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癌症分子標靶治療學

市場調查報告書

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1593543

Claudin18.2標靶治療的全球市場:市場預測和臨床試驗趨勢(2029年)

Global Claudin 18.2 Targeted Therapy Market Forecast & Clinical Trials Insight 2029

出版日期: 2024年11月01日 | 出版商:

KuicK Research | 英文 240 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄圖表

緊密連接蛋白 18.2 (CLDN18.2) 是緊密連接蛋白家族成員緊密連接蛋白 18 的一種同工型。它在正常組織中的表達有限，但經常在多種原發性惡性腫瘤中異常表達，包括胃癌、胃食道連接部腫瘤、卵巢腫瘤和其他實體腫瘤。這項發現促成了旨在抑制claudin-18.2來治療這些癌症（主要是胃癌）的標靶療法的開發。截至 2024 年 11 月，一種此類治療方法已獲批准，另外幾種治療方法正在開發中。世界各地的製藥公司都大力投資這一前景廣闊的領域，治療方法涵蓋多個藥物類別。這些努力凸顯了claudin-18.2標靶治療改變胃癌治療前景的潛力，使其成為未來幾年值得密切關注的研究領域。

Vyloy（zolbetuximab）於2024年3月獲批，是首個針對緊密連接蛋白18.2的藥物，標誌著該領域的一個重要里程碑。 Vyloy 由 Ganymed Pharmaceuticals 開發，後來被安斯泰來製藥收購，已在美國、歐盟和日本等主要國家獲批與化療聯合作為 HER2 陰性 G/GEJ 腺癌（腫瘤表達緊密連接蛋白 18.2）患者的一線治療。此外，預計該療法將於 2024 年底在中國獲得批准，這將標誌著該療法在全球範圍內的推廣，並使其成為這些惡性腫瘤的重要治療選擇。

Vyloy 在美國銷售數據顯示該療法廣受歡迎，預計到 2024 年第三季末銷售額將超過 700 萬美元。不斷增長的市場滲透率表明，該領域對有效治療的需求尚未得到滿足，而且 claudin 18.2 作為標靶具有強大的治療潛力。目前，佐貝妥昔單抗正處於臨床開發階段，旨在探索其與各種治療方案的聯合應用，以及在 G/GEJ 腺癌以外的腫瘤（如胰腺癌）中的潛在應用。這些擴展可能會擴大針對 claudin-18.2 的藥物的範圍和影響。

除 Vyloy 外，還有許多針對 claudin-18.2 的藥物正在開發中，包括單株抗體、雙特異性抗體、CAR-T 細胞療法和抗體藥物偶聯物 (ADC)。其中五種候選藥物已進入 3 期臨床試驗，大多數針對 G/GEJ 惡性腫瘤，但在包括卵巢癌和肺癌在內的其他腫瘤類型中也取得了可喜的成果。如此多樣化的治療選擇凸顯了針對 claudin-18.2 在腫瘤學中日益增長的興趣和潛力。

展望未來，由於目前治療方法的良好表現和不斷增長的產品線，claudin 18.2 標靶治療市場預計將進一步擴大。雖然 G/GEJ 惡性腫瘤仍然是主要關注點，但探索其他適應症可能會擴大這些療法的使用範圍。市場的全球性，既有西方公司，也有亞洲公司，培育了一種協作而又競爭的氛圍，可能會促進進一步的創新。隨著更多治療方法的開發和批准，以及伴隨診斷的普及，claudin-18.2標靶療法對癌症治療的影響可能會顯著擴大，為難以治療的癌症患者帶來新的希望。

本報告提供全球Claudin18.2標靶治療市場相關調查，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。

Abpro Therapeutics
Antengene Corporation
Arovella Therapeutics
Astellas Pharma
AstraZeneca
Beijing Mabworks Biotech
Biotheus
CARsgen
Dragonboat Biopharmaceutical
Gracell Biotechnology
Harbour BioMed
Innovent Biologics
Klus Pharma
L and L Biopharma
LaNova Medicines Limited
Leap Therapeutics
Luye Pharma Group
Nanjing Bioheng Biotech
Nanjing KAEDI Biotech
OriCell Therapeutics
Shanghai Junshi Biosciences
SparX Biopharmaceutical
TORL Biotherapeutics
Transcenta Holding

簡介目錄圖表

Global Claudin 18.2 Targeted Therapy Market Forecast & Clinical Trials Insight 2029 Report Highlights:

