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  • Published On : Oct 2022
  • Code : CMI5276
  • Industry : Pharmaceutical
  • Pages : 178
  • Formats :

Methotrexate is a folate antagonist. Methotrexate is one of the most effective and widely used medications for treating inflammatory types of arthritis. It is also one of the safest arthritis drugs. Methotrexate drugs are indicated for the treatment of Psoriasis, Rheumatoid Arthritis. Methotrexate is also used to treat certain types of cancer including cancers that begin in the tissues that form around a fertilized egg in the uterus, breast cancer, lung cancer, certain cancers of the head and neck, certain types of lymphoma, and leukemia (cancer that begins in the white blood cells).

Methotrexate treats cancer by slowing the growth of cancer cells. Methotrexate treats psoriasis by slowing the growth of skin cells to stop scales from forming. Methotrexate may treat rheumatoid arthritis by decreasing the activity of the immune system.

Global methotrexate drugs market is estimated to be valued at US$ 590.2 million in 2022 and is expected to exhibit a CAGR of 2.6% during the forecast period (2022-2030).

Figure 1. Global Methotrexate Drugs Market Share (%), by Treatment Type, 2022

Methotrexate Drugs  | Coherent Market Insights

Global Methotrexate Drugs Market- Drivers

Increasing number of drug approvals by regulatory bodies is expected to drive the global methotrexate drugs market growth over the forecast period.

Increasing number of drug approvals by regulatory bodies is expected to boost the growth of global methotrexate drugs market. For instance, on March 30, 2022, NORDIC PHARMA, a SEVER Life Sciences company, announced the submission of a New Drug Submission to Health Canada for its methotrexate auto-injector, Nordimet for the treatment of severe disabling active rheumatoid arthritis (RA) and symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy.

Furthermore, on September 26, 2022, Eisai Co., Ltd., and nippon medac Co., Ltd., a subsidiary of medac Gesellschaft für klinische Spezialpräparate mbH announced that they have obtained manufacturing and marketing approval from the Japanese Ministry of Health, Labour and Welfare for the indication of the anti-rheumatic agent “Metoject Subcutaneous Injection 7.5mg syringe 0.15mL, 10mg syringe 0.20mL, 12.5mg syringe 0.25mL and 15mg syringe 0.30mL” (methotrexate) for the treatment of rheumatoid arthritis.

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Methotrexate Drugs Market Report Coverage

Report Coverage Details
Base Year: 2021 Market Size in 2022: US$ 590.2 Mn
Historical Data for: 2017 to 2020 Forecast Period: 2022 to 2030
Forecast Period 2022 to 2030 CAGR: 2.6% 2030 Value Projection: US$ 735.9 Mn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC Countries, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Treatment Type: Psoriasis, Rheumatoid Arthritis, Cancer
  • By Route of Administration: Oral, Injection
  • By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies 
Companies covered:

LEO Pharma A/S, Bristol Myers Squibb, Nordic Pharma, Eli Lilly and Company, Horizon Therapeutics plc., Cumberland Pharmaceuticals Inc., Azurity Pharmaceuticals, Inc., Pfizer Inc., Hikma Pharmaceuticals PLC., and Onco Therapies Limited (Strides Arcolab Limited)

Growth Drivers:
  • Increasing product approvals from regulatory bodies
  • Ongoing research and development and product launches of methotrexate drugs
Restraints & Challenges:
  • Side effects associated with methotrexate drugs

Figure 2.Global Methotrexate Drugs Market Share (%), by Region, 2022

Methotrexate Drugs  | Coherent Market Insights

Global Methotrexate Drugs Market- Driver

Ongoing research and development using methotrexate drugs is expected to drive the global methotrexate drugs market growth.

Key market players are focused on research and development of methotrexate drugs which is expected to drive the global methotrexate drugs market over the forecast period. For instance, Aclaris Therapeutics, Inc., a pharmaceutical company, announced that the company initiated Phase 2 trial of ATI-450 Plus Methotrexate (MTX), for the treatment of Rheumatoid Arthritis.  

