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The methotrexate market by indication is categorized into psoriasis, rheumatoid arthritis, cancer, and others. Rheumatoid arthritis (RA) segment held a significant revenue of the market accounting for over USD 250 million revenue in the year 2022. High growth rate is attributed to the growing prevalence of people suffering from the disease in developed as well as developing economies. Additionally, methotrexate is classified as a disease-modifying anti-rheumatic drug (DMARD), which means it can slow down the progression of RA by addressing the underlying autoimmune response and joint damage.
Further, methotrexate can be used as a monotherapy (single-drug treatment) or in combination with other DMARDs or biologics to enhance its effectiveness and address more severe cases of RA. Therefore, the several advantages offered by the drug for treatment of RA is anticipated to augment segment progress.
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Based on mode, the methotrexate market is segmented into in-house manufacturing and contract manufacturing. In-house manufacturing segment held the majority market share and is projected to grow at 4.8% CAGR from 2023 to 2032. Methotrexate is a highly potent drug used in the treatment of serious medical conditions, including cancer and autoimmune diseases. Quality control is of utmost importance to ensure the safety and efficacy of the product. Maintaining strict control over the manufacturing process in-house allows for more direct oversight of quality standards, minimizing the risk of product variability or contamination.
Moreover, large pharmaceutical companies often opt for in-house API production to maintain supply chain control, ensuring reliable, high-quality, and compliant access to critical raw materials while protecting intellectual property and enabling customization. Moreover, these companies focus over extensive research and development activities from preclinical trials to late-stage development which help them to develop more refine and efficient API’s. This approach enhances cost-efficiency, supports R&D endeavours, and mitigates external supply chain risks.
Based on synthesis type, the methotrexate market is segmented into chemical-based API, HPAPI. Chemical based API held a dominant market share in 2022 and is anticipated to reach USD 735.4 million by 2032. This high segmental share is owing to the rising demand and increasing awareness related to the extensive advantages delivered by the chemical based active pharmaceutical ingredients in drug development. These active pharmaceutical ingredients have a direct effect on the mitigation, diagnosis, and prevention of disease.
Moreover, chemical based API can be used in the qualitative and quantitative analysis including physicochemical factors such as light, temperatures, enzymes, or a particular solution pH. The quantity and strength of an API in a particular drug are often determined by chemical-based API manufacturers using pre-established guidelines. Moreover, favourable government regulations are encouraging drug manufacturers to obtain pharmaceutical raw materials at a lower cost.
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U.S. methotrexate market accounted for USD 165.3 million revenue size in 2022 and is predicted to witness substantial market growth over the analysis timeline. This high revenue growth is mainly attributed to the significant healthcare expenditure, supportive government initiatives, high number of pharmaceutical companies, rising disease awareness, etc. Favourable laws and policies implemented in the region by regulatory authorities would further aid the companies operating in the market.
Also, increasing prevalence of cancer in the U.S. is set to increase the demand for highly potent medications and drugs comprising of methotrexate. Further, product development by major market players and increased healthcare expenditure is anticipated to augment the market growth in North America.