Global KRAS Inhibitors Market & Clinical Trials Forecast 2028

Abstract
Global KRAS Inhibitors Market & Clinical Trials Forecast 2028

Report Highlights:

• KRAS Inhibitors Market Opportunity: > USD 4.5 Billion by 2028
• US To Dominate Global KRAS Inhibitors Market: >50% Market Share
• Number of KRAS Inhibitors In Trials: > 45 Drugs
• Number of Approved Drugs: 1 (Lumakras)
• Lumakras Dosage, Sales, Patent & Price Insight
• Solid Tumors Targeted Drugs Dominating The Clinical Trials
• Global KRAS Inhibitors Market Trends & Dynamics
• Global KRAS Inhibitors Market Future Opportunity Outlook

The advancement in the field of clinical research has led to identification of several oncogenes which are generally mutated in cancers. Kirsten rat sarcoma 2 viral oncogene homolog (KRAS) is the most frequently mutated oncogene in lung carcinomas, accounting for 25% of total incidence, with half of them being KRASG12C mutations. Therefore, suitable research and development activities were carried out by pharmaceutical companies to develop novel KRAS inhibitor. To date, Lumakras developed by Amgen is the only KRAS inhibitor which haven approved for the management of non-small cell lung cancer.

The approval of Lumakras for the treatment of patients with advanced KRAS G12C mutated non-small cell lung cancer marks a milestone for cancer therapy. Apart from small molecule inhibitor approach, researchers are also utilizing several other novel mechanisms to directly target KRAS including vaccines, adoptive T cell therapy, PROTACs, and CRISPR/Cas9 are emerging. Amid these approaches, a few KRAS vaccines have entered initial phase of clinical trials. ELI-002 developed by Elicio Therapeutics is a structurally novel AMP vaccine targeting KRAS driven cancers. The company is currently enrolling patients in AMPLIFY-201, phase-I/II clinical trial of ELI-002 in patients with solid tumors, including colorectal cancer and pancreatic ductal adenocarcinoma.

Since the entry of Lumakras in the market, the drug has shown high adoption rates in the market with global sales of about US$ 90 Million in 2021. The encouraging response of the novel drug has propelled the further research and development activities in this segment. The pipeline of KRAS inhibitor is highly crowded and consists of several potential candidates including Adagrasib, JQ443, GDC-6036, BI 1823911, JNJ-74699157, MK-1084, and others. Among them, Adagrasib is one of the most advanced KRAS inhibitor in phase-III clinical trial while the others are mainly present in phase-I/II clinical trial.

Although KRAS G12C inhibitors offer an important new therapeutic option for a subset of patients with cancers, clinical trial experience suggests that fewer than half of patients respond and responses can be short-lived. To mitigate these challenges, ongoing clinical trials of KRAS inhibitors are largely focused on the evaluating novel rational combinations based on positive preclinical results. For instance, Bridge Bio Pharma in collaboration with Amgen is evaluating the combination of BBP-398, SHP2 inhibitor in combination with Lumakras in patients with advanced solid tumors with the KRAS G12C mutations. In addition to this, Mirati Therapeutics also announced a non-exclusive clinical collaboration agreement with Sanofi to evaluate the combination of adagrasib with Sanofi’s investigational SHP2 inhibitor SAR442720 (RMC-4630).

With advances in precision medicine, there is unmet need for biomarker testing as it informs the treatment options during the course of disease. For KRAS mutations, Qiagen in 2021 announced the launch of an expanded scope of companion diagnostic (CDx) claims for the therascreen KRAS RCQ PCR kit (therascreen KRAS Kit) after it received US regulatory approval as a companion diagnostic to aid in the identification of non-small cell lung cancer (NSCLC) patients that may be eligible for treatment with Lumakras. The company has collaborated with Labcorp to market the diagnostic test in US.

As per report findings, it is estimated that global KRAS inhibitor market will surpass US$ 4.5 Billion by 2028 driven by growing demand of targeted therapies and high acceptance in cancer management. The report offers comprehensive insights of the pipeline therapeutics scenario and growth prospects across KRAS Inhibitor development. The report provides detailed coverage of the pipeline landscape for this mechanism of action, commercial information of already available KRAS inhibitor, and sales forecast till 2028. The report also provides regional analysis of the KRAS inhibitor market in US, Europe, China, Japan, Canada, Brazil, and other promising region.

