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基因治療學和RNAi 以基因為基之藥物開發

市場調查報告書

商品編碼

1856952

全球 CRISPR 基因編輯療法市場：預測至 2032 年—按產品、應用、最終使用者和地區分類的分析

CRISPR Gene Editing Therapies Market Forecasts to 2032 - Global Analysis By Product, Application, End User and By Geography

出版日期: 2025年10月01日 | 出版商:

Stratistics Market Research Consulting | 英文 200+ Pages | 商品交期: 2-3個工作天內

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簡介目錄圖表

根據 Stratistics MRC 的數據，全球 CRISPR 基因編輯療法市場預計到 2025 年將達到 53 億美元，到 2032 年將達到 144 億美元，預測期內複合年成長率為 15.2%。

CRISPR基因編輯療法是一種先進的醫療干預手段，它利用CRISPR-Cas9技術精確地修改生物體的DNA。透過針對特定基因，這些治療方法可以糾正基因突變、抑制有害基因或引入有益基因序列，從而為遺傳性疾病、癌症和病毒感染提供潛在的治療方法。與傳統醫療手段不同，CRISPR療法旨在從基因層面解決疾病的根本原因。目前的研究重點在於提高CRISPR療法的精準性、安全性和遞送方式，使其成為個人化和再生醫學領域的一項革命性技術。

CRISPR平台技術的快速發展

精準編輯工具，例如鹼基編輯器和先導編輯器，正在提高標靶準確性並減少脫靶效應。與人工智慧驅動的設計和高通量篩檢的結合，正在增強候選藥物的選擇和檢驗。開發人員正在為複雜的適應症引入模組化遞送系統和多重編輯通訊協定。對平台可擴展性和自動化的投資正在提高可重複性和監管合應對力。這些創新正在推動全球生物技術生態系統的臨床應用和產品線擴展。

體內標靶遞送的挑戰

病毒載體和脂質奈米顆粒在組織特異性、免疫抗原性和有效載荷能力方面面臨許多挑戰。對於神經系統疾病和代謝性疾病而言，如何穿過血腦障壁並實現全身分佈仍然是一大難題。研發人員必須權衡基因編輯效率、毒性和免疫反應控制。在臨床試驗過程中，監管機構對遞送平台的審查力度也不斷增加。這些限制持續限制全身性和多器官療法的發展。

遺傳疾病和罕見疾病的興起

單株疾病，例如鐮狀細胞貧血症、Duchenne氏肌肉失養症和囊腫纖維化，正在推動早期臨床應用。罕見疾病基金會和患者權益組織正在資助轉化研究和臨床試驗招募。監管機構正在為罕見疾病適應症和突破性治療方法提供快速核准途徑。與新生兒篩檢和基因組診斷的整合正在提高早期療育的可能性。這些趨勢正在推動對精準基因編輯解決方案的長期需求。

高昂的製造和處理成本

生產符合GMP標準的試劑、載體和細胞療法需要專門的基礎設施和熟練的員工。批次差異和品管的複雜性增加了營運負擔和監管風險。一次性治療藥物的定價模式對支付者和醫療保健系統而言仍然不透明。報銷框架正在緩慢發展，尤其是在罕見疾病和超罕見疾病領域。這些成本壓力持續阻礙商業性可行性和公平取得。

新冠疫情的影響：

疫情加速了對CRISPR技術在診斷、疫苗研發和治療創新方面的投資。基於CRISPR的檢測平台被部署用於快速篩檢新冠病毒和追蹤變異株。供應鏈中斷影響了試劑可得性，並延緩了基因編輯專案的檢測週期。遠端協作和數位實驗室工具在學術機構和生物技術公司中變得司空見慣。隨著CRISPR技術進入主流視野，大眾對基因組醫學的認知度也隨之提升。這些轉變正在加速CRISPR技術長期融入全球衛生策略。

預計在預測期內，CRISPR試劑盒和試劑細分市場將成為最大的細分市場。

由於CRISPR試劑盒和試劑在研究、診斷和治療開發中發揮基礎性作用，預計在預測期內，該細分市場將佔據最大的市場佔有率。這些產品包括核酸酶、引導RNA、遞送系統和檢驗工具，廣泛應用於學術、臨床和商業實驗室。市場對高保真度酶、可定製文庫和可擴展試劑規格的需求日益成長。供應商提供針對不同細胞類型、生物體和編輯工作流程量身訂製的模組化試劑盒。與自動化平台和雲端基礎設計工具的整合正在提高通量和可重複性。

