Report Highlights
- Global KRAS Inhibitors Market Opportunity > USD 4 Billion By 2029
- Global KRAS Drug Market Growth In 2022 > 200%
- Number Of Approved Drugs: 2 Drugs
- Approved Drug Global & Regional Sales Insight
- Approved Drugs Patent, Price & Dosage Analysis
- Regional Analysis: USA, UK, China Europe, Japan, South Korea
- Number Of Drugs In Clinical Trials: > 60 Drugs
- Insight On All Drugs In Clinical Trials By Phase, Company, Country, Indication & Patient Segment
The advancement in the field of biology has led to the discovery of several oncogenes that play a critical role in cancer development and thus presenting researchers with opportunities to target them. KRAS is one such oncogene that is the most frequently mutated and therefore, specific research and clinical activities are being carried out for the possible development of novel KRAS inhibitors. The future pipeline of this target looks flourishing as several pharmaceutical companies also plan on bringing novel drug candidates against KRAS.
Researchers worldwide have known about KRAS mutations for several years; however, the available therapies against it were proven to be indefinable. But after the approval of first-ever KRAS inhibitor, Lumakras (Sotorasib) developed by Amgen in 2021 for the treatment of patients with advanced KRAS G12C mutated non-small cell lung cancer, the product market showed significant growth in terms of both commercial sale success and enhanced overall survival rates. Its sales grew more than twice in 2022 as compared to 2021 levels. The drug is the first ever targeted anti-cancer treatment drug against KRAS mutations.
Furthermore, Qiagen also launched Therascreen KRAS RGQ PCR Kit after it received US regulatory approval as a companion diagnostic in aiding the diagnosis of non-small cell lung cancer. This was the first companion diagnostic kit to have received premarket approval from the US FDA. Nevertheless, additional progress has been made in the industry and FDA has further approved companion diagnosis kits. In December 2022 Agilent Resolution’s ctDx FIRST was granted approval by the FDA as a companion diagnostic for patients with NSCLC.
The ever-increasing cases of cancer and the ability of the tumor to develop new and frequent mutations signify an unmet need for advancement of novel therapies in the management and treatment of cancer. However, with discoveries like that of Kristen rat sarcoma viral oncogene homolog (KRAS), the future of cancer-targeted therapies is something to look forward to. It is both interesting and concerning how KRAS mutations play a significant role in the pathogenesis and proliferation of cancer.
With booming research and development strategies, pharmaceutical companies are rapidly moving forward and aiming for this oncogene. Recently, VITRAC Therapeutic has initiated a phase I clinical trial with AURKA Inhibitor VIC-1911 and Sotorasib a G12C inhibitor for the treatment of KRAS G12C-mutant non-small cell lung cancer (NSCLC). This study of VIC-1911 as monotherapy and in combination with Sotorasib is being performed at Yale Cancer Centre. The preclinical studies have strongly supported the combinational use of both drugs. By using this multi-targeted approach, the study aims to provide a more effective therapeutic outcome for patients with KRAS G12C-mutated NSCLC.
The market for KRAS-targeted drugs is poised with exponential growth with several factors determining its potential. The KRAS market is widely supported by the accelerating trend of preclinical and in vitro studies which has increased the number of patients that are seeking out treatment opportunities. The rising demand for this therapy has resulted in increasing acceptance of cancer management treatments. The market expects new medications to swiftly and rapidly enter the commercial sector.
There are also factors that will be challenging the future potential of this market. With increased research and development activity, there also increases in the number of competitors in the market. Drug manufacturers need to develop medications that have innovation and creativity and the ability to show better outcomes than its opponents. Currently, Amgen is in the lead for KRAS targeted therapy market but with the incoming of more drugs in the future, some challenges are bound to be faced by the company if it wants to keep its position as the topmost stakeholder in the KRAS inhibitors drug market.
For instance, on December 2022, the US FDA granted accelerated approval to Mirati Therapeutics’ Adagrasib (Krazati) which is a RAS GTPase family inhibitor for adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer who have received at least one prior systemic therapy. This approval was based on KRYSTAL-1, a multicenter, open-label clinical trial and the indication was approved under accelerated approval based on the overall response rate and duration of response.