Global & Regional Market Trends Insight
Currently Only 1 Claudin 18.2 Targeted Drug Is Approved: Vyloy (zolbetuximab)
Approved Drug Dosage, Pricing & Sales Insight
Claudin 18.2 Therapy Clinical Trends & Innovations by Indication
Number Claudin 18.2 Drugs In Clinical Trials: > 60 Drugs
Global Claudin 18.2 Drugs Clinical Trials By Company, Indication & Phase
Insight On Technical & Clinical Platforms For Developing Advanced Claudin 18.2 Therapy

Claudin18.2 (CLDN18.2) is an isoform of Claudin18, a member of the tight junction protein family. It serves as a highly selective biomarker, exhibiting limited expression in normal tissues but often showing abnormal expression in various primary malignancies, including gastric cancer, gastroesophageal junction cancer, ovarian cancer, and a few other solid tumors. This finding has led to the development of targeted therapies aimed at inhibiting Claudin18.2 for treating these cancers, majorly gastric cancers. As of November 2024, one such therapy has been approved, with several others in advanced stages of development. Pharmaceutical companies around the world are investing heavily in this promising field, with treatments spanning a range of drug classes. These efforts underscore the potential of Claudin18.2-targeted therapies to transform the treatment landscape for gastric cancer, making this area of research one to watch closely in the coming years.

The approval of Vyloy (zolbetuximab) in March 2024 marked a significant milestone in the field, as it is the first medication to target Claudin18.2. Vyloy, developed by Ganymed Pharmaceuticals and later acquired by Astellas Pharma, has already been approved in major countries, such as the US, the EU, and Japan, for use in combination with chemotherapy as the first-line treatment of patients with HER2-negative G/GEJ adenocarcinoma whose tumors express Claudin18.2. Additionally, the anticipated approval in China by the end of 2024 suggests a global expansion of this therapy, establishing it as a crucial treatment option for these aggressive tumors.

Sales data for Vyloy has indicated a strong adoption, with the therapy's sales surpassing US$ 7 Million by the end of the third quarter of 2024. This increasing market penetration demonstrates both the unmet need for effective treatments in this domain and Claudin18.2's strong therapeutic potential as a target. Zolbetuximab is now in clinical development, with trials investigating its application in combination with various therapy regimens as well as potential applications in tumors other than G/GEJ adenocarcinoma, such as pancreatic carcinoma. These expansions may extend the spectrum and impact of Claudin18.2-targeted medicines.

Aside from Vyloy, numerous other Claudin18.2-targeting medicines are under development, including monoclonal antibodies, bispecific antibodies, CAR-T cell therapies, and antibody-drug conjugates (ADCs). Five of these candidates are already in phase 3 clinical trials, largely for G/GEJ malignancies, but research is showing promise in other tumor types, including as ovarian and lung cancers. This varied pipeline of treatment options highlights the increased interest and potential for targeting Claudin18.2 in oncology.

The competitive landscape for Claudin18.2-targeting therapies is becoming more dynamic, with major corporations investing in research and development. China, in particular, has emerged as a hub of innovation in this field, with numerous companies, including Innovent, MabWorks, and Biotheus, making substantial progress in developing Claudin18.2-targeting medicines.

Companion diagnostic tests are an important element of the Claudin18.2-targeting therapeutic industry. Roche Diagnostics developed the Ventana(R) CLDN18 (43-14A) RxDx Assay, the first immunohistochemistry-based test approved to detect Claudin18.2 expression in patients with G/GEJ adenocarcinoma. This test identifies which patients are most likely to benefit from Vyloy treatment, resulting in more precise and successful therapy selection. As the market for Claudin18.2-targeted therapies grows, the development and implementation of companion diagnostics will be critical in improving treatment results.

Looking ahead, the Claudin18.2-targeting therapy market is expected to increase further, owing to the encouraging results of current medications and a growing pipeline. While G/GEJ malignancies remain the primary focus, research into additional indications may broaden the uses of these therapies. The market's global nature, with strong representation from both Western and Asian enterprises, creates a collaborative and competitive atmosphere that is likely to encourage further innovation. As more therapies are developed and approved, and as companion diagnostics become more widely available, the impact of Claudin18.2-targeted therapies on cancer treatment is expected to grow significantly, offering new hope for patients with difficult-to-treat cancers.

