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市场调查报告书
商品编码
1830960

基因治疗市场

Gene Therapy Market
出版日期: | 出版商: The Insight Partners | 英文 150 Pages | 商品交期: 1-5个工作天内

价格
简介目录

基因治疗市场预计将从 2024 年的 58.4 亿美元成长到 2031 年的 293.6 亿美元，预计 2025 年至 2031 年的复合年增长率为 14.3%。市场洞察与分析师观点：基因治疗涉及透过灭活有害基因、用健康基因取代有害基因或引入新的或修饰的基因来帮助治疗和预防疾病来治疗疾病。这种疗法可以分为体内和体外方法。基因治疗的主要目标是用正常基因替换或纠正缺陷基因，使身体能够产生正常功能所需的蛋白质或酶，这可能解决各种疾病的根本原因。全球遗传疾病和癌症发病率的上升，以及 FDA 批准的基因疗法数量的增加，正在推动基因治疗市场的成长。此外，预计未来基因治疗技术的进步将进一步促进市场成长。

成长催化剂：生物技术的最新进展促进了多种疾病的治疗。基因疗法目前被用于治疗各种疾病，包括癌症、神经系统疾病和遗传疾病。全球基因疗法的采用正在上升，这主要得益于FDA核准产品的普及。以下是近年来获得FDA批准的一些值得关注的基因疗法产品：

2023 年 12 月，FDA 核准了两种针对镰状细胞疾病的细胞基因疗法：Bluebird Bio 公司的 Lyfgenia（lovotibeglogene autotemcel），用于治疗有血管闭塞事件病史的 12 岁及以上患者，以及 Vertex Pharmaceuticals 和 CRISPR Therapeutics 公司的 12 岁及以上患者，以及 Vertex Pharmaceuticals 和 CRISPR Therapeutics 公司的 Casactics）。 2023 年 6 月，FDA 批准了 Roctavian，这是一种利用腺相关病毒载体的基因疗法，用于治疗没有腺相关病毒血清型 5 抗体的严重血友病 A 成人患者。这种一次性治疗针对的是负责产生凝血因子 VIII (FVIII) 的基因突变。 2023 年 6 月，FDA 也批准了 Elevidys，这是第一个用于治疗 4 至 5 岁儿童杜氏肌肉营养不良症的基因疗法，这些患者的基因已确认突变杜氏肌肉营养不良症基因患者，前提是他们没有任何会妨碍治疗的既往疾病。 2022 年 11 月，FDA 批准了 CSL Behring LLC 开发的重组腺相关病毒 5 型基因疗法 HEMGENIX，用于治疗特定类型血友病 B 的成年患者。因此，核准基因疗法数量的增加显着推动了基因治疗市场的成长。

策略洞察报告细分与范围：基因治疗市场分析透过检视载体、适应症​​、递送方式和地理区域等不同部分进行。市场分为非病毒载体和病毒载体。就适应症而言，它包括神经系统疾病、癌症、杜氏肌肉营养不良症、肝病和其他疾病。递送方式分为体内和体外。该报告涵盖北美（美国、加拿大和墨西哥）、欧洲（法国、德国、英国、西班牙、义大利和欧洲其他地区）、亚太地区（中国、日本、印度、澳洲、韩国和亚太其他地区）、中东和非洲（沙乌地阿拉伯、南非、阿联酋和中东和非洲其他地区）以及南美洲和中美洲（巴西、阿根廷和南美洲和中美洲其他地区）的基因治疗市场。

分段分析：基因治疗市场按载体细分为非病毒载体和病毒载体，其中病毒载体部分在 2023 年占据相当大的市场份额，预计在 2023 年至 2030 年期间实现更高的复合年增长率。

依适应症划分，市场涵盖神经系统疾病、癌症、杜氏肌肉营养不良症、肝病和其他疾病。 2023年，癌症领域占据了基因治疗市场的很大份额，预计在2023年至2030年期间将经历最高的复合年增长率。

就递送方式而言，市场分为体内和体外两种。体内治疗在2023年占据了相当大的市场份额，预计在2023年至2030年期间将实现更高的复合年增长率。体内基因治疗可以进行全身性治疗，覆盖全身多个部位和器官，这对于影响多个部位或表现出全身症状的疾病尤其有益，从而实现综合治疗。此外，病毒载体、奈米颗粒和脂质载体等递送技术的进步增强了体内治疗的有效性和特异性，提高了遗传物质的标靶递送能力，并提高了治疗的整体安全性和有效性。

