KRAS阻害剤の世界市場：臨床試験の将来の見通し（2030年）

がん疾患の蔓延は年々変化しており、洗練された治療法が広く求められています。この点で、世界のKRAS阻害剤セクターの領域に関する予測と相まって、市場は、医療およびバイオテクノロジー分野の株主や研究者にとって新しい主力として浮上しています。現在、このセグメントの市場は、この地域の強力な医薬品販売、米国政府によるKRAS阻害剤の承認の増加、およびさまざまな資金提供機関の存在により、米国が支配していますが、中国などの他の地域も、前臨床および臨床研究から明らかなように新興地域です。KRAS阻害剤の領域は進化とともに先駆的な進歩を取り巻いているため、KRAS阻害剤の分野での注目すべき業界の重点が、近い将来、かなりの進歩の機会とともに期待されています。

これまで、KRAS阻害剤の世界的産業は、研究開発の著しい成長、商業部門での臨床的成功、そしてこの革新的な治療法の変革の可能性に後押しされ、驚異的な成長を遂げてきました。2021年5月にAmgenが開発した最初のKRAS阻害剤であるLumakras（ソトラシブ）と、その後Bristol Myers Squibbの完全子会社であるMirati Therapeuticsが開発したRAS GTPaseファミリーの阻害剤であるKrazati（アダグラシブ）の承認は、市販されている2番目のKRAS阻害剤であり、がん治療の分野における画期的な躍進を示しています。

KRAS阻害剤の商業市場が近年、いくつかの市場力学により活況を呈していることは明らかです。前臨床および臨床試験の増加、利害関係者の関与、ヘルスケア費の増加と相まって技術の進歩などの側面が、KRAS阻害剤の市場成長を後押ししています。たとえば、浙江がん病院は蘇州ジェンハウスバイオと共同で、KRAS G12C変異を有する進行性または転移性固形腫瘍の患者を対象に、GH21とD-1553の併用の安全性、忍容性、薬物動態、有効性を評価するために、2024年7月に多施設、非盲検、第Ib/II相試験を開始する予定です。

当レポートは、世界のKRAS阻害剤市場について調査し、市場の概要とともに、薬剤動向、臨床試験動向、地域別動向、および市場に参入する企業の競合情勢などを提供しています。

目次

第1章 KRAS阻害剤のイントロダクション

第2章 ルマクラス- 初めて承認されたKRAS阻害剤

第3章 クラザティ-2番目に承認されたKRAS阻害剤

第4章 世界のKRAS阻害剤市場の見通し

第5章 KRAS阻害剤市場の地域分析：商業および臨床開発の見通し

• 米国
• 英国
• 中国
• 欧州
• 日本
• 韓国
• カナダ
• 台湾
• オーストラリア

第6章 KRAS阻害剤市場：臨床試験と近代化の洞察、適応症別

• 肺がん
• 大腸がん
• 膵臓がん
• その他

第7章 世界のKRAS阻害剤の臨床パイプラインの概要

• 国別
• 相別
• 企業別
• 適応症別
• 患者セグメント別

第8章 世界のKRAS阻害剤の臨床試験の洞察：国、企業、適応症、相別

• 研究
• 前臨床
• 第I相
• 第I/II相
• 第II相
• 第II/III相
• 第III相
• 事前登録

第9章 市販されているKRAS阻害剤の臨床試験の洞察：国別、企業別、適応症別

第10章 KRAS阻害剤との併用戦略

• 免疫療法
• 腫瘍溶解性ウイルス免疫療法
• 化学療法
• 標的療法

第11章 世界のKRAS阻害剤市場力学

• 市場の促進要因
• 市場の課題

第12章 競合情勢

• Array BioPharma (Pfizer)
• Applied Pharmaceutical Science
• Amgen
• AnBogen Therapeutics
• Ascentage Pharma
• AstraZeneca
• Biond Biologics
• BridgeBio Pharma
• Bristol Myers Squibb
• Boehringer Ingelheim
• Carmot Therapeutics (Roche)
• Eli Lilly
• Erasca
• FogPharma
• Frontier Medicines
• Jacobio Pharmaceuticals
• Jemincare
• Jiangsu Hansoh Pharmaceutical
• Jiangsu Hengrui Medicine Co.
• Loxo Oncology (Eli Lilly)
• Mirati Therapeutics
• Quanta Therapeutics
• REVOLUTION Medicines
• Roche
• Suzhou Genhouse Bio
• Suzhou Zelgen Biopharmaceuticals

