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市場調查報告書
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1699607

KRAS抑制劑的全球市場:藥物銷售額，專利，價格，臨床試驗趨勢(2030年)

Global KRAS Inhibitors Market, Drug Sales, Patent, Price & Clinical Trials Insight 2030
出版日期: | 出版商: KuicK Research | 英文 240 Pages | 商品交期: 最快1-2個工作天內

價格

預計到 2030 年，KRAS 抑制劑的全球市場規模將超過 20 億美元。

這主要是因為人們越來越認識到 KRAS 突變是各種實體癌症（包括肺癌、大腸直腸癌和胰腺癌）發展的重要因素。 KRAS 是控制細胞增殖的重要基因，由於其複雜的生物學特性和支持腫瘤存活的功能，歷來被視為具有課題性的治療標靶。儘管如此，隨著分子生物學的進步和標靶治療方法的創造，KRAS 抑制劑已成為一種很有前途的藥物類別。

KRAS 抑制劑市場的一個關鍵事件是 2021 年 Lumaclas 獲準用於治療非小細胞肺癌 (NSCLC)。這項批准標誌著標靶癌症治療的新篇章，針對非小細胞肺癌，Krazati 將於 2022 年獲批，Dupert 和 Anfangning 將於 2024 年獲批，從而拓寬了具有這種特定基因突變的患者的治療前景。 2024年和2025年，Crazati和Lumaclas都獲得了用於治療大腸直腸癌（CRC）的額外批准，市場繼續擴大。

目前，全球有超過80種KRAS抑制劑處於不同階段的臨床試驗中，其中包括羅氏公司的diverasib，目前正處於III期臨床試驗階段；加科思製藥公司的glesilasib（JAB-21822）正在中國進行註冊試驗。這些藥物的持續開發表明 KRAS 抑制劑在一系列惡性腫瘤中具有廣泛的潛力，並且正在許多臨床試驗中探索它們與其他癌症治療方法（包括化療、免疫療法和標靶療法）的結合。 KRAS 抑制劑的核准和廣泛應用凸顯了其在腫瘤學中的重要性，尤其是對於幾乎沒有替代療法且預後不良的癌症。

肺癌，尤其是非小細胞肺癌 (NSCLC)，仍然是 KRAS 抑制劑研究的主要焦點，其中有許多臨床試驗正在研究 KRAS G12C 突變。儘管如此，大腸直腸癌和胰臟癌也是重要的研究領域，因為在這些類型的癌症中很常見 KRAS 突變。 KRAS 抑制劑的治療潛力不僅限於這些惡性腫瘤，目前正在進行的研究也探討了其對卵巢癌、腦癌和子宮內膜癌等其他癌症的療效。因此，隨著越來越多的臨床證據支持這些療法對不同腫瘤類型的療效，KRAS 抑制劑的全球市場預計將擴大到涵蓋更廣泛的癌症類型。

KRAS 抑制劑主要針對 KRAS 基因中的特定突變，最常見的是 G12C、G12V 和 G12D。這些突變在 KRAS 的致癌活化中起著關鍵作用，是治療策略的重要目標。雖然傳統的 KRAS 抑制劑主要針對 KRAS 蛋白的活性或非活性狀態，但可以針對 KRAS 的 "開啟" 和 "關閉" 狀態的下一代抑制劑的出現提供了新的治療可能性。這種抑制劑的例子是 BridgeBio Oncology Therapeutics 公司的 BBO-8520。 BBO-8520 與 KRAS G12C 的活性和非活性形式共價結合，有效阻斷效應物結合併抑制 KRAS 功能。在臨床前研究中，BBO-8520 與標準 KRAS G12C 抑制劑相比，表現出更高的療效、更深的腫瘤反應和延遲的抗藥性，使其成為解決現有療法局限性的有希望的選擇。

隨著越來越多的抑制劑透過臨床試驗獲得批准，預計未來 KRAS 抑制劑的全球市場將大幅成長。正在進行的聯合療法研究有望透過針對不同的 KRAS 突變亞型來擴大可用的治療選擇範圍，並將癌症範圍擴展到非小細胞肺癌 (NSCLC) 之外。此外，更多國際聯盟和合作的出現可能會增強全球獲得這些重要療法的機會，從而使更多的癌症患者受益。然而，為了使市場可持續發展，必須解決高治療成本、取得問題以及需要繼續研究長期療效和安全性等課題。

