Summary

Global Gene Therapy Starting Materials Market is valued approximately at USD 1.59 billion in 2023 and is anticipated to grow with an impressive growth rate of more than 19.24% over the forecast period 2024-2032. Gene therapy, a paradigm-shifting advancement in the realm of precision medicine, hinges on the foundation of robust and high-quality starting materials such as viral vectors, plasmid DNA, and specialized cell lines. These materials are integral to the development and manufacturing of gene therapy products, which aim to treat, prevent, or potentially cure genetic disorders by introducing, altering, or silencing genes within a patient’s cells. With an expanding array of gene-based therapies advancing from the lab bench to clinical pipelines and beyond, the demand for highly specialized raw materials has surged exponentially. The complexity of producing safe and efficacious gene therapies has spurred a wave of innovation in the production and standardization of these inputs, ushering in a new era for upstream bioprocessing capabilities.
The market is witnessing an accelerated momentum owing to a confluence of pivotal factors. The rising incidence of genetic disorders and rare diseases, combined with the surging number of gene therapy clinical trials, continues to amplify the urgency for streamlined and scalable manufacturing solutions. Governments and private entities alike are funneling unprecedented investments into gene therapy infrastructure. For example, public-private partnerships and regulatory incentives across the U.S. and EU are expediting the development and commercialization of advanced therapies, including those based on adeno-associated virus (AAV) and lentiviral vectors. Moreover, the growing adoption of CRISPR and other gene editing platforms has substantially increased the complexity and volume of genetic payloads, thus driving demand for bespoke plasmids and tailor-engineered cell lines. Despite these tailwinds, challenges such as regulatory variability, production scalability, and high costs associated with GMP-grade material production remain pressing concerns, restraining the market’s full potential.
The surge in biopharmaceutical R&D activities globally is fueling the requirement for optimized gene therapy starting materials. Emerging biotech firms and research institutes are increasingly outsourcing the production of vectors and plasmids to specialized CDMOs to reduce time-to-market. Furthermore, integration of AI-powered analytics and automation in upstream bioprocess development is poised to enhance productivity and consistency in raw material manufacturing. Additionally, companies are working on establishing platform-based production strategies that allow faster and cost-effective scale-up of clinical-grade vectors. This focus on standardization is not only ensuring product reproducibility but is also helping in addressing the batch-to-batch variability—a long-standing hurdle in gene therapy production.
Several regional markets are displaying dynamic patterns of growth. North America currently holds the lion’s share of the global market, bolstered by the presence of leading biotechnology firms, favorable reimbursement structures, and advanced regulatory frameworks. The United States, in particular, has established itself as a nucleus for gene therapy innovation, with a growing number of FDA-approved therapies and an increasing volume of IND filings. Europe follows closely, driven by a robust academic research base and initiatives such as the EU’s Horizon Europe program, which supports gene therapy-focused projects. Meanwhile, the Asia Pacific region is emerging as the fastest-growing market, catalyzed by rising investments in genomic medicine, expanding biomanufacturing capabilities in countries like China, India, and South Korea, and a rapidly evolving regulatory environment conducive to gene therapy development.
Major market player included in this report are:
• Thermo Fisher Scientific, Inc.
• Charles River Laboratories International, Inc.
• Catalent, Inc.
• Lonza Group Ltd.
• Oxford Biomedica plc
• Wuxi AppTec Co., Ltd.
• FUJIFILM Diosynth Biotechnologies
• Takara Bio Inc.
• Aldevron LLC
• MilliporeSigma (Merck KGaA)
• Bio-Techne Corporation
• Cobra Biologics (Charles River)
• Sarepta Therapeutics, Inc.
• GenScript Biotech Corporation
• AGC Biologics
The detailed segments and sub-segment of the market are explained below:
By Product
• Viral Vectors
• Plasmid DNA
• Cell Lines
By Development Stage
• Preclinical
• Clinical
• Commercial
By Application
• Gene Editing
• Cell Therapy
• Genetic Disorders
• Oncology
• Others
By End Use
• Biotechnology and Pharmaceutical Companies
• Academic and Research Institutes
• CDMOs (Contract Development and Manufacturing Organizations)
• Hospitals and Clinics
By Region:
North America
• U.S.
• Canada
Europe
• UK
• Germany
• France
• Spain
• Italy
• Rest of Europe
Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• Rest of Asia Pacific
Latin America
• Brazil
• Mexico
Middle East & Africa
• Saudi Arabia
• South Africa
• Rest of Middle East & Africa
Years considered for the study are as follows:
Historical year – 2022
Base year – 2023
Forecast period – 2024 to 2032
Key Takeaways:
• Market Estimates & Forecast for 10 years from 2022 to 2032.
• Annualized revenues and regional level analysis for each market segment.
• Detailed analysis of geographical landscape with Country level analysis of major regions.
• Competitive landscape with information on major players in the market.
• Analysis of key business strategies and recommendations on future market approach.
• Analysis of competitive structure of the market.
• Demand side and supply side analysis of the market.

