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基因治療學和RNAi 基因療法

市場調查報告書

商品編碼

1800232

全球基因治療市場 - 2025 年至 2030 年預測

Global Gene Therapy Market - Forecasts fom 2025 to 2030

出版日期: 2025年08月13日 | 出版商:

Knowledge Sourcing Intelligence | 英文 152 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

基因治療市場預計將從 2025 年的 78.76 億美元成長到 2030 年的 184.19 億美元，複合年成長率為 18.52%。

基因治療市場預計將在 2025 年至 2030 年期間經歷強勁成長，這得益於研發投入的增加以及癌症等疾病發病率的上升。基因治療透過糾正或取代缺陷基因來治療或預防疾病，由於其在治療癌症和罕見遺傳疾病等複雜疾病方面的潛力，正日益受到歡迎。免疫療法的進步、良好的法規環境以及創新療法資金的增加為基因治療市場提供了支持。在巨額研發投入和高癌症發生率的推動下，美國引領市場。然而，高昂的治療費用和複雜的法規也帶來了挑戰。

市場促進因素

癌症發生率上升

癌症發生率的上升是基因治療市場的主要驅動力。預計到2022年，美國癌症患者人數將增加至約192萬，導致60.9萬人死亡，凸顯了對創新療法的迫切需求。基因療法，尤其是透過免疫療法針對晚期腫瘤的基因療法，因其能夠提高緩解率而日益重要。不斷成長的患者群體推動了對各種癌症類型提供標靶解決方案的治療需求，例如嵌合體抗原受體T細胞（CAR-T）和基於載體的療法。

增加研發投入

基因治療研發的大量投入正在推動市場成長。世界衛生組織 (WHO) 報告稱，2023 年，包括基因療法在內的全球醫療保健研發支出呈上升趨勢，西太平洋國家領先，佔 GDP 的 0.07%。在美國，美國國立衛生研究院 (NIH) 為基因治療研究撥出大量資金，以促進癌症和罕見疾病治療的創新。此類投資支持溶瘤病毒療法和基於載體的治療方法等先進治療方法的開發，從而推動市場滲透。

有利的法規環境

監管環境，尤其是在美國，正在支撐市場成長。 FDA 於 2023 年 5 月核准了用於治療營養不良性大皰性先天性水皰症症的 Vyjuvek，並於 2022 年 12 月批准了用於治療非肌肉層浸潤性膀胱癌的 Adstiladrin，這體現了其致力於推進基因治療發展的決心。這些核准，加上簡化的監管途徑，正在刺激創新和市場准入，支持基因治療在各種適應症中的應用。

市場限制

基因治療市場面臨挑戰，因為高昂的治療費用（每位患者高達數百萬美元）限制了基因治療的可近性，尤其是在新興市場。監管的複雜性，包括嚴格的安全性和有效性要求，導致核准延遲並增加開發成本。此外，基因療法的生產過程（例如病毒載體）的複雜性也帶來了可擴展性的挑戰。透過成本最佳化和生產流程標準化來克服這些障礙，對於市場的持續成長至關重要。

The global gene therapy market is experiencing robust growth from 2025 to 2030, driven by increased investment in research and development (R&D) and the rising prevalence of diseases like cancer. Gene therapy, which involves modifying or replacing defective genes to treat or prevent diseases, is gaining traction due to its potential to address complex conditions such as cancer and rare genetic disorders. The market is propelled by advancements in immunotherapy, favorable regulatory environments, and growing funding for innovative treatments. The United States leads the market, supported by significant R&D investments and a high incidence of cancer. However, high treatment costs and regulatory complexities may pose challenges.

Market Drivers

Rising Prevalence of Cancer

The increasing incidence of cancer is a primary driver of the gene therapy market. In the United States, cancer cases rose to approximately 1.92 million in 2022, with 609,000 deaths, underscoring the urgent need for innovative treatments. Gene therapies, particularly those targeting advanced-stage tumors through immunotherapy, are gaining importance for their ability to improve remission rates. The growing patient pool drives demand for therapies like chimeric antigen receptor T-cell (CAR-T) and vector-based treatments, which offer targeted solutions for various cancer types.

Increased R&D Investment

Significant investments in gene therapy R&D are fueling market growth. In 2023, the World Health Organization reported that global healthcare R&D spending, including for gene therapy, continues to rise, with Western Pacific countries leading at 0.07% of GDP. In the United States, the National Institutes of Health (NIH) allocated substantial funding for gene therapy research, fostering innovation in treatments for cancer and rare diseases. These investments support the development of advanced therapies, such as oncolytic virotherapy and vector-based treatments, enhancing market penetration.

Favorable Regulatory Environment

The regulatory landscape, particularly in the United States, supports market growth. The FDA's approval of therapies like Vyjuvek in May 2023 for dystrophic epidermolysis bullosa and Adstiladrin in December 2022 for non-muscle-invasive bladder cancer demonstrates a commitment to advancing gene therapy. These approvals, coupled with streamlined regulatory pathways, encourage innovation and market entry, boosting the adoption of gene therapies for various indications.

Market Restraints

The gene therapy market faces challenges due to the high cost of treatments, often reaching millions of dollars per patient, which limits accessibility, particularly in developing regions. Regulatory complexities, including stringent safety and efficacy requirements, can delay approvals and increase development costs. Additionally, the complexity of manufacturing gene therapies, such as viral vectors, poses scalability challenges. Addressing these barriers through cost optimization and standardized production processes will be critical for sustained market growth.