This report aims to provide an in-depth analysis of the current market scenario of KRAS-targeted therapies and the future potential this segment holds. Overall, as per the analysis, the market for KRAS inhibitors will see exponential growth mainly attributed to the robust research and development activities in this domain as well as the presence of a strong clinical pipeline of drug candidates. The report sheds light on the factors that will propel the market's growth as well as factors that will be challenging the market opportunity.
Table of Contents
1. Introduction to KRAS Inhibitors
1.1 Development of KRAS Inhibitors
1.2 Mechanism Of Action
2. Role of KRAS Inhibitors in Cancer Therapy
2.1 Lung Cancer
2.2 Pancreatic Cancer
2.3 Colorectal Cancer
2.4 Other Cancers
3. Lumakras - First Approved KRAS Inhibitor
3.1 Overview & Patent Insight
3.2 Dosage & Price Analysis
3.3 Sales Analysis
4. Krazati - Second Approved KRAS Inhibitor
4.1 Overview & Patent Insight
4.2 Dosage & Price Analysis
5. Global KRAS Inhibitor Market Outlook
5.1 Current Market Scenario
5.2 Future Market Opportunity
6. KRAS Inhibitor Market Regional Analysis
6.1 US
6.2 UK
6.3 China
6.4 Europe
6.5 Japan
6.6 South Korea
6.7 Canada
7. Global KRAS Inhibitors Clinical Pipeline Overview
7.1 By Country
7.2 By Phase
7.3 By Company
7.4 By Indication
7.5 By Patient Segment
8. Global KRAS Inhibitors Clinical Pipeline By Company, Indication & Phase
8.1 Research
8.2 Preclinical
8.3 Phase-I
8.4 Phase-I/II
8.5 Phase-II
8.6 Phase-III
9. Marketed KRAS Inhibitors Clinical Insight
9.1 Sotorasib - Amgen
9.2 Adagrasib - Mirati Therapeutics
10. Global KRAS Inhibitors Market Dynamics
10.1 Market Drivers & Opportunities for KRAS Inhibitors
10.2 Challenges for KRAS Inhibitors Market
11. Competitive Landscape
11.1 Array BioPharma
11.2 Applied Pharmaceutical Science
11.3 Amgen
11.4 AnBogen Therapeutics
11.5 Ascentage Pharma
11.6 AstraZeneca
11.7 BridgeBio Pharma
11.8 Boehringer Ingelheim
11.9 Erasca
11.10 Carmot Therapeutics
11.11 FogPharma
11.12 Frontier Medicines
11.13 Jacobio Pharmaceuticals
11.14 Jemincare
11.15 Jiangsu Hansoh Pharmaceutical
11.16 Jiangsu Hengrui Medicine Co.
11.17 Leidos Biomedical Research
11.18 Mirati Therapeutics
11.19 REVOLUTION Medicines
11.20 Roche
11.21 Shanghai Euregen Biopharma
11.22 Shanghai Yingli Pharmaceutical
11.23 Singh Biotechnology
11.24 Suzhou Genhouse Bio
11.25 Suzhou Zelgen Biopharmaceuticals
List of Figures
Figure 1-1: RAS Mutation - Frequency of KRAS Mutation v/s HRAS & NRAS Mutations
Figure 1-2: Historical Development of KRAS Inhibitors
Figure 1-3: General Mechanism of KRAS Inhibitors against Cancer
Figure 1-4: Targeting Approaches of KRAS Inhibitors
Figure 1-5: Direct Targeting of Mutant KRAS
Figure 1-6: Targets for Modifying the KRAS Membrane Association
Figure 2-1: KRAS Mutational Frequency by Organs (%)
Figure 2-2: Roles of KRAS Inhibitors in Cancer Treatment
Figure 2-3: Global - Estimated Newly Diagnosed Lung Cancer Cases & Deaths (Millions), 2020
Figure 2-4: Global - Lung Cancer Incidence by Type (%), 2020
Figure 2-5: Impact of KRAS Inhibitor on Lung Cancer
Figure 2-6: Investigational KRAS Inhibitors for Lung Cancer
Figure 2-7: RMC-6291 Phase I Trial - Study Initiation & Expected Completion Year
Figure 2-8: Revolution Medicines - KRAS inhibitors & Status
