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市場調查報告書
商品編碼
1830960

基因治療市場

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

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簡介目錄

基因治療市場預計將從 2024 年的 58.4 億美元成長到 2031 年的 293.6 億美元，預計 2025 年至 2031 年的複合年成長率為 14.3%。市場洞察與分析師觀點：基因治療涉及透過去活化有害基因、用健康基因取代有害基因或引入新的或修飾的基因來幫助治療和預防疾病來治療疾病。這種療法可以分為體內和體外方法。基因治療的主要目標是用正常基因替換或糾正缺陷基因，使身體能夠產生正常功能所需的蛋白質或酶，這可能解決各種疾病的根本原因。全球遺傳疾病和癌症發病率的上升，以及 FDA 批准的基因療法數量的增加，正在推動基因治療市場的成長。此外，預計未來基因治療技術的進步將進一步促進市場成長。

成長催化劑：生物技術的最新進展促進了多種疾病的治療。基因療法目前被用於治療各種疾病，包括癌症、神經系統疾病和遺傳疾病。全球基因療法的採用正在上升，這主要得益於FDA核准產品的普及。以下是近年來獲得FDA批准的一些值得關注的基因療法產品：

2023 年 12 月，FDA 核准了兩種針對鐮狀細胞疾病的細胞基因療法：Bluebird Bio 公司的 Lyfgenia（lovotibeglogene autotemcel），用於治療有血管閉塞事件病史的 12 歲及以上患者，以及 Vertex Pharmaceuticals 和 CRISPR Therapeutics 公司的 12 歲及以上患者，以及 Vertex Pharmaceuticals 和 CRISPR Therapeutics 公司的 Casactics）。 2023 年 6 月，FDA 批准了 Roctavian，這是一種利用腺相關病毒載體的基因療法，用於治療沒有腺相關病毒血清型 5 抗體的嚴重血友病 A 成人患者。這種一次性治療針對的是負責產生凝血因子 VIII (FVIII) 的基因突變。 2023 年 6 月，FDA 也批准了 Elevidys，這是第一個用於治療 4 至 5 歲兒童杜氏肌肉營養不良症的基因療法，這些患者的基因已確認突變杜氏肌肉營養不良症基因患者，前提是他們沒有任何會妨礙治療的既往疾病。 2022 年 11 月，FDA 批准了 CSL Behring LLC 開發的重組腺相關病毒 5 型基因療法 HEMGENIX，用於治療特定類型血友病 B 的成年患者。因此，核准基因療法數量的增加顯著推動了基因治療市場的成長。

策略洞察報告細分與範圍：基因治療市場分析透過檢視載體、適應症​​、遞送方式和地理區域等不同部分進行。市場分為非病毒載體和病毒載體。就適應症而言，它包括神經系統疾病、癌症、杜氏肌肉營養不良症、肝病和其他疾病。遞送方式分為體內和體外。該報告涵蓋北美（美國、加拿大和墨西哥）、歐洲（法國、德國、英國、西班牙、義大利和歐洲其他地區）、亞太地區（中國、日本、印度、澳洲、韓國和亞太其他地區）、中東和非洲（沙烏地阿拉伯、南非、阿拉伯聯合大公國和中東和非洲其他地區）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區）的基因治療市場。

分段分析：基因治療市場按載體細分為非病毒載體和病毒載體，其中病毒載體部分在 2023 年佔據相當大的市場佔有率，預計在 2023 年至 2030 年期間實現更高的複合年成長率。

依適應症分類，市場涵蓋神經系統疾病、癌症、杜氏肌肉營養不良症、肝病和其他疾病。 2023年，癌症領域佔據了基因治療市場的很大佔有率，預計在2023年至2030年期間將經歷最高的複合年成長率。

就遞送方式而言，市場分為體內和體外兩種。體內治療在2023年佔據了相當大的市場佔有率，預計在2023年至2030年期間將實現更高的複合年成長率。體內基因治療可以進行全身性治療，覆蓋全身多個部位和器官，這對於影響多個部位或表現出全身症狀的疾病尤其有益，從而實現綜合治療。此外，病毒載體、奈米顆粒和脂質載體等遞送技術的進步增強了體內治療的有效性和特異性，提高了遺傳物質的標靶遞送能力，並提高了治療的整體安全性和有效性。

