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Methotrexate Market Size and Forecast, by Application (Cancer Treatment, Autoimmune Diseases, Psoriasis); Formulation; Distribution Channel; End use - Growth Trends, Key Players, Regional Analysis 2026-2035

  • Report ID: 6872
  • Published Date: Sep 18, 2025
  • Report Format: PDF, PPT

Methotrexate Market Outlook:

Methotrexate Market size was valued at USD 1.19 billion in 2025 and is likely to cross USD 1.88 billion by 2035, expanding at more than 4.7% CAGR during the forecast period i.e., between 2026-2035. In the year 2026, the industry size of methotrexate is assessed at USD 1.24 billion.

Methotrexate Market Overview
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The rising prevalence of autoimmune diseases such as psoriasis and rheumatoid arthritis is augmenting the consumption of methotrexate solutions. For instance, according to the National Psoriasis Foundation, millions of people across the world are living with psoriatic arthritis, and around 2% to 3% of the total population have psoriasis. The report by the Global Psoriasis Atlas reveals that an estimated 60 million individuals are living with psoriasis, globally. Furthermore, the Global RA Network reveals that around 350 million people worldwide are living with arthritis issues. 1 in 100 people often are diagnosed with rheumatoid arthritis and if not treated are leading to work disability.

For instance, in January 2024, Novartis AG one of the leading manufacturers of methotrexate solutions revealed that its robust operational performance led to huge double-digit top and bottom-line growth. The company estimates 40.0%+ margin growth by 2027 and 5.0% cc CAGR between 2023 and 2028. Furthermore, the net sales increased by +10.0% with core operating income growth of +18.0%. Cardiovascular-renal-metabolic, immunology, neuroscience, and oncology are four core therapeutic areas driving the company’s growth.

Key Methotrexate Market Insights Summary:

  • Regional Highlights:

    • North America methotrexate market will account for 33.70% share by 2035, driven by presence of advanced healthcare facilities and rising prevalence of autoimmune diseases.

  • Segment Insights:

    • The cancer treatment segment in the methotrexate market is expected to secure a 54.30% share by 2035, fueled by increasing cases of cancer driving demand for methotrexate drugs for effective treatment.
    • The tablet segment in the methotrexate market is expected to achieve dominant growth till 2035, driven by the convenience, accurate dosage, and cost-effectiveness of methotrexate tablets, especially for pediatric and older patients.

  • Key Growth Trends:

    • Combination therapies
    • Personalized treatment approaches

  • Major Challenges:

    • Availability of alternatives
    • Stringent regulatory policies

  • Key Players: Pfenex, Inc., Zydus Lifesciences, Alvogen, Teva Pharmaceutical Industries, Bristol-Myers Squibb, and Mylan N.V.

Global Methotrexate Market Forecast and Regional Outlook:

  • Market Size & Growth Projections:

    • 2025 Market Size: USD 1.19 billion
    • 2026 Market Size: USD 1.24 billion
    • Projected Market Size: USD 1.88 billion by 2035
    • Growth Forecasts: 4.7% CAGR (2026-2035)

  • Key Regional Dynamics:

    • Largest Region: North America (33.7% Share by 2035)
    • Fastest Growing Region: Asia Pacific
    • Dominating Countries: United States, Germany, Japan, China, United Kingdom
    • Emerging Countries: China, India, Japan, South Korea, Thailand

    • Last updated on : 18 September, 2025

Growth Drivers

  • Combination therapies: Methotrexate combination therapies are emerging as an advanced approach to treat several autoimmune diseases. Methotrexate when combined with leflunomide offers effective results in rheumatoid arthritis treatment. Many researchers are constantly focusing on the introduction of advanced combination therapies to improve the efficiency of treatment and patient care. For instance, in March 2023, researchers from the Massachusetts Institute of Technology (MIT) developed a novel combination therapy for the treatment of vancomycin-resistant bacterial infections. This combination therapy makes use of mitoxantrone an anticancer agent together with an antibiotic vancomycin. Mitoxantrone and methotrexate with no significant difference in clinical response are expected to drive lucrative opportunities for innovations. Such advancements are set to propel the overall methotrexate market growth in the coming years.

