KRAZATI Market Summary

Key Factors Driving KRAZATI Growth

1. Expansion into KRAS G12C-mutated colorectal cancer is the biggest incremental growth driver: In June 2024, the FDA granted accelerated approval to KRAZATI + cetuximab for adults with KRAS G12C-mutated locally advanced/metastatic CRC previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. In the KRYSTAL-1 study, the combination produced a 34% objective response rate, 85.1% disease-control rate, median PFS of 6.9 months, and median OS of 15.9 months. This expanded KRAZATI from a lung-cancer product into another KRAS G12C-positive tumor type.

2. Strong activity in heavily pretreated KRAS G12C-positive NSCLC supports the established franchise: In the pivotal KRYSTAL-1 NSCLC study, adagrasib achieved a 42.9% objective response rate, median duration of response of 8.5 months, median PFS of 6.5 months, and median OS of 12.6 months in patients who had already received prior systemic therapies. This provides an established clinical foundation for continued use in second-line KRAS G12C-mutated NSCLC.

3. CNS penetration and intracranial activity provide an important differentiator: KRAZATI has demonstrated activity against CNS disease, which is clinically relevant because brain metastases are common in advanced NSCLC. In a prospective KRYSTAL-1 analysis of patients with untreated CNS metastases, adagrasib achieved an intracranial ORR of 42%, intracranial disease-control rate of 90%, median intracranial/PFS of 5.4 months, and median OS of 11.4 months. The study described this as the first prospective demonstration of intracranial activity for a KRAS G12C inhibitor in this setting.

4. Combination strategies can broaden the addressable population: KRAZATI's development strategy is not limited to monotherapy. In CRC, combining adagrasib with cetuximab substantially improved activity versus adagrasib alone in early KRYSTAL-1 analyses—the combination produced a 46% response rate versus 19% with monotherapy and median PFS of 6.9 versus 5.6 months. BMS is also pursuing adagrasib-based combinations and earlier-line strategies in NSCLC, which could materially increase the number of patients eligible for treatment if successful.

5. Rapid growth in US demand is already translating into higher sales: BMS reported that KRAZATI US revenue increased 116% year over year in Q1 2025, 82% year-to-date in Q2 2025, and 70% year-to-date in Q3 2025, with the increases primarily attributed to higher demand. For full-year 2025, worldwide KRAZATI revenue reached $205 million, up approximately 62% from 2024. This demonstrates that the product was still in an expansion phase after BMS acquired Mirati and its commercial rights in January 2024.

KRAZATI Recent Developments

In 2026, the confirmatory KRYSTAL-10 trial did not demonstrate the expected PFS advantage for adagrasib + cetuximab versus chemotherapy, with reported median PFS of 7.5 months versus 8.1 months for chemotherapy. This creates a risk to the durability of the accelerated CRC approval and limits how aggressively CRC should be treated as a future growth driver. BMS has said it continues to evaluate the broader opportunity, particularly in lung cancer.

“KRAZATI Sales Forecast, and Market Size Analysis – 2034” report provides comprehensive insights of KRAZATI for approved indication like Colorectal cancer and Non-small cell lung cancer; as well as potential indication like Solid tumours and Bladder cancer in the 7MM. A detailed picture of KRAZATI’s existing usage in approved and anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 –2034 is provided in this report along with a detailed description of the KRAZATI for approved and potential indications. The KRAZATI market report provides insights about KRAZATI’s sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current KRAZATI performance, future market assessments inclusive of the KRAZATI market forecast analysis for approved and potential indications in the 7MM, SWOT, analysts’ views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of KRAZATI sales forecasts, along with factors driving its market.