預計在預測期內，學術和研究機構領域將實現最高的複合年成長率。

預計在預測期內，學術和研究機構領域將呈現最高的成長率，因為大學和公共研究機構正將其 CRISPR 計畫擴展到基礎科學和轉化醫學領域。研究機構正推出基因組工程中心、合作聯盟和開放取用工具包來加速創新。政府機構和慈善組織的資助正在支持早期和概念驗證研究。學術實驗室正在推動遞送、特異性和多重化方面的突破，並將其轉化為商業性產品線。與生物技術公司和合約研究組織 (CRO) 的夥伴關係正在促進臨床試驗的準備和智慧財產權許可。

佔比最大的地區：

在預測期內，北美預計將佔據最大的市場佔有率，這主要得益於其先進的生物技術基礎設施、積極的監管參與以及卓越的學術水平。美國擁有數量最多的CRISPR新興企業、研究機構和臨床試驗贊助商。美國國立衛生研究院（NIH）和美國國防高級研究計劃局（DARPA）的資助正在支持平台創新以及罕見疾病和複雜疾病的治療方法檢驗。美國食品藥物管理局（FDA）關於基因編輯療法的指導正在提高透明度並加快核准。加拿大正在基因組學和再生醫學領域拓展轉化研究和官民合作關係。這些因素共同推動了北美在基於CRISPR的療法開發領域的領先地位。

複合年成長率最高的地區：

由於基因組醫學、學術投資和轉化基礎設施的融合，亞太地區預計將在預測期內呈現最高的複合年成長率。中國、日本、韓國和印度等國家正在農業、診斷和人類治療領域擴大CRISPR研究。政府支持的計畫正在資助基因組編輯中心、生物製造中心和臨床試驗網路。當地企業正在推出針對特定區域、並根據人群遺傳學和疾病負擔量身定做的治療方法。學術機構正在發表具有影響力的研究成果，並與全球生物技術領導者合作。

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訂閱本報告的用戶可從以下免費自訂選項中選擇一項：

公司簡介
- 對最多三家其他公司進行全面分析
- 對主要企業進行SWOT分析（最多3家公司）
區域分類
- 根據客戶興趣對主要國家進行市場估算、預測和複合年成長率分析（註：基於可行性檢查）
競爭基準化分析
- 基於產品系列、地域覆蓋和策略聯盟對主要企業基準化分析

北美洲
- 美國
- 加拿大
- 墨西哥
歐洲
- 德國
- 英國
- 義大利
- 法國
- 西班牙
- 其他歐洲
亞太地區
- 日本
- 中國
- 印度
- 澳洲
- 紐西蘭
- 韓國
- 亞太其他地區
南美洲
- 阿根廷
- 巴西
- 智利
- 其他南美洲
中東和非洲
- 沙烏地阿拉伯
- 阿拉伯聯合大公國
- 卡達
- 南非
- 其他中東和非洲地區

第9章：主要趨勢

合約、商業夥伴關係和合資企業
企業合併（M&A）
新產品發布
業務拓展
其他關鍵策略

第10章：公司簡介

CRISPR Therapeutics AG
Editas Medicine, Inc.
Intellia Therapeutics, Inc.
Beam Therapeutics Inc.
Caribou Biosciences, Inc.
Mammoth Biosciences, Inc.
Scribe Therapeutics, Inc.
Graphite Bio, Inc.
Tessera Therapeutics, Inc.
eGenesis, Inc.
Verve Therapeutics, Inc.
Sherlock Biosciences, Inc.
Metagenomi, Inc.
ToolGen, Inc.
Cellectis SA

簡介目錄圖表

Product Code: SMRC31816

According to Stratistics MRC, the Global CRISPR Gene Editing Therapies Market is accounted for $5.3 billion in 2025 and is expected to reach $14.4 billion by 2032 growing at a CAGR of 15.2% during the forecast period. CRISPR gene editing therapies are advanced medical interventions that utilize the CRISPR-Cas9 technology to precisely modify an organism's DNA. By targeting specific genes, these therapies can correct genetic mutations, disable harmful genes, or introduce beneficial genetic sequences, offering potential cures for inherited disorders, cancers, and viral infections. Unlike traditional treatments, CRISPR therapies aim to address the root cause of diseases at the genetic level. Ongoing research focuses on improving precision, safety, and delivery methods, making CRISPR a transformative approach in personalized and regenerative medicine.