  • Personalized treatment approaches: The personalization treatment approaches are anticipated to fuel the use of methotrexate in the coming years. Tailored medicines developed considering the genetic makeup, disease subtype, and response to previous therapies are gaining traction. Personalized approaches, essential for improving patient outcomes and minimizing unnecessary treatments are set to double the revenue shares of the manufacturers in the coming years. For instance, in April 2024, PrecisePK announced the launch of 3 innovative drugs methotrexate, cyclosporine, and infliximab for Bayesian precision dosing. These models are expected to revolutionize therapeutic drug monitoring and analysis for transplantation and immunosuppressive therapy patients. Through this move, the company is making strides in the personalized medicine approach.

Challenges

  • Availability of alternatives: The easy availability of substitutes is emerging as a major challenge for methotrexate manufacturers. Biologics are increasingly replacing methotrexate for the treatment of autoimmune diseases such as psoriasis and rheumatoid arthritis (RA). This is widely observed in patients who don't respond to conventional disease-modifying antirheumatic drugs (DMARDs). Thus, these newer therapeutics with better efficacy and fewer side effects are expected to lower the sales of methotrexate solutions.

  • Stringent regulatory policies: The strict and time-consuming regulatory approvals hinder the methotrexate market to some extent. These long procedures often hamper the profits of the manufacturers, as they are not able to grab trending opportunities. This factor majorly challenges budget-conscious end users such as small companies and start-ups.

Methotrexate Market Size and Forecast:

Report Attribute Details

Base Year

2025

Forecast Period

2026-2035

CAGR

4.7%

Base Year Market Size (2025)

USD 1.19 billion

Forecast Year Market Size (2035)

USD 1.88 billion

Regional Scope

  • North America (U.S., and Canada)
  • Asia Pacific (Japan, China, India, Indonesia, Malaysia, Australia, South Korea, Rest of Asia Pacific)
  • Europe (UK, Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Latin America (Mexico, Argentina, Brazil, Rest of Latin America)
  • Middle East and Africa (Israel, GCC North Africa, South Africa, Rest of the Middle East and Africa)
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Methotrexate Market Segmentation:

Application Segment Analysis

The cancer treatment segment is likely to capture methotrexate market share of over 54.3% by 2035. The increasing cases of cancer are pushing the demand for methotrexate drugs for effective treatment. The World Health Organization (WHO) reveals that around 20 million new cancer cases were diagnosed in 2022. Also, the same source estimates that one in five individuals experience cancer growth in their lifetime. Manufacturers’ continuous focus on innovations is leading to the development of advanced and effective anti-cancer methotrexate solutions. For instance, in August 2024, STAQ Pharma announced the expansion of its oncology portfolio starting with methotrexate. The methotrexate solution is widely used for the treatment of pediatric cancer patients.

Formulation Segment Analysis

The tablet segment is expected to hold a dominating methotrexate market share throughout the projected period. Convenience and accurate dosage are prime factors driving the sales of methotrexate tablets. The pediatric and older patient demographics find tablets a more convenient form of administration than injections. The quick effect and cost-effectiveness are other aspects augmenting the demand for methotrexate tablets. Considering these drivers, manufacturers are more concentrated on the development of methotrexate tablets than other formulations. For instance, in August 2024, Elite Pharmaceuticals, Inc. announced the introduction of generic methotrexate sodium 2.5 mg tablets. These tablets are used for acute lymphoblastic leukemia treatment among adults.

Our in-depth analysis of the global methotrexate market includes the following segments:

Application
  • Cancer Treatment
  • Autoimmune Diseases
  • Psoriasis

Formulation
  • Tablet
  • Injection
  • Liquid

Distribution Channel
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies

End use
  • Hospitals
  • Specialty Clinics
  • Homecare
Vishnu Nair
Vishnu Nair
Head - Global Business Development

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Methotrexate Market Regional Analysis:

North America Market Insights

In methotrexate market, North America region is likely to hold more than 33.7% revenue share by 2035. The presence of advanced healthcare facilities, the existence of key pharma companies, and the rising prevalence of autoimmune diseases are augmenting the demand for methotrexate solutions. The supportive reimbursement policies are further contributing to the overall market growth.

In, the U.S., the increasing cases of cancer coupled with the rise in the stressful lifestyles of individuals is pushing the demand for effective treatment formulations such as methotrexate. The National Cancer Institute reveals that in 2024, an estimated 2.0 million new cancer cases were diagnosed in the U.S. Furthermore, manufacturers’ continuous investments in R&D are leading to the development of innovative methotrexate drug formulations, uplifting the country’s position in the regional market.

