HUMIRA BIOSIMILAR MARKET ANALYSIS

Global humira biosimilar market is projected to witness substantial growth in the near future, and the market size is expected to increase from US$ 772.1 Mn in 2023 to US$ 3,871.4 Mn by 2030, with a compound annual growth rate (CAGR) of 25.9%. This growth is due to several factors, including the rising prevalence of autoimmune diseases, a growing demand for biosimilars, and favorable reimbursement policies.

Humira is a biologic drug used to treat various autoimmune diseases, including rheumatoid arthritis and psoriasis, holds the distinction of being the top-selling biologic drug globally, generating annual sales exceeding US$ 20 billion.

Biosimilars, which are highly similar copies of biologic drugs in terms of safety, efficacy, and quality, have entered the humira market following the expiration of patent protection in certain regions. These biosimilars create competition in the market and have the potential to offer cost savings. By providing more affordable treatment options, they contribute to driving down prices and improving access to critical medications for patients. Various pharmaceutical companies have obtained regulatory approvals for humira biosimilars, with the market size and growth rate influenced by factors such as regulatory frameworks, market access, and acceptance by physicians and patients.

Global Humira Biosimilar Market Regional Insights

North America: The North American market, particularly the U.S., has been a significant player in the humira biosimilar market. However, the introduction of biosimilars in this region faced challenges due to patent protections and complex regulatory processes. With the expiration of humira's patents, the market for biosimilars is expected to grow in North America. North America holds a substantial percentage of the market share, accounting for approximately 45.2%.

Europe: Europe has been at the forefront of biosimilar adoption and witnessed the approval and launch of several humira biosimilars in its market. The region established regulatory pathways and policies that support the uptake of biosimilars, leading to increased market competition and potential cost savings. Europe holds around 30.7% of the market share, highlighting its significance in the humira biosimilar market.

Asia Pacific: The Asia Pacific region, including countries like Japan, South Korea, and Australia, witnessed the emergence of humira biosimilars. Factors such as the increasing prevalence of autoimmune diseases and the need for more affordable treatment options have driven the market in this region. However, regulatory approvals and market access for biosimilars vary across countries within the Asia Pacific region. Asia-Pacific accounts for approximately 16.8% of the market share.

Analyst View’s

The effectiveness of Humira biosimilars in treating certain autoimmune diseases has been proven in clinical trials. They have shown comparable efficacy and safety to the original Humira. And, also, patients do not show any trust issues, which leads to market expansion over the forecast period. Patients do not show any trust issues, which leads to market expansion over the forecast period, indicating a promising future for these treatments in managing autoimmune diseases. The positive results from clinical trials, demonstrating comparable efficacy and safety of Humira biosimilars to the original Humira, have instilled confidence in both healthcare professionals and patients. This trust in the effectiveness of these treatments has paved the way for market expansion over the forecast period, indicating a promising future for managing autoimmune diseases with Humira biosimilars. 

Figure 1. Global Humira Biosimilar Share (%), By Region, 2023

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Global Humira Biosimilar Market Drivers:

• Patent expiration: The expiration of the patents protecting humira paved the way for the entry of biosimilars. Once the patents expire, it allows other pharmaceutical companies to develop and market biosimilar versions of humira, creating competition in the market.
• Cost savings: Biosimilars offer a more cost-effective alternative to the reference biologic drug. With the increasing demand for affordable healthcare, biosimilars provide an opportunity to reduce treatment costs for patients, healthcare systems, and payers. This cost-saving potential is a significant driver for the adoption of humira biosimilars. For instance, on October 26, 2023, Celltrion USA, Inc., a biopharmaceutical company, announced its FDA-approved biosimilar, YUFLYMA (adalimumab-aaty), has been added to CarePartners Specialty Pharmacy Cost Savings Programs. YUFLYMA is a high-concentration (100mg/mL) and citrate-free formulation of the Humira (adalimumab) biosimilar. CarePartners and its strategic partners will offer and distribute YUFLYMA as the lowest net cost high-concentration Humira (adalimumab) biosimilar to over 10 million plan members.
• Increasing prevalence of autoimmune diseases: Autoimmune diseases, such as rheumatoid arthritis, psoriasis, and crohn's disease, are on the rise globally. The growing prevalence of these conditions drives the demand for effective and accessible treatments, including biosimilars of humira, which are proven therapies for autoimmune diseases.
• Favorable regulatory environment: Regulatory agencies in various regions had established guidelines and pathways for the approval and market access of biosimilars. These frameworks provide clarity and facilitate the development, evaluation, and commercialization of humira biosimilars. Favorable regulatory environments encourage pharmaceutical companies to invest in the development of biosimilars.

