 |
市場調查報告書
商品編碼
2112619
全球個人化癌症疫苗市場：市場機會、臨床創新、開發技術平台和臨床試驗洞察（2031 年）Global Personalized Cancer Vaccines Market Opportunity, Clinical Innovation, Development Technology Platforms & Clinical Trials Insight 2031 |
||||||
「全球個人化癌症疫苗市場—市場機會、臨床創新、開發技術平台和臨床試驗洞察（2031 年）」報告的主要發現和亮點：
- 目前市面上只有一種核准疫苗：Provenz。
- 預計到 2031 年，非小細胞肺癌 (NSCLC) 和惡性黑色素瘤的下一批上市批准藥物將陸續獲批。
- 唯一已通過核准的個人化癌症疫苗的價格和劑量分析
- 按適應症和地區分類的臨床創造趨勢展望
- 臨床試驗中個人化癌症疫苗的最新進展：超過20種疫苗
- 依研發公司、適應症和試驗階段分析個人化癌症疫苗臨床試驗。
- 對一種用於個人化癌症疫苗的專有開發平台進行分析
- 競爭格局
個人化癌症疫苗的必要性及本報告的意義
個人化癌症疫苗已成為下一代癌症免疫療法的關鍵領域，這主要得益於人們對針對個別腫瘤獨特分子特徵量身定做的治療方法的日益關注。與基於腫瘤相關抗原的傳統癌症疫苗不同，個人化疫苗專注於特定的患者突變或新抗原。基因測序、人工智慧驅動的抗原預測、mRNA技術和個人化生產技術的進步顯著提升了多種癌症適應症的研發活動。市場已超越純粹的實驗階段，候選藥物如Intismeran Autogene已進入III期臨床試驗，而Autogene Cevumeran也已進入II期臨床試驗。個人化癌症疫苗「Provenge」已取得商業性成功，成為首個獲得FDA批准的個人化癌症疫苗。
本報告對個人化癌症疫苗市場進行了全面評估，內容涵蓋科學證據、臨床開發、技術趨勢、競爭格局和商業化潛力。報告也分析了癌症疫苗研發策略的演變、新抗原和人類白血球抗原（HLA）的重要性，以及藥物基因體學、預後生物標記和預測生物標記在個人化疫苗開發中的作用。最後，報告檢驗了包括Provenge在內的新型個人化癌症疫苗產品，評估了它們的臨床開發現狀、治療方案和商業化機會。本報告旨在為製藥和生物技術公司、投資者、研究人員、醫療機構以及其他對了解個人化癌症疫苗發展趨勢感興趣的相關人員提供指南。
本報告中包含對臨床試驗的深入分析
臨床開發是個人化癌症疫苗市場的關鍵領域，目前針對多種固體癌和血液系統惡性腫瘤的研究正在積極進行中。現有研究正在評估個人化癌症疫苗在治療黑色素瘤、肺癌、胃腸道癌症（包括胰臟癌）、乳癌、攝護腺癌、婦科癌症、腦腫瘤和血液系統惡性腫瘤的療效。尤其值得關注的是，個人化癌症疫苗與腫瘤切除術合併作為輔助性治療的應用。此外，與免疫查核點抑制劑聯合治療也引起了臨床開發的關注。
本報告深入分析了正在進行和已完成的臨床試驗，重點關注癌症類型、疫苗平台、治療環境、聯合治療、臨床終點和研發狀態等關鍵特徵。該報告還考察了主要項目的長期臨床結果，概述了個人化疫苗的最新證據。該分析反映了個人化疫苗領域如何從概念驗證階段發展到高級臨床開發階段。
參與個人化癌症疫苗研發的領導公司
除了製藥和生技公司外，許多科技公司也紛紛進軍個人化癌症疫苗領域。 Moderna 和 Merck 是兩家在個人化癌症疫苗研發領域最為突出的公司，這主要得益於其研發的 intismeran autogene，這是目前唯一一款正在研發並進行 III 期臨床試驗的個人化癌症疫苗。 BioNTech 也憑藉其個人化新抗原疫苗平台和 autogene cevumeran（一種目前正在進行 II 期臨床試驗的候選藥物）確立了強大的市場地位。
其他在該領域做出貢獻的公司包括CureVac、Geneos Therapeutics、Genentech和TuHURA Biosciences。這些公司利用各自的平台，探索mRNA、胜肽、病毒載體、生物材料和其他類型疫苗的不同研發方法。用於疫苗研發的專有平台包括BioNTech的「iNeST」、Moderna的「mRNA Design Studio」和Transgene的「myvac」。製藥公司、生物技術公司、大學和技術供應商之間的合作持續推動臨床開發和平台開發領域的市場成長。