Global Methotrexate Drugs Market– Impact of Coronavirus (COVID-19) Pandemic

The COVID-19 pandemic has drastically affected clinical trials. Many trials have paused enrollment and researchers are facing multiple challenges associated with setting up remote visits, and performing laboratory and other study assessments.

The ability to conduct clinical trials has been significantly impacted by the COVID-19 pandemic. Many clinical trials have been halted or delayed and the enrollment of new participants is being postponed. Without important data on the safety and effectiveness of treatments from clinical trials, the arrival of new treatments in the marketplace will ultimately be delayed. In addition, patients fighting serious and life-threatening diseases may not be able to access investigational products because of suspended clinical trials.

According to NORD, the U.S. FDA issued a guidance for industry, investigators, and institutional review boards (IRBs) to inform key considerations (such as the decision to continue or suspend a clinical trial) and requirements for sponsors undertaking clinical trials during the COVID-19 outbreak. FDA’s guidance provides flexibility to sponsors to continue clinical trials where feasible and appropriate. The following are key points from the guidance:

  • The safety and well-being of clinical trial participants is most important and must be the focus for decision-making
  • Trial participants should be informed of changes to the study and monitoring plans that could impact them. Sponsors should engage with Institutional Review Board (IRBs) about protocol changes and consult with FDA as early as possible regarding protocol changes.
  • Modifications to data collection and safety assessments may be made, but every effort must be made to preserve the integrity of the study
  • All changes to the study protocol must be documented to explain why the changes were made, what the changes were, and the impact of the changes on the study

Global Methotrexate Drugs Market: Key Developments

Market players are focused on gaining product approvals from regulatory bodies is expected to drive the growth of global methotrexate drugs market. For instance, in January 2020, Aurobindo Pharma Limited., announced that its joint venture company, Eugia Pharma Specialities Limited, has received a final approval from the U.S. Food & Drug Administration (USFDA) to manufacture and market Methotrexate tablets, 2.5 mg. Methotrexate tablets are generic version of Dava Pharmaceuticals’ Rheumatrex Tablets.

Global Methotrexate Drugs Market: Restraint

Side effects associated to Methotrexate drugs, is expected to hinder the growth of global methotrexate drugs market. Side effects associated with methotrexate drugs are:

  • Methotrexate may cause lung damage
  • Methotrexate may cause damage to the lining of your mouth, stomach, or intestines
  • Methotrexate may decrease the activity of immune system
  • Methotrexate drugs taken while being treated with radiation therapy for cancer, methotrexate may increase the risk that the radiation therapy will cause damage to skin, bones, or other parts of body

Key Players

Major players operating in the global methotrexate drugs market include LEO Pharma A/S, Bristol Myers Squibb, Nordic Pharma, Eli Lilly and Company, Horizon Therapeutics plc., Cumberland Pharmaceuticals Inc., Azurity Pharmaceuticals, Inc., Pfizer Inc., Hikma Pharmaceuticals PLC., and Onco Therapies Limited (Strides Arcolab Limited).

Methotrexate is a type of disease-modifying anti-rheumatic drug (DMARD). It is used to reduce the activity of the immune system for people who have certain conditions. The immune system normally protects the body from infections by causing inflammation to fight them. Inflammation can cause swelling, heat, redness and pain. Methotrexate is available in tablet, liquid or injection form. Methotrexate tablets come in two strengths: 2.5 mg and 10 mg. Methotrexate interferes with the growth of certain cells of the body, especially cells that reproduce quickly, such as cancer cells, bone marrow cells, and skin cells.