Global Humira Biosimilar Market Opportunities:

• Increased access to treatment: The availability of humira biosimilars offers an opportunity to improve access to treatment for patients with autoimmune diseases. Biosimilars provide a more affordable alternative to the reference biologic drug, allowing a broader population to benefit from effective therapies.
• Market expansion and competitiveness: The introduction of humira biosimilars creates competition in the market, thereby driving innovation and cost optimization. This competition encourages pharmaceutical companies to develop and launch biosimilars, thus leading to a more competitive landscape. It also promotes market growth and the development of a diverse range of treatment options for patients.
• Enhanced treatment choices: The availability of humira biosimilars expands the range of treatment choices for physicians and patients. Physicians can select from multiple biosimilar options based on factors such as patient needs, pricing, and clinical evidence. Patients can benefit from a wider selection of therapies which are tailored for their specific conditions and preferences.
• Global market expansion: The humira biosimilar market presents opportunities for global expansion. As regulatory pathways and guidelines for biosimilars continue to evolve and improve worldwide, pharmaceutical companies can seek approvals in various regions, thus tapping into new markets and reaching a larger patient population.

Global Humira Biosimilar Market Trends:

• Regulatory approvals and market entry: Regulatory agencies worldwide have established pathways and guidelines for the approval and market entry of biosimilars, including those for humira. The number of regulatory approvals for humira biosimilars has been growing, allowing for expanded market availability and adoption.
• Market expansion and regional variations: The humira biosimilar market is expanding globally, with biosimilars becoming available in various regions. Europe has been at the forefront of biosimilar adoption, with a relatively higher number of approved humira biosimilars. However, other regions, including North America, Asia Pacific, and Latin America, are also witnessing the entry and growth of humira biosimilars.
• Physician and patient acceptance: As physicians gain more experience and confidence in prescribing biosimilars, biosimilar acceptance and adoption are increasing. Patient acceptance of biosimilars is also growing, driven by factors such as positive clinical outcomes, cost savings, and improved access to treatment options.
• Collaborations and partnerships: Collaborative partnerships between pharmaceutical companies, healthcare providers, and payers are emerging to drive the development, market access, and adoption of humira biosimilars. Such collaborations aim to improve patient access, education, and awareness about biosimilars, as well as address potential barriers to their uptake.

Global Humira Biosimilar Market Restraints:

• Complex regulatory processes: The regulatory approval process for biosimilars can be lengthy and complex. The requirements for demonstrating similarity to the reference product and ensuring safety and efficacy can pose challenges for biosimilar manufacturers. These regulatory hurdles can delay market entry and hinder the availability of humira biosimilars.
• Intellectual property and patent litigation: Intellectual property rights and patent litigation can create barriers to the entry of humira biosimilars. Original biologic manufacturers may engage in legal disputes to protect their patents, leading to delays in biosimilar market entry. These legal complexities can impact the competitive landscape and slow down the availability of more affordable biosimilar options.
• Physician and patient awareness and Aacceptance: Limited awareness and understanding among physicians and patients about biosimilars can hinder their adoption. Physicians may have concerns about efficacy, safety, and interchangeability, while patients may be hesitant to switch from the reference biologic drug. Educating both physicians and patients about the benefits and similarities of humira biosimilars is essential to overcome these barriers.