Content
Table of Contents

1. Introduction to KRAS Inhibitors
1.1 Overview
1.2 Evolution of KRAS Inhibitors

2. KRAS Inhibitors - Mode of Action

3. Role of KRAS Inhibitors in Cancer Therapy

4. KRAS Inhibitors For Targeting Lung Cancer
4.1 Impact of KRAS Inhibitors on Lung Cancer
4.2 Ongoing Research & Development

5. KRAS Inhibitors in Pancreatic Cancer
5.1 Role of KRAS Inhibitors in Pancreatic Cancer
5.2 Recent Advancement in Pancreatic Cancer Targeting KRAS Inhibitors

6. KRAS Inhibitors for Colorectal Cancer
6.1 Potential of KRAS Inhibitors Against Colorectal Cancer
6.2 Ongoing Research & Development

7. KRAS inhibitors For Other Cancers
7.1 Potential of KRAS Inhibitors as Hematological Cancer Therapeutics
7.2 KRAS inhibitors in Prostate Cancer
7.3 KRAS Inhibitors for Gastric Cancer
7.4 KRAS Inhibition in Endometrium Cancer
7.5 Role of KRAS Inhibitors in Brain Cancer

8. Lumakras – 1st Approved KRAS Inhibitor
8.1 Overview & Patent Insight
8.2 Dosage & Price Analysis
8.3 Sales Analysis & Forecast Till 2028

9. Global KRAS Inhibitor Market Overview
9.1 Current Market Scenario
9.2 Future Market Opportunity

10. KRAS Inhibitor Market Regional Analysis - Based On Drug Approval
10.1 US
10.2 UK
10.3 China
10.4 Europe
10.5 Japan
10.6 South Korea
10.7 Canada

11. Global KRAS Inhibitors Clinical Trials Indicators
11.1 By Country
11.2 By Phase
11.3 By Company
11.4 By Indication
11.5 By Patient Segment

12. Global KRAS Inhibitors Clinical Pipeline By Company, Indication & Phase
12.1 Research
12.2 Preclinical
12.3 Phase-I
12.4 Phase-I/II
12.5 Phase-III
12.6 Preregistration

13. Marketed KRAS Inhibitors Clinical Insight

14. Global KRAS Inhibitors Market Dynamics
14.1 Driving Factors for KRAS Inhibitor Market
14.2 Challenges for KRAS Inhibitors Market

15. Competitive Landscape
15.1 Amgen
15.2 Mirati Therapeutics
15.3 Revolution Medicines
15.4 Boehringer Ingelheim
15.5 Merck
15.6 Moderna
15.7 Silenseed Ltd
15.8 Johnson & Johnson
15.9 Eli Lilly
15.10 Oblique Therapeutics
15.11 Cotinga Pharmaceuticals
15.12 Codiak Biosciences
15.13 Gilead

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 2-1: General Mechanism of KRAS Inhibitors against Cancer
Figure 2-2: Targeting Approaches of KRAS Inhibitors
Figure 2-3: Direct Targeting of Mutant KRAS
Figure 2-4: Targets for Modifying the KRAS Membrane Association

Figure 3-1: KRAS Mutational Frequency by Organs (%)
Figure 3-2: Roles of KRAS Inhibitors in Cancer Treatment

Figure 4-1: Global – Newly Diagnosed Cases & Deaths related to Lung Cancer (Million), 2020
Figure 4-2: Global – Lung Cancer Incidence by Type (%), 2020
Figure 4-3: Impact of KRAS Inhibitor on Lung Cancer
Figure 4-4: Investigational KRAS Inhibitors for Lung Cancer
Figure 4-5: Codebreak 200 Trial – Study Initiation & Expected Completion Year
Figure 4-6: Codebreak 105 Trial – Study Initiation & Expected Completion Year
Figure 4-7: Codebreak 101 Trial – Study Initiation & Expected Completion Year
Figure 4-8: Krystal 7 trial – Study Initiation & Expected Completion Year
Figure 4-9: Krystal 1 trial – Study Initiation & Expected Completion Year
Figure 4-10: Krystal 2 trial – Study Initiation & Expected Completion Year
Figure 4-11: BI-1701963 Phase I Trial – Study Initiation & Expected Completion Year
Figure 4-12: mRNA-5671 Phase I Trial – Study Initiation & Expected Completion Year
Figure 4-13: Mechanism of BI-2852 against Lung Cancer

Figure 5-1: Global – Newly Diagnosed Cases & Deaths related to Pancreatic Cancer, 2020
Figure 5-2: Ideal Targets of Inhibiting KRAS Mutation of Pancreatic Cancer
Figure 5-3: Role of KRAS Inhibitors in Pancreatic Cancer
Figure 5-4: Investigational KRAS Inhibitors for Pancreatic Cancer
Figure 5-5: siG12D LODER Phase II Trial – Study Initiation & Expected Completion Year
Figure 5-6: iExosomes Phase I Trial – Study Initiation & Expected Completion Year
Figure 5-7: KRAS mTCR PBL Phase I/II Trial – Study Initiation & Expected Completion Year

Figure 6-1: Global – Newly Diagnosed Cases & Deaths related to Colon Cancer (Million), 2020
Figure 6-2: Global – Newly Diagnosed Cases & Deaths related to Rectum Cancer (Million), 2020
Figure 6-3: Ideal Targets for Inhibiting KRAS Mutation of Pancreatic Cancer
Figure 6-4: Investigational KRAS Inhibitors for Colorectal Cancer