In Canada, the strong presence of research organizations such as the Canadian Cancer Society, the Canadian Breast Cancer Foundation, and the Canadian Institutes of Health Research and the government’s supportive policies for drug discovery are augmenting the methotrexate market growth. For instance, in November 2024, McMaster University revealed that it received around USD 4.0 million from the government for the upgradation and future-proofing of its drug discovery infrastructure.

Asia Pacific Market Insights

The Asia Pacific methotrexate market is anticipated to expand at the fastest pace during the forecast period. The increasing expansion of international pharma companies, the growing governments’ investments in advancing their medical baskets, and rising investments in R&D for the development of effective autoimmune disorders are set to propel the sales of methotrexate solutions in the coming years. China, India, South Korea, and Japan are high-earning marketplaces for methotrexate producers.

In India, the rising cases of cancer are generating robust strides for the adoption of methotrexate drugs. For instance, according to the National Institutes of Health (NIH), cancer cases are set to rise from 1.4 million in 2022 to 1.5 million by 2025, in India. The government’s support for the expansion of the pharma sector is anticipated to boost the production of methotrexate drugs in the country. The India Brand Equity Foundation (IBEF) reveals that the government under its Strengthening of Pharmaceutical Industry (SPI) scheme invested around USD 60.,9 million to enhance the productivity, quality, and sustainability of the existing pharma clusters and MSMEs in the country.

In China, the rising population of senior citizens who are more susceptible to autoimmune disorders such as cancer and arthritis is fueling the consumption of methotrexate drugs. The government's increasing investments in advancing its healthcare facilities are creating lucrative opportunities for methotrexate market.

Methotrexate Market share
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Methotrexate Market Players:

    Key players in the methotrexate market are employing several organic and inorganic tactics such as new product launches, technological innovations, investments in R&D, strategic collaborations & partnerships, mergers & acquisitions, and global expansions to earn high profits and maximize their presence. Industry giants are collaborating with research organizations and partnering with other players to develop innovative methotrexate drug formulations. They are also acquiring smaller pharma companies or start-ups with advanced methotrexate formulations to expand their product offering at minimum CAPEX. Furthermore, the regional expansion tactics are aiding them to grab untapped opportunities.

    Some of the key players include in methotrexate market:

    • Pharmascience, Inc.
      • Company Overview
      • Business Strategy
      • Key Product Offerings
      • Financial Performance
      • Key Performance Indicators
      • Risk Analysis
      • Recent Development
      • Regional Presence
      • SWOT Analysis
    • Eversana Life Science Services, LLC
    • Elite Pharmaceuticals, Inc.
    • STAQ Pharma
    • PrecisePK
    • Novartis AG
    • Pfenex, Inc.
    • Zydus Lifesciences
    • Alvogen
    • Teva Pharmaceutical Industries
    • Bristol-Myers Squibb
    • Mylan N.V.
    • Hikma Pharmaceuticals Plc
    • Fresenius Kabi
    • Reddy's Laboratories
    • Aurobindo Pharma Ltd
    • Accord Healthcare Limited
    • Amgen, Inc.
    • Sun Pharmaceutical Industries
    • Sandoz Group AG

Recent Developments

  • In March 2024, Pharmascience, Inc. announced the launch of its new methotrexate injection of 50 mg/ml in Canada. This product line is estimated to be effective for the treatment of psoriasis, psoriatic arthritis, and rheumatoid arthritis in adults.
  • In December 2023, Shorla Oncology & Eversana Life Science Services, LLC announced the launch of FDA-approved JYLAMVO the first methotrexate solution in the U.S. This solution is effective for the treatment of adults with acute lymphoblastic leukemia as part of a combination chemotherapy.
  • Report ID: 6872
  • Published Date: Sep 18, 2025
  • Report Format: PDF, PPT
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Frequently Asked Questions (FAQ)

In the year 2026, the industry size of methotrexate is assessed at USD 1.24 billion.

The global methotrexate market size was valued at over USD 1.19 billion in 2025 and is expected to expand at a CAGR of over 4.7%, surpassing USD 1.88 billion revenue by 2035.

North America methotrexate market will account for 33.70% share by 2035, driven by presence of advanced healthcare facilities and rising prevalence of autoimmune diseases.

Key players in the market include Pfenex, Inc., Zydus Lifesciences, Alvogen, Teva Pharmaceutical Industries, Bristol-Myers Squibb, and Mylan N.V.

Methotrexate Market Report Scope

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