Methotrexate Drug Market

Analysis by Type (2.5mg/ml and 2mg/ml); by Route of Administration (Intravenous and Oral); by Application (Cancer, Autoimmune Diseases, Ectopic Pregnancy and Others); by End Users (Hospitals, Homecare, Specialty Clinics and Others); by Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Others) – Global Supply & Demand Analysis & Opportunity Outlook 2023-2035

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Report ID: 2738 | Published On: Feb 15, 2023
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Global Methotrexate Drug Market Size, Forecast, and Trend Highlights Over 2023 - 2035

The global methotrexate drug market size is estimated to reach ~USD 850 million by the end of 2035 by growing at a CAGR of ~4% over the forecast period, i.e., 2023 – 2035. In addition to this, in the year 2022, the market size of methotrexate drug was ~USD 590 million. The growth of the market can be attributed to the increasing prevalence of cancer and autoimmune disorders such as rheumatoid arthritis. According to the World Health Organization (WHO), cancer is the leading cause of death Worldwide with over 10 million deaths in 2020. Methotrexate which is a folate antagonist is widely used in the effective treatments of these disorders. The National Cancer Institute (NCI) listed methotrexate sodium as an approved drug for many clinical trials such as breast cancer, lung cancer. The increased use of methotrexate in chemotherapy treatments to treat rare, cancerous tumors is another factor that is predicted to increase the market in the years to come.

In addition to these, factors that are believed to fuel the market growth of methotrexate drugs include the new product launches and increased focus of gaining product approvals from regulatory bodies. For instance, on May, 2018, Hikma Pharmaceuticals PLC., announced the launch of methotrexate injections as 2mL vials.  Additionally, Silvergate Pharmaceuticals announced FDA approval for XATMEP, the first and only ready to use oral methotrexate solution in the world. Additionally, the growing number of research and development activities on the production of methotrexate drugs is also predicted to present the potential for market expansion over the projected period.

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Global Methotrexate Drug Market: Key Insights

Base Year


Forecast Year




Base Year Market Size (2022)

~ USD 590 Million

Forecast Year Market Size (2035)

~ USD 850 Million

Regional Scope

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

Global Methotrexate Drug Market: Growth Drivers and Challenges

Growth Drivers

  • Rising Cases of Arthritis– On account of the increasing cases of arthritis and inflammatory forms of it, the market for methotrexate is expected to expand more in the upcoming years. It is estimated that the number of men and women with arthritis will increase 49% more by the year 2040. The use of methotrexate to reduce swelling, joint damage and disease progression is predicted to increase in the coming years. Methotrexate is the first line of therapy for patients with rheumatoid arthritis and other inflammatory arthritis.
  • Increasing Application of Methotrexate in Cancer Treatment– Methotrexate Sodium, a type of chemotherapy called antimetabolite helps kill cancer cells from making any DNA and strengthens body’s immune system to kill the cancer. This increasing use of methotrexate in treating cancer is estimated to drive market growth. The methotrexate sodium is approved by the US Food and Administration (FDA) to be used alone or in combination to treat acute lymphoblastic leukemia. It has also been approved to treat non-Hodgkin lymphoma.
  • Growing Awareness of Methotrexate Drugs and its Effectiveness – Methotrexate drug awareness and therapeutic monitoring of it is anticipated to boost the growth of the market. On January 19, 2022 World Health Organization (WHO) released the application for WHO’s list of Essential In-Vitro Diagnostics (EDL) that included the therapeutic drug monitoring of methotrexate. It is estimated that inclusion of methotrexate in the list would boost its market growth.
  • Growing Incidences of Methotrexate Drug Approval by Regulatory Bodies – It is expected that increasing number of methotrexate drug approvals by Government and regulatory bodies will boost its market growth. For instance, on September 26,2022, Eisai Co.Ltd., and Nippon Medac Co., Ltd., announced the obtaining of manufacturing and marketing approval for Metoject Subcutaneous injection by the Japanese Ministry of Health, Labor and Welfare. 
  • Increasing Use of Methotrexate in Combination Therapy – There is a rise in use of methotrexate drugs along with other Disease Modifying Anti-Rheumatic Drugs (DMARDs) for the treatment of rheumatoid arthritis, which is anticipated to drive the market growth.  Research cites that combination of methotrexate and DMARDs reduce joint damage and improves ability of the patient to move.  


