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世界のTCR療法市場(第2版)、2022-2035年:標的適応症別(上咽頭がん、多発性骨髄腫、頭頸部がん、肉腫、黒色腫、急性骨髄性白血病、肺がん、卵巣がん、メルケル細胞がん)、標的抗原別(NY-ESO-1、EBV、gp100、その他)、主要メーカー別、主要地域別(北米、欧州、アジア太平洋、中南米、中東・北アフリカ、その他地域)の分布:産業動向と世界予測、2022-2035年


Global TCR Therapy Market (2nd Edition), 2022-2035: Distribution by Target Indication (Nasopharyngeal Carcinoma, Multiple Myeloma, Head and Neck Carcinoma, Sarcoma, Melanoma, Acute Myeloid Leukemia, Lung Cancer, Ovarian Cancer, and Merkel Cell Cancer), Target Antigen (NY-ESO-1, EBV, gp100, and others), Key Players and Key Geographies (North America, Europe, Asia Pacific, Latin America, Middle East and North Africa, and Rest of the World): Industry Trends and Global Forecasts, 2022-2035

TCR療法市場は、2023年には10億3,000万米ドルに達し、2023年から2035年の予測期間中にCAGR 51%で成長すると予測されている。 T細胞受容体(TCR)ベースの療法は、養子細胞療法の中でも急成長している分野であ... もっと見る

 

 

出版社 出版年月 電子版価格 ページ数 言語
Roots Analysis
ルーツアナリシス
2023年1月1日 US$4,799
シングルユーザライセンス
ライセンス・価格情報
注文方法はこちら
363 英語

 

サマリー

TCR療法市場は、2023年には10億3,000万米ドルに達し、2023年から2035年の予測期間中にCAGR 51%で成長すると予測されている。

T細胞受容体(TCR)ベースの療法は、養子細胞療法の中でも急成長している分野である。TCR療法は、特定の腫瘍マーカーを標的にするために、遺伝子組み換えによってリンパ球を操作するものである。腫瘍細胞を除去するこれらの治療法の有効性は、主にがん特異的抗原に対するこれまでの感作に依存している。この特性により、治療に伴う潜在的な副作用を軽減しながら、体内の腫瘍細胞を選択的に見つけ、除去することが可能となる。この分野への関心が高まっているのは、特に様々な血液癌や固形癌を対象とした過去の臨床試験で認められた有望な結果によるものである。この勢いは、投資家からの多額の資金援助と臨床試験結果の楽観的な傾向によってさらに加速している。その結果、T細胞受容体治療市場は予測期間中に大幅な成長が見込まれる。

レポート範囲
 本調査で得られた知見をまとめたエグゼクティブサマリー。短中期および長期的なTCRベースの治療市場の進化に関するハイレベルな見解を提供しています。
 TCRベース療法の概要。本セクションでは、様々な腫瘍学的適応症の治療に使用されている従来型の治療法について簡単に説明した。さらに、がん免疫療法の出現と歴史的変遷、T細胞免疫療法の一般的な製造手順、TCRベースの治療法開発における主要な属性についての考察も含まれている。
 現在承認されている、あるいは開発段階にある190以上のTCRベースの治療薬の現在の市場状況を詳細に評価。開発者のタイプ(産業/非産業)、開発フェーズ(承認済み、フェーズⅡ、フェーズⅠ/Ⅱ、フェーズⅠ、前臨床)、治療領域(血液がん、固形がん、非公開)、主要標的適応症(肺がん、メラノーマ、肝細胞がん、子宮頸がん、卵巣がん、肉腫、乳がん、胃がん、多発性骨髄腫、膵がん、急性骨髄性白血病、骨髄異形成症候群、上咽頭癌、その他)、主要標的抗原(NY-ESO-1、MAGE、HBV、PRAME、KRAS、EBV、HPV、ネオアンチゲン、LAGE-1a、Meso、HLA、その他)、T細胞の供給源(自家/同種)、投与経路(静脈内投与、腫瘍内投与)、投与回数(単回投与、複数回投与、分割投与)、対象患者セグメント(小児、成人、高齢者)、治療タイプ(単剤治療、併用療法)。さらに、TCRに基づく治療法の開発に最も積極的に取り組んでいる業界および非業界のプレーヤー(パイプライン候補の数で)を取り上げている。さらに本章では、設立年、企業規模(小規模、中規模、大規模)、本社所在地(北米、欧州、アジア太平洋)など、いくつかの関連パラメータに基づく開発企業ランドスケープ分析も掲載している。
 包括的な標的抗原分析。血液悪性腫瘍および固形癌に関連する最も人気のある標的抗原にスポットを当て、潜在的な標的を特定するため、様々な業界関係者が特定のタイプの抗原に対して開発中の TCR ベースの治療薬の数に基づく。
 臨床試験登録年、登録患者数、臨床試験募集状況、臨床試験フェーズ、対象患者セグメント、スポンサー/共同研究者のタイプ、最も活発なプレーヤー(登録試験数)、地域など、いくつかの関連パラメータに基づく、TCRベース療法に関連する完了済み、進行中、および計画中の臨床試験の詳細分析。
 この領域におけるキー・オピニオン・リーダー(KOL)に焦点を当てた分析で、TCRに基づく治療法の研究開発に積極的に関与しているKOLとみなし、TCRに基づく治療法に関連する臨床試験の様々な治験責任医師を分析している。また、独自の採点基準に基づき、KOLの相対的な専門性を第三者と比較している。
 上市済みおよび中期・後期段階のTCRベース治療薬(第I/II相以上)の詳細なプロフ ァイル。各プロフィールには、治療法の概要、作用機序、用法・用量、費用や販売情報(入手可能な場合)の詳細、臨床開発計画、主要な臨床試験結果などが掲載されています。
 研究開発契約、ライセンス契約(技術プラットフォームや製品候補に特化)、製品開発・商業化契約、製造契約、臨床試験提携、製品供給管理契約、合弁事業、その他、関係企業、治療法の種類、主要な製品候補、提携の地域分布を網羅。
 シード・ファイナンス、ベンチャー・キャピタルからの資金調達、IPOやその後の株式公開による資金調達、助成金、デット・ファイナンスなど、独自のTCRベースの製品/技術を持つ企業に対して行われた様々な資金調達や投資の詳細。2005年から2022年の間に行われた資金調達事例の詳細な分析も含まれており、ベンチャーキャピタル(VC)コミュニティやその他の戦略的投資家のこの分野への関心の高まりを浮き彫りにしています。
 特許の種類(付与、特許出願、調査報告)、特許公開年、地理的分布、特許分類(CPC)記号、新たな重点分野、プレーヤーの種類、リーディングプレーヤー(特許数)、特許ベンチマークなど、複数の関連パラメータに基づき、2022年までに出願/付与されたTCRベースの治療に関連する特許を詳細に分析。さらに、特許の質的・量的側面を評価する特許評価分析も備えています。
 細胞治療製造に関するケーススタディでは、この領域に存在する現在の課題と、細胞治療製造施設を所有・維持するための前提条件を強調している。さらに、様々な細胞治療メーカーの詳細なリストが含まれており、製造受託機関と自社製造能力を持つ企業の両方を網羅している。本章で取り上げた企業については、様々な製造施設の所在地、製造している製品、事業規模、cGMP基準への準拠に関する詳細を記載している。
 細胞治療薬の価格を決定する際に考慮しなければならない様々な要因についての見解。製薬会社がTCRベースの治療製品の販売価格を決定するために選択しうる様々なモデル/アプローチに関する議論を掲載しています。さらに、TCRをベースとした治療薬の償還に関する考察についても簡単に概説している。
 TCRベース療法が提供する将来の商業的機会に関する詳細な考察。承認済み、または第I/II相、第II相の開発段階にあるTCRベースの製品について、対象となる患者層、既存/将来の競合、採用される可能性のある割合、異なる治療法の予想価格などを考慮した包括的な市場予測分析を行っている。また、本章では、標的適応症(上咽頭がん、多発性骨髄腫、頭頸部がん、肉腫、黒色腫、急性骨髄性白血病、肺がん、卵巣がん、メルケル細胞がん)、標的抗原(NY-ESO-1、EBV、gp100、その他)、主要プレイヤー、主要地域(北米、欧州、アジア太平洋、中南米、中東・北アフリカ、その他の地域)に基づく詳細な市場セグメンテーションも示しています。

