North America Biosimilars Market Outlook, 2030

Biosimilars are biological products that are highly similar to already approved reference biologics, offer significant promise in terms of enhancing patient access to critical therapies for chronic and life-threatening conditions such as cancer, rheumatoid arthritis, and diabetes. The United States and Canada are the primary contributors to this market in North America, with the U.S. being the dominant force due to its massive healthcare expenditure, sophisticated pharmaceutical infrastructure, and a growing patient population in need of affordable alternatives to high-cost biologics. The U.S.

Food and Drug Administration (FDA) has played a crucial role in shaping this market, offering a defined regulatory pathway for biosimilars under the Biologics Price Competition and Innovation Act (BPCIA) since 2010. This has resulted in an increasing number of FDA-approved biosimilars, particularly in oncology and immunology, fostering competitive dynamics that have started to reshape pricing strategies and market access policies. As of April 2022, the number of approved biosimilars by the U.S. FDA in the U.S. is 35, out of which 21 have been made commercially available in the U.S. market. They offer comparable clinical utility over their reference products at a lower cost, which is a key factor for their rising uptake in the U.S. market.

In terms of production, the region is home to several leading biosimilar developers and contract manufacturing organizations (CMOs), supported by advanced research facilities and a skilled workforce. Biotech hubs like Boston, San Francisco, Toronto, and Montreal play key roles in fostering innovation and scaling up biosimilar production, often in partnership with global pharmaceutical firms. Low profitability is another attribute restricting the growth rate of the market, due to the increasing cases of COVID-19, many hospitals in the U.S. have restricted physical consultancies, which slowly limits the market's demand.

According to the research report "North America Biosimilars Market Outlook, 2030," the North America Biosimilars market was valued at more than USD 9.44 Billion in 2024. Biosimilar manufacturers are leveraging North America’s advanced biotech infrastructure to scale production. The presence of leading biopharmaceutical clusters in areas like Boston, San Diego, and Toronto supports a strong research and innovation ecosystem, allowing developers to refine manufacturing processes and enhance biosimilar comparability to originator drugs.

For instance, according to a 2021 article by Dotdash Publishing, Amgen drug Neulasta to treat neutropenia costs more than USD 10,000 per ml, whereas its biosimilar, Ziextenzo, costs around USD 6,500 per ml, which saves around 37% overall cost. According to the International Diabetes Federation (IDF), diabetic cases in North America are expected to reach 62 million by 2045 from 46 million in 2017. The substantial healthcare spending in the U.S. makes it a critical battleground for biosimilar manufacturers, despite adoption challenges.

The financial implications of policy programs on biosimilar adoption become evident when examining the 340B program's impact: eligible hospitals received $41,298 in Medicare reimbursement compared to $23,379 for non-eligible hospitals - a 77% increase in reimbursement associated with 340B eligibility. Furthermore, the data reported that 425 million people were suffering from diabetes in 2017, and the count is expected to reach 629 million by 2045 across the world. The disease prevalence is likely to increase by about 35% during the forecast period. Canadian health authorities have implemented initiatives that directly address the interchangeability concerns that often limit biosimilar uptake elsewhere.

The publicly funded healthcare system provides a centralized decision-making framework that, once penetrated, can enable rapid market access across provinces. British Columbia's Biosimilars Initiative, which mandates switching from originators to biosimilars for public reimbursement, has become a model being replicated across other provinces. For manufacturers, Canada's growth trajectory offers valuable lessons about how coordinated policy approaches can overcome physician and patient hesitancy a challenge that continues to limit uptake in other markets despite demonstrated safety and efficacy profiles of biosimilar products.

Market Drivers

• Patent Expirations of Biologic Drugs: One of the primary drivers of the North American biosimilars market is the wave of patent expirations for major biologic drugs. Blockbuster biologics such as Humira (adalimumab), Remicade (infliximab), and Enbrel (etanercept) have faced or are approaching the end of their exclusivity periods. As these patents expire, opportunities open up for biosimilar manufacturers to introduce more affordable alternatives. The legal and regulatory framework, especially the Biologics Price Competition and Innovation Act (BPCIA) in the U.S., supports this transition by providing a clear pathway for biosimilar approval.
• Increasing Demand for Cost-effective Treatments: Healthcare systems across North America, especially in the United States and Canada, are under pressure to reduce spending while maintaining high-quality patient care. Biosimilars offer a promising solution by providing cost-effective alternatives to expensive biologics used to treat chronic conditions such as cancer, autoimmune diseases, and diabetes. With the rise in chronic disease prevalence and an aging population, the demand for affordable therapies is growing. Payers, including insurance companies and government programs like Medicare and Medicaid, are increasingly incentivizing or mandating the use of biosimilars to help manage healthcare budgets.