  • Side effects of methotrexate drugs - The increasing concern amongst individuals for the side effects associated with the consumption of methotrexate drugs is one of the major factors predicted to slow down the market growth. For instance, hepatotoxicity a serious condition of liver injury, can arise from the accumulation of the intracellular MTX Polyglutamate that triggers inflammation, oxidative stress and fibrosis.
  • High cost of treatment using the methotrexate drugs
  • Lack of favorable medical insurance systems for methotrexate

Global Methotrexate Drug Market Segmentation

The global methotrexate drug market is segmented and analyzed for demand and supply by route of administration into intravenous and oral. Out of the two types of methotrexate drug administration, the intravenous segment is estimated to be growing at a CAGR ⁓16% in the forecast period. The growth of the segment can be attributed to the increasing efficacy of methotrexate intramuscular and subcutaneous injection for treatment of rheumatoid arthritis, cancer and others. For instance, research conducted by the Department of Immunology and Rheumatology, to compare efficacy of methotrexate injections and oral administration for treatment of rheumatoid arthritis, concluded that with intravenous injections there is improved clinical efficacy, tolerance and fewer side effects than with oral administration.  It was also noted that the disease manifestations were improved with intravenous injections. This is anticipated to boost the market growth of the segment in coming years.

The global methotrexate drug market is also segmented and analyzed for demand and supply by end-user into hospital pharmacies, retail pharmacies and others. Amongst these three segments, the hospital pharmacies segment is expected to garner a significant share by the year 2035. Patients suffering from diseases such as such as cancer, auto-immune conditions- rheumatoid arthritis, lupus often visit hospitals for treatment, and it’s easier and convenient for them to purchase the prescribed drugs directly from the same hospital premises. On the other hand, the online pharmacies segment is projected to witness a massive CAGR during the forecast period, owing to the rising awareness for these online platforms amongst the users worldwide. Purchasing medicines online help the user to receive the prescribed drugs directly at their homes, without the need to visit offline stores. Besides this, methotrexate drugs are expensive and with mail orders the patient could avail discounts for the same. This, as a result, is anticipated to create numerous opportunities for the growth of the segment in the coming years.

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

       By Type

  • 2.5 mg/ml
  • 2 mg/ml

      By Administration

  • Intravenous
  • Oral

     By Application

  • Cancer
  • Autoimmune disease
  • Ectopic pregnancy
  • Others

      By End Users

  • Hospitals
  • Homecare
  • Specialty Clinics
  • Others

    By Distribution Channel

  • Hospital Pharmacies
  • Retail Pharmacies
  • Others

Global Methotrexate Drug Market Regional Synopsis

The market share of methotrexate drug in North America, amongst the market in all the other regions, is projected to be the largest with a share of about ~38% by the end of 2035. The growth of the market can be attributed majorly to the increasing frequency of cancer, arthritis, psoriasis amongst people, backed by the change in lifestyle of individuals. For instance, the National Cancer Institute (NCI) estimated 1,806, 590 new cases in 2020 with a 606,520 patient’s death. The cancer incidence is reported as 442 per 100,000 men and women per year. Further, the presence of a strong healthcare network in the region, along with the presence of key manufacturers, are also anticipated to contribute to the market growth in the region. For instance, NORDIC Pharma has announced the submission of marketing authorization of methotrexate auto injector called Nordimet to the Health Canada. Nordimet helps in disabling rheumatoid arthritis and psoriasis in adults that are unresponsive to other treatment methods. The region's increasing R&D activities in creating new formulations of methotrexate drugs are also anticipated to boost the market growth during the forecast period.

The European methotrexate drug market is estimated to be the second largest by the end of 2035. The growth of the market can be attributed majorly to the increasing government monitoring, expenditure on healthcare industry, and new product launches. For instance, on 22 August, 2019 European Medicines Agency announced strict monitoring for methotrexate dosing and newer measures were introduced for better dosage of the drug and its efficacy. On 15th February, 2022, AbbVie announced that the European Commission has approved SKYRIZI to be used with methotrexate to effectively treat psoriatic arthritis in adults. Further, the presence of a strong healthcare network in the region, along with the availability of supportive policies by the regulatory bodies are also anticipated to contribute to the market growth in the region. In addition, the region's expanding healthcare industry and newer method adoption for treatment of Psoriasis and other skin conditions using low doses of methotrexate are also anticipated to boost the market growth during the forecast period.

Further, the market in the Asia Pacific, amongst the market in all the other regions, is projected to hold a majority of the share by the end of 2035. The growth of the market can be attributed majorly to the increasing frequency of disorders such as cancer, auto-immune conditions and other disorders that use methotrexate for effective management. An increase of women choosing abortions is yet another reason for the market growth. For instance, according to the World Health Organization (WHO), less than half of abortions in South and Central Asia are safe.  It was also estimated that illegal abortions in countries such as India, Bangladesh, Nepal range from 58% to over 90%. The use of methotrexate along with misoprostol to terminate pregnancy could pave way to safer abortions with lower mortality rate. Further, the upsurge in the healthcare network and expenditure in the region are also anticipated to contribute to the market growth in the region.