個人化癌症疫苗市場未來展望
個人化癌症疫苗市場預計將朝著多個方向發展，包括臨床療效檢驗、拓展應用範圍至其他癌症類型，以及個人化疫苗設計和生產技術的進步。全基因組定序和腫瘤定序與人工智慧（AI）的結合有望增加每位患者可識別的新抗原數量。同時，mRNA和其他高度柔軟性的疫苗平台將推動個人化疫苗的大規模開發。
此外，個人化疫苗預計將擴大與免疫療法（尤其是免疫查核點抑制劑）合併使用。生物標記研發的進展也有助於臨床試驗的病患篩選和試驗設計改進。北美、歐洲和亞太地區的活躍度活性化顯示個人化癌症疫苗研發正走向全球化。總之，後期候選藥物的研發、不斷擴大的臨床試驗以及大型製藥和生物技術公司的參與表明，個人化癌症疫苗領域在不斷發展的癌症免疫療法領域中正佔日益重要的地位。
目錄
第1章：調查方法
第2章：個人化癌症疫苗：推動下一代癌症免疫療法
- 癌症疫苗策略方法
- 癌症疫苗－當前進展與挑戰
第3章：支持個人化癌症疫苗有效性的機制
- 腫瘤新抗原和人類白血球抗原的作用
- 個性化癌症疫苗的作用機制
- 藥理基因體學中的遺傳多態性
- 癌症藥理基因體學和體細胞突變
第4章：生物標記在個人化癌症疫苗設計中的重要性
- 藥理基因生物標記
- 預後生物標記
第5章：個人化癌症疫苗臨床試驗的啟示：依研發者、適應症和分期分類
第6章： Provenge首個核准的個人化癌症疫苗
- 概述和專利考量
- 定價和劑量方面的見解
第7章 當前臨床開發及未來商業化前景
- 當前市場趨勢
- 未來市場展望
第8章：個人化癌症疫苗的臨床趨勢與發展現況及適應症分析
- 黑色素瘤
- 肺癌
- 乳癌
- 攝護腺癌
- 胃腸道癌症
- 婦科癌症
- 腦腫瘤
- 骨髓惡性腫瘤
第9章：按地區分類的個人化癌症疫苗的臨床和市場趨勢
- 美國
- 歐洲聯盟
- 中國
- 印度
- 澳洲
- 韓國
- 台灣
- 英國
第10章：用於個人化癌症疫苗的專有開發平台
第11章：個人化癌症疫苗的市場動態
- 市場促進因素與機遇
- 市場挑戰與限制因素
第12章 競爭格局
- BioNtech AG
- CureVac AG
- Evaxion Biotech
- Geneos Therapeutics
- Genentech
- Merck
- Moderna Therapeutics
- NeoCura
- Transgene
- TuHURA Biosciences
Global Personalized Cancer Vaccines Market Opportunity, Clinical Innovation, Development Technology Platforms & Clinical Trials Insight 2031 Report Findings & Highlights:
- Currently Only 1 Vaccine Approved In Market: Provenge
- Next Commercial Approval Expected By 2031 For NSCL/Melanoma
- Pricing & Dosing Insight On Only Approved Personalized Cancer Vaccine
- Clinical Innovation Trends Outlook By Indication & Region
- Insight On Personalized Cancer Vaccines In Clinical Trials: > 20 Vaccines
- Personalized Cancer Vaccines Clinical Trials Insight By Developer, Indication & Phase
- Personalized Cancer Vaccines Proprietary Development Platforms Insight
- Competitive Landscape
Need For Personalized Cancer Vaccines & Why This Report?