Market Dynamics

Key players in market are involved in research and development activities to develop Methotrexate drugs which is expected to drive the growth of global methotrexate drugs market over the forecast period. For instance, in June 2019, Pfizer Inc., announced positive results from ORAL Shift, a Phase 3b/4 study in adult patients with moderately to severely active rheumatoid arthritis (RA). Patients who achieved low disease activity (LDA) with XELJANZ (tofacitinib) extended release (XR) 11 mg once daily (QD) plus methotrexate (MTX) after a 24-week open-label run-in period, were randomized to evaluate the efficacy and safety of XELJANZ XR 11 mg QD as monotherapy after MTX withdrawal compared with XELJANZ XR with continued MTX.

Factors such as awareness initiatives by organizations, increasing prevalence of Arthritis, and product launches are driving the global methotrexate drugs market growth. For instance, in May 2018, Hikma Pharmaceuticals PLC., announced that it is wholly owned U.S. subsidiary West-Ward Pharmaceuticals Corp., has launched Methotrexate for Injection, USP in a 1g preservative-free presentation and Methotrexate Injection, USP 50mg/2mL, 2 mL vials. Such initiatives by market players are expected to boost the global methotrexate drugs market growth over the forecast period. Moreover, pipeline for Arthtitis, cancers has several potential medications, which is expected to drive global methotrexate drugs market growth.

Key features of the study:

  • This report provides an in-depth analysis of the global methotrexate drugs market, and provides market size (US$ Million) and compound annual growth rate (CAGR%) for the forecast period (2022–2030), considering 2021 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players
  • It profiles key players in the global methotrexate drugs market  based on the following parameters – company highlights, products portfolio, key highlights, financial performance, and strategies
  • Key companies covered as a part of this study include LEO Pharma A/S, Bristol Myers Squibb, Nordic Pharma, Eli Lilly and Company, Horizon Therapeutics plc., Cumberland Pharmaceuticals Inc., Azurity Pharmaceuticals, Inc., Pfizer Inc., Hikma Pharmaceuticals PLC., and Onco Therapies Limited (Strides Arcolab Limited).
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
  • The global methotrexate drugs market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global methotrexate drugs market.

Detailed Segmentation:

  • Global Methotrexate Drugs Market, By Treatment Type:
    • Psoriasis
    • Rheumatoid Arthritis
    • Cancer
  • Global Methotrexate Drugs Market, By Route of Administration:
    • Oral
    • Injection
  • Global Methotrexate Drugs Market, By Distribution Channel:
    • Hospital Pharmacies
    • Retail Pharmacies 
    • Online Pharmacies
  • Global Methotrexate Drugs Market, By Region:
    • North America
      • By Country
        • U.S.
        • Canada
    • Latin America
      • By Country
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Country
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Country
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • By Country
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Region/Country
        • South Africa
        • Central Africa
        • North Africa
  • Company Profiles
    • LEO Pharma A/S*
      • Company Highlights
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • Bristol Myers Squibb
    • Nordic Pharma
    • Eli Lilly and Company
    • Horizon Therapeutics plc.
    • Cumberland Pharmaceuticals Inc.
    • Azurity Pharmaceuticals, Inc.
    • Pfizer Inc.
    • Hikma Pharmaceuticals PLC.
    • Onco Therapies Limited (Strides Arcolab Limited)

“*” marked represents similar segmentation in other categories in the respective section.

Frequently Asked Questions

The global methotrexate drugs market size is estimated to be valued at US$ 590.2 million in 2022 and is expected to exhibit a CAGR of 2.6% between 2022 and 2030.
Factors such as market players are focused on gaining product approvals from regulatory bodies and ongoing research and development and product launches of methotrexate drugs are expected to drive the market growth.
Psoriasis is the leading treatment type segment in the market.
Side effects associated with methotrexate drugs is expected to hamper the growth of the market.
Major players operating in the market include LEO Pharma A/S, Bristol Myers Squibb, Nordic Pharma, Eli Lilly and Company, Horizon Therapeutics plc., Cumberland Pharmaceuticals Inc., Azurity Pharmaceuticals, Inc., Pfizer Inc., Hikma Pharmaceuticals PLC., and Onco Therapies Limited (Strides Arcolab Limited).

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