Figure 2-9: JAB-21822 Phase I/II Monotherapy Trial - Study Initiation & Expected Completion Year
Figure 2-10: JAB-21822 Phase I/II Monotherapy & Combination Therapy Trial - Study Initiation & Expected Completion Year
Figure 2-11: JAB-21822 Phase I/II Combination Therapy Trial - Study Initiation & Expected Completion Year
Figure 2-12: JAB-21822 Phase I/II Co Mutation Trial - Study Initiation & Expected Completion Year
Figure 2-13: Global - Estimated Newly Diagnosed Pancreatic Cancer Cases & Deaths, 2020
Figure 2-14: Ideal Targets of Inhibiting KRAS Mutation of Pancreatic Cancer
Figure 2-15: Role of KRAS Inhibitors in Pancreatic Cancer
Figure 2-16: Investigational KRAS Inhibitors for Pancreatic Cancer
Figure 2-17: siG12D LODER Phase II Trial - Study Initiation & Expected Completion Year
Figure 2-18: iExosomes Phase I Trial - Study Initiation & Expected Completion Year
Figure 2-19: HBI-2438 Phase I Trials - Study Initiation & Expected Completion Year
Figure 2-20: KRAS mTCR PBL Phase I/II Trials - Study Initiation & Expected Completion Year
Figure 2-21: Global - Estimated Newly Diagnosed Colorectal Cancer Cases & Deaths (Millions), 2020
Figure 2-22: Global - New Colorectal Cancer Incidences By Type (%), 2020
Figure 2-23: Ideal Targets for Inhibiting KRAS Mutation of Pancreatic Cancer
Figure 2-24: Investigational KRAS Inhibitors for Colorectal Cancer
Figure 2-25: KRAS mTCR PBL Phase I/II Trials - Study Initiation & Expected Completion Year
Figure 2-26: IBI351 Phase Ib Trial - Study Initiation & Expected Completion Year
Figure 2-27: Global - Estimated Newly Diagnosed Leukemia & Lymphoma Cases & Deaths (Millions), 2020
Figure 2-28: US - Estimated New Hodgkin and Non Hodgkin Lymphoma Cases & Deaths (Millions), 2022
Figure 2-29: Frequency of KRAS Mutation in Hematological Cancer (%)
Figure 2-30: Global - Newly Diagnosed Prostate Cancer Cases & Deaths (Millions), 2020
Figure 2-31: Global - Number of Newly Diagnosed Gastric Cancer Cases & Deaths (Millions), 2020
Figure 2-32: Global - Number of Newly Diagnosed Endometrial Cancer Cases & Deaths (Millions), 2020
Figure 2-33: Global - Gynecological Cancer Incidence By Type, 2020
Figure 2-34: Global - Newly Diagnosed Cases & Deaths related to Brain Cancer (Millions), 2020
Figure 3-1: Lumakras - Approval Year By Region
Figure 3-2: US - Lumakras Patent Filing & Expiration Year
Figure 3-3: US - Lumakras FDA Approval & Patent Exclusivity Year
Figure 3-4: US - Number Of Physicians Prescribing Lumakras Annually, 2021 & 2022
Figure 3-5: US - Number Of Patients Getting Prescribed Lumakras Annually, 2021 & 2022
Figure 3-6: US - Number Of Physicians Prescribing Lumakras Annually Quarterly, 2022
Figure 3-7: US - Number Of Patients Getting Prescribed Lumakras Quarterly, 2022
Figure 3-8: US - Price for 240 Tablet Lumakras Supply & Price Per Unit of 120mg Tablet (US$), February’2023
Figure 3-9: UK - Price for 240 Tablet Lumakras Supply & Price Per Unit of 120mg Tablet (GBP/US$), February’2023
Figure 3-10: US - Monthly & Annual Treatment Cost with Lumakras (US$), February’2023
Figure 3-11: Lumakras - Recommended Initial & Reduced Dose (mg/day)
Figure 3-12: Global - Lumakras/Lumykras Annual Sales (US$ Million), 2021-2022
Figure 3-13: Global - Lumakras/Lumykras Sales by Region (US$ Million), 2022
Figure 3-14: Global - Lumakras/Lumykras Annual Sales by Region (%), 2022
