The KRAS inhibitors market is undergoing a transformative phase, fueled by a surge in novel treatments targeting various KRAS mutations across multiple cancer types. According to a new report by DelveInsight, the market, valued at approximately USD 500 million in 2023, is expected to grow substantially by 2034, driven by increasing incidence rates, heightened awareness, and robust pipeline activity in the 7MM (United States, EU4, United Kingdom, and Japan).
Current Market Landscape
The current treatment landscape is dominated by two FDA-approved KRAS G12C inhibitors: LUMAKRAS (sotorasib) by Amgen and KRAZATI (adagrasib) initially developed by Mirati Therapeutics and now owned by Bristol Myers Squibb. LUMAKRAS gained initial approval for advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation, while KRAZATI has expanded its indication to include colorectal cancer in combination with ERBITUX (cetuximab).
KRAZATI vs. LUMAKRAS
Among the approved therapies, KRAZATI is projected to generate higher revenue compared to LUMAKRAS during the study period (2020-2034). This edge is attributed to its recent approval for colorectal cancer, addressing a significant unmet need. "KRAZATI became the first KRAS inhibitor to get the regulatory nod for the treatment of KRAS G12C–mutant locally advanced or metastatic colorectal cancer," the report notes.
Unmet Needs and Market Opportunities
Despite advancements, significant unmet needs persist, particularly in biomarker-specific therapies for pancreatic cancer. KRAS mutations are prevalent in 60-90% of pancreatic cancer patients, with G12D being the most common variant. This gap presents a substantial market opportunity for pharmaceutical companies focusing on Pan-KRAS drugs.
Emerging Therapies
The KRAS inhibitor pipeline is robust, with several promising drugs in development. Key emerging therapies include:
- JDQ443 (Novartis): An oral drug selectively targeting and covalently inhibiting KRASG12C. Phase Ib results showed a 57% overall response rate in advanced NSCLC patients. A Phase III trial is underway comparing JDQ443 to docetaxel in advanced NSCLC patients with KRASG12C mutation.
- Avutometinib (Verastem Oncology): Granted Fast Track Designation by the FDA for treating NSCLC in combination with LUMAKRAS. This designation aims to expedite the development and review of avutometinib for KRAS G12C-mutant metastatic NSCLC patients previously treated with systemic therapy.
Other notable KRAS inhibitors in the pipeline include divarasib (Roche/Genentech), onvansertib (Cardiff Oncology), and MRTX1133 (Mirati Therapeutics), among others.
Impact of Pan-KRAS Inhibitors
Companies developing Pan-KRAS drugs are expected to have tremendous market potential due to the broad target patient population they can address. By targeting multiple KRAS mutations, these drugs have the potential to benefit a wider range of cancer patients, opening up opportunities for improved treatment options and potentially transforming the landscape of cancer care.
Regional Insights
The United States reports the highest number of KRAS mutation cases in NSCLC within the 7MM, accounting for approximately 46% of all cases. Western nations generally have a higher incidence of KRAS mutations compared to Asian nations. Colorectal cancer exhibits the most KRAS mutant cases, followed by pancreatic cancer and NSCLC.
Challenges and Future Directions
The KRAS inhibitor market faces challenges such as high drug development costs, potential side effects, and the need for companion diagnostic tests. The emergence of resistance mechanisms also necessitates the development of next-generation inhibitors. Despite these challenges, the market is poised for growth, driven by ongoing research, technological advancements, and the evolving landscape of cancer treatment.
