北米のT細胞療法：2030年までの市場予測 - 地域別分析 - モダリティ別、治療タイプ別、適応症別

北米のT細胞療法市場は、2022年に16億4,552万米ドルと評価され、2030年には53億2,975万米ドルに達すると予測され、2022年から2030年までのCAGRは15.8%で成長すると予測されています。

T細胞療法の承認件数の増加が北米のT細胞療法市場を後押し

標的を絞った治療、より迅速で効率的な回復、副作用の軽減などは、細胞療法の利点のひとつです。細胞療法は、FDA（米国食品医薬品局）が承認した製品を利用できることから、世界的に広く採用されています。以下は、近年FDAによって承認されたT細胞療法製品のリストである：

例えば、2022年6月、ブリストル・マイヤーズスクイブ社は、CD19指向性キメラ抗原受容体（CAR）T細胞療法であるBreyanzi（lisocabtagene maraleucel）について、大細胞型B細胞リンパ腫（LBCL）成人患者の治療薬としてFDAの承認を取得しました。

2022年2月、米国食品医薬品局（FDA）は、一次化学免疫療法不応または一次化学免疫療法後12カ月以内に再発した大細胞型B細胞リンパ腫の成人患者を対象とするCAR T細胞療法として、Yescarta（axicabtagene ciloleucel）を承認しました。Yescartaは、National Comprehensive Cancer Network（NCCN）のカテゴリー1推奨を受けた最初のCAR T細胞療法です。

2022年2月、FDAはciltacabtagene autoleucel（商品名CARVYKTI）を、プロテアソーム阻害剤、免疫調節剤、抗CD38モノクローナル抗体を含む4種類以上の前治療歴のある再発または難治性の多発性骨髄腫の成人患者の治療薬として承認しました。

2022年1月、FDAはHLA-A*02：01陽性の切除不能または転移性ぶどう膜黒色腫患者の治療薬としてキムトラック（tebentafusp-tebn）を承認しました。

2021年3月、アベクマ（idecabtagene vicleucel）は再発または難治性の多発性骨髄腫の治療薬としてFDAに承認されました。この治療薬は、B細胞成熟抗原（BCMA）指向性の遺伝子組換え自己T細胞免疫療法であり、難治性多発性骨髄腫の成人患者の治療に適応されます。

したがって、T細胞療法の承認件数の増加が北米のT細胞療法市場の成長を後押ししています。

北米のT細胞療法市場概要

北米のT細胞療法市場は米国、カナダ、メキシコに区分されます。2022年には、米国がこの地域で最大の市場シェアを占めており、がんや自己免疫疾患などの慢性疾患による負担の増加、研究開発活動の成長、強力で確立された市場プレイヤーにより、予測期間中もその優位性が続くと予想されます。また、CAR T細胞療法の臨床研究が増加していることから、北米市場は予測期間中に成長すると予想されます。CDCによると、米国では2020年に新たに160万3,844人のがん患者が報告され、60万2,347人が死亡しました。2023年には米国で推定184,720人が白血病、リンパ腫、骨髄腫と診断されます。

Tisagenlecleucel（KymriahTM、Novartis、Morris Plains、NJ、米国）とaxicabtagene ciloleucel（YescartaTM、Gilead Sciences Canada、El Segundo、CA、米国）は、市販された最初の2つのCAR T細胞であり、それぞれ2018年と2019年にカナダ保健省によりカナダで承認されました。いずれも第2世代の抗CD19 CAR T細胞で、r/r DLBCL、原発性縦隔B細胞リンパ腫、形質転換濾胞性リンパ腫の成人患者を対象に承認されています。さらに、Canadian-Led Immunotherapies in Cancer-01（CLIC-01）は、カナダで初めてCAR T細胞療法を導入しました。この治療法は、より安価で、より公平な治療法を明らかにする、異なる種類の細胞製造法を用いています。ハリファックスのクイーン・エリザベス2世健康科学センターは、2022年3月よりアトランティック・カナダで初めてCAR T細胞療法を提供する施設となった。それ以前は、この高度に個別化されたがん治療薬を推奨されたノバスコシア州の患者は、治療を受けるために国外に渡航しなければならなかった。このプログラムは、米国政府の年間670万米ドルの投資によって実現しました。このように、がん患者の増加と政府による取り組みが、北米のT細胞療法市場を後押ししています。

