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Methotrexate Drugs Market - By Indication (Psoriasis, Cancer, Rheumatoid Arthritis), Drug Type (Branded, Generic), Drug Form (Tablet, Liquid, Injectable), Route of Administration (Oral, Subcutaneous), Distribution Channel– Global Forecast (2024 – 2032)

  • Report ID: GMI9756
  • Published Date: Jun 2024
  • Report Format: PDF

Methotrexate Drugs Market Size

Methotrexate Drugs Market size was valued at around USD 590.4 million in 2023 and is estimated to grow at 3.1% CAGR from 2024 to 2032. Methotrexate drugs is a versatile medication with a wide range of therapeutic applications. Originally developed as a chemotherapy agent for treating cancer, it has since found extensive use in the management of autoimmune disorders and inflammatory conditions due to its immunosuppressive and anti-inflammatory properties.

Methotrexate Drugs Market

It works by inhibiting the enzymes dihydrofolate reductase, which is involved in the synthesis of DNA, RNA, and proteins. By interfering with folate metabolism, methotrexate disrupts the proliferation of rapidly dividing cells, including cancer cells and cells of the immune system responsible for inflammation in autoimmune diseases.

The rising prevalence of cancer is a significant driving factors for the market. For instance, according to the World Health Organization (WHO), in 2022, there were an estimated 20 million new cancer cases and 9.7 million deaths worldwide. Thus, this underscores the urgent need for effective treatments such as cancer immunotherapy, driving its demand and market growth.

Furthermore, ongoing research and development using methotrexate, which is estimated to reach USD 921 million by 2032, drugs, rising technological advancements and demand for personalized medicine, are the promoting factors fostering the growth of the market.

Methotrexate Drugs Market Trends

Advancements in technology and a growing emphasis on personalized medicine are fundamentally reshaping the landscape of methotrexate drugs, ushering in a new era of innovation and tailored therapeutic approaches. As one of the most versatile medications in modern medicine, methotrexate is witnessing a paradigm shift driven by emerging trends in pharmacogenomics, targeted drug delivery systems, biomarker development, digital health technologies, and patient-centered care models.

  • Advancements in pharmacogenomics, which involves studying an individual's genetic makeup influences their response to drugs, are paving the way for personalized medicine approaches in methotrexate therapy. By analyzing genetic variations, healthcare providers can tailor methotrexate dosages and treatment regimens to maximize efficacy while minimizing adverse effects.
  • Technological innovations in novel drug delivery systems are enhancing the targeted delivery of methotrexate to specific sites within the body, thereby improving its therapeutic efficacy and reducing systemic side effects. Nanotechnology-based approaches such as nanoparticle formulations and liposomal encapsulation, enable the precise delivery of methotrexate to inflamed joints in conditions such as rheumatoid arthritis or to tumor sites in cancer therapy.
  • Further, the emergence of precision medicine paradigms is driving the identification and validation of biomarkers that can predict individual responses to methotrexate therapy. Biomarkers such as specific cytokine levels, immune cell profiles, or genetic markers, provide valuable insights into disease activity, treatment response, and the likelihood of adverse events. Thus, driving the growth of the market.

Methotrexate Drugs Market Analysis

Methotrexate Drugs Market, By Indication, 2021 – 2032(USD Million)

Based on indication, the market is divided into psoriasis, rheumatoid arthritis, cancer, and other indications. The cancer segment of the market is forecasted to reach USD 263.4 million by 2032, displaying robust growth propelled by several key factors.

  • Methotrexate, originally developed as a chemotherapy agent for cancer treatment, continues to play a crucial role in the management of various types of cancer. Its mechanism of action as an antimetabolite disrupts the synthesis of DNA, RNA, and proteins in rapidly dividing cells, making it effective against cancer cells that proliferate rapidly.
  • It is commonly used in the treatment of acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), particularly in combination chemotherapy regimens. It helps to suppress the growth of leukemia cells and induce remission in affected patients.
  • Further, methotrexate may be used in combination chemotherapy regimens for the treatment of advanced or metastatic breast cancer. It is often combined with other chemotherapeutic agents to enhance treatment efficacy, thereby fueling market growth.
Methotrexate Drugs Market, By Drug Type (2023)

Based on drug type, the methotrexate drugs market is bifurcated into branded and generic. The branded segment accounted for USD 346.6 million in 2023.