本報告提供全球KRAS抑制劑市場相關調查，提供市場概要，以及藥物趨勢，臨床試驗趨勢，各地區趨勢，及加入此市場的主要企業競爭情形等資訊。

目錄

第1章 KRAS抑制劑的簡介

  • KRAS抑制劑的開發
  • 作用機制

第2章 癌症治療的KRAS抑制劑所扮演的角色

第3章 全球KRAS抑制劑市場展望

  • 目前市場情勢
  • KRAS抑制劑作為劃時代的治療藥，貿易快速審批，罕見疾病用醫藥品核准
  • 未來市場機會

第4章 Lumakras-概要，價格，劑量，銷售分析

  • 概要與專利資訊
  • 與劑量價格分析
  • 銷售額分析

第5章 Krazati-概要，價格，劑量，銷售分析

  • 概要與專利資訊
  • 與劑量價格分析
  • 銷售額分析

第6章 Dupert - 臨床性洞察

第7章 臨床性洞察

第8章 KRAS抑制劑市場地區分析- 商業及臨床開發的展望

  • 美國
  • 中國
  • EU
  • 英國
  • 日本
  • 韓國
  • 加拿大
  • 台灣
  • 澳洲

第9章 各適應症的KRAS抑制劑開發趨勢

  • 肺癌症
  • 大腸癌症
  • 胰臟癌症
  • 其他

第10章 世界KRAS抑制劑的臨床實驗平台概要

  • 各國
  • 各相
  • 各企業
  • 各適應症
  • 各優先狀態

第11章 世界KRAS抑制劑臨床試驗的洞察，國家，企業，適應症，各相

  • 研究
  • 前臨床
  • 第一階段
  • 第一/二階段
  • 第二階段
  • 第三階段
  • 預註冊
  • 登記完畢

第12章 市售KRAS抑制劑的臨床試驗的洞察

第13章 KRAS抑制劑的組合策略

  • 免疫療法
  • 化療
  • 標靶治療
  • 放射線

第14章 全球KRAS抑制劑市場動態

  • 市場促進因素
  • 市場課題

第15章 競爭情形

  • Applied Pharmaceutical Science
  • Amgen
  • AnBogen Therapeutics
  • AstraZeneca
  • Biond Biologics
  • BridgeBio Oncology Therapeutics
  • Bristol Myers Squibb
  • Boehringer Ingelheim
  • Eli Lilly
  • Erasca
  • Frontier Medicines
  • GenFleet Therapeutics
  • Innovent Bio
  • Jacobio Pharmaceuticals
  • Jiangsu Hansoh Pharmaceutical
  • Jiangsu Hengrui Medicine Co.
  • Quanta Therapeutics
  • Revolution Medicines
  • Roche
  • Suzhou Zelgen Biopharmaceuticals

Global KRAS Inhibitors Market, Drug Sales, Patent, Price & Clinical Trials Insight 2030 Report Findings & Highlights:

  • Research Methodology
  • Global & Regional Market Trends Insight
  • First KRAS Inhibitor Drug Approved In 2021
  • Global KRAS Market Opportunity To Surpass US$ 2 Billion By 2030
  • KRAS Inhibitors Market Absolute Growth: >400% Since First Drug Approval
  • Approved KRAS Inhibitors Drugs: 4 Drugs
  • Approved Drugs Dosage, Price & Sales Insight
  • Insight On More Than 80 Drugs In Clinical Trials
  • KRAS Inhibitor Clinical Trials Insight By Country, Company, Indication & Phase

The global market for KRAS inhibitors has seen substantial growth in recent years, largely due to the heightened awareness of KRAS mutations as significant contributors to cancer development in various solid tumors, including lung, colorectal, and pancreatic cancers. KRAS, an essential gene that regulates cell proliferation, has historically posed a challenge as a therapeutic target because of its intricate biology and its function in supporting tumor survival. Nevertheless, advancements in molecular biology and the creation of targeted therapies have led to the emergence of KRAS inhibitors as a promising category of medications.

A pivotal moment in the KRAS inhibitor market occurred in 2021 with the approval of Lumakras for the treatment of non-small cell lung cancer (NSCLC), representing a significant breakthrough for patients with KRAS G12C mutations. This approval heralded a new phase in targeted cancer therapies, followed by the authorization of Krazati in 2022, and Dupert and Anfangning in 2024 for NSCLC, thereby broadening the treatment landscape for patients with this particular genetic alteration. In 2024 and 2025, the market continued to expand, with both Krazati and Lumakras receiving additional approvals for colorectal cancer (CRC).