Market Dynamics:

Driver:

Rapid technological advances in CRISPR platforms

Precision editing tools such as base editors and prime editors are improving targeting accuracy and reducing off-target effects. Integration with AI-driven design and high-throughput screening is enhancing candidate selection and validation. Developers are launching modular delivery systems and multiplexed editing protocols for complex indications. Investment in platform scalability and automation is improving reproducibility and regulatory readiness. These innovations are propelling clinical translation and pipeline expansion across global biotech ecosystems.

Restraint:

Delivery challenges for in vivo targets

Viral vectors and lipid nanoparticles face barriers in tissue specificity, immunogenicity, and payload capacity. Crossing the blood-brain barrier and achieving systemic distribution remain difficult for neurological and metabolic disorders. Developers must balance editing efficiency with toxicity and immune response management. Regulatory scrutiny around delivery platforms is increasing across clinical trials. These limitations continue to constrain progress in systemic and multi-organ therapies.

Opportunity:

Growing prevalence of genetic and rare diseases

Monogenic disorders such as sickle cell anemia, Duchenne muscular dystrophy, and cystic fibrosis are driving early clinical adoption. Rare disease foundations and patient advocacy groups are funding translational research and trial recruitment. Regulatory agencies are offering expedited pathways for orphan indications and breakthrough therapies. Integration with newborn screening and genomic diagnostics is improving early intervention potential. These dynamics are fostering long-term demand for precision gene editing solutions.

Threat:

High manufacturing and therapy costs

GMP-grade production of reagents, vectors, and cell therapies requires specialized infrastructure and skilled labor. Batch variability and quality control complexity increase operational burden and regulatory risk. Pricing models for one-time curative therapies remain uncertain across payers and health systems. Reimbursement frameworks are evolving slowly, especially for rare and ultra-rare conditions. These cost pressures continue to hamper commercial viability and equitable access.

Covid-19 Impact:

The pandemic accelerated investment in CRISPR technologies for diagnostics, vaccine development, and therapeutic innovation. CRISPR-based detection platforms were deployed for rapid COVID-19 screening and variant tracking. Supply chain disruptions affected reagent availability and delayed trial timelines across gene editing programs. Remote collaboration and digital lab tools gained traction in academic and biotech settings. Public awareness of genomic medicine increased as CRISPR entered mainstream discourse. These shifts are accelerating long-term integration of CRISPR into global health strategies.

The CRISPR kits & reagents segment is expected to be the largest during the forecast period

The CRISPR kits & reagents segment is expected to account for the largest market share during the forecast period due to their foundational role in research, diagnostics, and therapeutic development. These products include nucleases, guide RNAs, delivery systems, and validation tools used across academic, clinical, and commercial labs. Demand is rising for high-fidelity enzymes, customizable libraries, and scalable reagent formats. Vendors are offering modular kits tailored to cell type, organism, and editing workflow. Integration with automation platforms and cloud-based design tools is improving throughput and reproducibility.

The academic & research institutes segment is expected to have the highest CAGR during the forecast period

Over the forecast period, the academic & research institutes segment is predicted to witness the highest growth rate as universities and public labs expand CRISPR programs across basic science and translational medicine. Institutions are launching genome engineering centers, collaborative consortia, and open-access toolkits to accelerate innovation. Funding from government agencies and philanthropic organizations is supporting early-stage research and proof-of-concept studies. Academic labs are driving breakthroughs in delivery, specificity, and multiplexing that feed into commercial pipelines. Partnerships with biotech firms and CROs are enabling clinical trial readiness and IP licensing.