Personalized cancer vaccines have emerged as a significant area of next generation cancer immunotherapy, driven by increasing interest in therapeutic approaches tailored to the unique molecular characteristics of individual tumors. Differing from traditional cancer vaccines, which are based on tumor associated antigens, personalized vaccines are focused on particular patient mutations and neoantigens. Due to advancements in genomic sequencing, AI-driven antigen prediction, mRNA technology, and personalized manufacturing, a significant increase in R&D activity has been observed across various indications of cancer. The market has moved beyond purely experimental stage, and some of the candidates, such as intismeran autogene, have reached Phase 3 clinical trials, while autogene cevumeran is already undergoing Phase 2 evaluation. Personalized cancer vaccine Provenge has shown its commercial success as the first approved by FDA personalized cancer vaccine.
This report offers an overall evaluation of the personalized cancer vaccine market that includes scientific basis, clinical developments, technological trends, competitive landscape, and commercialization possibilities. The review also analyzes the evolution of cancer vaccine approaches, the importance of neoantigen and human leukocyte antigen and the involvement of pharmacogenomic, prognostic, and predictive biomarkers in the development of individualized vaccines. Finally, the report examines Provenge as well as new personalized cancer vaccine products and assesses their clinical developments, treatment options, and commercialization opportunities. The report aims to provide guidance for pharmaceutical and biotechnology companies, investors, researchers, healthcare organizations, and any other stakeholder that may be interested in understanding the evolving landscape of personalized cancer vaccines.
Clinical Trials Insight Included In Report
The clinical development segment is one of the major segments in the market for personalized cancer vaccines, with growing research being conducted on various solid and hematological cancers. At present, the studies are assessing the efficacy of personalized cancer vaccines in the treatment of melanoma, lung cancer, gastrointestinal cancer (pancreatic cancer included), breast cancer, prostate cancer, gynecological cancer, brain cancer, and hematological cancer. The focus is being laid on the use of personalized cancer vaccines in combination with surgical resection of tumors for adjuvant therapy. In addition, combination treatments with immune checkpoint inhibitors are gaining popularity in clinical development.
The report provides insights on ongoing and concluded clinical trials, analyzing their important characteristics, such as type of cancer, vaccine platform, treatment setting, combination therapies, clinical endpoints, and development status. Clinical results from major programs for a longer period of time are also considered in order to give an overview of the recent evidence on personalized vaccines. The analysis reflects how the area of personalized vaccine has transformed from the stage of proving the concept to the stage of advanced clinical development.
Major Companies Involved In Personalized Cancer Vaccine R&D
In terms of personalized cancer vaccine, there is a number of pharmaceutical and biotech companies, as well as technology firms. Moderna and Merck are two of the most prominent companies involved in personalized cancer vaccine development thanks to intismeran autogene, the most advanced personalized cancer vaccine currently and the only one being assessed in Phase 3 trials. BioNTech has also managed to make a strong position thanks to its individualized neoantigen vaccine platform and their candidate, autogene cevumeran, that is under investigation in Phase 2.
Other companies that are making contributions in this sector include CureVac, Geneos Therapeutics, Genentech, TuHURA Biosciences, among others. They are taking different directions with regard to mRNA, peptide, viral vector, biomaterial and other types of vaccines using their platforms. Some examples of proprietary platforms that have been used to develop such vaccines include iNeST by BioNTech, mRNA Design Studio by Moderna, and myvac by Transgene. Partnerships among pharmaceutical companies, biotech companies, universities, and technology providers also continue to facilitate the growth of the market in terms of both clinical and platform development.
Future Outlook For Personalized Cancer Vaccines Market
The direction that the personalized cancer vaccine market is likely to take will involve clinical validation, expansion into other types of cancers, as well as developments in the areas of individualized vaccine design and manufacturing. Integration of whole genome and tumor sequencing with artificial intelligence is likely to increase the number of neoantigens identified for patients, while mRNA and other flexible vaccine platforms will allow the development of individualized vaccines in larger volumes.
In addition to that, personalized vaccines are expected to be increasingly used in conjunction with immunotherapies, especially immune checkpoint inhibitors. In addition, advances in biomarker development may facilitate patient selection for trials as well as improve the design of trials. The growing activity in North America, Europe, and Asia-Pacific shows that the field of personalized cancer vaccine development is becoming global. In summary, late-stage candidate development, the expansion of clinical trials, and the involvement of large pharma and biotech companies indicate that the personalized cancer vaccine space is becoming an increasingly important part of the changing cancer immunotherapy landscape.