KRAZATI Drug Summary

KRAZATI (Adagrasib) is an orally administered, small-molecule, covalent inhibitor of KRAS G12C developed by Mirati Therapeutics, now a Bristol Myers Squibb company, for the treatment of cancers driven by the KRAS G12C mutation. The drug selectively binds to the mutant KRAS G12C protein and locks it in an inactive state, thereby suppressing downstream signaling pathways that promote tumor-cell proliferation and survival. KRAZATI is approved as a single agent for adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy, and in combination with cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC) who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. The recommended dose is 600 mg orally twice daily, with tablets taken with or without food until disease progression or unacceptable toxicity. Common adverse reactions include nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, hepatotoxicity, and edema, while important warnings include gastrointestinal toxicity, QTc interval prolongation, hepatotoxicity, and interstitial lung disease/pneumonitis. The report provides KRAZATI’s sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the KRAZATI Market Report

The report provides insights into:

• A comprehensive product overview including the KRAZATI MoA, description, dosage and administration, research and development activities in approved indications like Colorectal cancer and Non-small cell lung cancer; as well as potential indication like Solid tumours and Bladder cancer.
• Elaborated details on KRAZATI regulatory milestones and other development activities have been provided in KRAZATI market report.
• The report also highlights KRAZATI‘s cost estimates and regional variations, reported and estimated sales performance, research and development activities in approved and potential indications across the United States, Europe, and Japan.
• The KRAZATI market report also covers the patents information, generic entry and impact on cost cut.
• The KRAZATI market report contains current and forecasted KRAZATI sales for approved and potential indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The KRAZATI market report also features the SWOT analysis with analyst views for KRAZATI in approved and potential indications.

Methodology

The KRAZATI market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight’s team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

KRAZATI Analytical Perspective by DelveInsight

• In-depth KRAZATI Market Assessment

This KRAZATI sales market forecast report provides a detailed market assessment of KRAZATI for approved indication like Colorectal cancer and Non-small cell lung cancer; as well as potential indication like Solid tumours and Bladder cancer in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted KRAZATI sales data uptil 2034.

• KRAZATI Clinical Assessment

The KRAZATI market report provides the clinical trials information of KRAZATI for approved and potential indications covering trial interventions, trial conditions, trial status, start and completion dates.

KRAZATI Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

KRAZATI Market Potential & Revenue Forecast

• Projected market size for the KRAZATI and its key indications
• Estimated KRAZATI sales potential (KRAZATI peak sales forecasts)
• KRAZATI Pricing strategies and reimbursement landscape

KRAZATI Competitive Intelligence

• Number of competing drugs in development (pipeline analysis)
• KRAZATI Market positioning compared to existing treatments
• KRAZATI Strengths & weaknesses relative to competitors

KRAZATI Regulatory & Commercial Milestones

• KRAZATI Key regulatory approvals & expected launch timelines
• Commercial partnerships, licensing deals, and M&A activity

KRAZATI Clinical Differentiation

• KRAZATI Efficacy & safety advantages over existing drugs
• KRAZATI Unique selling points

KRAZATI Market Report Highlights

• In the coming years, the KRAZATI market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
• The KRAZATI companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence KRAZATI’s dominance.
• Other emerging products for Colorectal cancer and Non-small cell lung cancer; as well as potential indication like Solid tumours and Bladder cancer are expected to give tough market competition to KRAZATI and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of KRAZATI in approved and potential indications.
• Analyse KRAZATI cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted KRAZATI sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of KRAZATI in approved and potential indications.

Key Questions

• What is the class of therapy, route of administration and mechanism of action of KRAZATI? How strong is KRAZATI’s clinical and commercial performance?
• What is KRAZATI’s clinical trial status in each individual indications such as Colorectal cancer and Non-small cell lung cancer; as well as potential indication like Solid tumours and Bladder cancer and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the KRAZATI Manufacturers?
• What are the key designations that have been granted to KRAZATI for approved and potential indications? How are they going to impact KRAZATI’s penetration in various geographies?
• What is the current and forecasted KRAZATI market scenario for approved and potential indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of KRAZATI in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
• What are the other emerging products available and how are these giving competition to KRAZATI for approved and potential indications?
• Which are the late-stage emerging therapies under development for the treatment of approved and potential indications?
• How cost-effective is KRAZATI? What is the duration of therapy and what are the geographical variations in cost per patient?