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市场调查报告书
商品编码
1699607
KRAS抑制剂的全球市场:药物销售额,专利,价格,临床试验趋势(2030年)Global KRAS Inhibitors Market, Drug Sales, Patent, Price & Clinical Trials Insight 2030 |
预计到 2030 年,KRAS 抑制剂的全球市场规模将超过 20 亿美元。
这主要是因为人们越来越认识到 KRAS 突变是各种实体癌症(包括肺癌、大肠直肠癌和胰腺癌)发展的重要因素。 KRAS 是控制细胞增殖的重要基因,由于其复杂的生物学特性和支持肿瘤存活的功能,历来被视为具有课题性的治疗标靶。儘管如此,随着分子生物学的进步和标靶治疗方法的创造,KRAS 抑制剂已成为一种很有前途的药物类别。
KRAS 抑制剂市场的一个关键事件是 2021 年 Lumaclas 获准用于治疗非小细胞肺癌 (NSCLC)。这项批准标誌着标靶癌症治疗的新篇章,针对非小细胞肺癌,Krazati 将于 2022 年获批,Dupert 和 Anfangning 将于 2024 年获批,从而拓宽了具有这种特定基因突变的患者的治疗前景。 2024年和2025年,Crazati和Lumaclas都获得了用于治疗大肠直肠癌(CRC)的额外批准,市场继续扩大。
目前,全球有超过80种KRAS抑制剂处于不同阶段的临床试验中,其中包括罗氏公司的diverasib,目前正处于III期临床试验阶段;加科思製药公司的glesilasib(JAB-21822)正在中国进行註册试验。这些药物的持续开发表明 KRAS 抑制剂在一系列恶性肿瘤中具有广泛的潜力,并且正在许多临床试验中探索它们与其他癌症治疗方法(包括化疗、免疫疗法和标靶疗法)的结合。 KRAS 抑制剂的核准和广泛应用凸显了其在肿瘤学中的重要性,尤其是对于几乎没有替代疗法且预后不良的癌症。
肺癌,尤其是非小细胞肺癌 (NSCLC),仍然是 KRAS 抑制剂研究的主要焦点,其中有许多临床试验正在研究 KRAS G12C 突变。儘管如此,大肠直肠癌和胰臟癌也是重要的研究领域,因为在这些类型的癌症中很常见 KRAS 突变。 KRAS 抑制剂的治疗潜力不仅限于这些恶性肿瘤,目前正在进行的研究也探讨了其对卵巢癌、脑癌和子宫内膜癌等其他癌症的疗效。因此,随着越来越多的临床证据支持这些疗法对不同肿瘤类型的疗效,KRAS 抑制剂的全球市场预计将扩大到涵盖更广泛的癌症类型。
KRAS 抑制剂主要针对 KRAS 基因中的特定突变,最常见的是 G12C、G12V 和 G12D。这些突变在 KRAS 的致癌活化中起着关键作用,是治疗策略的重要目标。虽然传统的 KRAS 抑制剂主要针对 KRAS 蛋白的活性或非活性状态,但可以针对 KRAS 的 "开启" 和 "关闭" 状态的下一代抑制剂的出现提供了新的治疗可能性。这种抑制剂的例子是 BridgeBio Oncology Therapeutics 公司的 BBO-8520。 BBO-8520 与 KRAS G12C 的活性和非活性形式共价结合,有效阻断效应物结合併抑制 KRAS 功能。在临床前研究中,BBO-8520 与标准 KRAS G12C 抑制剂相比,表现出更高的疗效、更深的肿瘤反应和延迟的抗药性,使其成为解决现有疗法局限性的有希望的选择。
随着越来越多的抑制剂透过临床试验获得批准,预计未来 KRAS 抑制剂的全球市场将大幅成长。正在进行的联合疗法研究有望透过针对不同的 KRAS 突变亚型来扩大可用的治疗选择范围,并将癌症范围扩展到非小细胞肺癌 (NSCLC) 之外。此外,更多国际联盟和合作的出现可能会增强全球获得这些重要疗法的机会,从而使更多的癌症患者受益。然而,为了使市场可持续发展,必须解决高治疗成本、取得问题以及需要继续研究长期疗效和安全性等课题。
本报告提供全球KRAS抑制剂市场相关调查,提供市场概要,以及药物趋势,临床试验趋势,各地区趋势,及加入此市场的主要企业竞争情形等资讯。
Global KRAS Inhibitors Market, Drug Sales, Patent, Price & Clinical Trials Insight 2030 Report Findings & Highlights:
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.
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