List of Tables

Table 2 1: Recommended Lumakras Dosage Modifications for Adverse Reactions

Table 3 1: Recommended Krazati Dosage Modifications for Adverse Reactions

Table 4 1 KRAS inhibitors Granted Designations

• Table 5-1: UK - Ongoing Clinical Trials for KRAS Inhibitors
• Table 5-2: China - Some KRAS inhibitors in Ongoing Clinical trials
• Table 5-3: Japan -Ongoing Clinical Trials for KRAS inhibitor as Monotherapy
• Table 5-4: Japan -Ongoing Clinical Trials for KRAS inhibitor as Combination Therapies
• Table 5-5: South Korea - Ongoing Clinical Trials for KRAS Inhibitors
• Table 5-6: Canada - Ongoing Clinical Trials for KRAS Inhibitors
• Table 5-7: Taiwan - Ongoing Clinical Trials for KRAS Inhibitors
• Table 5-8: Australia - Ongoing Clinical Trials for KRAS Inhibitors
• Table 6-1: Colorectal Cancer - KRAS Inhibitors in Clinical Trials
• Table 6-2: Colorectal Cancer - KRAS Inhibitors with Regulatory Designations
• Table 6-3: Pancreatic Cancer - KRAS Inhibitors in Clinical Trials
• Table 6-4: Pancreatic Cancer - KRAS Inhibitors with Regulatory Designations