區域分析：從區域來看，基因療法市場分為北美、歐洲、亞太地區、南美和中美以及中東和非洲。 2023年，北美佔據了相當大的市場佔有率，其中美國在該地區的基因治療市場中處於領先地位。北美的成長得益於遺傳疾病盛行率的上升、癌症患者數量的增加、政府資金的增加、先進基因療法的廣泛應用以及產品獲準數量的增加。

根據美國疾病管制與預防中心 (CDC) 的數據，2020 年美國新增癌症病例約 1,603,844 例，導致 602,347 人死於癌症。這相當於每 10 萬人新增 403 例癌症病例。此外，國際癌症研究機構預測，到 2040 年，新增癌症病例可能達到 3,020 萬例。美國政府責任署 2021 年 10 月發布的估計數據顯示，美國約有 2,500 萬至 3,000 萬人患有罕見疾病，其中近 50% 為兒童。許多罕見疾病源自於基因突變，約 80% 被歸類為遺傳性疾病。

截至2021年10月，美國國立衛生研究院報告稱，10家製藥公司和5家非營利組織正在合作，加速開發基因療法，造福3,000萬受罕見疾病影響的美國人。美國食品藥物管理局（FDA）已核准7種細胞及基因治療藥物，目前約有1,200種實驗療法在研，其中一半處於第二期臨床試驗階段。根據《化學與工程新聞》2023年的報道，預計細胞療法的年銷售額將成長15%，基因療法的年銷售額將成長約30%。所有這些因素都推動了該地區基因治療市場的不斷擴張。

基因治療市場報告範圍產業發展與未來機會：以下是全球基因療法市場主要參與者採取的一些措施：

2022 年 1 月，Ori Biotech Ltd 在超額認購的 B 輪融資中籌集了超過 1 億美元，用於推出創新的細胞和基因治療生產平台。 2020 年 1 月，安斯泰來製藥公司收購了 Audentes Therapeutics, Inc.，將合併後的實體定位為基於 AAV 的基因醫學的全球領導者。競爭格局與關鍵公司：基因治療市場預測為利害關係人制定成長計畫提供了寶貴的見解。基因治療市場報告中介紹的關鍵參與者包括諾華公司、安斯泰來製藥公司、百時美施貴寶公司、Bluebird Bio Inc.、傑特羅貝林、賽諾菲、羅氏有限公司、第一三共、Biogen 和 Oxford Biomedica。這些公司專注於推出新的高科技產品、增強現有產品和擴展地理以滿足日益成長的全球消費者需求。

目錄

第1章：簡介

第2章：執行摘要

  • 關鍵見解
  • 市場吸引力分析

第3章：研究方法

第4章：基因治療市場格局

  • 概述
  • PEST分析
  • 生態系分析
    • 價值鏈中的供應商列表

第5章：基因治療市場－關鍵市場動態

  • 關鍵市場促進因素
  • 主要市場限制因素
  • 關鍵市場機會
  • 未來趨勢
  • 促進因素和限制因素的影響分析

第6章：基因治療市場－全球市場分析

  • 基因治療—全球市場概覽
  • 基因治療－全球市場及2031年預測

第7章：基因治療市場-收入分析-依載體類型，2021-2031

  • 概述
  • 病毒載體
  • 非病毒載體

第 8 章：基因治療市場 - 收入分析 - 依方法，2021-2031 年

  • 概述
  • 離體
  • 體內

第9章：基因治療市場-收入分析-按應用，2021-2031

  • 概述
  • 神經系統疾病
  • 癌症
  • 杜氏肌肉營養不良症
  • 肝病
  • 其他適應症

第 10 章：基因治療市場 - 收入分析，2021-2031 - 地理分析

  • 北美洲
    • 美國
    • 加拿大
    • 墨西哥
  • 歐洲
    • 德國
    • 法國
    • 義大利
    • 西班牙
    • 英國
    • 歐洲其他地區
  • 亞太
    • 澳洲
    • 中國
    • 印度
    • 日本
    • 韓國
    • 亞太其他地區
  • 中東和非洲
    • 南非
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 中東和非洲其他地區
  • 南美洲和中美洲
    • 巴西
    • 阿根廷
    • 南美洲和中美洲其他地區

第 11 章：產業格局

  • 併購
  • 協議、合作、合資企業
  • 新產品發布
  • 擴張和其他策略發展

第 12 章：競爭格局

  • 關鍵參與者的熱圖分析
  • 公司定位與集中度

第 13 章：基因治療市場 - 主要公司簡介

  • 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：附錄

簡介目錄
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