主要市場企業
 Adaptimmune Therapeutics
 Alaunos Therapeutics
 ブリストル・マイヤーズスクイブ
 セルラーバイオメディシン
 ギリアド・バイオサイエンス
 グラクソ・スミスクライン
 イマティクス
 イムノコア
 ライオン TCR
 タカラバイオ
 ゼルナ免疫療法

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目次

1. PREFACE
1.1. Chapter Overview
1.2. Market Segmentations
1.3. Research Methodology
1.4. Key Questions Answered
1.5. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Pillars of Cancer Therapy
3.3. Overview of Immunotherapies
3.4. Fundamentals of Cancer Immunotherapy
3.5. Classification of Cancer Immunotherapies
3.5.1. By Mechanism of Action
3.5.1.1. Active Immunotherapy
3.5.1.2. Passive Immunotherapy
3.5.2. By Type of Target
3.5.3. By Approach
3.5.3.1. Activation and Suppression Immunotherapy
3.5.4. By Product Class
3.5.4.1. Monoclonal Antibodies
3.5.4.2. Bispecific Antibodies
3.5.4.3. Cytokines
3.5.4.4. Oncolytic Virus Therapy
3.5.4.5. Therapeutic Cancer Vaccines
3.5.4.6. Cell-based Therapies
3.6. T Cell Immunotherapies
3.6.1. Historical Evolution
3.6.2. Key Considerations for Developing T Cell Immunotherapies
3.6.3. Strategies Employed for the Redirection of T-Cells
3.6.4. Manufacturing of Engineered T Cells
3.6.5. T-Cell Transduction and Transfection Methods
3.6.5.1. Retroviral Vectors
3.6.5.2. Lentiviral Vectors
3.6.5.3. Non-viral Transfection Methods
3.7. T-Cell Receptor (TCR)-based Cell Therapy
3.7.1. Development History
3.7.2. Anatomical Layout of TCR
3.7.3. Development of TCR Therapy
3.7.4. Differences between CAR-T and TCR Therapies
3.8. Concluding Remarks
4. TCR THERAPIES: MARKET LANDSCAPE
4.1. Chapter Overview
4.2. TCR Therapies: Overall Market Landscape
4.2.1. Analysis by Type of Developer
4.2.2. Analysis by Phase of Development
4.2.3. Analysis by Therapeutic Area
4.2.4. Analysis by Phase of Development and Therapeutic Area
4.2.5. Analysis by Key Target Indication
4.2.6. Analysis by Key Target Antigen
4.2.7. Analysis by Source of T-Cells
4.2.8. Analysis by Route of Administration
4.2.9. Analysis by Phase of Development and Route of Administration
4.2.10. Analysis by Dosing Frequency
4.2.11. Analysis by Target Patient Segment
4.2.12. Analysis by Type of Therapy
4.2.13. Analysis by Phase of Development and Type of Therapy
4.2.14. Most Active Industry Players: Analysis by Number of TCR Therapies
4.2.15. Most Active Non-Industry Players: Analysis by Number of TCR Therapies
4.3. TCR Therapies: Overall Developer Landscape
4.3.1. Analysis by Year of Establishment
4.3.2. Analysis by Company Size
4.3.3. Analysis by Location of Headquarters
5. POPULAR TARGET ANTIGEN ANALYSIS
5.1. Chapter Overview
5.2. Competitive Analysis: Popular Target Antigens of TCR Therapies
5.2.1. Popular Targets Related to Hematological Malignancies
5.2.2. Popular Targets Related to Solid Tumors
6. CLINICAL TRIAL ANALYSIS
6.1. Chapter Overview
6.2. Scope and Methodology
6.3. TCR Therapies: Clinical Trial Analysis
6.3.1. Analysis by Trial Registration Year
6.3.2. Analysis by Trial Registration Year and Enrolled Patient Population
6.3.3. Analysis by Trial Status
6.3.4. Analysis by Trial Registration Year and Trial Status
6.3.5. Analysis by Trial Phase
6.3.6. Analysis of Enrolled Patient Population by Trial Phase
6.3.7. Analysis by Target Patient Segment
6.3.8. Analysis by Type of Sponsor / Collaborator
6.3.9. Analysis by Study Design
6.3.10. Most Active Industry Players: Analysis by Number of Registered Trials
6.3.11. Most Active Non-Industry Players: Analysis by Number of Registered Trials
6.3.12. Word Cloud Representation Analysis: Emerging Focus Areas
6.3.13. Analysis of Clinical Trials by Geography
6.3.14. Analysis of Enrolled Patient Population by Geography
7. KEY OPINION LEADERS
7.1. Chapter Overview
7.2. Assumptions and Key Parameters
7.3. Methodology
7.4. TCR Therapies: Key Opinion Leaders
7.4.1. Analysis by Type of Organization
7.4.2. Analysis by Affiliated Organization
7.4.3. Analysis by Qualification
7.4.4. Analysis by Geographical Location of KOLs
7.4.5. KOL Activeness versus KOL Strength
7.4.6. Most Prominent KOLs: Analysis by RA score
7.4.7. Most Prominent KOLs: Comparison of RA Score and Third-Party Score
8. T CELL RECEPTOR THERAPY PROFILES
8.1. Chapter Overview
8.2. Kimmtrak® / IMCgp100 / Tebentafusp (Immunocore)
8.2.1. Therapy Overview
8.2.2. Clinical Trial Information
8.2.3. Clinical Trial Endpoints
8.2.4. Clinical Trial Results
8.2.5. Estimated Sales Revenues
8.3. GSK3377794 / NY-ESO-1C259 T-cells / Letetresgene Autoleucel (GlaxoSmithKline)
