North America Adalimumab Market Size, Share, Trends and Forecasts 2031

Key Findings

• The North America Adalimumab Market is expanding rapidly due to rising cases of autoimmune diseases such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease.
• Patent expiries of branded adalimumab are creating opportunities for biosimilars to penetrate the North America market.
• Healthcare reforms in North America aimed at reducing biologic therapy costs are accelerating the adoption of biosimilars.
• Increasing awareness of biologic therapies among patients in North America is boosting demand for advanced treatment options.
• Expansion of clinical research in North America is supporting innovation in biosimilar formulations and delivery mechanisms.
• Rising healthcare expenditure in North America is driving wider adoption of costly biologic treatments like adalimumab.
• Distribution partnerships in North America are strengthening market access and improving affordability of adalimumab products.
• Patient assistance programs in North America are enhancing accessibility for underserved populations.

North America Adalimumab Market Size and Forecast

The North America Adalimumab Market is projected to grow from USD 7.9 billion in 2025 to USD 15.6 billion by 2031, at a CAGR of 12.1% during the forecast period. Market expansion will be driven by growing demand for biosimilars, increased diagnosis of autoimmune conditions, and supportive healthcare policies aimed at promoting biologics adoption across North America.

Introduction

Adalimumab is a monoclonal antibody targeting tumor necrosis factor (TNF) and is widely prescribed for managing autoimmune and inflammatory diseases. In North America, adalimumab is available as both branded biologics and biosimilars, with increasing competition shaping the market landscape. Growing clinical acceptance, wider patient coverage, and expanding distribution channels are strengthening demand. The rising burden of chronic autoimmune conditions is further propelling long-term reliance on adalimumab therapies.

Future Outlook

By 2031, biosimilars are expected to capture a significant portion of the North America Adalimumab Market, driving down costs and expanding patient access. Manufacturers will increasingly focus on value-added services such as patient support programs and improved drug delivery devices to differentiate their offerings. Partnerships between global pharma leaders and regional players in North America will be critical in ensuring accessibility. With continued regulatory support and rising healthcare infrastructure investments, the outlook for adalimumab adoption in North America remains strong.

North America Adalimumab Market Trends

• Rising Biosimilar Adoption
  Biosimilars of adalimumab are witnessing strong acceptance in North America due to their cost-effectiveness and comparable efficacy to branded products. Healthcare providers are increasingly prescribing biosimilars as governments and payers push for cost containment. This trend is intensifying competition in the market, lowering treatment costs for patients. Increased awareness and trust in biosimilars are expected to significantly boost their penetration in North America over the next decade.
• Regulatory Support for Affordable Biologics
  Regulatory bodies in North America are actively encouraging the adoption of biosimilars by streamlining approval processes and providing favorable guidelines. Such measures are aimed at reducing healthcare expenditure while ensuring safety and efficacy. Faster approval timelines are enabling quicker market entry for new biosimilars. This regulatory push is expected to accelerate the transition from branded to biosimilar adalimumab therapies in North America.
• Patient-Centric Care Models
  The North America healthcare system is shifting toward patient-centric care, with emphasis on long-term disease management. Companies are introducing self-injection devices and home-care administration solutions to enhance convenience. These innovations are improving adherence rates and treatment outcomes. Patient assistance programs are also playing a crucial role in improving therapy accessibility across diverse populations in North America.
• Increased R&D in Biologics and Biosimilars
  Pharmaceutical companies in North America are investing heavily in research to improve biologic therapies and develop next-generation biosimilars. Focus areas include enhanced drug delivery systems, better safety profiles, and expanded therapeutic indications. Clinical trials are growing across North America, with collaborations between academia, local firms, and global players. This R&D momentum is shaping the competitive edge of regional manufacturers.
• Strategic Collaborations and Partnerships
  Market players in North America are forming partnerships with distributors, healthcare providers, and local manufacturers to strengthen their market presence. These collaborations are ensuring broader reach, faster regulatory approvals, and better supply chain efficiency. Such strategic moves are particularly important for biosimilar companies competing against established branded biologics. These alliances are expected to drive growth and sustain market competitiveness in North America.