北米のT細胞療法市場の収益と2030年までの予測（US$Mn）

北米のT細胞療法市場のセグメンテーション

北米のT細胞療法市場は、治療法、治療タイプ、適応症、国別に区分されます。

モダリティに基づき、北米のT細胞療法市場は研究と商業化に二分されます。2022年の市場シェアは商業化セグメントで大きくなっています。

治療タイプに基づき、北米のT細胞療法市場はCAR T細胞療法とT細胞受容体（TCR）ベースに分けられます。2022年の市場シェアはCAR T細胞療法が上回った。

適応症に基づくと、北米のT細胞療法市場は血液悪性腫瘍と固形腫瘍に二分されます。2022年には血液悪性腫瘍分野が最大の市場シェアを占めました。

国別では、北米のT細胞療法市場は米国、カナダ、メキシコに区分されます。2022年の北米のT細胞療法市場シェアは米国が独占しました。

Bluebird Bio Inc、Bristol-Myers Squibb Co、Cartesian Therapeutics Inc、Gilead Sciences Inc、Innovent Biologics Inc、Janssen Global Services LLC、Novartis AGは、北米のT細胞療法市場で事業を展開する大手企業です。

目次

第1章 イントロダクション

第2章 エグゼクティブサマリー

• 主要洞察
• 北米のT細胞療法市場、国別

第3章 調査手法

• 調査範囲
• 2次調査
• 1次調査

第4章 北米のT細胞療法市場：主要産業力学

• 市場促進要因
  • 世界のがん罹患率の増加
  • T細胞療法の承認数の増加
• 市場抑制要因
  • CAR T細胞療法の副作用
• 市場機会
  • T細胞療法への投資の増加
• 今後の動向
  • 臨床試験中のCAR T細胞療法数の増加
• インパクト分析

第5章 T細胞療法市場：北米市場分析

• 北米のT細胞療法市場売上高、2022年～2030年

第6章 北米のT細胞療法市場：収益と2030年までの予測 - モダリティ別

• 市場収益シェア（%）、2022年および2030年
• 研究
• 商業化

第7章 北米のT細胞療法市場：収益と2030年までの予測 - 治療タイプ別

• 市場収益シェア（%）、2022年および2030年
• CAR T細胞療法
• T細胞受容体（TCR）ベース

第8章 北米のT細胞療法市場：収益と2030年までの予測 - 適応症別

• 市場収益シェア（%）、2022年および2030年
• 血液悪性腫瘍
• 固形がん

第9章 北米のT細胞療法市場：国別分析

• 北米のT細胞療法市場：国別
• 米国
• カナダ
• メキシコ

第10章 T細胞療法市場：業界情勢

• T細胞療法市場の成長戦略
• 有機的成長戦略
• 無機的成長戦略

第11章 企業プロファイル

• Legend Biotech Corp
• Janssen Global Services LLC
• Gilead Sciences Inc
• Bristol-Myers Squibb Co
• Novartis AG
• Cartesian Therapeutics Inc
• Innovent Biologics Inc

