Global Market Size, Forecast, and Trend Highlights Over 2025-2037
Adalimumab Biosimilar Market size was over USD 914.5 million in 2024 and is projected to reach USD 11.8 billion by the end of 2037, escalating at a CAGR of 23.8% during the forecast timeline, i.e., 2025-2037. In 2025, the industry size of adalimumab biosimilar is evaluated at USD 1.1 billion.
Adalimumab is the FDA-approved monoclonal antibody which is commonly referred to as Humira, suitable for the treatment of numerous inflammatory and immune disorders. These also demonstrate immunogenicity, safety, and efficacy, thereby driving the growth of the market globally. According to the October 2023 NLM article, the market gained extreme popularity in Europe with 35% of patients switching to adalimumab biosimilar. In addition, the article also denoted that 90.5% of patients across nations prefer the use of Humira pen in comparison to 18.2% preferring Imraldi pen, thus uplifting market expansion.
Furthermore, the adalimumab biosimilar market is experiencing expansion since it has been recognized as the best-selling drug since its approval. Besides, the December 2024 NLM article conducted a cross-sectional study regarding the pricing strategy of adalimumab biosimilars. The overall utilization of this antibody was estimated to be 1 million prescriptions per quarter with an increase to 1.35% in 2023. The net sales were USD 5.0 billion which diminished to USD 2.8 billion. Besides, the Net price per prescription was reduced to USD 2,837 from USD 5,007. On the other hand, the net price of Humira ranged between USD 3,452 to USD 4,793, effectively lower than other biosimilars, thereby a prolific approach for market demand.
Adalimumab Biosimilar Sector: Growth Drivers and Challenges
Growth Drivers
- Rising occurrence of non-communicable conditions: The growth of the adalimumab biosimilar market is highly fueled by the increase in the prevalence of rare disorders. As stated in the December 2024 WHO report, 43 million people in 2021 readily suffered from non-communicable disorders and 18% of people experienced death before 70 years of age. In addition, 82% of the deaths occurred in low- and middle-income nations. Therefore, with the rise of these conditions, there is a huge demand for cost-effective treatment options which is positively impacting the overall market internationally.
- Focus on cost-efficient medical solutions: The demand for the adalimumab biosimilar is growing day by day, and both patients and healthcare professionals are increasingly adopting it to cater to suitable medical conditions. This eventually resulted in the enhanced manufacturing and production of adalimumab-based drugs, which is inevitably leading to market expansion. Besides, the intake of these drugs is appropriate and constitutes an effective alternative to conventional treatment options that are expensive, thereby creating a surge in developing nations.
Challenges
- Complicated process of manufacturing: The production procedure of antibodies can be complex which creates a hindrance in the expansion of the adalimumab biosimilar globally. This categorically results in huge manufacturing expenditures and probable challenges that ensure increased difficulty to maintain the quality of drugs. This, in turn, results in the poor management of health which deteriorates the condition of patients and limits the commercialization of drugs in the existing market.
- Strict regulatory policies: The development of the adalimumab biosimilar market is projected to have limitations based on the presence of rigid administrative strategies. These tend to restrain the market from making expansion across nations, thereby limiting the manufacturing process. The aspect of meeting these policies requires substantial funding, especially in research and development activities. This also creates a challenge for the manufacturers as well as organizations to make appropriate contributions in the market.
Adalimumab Biosimilar Market: Key Insights
|
Base Year |
2024 |
|
Forecast Year |
2025-2037 |
|
CAGR |
23.8% |
|
Base Year Market Size (2024) |
USD 914.5 million |
|
Forecast Year Market Size (2037) |
USD 11.8 billion |
|
Regional Scope |
|
Adalimumab Biosimilar Segmentation
Product (Exemptia, Adalirel, Cipleumab)
Exemptia segment is expected to capture adalimumab biosimilar market share of over 36.8% by 2037. This has been readily accepted by medical professionals owing to its progressive formulation, efficiency in aiding autoimmune conditions, inexpensive pricing approach, and cost-effective solutions. As per the March 2020 NLM article, patients deliberately received biologic therapy with the utilization of exemptia, constituting an initial dose of 80 mg which was followed by 40 mg for almost 16 weeks. This treatment was successful without the absence of any side effects, thus an optimistic outlook for the segment.
Distribution Channel (Hospitals Pharmacies, Retail Pharmacies)
Based on the distribution channel, the hospitals pharmacies segment is expected to garner a lucrative share in the adalimumab biosimilar market during the forecast timeline. This segment is crucial and demonstrates effective exposure owing to its standard positioning in the overall health ecosystem. As stated in the January 2020 NLM article, a study was conducted on 42 clinical pharmacists wherein they evaluated 104,728 patients. They initiated an adjusted average of 1,221 interventions with a 91.5% acceptance rate, 700 follow-ups and consultations, 325 discharge recommendations, and 273 medication reconciliations, thereby fueling the upliftment of the segment.
