Sotorasib API Market

Sotorasib market is experiencing a CAGR of 7.2% during the forecast period, The growth of the market is primarily fueled by rising cases of non-small cell lung cancer (NSCLC) associated with KRAS G12C mutations, for which Sotorasib (marketed as Lumakras) is the first targeted therapy approved by the U.S. FDA. The growing demand for precision oncology treatments and rising investments in targeted therapies are propelling API demand globally.

Among market segments, synthetic APIs dominate due to the complex chemical synthesis involved in Sotorasib production. While biotechnological methods are under exploration, they are still in nascent stages. In terms of end-users, pharmaceutical companies hold the largest market share, followed by Contract Manufacturing Organizations (CMOs) that support production scalability and regulatory compliance. The demand from research institutions is also rising, driven by ongoing clinical trials and interest in KRAS inhibitors beyond lung cancer.

North America is the leading region in the Sotorasib API market, supported by early regulatory approvals, strong oncology R&D infrastructure, and established pharmaceutical players. Asia-Pacific, particularly India and China, is expected to witness the fastest growth due to expanding API manufacturing capabilities, cost-efficient production, and supportive government initiatives. Europe remains a key region, benefitting from EMA approvals and a growing focus on cancer treatment innovation.

Key players shaping the competitive landscape include Amgen Inc. (the original developer of Sotorasib), along with API manufacturers and CMOs such as Dr. Reddy’s Laboratories, Laurus Labs, Sai Life Sciences, Hetero Labs, and Teva API. These companies are investing in API development, process optimization, and global distribution networks to capitalize on the rising demand for targeted cancer therapies.