第12章 付録

List Of Tables

• Table 1. North America T Cell Therapy Market Segmentation
• Table 2. North America T Cell Therapy Market, by Hematological Malignancies - Revenue and Forecast to 2030 (US$ Million)
• Table 3. US: North America T Cell Therapy Market, by Modality - Revenue and Forecast to 2030 (US$ Million)
• Table 4. US: North America T Cell Therapy Market, by Therapy Type - Revenue and Forecast to 2030 (US$ Million)
• Table 5. US: North America T Cell Therapy Market, by Indication - Revenue and Forecast to 2030 (US$ Million)
• Table 6. US: North America T Cell Therapy Market, For Hematologic Malignancies by Indication - Revenue and Forecast to 2030 (US$ Million)
• Table 7. Canada: North America T Cell Therapy Market, by Modality - Revenue and Forecast to 2030 (US$ Million)
• Table 8. Canada: North America T Cell Therapy Market, by Therapy Type - Revenue and Forecast to 2030 (US$ Million)
• Table 9. Canada: North America T Cell Therapy Market, by Indication - Revenue and Forecast to 2030 (US$ Million)
• Table 10. Canada: North America T Cell Therapy Market, For Hematologic Malignancies by Indication - Revenue and Forecast to 2030 (US$ Million)
• Table 11. Mexico: North America T Cell Therapy Market, by Modality - Revenue and Forecast to 2030 (US$ Million)
• Table 12. Mexico: North America T Cell Therapy Market, by Therapy Type - Revenue and Forecast to 2030 (US$ Million)
• Table 13. Mexico: North America T Cell Therapy Market, by Indication - Revenue and Forecast to 2030 (US$ Million)
• Table 14. Mexico: North America T Cell Therapy Market, For Hematologic Malignancies by Indication - Revenue and Forecast to 2030 (US$ Million)
• Table 15. Recent Organic Growth Strategies in T Cell Therapy Market
• Table 16. Recent Inorganic Growth Strategies in the T Cell Therapy Market
• Table 17. Glossary of Terms, North America T Cell Therapy Market

List Of Figures

• Figure 1. North America T Cell Therapy Market Segmentation, By Country
• Figure 2. North America T Cell Therapy Market - Key Industry Dynamics
• Figure 3. Impact Analysis of Drivers and Restraints
• Figure 4. North America T Cell Therapy Market Revenue (US$ Mn), 2022 - 2030
• Figure 5. North America T Cell Therapy Market Revenue Share, by Modality, 2022 & 2030 (%)
• Figure 6. Research: North America T Cell Therapy Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 7. Commercialized: North America T Cell Therapy Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 8. North America T Cell Therapy Market Revenue Share, by Therapy Type 2022 & 2030 (%)
• Figure 9. CAR T-cell Therapy: North America T Cell Therapy Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 10. T-cell Receptor (TCR)-based: North America T Cell Therapy Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 11. North America T Cell Therapy Market Revenue Share, by Indication, 2022 & 2030 (%)
• Figure 12. Hematologic Malignancies: North America T Cell Therapy Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 13. Solid Tumor: North America T Cell Therapy Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 14. North America T Cell Therapy Market, by Key Country - Revenue (2022) (US$ Million)
• Figure 15. North America T Cell Therapy Market, By Key Countries, 2022 and 2030 (%)
• Figure 16. US: North America T Cell Therapy Market Revenue and Forecast to 2030 (US$ Mn)
• Figure 17. Canada: North America T Cell Therapy Market Revenue and Forecast to 2030 (US$ Mn)
• Figure 18. Mexico: North America T Cell Therapy Market Revenue and Forecast to 2030 (US$ Mn)
• Figure 19. Growth Strategies in T Cell Therapy Market

The North America T cell therapy market was valued at US$ 1,645.52 million in 2022 and is expected to reach US$ 5,329.75 million by 2030; it is estimated to grow at a CAGR of 15.8% from 2022 to 2030.

Increasing Number of T-Cell Therapy Approvals Fuels the North America T Cell Therapy Market

Targeted treatment, faster and more efficient recovery, and reduced side effects are among the advantages of cell therapy. Globally, cell therapies are widely adopted owing to the availability FDA approved products. Following is the list of T-cell therapy products approved by FDA in recent years:

For instance, in June 2022, Bristol Myers Squibb received FDA approval for Breyanzi (lisocabtagene maraleucel), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adult patients with large B-cell lymphoma (LBCL).

