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Methotrexate Market Size By Indication (Psoriasis, Rheumatoid Arthritis, Cancer), By Mode (In-house, Contract Manufacturing), By Synthesis Type (Chemical Based API, Highly Potent API (HPAPI)) – Global Forecast, 2023-2032

  • Report ID: GMI6835
  • Published Date: Oct 2023
  • Report Format: PDF

Methotrexate Market Size

Methotrexate Market size was valued at USD 553 million in 2022 and is estimated to account for USD 921 million by 2032.

Methotrexate Market

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Methotrexate is a versatile medication that is used to treat a variety of medical conditions, including cancer, autoimmune diseases, and severe skin disorders. It is classified as a disease-modifying anti-rheumatic drug (DMARD) when used for autoimmune diseases and as a chemotherapeutic agent for cancer treatment. Methotrexate is a medication that has been used for several decades for the treatment of various cancers. It belongs to a class of drugs known as antimetabolites and is considered as a cytotoxic chemotherapy agent. The methotrexate market is growing majorly owing to increasing patient population base with chronic health conditions such as cancer, autoimmune disorders, rheumatoid arthritis, among others.

For instance, according to estimates, about 28.4 million new cancer cases will arise worldwide by 2040, which is an increase from 19.3 million cases from the year 2020, a 47% rise. This prediction is primarily based on the increasing ageing population and is further accelerated by the rising incidence of risk factors such as smoking, unhealthy lifestyle, among others in various regions of the world. Thus, the rising prevalence of cancer is estimated to augment the market trends.

The increasing number of pharmaceutical research and development activities is anticipated to drive the market growth in the coming years. Development of novel drugs with an aim to achieve the unmet medical requirements are amongst the primary factors of research-based pharmaceutical & biotechnology companies’ growth. The pharmaceutical sector develops several novel drugs that offer valuable clinical benefits. The surging number of investments by government as well as private players are amongst the prime variables that will propel the number of pharmaceutical research and development activities.

Although methotrexate is well-established and primarily focused on optimizing its use in existing conditions such as cancer, psoriasis, and rheumatoid arthritis, its potential new applications are being explored. For instance, the use of methotrexate in the treatment of ankylosing spondylitis was investigated. This clinical trial aimed to evaluate the effectiveness of methotrexate in the treatment of ankylosing spondylitis, a type of inflammatory arthritis.

COVID-19 Impact

The COVID-19 pandemic impacted the overall economy negatively, including the pharmaceutical & overall healthcare sector. The impact of COVID-19 peaked during the initial months of 2020 wherein, the stakeholders stockpiled pharmaceutical products resulting in declining sales in those months. Numerous factors comprising demand change, supply shortages, panic buying & stocking, regulation changes, and research and development (R&D) process changes influenced the market revenue. Several suppliers failed to supply raw materials required for drug manufacturing attributable to numerous challenges faced due to the pandemic.

Some of the API manufacturing units ran at decreased capacity due to lack of labor, disrupted supply chain, unavailability of raw materials & packaging sources. Although, as the COVID-19 crisis unravels, the short-term effect of the pandemic had been mixed and the market was set to benefit owing to the surged demand for certain pharmaceuticals that propelled the demand and adoption of APIs including methotrexate used in manufacturing of these drugs. Thus, the effects in the shorter run were complex and contrasting, although the market witnessed surge in the growth rate eventually during the COVID-19 pandemic.  

Methotrexate Market Trends

Rising technological advancements and the demand for personalized medicine have led to innovations in drug development and treatment strategies. Methotrexate is a medication commonly used in the treatment of various medical conditions, including cancer, autoimmune diseases, and rheumatoid arthritis. With the use of advancements in injectable technologies, methotrexate injections can be made more practical, secure, and patient-compliant. Better equipment, including auto-injectors and wearable injectors will be able to improve the patient experience and create potential for differentiation.

For instance, Atomwise utilizes artificial intelligence (AI) in drug discovery. MethoAI is an example of the way AI is used to design novel methotrexate derivatives with improved efficacy and reduced side effects, tailoring treatments to individual patient needs. Additionally, HealthTech Inc. offers a mobile app called MedMethoCare that helps patients track their methotrexate treatment, record symptoms, and receive personalized reminders and dosing instructions based on their health data and treatment response. Therefore, increasing technological advancements and product approvals are projected to accelerate industry expansion.

Methotrexate Market Analysis

Methotrexate Market Size, By Indication, 2021 - 2032 (USD Million)

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The methotrexate market by indication is categorized into psoriasis, rheumatoid arthritis, cancer, and others. Rheumatoid arthritis (RA) segment held a significant revenue of the market accounting for over USD 250 million revenue in the year 2022. High growth rate is attributed to the growing prevalence of people suffering from the disease in developed as well as developing economies. Additionally, methotrexate is classified as a disease-modifying anti-rheumatic drug (DMARD), which means it can slow down the progression of RA by addressing the underlying autoimmune response and joint damage.

Further, methotrexate can be used as a monotherapy (single-drug treatment) or in combination with other DMARDs or biologics to enhance its effectiveness and address more severe cases of RA. Therefore, the several advantages offered by the drug for treatment of RA is anticipated to augment segment progress.

 Methotrexate Market Share, By Mode, 2022 (%)

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Based on mode, the methotrexate market is segmented into in-house manufacturing and contract manufacturing. In-house manufacturing segment held the majority market share and is projected to grow at 4.8% CAGR from 2023 to 2032. Methotrexate is a highly potent drug used in the treatment of serious medical conditions, including cancer and autoimmune diseases. Quality control is of utmost importance to ensure the safety and efficacy of the product. Maintaining strict control over the manufacturing process in-house allows for more direct oversight of quality standards, minimizing the risk of product variability or contamination.