At present, more than 80 KRAS inhibitors are in various stages of clinical trials, including Roche's Divarasib, which is currently in Phase 3 trials, and Jacobio Pharma's Glecirasib (JAB-21822), which is undergoing registrational trials in China. The ongoing development of these agents highlights the extensive potential of KRAS inhibitors in addressing a range of malignancies, with numerous clinical trials exploring their use in combination with other cancer treatments, such as chemotherapy, immunotherapy, and targeted therapies. The approval and growing utilization of KRAS inhibitors emphasize their importance in oncology, especially for cancers that have few treatment alternatives and poor outcomes.

Lung cancer, especially non-small cell lung cancer (NSCLC), continues to be the primary focus of research on KRAS inhibitors, with many clinical trials investigating KRAS G12C mutations. Nonetheless, colorectal and pancreatic cancers are also critical areas of study, as KRAS mutations are commonly observed in these types of cancer. The therapeutic potential of KRAS inhibitors extends beyond these malignancies, with ongoing investigations into their effectiveness against other cancers, such as ovarian, brain, and endometrial cancers. Consequently, the global market for KRAS inhibitors is anticipated to broaden, encompassing a wider variety of cancer types, fueled by increasing clinical evidence that supports the efficacy of these treatments across diverse tumor types.

KRAS inhibitors primarily target specific mutations in the KRAS gene, with G12C, G12V, and G12D being the most prevalent. These mutations play a significant role in the oncogenic activation of KRAS, making it an important target for therapeutic strategies. While traditional KRAS inhibitors have focused on either the active or inactive states of the KRAS protein, the emergence of next-generation inhibitors capable of targeting both the "ON" and "OFF" states of KRAS has created new therapeutic possibilities. An example of such an inhibitor is BBO-8520 from BridgeBio Oncology Therapeutics, which covalently binds to both the active and inactive forms of KRAS G12C, effectively preventing effector binding and inhibiting KRAS function. Preclinical studies indicate that BBO-8520 demonstrates greater potency, more profound tumor responses, and a delay in resistance compared to standard KRAS G12C inhibitors, positioning it as a promising option to address the limitations of existing therapies.

Looking ahead, the global market for KRAS inhibitors is set for significant growth as an increasing number of inhibitors advance through clinical trials and receive regulatory approval. Ongoing investigations into combination therapies are expected to broaden the range of treatment options available, targeting various KRAS mutation subtypes and extending to other cancers beyond non-small cell lung cancer (NSCLC). Furthermore, the emergence of more international partnerships and collaborations will likely enhance global access to these vital treatments, thereby benefiting a larger segment of cancer patients. Nevertheless, challenges such as high treatment costs, issues related to accessibility, and the necessity for continued research into long-term efficacy and safety must be addressed to ensure the market's sustainable development.

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

3. Global KRAS Inhibitor Market Outlook

  • 3.1 Current Market Scenario
  • 3.2 KRAS Inhibitors Granted Breakthrough Therapy, Fast Track & Orphan

Designation

  • 3.3 Future Market Opportunity

4. Lumakras - Overview, Pricing, Dosing & Sales Analysis

  • 4.1 Overview & Patent Insight
  • 4.2 Dosage & Price Analysis
  • 4.3 Sales Analysis

5. Krazati - Overview, Pricing, Dosing & Sales Analysis

  • 5.1 Overview & Patent Insight
  • 5.2 Dosage & Price Analysis
  • 5.3 Sales Analysis

6. Dupert - Clinical Insight

7. Anfangning - Clinical Insight

8. KRAS Inhibitor Market Regional Analysis - Commercial & Clinical Development Outlook

  • 8.1 US
  • 8.2 China
  • 8.3 EU
  • 8.4 UK
  • 8.5 Japan
  • 8.6 South Korea
  • 8.7 Canada
  • 8.8 Taiwan
  • 8.9 Australia

9. KRAS Inhibitor Development Trends By Indications

  • 9.1 Lung Cancer
  • 9.2 Colorectal Cancer
  • 9.3 Pancreatic Cancer
  • 9.4 Other Indications

10. Global KRAS Inhibitors Clinical Pipeline Overview

  • 10.1 By Country
  • 10.2 By Phase
  • 10.3 By Company
  • 10.4 By Indication
  • 10.5 By Priority Status

11. Global KRAS Inhibitor Clinical Trials Insight By Country, Company, Indication & Phase

  • 11.1 Research
  • 11.2 Preclinical
  • 11.3 Phase I
  • 11.4 Phase I/II
  • 11.5 Phase II
  • 11.6 Phase III
  • 11.7 Preregistration
  • 11.8 Registered