Figure 7-1: Global – Newly Diagnosed Cases by Leading Types of Blood Cancer, 2020
Figure 7-2: Global – Newly Diagnosed Cases by Leading Types of Blood Cancer, 2020
Figure 7-3: Frequency of KRAS Mutation in Hematological Cancer (%)
Figure 7-4: Global – Newly Diagnosed Cases & Deaths related to Prostate Cancer (Million), 2020
Figure 7-5: Global – Number of Newly Diagnosed Gastric Cancer Cases & Deaths, 2020
Figure 7-6: Global – Number of Newly Diagnosed Cases of Endometrial Cancer by Type, 2020
Figure 7-7: Global – Number of Deaths of Endometrium Cancer by Type, 2020
Figure 7-8: Global – Newly Diagnosed Cases & Deaths related to Brain Cancer, 2020

Figure 8-1: Lumakras – Approval Year by Region
Figure 8-2: US – Lumakras Patent Expiration Year
Figure 8-3: US - Lumakras FDA Approval & Patent Exclusivity Year
Figure 8-4: US - Price for 240 Tablet Lumakras Supply & Price Per Unit of 120mg Tablet (US$), March’2022
Figure 8-5: UK - Price for 240 Tablet Lumakras Supply & Price Per Unit of 120mg Tablet (GBP/US$), March’2022
Figure 8-6: US - Monthly & Annual Treatment Cost with Lumakras (US$), March’2022
Figure 8-7: Lumakras – Recommended Initial & Reduced Dose (mg/day)
Figure 8-8: Global – Lumakras/Lumykras Annual Sales by Region (US$ Million), 2021
Figure 8-9: Global – Lumakras/Lumykras Annual Sales by Region (%), 2021
Figure 8-10: Global – Lumakras/Lumykras Quarterly Sales (US$ Million), Q2-Q4’2021
Figure 8-11: US – Lumakras/Lumykras Quarterly Sales (US$ Million), Q2-Q4’2021
Figure 8-12: ROW – Lumakras/Lumykras Quarterly Sales (US$ Million), Q3 & Q4’2021
Figure 8-13: Global – Lumakras Sales Forecast (US$ Million), 2022 - 2028
Figure 8-14: US – Lumakras Sales Forecast (US$ Million), 2022 - 2028

Figure 9-1: Global – Cancer Incidences & Deaths (Million), 2020
Figure 9-2: KRAS Inhibitor Market Size by Region (US$ Million), 2021
Figure 9-3: KRAS Inhibitor Market Size by Region (%), 2021
Figure 9-4: Global – KRAS Inhibitor Market Size (US$ Million), 2022 - 2028
Figure 9-5: KRAS Inhibitor Market Size by Product (%), 2028

Figure 10-1: US – Cancer Incidences & Deaths (Million), 2020 & 2025
Figure 10-2: US vs. ROW – KRAS Inhibitor Market Size (US$ Million), 2021
Figure 10-3: US vs. ROW – KRAS Inhibitor Market Size (%), 2021
Figure 10-4: US – KRAS Inhibitor Market Size (US$ Million), 2022 - 2028
Figure 10-5: UK – Cancer Incidences & Deaths, 2020 & 2025
Figure 10-6: UK vs. ROW – KRAS Inhibitor Market Size (US$ Million), 2021
Figure 10-7: UK vs. ROW – KRAS Inhibitor Market Size (%), 2021
Figure 10-8: UK – KRAS Inhibitor Market Size (US$ Million), 2022 - 2028
Figure 10-9: China – Cancer Incidences & Deaths (Million), 2020 & 2025
Figure 10-10: China – KRAS Inhibitor Market Size (US$ Million), 2022 - 2028
Figure 10-11: Europe – Cancer Incidences & Deaths (Million), 2020 & 2025
Figure 10-12: Europe – KRAS Inhibitor Market Size (US$ Million), 2022 - 2028
Figure 10-13: Japan – Cancer Incidences & Deaths (Million), 2020 & 2025
Figure 10-14: Japan – KRAS Inhibitor Market Size (US$ Million), 2022 - 2028
Figure 10-15: South Korea – Cancer Incidences & Deaths, 2020 & 2025
Figure 10-16: South Korea – KRAS Inhibitor Market Size (US$ Million), 2022 - 2028
Figure 10-17: Canada – Cancer Incidences & Deaths, 2020 & 2025
Figure 10-18: Canada vs. ROW – KRAS Inhibitor Market Size (US$ Million), 2021
Figure 10-19: Canada vs. ROW – KRAS Inhibitor Market Size (%), 2021
Figure 10-20: Canada – KRAS Inhibitor Market Size (US$ Million), 2022 - 2028

Figure 11-1: Global - KRAS Protein inhibitors Clinical Trials by Country, 2022 -2028
Figure 11-2: Global - KRAS Protein inhibitors Clinical Trials by Phase, 2022 -2028
Figure 11-3: Global - KRAS Protein inhibitors Clinical Trials by Company, 2022 -2028
Figure 11- 4: Global - KRAS Protein inhibitors Clinical Trials by Indication, 2022 -2028
Figure 11-5: Global - KRAS Protein inhibitors Clinical Trials by Patient Segment, 2022 -2028

Figure 14-1: Drivers for KRAS Inhibitor Market
Figure 14-2: Challenges for KRAS Inhibitor Market
Figure 14-3: Global – Estimated Monthly Treatment Cost of AMG 150 v/s Other Cell Signal Targeting Therapeutics