Humira Biosimilar Market Gains Momentum Post-Patent Expiry & Biosimilar Launches, 2025-2032 | Amgen Inc., Samsung Bioepis Co., Ltd.

The Humira Biosimilar Market is witnessing transformative growth driven by increasing demand for affordable alternatives to originator biologics and rising prevalence of autoimmune disorders globally. Advances in biotechnology and the expiration of Humira's patent exclusivity have significantly broadened market opportunities, fueling competitive dynamics among market players. The integration of advanced manufacturing processes and rising awareness among healthcare providers have further expanded the market scope. The Global Humira Biosimilar Market size is estimated to be valued at USD 1,540.5 million in 2025 and is expected to reach USD 7,724.0 million by 2032, exhibiting a compound annual growth rate (CAGR) of 25% from 2025 to 2032.

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➤ Actionable Insights

● Production capacities across key manufacturing hubs increased by approximately 18% in 2024, enabling enhanced supply chain resilience for Humira biosimilars.
● Pricing strategies vary widely; biosimilars show a 30-40% reduction compared to originator biologics, significantly driving adoption across emerging markets.
● Exports from Asia-Pacific, especially South Korea and India, surged by over 25% in 2024, consolidating their role as primary supply regions.
● Demand-side indicators highlight rising imports in Europe and North America, with biosimilar utilization growing steadily across rheumatology, dermatology, and gastroenterology use cases.
● Micro-indicators suggest increased patient accessibility through government reimbursement policies in countries including Germany and Canada, directly impacting market growth.

➤ Market Segment and Regional Coverage

● By Product: Adalimumab Biosimilars, Indication-specific Biosimilars, Next-Generation Biosimilars, and Others.
● By Application: Rheumatoid Arthritis, Psoriasis, Crohn's Disease, Ulcerative Colitis, and Others.
● By Route of Administration: Subcutaneous Injection, Intravenous Injection, and Others.

Regional and Country Analysis:

● North America: U.S. and Canada
● Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
● Europe: Germany, U.K., Spain, France, Italy, Benelux, Denmark, Norway, Sweden, Russia, and Rest of Europe
● Asia Pacific: China, Taiwan, India, Japan, South Korea, Indonesia, Malaysia, Philippines, Singapore, Australia, and Rest of Asia Pacific
● Middle East & Africa: Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, United Arab Emirates, Israel, South Africa, North Africa, Central Africa, and Rest of MEA

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➤ Key Players

● Amgen Inc.
● Samsung Bioepis Co., Ltd.
● Sandoz International GmbH (Novartis AG)
● Mylan N.V.
● Boehringer Ingelheim International GmbH
● Pfizer Inc.
● Fresenius Kabi AG
● Coherus BioSciences, Inc.
● Biogen Inc.
● AbbVie Inc.
● Celltrion Inc.
● Rani Therapeutics Holdings, Inc.
● Teva Pharmaceutical Industries Ltd
● Merck & Co., Inc.
● Viatris Inc.
● Alvotech
● Several key players have employed aggressive market penetration strategies such as licensing agreements and portfolio diversification. For instance, Samsung Bioepis' strategic collaboration with Biogen led to expanded biosimilar launches across Europe, increasing its competitive foothold. Amgen Inc. enhanced production efficiency by investing in bioprocess innovation, resulting in a 15% cost reduction and faster time-to-market for new biosimilars. Pfizer Inc. adopted targeted market access programs in Latin America, improving their endorsement among healthcare stakeholders and accelerating market uptake.

➤Growth Factors
● Patent expiration of Humira's originator drug has unlocked substantial market opportunities, catalyzing biosimilar development pipelines globally.
● The expanding patient pool suffering from autoimmune diseases such as rheumatoid arthritis and psoriasis has led to consistent demand growth, particularly in North America and Europe.
● Government initiatives promoting biosimilar adoption via pricing incentives and inclusion in national formularies boosted biosimilar prescriptions by 20% in 2024.
● Technological advancements in biologics manufacturing, especially continuous bioprocessing, helped reduce production costs and improve scalability, thus fueling market growth.

➤ Market Trends

● Increasing convergence of digital health technologies in biologics supply chain management is enhancing traceability and compliance, critical for biosimilar market expansion.
● Emergence of next-generation biosimilars with improved delivery mechanisms, such as auto-injectors, is elevating patient adherence across chronic treatment regimens.
● Rise in partnerships between pharmaceutical companies and contract manufacturing organizations (CMOs) is enabling rapid scale-up and geographic penetration of biosimilars.
● Shifts in regulatory landscapes, with accelerated approvals in regions like the U.S. and Japan, have shortened time frames to market introduction for biosimilars since 2024.

➤ Key Takeaways

● The Rheumatoid Arthritis segment dominates application categories, driven by high disease prevalence and broad biosimilar accessibility.
● Adalimumab Biosimilars remain the largest product segment, reflecting continuing patent cliffs and expanding indication portfolios.
● Subcutaneous injection route leads among administration methods due to patient convenience and cost-effectiveness.
● North America exhibits robust business growth due to strong reimbursement frameworks and physician acceptance.
● Europe remains a key region for biosimilar adoption, supported by comprehensive regulatory pathways and payer support.
● Asia Pacific is an emerging hub for production capacity and exports, particularly from South Korea and India, influencing market revenue significantly.

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❓ Frequently Asked Questions

1. Who are the dominant players in the Humira Biosimilar Market?
- Leading companies include Amgen Inc., Samsung Bioepis Co., Ltd., Sandoz International GmbH, and Pfizer Inc., all of which leverage diverse strategies such as collaborations and technological advancements to secure market share.

2. What will be the size of the Humira Biosimilar Market in the coming years?
- The market is projected to grow from USD 1,540.5 million in 2025 to USD 7,724.0 million by 2032, with a CAGR of 25%, driven by increased biosimilar adoption and expanding therapeutic indications.

3. Which end users industry has the largest growth opportunity?
- The healthcare sectors serving autoimmune disorders, particularly rheumatology and dermatology, present the largest growth prospects due to the high prevalence of conditions treated with Humira biosimilars.

4. How will market development trends evolve over the next five years?
- Trends point to accelerated biosimilar approvals, innovation in drug delivery systems, expanded digital health integration, and rising partnerships between pharma and CMOs, enhancing market growth and accessibility.

5. What is the nature of the competitive landscape and challenges in the Humira Biosimilar Market?
- The market is characterized by intense competition based on pricing, manufacturing efficiency, and regulatory approvals. Challenges include regulatory complexities and market penetration in price-sensitive regions.

6. What go-to-market strategies are commonly adopted in the Humira Biosimilar Market?
- Key strategies include forming licensing partnerships, investing in production technology, deploying targeted market access programs, and expanding product portfolios to cover multiple indications.

Author of this Marketing PR:

Ravina Pandya, PR Writer, has a strong foothold in the market research industry. She specializes in writing well-researched articles from different industries, including food and beverages, information and technology, healthcare, chemical and materials, etc. With an MBA in E-commerce, she has an expertise in SEO-optimized content that resonates with industry professionals.

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