  • Branded methotrexate drugs may feature proprietary formulations that offer enhanced bioavailability, stability, and dosing convenience compared to generic versions. These formulations may include extended-release formulations, novel delivery systems such as subcutaneous injections or oral solutions or modified-release technologies designed to optimize drug absorption and minimize variability in plasma concentrations.
  • They typically undergo extensive clinical research and development, including Phase I, II, and III clinical trials, to establish their safety, efficacy, and therapeutic benefits in specific patient populations. This rigorous research process generates robust clinical data and evidence supporting the use of branded formulations, providing healthcare providers with confidence in their prescribing decisions.
  • Additionally, branded methotrexate drugs are manufactured under stringent quality assurance standards and regulatory oversight to ensure product consistency, purity, and pharmaceutical quality. Branded manufacturers adhere to good manufacturing practice (GMP) guidelines and invest in state-of-the-art manufacturing facilities and processes to maintain product integrity and meet regulatory requirements. Thus, propelling the growth of the market.

Based on drug form, the methotrexate drugs market is divided into tablet, liquid, and injectable. The tablet segment of the market is forecasted to reach USD 375.5 million by 2032, displaying robust growth propelled by several key factors.

  • Tablets offer a convenient dosing option for patients who prefer oral administration over injections. They can be easily swallowed with water and taken at home without the need for specialized medical equipment or healthcare provider assistance.
  • Methotrexate tablets are simple to administer, requiring no special preparation or handling. Patients can take their prescribed dose at a scheduled time, making it easier to incorporate it into their daily routine.
  • Further, they are available in precise dosage strengths, allowing for accurate dosing and consistent medication delivery. This helps healthcare providers tailor the dose to meet individual patient needs and optimize treatment outcomes. Thus, driving the growth of the market.

Based on route of administration, the methotrexate drugs market is bifurcated into oral, subcutaneous, intramuscular, and intravenous. The oral segment accounted for USD 268.6 million in 2023.

  • Oral methotrexate administration offers convenience, as it can be taken at home without the need for medical assistance. Patients can adhere to their treatment regimen more easily, as they can take their medication at a scheduled time without having to visit a healthcare facility for injections.
  • The convenience and ease of oral administration can improve patient compliance with Methotrexate therapy. Patients are more likely to adhere to their prescribed treatment regimen when it is convenient and non-invasive, leading to better treatment outcomes and disease management.
  • Oral methotrexate allows for flexibility in dosing, as tablets can be easily divided or adjusted to achieve the desired dose. This flexibility enables healthcare providers to tailor the dose to individual patient needs and optimize treatment outcomes. Thus, escalating the growth of the market.

Based on distribution channel, the methotrexate drugs market is bifurcated into hospital pharmacies, retail pharmacies, and online pharmacies. The hospitals pharmacies segment accounted for USD 248.6 million in 2023.

  • Hospital pharmacies may have access to specialized formulations of Methotrexate, such as injectable solutions or compounded preparations, which may be required for specific patient populations or clinical situations.
  • Hospital pharmacists possess specialized knowledge and expertise in the management of medications, including Methotrexate. They are trained to ensure the safe and appropriate use of the drug, including dosage calculations, drug interactions, and monitoring for potential adverse effects.
  • Further, hospital pharmacies have robust medication safety protocols in place to prevent medication errors and ensure patient safety. This includes double-checking prescriptions, verifying dosages, and providing clear instructions to patients on how to take Methotrexate properly.
North America Methotrexate Drugs Market, 2021- 2032 (USD Million)

The U.S. methotrexate drugs market is forecasted to reach USD 281.5 million by 2032.

  • The U.S. boasts a robust healthcare infrastructure, including hospitals, clinics, specialty pharmacies, and academic medical centers, which facilitate the delivery and management of Methotrexate therapy. This infrastructure supports comprehensive patient care, medication management, and adherence support services, enhancing treatment outcomes for patients with diverse medical condition.
  • The increasing prevalence of cancer in U.S. is driving substantial growth in the market. For instance, according to the Centers for Disease Control and Prevention (CDC) in 2020, there were 1,603,844 new cases of cancer reported, with 602,347 individuals losing their lives to this disease, in U.S.

The methotrexate drugs market in UK is expected to experience significant and promising growth from 2024 to 2032.

  • The U.K. benefits from the presence of the National Health Service (NHS), which provides universal healthcare coverage to residents. Under the NHS, patients have access to a wide range of medical services, including prescription medications like Methotrexate, at little to no cost at the point of delivery. This ensures equitable access to treatment for all patients, regardless of their socioeconomic status.

Japan market is anticipated to witness lucrative growth between 2024 – 2032.