区域分析：从区域来看，基因疗法市场分为北美、欧洲、亚太地区、南美和中美以及中东和非洲。 2023年，北美占据了相当大的市场份额，其中美国在该地区的基因治疗市场中处于领先地位。北美的成长得益于遗传疾病盛行率的上升、癌症患者数量的增加、政府资金的增加、先进基因疗法的广泛应用以及产品获准数量的增加。

根据美国疾病管制与预防中心 (CDC) 的数据，2020 年美国新增癌症病例约 1,603,844 例，导致 602,347 人死于癌症。这相当于每 10 万人新增 403 例癌症病例。此外，国际癌症研究机构预测，到 2040 年，新增癌症病例可能达到 3,020 万例。美国政府问责局 2021 年 10 月发布的估计数据显示，美国约有 2,500 万至 3,000 万人患有罕见疾病，其中近 50% 为儿童。许多罕见疾病源自于基因突变，约 80% 被归类为遗传性疾病。

截至2021年10月，美国国立卫生研究院报告称，10家製药公司和5家非营利组织正在合作，加速开发基因疗法，造福3,000万受罕见疾病影响的美国人。美国食品药物管理局（FDA）已核准7种细胞及基因治疗药物，目前约有1,200种实验疗法在研，其中一半处于第二期临床试验阶段。根据《化学与工程新闻》2023年的报道，预计细胞疗法的年销售额将成长15%，基因疗法的年销售额将成长约30%。所有这些因素都推动了该地区基因治疗市场的不断扩张。

基因治疗市场报告范围产业发展与未来机会：以下是全球基因疗法市场主要参与者采取的一些措施：

2022 年 1 月，Ori Biotech Ltd 在超额认购的 B 轮融资中筹集了超过 1 亿美元，用于推出创新的细胞和基因治疗生产平台。 2020 年 1 月，安斯泰来製药公司收购了 Audentes Therapeutics, Inc.，将合併后的实体定位为基于 AAV 的基因医学的全球领导者。竞争格局与关键公司：基因治疗市场预测为利害关係人制定成长计画提供了宝贵的见解。基因治疗市场报告中介绍的关键参与者包括诺华公司、安斯泰来製药公司、百时美施贵宝公司、Bluebird Bio Inc.、杰特罗贝林、赛诺菲、罗氏有限公司、第一三共、Biogen 和 Oxford Biomedica。这些公司专注于推出新的高科技产品、增强现有产品和扩展地理以满足日益增长的全球消费者需求。

目录

第一章：简介

第二章：执行摘要

  • 关键见解
  • 市场吸引力分析

第三章：研究方法

第四章：基因治疗市场格局

  • 概述
  • PEST分析
  • 生态系分析
    • 价值链中的供应商列表

第五章：基因治疗市场－关键市场动态

  • 关键市场驱动因素
  • 主要市场限制因素
  • 关键市场机会
  • 未来趋势
  • 驱动因素和限制因素的影响分析

第六章：基因治疗市场－全球市场分析

  • 基因治疗—全球市场概览
  • 基因治疗－全球市场及2031年预测

第七章：基因治疗市场-收入分析-依载体类型，2021-2031

  • 概述
  • 病毒载体
  • 非病毒载体

第 8 章：基因治疗市场 - 收入分析 - 依方法，2021-2031 年

  • 概述
  • 离体
  • 体内

第九章：基因治疗市场-收入分析-按应用，2021-2031

  • 概述
  • 神经系统疾病
  • 癌症
  • 杜氏肌肉营养不良症
  • 肝病
  • 其他适应症

第 10 章：基因治疗市场 - 收入分析，2021-2031 - 地理分析

  • 北美洲
    • 美国
    • 加拿大
    • 墨西哥
  • 欧洲
    • 德国
    • 法国
    • 义大利
    • 西班牙
    • 英国
    • 欧洲其他地区
  • 亚太
    • 澳洲
    • 中国
    • 印度
    • 日本
    • 韩国
    • 亚太其他地区
  • 中东和非洲
    • 南非
    • 沙乌地阿拉伯
    • 阿联酋
    • 中东和非洲其他地区
  • 南美洲和中美洲
    • 巴西
    • 阿根廷
    • 南美洲和中美洲其他地区