In February 2022, the US Food and Drug Administration (FDA) approved Yescarta (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first line chemoimmunotherapy or that relapses within 12 months of first line chemoimmunotherapy. Yescarta is the first CAR T-cell therapy to receive a National Comprehensive Cancer Network (NCCN) Category 1 recommendation.

In February 2022, the FDA approved ciltacabtagene autoleucel (brand name CARVYKTI) for treating adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

In January 2022, the FDA approved Kimmtrak (tebentafusp-tebn) for treating unresectable or metastatic uveal melanoma patients who are HLA-A*02:01 positive.

In March 2021, Abecma (idecabtagene vicleucel) was approved by the FDA for treating relapsed or refractory multiple myeloma. The treatment is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T-cell immunotherapy indicated for treating adult patients with refractory multiple myeloma.

Therefore, the increasing number of approvals for T-cell therapies is fueling the North America T cell therapy market growth.

North America T Cell Therapy Market Overview

The T-cell therapy market in North America is segmented into the US, Canada, and Mexico. In 2022, the US held the largest market share in this region and is expected to continue its dominance during the forecast period due to the increasing burden of chronic disorders such as cancer and autoimmune disorders, growth in research and development activities, and strong and established market players. Also, with an increase in clinical studies in CAR T-cell therapies, the market in North America is expected to grow during the forecast period. According to CDC, 1,603,844 new cancer cases were reported and 602,347 people died in the US in 2020. An estimated 184,720 people in the US will be diagnosed with leukemia, lymphoma, or myeloma in 2023.

Tisagenlecleucel (KymriahTM, Novartis, Morris Plains, NJ, US) and axicabtagene ciloleucel (YescartaTM, Gilead Sciences Canada, El Segundo, CA, US) were the first two CAR T-cells commercially available and approved in Canada by Health Canada in 2018 and 2019, respectively. Both are second-generation anti-CD19 CAR T-cells, approved for adult patients with r/r DLBCL, primary mediastinal B-cell lymphoma, and transformed follicular lymphoma. Moreover, Canadian-Led Immunotherapies in Cancer-01 (CLIC-01) is the first to introduce CAR T-cell therapy in Canada. It uses a different kind of cell manufacturing that unveils less expensive and more equitable treatment. The Queen Elizabeth II Health Sciences Centre in Halifax became the first facility in Atlantic Canada to offer CAR T-cell therapy locally as of March 2022. Prior to this, Nova Scotia patients who were recommended for this highly personalized cancer medicine had to travel outside the country to receive the treatment. The program was made possible with a government investment of US$ 6.7 million annually. Thus, the rising cancer cases and initiative by the government fuel the T-cell therapy market in North America.

North America T Cell Therapy Market Revenue and Forecast to 2030 (US$ Mn)

North America T Cell Therapy Market Segmentation

The North America T cell therapy market is segmented into modality , therapy type, indication, and country.

Based on modality, the North America T cell therapy market is bifurcated into research and commercialized. The commercialized segment held a larger market share in 2022.

Based on therapy type, the North America T cell therapy market is divided into CAR T-cell therapy and T-cell Receptor (TCR)-based. The CAR T-cell therapy segment held a larger market share in 2022.

Based on indication, the North America T cell therapy market is bifurcated into hematologic malignancies and solid tumors. The hematologic malignancies segment held the largest market share in 2022.

Based on country, the North America T cell therapy market is segmented into the US, Canada, and Mexico. The US dominated the North America T cell therapy market share in 2022.

Bluebird Bio Inc, Bristol-Myers Squibb Co, Cartesian Therapeutics Inc, Gilead Sciences Inc, Innovent Biologics Inc, Janssen Global Services LLC, and Novartis AG are some of the leading companies operating in the North America T cell therapy market.

