 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