第 11 章：产业格局

  • 併购
  • 协议、合作、合资企业
  • 新产品发布
  • 扩张和其他策略发展

第 12 章：竞争格局

  • 关键参与者的热图分析
  • 公司定位与集中度

第 13 章：基因治疗市场 - 主要公司简介

  • Novartis AG
  • Astellas Pharma Inc
  • Bristol-Myers Squibb Company
  • Bluebird Bio Inc.
  • Sanofi
  • F. Hoffmann-La Roche Ltd.
  • Daiichi Sankyo
  • CSL Behring
  • Biogen
  • Oxford Biomedica

第 14 章：附录

简介目录
Product Code: TIPHE100001165

The gene therapy market is anticipated to grow from US$ 5.84 billion in 2024 to US$ 29.36 billion by 2031, reflecting a projected CAGR of 14.3% from 2025 to 2031.

Market Insights and Analyst Perspective:Gene therapy involves treating diseases by either inactivating a harmful gene, replacing it with a healthy version, or introducing a new or modified gene to aid in disease treatment and prevention. This therapy can be categorized into in vivo and ex vivo methods. The primary goal of gene therapy is to replace or correct defective genes with normal ones, enabling the body to produce the necessary proteins or enzymes for proper functioning, which may potentially address the root causes of various diseases. The rising incidence of genetic disorders and cancer globally, along with an increasing number of FDA approvals for gene therapies, is propelling the growth of the gene therapy market. Furthermore, advancements in gene therapy technologies are expected to further enhance market growth in the future.

Growth Catalysts:Recent advancements in biotechnology have facilitated the creation of treatments for a broad spectrum of conditions. Gene therapies are now being utilized to address various ailments, including cancer, neurological disorders, and genetic diseases. The global adoption of gene therapies is on the rise, largely due to the availability of FDA-approved products. Here are some notable examples of gene therapy products that have received FDA approval in recent years:

In December 2023, the FDA approved two cell-based gene therapies for sickle cell disease: Bluebird Bio's Lyfgenia (lovotibeglogene autotemcel) for patients aged 12 and older with a history of vaso-occlusive events, alongside Casgevy (exagamglogene autotemcel) from Vertex Pharmaceuticals and CRISPR Therapeutics.

In June 2023, the FDA approved Roctavian, a gene therapy utilizing an adeno-associated virus vector for adults with severe hemophilia A who do not have pre-existing antibodies to adeno-associated virus serotype 5. This one-time treatment addresses a gene mutation responsible for producing factor VIII (FVIII), a crucial protein for blood clotting.

In June 2023, the FDA also approved Elevidys, marking the first gene therapy for treating Duchenne muscular dystrophy in pediatric patients aged 4 to 5 years with a confirmed mutation in the Duchenne muscular dystrophy gene, provided they do not have any pre-existing medical conditions that would hinder treatment.

In November 2022, the FDA approved HEMGENIX, a recombinant Adeno-associated virus type 5 gene therapy developed by CSL Behring LLC, for adult patients with specific types of Hemophilia B.Thus, the increasing number of approved gene therapies is significantly driving the growth of the gene therapy market.

Strategic Insights

Report Segmentation and Scope:The analysis of the gene therapy market has been conducted by examining various segments: vectors, indications, delivery modes, and geographical regions. The market is divided into non-viral and viral vectors. In terms of indications, it includes neurological diseases, cancer, Duchenne muscular dystrophy, hepatological diseases, and other conditions. The delivery modes are categorized into in vivo and ex vivo. The report encompasses the gene therapy market across North America (the US, Canada, and Mexico), Europe (France, Germany, the UK, Spain, Italy, and the Rest of Europe), Asia Pacific (China, Japan, India, Australia, South Korea, and the Rest of Asia Pacific), the Middle East & Africa (Saudi Arabia, South Africa, the UAE, and the Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and the Rest of South & Central America).

Segmental Analysis:The gene therapy market is segmented by vectors into non-viral and viral vectors, with the viral vectors segment holding a substantial market share in 2023 and expected to achieve a higher CAGR from 2023 to 2030.

By indication, the market includes neurological diseases, cancer, Duchenne muscular dystrophy, hepatological diseases, and other conditions. The cancer segment represented a significant share of the gene therapy market in 2023 and is projected to experience the highest CAGR during 2023 to 2030.