  • Japan's healthcare system provides universal health coverage to its citizens through a mandatory health insurance system. This ensures that all residents have access to essential healthcare services, including prescription medications like Methotrexate, without facing financial barriers to treatment.

The methotrexate drugs market in Saudi Arabia is expected to experience significant and promising growth from 2024 to 2032.

  • Saudi Arabia has specialized treatment centers and hospitals dedicated to the management of conditions treated with Methotrexate, such as rheumatoid arthritis, psoriasis, and certain types of cancer. These centers provide comprehensive care, multidisciplinary support, and access to advanced treatment options, including Methotrexate drugs, for patients with complex medical needs.

Methotrexate Drugs Market Share

The methotrexate drugs industry is competitive in nature, with several large multinationals and small and mid-sized companies competing in the industry. The development and launch of novel advanced products and services based on different technologies is among a key market strategy. Some of the leading industry players have a notable presence in the market.

Methotrexate Drugs Market Companies

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

  • Accord Healthcare
  • Amneal Pharmaceuticals LLC
  • Apotex Inc.
  • Cipla Limited
  • Dr. Reddy’s Laboratories Ltd.
  • Hikma Pharmaceuticals PLC
  • Intas Pharmaceuticals Ltd.
  • Lupin Limited
  • Merck KGaA
  • Novartis AG
  • Pfizer Inc.
  • Sun Pharmaceutical Industries Ltd.
  • Teva Pharmaceutical Industries Ltd.
  • Viatris Inc.
  • Zydus Cadila

Methotrexate Drugs Industry News:

  • In April 2021, Amneal Pharmaceuticals, Inc. announced the acquisition of Kashiv Specialty Pharmaceuticals, LLC, specialized in developing complex generics, innovative drug delivery platforms, and novel drugs. This acquisition allowed Amneal Pharmaceuticals to expand its portfolio of products, enhance its capabilities in developing innovative drug delivery technologies, and strengthen its position in the competitive pharmaceutical market.
  • In May 2020, Teva Pharmaceuticals USA, Inc. and Celltrion Healthcare, Co., Ltd. announced that TRUXIMA injection was available in the U.S. for the treatment of Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who had inadequate responses to one or more TNF antagonist therapies. This collaboration strengthened Teva's position in the competitive biologics market and allowed Celltrion to further penetrate the U.S. market with its biosimilar products.

The methotrexate drugs market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 – 2032 for the following segments:

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Market, By Indication

  • Psoriasis
  • Rheumatoid arthritis
  • Cancer
  • Other indications

Market, By Drug Type

  • Branded
  • Generic

Market, By Drug Form

  • Tablet
  • Liquid
  • Injectable

Market, By Route of Administration

  • Oral   
  • Subcutaneous
  • Intramuscular
  • Intravenous

Market, By Distribution Channel

  • Hospital pharmacies
  • Retail pharmacies
  • Online pharmacies

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

  • North America 
    • U.S.
    • Canad 
  • Europe
    • Germany
    • UK
    • France
    • Spain
    • Italy
    • Netherlands
    • Rest of Europe
  • Asia Pacific 
    • Japan
    • China
    • India
    • Australia
    • South Korea
    • Rest of Asia Pacific
  • Latin America 
    • Brazil
    • Mexico
    • Argentina
    • Rest of Latin America
  • Middle East and Africa 
    • Saudi Arabia
    • South Africa
    • UAE
    • Rest of Middle East and Africa


Authors: Mariam Faizullabhoy , Gauri Wani

Frequently Asked Questions (FAQ) :

Global methotrexate drugs industry size was valued at USD 590.4 billion in 2023 and is estimated to grow at 3.1% CAGR from 2024 to 2032 due to increasing prevalence of cancer and the ongoing R&D using methotrexate drugs.

The cancer segment of the market is forecasted to reach USD 263.4 million by 2032 due to its effectiveness in treating various cancers, especially leukemia and metastatic breast cancer.

The hospital pharmacies segment of the methotrexate drugs market recorded USD 248.6 million in 2023 due to the need for provide specialized methotrexate formulations and follow robust safety protocols to enhance patient care and safety in clinical settings.

Accord Healthcare, Amneal Pharmaceuticals LLC, Apotex Inc., Cipla Limited, Dr. Reddy’s Laboratories Ltd., Hikma Pharmaceuticals PLC, Intas Pharmaceuticals Ltd., Lupin Limited, and Merck KGaA, among others.

Methotrexate Drugs Market Scope

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Premium Report Details

  • Base Year: 2023
  • Companies covered: 20
  • Tables & Figures: 343
  • Countries covered: 23
  • Pages: 265
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