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 1-7: KRAS Mutational Frequency by Organs (%)
• Figure 1-8: Roles of KRAS Inhibitors in Cancer Treatment
• Figure 2-1: Lumakras - Approval Year By Region
• Figure 2-2: US - Lumakras Patent Expiration Year
• Figure 2-3: Europe - Lumakras Patent Expiration Year
• Figure 2-4: Lumakras - Cost per Tablet & Supply of 120mg (US$), June'2024
• Figure 2-5: Lumakras - Cost per Tablet & Supply of 320mg (US$), June'2024
• Figure 2-6: Lumakras - Cost per Tablet & Supply of 120mg (EUR & US$), June'2024
• Figure 2-7: Lumakras - Recommended Dose Reduction Level for Adverse Reaction
• Figure 2-8: Global - Lumakras/Lumykras Annual Sales (US$ Million), 2021-2024*
• Figure 2-9: Global - Lumakras/Lumykras Quarterly Sales (US$ Million), 2024
• Figure 2-10: Global - Lumakras/Lumykras Sales by Region (US$ Million), 2023
• Figure 2-11: Global - Lumakras/Lumykras Annual Sales by Region (%), 2023
• Figure 2-12: Global - Lumakras/Lumykras Quarterly Sales (US$ Million), 2023
• Figure 2-13: US - Lumakras/Lumykras Quarterly Sales (US$ Million), 2023
• Figure 2-14: ROW - Lumakras/Lumykras Quarterly Sales (US$ Million), 2023
• Figure 3-1: Krazati - Approval Year By Region
• Figure 3-2: Krazati - Cost per Tablet & Supply of 200mg (US$), June'2024
• Figure 3-3: Krazati - Recommended Dosage Reduction for Adverse Reactions
• Figure 3-4: US - Krazati Annual Sales (US$ Million), 2024
• Figure 4-1: Global - KRAS Inhibitors Sales (US$ Million), 2021-2024*
• Figure 4-2: KRAS Inhibitors - Future Market Opportunities
• Figure 4-3: Global - KRAS Inhibitors Sales (US$ Million), 2024-2030
• Figure 5-1: Quanta Therapeutics - KRAS Inhibitors IND Clearance & Submission Status
• Figure 5-2: QTX3034 with Cetuximab Phase I (NCT06227377) Study - Initiation & Completion Year
• Figure 5-3: Krazati with Cetuximab Granted FDA Priority Review & PFUDA Date of June'24
• Figure 5-4: MK-1084 With Pembrolizumab Phase III (NCT06345729) Study - Initiation & Completion Year
• Figure 5-5: Verastem Oncology KRAS Combiantional Study
• Figure 5-6: KRAS Vaccine Combined with Balstilimab & Botensilimab Phase I (NCT06411691) Study - Initiation & Completion Year
• Figure 5-7: BBO-8520 with Pembrolizumab Phase I (NCT06343402) Study - Initiation & Completion Year
• Figure 5-8: INCB161734 Phase I (NCT06179160) Study - Initiation & Completion Year
• Figure 5-9: Avutometinib (VS-6766) in Combination With Sotorasib With or Without Defactinib Phase I/II (NCT05074810) Study - Initiation & Completion Year
• Figure 5-10: Jazz Pharmaceutical & Redx Pharma Collaboration
• Figure 5-11: BI 3706674 Phase I (NCT06056024) Study - Initiation & Completion Year
• Figure 5-12: JDQ443 Phase III (NCT05132075) Study - Initiation & Completion Year
• Figure 5-13: Divarasib (GDC-6036) Phase I/II (NCT05789082) Study - Initiation & Completion Year
• Figure 5-14: Japan - Approved Companion Diagnostic Tests Lumakras
• Figure 5-15: Sotorasib Phase I (NCT05451056) Study - Initiation & Completion Year
• Figure 5-16: Hanmi Group - HM99462
• Figure 5-17: DigmBio & Inno Pharma Screen Collaboration
• Figure 5-18: Canada - Key Universities & Institutes Steering KRAS Clinical Trials
• Figure 5-19: Anbogen Therapeutics - ABT-202 Insights
• Figure 5-20: BBP-398 in Combination With Sotorasib Phase I (NCT05480865) Study - Initiation & Completion Year
• Figure 6-1: D-1553 Phase III (NCT06300177) Study - Initiation & Completion Year
• Figure 6-2: D-1553/Garsorasib - NMPA Prioritized Evaluation & Breakthrough Designations
• Figure 6-3: JAB-21822 with JAB-3312 Phase III (NCT06416410) Study - Initiation & Completion Year
• Figure 6-4: Sotorasib Phase 3 (NCT05198934) Study - Initiation & Completion Year
• Figure 6-5: Sotorasib Phase 3 (NCT06252649) Study - Initiation & Completion Year
• Figure 6-6: Adagrasib Phase 1/2 (NCT03785249) Study - Initiation & Completion Year
• Figure 6-7: Divarasib Phase 1 (NCT04449874) Study - Initiation & Completion Year
• Figure 6-8: Adagrasib Phase 1 (NCT05634525) Study - Initiation & Completion Year
• Figure 6-9: Adagrasib Phase 1 (NCT06130254) Study - Initiation & Completion Year
• Figure 6-10: JAB-21822 Phase 2 (NCT06008288) Study - Initiation & Completion Year
• Figure 6-11: Anti-KRAS G12V mTCR PBL Phase I/II (NCT03190941) Study - Initiation & Completion Year
• Figure 7-1: Global - KRAS Protein inhibitors Clinical Trials by Country, 2024 -2030
• Figure 7-2: Global - KRAS Protein inhibitors Clinical Trials by Phase, 2024 -2030
• Figure 7-3: Global - KRAS Protein inhibitors Clinical Trials by Company, 2024 -2030
• Figure 7-4: Global - KRAS Protein inhibitors Clinical Trials by Indication, 2024 -2030
• Figure 7-5: Global - KRAS Protein inhibitors Clinical Trials by Patient Segment, 2024 -2030
• Figure 10-1: Combination of KRAS inhibitors with Various Immunotherapeutic Modalities
• Figure 10-2: RMC-6236 with Bevacizumab Phase I/II (NCT06445062) Study - Initiation & Completion Year
• Figure 10-3: JDQ443 With Trametinib Phase I/II (NCT05358249) Study - Initiation & Completion Year
• Figure 10-4: D-1553 With GH21 Phase I/II (NCT06435455) Study - Initiation & Completion Year
• Figure 11-1: KRAS Inhibitors Market - Drivers & Opportunities
• Figure 11-2: KRAS Inhibitors Market - Drivers & Opportunities