Market Segmentation

By Application

The market is segmented into oncology, rare genetic disorders, neurological disorders, and others. Oncology dominates due to the high prevalence of cancer and the focus on immunotherapies like CAR-T and oncolytic virotherapy. Rare genetic disorders, such as Duchenne muscular dystrophy, are also significant, driven by therapies like RGX-202.

By Geography

The market is segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America, led by the United States, holds a dominant share due to its high cancer incidence, substantial R&D funding, and favorable regulatory environment. Asia-Pacific is expected to grow rapidly, driven by increasing healthcare investments and rising disease prevalence in countries like India. Europe, South America, and the Middle East and Africa are emerging markets, supported by improving healthcare infrastructure.

The gene therapy market is set for robust growth from 2025 to 2030, driven by rising cancer prevalence, increased R&D investment, and favorable regulations, particularly in the United States. Despite challenges from high costs and regulatory complexities, the market's outlook remains positive, with strong growth in North America and Asia-Pacific. Industry players must focus on cost-effective therapies, scalable manufacturing, and strategic collaborations to capitalize on the growing demand for innovative gene therapy solutions.

Key Benefits of this Report:

Insightful Analysis: Gain detailed market insights covering major as well as emerging geographical regions, focusing on customer segments, government policies and socio-economic factors, consumer preferences, industry verticals, and other sub-segments.
Competitive Landscape: Understand the strategic maneuvers employed by key players globally to understand possible market penetration with the correct strategy.
Market Drivers & Future Trends: Explore the dynamic factors and pivotal market trends and how they will shape future market developments.
Actionable Recommendations: Utilize the insights to exercise strategic decisions to uncover new business streams and revenues in a dynamic environment.
Caters to a Wide Audience: Beneficial and cost-effective for startups, research institutions, consultants, SMEs, and large enterprises.

What do businesses use our reports for?

Industry and Market Insights, Opportunity Assessment, Product Demand Forecasting, Market Entry Strategy, Geographical Expansion, Capital Investment Decisions, Regulatory Framework & Implications, New Product Development, Competitive Intelligence

Report Coverage:

Historical data from 2020 to 2024 & forecast data from 2025 to 2030
Growth Opportunities, Challenges, Supply Chain Outlook, Regulatory Framework, and Trend Analysis
Competitive Positioning, Strategies, and Market Share Analysis
Revenue Growth and Forecast Assessment of segments and regions including countries
Company Profiling (Strategies, Products, Financial Information, and Key Developments among others.

Segmentation:

By Therapy Type

Ex Vivo
In Vivo
In Situ

By Vector Type

Viral
Non-Viral

By Technique Type

Gene Augmentation
Gene Inhibition
Specific Cell Kill

By Disease Type

Cancer
Heart Disease
Diabetes
HIV
Others

By Geography

North America
USA
Canada
Mexico
South America
Brazil
Argentina
Others
Europe
Germany
France
United Kingdom
Spain
Others
Middle East and Africa
Saudi Arabia
UAE
Others
Asia Pacific
China
India
Japan
South Korea
Indonesia
Thailand
Others

1. EXECUTIVE SUMMARY

2. MARKET SNAPSHOT

2.1. Market Overview
2.2. Market Definition
2.3. Scope of the Study
2.4. Market Segmentation

3. BUSINESS LANDSCAPE

3.1. Market Drivers
3.2. Market Restraints
3.3. Market Opportunities
3.4. Porter's Five Forces Analysis
3.5. Industry Value Chain Analysis
3.6. Policies and Regulations
3.7. Strategic Recommendations

4. TECHNOLOGICAL OUTLOOK

5. GLOBAL GENE THERAPY MARKET BY THERAPY TYPE

5.1. Introduction
5.2. Ex Vivo
5.3. In Vivo
5.4. In Situ

6. GLOBAL GENE THERAPY MARKET BY VECTOR TYPE

6.1. Introduction
6.2. Viral
6.3. Non-Viral

7. GLOBAL GENE THERAPY MARKET BY TECHNIQUE TYPE

7.1. Introduction
7.2. Gene Augmentation
7.3. Gene Inhibition
7.4. Specific Cell Kill

8. GLOBAL GENE HERAPY MARKET BY DISEASE TYPE

8.1. Introduction
8.2. Cancer
8.3. Heart Disease
8.4. Diabetes
8.5. HIV
8.6. Others

9. GLOBAL GENE THERAPY MARKET BY GEOGRAPHY

9.1. Introduction
9.2. North America
- 9.2.1. USA
- 9.2.2. Canada
- 9.2.3. Mexico
9.3. South America
- 9.3.1. Brazil
- 9.3.2. Argentina
- 9.3.3. Others
9.4. Europe
- 9.4.1. Germany
- 9.4.2. France
- 9.4.3. United Kingdom
- 9.4.4. Spain
- 9.4.5. Others
9.5. Middle East and Africa
- 9.5.1. Saudi Arabia
- 9.5.2. UAE
- 9.5.3. Others
9.6. Asia Pacific
- 9.6.1. China
- 9.6.2. India
- 9.6.3. Japan
- 9.6.4. South Korea
- 9.6.5. Indonesia
- 9.6.6. Thailand
- 9.6.7. Others