Region with largest share:

During the forecast period, the North America region is expected to hold the largest market share due to its advanced biotech infrastructure, regulatory engagement, and academic excellence. The United States hosts the largest concentration of CRISPR startups, research institutions, and clinical trial sponsors. NIH and DARPA funding is supporting platform innovation and therapeutic validation across rare and complex diseases. FDA guidance on gene editing therapies is improving clarity and accelerating approvals. Canada is scaling translational research and public-private partnerships across genomics and regenerative medicine. These factors are boosting North America's leadership in CRISPR-based therapeutic development.

Region with highest CAGR:

Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR as genomic medicine, academic investment, and translational infrastructure converge. Countries like China, Japan, South Korea, and India are expanding CRISPR research across agriculture, diagnostics, and human therapeutics. Government-backed programs are funding genome editing centers, biomanufacturing hubs, and clinical trial networks. Local firms are launching region-specific therapies tailored to population genetics and disease burden. Academic institutions are publishing high-impact research and collaborating with global biotech leaders.

Key players in the market

Some of the key players in CRISPR Gene Editing Therapies Market include CRISPR Therapeutics AG, Editas Medicine, Inc., Intellia Therapeutics, Inc., Beam Therapeutics Inc., Caribou Biosciences, Inc., Mammoth Biosciences, Inc., Scribe Therapeutics, Inc., Graphite Bio, Inc., Tessera Therapeutics, Inc., eGenesis, Inc., Verve Therapeutics, Inc., Sherlock Biosciences, Inc., Metagenomi, Inc., ToolGen, Inc. and Cellectis S.A.

Key Developments:

In September 2025, Editas Medicine officially selected EDIT-401 as its lead in vivo development candidate, signaling a strategic pivot toward cardiometabolic applications. The company emphasized its focus on durable, single-dose therapies using optimized CRISPR/Cas9 delivery platforms.

In May 2025, CRISPR Therapeutics entered a multi-target strategic collaboration with Sirius Therapeutics to co-develop and co-commercialize long-acting siRNA programs (notably SRSD107), committing upfront cash and equity investments and agreeing to a cost/profit sharing and regional commercialization split.

Products Covered:

CRISPR Kits & Reagents
CRISPR Plasmids & Vectors
Design & Customization Tools
Gene Editing Platforms & Software
Contract Research & Manufacturing Services (CRO/CMO)
Gene Synthesis & Sequencing Services
Gene Expression Analysis Tools
Other Products

Applications Covered:

Therapeutic Development
Drug Discovery & Screening
Functional Genomics
Stem Cell & Regenerative Medicine
Precision Medicine / Personalized Therapy
Immunotherapy Development
Gene Therapy Clinical Trials
Pharmacogenomics
Target Validation
Other Applications

End Users Covered:

Pharmaceutical & Biotech Companies
Academic & Research Institutes
Hospitals & Specialty Clinics
Government & Regulatory Bodies
Diagnostics Companies
Biomanufacturing Firms
Other End Users

Regions Covered:

North America
- US
- Canada
- Mexico
Europe
- Germany
- UK
- Italy
- France
- Spain
- Rest of Europe
Asia Pacific
- Japan
- China
- India
- Australia
- New Zealand
- South Korea
- Rest of Asia Pacific
South America
- Argentina
- Brazil
- Chile
- Rest of South America
Middle East & Africa
- Saudi Arabia
- UAE
- Qatar
- South Africa
- Rest of Middle East & Africa

What our report offers:

Market share assessments for the regional and country-level segments
Strategic recommendations for the new entrants
Covers Market data for the years 2024, 2025, 2026, 2028, and 2032
Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
Strategic recommendations in key business segments based on the market estimations
Competitive landscaping mapping the key common trends
Company profiling with detailed strategies, financials, and recent developments
Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

Company Profiling
- Comprehensive profiling of additional market players (up to 3)
- SWOT Analysis of key players (up to 3)
Regional Segmentation
- Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
Competitive Benchmarking
- Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

1 Executive Summary

2 Preface

2.1 Abstract
2.2 Stake Holders
2.3 Research Scope
2.4 Research Methodology
- 2.4.1 Data Mining
- 2.4.2 Data Analysis
- 2.4.3 Data Validation
- 2.4.4 Research Approach
2.5 Research Sources
- 2.5.1 Primary Research Sources
- 2.5.2 Secondary Research Sources
- 2.5.3 Assumptions