Global KRAS Inhibitors Market & Clinical Trials Future Outlook 2030 Report Highlights:

• Global KRAS Inhibitors Sales Growth In 2023: 10%
• Global KRAS Inhibitors Market Opportunity: > 600 Million By 2030
• Global KRAS Inhibitor Market Insight By Region & Indications
• Approved KRAS Inhibitors: 2
• KRAS Inhibitors In Clinical Trials > 90 Drugs
• Global KRAS Inhibitor Clinical Trials Insight By Country, Company, Indication & Phase

With the ubiquitous prevalence of cancer ailments oscillating year by year, the sophisticated treatment approaches are vastly sought subsequently. With this respect, the market in conjugation with forecast for the domain of global KRAS inhibitor sector emerges as a newfangled mainstay for shareholders as well as researchers in the medical and biotechnological panorama. Currently, the market for this segment is dominated by the US due to the region's strong drug sales, augmenting approval of KRAS inhibitors by the US government and presence of different funding agencies; however, other region, like China, is also an emerging area as evident from preclinical and clinical studies. As the realm of KRAS inhibitor encircles trailblazing advancements along with evolution; a noteworthy industry emphasis in KRAS inhibitor sphere, with opportunities of considerable progress, is expected in the imminent years.

Hitherto, the global industry of KRAS inhibitor has acknowledged an incredible growth, fueled by the remarkable growth in research and development, clinical triumph in commercial sector in addition to the transformative potential of this innovative treatment modality. The first KRAS inhibitor, Lumakras (sotorasib), developed by Amgen in May 2021, and subsequent approval of inhibitor of the RAS GTPase family, Krazati (adagrasib), developed by Mirati Therapeutics, a wholly owned subsidiary of Bristol Myers Squibb, is second commercially accessible KRAS inhibitor, marking a chronicle breakthrough in the field of cancer care.

It is clearly evident that the commercial market of KRAS inhibitor is witnessing boom in the recent years on the account of several market dynamics. Aspects such as rise in preclinical and clinical trials, involvement of stakeholders, and technological advancement coupled with increase in healthcare expenditure are fueling the market growth of KRAS inhibitors. For instance, Zhejiang Cancer Hospital in collaboration with Suzhou Genhouse Bio plans to begin a multi-center, open-label phase Ib/II study in order to evaluate the safety, tolerability, pharmacokinetics, and efficacy of GH21 combined with D-1553 in patients with advanced or metastatic solid tumors harboring KRAS G12C mutation in July 2024.

The up-to-date global market trend of combination therapies has gained limelight in the recent years in which the notion of using combination of KRAS inhibitors with other therapeutic approaches is experimental. Data from preliminary studies have revealed that amalgamation therapies contain diverse drugs that target different proteins in order to empower the blockade of different pathways at once. Henceforth, many combination studies of KRAS inhibitors with immune checkpoint inhibitors, antibodies, cancer vaccines, chemotherapy, targeted therapies and many more are ongoing in the KRAS inhibitor realm. Such as, a phase 3 trial, CodeBreaK 200, is evaluating sotorasib in combination with chemotherapy (docetaxel or pemetrexed/platinum) in advanced non-small cell lung cancer patients with KRAS G12C mutations is one example, representing novel avenue.

Above and beyond, it is foreseeable that a handful of more KRAS inhibitors are anticipated to be launched in the approaching years as many innovative KRAS inhibitors have received priority designations in the recent years. For instance, in February 2024, FDA has acknowledged priority review the supplemental new drug application (sNDA) for Krazati (adagrasib) in combination with cetuximab for the management of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC) and the FDA allocated a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024.