1. Introduction To Claudin 18.2 Therapy

1.1 Understanding Claudin 18.2 Proteins
1.2 Development Of Claudin 18.2 Therapy
1.3 Need For Claudin 18.2 Targeted Therapy

2. Research Advancement Targeting Claudin 18.2 For Cancer Immunotherapy

2.1 Monoclonal Antibody
2.2 Bispecific Antibody
2.3 CAR T Cell Therapy
2.4 Antibody Drug Conjugate

3. Approved Claudin 18.2 Targeting Therapies

4. Vyloy - 1st Approved Claudin 18.2 Targeted Therapy

4.1 Clinical Insight
4.2 Pricing & Dosing Insight
4.3 Sales Insight

5. Global Claudin 18.2 Market Scenario

5.1 Current Market Overview
5.2 Favorable Market Development Parameters
5.3 Key Developmental Challenges
5.4 Future Market Outlook

6. Claudin 18.2 Therapy Trend Analysis By Region

6.1 US
6.2 China
6.3 Europe
6.4 UK
6.5 Japan
6.6 Australia
6.7 South Korea

7. Claudin 18.2 Therapy Clinical Trends & Innovations by Indication

7.1 Gastric Cancer
7.2 Pancreatic Cancer
7.3 Ovarian Cancer
7.4 Lung Cancer

8. Technical & Clinical Platforms For Developing Advanced Claudin 18.2 Therapy

9. Global Claudin 18.2 Drugs Clinical Trials Overview

9.1 By Company
9.2 By Country
9.3 By Indication
9.4 By Patient Segment
9.5 By Phase

10. Global Claudin 18.2 Drugs Clinical Trials By Company, Indication & Phase

10.1 Research
10.2 Preclinical
10.3 Phase 0
10.4 Phase I
10.5 Phase I/II
10.6 Phase II
10.7 Phase III

11. Marketed Claudin 18.2 Drugs Clinical Insight

12. Competitive Landscape

12.1 Abpro Therapeutics
12.2 Antengene Corporation
12.3 Arovella Therapeutics
12.4 Astellas Pharma
12.5 AstraZeneca
12.6 Beijing Mabworks Biotech
12.7 Biotheus
12.8 CARsgen
12.9 Dragonboat Biopharmaceutical
12.10 Gracell Biotechnology
12.11 Harbour BioMed
12.12 Innovent Biologics
12.13 Klus Pharma
12.14 L and L Biopharma
12.15 LaNova Medicines Limited
12.16 Leap Therapeutics
12.17 Luye Pharma Group
12.18 Nanjing Bioheng Biotech
12.19 Nanjing KAEDI Biotech
12.20 OriCell Therapeutics
12.21 Shanghai Junshi Biosciences
12.22 SparX Biopharmaceutical
12.23 TORL Biotherapeutics
12.24 Transcenta Holding