Moreover, large pharmaceutical companies often opt for in-house API production to maintain supply chain control, ensuring reliable, high-quality, and compliant access to critical raw materials while protecting intellectual property and enabling customization. Moreover, these companies focus over extensive research and development activities from preclinical trials to late-stage development which help them to develop more refine and efficient API’s. This approach enhances cost-efficiency, supports R&D endeavours, and mitigates external supply chain risks.

Based on synthesis type, the methotrexate market is segmented into chemical-based API, HPAPI. Chemical based API held a dominant market share in 2022 and is anticipated to reach USD 735.4 million by 2032. This high segmental share is owing to the rising demand and increasing awareness related to the extensive advantages delivered by the chemical based active pharmaceutical ingredients in drug development. These active pharmaceutical ingredients have a direct effect on the mitigation, diagnosis, and prevention of disease.

Moreover, chemical based API can be used in the qualitative and quantitative analysis including physicochemical factors such as light, temperatures, enzymes, or a particular solution pH. The quantity and strength of an API in a particular drug are often determined by chemical-based API manufacturers using pre-established guidelines. Moreover, favourable government regulations are encouraging drug manufacturers to obtain pharmaceutical raw materials at a lower cost.

U.S. Methotrexate Market Size, 2020 -2032 (USD Million)

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U.S. methotrexate market accounted for USD 165.3 million revenue size in 2022 and is predicted to witness substantial market growth over the analysis timeline. This high revenue growth is mainly attributed to the significant healthcare expenditure, supportive government initiatives, high number of pharmaceutical companies, rising disease awareness, etc. Favourable laws and policies implemented in the region by regulatory authorities would further aid the companies operating in the market.

Also, increasing prevalence of cancer in the U.S. is set to increase the demand for highly potent medications and drugs comprising of methotrexate. Further, product development by major market players and increased healthcare expenditure is anticipated to augment the market growth in North America.

Methotrexate Market Share

Some of the eminent market participants operating in the methotrexate market include:

  • Novartis AG (Sandoz)
  • Merck & Co., Inc
  • Lonza
  • Sun Pharmaceutical Industries Ltd.
  • Teva Pharmaceutical Industries Ltd.
  • Aurobindo Pharma Ltd
  • Fermion (Orion Corporation)
  • Avra Laboratories Pvt Ltd
  • LGM Pharma
  • Rochem International Inc

These market players are undertaking several growth strategies including partnerships, collaborations, acquisitions & mergers, and new product development & launches to strengthen their product portfolio as well as gain a competitive edge over others.

Company Market Share Analysis:

Within the methotrexate industry, numerous large companies compete to offer cost-effective biologic drugs as alternatives to methotrexate in the treatment of autoimmune diseases. Analysing market share involves identifying and evaluating the many players that manufacture and sell this active pharmaceutical ingredient.

For instance, Teva Pharmaceutical Industries Ltd is one of the growing players in the methotrexate market. The company holds around 4-5% market share in the industry coupled with being a well-established player across the world. The strategy adopted by the company to sustain its leading position involves offering comprehensive customer support, leveraging on their extensive distribution network, and offering superior quality API.

Methotrexate Industry News:

  • In January 2020, Eugia Pharma Specialities Limited the joint venture company of Aurobindo Pharma Limited announced the final approval from the U.S. Food & Drug Administration (USFDA) to produce and distribute 2.5 mg Methotrexate tablets. This approval helped company to expand their product portfolio in the field of antineoplastic agents and treatments for Rheumatoid Arthritis.
  • In July 2020, LGM Pharma acquired Nexgen Pharma, Inc.'s formulation and drug manufacturing business. This acquisition enabled LGM Pharma to offer a more complete set of services to its clients, potentially increasing revenue, expanding market reach, and enhancing competitiveness in the pharmaceutical industry.

Methotrexate market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2018 to 2032 for the following segments:

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By Indication (USD Million)

  • Psoriasis
  • Rheumatoid arthritis
  • Cancer
  • Other indications

By Mode (USD Million)

  • In-house manufacturing
  • Contract manufacturing

By Synthesis Type (USD Million)

  • Chemical based API
  • Highly potent API (HPAPI)

The above information is provided for the following regions and countries:

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • Russia
    • France
    • Italy
    • Spain
  • Asia Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Malaysia
  • Latin America
    • Brazil
    • Mexico
  • Middle East & Africa
    • Saudi Arabia
    • South Africa
    • UAE


Authors: Mariam Faizullabhoy, Gauri Wani

Frequently Asked Questions (FAQ) :

The global methotrexate industry was valued at USD 553 million in 2022 and is estimated to account for USD 921 million by 2032 as methotrexate is a versatile medication that is used to treat a variety of medical conditions, including cancer, autoimmune diseases, and severe skin disorders.

Rheumatoid arthritis (RA) segment accounted for over USD 250 million in the year 2022, supported by the growing prevalence of people suffering from the disease in developed as well as developing economies.

U.S. methotrexate market accounted for USD 165.3 million in 2022 and is predicted to witness substantial growth through 2032, attributed to the significant healthcare expenditure, supportive government initiatives, high number of pharmaceutical companies, and rising disease awareness.

Novartis AG (Sandoz), Merck & Co., Inc, Lonza, Sun Pharmaceutical Industries Ltd., Teva Pharmaceutical Industries Ltd., Aurobindo Pharma Ltd, Fermion (Orion Corporation), Avra Laboratories Pvt Ltd, LGM Pharma, and Rochem International Inc among others.

Methotrexate Market Scope

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Premium Report Details

  • Base Year: 2022
  • Companies covered: 10
  • Tables & Figures: 230
  • Countries covered: 23
  • Pages: 164
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