Figure 3-15: Global - Lumakras/Lumykras Quarterly Sales (US$ Million), 2022
Figure 3-16: US - Lumakras/Lumykras Annual Sales (US$ Million), 2021 - 2022
Figure 3-17: US - Lumakras/Lumykras Quarterly Sales (US$ Million), 2022
Figure 3-18: ROW - Lumakras/Lumykras Quarterly Sales (US$ Million), 2022
Figure 4-1: US - Adagrasib Patent Filing & Publication Year
Figure 4-2: US - WAC Price for 180-Tablet Krazati Supply & Price Per Unit of 200mg Tablet (US$), January’2023
Figure 4-3: Krazati - Recommended Initial & Reduced Dose (mg/day)
Figure 4-4: US - Estimated Monthly & Annual Treatment Cost with Krazati (US$), January’2023
Figure 5-1: Global - Cancer Incidences & Deaths (Million), 2020
Figure 5-2: Global - KRAS Inhibitor Market (US$ Million), 2021 & 2022
Figure 5-3: Global - KRAS Inhibitor Market Size by Region (US$ Million), 2022
Figure 5-4: Global - KRAS Inhibitor Market Size (US$ Million), 2023 - 2029
Figure 6-1: US - Cancer Incidences & Deaths (Million), 2020 & 2025
Figure 6-2: US vs. ROW - KRAS Inhibitor Market Size (US$ Million), 2022
Figure 6-3: US vs. ROW - KRAS Inhibitor Market Size (%), 2022
Figure 6-4: US - KRAS Inhibitor Market Size (US$ Million), 2022 - 2029
Figure 6-5: UK - Cancer Incidences & Deaths, 2020 & 2025
Figure 6-6: UK - KRAS Inhibitor Market Size (US$ Million), 2022 - 2029
Figure 6-7: China - Cancer Incidences & Deaths (Million), 2020 & 2025
Figure 6-8: China - KRAS Inhibitor Market Size (US$ Million), 2022 - 2029
Figure 6-9: Europe - Cancer Incidences & Deaths (Million), 2020 & 2025
Figure 6-10: Europe - KRAS Inhibitor Market Size (US$ Million), 2022 - 2029
Figure 6-11: Japan - Cancer Incidences & Deaths (Million), 2020 & 2025
Figure 6-12: Japan - KRAS Inhibitor Market Size (US$ Million), 2022 - 2029
Figure 6-13: South Korea - Cancer Incidences & Deaths (Million), 2020 & 2025
Figure 6-14: South Korea - KRAS Inhibitor Market Size (US$ Million), 2022 - 2029
Figure 6-15: Canada - Cancer Incidences & Deaths (Million), 2020 & 2025
Figure 6-16: Canada - KRAS Inhibitor Market Size (US$ Million), 2022 - 2029
Figure 7-1: Global - KRAS Protein inhibitors Clinical Trials by Country, 2023 -2029
Figure 7-2: Global - KRAS Protein inhibitors Clinical Trials by Phase, 2023 -2029
Figure 7-3: Global - KRAS Protein inhibitors Clinical Trials by Company, 2023 -2029
Figure 7-4: Global - KRAS Protein inhibitors Clinical Trials by Indication, 2023 -2029
Figure 7-5: Global - KRAS Protein inhibitors Clinical Trials by Patient Segment, 2023 -2029
Figure 10-1: Drivers for KRAS Inhibitor Market
Figure 10-2: Challenges for KRAS Inhibitor Market
Figure 10-3: US - Estimated Monthly Treatment Cost of Lumakras & Krazati v/s Other Cell Signal Targeting Therapeutics
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Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Amgen
- AnBogen Therapeutics
- Applied Pharmaceutical Science
- Array BioPharma
- Ascentage Pharma
- AstraZeneca
- Boehringer Ingelheim
- BridgeBio Pharma
- Carmot Therapeutics
- Erasca
- FogPharma
- Frontier Medicines
- Jacobio Pharmaceuticals
- Jemincare
- Jiangsu Hansoh Pharmaceutical
- Jiangsu Hengrui Medicine Co.
- Leidos Biomedical Research
- Mirati Therapeutics
- REVOLUTION Medicines
- Roche
- Shanghai Euregen Biopharma
- Shanghai Yingli Pharmaceutical
- Singh Biotechnology
- Suzhou Genhouse Bio
- Suzhou Zelgen Biopharmaceuticals