As a final point, the segment of KRAS inhibitors is vastly promising that clenches plausibility to alter treatment landscape of cancer diseases. Apart from that, KRAS inhibitors can additionally be utilized to treat other diseases, besides cancer, including inflammatory, eye disorders etc. Moreover, the presences of pharma companies, comprising Revolution Medicine, Erasca, Jacobio Pharma Gr Co, Quanta Therapeutics along with giant pharma like Bristol Myers Squibb, AstraZeneca, Roche, Merck, Incyte Corporation, Sanofi, etc. further aid to expand the KRAS inhibitor arena by conducting enormous preclinical and clinical studies. Overall, the future for KRAS inhibitors looks optimistic, offering beacon of anticipation to patients.

Table of Contents

1. Introduction to KRAS Inhibitors

• 1.1 Development of KRAS Inhibitors
• 1.2 Mechanism Of Action
• 1.3 Role of KRAS Inhibitors in Cancer Therapy

2. Lumakras - First Approved KRAS Inhibitor

• 2.1 Overview & Patent Insight
• 2.2 Dosage & Price Analysis
• 2.3 Sales Analysis

3. Krazati - Second Approved KRAS Inhibitor

• 3.1 Overview & Patent Insight
• 3.2 Dosage & Price Analysis
• 3.3 Sales Analysis

4. Global KRAS Inhibitor Market Outlook

• 4.1 Current Market Scenario
• 4.2 KRAS Inhibitors Candidates Granted Breakthrough & Orphan Designations
• 4.3 Future Market Opportunity

5. KRAS Inhibitor Market Regional Analysis: Commercial & Clinical Development Outlook

• 5.1 US
• 5.2 UK
• 5.3 China
• 5.4 Europe
• 5.5 Japan
• 5.6 South Korea
• 5.7 Canada
• 5.8 Taiwan
• 5.9 Australia

6. KRAS Inhibitor Market By Indications: Clinical Trials & Modernization Insights

• 6.1 Lung Cancer
• 6.2 Colorectal Cancer
• 6.3 Pancreatic Cancer
• 6.4 Other Indications

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 Inhibitor Clinical Trials Insight By Country, 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 II/III
• 8.7 Phase III
• 8.8 Preregistration

9. Marketed KRAS Inhibitor Clinical Trials Insight By Country, Company & Indication

10. Combination Strategies with KRAS Inhibitors

• 10.1 Immunotherapy
• 10.2 Oncolytic Virus Immunotherapy
• 10.3 Chemotherapy
• 10.4 Targeted Therapies

11. Global KRAS Inhibitors Market Dynamics

• 11.1 Market Drivers
• 11.2 Market Challenges

12. Competitive Landscape

• 12.1 Array BioPharma (Pfizer)
• 12.2 Applied Pharmaceutical Science
• 12.3 Amgen
• 12.4 AnBogen Therapeutics
• 12.5 Ascentage Pharma
• 12.6 AstraZeneca
• 12.7 Biond Biologics
• 12.8 BridgeBio Pharma
• 12.9 Bristol Myers Squibb
• 12.10 Boehringer Ingelheim
• 12.11 Carmot Therapeutics (Roche)
• 12.12 Eli Lilly
• 12.13 Erasca
• 12.14 FogPharma
• 12.15 Frontier Medicines
• 12.16 Jacobio Pharmaceuticals
• 12.17 Jemincare
• 12.18 Jiangsu Hansoh Pharmaceutical
• 12.19 Jiangsu Hengrui Medicine Co.
• 12.20 Loxo Oncology (Eli Lilly)
• 12.21 Mirati Therapeutics
• 12.22 Quanta Therapeutics
• 12.23 REVOLUTION Medicines
• 12.24 Roche
• 12.25 Suzhou Genhouse Bio
• 12.26 Suzhou Zelgen Biopharmaceuticals