8.3.1. Therapy Overview
8.3.2. Clinical Trial Information
8.3.3. Clinical Trial Endpoints
8.3.4. Clinical Trial Results
8.3.5. Estimated Sales Revenues
8.4. ADP-A2M4 / Afamitresgene Autoleucel / Afami-cel (Adaptimmune Therapeutics)
8.4.1. Therapy Overview
8.4.2. Clinical Trial Information
8.4.3. Clinical Trial Endpoints
8.4.4. Clinical Trial Results
8.4.5. Estimated Sales Revenues
8.5. JTCR016 (Juno Therapeutics)
8.5.1. Therapy Overview
8.5.2. Clinical Trial Information
8.5.3. Clinical Trial Endpoints
8.6. TBI-1301 (Takara Bio)
8.6.1. Therapy Overview
8.6.2. Clinical Trial Information
8.6.3. Clinical Trial Endpoints
8.6.4. Clinical Trial Results
8.6.5. Estimated Sales Revenues
8.7. MDG1011 (Medigene)
8.7.1. Therapy Overview
8.7.2. Clinical Trial Information
8.7.3. Clinical Trial Endpoints
8.7.4. Clinical Trial Results
9. PARTNERSHIPS AND COLLABORATIONS
9.1. Chapter Overview
9.2. Partnership Models
9.3. TCR Therapies: Partnerships and Collaborations
9.3.1. Analysis by Year of Partnership
9.3.2. Analysis by Type of Partnership
9.3.3. Analysis by Year of Partnership and Type of Partnership
9.3.4. Analysis by Type of Partner
9.3.5. Most Popular Products: Analysis by Number of Partnerships
9.3.6. Most Active Industry Players: Analysis by Number of Partnerships
9.3.7. Most Active Non-Industry Players: Analysis by Number of Partnerships
9.3.8. Analysis by Geography
9.3.8.1. Intercontinental and Intracontinental Deals
9.3.8.2. International and Local Deals
10 FUNDING AND INVESTMENT ANALYSIS
10.1. Chapter Overview
10.2. Types of Funding
10.3. TCR Therapies: Funding and Investment Analysis
10.3.1. Analysis of Instances by Year
10.3.2. Analysis of Amount Invested by Year
10.3.3. Analysis by Type of Funding
10.3.4. Analysis by Type of Investor
10.3.5. Most Active Players: Analysis by Number of Instances
10.3.6. Most Active Investors: Analysis by Amount Invested
10.3.7. Analysis of Amount Invested by Geography
10.3.8. Most Active Investors: Analysis by Number of Funding Instances
11. PATENT ANALYSIS
11.1. Chapter Overview
11.2. Scope and Methodology
11.3. TCR Therapies: Patent Analysis
11.3.1. Analysis by Patent Publication Year
11.3.2. Analysis By Patent Application Year
11.3.3. Analysis by Geography
11.3.4. Analysis by Type of Player
11.3.5. Analysis by CPC Symbols
11.3.6. Analysis by Key Focus Area
11.3.7. Leading Player: Analysis by Number of Patents
11.3.8. TCR Therapies: Patent Benchmarking
11.3.9. Analysis By Patent Characteristics
11.3.10. TCR Therapies: Patent Valuation
12. CASE STUDY: CELL THERAPY MANUFACTURING
12.1. Chapter Overview
12.2. Overview of Cell Therapy Manufacturing
12.3. Cell Therapy Manufacturing Models
12.3.1. Centralized Manufacturing Model
12.3.2. Decentralized Manufacturing Model
12.4. Scalability of Cell Therapy Manufacturing Processes
12.4.1. Scale-Up
12.4.2. Scale-Out
12.5. Types of Cell Therapy Manufacturers
12.6. Key Challenges Related to Manufacturing of Cell Therapies
12.7. Important Factors for Cell Therapy Manufacturing
12.7.1. Characterization
12.7.2. Cost of Goods
12.8. Automation of Cell Therapy Manufacturing Processes
12.9. Cell Therapy Manufacturing Supply Chain
12.10. Comparison of Player Having In-House Capabilities and Contract Manufacturers
12.11. Regulatory Landscape
12.12. Future Perspectives
13. COST PRICE ANALYSIS
13.1. Chapter Overview
13.2. Factors Contributing to the High Price of Cell / Gene Therapies
13.3. Pricing Models for T-Cell Immunotherapies
13.3.1. Based on Associated Costs
13.3.2. Based on Availability of Competing Products
13.3.3. Based on Patient Segment
13.3.4. Based on Opinions of Industry Experts
13.4. Reimbursement related Considerations for T-cell Immunotherapies
13.4.1. Case Study: The National Institute for Health and Care Excellence (NICE) Appraisal of CAR-T Therapies
14. MARKET FORECAST AND OPPORTUNITY ANALYSIS
14.1. Chapter Overview
14.2. Scope and Limitations
14.3. Key Assumptions and Forecast Methodology
14.4. Global TCR Therapy Market, 2022-2035
14.4.1. TCR Therapy Market: Analysis by Target Indication
14.4.2. TCR Therapy Market: Analysis by Target Antigen
14.4.3. TCR Therapy Market: Analysis by Key Players
14.4.4. TCR Therapy Market: Distribution by Geography
14.4.5. Product Wise Sales Forecast
14.4.5.1. Kimmtrak® (IMCgp100 / Tebentafusp) (Immunocore)
14.4.5.1.1. Sales Forecast (USD Million)
14.4.5.1.2. Net Present Value (USD Million)
14.4.5.1.3. Value Creation Analysis