In terms of delivery mode, the market is divided into in vivo and ex vivo, with the in vivo segment holding a considerable market share in 2023 and anticipated to register a higher CAGR from 2023 to 2030. In vivo gene therapy allows for systemic treatment, reaching multiple sites and organs throughout the body, which is particularly beneficial for diseases that affect various areas or exhibit systemic symptoms, enabling a comprehensive therapeutic approach. Additionally, advancements in delivery technologies, such as viral vectors, nanoparticles, and lipid-based carriers, have enhanced the effectiveness and specificity of in vivo therapies, improving the targeted delivery of genetic material and the overall safety and efficacy of treatments.

Regional Analysis:Regionally, the gene therapy market is divided into North America, Europe, Asia Pacific, South & Central America, and the Middle East & Africa. In 2023, North America held a significant market share, with the US leading the gene therapy market in this region. The growth in North America is driven by the increasing prevalence of genetic disorders, a rising number of cancer patients, enhanced government funding, greater adoption of advanced gene therapies for treatment, and a growing number of product approvals.

According to the Centers for Disease Control and Prevention (CDC), approximately 1,603,844 new cancer cases were diagnosed in 2020, resulting in 602,347 cancer-related deaths in the US. This translates to 403 new cancer cases per 100,000 individuals. Furthermore, the International Agency for Research on Cancer projects that new cancer cases could reach 30.2 million by 2040. Estimates from the US Government Accountability Office published in October 2021 indicate that around 25 to 30 million people in the US suffer from rare diseases, with nearly 50% of these patients being children. Many rare diseases stem from genetic mutations, with approximately 80% classified as genetic disorders.

As of October 2021, the National Institutes of Health reported that 10 pharmaceutical companies and 5 non-profit organizations are collaborating to expedite the development of gene therapies for the 30 million Americans affected by rare diseases. The US FDA has approved 7 cell and gene therapy drugs, with a pipeline of around 1,200 experimental therapies, half of which are in Phase 2 clinical trials. Annual sales growth estimates suggest a 15% increase for cell therapies and approximately 30% for gene therapies, according to the Chemical & Engineering News report from 2023. All these factors contribute to the expanding gene therapy market in the region.

Gene Therapy Market Report Scope

Industry Developments and Future Opportunities:Below are some initiatives undertaken by key players in the global gene therapy market:

In January 2022, Ori Biotech Ltd raised over US$ 100 million in an oversubscribed Series B funding round to launch an innovative cell and gene therapy manufacturing platform.

In January 2020, Astellas Pharma Inc. acquired Audentes Therapeutics, Inc., positioning the combined entity as a global leader in AAV-based genetic medicine.Competitive Landscape and Key Companies:The gene therapy market forecast provides valuable insights for stakeholders to strategize their growth plans. Key players profiled in the gene therapy market report include Novartis AG, Astellas Pharma Inc., Bristol-Myers Squibb Company, Bluebird Bio Inc., CSL Behring, Sanofi, F. Hoffmann-La Roche Ltd, Daiichi Sankyo, Biogen, and Oxford Biomedica. These companies are focused on launching new high-tech products, enhancing existing offerings, and expanding geographically to meet the increasing global consumer demand.

Table Of Contents

1. Introduction

  • 1.1 Scope of the Study
  • 1.2 Market Definition, Assumptions and Limitations
  • 1.3 Market Segmentation

2. Executive Summary

  • 2.1 Key Insights
  • 2.2 Market Attractiveness Analysis

3. Research Methodology

4. Gene Therapy Market Landscape

  • 4.1 Overview
  • 4.2 PEST Analysis
  • 4.3 Ecosystem Analysis
    • 4.3.1 List of Vendors in the Value Chain

5. Gene Therapy Market - Key Market Dynamics

  • 5.1 Key Market Drivers
  • 5.2 Key Market Restraints
  • 5.3 Key Market Opportunities
  • 5.4 Future Trends
  • 5.5 Impact Analysis of Drivers and Restraints

6. Gene Therapy Market - Global Market Analysis

  • 6.1 Gene Therapy - Global Market Overview
  • 6.2 Gene Therapy - Global Market and Forecast to 2031