Table of Contents
1. Research Methodology
2. Personalized Cancer Vaccines: Advancing Next Generation Cancer Immunotherapy
- 2.1 Approach To Cancer Vaccine Strategy
- 2.2 Cancer Vaccines - Current Progress & Challenges
3. Mechanism Underlying Personalized Cancer Vaccine Efficacy
- 3.1 Role of Tumor Neoantigens & Human Leukocyte Antigen
- 3.2 Personalized Cancer Vaccine Working Mechanism
- 3.3 Genetic Polymorphism In Pharmacogenomics
- 3.4 Cancer Pharmacogenomics & Somatic Mutations
4. Significance Of Biomarkers In Personalized Cancer Vaccine Design
- 4.1 Pharmacogenomic Biomarkers
- 4.2 Prognostic & Predictive Biomarkers
5. Personalized Cancer Vaccines Clinical Trials Insight By Developer, Indication & Phase
6. Provenge - 1st Approved Personalized Cancer Vaccine
- 6.1 Overview & Patent Insight
- 6.2 Pricing & Dosing Insight
7. Current Clinical Development & Future Commercialization Outlook
- 7.1 Current Market Development Scenario
- 7.2 Future Market Outlook
8. Personalized Cancer Vaccines Clinical Tends & Developments Insight By Indication
- 8.1 Melanoma
- 8.2 Lung Cancer
- 8.3 Breast Cancer
- 8.4 Prostate Cancer
- 8.5 Gastrointestinal Cancers
- 8.6 Gynecological Cancers
- 8.7 Brain Tumor
- 8.8 Hematological Malignancies
9. Personalized Cancer Vaccines Clinical & Market Insight By Region
- 9.1 US
- 9.2 EU
- 9.3 China
- 9.4 India
- 9.5 Australia
- 9.6 South Korea
- 9.7 Taiwan
- 9.8 UK
10. Personalized Cancer Vaccines Proprietary Development Platforms
11. Personalized Cancer Vaccine Market Dynamics
- 11.1 Market Drivers & Opportunities
- 11.2 Market Challenges & Restraints
12. Competitive Landscape
- 12.1 BioNtech AG
- 12.2 CureVac AG
- 12.3 Evaxion Biotech
- 12.4 Geneos Therapeutics
- 12.5 Genentech
- 12.6 Merck
- 12.7 Moderna Therapeutics
- 12.8 NeoCura
- 12.9 Transgene
- 12.10 TuHURA Biosciences
List of Figures
- Figure 2-1: Cancer Vaccine Types
- Figure 2-2: Advantages Of Targeting Neoantigens In Cancer Vaccine Development
- Figure 3-1: Neoantigen-T-cell recognition
- Figure 3-2: Personalized Cancer Vaccine - Mechanism
- Figure 3-3: Demonstrating Genomic Polymorphism In Pharmacogenomics
- Figure 3-4: Source of Pharmacological & Pharmacogenetic Variability
- Figure 3-5: Tumor vs. Normal Genetic Profile
- Figure 4-1: Biomarkers In Personalized Medicine
- Figure 4-2: Pharmacogenomic Biomarkers In Cancer Vaccines
- Figure 4-3: Prognostic vs Predictive Biomarkers
- Figure 4-4: Roadmap For Developing Predictive Biomarkers
- Figure 6-1: Provenge - Approval Year By Region
- Figure 6-2: Provenge - Cost Per Unit & Supply (US$), August'2026
- Figure 7-1: Global Personalized Cancer Vaccines Market - Future Outlook
- Figure 8-1: KEYNOTE-942 Phase 2 (NCT03897881) Study - Initiation & Completion Year
- Figure 8-2: INTerpath-001 Phase 3 (NCT05933577) Study - Initiation & Completion Year
- Figure 8-3: KEYNOTE-D36 Phase 2 (NCT05309421) Study - Initiation & Completion Year
- Figure 8-4: 18-279 Phase 1 (NCT03929029) Study - Initiation & Completion Year
- Figure 8-5: KEYNOTE-603 Phase 1 (NCT03313778) Study - Initiation & Completion Year