Our in-depth analysis of the global adalimumab biosimilar market includes the following segments:
|
Product |
|
|
Distribution Channel |
|
Want to customize this research report as per your requirements? Our research team will cover the information you require to help you take effective business decisions.
Customize this ReportAdalimumab Biosimilar Industry - Regional Synopsis
North America Market Analysis
By 2037, North America adalimumab biosimilar market is poised to capture over 48.2% revenue share. This growth is fueled by several factors such as robust health and medical systems, standard reimbursement policies, and awareness of a healthy lifestyle. Besides, there is an increasing burden of autoimmune illnesses including inflammatory bowel disease and rheumatoid arthritis in the region due to which the demand for adalimumab is increasing, thereby a prolific opportunity for the evolution of the market.
There is a huge opportunity for the adalimumab biosimilar market to flourish in the U.S. due to the availability of biosimilar medications. For instance, in May 2024, Teva Pharmaceuticals declared the accessibility of SIMLANDI injection in the country. It is a substitutable biosimilar to Humira for the ailment of different categories of arthritis including juvenile idiopathic arthritis, adult rheumatoid arthritis, adult ankylosing spondylitis, and adult psoriatic arthritis. In addition, it is suitable for the treatment of Crohn’s disease, adult plaque psoriasis, adult ulcerative colitis, adult hidradenitis suppurativa, and adult uveitis, thus driving market expansion.
The adalimumab biosimilar market demand in Canada is facing an upliftment owing to the increasing sales of biologic medicines. According to the May 2022 Government of Canada report, the overall sales tripled and rose to USD 10.0 billion from USD 3.3 billion in past years. Additionally, biologics comprise 33.9% of pharmaceutical sales in the country, accounting for the third-highest share in the OECD and surpassing the average of 27.4%. Moreover, the population makes a spending of USD 262 on biologics medicines every year, thereby prompting a prolific opportunity for market growth.
APAC Market Statistics
The Asia Pacific region is poised to be the fastest-growing region in the adalimumab biosimilar market during the forecast period. Factors such as the surge in disposable income, medical expenditures, and increasing patient pool are effectively responsible for the market expansion in the region. In addition, the presence of organization contributions as well as regulatory policies are readily driving the market in the region, especially in countries including India and China.
The adalimumab biosimilar market in India is gaining more exposure owing to the utilization of ultrasound solutions in conjunction with adalimumab treatment. For instance, in January 2023, FUJIFILM Sonosite, Inc. declared the unveiling of the latest Sonosite PX ultrasound system in the country. It comprises an advanced image clarity owing to an innovative proprietary imaging technology that provides clear levels of procedural and diagnostics applications during the treatment process. Therefore, the presence of technology is also a driving factor for the market upliftment in the country.
The adalimumab biosimilar market in China is expanding owing to the approval of different antibody-based biosimilars. As per the February 2024 Biologicals article, the country has successfully approved 31 biosimilars that include 2 versions of Tocilizumab and Denosumab, 3 versions of Trastuzumab, Rituximab, and Infliximab, 7 versions of Adalimumab, and 10 versions of Bevacizumab. The China National Medical Products Administration (NMPA) has played a vital role in approving these biosimilars, which are effectively contributing toward the evolution of the market in the country.
Companies Dominating the Adalimumab Biosimilar Landscape
- Alvotech
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
- ADVANZ PHARMA
- Alfred E. Tiefenbacher
- Amgen Inc.
- Boehringer Ingelheim International GmbH
- Glenmark
- Zydus Group
- Torrent Pharmaceuticals Ltd.
- Emcure Pharmaceuticals Ltd
- AET BioTech
- Coherus Biosciences
- Biocon Biologics Ltd
- FUJIFILM Sonosite, Inc.
- Teva Pharmaceuticals
- Mylan N.V.
- Samsung Bioepis Co., Ltd.
- Organon & Co.
Major organizations are implementing numerous strategies to positively impact the adalimumab biosimilar market globally. These strategies include product commercialization through collaborations, infrastructure expansion, investments, service integration, and mergers and acquisitions. For instance, in June 2024, Alvotech and ADVANZ PHARMA partnered with each other for the effective marketing and supply of Alvotech’s anticipated biosimilar to Eylea (aflibercept). It is an extensively utilized biologic for the diagnosis of eye issues that can lead to vision loss or blindness such as wet AMD, macular edema, and diabetic retinopathy.
Here's the list of some key players:
In the News
- In April 2024, Samsung Bioepis Co., Ltd. notified the commencement of Phase 3 clinical trial for SB27 which is a randomized, double-blind, parallel-group, multicenter study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB27 and Keytruda in patients with metastatic non-squamous non-small cell lung cancer.
- In August 2022, Organon & Co. and Samsung Bioepis Co., Ltd. received the U.S. FDA approval for HADLIMA, a biosimilar that will be available in pre-filled syringe and autoinjector options, and the autoinjector was specifically designed with the patient in mind.
Author Credits: Radhika Pawar
- Report ID: 7551
- Published Date: Apr 25, 2025
- Report Format: PDF, PPT