14.4.5.2. GSK3377794 (GlaxoSmithKline)
14.4.5.2.1. Sales Forecast (USD Million)
14.4.5.2.2. Net Present Value (USD Million)
14.4.5.2.3. Value Creation Analysis
14.4.5.3. YT-E001 (China Immunotech)
14.4.5.3.1. Sales Forecast (USD Million)
14.4.5.3.2. Net Present Value (USD Million)
14.4.5.3.3. Value Creation Analysis

14.4.5.4. ADP-A2M4 / Afamitresgene Autoleucel / Afami-cel (Adaptimmune Therapeutics)
14.4.5.4.1. Sales Forecast (USD Million)
14.4.5.4.2. Net Present Value (USD Million)
14.4.5.4.3. Value Creation Analysis
14.4.5.5. EBV-specific TCR-T cell with Anti-PD1 Aauto-secreted Element (TCRCure Biopharma)
14.4.5.5.1. Sales Forecast (USD Million)
14.4.5.5.2. Net Present Value (USD Million)
14.4.5.5.3. Value Creation Analysis
14.4.5.6. NTLA-5001 (Intellia Therapeutics)
14.4.5.6.1. Sales Forecast (USD Million)
14.4.5.6.2. Net Present Value (USD Million)
14.4.5.6.3. Value Creation Analysis
14.4.5.7. TBI-1301 (Takara Bio)
14.4.5.7.1. Sales Forecast (USD Million)
14.4.5.7.2. Net Present Value (USD Million)
14.4.5.7.3. Value Creation Analysis
14.4.5.8. LMBP2-specific TCR-T (Xinqiao Hospital of Chongqing / TCR CURE Biopharma Technology)
14.4.5.8.1. Sales Forecast (USD Million)
14.4.5.8.2. Net Present Value (USD Million)
14.4.5.8.3. Value Creation Analysis
14.4.5.9. FH-MCVA2TCR (TCRCure Biopharma)
14.4.5.9.1. Sales Forecast (USD Million)
14.4.5.9.2. Net Present Value (USD Million)
14.4.5.9.3. Value Creation Analysis
15. PROMOTIONAL ANALYSIS
15.1. Chapter Overview
15.2. Channels Used for Promotional Campaigns
15.3. Kimmtrak: Promotional Analysis
15.3.1. Drug Overview
15.3.2. Product Website Analysis
15.3.2.1. Message for Healthcare Professionals
15.3.2.2. Message for Patients
15.3.2.3. Informative Downloads
15.3.3. Patient Support Services
16. COMPANY PROFILES
16.1. Chapter Overview
16.2. Adaptimmune Therapeutics
16.3. Alaunos Therapeutics
16.4. Company Profiles
16.5. Bristol Myers Squibb
16.6. Cellular Biomedicine Group
16.7. Gilead Sciences
16.8. Cellular Biomedicine Group
16.9. GlaxoSmithKline
16.10. Immatics
16.11. Immunocore
16.12. Lion TCR
16.13. Takara Bio
16.14. Zelluna immunotherapy
17. CONCLUDING REMARKS
18. EXECUTIVE INSIGHTS
18.1. Chapter Overview
18.2. Celyad
18.2.1. Interview Transcript: Vincent Brichard, Vice President, Immuno-Oncology
18.3. Kite Pharma
18.3.1. Interview Transcript: Adrian Bot, Vice President, Scientific Affairs
18.4. Lion TCR
18.4.1. Interview Transcript: Victor Lietao Li, Co-Founder and Chief Executive Officer
18.5. TxCell
18.5.1. Interview Transcript: Miguel Forte, Chief Operating Officer
19. APPENDIX 1: TABULATED DATA
20. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