Market Challenges

• Physician and Patient Skepticism: Despite regulatory approvals, many physicians and patients remain cautious about switching from originator biologics to biosimilars. Concerns revolve around the efficacy, safety, and immunogenicity of biosimilars, even though they are highly similar to the reference products. This skepticism can be attributed to a lack of familiarity, limited real-world evidence, and the historical perception that biosimilars are not equivalent to generics. Overcoming these concerns requires continuous education, robust post-marketing surveillance, and transparent communication from manufacturers and regulators to build trust in the biosimilar landscape.
• Regulatory and Market Access Barriers: The regulatory environment for biosimilars in North America, while evolving, still poses challenges. The U.S. Food and Drug Administration (FDA) has made strides in establishing pathways for approval, but the complexity of biologic drugs makes biosimilar development more difficult and costly than for traditional generics. Additionally, gaining market access can be difficult due to entrenched relationships between providers and original biologic manufacturers, rebate strategies that favor originators, and formulary exclusions. These hurdles can delay market entry and limit the competitive impact of biosimilars.

Market Trends

• Rising Interchangeability Designations: A growing trend in the biosimilars market is the push for interchangeability designations by the FDA. An interchangeable biosimilar can be substituted for the reference product at the pharmacy level without physician intervention, much like generic drugs. Achieving this status requires additional studies to demonstrate that the switch between the biosimilar and the reference product does not impact safety or efficacy. More biosimilars are pursuing this designation as it can significantly enhance uptake and acceptance, particularly in retail and outpatient settings. As more products earn interchangeability, the market is likely to see broader adoption and increased competition.
• Strategic Collaborations and Partnerships: Pharmaceutical companies are increasingly forming strategic alliances to develop, manufacture, and distribute biosimilars. These collaborations help share the high costs and technical complexities associated with biosimilar development. Partnerships between big pharma and specialized biosimilar developers, as well as between Western and Asian firms, are becoming more common. Such alliances accelerate product pipelines, improve market access, and foster innovation in manufacturing processes. This trend indicates a maturing market where stakeholders recognize the long-term value and sustainability of biosimilars in North America.

Erythropoietin is the fastest-growing biosimilar in the North American market due to its high clinical demand driven by the large prevalence of chronic kidney disease (CKD) and cancer-related anemia.

The rapid growth of erythropoietin biosimilars in North America is primarily fueled by the significant and rising clinical need for effective anemia management, particularly among patients with chronic kidney disease (CKD) and those undergoing chemotherapy for cancer. Erythropoietin-stimulating agents (ESAs), which promote red blood cell production, are critical for these patient groups. As the incidence of CKD and cancer continues to rise across North America - driven by aging populations, increasing diabetes rates, and heightened cancer detection - the demand for affordable erythropoietin products has intensified.

Biosimilars offer a cost-effective alternative to branded biologics such as Epogen® and Procrit®, both of which have been long established in the treatment landscape. The high cost burden of originator erythropoietin agents on healthcare systems has incentivized payers, providers, and institutions to transition to lower-cost biosimilar options. This shift is supported by policy frameworks such as the Biologics Price Competition and Innovation Act (BPCIA) in the U.S. and Health Canada's expedited biosimilar approval process, both of which promote biosimilar uptake through regulatory clarity and interchangeability guidelines. The U.S.

Food and Drug Administration (FDA) has approved biosimilars like Retacrit®, which have demonstrated comparable efficacy, safety, and immunogenicity to their reference products. This has built clinician confidence and encouraged broader adoption. Moreover, group purchasing organizations and large integrated health systems in North America are increasingly aligning with biosimilar procurement to reduce pharmaceutical expenditures.

Additionally, patient access programs and provider education initiatives have accelerated trust and usage among prescribers. The combination of a sizable and growing patient population, regulatory support, cost pressures in healthcare, and clinical familiarity with erythropoietin therapies has uniquely positioned this class of biosimilars for exceptional growth.

Blood disorder biosimilars are experiencing moderate growth in North America due to steady but cautious adoption, driven by clinical demand and cost considerations.

The biosimilars market for blood disorders in North America is witnessing moderate growth, largely influenced by a balanced interplay between clinical necessity, economic pressures, and regulatory developments. Blood disorders such as hemophilia, immune thrombocytopenia, and various forms of anemia require biologic therapies that are often costly and long-term, creating a clear need for more affordable alternatives like biosimilars. However, the uptake has been gradual rather than explosive. On one hand, there is growing awareness of the financial burden associated with biologics in treating hematologic diseases, and both private and public payers are pushing for cost-saving measures that include biosimilar adoption.

Patients and providers recognize the potential of biosimilars to enhance accessibility and reduce out-of-pocket costs, especially in chronic conditions requiring lifelong treatment. Furthermore, compared to more commoditized biologics such as erythropoietin or filgrastim, the development and approval of biosimilars for blood disorders are more complex and slower, limiting the number of available biosimilar options in this therapeutic class.

Regulatory bodies such as the FDA and Health Canada have established pathways for biosimilar approval, but rigorous evidence of similarity in efficacy, safety, and immunogenicity is required, especially for use in rare or vulnerable populations. As a result, fewer biosimilars for complex hematology biologics have reached the market in North America. The moderate growth also reflects a transitional phase where educational efforts, real-world evidence, and post-marketing surveillance are beginning to build physician confidence, but full-scale market penetration is still in progress.