簡介目錄圖表

List of Figures

Figure 1-1: Claudin 18.2 Protein - Functions
Figure 1-2: Functional Classification of the Claudin Family Proteins
Figure 1-3: Dichotomous Role of Claudin 18.2 Protein in Cancer
Figure 1-4: Claudin 18 Isoforms
Figure 1-5: Global - Gastric Cancer Incidences & Deaths (Million), 2022
Figure 2-1: Therapeutic Approach for Claudin 18.2 protein
Figure 2-2: Monoclonal Antibody - Mode of Action
Figure 2-3: Claudin 18.2 - Novel Monoclonal Antibodies in Clinical Research
Figure 2-4: Bispecific Antibody - Advantages
Figure 2-5: PT886 - Phanes Therapeutics Development Vista
Figure 2-6: QLS31905 Phase 1/2 Study - Initiation & Completion Year
Figure 2-7: ASP2138 - Astellas Pharma
Figure 2-8: CARsgen Pharmaceuticals Collaboration - Fudan & Peking University for CT041 & CT048
Figure 2-9: Immunofoco - Pipeline for Claudin 18.2 Therapy
Figure 2-10: NCT06084286 Phase 1 Study - Initiation & Completion Year
Figure 2-11: Claudin 18.2 - ADC Candidates
Figure 2-12: SKB315 - Clinical Trial & Collaboration Overview
Figure 4-1: Vyloy - Approval Year by Region
Figure 4-2: Global - Annual Vyloy Sales (US$ Million), 2024
Figure 4-3: Global - Quarterly Vyloy Sales (US$ Million), Q2-Q3'2024
Figure 5-1: Current Claudin 18.2 Therapy Market - Influencing Factors
Figure 5-2: Global - Claudin 18.2 Targeted Therapy Market, (US$ Million), 2024
Figure 5-3: Global - Claudin 18.2 Targeted Therapy Market, (US$ Million), Q2-Q3'2024
Figure 5-4: Market Drivers for Claudin 18.2 Therapy
Figure 5-5: Market Challenges for Claudin 18.2 Therapy
Figure 5-6: Global - Claudin18.2 Targeted Therapies Market (US$ Million), 2024 - 2029
Figure 5-7: Future Claudin 18.2 Therapy Market - Influencing Factors
Figure 6-1: Triumvira Immunologics - Pipeline for Claudin 18.2 Therapies
Figure 6-2: US - Factors Influencing Claudin 18.2 Therapy Development
Figure 6-3: China - Major Candidates in Clinical Trial
Figure 6-4: LM-302 Phase 2 Study - Initiation & Completion Year
Figure 6-5: TQB2103 Phase 1 Study - Initiation & Completion Year
Figure 6-6: CT048 Phase 1 Study - Initiation & Completion Year
Figure 6-7: SOT102 Phase 1/2 Study - Initiation & Completion Year
Figure 6-8: AZD0901 Phase 2 Study - Initiation & Completion Year
Figure 6-9: AZD5863 Phase 1/2 Study - Initiation & Completion Year
Figure 6-10: SPOTLIGHT Phase 3 Study - Initiation & Completion Year
Figure 6-11: GLOW Phase 3 Study - Initiation & Completion Year
Figure 6-12: ATG-022 Phase 1 Study - Initiation & Completion Year
Figure 7-1: Claudin 18.2 - Upregulation in Gastric Cancer
Figure 7-2: HEC-016 Phase 1 Study - Initiation & Completion Year
Figure 7-3: TJ-CD4B - Structure & Mode of Action
Figure 7-4: Osemitamab Phase 1/2 Study - Initiation & Completion Year
Figure 7-5: SOT102 Phase 1/2 Study - Initiation & Completion Year
Figure 7-6: KD-496 Early Phase 1 Study - Initiation & Completion Year
Figure 7-7: Zolbetuximab Phase 2 Study - Initiation & Completion Year
Figure 7-8: IMC002 Phase 1 Study - Initiation & Completion Year
Figure 7-9: TAC01-CLDN18.2 Phase 1/2 Study - Initiation & Completion Year
Figure 7-10: ZZCART-002 Phase 1 Study - Initiation & Completion Year
Figure 8-1: CARsgen Pharmaceuticals - CycloCAR platform
Figure 8-2: LaNova - LX-ADC(TM) Platform
Figure 8-3: Phanes Therapeutics - PACbody
Figure 8-4: Phanes Therapeutics - SPECpair
Figure 9-1: Global - Claudin 18.2 Drugs Clinical Trials by Company (Numbers), 2024 till 2029
Figure 9-2: Global - Claudin 18.2 Drugs Clinical Trials by Country (Numbers), 2024 till 2029
Figure 9-3: Global - Claudin 18.2 Drugs Clinical Trials by Indication (Numbers), 2024 till 2029
Figure 9-4: Global - Claudin 18.2 Drugs Clinical Trials by Patient Segment (Numbers), 2024 till 2029
Figure 9-5: Global - Claudin 18.2 Drugs Clinical Trials by Phase (Numbers), 2024 till 2029

List of Tables

Table 1-1: Subfamilies of Claudin involved in Different Types of Cancer Formation
Table 2-1: Monoclonal Antibodies Targeting Claudin 18.2 in Clinical Trials
Table 2-2: Bispecific Antibodies Targeting Claudin 18.2 in Clinical Trials
Table 2-3: CAR-T Therapies Targeting Claudin 18.2 in Clinical Trials
Table 2-4: Antibody Drug Conjugates Targeting Claudin 18.2 in Clinical Trials
Table 3-1: Approved Claudin 18.2 Targeting Therapies
Table 4-1: Vyloy - Recommended Dose Modifications in case of Adverse Reactions
Table 5-1: Claudin18.2 Targeting Therapies in Phase 3
Table 6-1: US - Claudin 18.2 Therapies in Ongoing Clinical Trials
Table 6-2: China - Claudin 18.2 Therapies in Ongoing Clinical Trials
Table 6-3: EU - Claudin 18.2 Therapies in Ongoing Clinical Trials
Table 6-4: UK - Claudin 18.2 Therapies in Ongoing Clinical Trials
Table 6-5: Japan - Claudin 18.2 Therapies in Ongoing Clinical Trials
Table 6-6: Australia - Claudin 18.2 Therapies in Ongoing Clinical Trials

Table 6 7: South Korea - Claudin 18.2 Therapies in Ongoing Clinical Trials

Table 7-1: Gastric Cancer - Claudin 18.2 Therapies in Ongoing Clinical Trials
Table 7-2: Pancreatic Cancer - Claudin 18.2 Therapies in Ongoing Clinical Trials

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