- Figure 8-6: V940-002 Phase 3 (NCT06077760) Study - Initiation & Completion Year
- Figure 8-7: INTerpath-009 Phase 3 (NCT06623422) Study - Initiation & Completion Year
- Figure 8-8: INTerpath-013 Phase 2 (NCT07221474) Study - Initiation & Completion Year
- Figure 8-9: INTerpath-014 Phase 3 (NCT07513376) Study - Initiation & Completion Year
- Figure 8-10: CHUV-DO-0022-LUNGVAC-2019 Phase 1 (NCT06077760) Study - Initiation & Completion Year
- Figure 8-11: 202104143 Phase 2 (NCT04397003) Study - Initiation & Completion Year
- Figure 8-12: MCC-20915 Phase 2 (NCT05325632) Study - Initiation & Completion Year
- Figure 8-13: PNeoVCA Phase 1/2 (NCT05269381) Study - Initiation & Completion Year
- Figure 8-14: MCC-22003 Phase 2 (NCT05751941) Study - Initiation & Completion Year
- Figure 8-15: 2000035188 Phase 2 (NCT06100705) Study - Initiation & Completion Year
- Figure 8-16: ProvONE Phase 2 (NCT06134232) Study - Initiation & Completion Year
- Figure 8-17: FK-PC101-01 Phase 2 (NCT06636682) Study - Initiation & Completion Year
- Figure 8-18: LEGION-100-2a Phase 2 (NCT06533644) Study - Initiation & Completion Year
- Figure 8-19: 19-039 Phase 1 (NCT04161755) Study - Initiation & Completion Year
- Figure 8-20: IMCODE003 Phase 2 (NCT05968326) Study - Initiation & Completion Year
- Figure 8-21: GT-30 Phase 1/2 (NCT04251117) Study - Initiation & Completion Year
- Figure 8-22: NCI-2016-00015 Phase 1 (NCT02600949) Study - Initiation & Completion Year
- Figure 8-23: CHANT-191 Phase 1 (NCT04147078) Study - Initiation & Completion Year
- Figure 8-24: QUILT 502 Phase 1/2 (NCT06253494) Study - Initiation & Completion Year
- Figure 8-25: CIP2023-001 Phase 1 (NCT06366490) Study - Initiation & Completion Year
- Figure 8-26: NCI-2024-00210 Phase 1 (NCT06342908) Study - Initiation & Completion Year
- Figure 8-27: GT-20 Phase 1 (NCT04015700) Study - Initiation & Completion Year
- Figure 8-28: 14-362 Phase 1 (NCT02287428) Study - Initiation & Completion Year
- Figure 8-29: 17-1051 Phase 1 (NCT03219450) Study - Initiation & Completion Year
- Figure 8-30: 17-353 Phase 1 (NCT03361852) Study - Initiation & Completion Year
- Figure 8-31: 24-439 Phase 1 (NCT06799026) Study - Initiation & Completion Year
- Figure 10-1: BioNTech - iNeST
- Figure 10-2: BioVaxys - DPX & Haptenix Platforms
- Figure 10-3: CureVac - proprietary mRNA technology
- Figure 10-4: Evaxion -Proprietary Technologies
- Figure 10-5: Geneos - GT-EPIC Platform
- Figure 10-6: Moderna - mRNA Design Studio Features
- Figure 10-7: myNEO Therapeutics - ImmunoEngine
- Figure 10-8: Nouscom - Unnamed Technology
- Figure 10-9: Nykode Therapeutics - Vaccibody Structure
- Figure 10-10: Nykode Therapeutics - Vaccibody Mechanism Of Action
- Figure 10-11: Transgene - myvac Platform
- Figure 11-1: Global Personalized Cancer Vaccines Market - Drivers & Opportunities
- Figure 11-2: Global Personalized Cancer Vaccines Market - Challenges & Restraints
List of Tables
- Table 3-1: Comparison Of HLA/MHC Class I & Class II
- Table 4-1: Prognostic & Predictive Biomarkers - Examples
- Table 5-1: Personalized Cancer Vaccines By Developer, Indication & Phase
