Methotrexate Drugs MarketSize and Trends

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

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

Market- Trends

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.