Table Of Contents

1. Introduction

• 1.1 The Insight Partners Research Report Guidance
• 1.2 Market Segmentation

2. Executive Summary

• 2.1 Key Insights
• 2.2 North America T Cell Therapy Market, by Country (US$ Million)

3. Research Methodology

• 3.1 Coverage
• 3.2 Secondary Research
• 3.3 Primary Research

4. North America T Cell Therapy Market - Key Industry Dynamics

• 4.1 Market Drivers:
  • 4.1.1 Growing Burden of Cancer Worldwide
  • 4.1.2 Increasing Number of T-Cell Therapy Approvals
• 4.2 Market Restraints
  • 4.2.1 Side-effects of CAR T-Cell Therapy
• 4.3 Market Opportunities
  • 4.3.1 Growing Investment in T-Cell Therapy
• 4.4 Future Trends
  • 4.4.1 Rising Number of CAR T-Cell Therapies in Clinical Trials
• 4.5 Impact Analysis:

5. T Cell Therapy Market - North America Market Analysis

• 5.1 North America T Cell Therapy Market Revenue (US$ Mn), 2022 - 2030

6. North America T Cell Therapy Market - Revenue and Forecast to 2030 - by Modality.

• 6.1 Overview
• 6.2 North America T Cell Therapy Market Revenue Share, by Modality, 2022 & 2030 (%)
• 6.3 Research
  • 6.3.1 Overview
  • 6.3.2 Research: North America T Cell Therapy Market - Revenue and Forecast to 2030 (US$ Million)
• 6.4 Commercialized
  • 6.4.1 Overview
  • 6.4.2 Commercialized: North America T Cell Therapy Market - Revenue and Forecast to 2030 (US$ Million)

7. North America T Cell Therapy Market - Revenue and Forecast to 2030 - by Therapy Type

• 7.1 Overview
• 7.2 North America T Cell Therapy Market Revenue Share, by Therapy Type 2022 & 2030 (%)
• 7.3 CAR T-cell Therapy
  • 7.3.1 Overview
  • 7.3.2 CAR T-cell Therapy: North America T Cell Therapy Market - Revenue and Forecast to 2030 (US$ Million)
• 7.4 T-cell Receptor (TCR)-based.
  • 7.4.1 Overview
  • 7.4.2 T-cell Receptor (TCR)-based: North America T Cell Therapy Market - Revenue and Forecast to 2030 (US$ Million)

8. North America T Cell Therapy Market - Revenue and Forecast to 2030 - by Indication.

• 8.1 Overview
• 8.2 North America T Cell Therapy Market Revenue Share, by Indication, 2022 & 2030 (%)
• 8.3 Hematologic Malignancies
  • 8.3.1 Overview
  • 8.3.2 Hematologic Malignancies: North America T Cell Therapy Market - Revenue and Forecast to 2030 (US$ Million)
  • 8.3.3 North America T Cell Therapy Market, by Haematological Malignancies, 2020-2030 (US$ Million)
• 8.4 Solid Tumor
  • 8.4.1 Overview
  • 8.4.2 Solid Tumor: North America T Cell Therapy Market - Revenue and Forecast to 2030 (US$ Million)