In-house manufacturing dominates the North American biosimilars industry because it allows companies greater control over product quality, regulatory compliance, and cost efficiencies.

In the North American biosimilars industry, in-house manufacturing has become the predominant approach due to the unique challenges and stringent requirements associated with producing complex biologic drugs. Biosimilars, unlike small-molecule generics, are large, structurally intricate molecules that require highly specialized manufacturing processes to ensure consistency, safety, and efficacy comparable to their reference biologics. North American biosimilar developers prioritize in-house manufacturing primarily to maintain direct oversight of these critical processes, enabling them to rigorously control quality parameters and swiftly respond to any deviations or production issues.

This hands-on approach is essential given the strict regulatory environment imposed by agencies like the U.S. Food and Drug Administration (FDA) and Health Canada, which require comprehensive data demonstrating biosimilarity, including detailed manufacturing and analytical comparability studies. While contract manufacturing organizations (CMOs) can offer flexible production capacity, reliance on external partners often introduces complexities related to intellectual property protection, supply chain security, and potential delays.

By managing manufacturing internally, biosimilar companies in North America can better safeguard proprietary technologies, maintain confidentiality, and ensure uninterrupted supply - critical factors for building trust with healthcare providers and payers. In-house manufacturing also enables firms to optimize production processes over time, improving yield and reducing costs, which is vital in a highly price-sensitive biosimilars market where margin pressures are intense. Furthermore, North American pharmaceutical companies benefit from advanced technological infrastructure and a skilled workforce capable of managing the sophisticated bioprocesses required for biosimilar production.

The USA leads the North American biosimilars industry primarily due to its advanced regulatory framework, strong biologics market, and substantial investment in biotechnology innovation and infrastructure.

The United States has emerged as the dominant force in the North American biosimilars industry, thanks to a combination of regulatory maturity, market potential, and technological leadership. At the heart of this leadership are the Biologics Price Competition and Innovation Act (BPCIA) of 2009, which established a clear legal and regulatory pathway for the approval of biosimilars by the U.S. Food and Drug Administration (FDA). This act provided a framework that not only ensured patient safety but also encouraged competition and innovation by enabling more companies to enter the biologics market with lower-cost alternatives.

The FDA has since become one of the most active and respected regulators of biosimilars, fostering industry confidence and guiding the development of high-quality biosimilar products. Additionally, the U.S. is home to the world’s largest biologics market, creating a powerful incentive for pharmaceutical companies to invest in biosimilar development to capture market share and address the rising demand for cost-effective therapies in areas such as oncology, rheumatology, and endocrinology. Major U.S. healthcare stakeholders - including insurance providers, hospital networks, and pharmacy benefit managers - are also increasingly supportive of biosimilars, recognizing their potential to reduce drug spending while maintaining treatment standards.

On the innovation front, the United States leads globally in biotechnology research and development, with a robust ecosystem of academic institutions, biotech startups, and large pharmaceutical companies driving advancements in biosimilar science, analytics, and manufacturing. Investment flows into R&D, coupled with access to cutting-edge biomanufacturing facilities and a skilled workforce, give the U.S. a distinct competitive edge in producing high-quality biosimilars that meet stringent regulatory standards.

Furthermore, strategic partnerships between U.S. firms and global biosimilar developers are accelerating technology transfer and market expansion. While initial adoption of biosimilars in the U.S. was slower compared to Europe, increased regulatory guidance, improved market education, and policy efforts to enhance pricing transparency and substitution practices have catalyzed recent growth.

Considered in this report

• Historic Year: 2019
• Base year: 2024
• Estimated year: 2025
• Forecast year: 2030

Aspects covered in this report

• Biosimilars Market with its value and forecast along with its segments
• Various drivers and challenges
• On-going trends and developments
• Top profiled companies
• Strategic recommendation

By Product

• Monoclonal Antibodies
• Insulin
• Erythropoietin
• Others (Includes recombinant glycosylated and non-glycosylated proteins)

By Application

• Oncology
• Chronic & Autoimmune Disorders
• Blood Disorders
• Growth Hormonal Deficiency
• Infectious Disease
• Others (Filgrastim/Pegfilgrastim, Teriparatide, Somatropin, Etanercept)

By Manufacturer

• In-house
• Contract Research and Manufacturing Services

The approach of the report:

This report consists of a combined approach of primary as well as secondary research. Initially, secondary research was used to get an understanding of the market and listing out the companies that are present in the market. The secondary research consists of third-party sources such as press releases, annual report of companies, analyzing the government generated reports and databases.

After gathering the data from secondary sources primary research was conducted by making telephonic interviews with the leading players about how the market is functioning and then conducted trade calls with dealers and distributors of the market. Post this we have started doing primary calls to consumers by equally segmenting consumers in regional aspects, tier aspects, age group, and gender. Once we have primary data with us we have started verifying the details obtained from secondary sources.

Intended audience

This report can be useful to industry consultants, manufacturers, suppliers, associations & organizations related to this industry, government bodies and other stakeholders to align their market-centric strategies. In addition to marketing & presentations, it will also increase competitive knowledge about the industry.