12. Marketed KRAS Inhibitor Clinical Trials Insight

13. KRAS Inhibitors Combination Strategies

  • 13.1 Immunotherapy
  • 13.2 Chemotherapy
  • 13.3 Targeted Therapies
  • 13.4 Radiation

14. Global KRAS Inhibitors Market Dynamics

  • 14.1 Market Drivers
  • 14.2 Market Challenges

15. Competitive Landscape

  • 15.1 Applied Pharmaceutical Science
  • 15.2 Amgen
  • 15.3 AnBogen Therapeutics
  • 15.4 AstraZeneca
  • 15.5 Biond Biologics
  • 15.6 BridgeBio Oncology Therapeutics
  • 15.7 Bristol Myers Squibb
  • 15.8 Boehringer Ingelheim
  • 15.9 Eli Lilly
  • 15.10 Erasca
  • 15.11 Frontier Medicines
  • 15.12 GenFleet Therapeutics
  • 15.13 Innovent Bio
  • 15.14 Jacobio Pharmaceuticals
  • 15.15 Jiangsu Hansoh Pharmaceutical
  • 15.16 Jiangsu Hengrui Medicine Co.
  • 15.17 Quanta Therapeutics
  • 15.18 Revolution Medicines
  • 15.19 Roche
  • 15.20 Suzhou Zelgen Biopharmaceuticals

List of Figures

  • Figure 1-1: RAS Mutation - Frequency of KRAS Mutation v/s HRAS & NRAS Mutations
  • Figure 1-2: KRAS Inhibitors - Development Milestones
  • Figure 1-3: KRAS Inhibitor - General Mechanism In Cancer
  • Figure 1-4: KRAS Inhibitors - Targeting Approaches
  • 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 Organ (%)
  • Figure 2-2: KRAS Inhibitor - Role In Cancer Treatment
  • Figure 3-1: Approved KRAS Inhibitors
  • Figure 3-2: Global - KRAS Inhibitors Sales (US$ Million), 2021-2024
  • Figure 3-3: Global - KRAS Inhibitors Quarterly Sales (US$ Million), Q1-Q4'2024
  • Figure 3-4: KRAS Inhibitor Market - Future Opportunities
  • Figure 3-5: Global - KRAS Inhibitors Sales (US$ Million), 2025-2030
  • Figure 4-1: Sotorasib - Approval Year By Indication
  • Figure 4-2: Sotorasib - Patent Expiration Year
  • Figure 4-3: US - Cost Per Unit & Supply Of Lumakras (US$), April'2025
  • Figure 4-4: EU - Cost Per Unit & Supply Of Lumakras (US$), April'2025
  • Figure 4-5: Lumakras - Recommended Dose Reduction Levels For Adverse Reaction
  • Figure 4-6: Global - Lumakras/Lumykras Annual Sales (US$ Million), 2021-2024
  • Figure 4-7: Global - Lumakras/Lumykras Sales (US$ Million), Q1-Q4'2024
  • Figure 4-8: Regional - US v/s ROW Lumakras/Lumykras Sales (US$ Million), 2024
  • Figure 4-9: Regional - US v/s ROW Lumakras/Lumykras Sales (%), 2024
  • Figure 4-10: US - Lumakras Sales (US$ Million), 2021-2024
  • Figure 4-11: US - Lumakras Sales (US$ Million), Q1-Q4'2024
  • Figure 4-12: ROW - Lumakras/Lumykras Sales (US$ Million), 2021-2024
  • Figure 4-13: ROW - Lumakras/Lumykras Sales (US$ Million), Q1-Q4'2024
  • Figure 5-1: Krazati - Approval Year By Indication
  • Figure 5-2: Krazati - Market Exclusivity Expiry By Region
  • Figure 5-3: US - Cost Per Unit & Supply Of Krazati (US$), April'2025
  • Figure 5-4: Krazati - Recommended Dosage Reduction for Adverse Reactions (mg/day)
  • Figure 5-5: Global - Krazati Annual Sales (US$ Million), 2023-2024
  • Figure 5-6: Global - Krazati Quarterly Sales (US$ Million), Q1-Q4'2024
  • Figure 5-7: Regional - US v/s ROW Krazati Sales (US$ Million), 2024
  • Figure 5-8: Regional - US v/s ROW Krazati Sales (%), 2024
  • Figure 5-9: US - Krazati Sales (US$ Million), Q1-Q4'2024
  • Figure 5-10: ROW - Krazati Sales (US$ Million), Q1-Q4'2024
  • Figure 7-1: Garsorasib - NMPA Breakthrough Therapy Designation Year By Indication
  • Figure 9-1: TBBO8520-101 Phase 1 Study (NCT06343402) - Initiation & Completion Year
  • Figure 9-2: KRYSTAL-12 Phase 3 Study (NCT04685135) - Initiation & Completion Year
  • Figure 9-3: RAMP203/VS-6766-203 Phase 1/2 Study (NCT05074810) - Initiation & Completion Year
  • Figure 9-4: RASolve 301 Phase 3 (NCT06881784) Study - Initiation & Completion Year
  • Figure 9-5: RMC-LUNG-101 Phase 1/2 (NCT06162221) Study - Initiation & Completion Year
  • Figure 9-6: CodeBreaK 301 Phase 3 (NCT06252649) Study - Initiation & Completion Year
  • Figure 9-7: CodeBreaK 101 Phase 3 (NCT04185883) Study - Initiation & Completion Year
  • Figure 9-8: KRYSTAL-10 Phase 3 (NCT04793958) Study - Initiation & Completion Year
  • Figure 9-9: RMC-6291-101 Phase 1 (NCT06128551) Study - Initiation & Completion Year
  • Figure 9-10: RMC-6236-001 Phase 1 (NCT05379985) Study - Initiation & Completion Year
  • Figure 9-11: RMC-9805-001 Phase 1 (NCT06040541) Study - Initiation & Completion Year
  • Figure 9-12: BrainMet ADePPT Phase 1 (NCT06807619) Study - Initiation & Completion Year
  • Figure 9-13: NCI-2023-09685 Phase 1 (NCT06130254) Study - Initiation & Completion Year
  • Figure 10-1: Global - KRAS Protein Inhibitors Clinical Trials By Country, 2025 -2030
  • Figure 10-2: Global - KRAS Protein Inhibitors Clinical Trials By Phase, 2025 -2030
  • Figure 10-3: Global - KRAS Protein Inhibitors Clinical Trials By Company, 2025 -2030
  • Figure 10-4: Global - KRAS Protein Inhibitors Clinical Trials By Indication, 2025 -2030
  • Figure 10-5: Global - KRAS Protein Inhibitors Clinical Trials By Priority Status, 2025 -2030
  • Figure 13-1: KRAS inhibitors & Immunotherapy Combinations
  • Figure 14-1: KRAS Inhibitors Market - Drivers
  • Figure 14-2: KRAS Inhibitors Market - Challenges

