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
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.
|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|
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)
|Restraints & Challenges:||
Figure 2.Global Methotrexate Drugs Market Share (%), by Region, 2022
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:
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:
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.
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:
“*” marked represents similar segmentation in other categories in the respective section.