9. North America T Cell Therapy Market - Country Analysis

• 9.1 Overview
  • 9.1.1.1 North America T Cell Therapy Market, by Country
  • 9.1.1.2 US
    • 9.1.1.2.1 US: North America T Cell Therapy Market Revenue and Forecast to 2030 (US$ Mn)
    • 9.1.1.2.2 US: North America T Cell Therapy Market, by Modality, 2020-2030 (US$ Million)
    • 9.1.1.2.3 US: North America T Cell Therapy Market, by Therapy Type, 2020-2030 (US$ Million)
    • 9.1.1.2.4 US: North America T Cell Therapy Market, by Indication, 2020-2030 (US$ Million)
    • 9.1.1.2.4.1 US: North America T Cell Therapy Market, For Hematologic Malignancies by Indication, 2020-2030 (US$ Million)
  • 9.1.1.3 Canada
    • 9.1.1.3.1 Canada: North America T Cell Therapy Market Revenue and Forecast to 2030 (US$ Mn)
    • 9.1.1.3.2 Canada: North America T Cell Therapy Market, by Modality, 2020-2030 (US$ Million)
    • 9.1.1.3.3 Canada: North America T Cell Therapy Market, by Therapy Type, 2020-2030 (US$ Million)
    • 9.1.1.3.4 Canada: North America T Cell Therapy Market, by Indication, 2020-2030 (US$ Million)
    • 9.1.1.3.4.1 Canada: North America T Cell Therapy Market, For Hematologic Malignancies by Indication, 2020-2030 (US$ Million)
  • 9.1.1.4 Mexico
    • 9.1.1.4.1 Mexico: North America T Cell Therapy Market Revenue and Forecast to 2030 (US$ Mn)
    • 9.1.1.4.2 Mexico: North America T Cell Therapy Market, by Modality, 2020-2030 (US$ Million)
    • 9.1.1.4.3 Mexico: North America T Cell Therapy Market, by Therapy Type, 2020-2030 (US$ Million)
    • 9.1.1.4.4 Mexico: North America T Cell Therapy Market, by Indication, 2020-2030 (US$ Million)
    • 9.1.1.4.4.1 Mexico: North America T Cell Therapy Market, For Hematologic Malignancies by Indication, 2020-2030 (US$ Million)

10. T Cell Therapy Market-Industry Landscape

• 10.1 Overview
• 10.2 Growth Strategies in T Cell Therapy Market
• 10.3 Organic Growth Strategies
  • 10.3.1 Overview
• 10.4 Inorganic Growth Strategies
  • 10.4.1 Overview

11. Company Profiles

• 11.1 Legend Biotech Corp
  • 11.1.1 Key Facts
  • 11.1.2 Business Description
  • 11.1.3 Products and Services
  • 11.1.4 Financial Overview
  • 11.1.5 SWOT Analysis
  • 11.1.6 Key Developments
• 11.2 Janssen Global Services LLC
  • 11.2.1 Key Facts
  • 11.2.2 Business Description
  • 11.2.3 Products and Services
  • 11.2.4 Financial Overview
  • 11.2.5 SWOT Analysis
  • 11.2.6 Key Developments
• 11.3 Gilead Sciences Inc
  • 11.3.1 Key Facts
  • 11.3.2 Business Description
  • 11.3.3 Products and Services
  • 11.3.4 Financial Overview
  • 11.3.5 SWOT Analysis
  • 11.3.6 Key Developments
• 11.4 Bristol-Myers Squibb Co
  • 11.4.1 Key Facts
  • 11.4.2 Business Description
  • 11.4.3 Products and Services
  • 11.4.4 Financial Overview
  • 11.4.5 SWOT Analysis
  • 11.4.6 Key Developments
• 11.5 Novartis AG
  • 11.5.1 Key Facts
  • 11.5.2 Business Description
  • 11.5.3 Products and Services
  • 11.5.4 Financial Overview
  • 11.5.5 SWOT Analysis
  • 11.5.6 Key Developments
• 11.6 Cartesian Therapeutics Inc
  • 11.6.1 Key Facts
  • 11.6.2 Business Description
  • 11.6.3 Products and Services
  • 11.6.4 Financial Overview
  • 11.6.5 SWOT Analysis
  • 11.6.6 Key Developments
• 11.7 Innovent Biologics Inc
  • 11.7.1 Key Facts
  • 11.7.2 Business Description
  • 11.7.3 Products and Services
  • 11.7.4 Financial Overview
  • 11.7.5 SWOT Analysis
  • 11.7.6 Key Developments

12. Appendix

• 12.1 About Us
• 12.2 Glossary of Terms