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Top Featured Companies Dominating the Global Methotrexate Drug Market

    • Pfizer Inc.
      • Company Overview
      • Business Strategy
      • Key Product Offerings
      • Financial Performance
      • Key Performance Indicators
      • Risk Analysis
      • Recent Development
      • Regional Presence
      • SWOT Analysis
    • Silvergate Pharmaceuticals, Inc.
    • Apotex Inc. 
    • Par Pharmaceutical
    • Amneal Pharmaceuticals LLC.
    • Teva Pharmaceutical Industries Ltd.
    • Hikma Pharmaceuticals PLC
    • LingNan Pharmaceutical
    • Sichuan Huiyu Pharmaceutical Co. Ltd
    • Eisai Co.Ltd.

In The News

  • Teva and Celltrion announced the launch of Truxima injection for effective treatment of rheumatoid arthritis. The drug that is similar to Rituxan is used with methotrexate for treatment of inflammatory arthritis. The product received approval from the approval from the US Food and Drug Administration.

  • Amgen introduces Amjevita, a biosimilar to AbbVie’s Humira. This FDA approved drug along with methotrexate is expected to reduce signs and symptoms of structural damage and help treat rheumatoid, psoriatic arthritis.

Global Economic Impact

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Despite Inflation & Fearing Recession, Businesses Across the Globe Expected to Do Better in 2023:

In 2023, market players might incur losses due to huge gap in currency translation followed by contracting revenues, shrinking profit margins & cost pressure on logistics and supply chain.
Controlling Inflation has become the first priority for global economies from last quarter of 2022 and to be followed in 2023. With skewed economic situations, rise in interest rate by governments to control spending and inflation, spiked oil and gas prices, high inflation, geo-political issues including U.S. & China trade war, Russia-Ukraine conflict to intensify the global economic issues.
The interest rates in the U.S. may be less sensitive in 2023 as compared to 2022; sigh of relief for businesses. Positive business sentiments, healthy business balance sheets, growth in construction spending (private construction value in 2022 stood at $1,429.2 billion, 11.7 percent (±1.0 percent) above the $1,279.5 billion spent in 2021, Residential construction in 2022 was $899.1 billion, up by 13.3 percent (±2.1 percent) from $793.7 billion in 2021, non-residential construction touched $530.1 billion, 9.1 percent (±1.0 percent) above the $485.8 billion in 2021.) showcases minimal impact of recession in the country.
Similarly, spiked spending in the European and major Asia economics including, India, China & Japan to showcase less impact on the global demand.

Key Questions Answered in the Report

1) What are the major factors driving the growth of the global methotrexate drug market?

Ans: Increasing incidences of arthritis, application of methotrexate in cancer treatments, combination therapy, increasing approval rates of the drug, awareness among people about the effectiveness of methotrexate drug are the major factors driving the market growth.

2) What would be the CAGR of global methotrexate drug market over the forecast period?

Ans: The market size of methotrexate drug market is anticipated to attain a CAGR of ~4% over the forecast period, i.e., 2023 – 2035.

3) What are the challenges affecting the global methotrexate drug market growth?

Ans: Side effects of methotrexate drug treatment, high cost of treatment, and less favorable medical policies and insurance are estimated to be the growth hindering factors for the market expansion.

4) Which region will provide more business opportunities for growth of global methotrexate drug market in future?

Ans: The market in the North American region is projected to hold the largest market share by the end of 2035 and provide more business opportunities in the future.

5) Who are the major players dominating the global methotrexate drug market?

Ans: The major players in the market are Pfizer Inc., Silvergate Pharmaceuticals, Inc., Apotex Inc., Par Pharmaceutical, Amneal Pharmaceuticals LLC., Teva Pharmaceutical Industries Ltd., Hikma Pharmaceuticals PLC, LingNan Pharmaceutical, Sichuan Huiyu Pharmaceutical Co. Ltd, and Eisai Co.Ltd., and others.

6) How are the company profiles selected?

Ans: The company profiles are selected based on the revenues generated from the product segment, the geographical presence of the company which determines the revenue generating capacity as well as the new products being launched into the market by the company.

7) What are the segments in the methotrexate drug market?

Ans: The market is segmented by type, administration, application, end user, distribution channel, and by region.

8) Which segment captures the largest market size in the route of administration segment in the methotrexate drug market?

Ans: The intravenous segment is anticipated to garner the largest market size by the end of 2035 and display significant growth opportunities.

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