List of Tables

  • Table 3-1: KRAS Inhibitors Breakthrough Therapy, Fast Track & Orphan Designation
  • Table 4-1: Lumakras - Recommended Dosage Modifications For Adverse Reactions
  • Table 5-1: Krazati - Recommended Dosage Modifications For Adverse Reactions
  • Table 8-1: US - Ongoing KRAS Inhibitor Clinical Trials
  • Table 8-2: China - Ongoing KRAS Inhibitor Clinical Trials
  • Table 8-3: UK - Ongoing KRAS Inhibitor Clinical Trials
  • Table 8-4: Japan - Ongoing KRAS Inhibitor Clinical Trials
  • Table 8-5: South Korea - Ongoing KRAS Inhibitor Clinical Trials
  • Table 8-6: Canada - Ongoing KRAS Inhibitor Clinical Trials
  • Table 8-7: Taiwan - Ongoing KRAS Inhibitor Clinical Trials
  • Table 8-8: Australia - Ongoing KRAS Inhibitor Clinical Trials
  • Table 9-1: Lung Cancer - KRAS Inhibitors In Clinical Trials
  • Table 9-2: Colorectal Cancer - KRAS Inhibitors In Clinical Trials
  • Table 9-3: Colorectal Cancer - KRAS Inhibitors With Regulatory Designations
  • Table 9-4: Pancreatic Cancer - KRAS Inhibitors in Clinical Trials
  • Table 9-5: Pancreatic Cancer - KRAS Inhibitors with Regulatory Designations
  • Table 13-1: KRAS Inhibitor & Immunotherapy Combinations In Clinical Trials
  • Table 13-2: KRAS Inhibitor & Chemotherapy Combinations In Clinical Trials
  • Table 13-3: KRAS Inhibitor & Targeted Therapy Combinations In Clinical Trials
  • Table 13-4: KRAS Inhibitor & Radiotherapy Combinations In Clinical Trials