 

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Summary

The TCR therapy market is expected to reach USD 0.03 billion in 2023 anticipated to grow at a CAGR of 51% during the forecast period 2023-2035.

T-cell receptor (TCR) based therapy is a burgeoning area within adoptive cell therapy. It involves the manipulation of lymphocytes through genetic modifications to target specific tumor markers. The effectiveness of these therapies in eliminating tumor cells primarily relies on their previous sensitization to cancer-specific antigens. This attribute enables these interventions to selectively locate and eliminate tumor cells in the body while mitigating potential side effects associated with treatment. The growing interest in this field is driven by promising results observed in previous trials, particularly focused on various hematological cancers and solid tumors. This momentum is further fueled by significant financial support from investors and the optimistic trends in clinical trial outcomes. As a result, the market for T-cell receptor therapy is expected to witness substantial growth in the forecasted period.

Report Coverage
 An executive summary of the insights captured in our research. It offers a high-level view on the likely evolution of the TCR-based therapy market in the short to mid-term and long term.
 A general overview of TCR-based therapies. In this section, we have briefly discussed the conventional forms of therapy that are being used for the treatment of various oncological indications. Further, it includes a discussion on the advent and historical evolution of cancer immunotherapy, general manufacturing procedure of T-cell immunotherapies, and key attributes in development of TCR-based therapies.
 Detailed assessment of the current market landscape of more than 190 TCR-based therapies that are currently approved or are in different stages of the development. It features a comprehensive analysis of pipeline molecules with respect to the type of developer (industry / non-industry), phase of development (approved, phase II, phase I / II, phase I, and preclinical), therapeutic area (hematological cancer, solid tumor, and undisclosed), key target indication (lung cancer, melanoma, hepatocellular carcinoma, cervical cancer, ovarian cancer, sarcoma, breast cancer, gastric cancer, multiple myeloma, pancreatic cancer, acute myeloid leukemia, myelodysplastic syndrome, nasopharyngeal carcinoma, and others), key target antigen (NY-ESO-1, MAGE, HBV, PRAME, KRAS, EBV, HPV, Neoantigen, LAGE-1a, Meso, HLA, and others), source of T-cells (autologous / allogeneic), route of administration (intravenous and intratumoral), dose frequency (single dose, multiple dose, and split dose), target patient segment (children, adults and elderly patients), type of therapy (monotherapy and combination therapy). Additionally, it highlights the most active industry and non-industry players (in terms of number of pipeline candidates) engaged in development of TCR-based therapies. Further, chapter also includes developer landscape analysis based on some relevant parameters, including year of establishment, company size (small, mid-sized, and large) and location of headquarters (North America, Europe, and Asia Pacific).
 A comprehensive target antigen analysis, highlighting the most popular target antigens related to hematological malignancies and solid tumors, based on the number of TCR-based therapies that are being developed for a particular type of antigen by various industry stakeholders to identify potential targets.
 A detailed analysis of completed, ongoing, and planned clinical studies related to TCR-based therapies, based on several relevant parameters, such as trial registration year, enrolled patient population, trial recruitment status, trial phase, target patient segment, type of sponsor / collaborator, most active players (in terms of number of registered trials), and geography.
 An analysis highlighting the key opinion leaders (KOLs) in this domain, featuring an analysis of the various principal investigators of clinical trials related to TCR-based therapies, considering them to be KOLs, who are actively involved in R&D of TCR-based therapies. In addition, it compares the relative expertise of KOLs based on a proprietary scoring criterion with that of a third party.
 Detailed profiles of marketed and mid to late stage TCR-based therapies (phase I/II or above). Each profile features an overview of the therapy, its mechanism of action, dosage information, details on the cost and sales information (wherever available), clinical development plan, and key clinical trial results.
 An analysis of the recent partnerships inked between several stakeholders engaged in this domain, covering R&D agreements, license agreements (specific to technology platforms and product candidates), product development and commercialization agreements, manufacturing agreements, clinical trial collaborations, product supply management agreements, joint ventures, and others, companies involved, type of therapy, prominent product candidates involved and regional distribution of the collaborations.
 Details on the various funding and investments that have been made into companies having proprietary TCR-based products / technologies, including seed financing, venture capital financing, capital raised from IPOs and subsequent offerings, grants, and debt financing. It includes a detailed analysis of the funding instances that have taken place in the period between 2005 to 2022, highlighting the growing interest of venture capital (VC) community and other strategic investors in this domain.
 An in-depth analysis of patents related to TCR-based therapies, filed / granted till 2022, based on several relevant parameters, such as type of patent (granted, patent applications, and search reports), patent publication year, geographical distribution, Cooperative Patent Classification (CPC) symbols, emerging focus area, type of player, leading player (in terms of number of patents), and patent benchmarking. In addition, it features a patent valuation analysis, which evaluates the qualitative and quantitative aspects of the patents.
 Case study on cell therapy manufacturing, highlighting the current challenges that exist in this domain, and the pre-requisites for owning and maintaining cell therapy manufacturing sites. Additionally, it includes a detailed list of various cell therapy manufacturers, covering both contract manufacturing organizations and companies with in-house manufacturing capabilities. For the players mentioned in the chapter, we have included details on location of various manufacturing facilities, the products being manufactured, scale of operation and compliance to cGMP standards.
 Views on the various factors that must be taken into consideration while deciding the prices of cell-based therapies. It features discussions on different models / approaches that a pharmaceutical company may choose to follow to decide the price at which their TCR-based therapy product can be marketed. Additionally, we have provided a brief overview of the reimbursement consideration for TCR-based therapies.
 An elaborate discussion on the future commercial opportunity offered by TCR-based therapies. It provides a comprehensive market forecast analysis for TCR-based products that are approved or are in phase I/II and phase II of development, taking into consideration the target patient population, existing / future competition, likely adoption rates and the likely price of different therapies. The chapter also presents a detailed market segmentation, based on target indication (nasopharyngeal carcinoma, multiple myeloma, head and neck carcinoma, sarcoma, melanoma, acute myeloid leukemia, lung cancer, ovarian cancer and merkel cell cancer), target antigen (NY-ESO-1, EBV, gp100 and others), key players, and key geographical regions (North America, Europe, Asia Pacific, Latin America, Middle East and North Africa, and Rest of the World).