3 Market Trend Analysis

3.1 Introduction
3.2 Drivers
3.3 Restraints
3.4 Opportunities
3.5 Threats
3.6 Product Analysis
3.7 Application Analysis
3.8 End User Analysis
3.9 Emerging Markets
3.10 Impact of Covid-19

4 Porters Five Force Analysis

4.1 Bargaining power of suppliers
4.2 Bargaining power of buyers
4.3 Threat of substitutes
4.4 Threat of new entrants
4.5 Competitive rivalry

5 Global CRISPR Gene Editing Therapies Market, By Product

5.1 Introduction
5.2 CRISPR Kits & Reagents
5.3 CRISPR Plasmids & Vectors
5.4 Design & Customization Tools
5.5 Gene Editing Platforms & Software
5.6 Contract Research & Manufacturing Services (CRO/CMO)
5.7 Gene Synthesis & Sequencing Services
5.8 Gene Expression Analysis Tools
5.9 Other Products

6 Global CRISPR Gene Editing Therapies Market, By Application

6.1 Introduction
6.2 Therapeutic Development
- 6.2.1 Rare Genetic Disorders
- 6.2.2 Oncology
- 6.2.3 Hematologic Diseases
- 6.2.4 Infectious Diseases
6.3 Drug Discovery & Screening
6.4 Functional Genomics
6.5 Stem Cell & Regenerative Medicine
6.6 Precision Medicine / Personalized Therapy
6.7 Immunotherapy Development
6.8 Gene Therapy Clinical Trials
6.9 Pharmacogenomics
6.10 Target Validation
6.11 Other Applications

7 Global CRISPR Gene Editing Therapies Market, By End User

7.1 Introduction
7.2 Pharmaceutical & Biotech Companies
7.3 Academic & Research Institutes
7.4 Hospitals & Specialty Clinics
7.5 Government & Regulatory Bodies
7.6 Diagnostics Companies
7.7 Biomanufacturing Firms
7.8 Other End Users

8 Global CRISPR Gene Editing Therapies Market, By Geography

8.1 Introduction
8.2 North America
- 8.2.1 US
- 8.2.2 Canada
- 8.2.3 Mexico
8.3 Europe
- 8.3.1 Germany
- 8.3.2 UK
- 8.3.3 Italy
- 8.3.4 France
- 8.3.5 Spain
- 8.3.6 Rest of Europe
8.4 Asia Pacific
- 8.4.1 Japan
- 8.4.2 China
- 8.4.3 India
- 8.4.4 Australia
- 8.4.5 New Zealand
- 8.4.6 South Korea
- 8.4.7 Rest of Asia Pacific
8.5 South America
- 8.5.1 Argentina
- 8.5.2 Brazil
- 8.5.3 Chile
- 8.5.4 Rest of South America
8.6 Middle East & Africa
- 8.6.1 Saudi Arabia
- 8.6.2 UAE
- 8.6.3 Qatar
- 8.6.4 South Africa
- 8.6.5 Rest of Middle East & Africa

9 Key Developments

9.1 Agreements, Partnerships, Collaborations and Joint Ventures
9.2 Acquisitions & Mergers
9.3 New Product Launch
9.4 Expansions
9.5 Other Key Strategies

10 Company Profiling

10.1 CRISPR Therapeutics AG
10.2 Editas Medicine, Inc.
10.3 Intellia Therapeutics, Inc.
10.4 Beam Therapeutics Inc.
10.5 Caribou Biosciences, Inc.
10.6 Mammoth Biosciences, Inc.
10.7 Scribe Therapeutics, Inc.
10.8 Graphite Bio, Inc.
10.9 Tessera Therapeutics, Inc.
10.10 eGenesis, Inc.
10.11 Verve Therapeutics, Inc.
10.12 Sherlock Biosciences, Inc.
10.13 Metagenomi, Inc.
10.14 ToolGen, Inc.
10.15 Cellectis S.A.