Counterbalance: The key market players should undertake programs and initiatives in creating about the awareness of the biosimilars among both the physicians and the patiens. Legal disputes regarding intellectual property and patent litigation need to be reduced.

Recent Developments

New product

• Abrilada (adalimumab-atto): ABRILADA is a citrate-free biosimilar to humira for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis. On October 5, 2023, the U.S. FDA granted interchangeability to Abrilada (adalimumab-afzb), the second adalimumab biosimilar to receive the designation.
• YUSIMRY (adalimumab-aqvh): YUSIMRY (adalimumab-aqvh), a biosimilar of humira (adalimumab), is a tumor necrosis factor (“TNF”) blocker indicated to reduce the signs and symptoms of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis, and to treat crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. On July 03, 2023, Coherus BioSciences, Inc., a commercial-stage biopharmaceutical company, announced that YUSIMRY (adalimumab-aqvh) is available for commercial sale in the U.S. at a list price of US$ 995 per carton for two 40 mg/0.8 mL autoinjectors, representing a discount of more than 85% to humira (adalimumab), currently priced at US$ 6,922 per carton of two pens.
• AMJEVITA (adalimumab-atto): AMJEVITA is a biosimilar to Humira (adalimumab), an anti-TNF-α monoclonal antibody. The active ingredient of AMJEVITA is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as humira. On January 31, 2023, Amgen, a U.S. multinational biopharmaceutical company, announced AMJEVITA (adalimumab-atto), a biosimilar to humira (adalimumab), is available in theU.S.

Acquisition and partnerships

• On July 24, 2023, Teva Pharmaceuticals, Inc., a global leader in generic and innovative medicines and Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced that they have agreed to expand their existing strategic partnership agreement. Teva Pharmaceuticals, Inc. will also acquire subordinated convertible bonds to be issued by Alvotech. The partners continue working closely on matters concerning pending approval in the U.S. for AVT02, an interchangeable high-concentration biosimilar candidate for humira (adalimumab). The existing strategic partnership agreement also includes four other biosimilar candidates, one of which is AVT04, a proposed biosimilar for Stelara (ustekinumab), which is  pending U.S. Food and Drug Administration (FDA) approval.
• On June 05, 2023, Rani Therapeutics Holdings, Inc., a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, announced that the company has expanded its partnership with Celltrion, Inc., a biopharmaceutical company, by entering into an agreement for the development of RT-105, an orally administered adalimumab biosimilar. Rani Therapeutics Holdings, Inc.,’s first partnership with Celltrion, for the development of RT-111, an orally administered ustekinumab biosimilar, was announced in January, 2023. Under the terms of the new license and supply agreement, Celltrion will exclusively supply to Rani Therapeutics Holdings, Inc., the adalimumab biosimilar drug substance (CT-P17) which is required for RT-105. Rani Therapeutics Holdings, Inc., granted an exclusive license to use CT-P17 in the development and commercialization of RT-105, and Celltrion is granted a right of first negotiation to acquire worldwide rights to RT-105 following a Phase 1 study.
• On June 01, 2023, Mark Cuban Cost Plus Drug Company, a public benefit corporation, and Coherus BioSciences, Inc., a global biosimilar company, announced plans to offer Mark Cuban Cost Plus Drug Company customers YUSIMRY (adalimumab-aqvh), a biosimilar of HUMIRA (adalimumab injection), in July 2023. Mark Cuban Cost Plus Drug Company plans to offer YUSIMRY to its customers at a price of US$ 569.27 plus dispensing and shipping fees starting in July 2023.

Figure 2. Global Humira Biosimilar Market Share (%), By Product type, 2023

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Top companies in Global Humira Biosimilar Market

• 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

Definition: Humira biosimilars are highly similar versions of the biologic drug humira (adalimumab) that have been developed and approved following the expiration of humira's patents. These biosimilars are designed to have comparable efficacy, safety, and quality to humira and provide more affordable treatment options for patients with autoimmune diseases such as rheumatoid arthritis, psoriasis, and crohn's disease.