Key Market Companies
 Adaptimmune Therapeutics
 Alaunos Therapeutics
 Bristol Myers Squibb
 Cellular Biomedicine
 Gilead Biosciences
 GlaxoSmithKline
 Immatics
 Immunocore
 Lion TCR
 Takara Bio
 Zelluna Immunotherapy



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Table of Contents

1. PREFACE
1.1. Chapter Overview
1.2. Market Segmentations
1.3. Research Methodology
1.4. Key Questions Answered
1.5. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Pillars of Cancer Therapy
3.3. Overview of Immunotherapies
3.4. Fundamentals of Cancer Immunotherapy
3.5. Classification of Cancer Immunotherapies
3.5.1. By Mechanism of Action
3.5.1.1. Active Immunotherapy
3.5.1.2. Passive Immunotherapy
3.5.2. By Type of Target
3.5.3. By Approach
3.5.3.1. Activation and Suppression Immunotherapy
3.5.4. By Product Class
3.5.4.1. Monoclonal Antibodies
3.5.4.2. Bispecific Antibodies
3.5.4.3. Cytokines
3.5.4.4. Oncolytic Virus Therapy
3.5.4.5. Therapeutic Cancer Vaccines
3.5.4.6. Cell-based Therapies
3.6. T Cell Immunotherapies
3.6.1. Historical Evolution
3.6.2. Key Considerations for Developing T Cell Immunotherapies
3.6.3. Strategies Employed for the Redirection of T-Cells
3.6.4. Manufacturing of Engineered T Cells
3.6.5. T-Cell Transduction and Transfection Methods
3.6.5.1. Retroviral Vectors
3.6.5.2. Lentiviral Vectors
3.6.5.3. Non-viral Transfection Methods
3.7. T-Cell Receptor (TCR)-based Cell Therapy
3.7.1. Development History
3.7.2. Anatomical Layout of TCR
3.7.3. Development of TCR Therapy
3.7.4. Differences between CAR-T and TCR Therapies
3.8. Concluding Remarks
4. TCR THERAPIES: MARKET LANDSCAPE
4.1. Chapter Overview
4.2. TCR Therapies: Overall Market Landscape
4.2.1. Analysis by Type of Developer
4.2.2. Analysis by Phase of Development
4.2.3. Analysis by Therapeutic Area
4.2.4. Analysis by Phase of Development and Therapeutic Area
4.2.5. Analysis by Key Target Indication
4.2.6. Analysis by Key Target Antigen
4.2.7. Analysis by Source of T-Cells
4.2.8. Analysis by Route of Administration
4.2.9. Analysis by Phase of Development and Route of Administration
4.2.10. Analysis by Dosing Frequency
4.2.11. Analysis by Target Patient Segment
4.2.12. Analysis by Type of Therapy
4.2.13. Analysis by Phase of Development and Type of Therapy
4.2.14. Most Active Industry Players: Analysis by Number of TCR Therapies
4.2.15. Most Active Non-Industry Players: Analysis by Number of TCR Therapies
4.3. TCR Therapies: Overall Developer Landscape
4.3.1. Analysis by Year of Establishment
4.3.2. Analysis by Company Size
4.3.3. Analysis by Location of Headquarters
5. POPULAR TARGET ANTIGEN ANALYSIS
5.1. Chapter Overview
5.2. Competitive Analysis: Popular Target Antigens of TCR Therapies
5.2.1. Popular Targets Related to Hematological Malignancies
5.2.2. Popular Targets Related to Solid Tumors
6. CLINICAL TRIAL ANALYSIS
6.1. Chapter Overview
6.2. Scope and Methodology
6.3. TCR Therapies: Clinical Trial Analysis
6.3.1. Analysis by Trial Registration Year
6.3.2. Analysis by Trial Registration Year and Enrolled Patient Population
6.3.3. Analysis by Trial Status
6.3.4. Analysis by Trial Registration Year and Trial Status
6.3.5. Analysis by Trial Phase
6.3.6. Analysis of Enrolled Patient Population by Trial Phase
6.3.7. Analysis by Target Patient Segment
6.3.8. Analysis by Type of Sponsor / Collaborator
6.3.9. Analysis by Study Design
6.3.10. Most Active Industry Players: Analysis by Number of Registered Trials
6.3.11. Most Active Non-Industry Players: Analysis by Number of Registered Trials
6.3.12. Word Cloud Representation Analysis: Emerging Focus Areas
6.3.13. Analysis of Clinical Trials by Geography
6.3.14. Analysis of Enrolled Patient Population by Geography
7. KEY OPINION LEADERS
7.1. Chapter Overview
7.2. Assumptions and Key Parameters
7.3. Methodology
7.4. TCR Therapies: Key Opinion Leaders
7.4.1. Analysis by Type of Organization
7.4.2. Analysis by Affiliated Organization
7.4.3. Analysis by Qualification
7.4.4. Analysis by Geographical Location of KOLs
7.4.5. KOL Activeness versus KOL Strength
7.4.6. Most Prominent KOLs: Analysis by RA score
7.4.7. Most Prominent KOLs: Comparison of RA Score and Third-Party Score
8. T CELL RECEPTOR THERAPY PROFILES
8.1. Chapter Overview
8.2. Kimmtrak® / IMCgp100 / Tebentafusp (Immunocore)
8.2.1. Therapy Overview
8.2.2. Clinical Trial Information
8.2.3. Clinical Trial Endpoints
8.2.4. Clinical Trial Results
8.2.5. Estimated Sales Revenues