簡介目錄圖表

List of Tables

Table 1 Global CRISPR Gene Editing Therapies Market Outlook, By Region (2024-2032) ($MN)
Table 2 Global CRISPR Gene Editing Therapies Market Outlook, By Product (2024-2032) ($MN)
Table 3 Global CRISPR Gene Editing Therapies Market Outlook, By CRISPR Kits & Reagents (2024-2032) ($MN)
Table 4 Global CRISPR Gene Editing Therapies Market Outlook, By CRISPR Plasmids & Vectors (2024-2032) ($MN)
Table 5 Global CRISPR Gene Editing Therapies Market Outlook, By Design & Customization Tools (2024-2032) ($MN)
Table 6 Global CRISPR Gene Editing Therapies Market Outlook, By Gene Editing Platforms & Software (2024-2032) ($MN)
Table 7 Global CRISPR Gene Editing Therapies Market Outlook, By Contract Research & Manufacturing Services (CRO/CMO) (2024-2032) ($MN)
Table 8 Global CRISPR Gene Editing Therapies Market Outlook, By Gene Synthesis & Sequencing Services (2024-2032) ($MN)
Table 9 Global CRISPR Gene Editing Therapies Market Outlook, By Gene Expression Analysis Tools (2024-2032) ($MN)
Table 10 Global CRISPR Gene Editing Therapies Market Outlook, By Other Products (2024-2032) ($MN)
Table 11 Global CRISPR Gene Editing Therapies Market Outlook, By Application (2024-2032) ($MN)
Table 12 Global CRISPR Gene Editing Therapies Market Outlook, By Therapeutic Development (2024-2032) ($MN)
Table 13 Global CRISPR Gene Editing Therapies Market Outlook, By Rare Genetic Disorders (2024-2032) ($MN)
Table 14 Global CRISPR Gene Editing Therapies Market Outlook, By Oncology (2024-2032) ($MN)
Table 15 Global CRISPR Gene Editing Therapies Market Outlook, By Hematologic Diseases (2024-2032) ($MN)
Table 16 Global CRISPR Gene Editing Therapies Market Outlook, By Infectious Diseases (2024-2032) ($MN)
Table 17 Global CRISPR Gene Editing Therapies Market Outlook, By Drug Discovery & Screening (2024-2032) ($MN)
Table 18 Global CRISPR Gene Editing Therapies Market Outlook, By Functional Genomics (2024-2032) ($MN)
Table 19 Global CRISPR Gene Editing Therapies Market Outlook, By Stem Cell & Regenerative Medicine (2024-2032) ($MN)
Table 20 Global CRISPR Gene Editing Therapies Market Outlook, By Precision Medicine / Personalized Therapy (2024-2032) ($MN)
Table 21 Global CRISPR Gene Editing Therapies Market Outlook, By Immunotherapy Development (2024-2032) ($MN)
Table 22 Global CRISPR Gene Editing Therapies Market Outlook, By Gene Therapy Clinical Trials (2024-2032) ($MN)
Table 23 Global CRISPR Gene Editing Therapies Market Outlook, By Pharmacogenomics (2024-2032) ($MN)
Table 24 Global CRISPR Gene Editing Therapies Market Outlook, By Target Validation (2024-2032) ($MN)
Table 25 Global CRISPR Gene Editing Therapies Market Outlook, By Other Applications (2024-2032) ($MN)
Table 26 Global CRISPR Gene Editing Therapies Market Outlook, By End User (2024-2032) ($MN)
Table 27 Global CRISPR Gene Editing Therapies Market Outlook, By Pharmaceutical & Biotech Companies (2024-2032) ($MN)
Table 28 Global CRISPR Gene Editing Therapies Market Outlook, By Academic & Research Institutes (2024-2032) ($MN)
Table 29 Global CRISPR Gene Editing Therapies Market Outlook, By Hospitals & Specialty Clinics (2024-2032) ($MN)
Table 30 Global CRISPR Gene Editing Therapies Market Outlook, By Government & Regulatory Bodies (2024-2032) ($MN)
Table 31 Global CRISPR Gene Editing Therapies Market Outlook, By Diagnostics Companies (2024-2032) ($MN)
Table 32 Global CRISPR Gene Editing Therapies Market Outlook, By Biomanufacturing Firms (2024-2032) ($MN)
Table 33 Global CRISPR Gene Editing Therapies Market Outlook, By Other End Users (2024-2032) ($MN)