Market Growth Drivers

• Growing Prevalence of Autoimmune Diseases
  The rising incidence of autoimmune disorders, including rheumatoid arthritis, ulcerative colitis, and psoriasis, is driving demand for adalimumab in North America. Increasing diagnosis rates and improved awareness of treatment options are expanding the eligible patient base. The chronic nature of these conditions requires long-term therapy, ensuring sustained market demand. This factor continues to make adalimumab one of the most prescribed biologics in North America.
• Patent Expiry and Biosimilar Launches
  The expiration of adalimumab patents is enabling multiple biosimilar entries in North America, driving competition and affordability. These biosimilars offer equivalent clinical outcomes at a fraction of the cost. This is increasing adoption among patients who previously could not afford branded biologics. The growing number of biosimilar launches is reshaping the market dynamics in North America.
• Rising Healthcare Expenditure
  Healthcare spending in North America is on the rise, creating more opportunities for advanced biologic therapies like adalimumab. Governments and private healthcare providers are expanding insurance coverage for autoimmune treatments. This increased funding is making high-cost therapies more accessible to patients. Consequently, the demand for adalimumab is expected to rise steadily in North America.
• Government Initiatives for Affordable Access
  Governments in North America are implementing policies to make biologics more affordable and accessible. Subsidies, insurance expansions, and price negotiation mechanisms are helping reduce patient out-of-pocket expenses. These initiatives are fostering greater adoption of adalimumab, especially in lower-income populations. Supportive government policies remain a critical growth enabler in this market.
• Improved Healthcare Infrastructure
  North America is witnessing rapid improvements in healthcare infrastructure, including specialized hospitals, diagnostic centers, and distribution networks. This expansion ensures wider availability of advanced biologic treatments like adalimumab. Better infrastructure is also increasing physician awareness and prescription rates. These developments are creating a more favorable environment for sustained market growth in North America.

Challenges in the Market

• High Treatment Costs
  Despite the entry of biosimilars, the cost of adalimumab therapies remains high in North America compared to conventional treatments. High pricing continues to limit access for patients without comprehensive insurance. Out-of-pocket expenditure remains a major concern, particularly in developing economies within North America. This cost challenge could slow down adoption among certain patient segments.
• Regulatory Hurdles for Biosimilars
  While regulatory agencies are supportive, navigating approval processes for biosimilars in North America can still be complex and time-consuming. Delays in obtaining approvals hinder timely launches and market penetration. Smaller companies often face resource constraints in meeting stringent regulatory requirements. These hurdles slow down the pace of biosimilar expansion in North America.
• Physician Reluctance Toward Biosimilars
  Some healthcare providers in North America remain cautious about prescribing biosimilars due to concerns over efficacy and safety. This reluctance is particularly strong in cases where branded biologics have long-established track records. Overcoming this hesitation requires significant education, clinical evidence, and post-marketing surveillance data. Without broader physician acceptance, biosimilar adoption may face limitations.
• Market Competition and Price Pressure
  The North America Adalimumab Market is highly competitive, with branded biologics and multiple biosimilar entrants fighting for share. This intense rivalry is driving price reductions and pressuring profit margins. Smaller players may struggle to survive in this environment, while large companies adopt aggressive pricing strategies. Sustaining profitability under these conditions remains a challenge.
• Supply Chain and Distribution Barriers
  Distribution of biologics like adalimumab requires robust cold-chain logistics and reliable infrastructure. In North America, supply chain disruptions, particularly in remote or rural areas, hinder consistent availability. Limited access in these regions restricts treatment adoption despite high demand. Strengthening distribution networks will be crucial to ensuring broader market reach in North America.

North America Adalimumab Market Segmentation

By Drug Type

• Branded Biologics
• Biosimilars

By Indication

• Rheumatoid Arthritis
• Psoriasis
• Crohn’s Disease
• Ulcerative Colitis
• Others

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

Leading Key Players

• AbbVie Inc.
• Amgen Inc.
• Samsung Bioepis Co., Ltd.
• Boehringer Ingelheim International GmbH
• Pfizer Inc.
• Novartis AG (Sandoz Division)
• Cipla Limited
• Biocon Limited
• Fresenius Kabi AG
• Mylan N.V.

Recent Developments

• AbbVie expanded patient support programs in North America to retain branded market share.
• Amgen launched a new biosimilar adalimumab product in North America.
• Biocon partnered with local distributors in North America to expand biosimilar access.
• Pfizerreceived regulatory approval for its adalimumab biosimilar in North America.
• Samsung Bioepis announced clinical trial results supporting long-term safety of biosimilars in North America.

This Market Report Will Answer the Following Questions

• What is the projected size and growth rate of the North America Adalimumab Market by 2031?
• How will biosimilar adoption impact branded biologic sales in North America?
• What regulatory factors are shaping the North America Adalimumab Market?
• Which distribution channels are most effective in North America?
• Who are the leading market players and what strategies are they pursuing in North America?

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