8.3. GSK3377794 / NY-ESO-1C259 T-cells / Letetresgene Autoleucel (GlaxoSmithKline)
8.3.1. Therapy Overview
8.3.2. Clinical Trial Information
8.3.3. Clinical Trial Endpoints
8.3.4. Clinical Trial Results
8.3.5. Estimated Sales Revenues
8.4. ADP-A2M4 / Afamitresgene Autoleucel / Afami-cel (Adaptimmune Therapeutics)
8.4.1. Therapy Overview
8.4.2. Clinical Trial Information
8.4.3. Clinical Trial Endpoints
8.4.4. Clinical Trial Results
8.4.5. Estimated Sales Revenues
8.5. JTCR016 (Juno Therapeutics)
8.5.1. Therapy Overview
8.5.2. Clinical Trial Information
8.5.3. Clinical Trial Endpoints
8.6. TBI-1301 (Takara Bio)
8.6.1. Therapy Overview
8.6.2. Clinical Trial Information
8.6.3. Clinical Trial Endpoints
8.6.4. Clinical Trial Results
8.6.5. Estimated Sales Revenues
8.7. MDG1011 (Medigene)
8.7.1. Therapy Overview
8.7.2. Clinical Trial Information
8.7.3. Clinical Trial Endpoints
8.7.4. Clinical Trial Results
9. PARTNERSHIPS AND COLLABORATIONS
9.1. Chapter Overview
9.2. Partnership Models
9.3. TCR Therapies: Partnerships and Collaborations
9.3.1. Analysis by Year of Partnership
9.3.2. Analysis by Type of Partnership
9.3.3. Analysis by Year of Partnership and Type of Partnership
9.3.4. Analysis by Type of Partner
9.3.5. Most Popular Products: Analysis by Number of Partnerships
9.3.6. Most Active Industry Players: Analysis by Number of Partnerships
9.3.7. Most Active Non-Industry Players: Analysis by Number of Partnerships
9.3.8. Analysis by Geography
9.3.8.1. Intercontinental and Intracontinental Deals
9.3.8.2. International and Local Deals
10 FUNDING AND INVESTMENT ANALYSIS
10.1. Chapter Overview
10.2. Types of Funding
10.3. TCR Therapies: Funding and Investment Analysis
10.3.1. Analysis of Instances by Year
10.3.2. Analysis of Amount Invested by Year
10.3.3. Analysis by Type of Funding
10.3.4. Analysis by Type of Investor
10.3.5. Most Active Players: Analysis by Number of Instances
10.3.6. Most Active Investors: Analysis by Amount Invested
10.3.7. Analysis of Amount Invested by Geography
10.3.8. Most Active Investors: Analysis by Number of Funding Instances
11. PATENT ANALYSIS
11.1. Chapter Overview
11.2. Scope and Methodology
11.3. TCR Therapies: Patent Analysis
11.3.1. Analysis by Patent Publication Year
11.3.2. Analysis By Patent Application Year
11.3.3. Analysis by Geography
11.3.4. Analysis by Type of Player
11.3.5. Analysis by CPC Symbols
11.3.6. Analysis by Key Focus Area
11.3.7. Leading Player: Analysis by Number of Patents
11.3.8. TCR Therapies: Patent Benchmarking
11.3.9. Analysis By Patent Characteristics
11.3.10. TCR Therapies: Patent Valuation
12. CASE STUDY: CELL THERAPY MANUFACTURING
12.1. Chapter Overview
12.2. Overview of Cell Therapy Manufacturing
12.3. Cell Therapy Manufacturing Models
12.3.1. Centralized Manufacturing Model
12.3.2. Decentralized Manufacturing Model
12.4. Scalability of Cell Therapy Manufacturing Processes
12.4.1. Scale-Up
12.4.2. Scale-Out
12.5. Types of Cell Therapy Manufacturers
12.6. Key Challenges Related to Manufacturing of Cell Therapies
12.7. Important Factors for Cell Therapy Manufacturing
12.7.1. Characterization
12.7.2. Cost of Goods
12.8. Automation of Cell Therapy Manufacturing Processes
12.9. Cell Therapy Manufacturing Supply Chain
12.10. Comparison of Player Having In-House Capabilities and Contract Manufacturers
12.11. Regulatory Landscape
12.12. Future Perspectives
13. COST PRICE ANALYSIS
13.1. Chapter Overview
13.2. Factors Contributing to the High Price of Cell / Gene Therapies
13.3. Pricing Models for T-Cell Immunotherapies
13.3.1. Based on Associated Costs
13.3.2. Based on Availability of Competing Products
13.3.3. Based on Patient Segment
13.3.4. Based on Opinions of Industry Experts
13.4. Reimbursement related Considerations for T-cell Immunotherapies
13.4.1. Case Study: The National Institute for Health and Care Excellence (NICE) Appraisal of CAR-T Therapies
14. MARKET FORECAST AND OPPORTUNITY ANALYSIS
14.1. Chapter Overview
14.2. Scope and Limitations
14.3. Key Assumptions and Forecast Methodology
14.4. Global TCR Therapy Market, 2022-2035
14.4.1. TCR Therapy Market: Analysis by Target Indication
14.4.2. TCR Therapy Market: Analysis by Target Antigen
14.4.3. TCR Therapy Market: Analysis by Key Players
14.4.4. TCR Therapy Market: Distribution by Geography
14.4.5. Product Wise Sales Forecast
14.4.5.1. Kimmtrak® (IMCgp100 / Tebentafusp) (Immunocore)
14.4.5.1.1. Sales Forecast (USD Million)
14.4.5.1.2. Net Present Value (USD Million)
14.4.5.1.3. Value Creation Analysis