7. Gene Therapy Market - Revenue Analysis (USD Million) - By Vector Type, 2021-2031

  • 7.1 Overview
  • 7.2 Viral Vector
  • 7.3 Non-Viral Vector

8. Gene Therapy Market - Revenue Analysis (USD Million) - By Method, 2021-2031

  • 8.1 Overview
  • 8.2 Ex-Vivo
  • 8.3 In-Vivo

9. Gene Therapy Market - Revenue Analysis (USD Million) - By Application, 2021-2031

  • 9.1 Overview
  • 9.2 Neurological Disorders
  • 9.3 Cancer
  • 9.4 Duchenne Muscular Dystrophy
  • 9.5 Hepatological Diseases
  • 9.6 Other Indications

10. Gene Therapy Market - Revenue Analysis (USD Million), 2021-2031 - Geographical Analysis

  • 10.1 North America
    • 10.1.1 North America Gene Therapy Market Overview
    • 10.1.2 North America Gene Therapy Market Revenue and Forecasts to 2031
    • 10.1.3 North America Gene Therapy Market Revenue and Forecasts and Analysis - By Vector Type
    • 10.1.4 North America Gene Therapy Market Revenue and Forecasts and Analysis - By Method
    • 10.1.5 North America Gene Therapy Market Revenue and Forecasts and Analysis - By Application
    • 10.1.6 North America Gene Therapy Market Revenue and Forecasts and Analysis - By Countries
      • 10.1.6.1 United States Gene Therapy Market
        • 10.1.6.1.1 United States Gene Therapy Market, by Vector Type
        • 10.1.6.1.2 United States Gene Therapy Market, by Method
        • 10.1.6.1.3 United States Gene Therapy Market, by Application
      • 10.1.6.2 Canada Gene Therapy Market
        • 10.1.6.2.1 Canada Gene Therapy Market, by Vector Type
        • 10.1.6.2.2 Canada Gene Therapy Market, by Method
        • 10.1.6.2.3 Canada Gene Therapy Market, by Application
      • 10.1.6.3 Mexico Gene Therapy Market
        • 10.1.6.3.1 Mexico Gene Therapy Market, by Vector Type
        • 10.1.6.3.2 Mexico Gene Therapy Market, by Method
        • 10.1.6.3.3 Mexico Gene Therapy Market, by Application
  • 10.2 Europe
    • 10.2.1 Germany
    • 10.2.2 France
    • 10.2.3 Italy
    • 10.2.4 Spain
    • 10.2.5 United Kingdom
    • 10.2.6 Rest of Europe
  • 10.3 Asia-Pacific
    • 10.3.1 Australia
    • 10.3.2 China
    • 10.3.3 India
    • 10.3.4 Japan
    • 10.3.5 South Korea
    • 10.3.6 Rest of Asia-Pacific
  • 10.4 Middle East and Africa
    • 10.4.1 South Africa
    • 10.4.2 Saudi Arabia
    • 10.4.3 U.A.E
    • 10.4.4 Rest of Middle East and Africa
  • 10.5 South and Central America
    • 10.5.1 Brazil
    • 10.5.2 Argentina
    • 10.5.3 Rest of South and Central America

11. Industry Landscape

  • 11.1 Mergers and Acquisitions
  • 11.2 Agreements, Collaborations, Joint Ventures
  • 11.3 New Product Launches
  • 11.4 Expansions and Other Strategic Developments

12. Competitive Landscape

  • 12.1 Heat Map Analysis by Key Players
  • 12.2 Company Positioning and Concentration

13. Gene Therapy Market - Key Company Profiles

  • 13.1 Novartis AG
    • 13.1.1 Key Facts
    • 13.1.2 Business Description
    • 13.1.3 Products and Services
    • 13.1.4 Financial Overview
    • 13.1.5 SWOT Analysis
    • 13.1.6 Key Developments
  • 13.2 Astellas Pharma Inc
  • 13.3 Bristol-Myers Squibb Company
  • 13.4 Bluebird Bio Inc.
  • 13.5 Sanofi
  • 13.6 F. Hoffmann-La Roche Ltd.
  • 13.7 Daiichi Sankyo
  • 13.8 CSL Behring
  • 13.9 Biogen
  • 13.10 Oxford Biomedica

14. Appendix

  • 14.1 Glossary
  • 14.2 About The Insight Partners
  • 14.3 Market Intelligence Cloud