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1496174

KRAS抑制劑的全球市場：臨床試驗的未來展望（2030年）

Global KRAS Inhibitors Market & Clinical Trials Future Outlook 2030

出版日期: 2024年06月01日 | 出版商:

KuicK Research | 英文 250 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄圖表

癌症疾病的盛行率逐年變化，廣泛需要複雜的治療方法。在這方面，再加上對全球 KRAS 抑制劑產業空間的預測，該市場已成為醫療和生物技術領域股東和研究人員的新旗艦。目前，由於該地區藥品銷售強勁、美國政府對 KRAS 抑制劑的批准不斷增加以及各種資助機構的存在，該細分市場由美國主導，而中國等其他國家地區也是一個重要的市場。臨床研究證明了新興領域。由於 KRAS 抑制劑領域圍繞著開創性的進步和發展，預計在不久的將來 KRAS 抑制劑領域將受到業界的高度重視，並有相當大的發展機會。

迄今為止，在研發的顯著成長、商業領域的臨床成功以及這種創新療法的變革潛力的推動下，全球 KRAS 抑制劑產業經歷了巨大的成長。批准Amgen公司於2021年5月開發的第一個KRAS抑制劑Lumakras（sotorasib），以及隨後由Bristol Myers Squibb全資子公司Mirati Therapeutics開發的RAS GTPase家族抑制劑Krazati（adagrasib）是第二個KRAS抑制劑上市，代表了癌症治療領域的突破。

很明顯，由於多種市場動態，KRAS 抑制劑的商業市場近年來一直在蓬勃發展。臨床前和臨床試驗的增加、利害關係人的參與、技術進步以及醫療保健成本的上升等方面正在推動 KRAS 抑制劑市場的成長。例如，浙江省腫瘤醫院與蘇州Genhouse Bio合作，評估GH21和D-1553聯合治療攜帶KRAS G12C突變的晚期或轉移性實體瘤患者的安全性、耐受性和藥物動力學，計劃開始多中心、 2024 年 7 月進行開放標籤 Ib/II 期研究以評估療效。

本報告調查了全球 KRAS 抑制劑市場，並提供了市場概況，包括藥物趨勢、臨床試驗趨勢、區域趨勢以及進入市場的公司競爭格局。

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

簡介目錄圖表

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.

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

簡介目錄圖表

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