14.4.5.2. GSK3377794 (GlaxoSmithKline)
14.4.5.2.1. Sales Forecast (USD Million)
14.4.5.2.2. Net Present Value (USD Million)
14.4.5.2.3. Value Creation Analysis
14.4.5.3. YT-E001 (China Immunotech)
14.4.5.3.1. Sales Forecast (USD Million)
14.4.5.3.2. Net Present Value (USD Million)
14.4.5.3.3. Value Creation Analysis

14.4.5.4. ADP-A2M4 / Afamitresgene Autoleucel / Afami-cel (Adaptimmune Therapeutics)
14.4.5.4.1. Sales Forecast (USD Million)
14.4.5.4.2. Net Present Value (USD Million)
14.4.5.4.3. Value Creation Analysis
14.4.5.5. EBV-specific TCR-T cell with Anti-PD1 Aauto-secreted Element (TCRCure Biopharma)
14.4.5.5.1. Sales Forecast (USD Million)
14.4.5.5.2. Net Present Value (USD Million)
14.4.5.5.3. Value Creation Analysis
14.4.5.6. NTLA-5001 (Intellia Therapeutics)
14.4.5.6.1. Sales Forecast (USD Million)
14.4.5.6.2. Net Present Value (USD Million)
14.4.5.6.3. Value Creation Analysis
14.4.5.7. TBI-1301 (Takara Bio)
14.4.5.7.1. Sales Forecast (USD Million)
14.4.5.7.2. Net Present Value (USD Million)
14.4.5.7.3. Value Creation Analysis
14.4.5.8. LMBP2-specific TCR-T (Xinqiao Hospital of Chongqing / TCR CURE Biopharma Technology)
14.4.5.8.1. Sales Forecast (USD Million)
14.4.5.8.2. Net Present Value (USD Million)
14.4.5.8.3. Value Creation Analysis
14.4.5.9. FH-MCVA2TCR (TCRCure Biopharma)
14.4.5.9.1. Sales Forecast (USD Million)
14.4.5.9.2. Net Present Value (USD Million)
14.4.5.9.3. Value Creation Analysis
15. PROMOTIONAL ANALYSIS
15.1. Chapter Overview
15.2. Channels Used for Promotional Campaigns
15.3. Kimmtrak: Promotional Analysis
15.3.1. Drug Overview
15.3.2. Product Website Analysis
15.3.2.1. Message for Healthcare Professionals
15.3.2.2. Message for Patients
15.3.2.3. Informative Downloads
15.3.3. Patient Support Services
16. COMPANY PROFILES
16.1. Chapter Overview
16.2. Adaptimmune Therapeutics
16.3. Alaunos Therapeutics
16.4. Company Profiles
16.5. Bristol Myers Squibb
16.6. Cellular Biomedicine Group
16.7. Gilead Sciences
16.8. Cellular Biomedicine Group
16.9. GlaxoSmithKline
16.10. Immatics
16.11. Immunocore
16.12. Lion TCR
16.13. Takara Bio
16.14. Zelluna immunotherapy
17. CONCLUDING REMARKS
18. EXECUTIVE INSIGHTS
18.1. Chapter Overview
18.2. Celyad
18.2.1. Interview Transcript: Vincent Brichard, Vice President, Immuno-Oncology
18.3. Kite Pharma
18.3.1. Interview Transcript: Adrian Bot, Vice President, Scientific Affairs
18.4. Lion TCR
18.4.1. Interview Transcript: Victor Lietao Li, Co-Founder and Chief Executive Officer
18.5. TxCell
18.5.1. Interview Transcript: Miguel Forte, Chief Operating Officer
19. APPENDIX 1: TABULATED DATA
20. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

 

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