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Table of Contents

Table of Contents
Chapter 1. Global Gene Therapy Starting Materials Market Executive Summary
1.1. Global Market Size & Forecast (2022 – 2032)
1.2. Regional Summary
1.3. Segmental Summary
1.3.1. By Product (Viral Vectors, Plasmid DNA, Cell Lines)
1.3.2. By Development Stage (Preclinical, Clinical, Commercial)
1.3.3. By Application (Gene Editing, Cell Therapy, Genetic Disorders, Oncology, Others)
1.3.4. By End Use (Biotech & Pharma, Academic & Research, CDMOs, Hospitals & Clinics)
1.4. Key Trends
1.5. Recession Impact
1.6. Analyst Recommendation & Conclusion
Chapter 2. Global Gene Therapy Starting Materials Market Definition and Research Assumptions
2.1. Research Objective
2.2. Market Definition
2.3. Research Assumptions
2.3.1. Inclusion & Exclusion
2.3.2. Limitations
2.3.3. Supply Side Analysis
2.3.3.1. Availability
2.3.3.2. Infrastructure
2.3.3.3. Regulatory Environment
2.3.3.4. Market Competition
2.3.3.5. Economic Viability (Customer Perspective)
2.3.4. Demand Side Analysis
2.3.4.1. Regulatory Frameworks
2.3.4.2. Technological Advancements
2.3.4.3. Ethical Considerations
2.3.4.4. Stakeholder Awareness & Acceptance
2.4. Estimation Methodology
2.5. Years Considered for the Study
2.6. Currency Conversion Rates
Chapter 3. Global Gene Therapy Starting Materials Market Dynamics
3.1. Market Drivers
3.1.1. Rising Prevalence of Genetic Disorders and Rare Diseases
3.1.2. Increase in Gene Therapy Clinical Trials
3.1.3. Expansion of CDMO Outsourcing and Contract Manufacturing
3.2. Market Challenges
3.2.1. Regulatory Variability and Complexity
3.2.2. High Production Costs and Scalability Issues
3.3. Market Opportunities
3.3.1. Advancements in Vector Design and Gene Editing Technologies
3.3.2. Growing Investments and Public–Private Partnerships
3.3.3. Expansion of Biomanufacturing Capabilities in Emerging Markets
Chapter 4. Global Gene Therapy Starting Materials Market Industry Analysis
4.1. Porter’s 5 Forces Model
4.1.1. Bargaining Power of Suppliers
4.1.2. Bargaining Power of Buyers
4.1.3. Threat of New Entrants
4.1.4. Threat of Substitutes
4.1.5. Competitive Rivalry
4.1.6. Futuristic Approach to Porter’s 5 Forces
4.1.7. Porter’s 5 Forces Impact Analysis
4.2. PESTEL Analysis
4.2.1. Political
4.2.2. Economic
4.2.3. Social
4.2.4. Technological
4.2.5. Environmental
4.2.6. Legal
4.3. Top Investment Opportunities
4.4. Top Winning Strategies
4.5. Disruptive Trends
4.6. Industry Expert Perspective
4.7. Analyst Recommendation & Conclusion
Chapter 5. Global Gene Therapy Starting Materials Market Size & Forecasts by Product 2022 – 2032
5.1. Segment Dashboard
5.2. Global Market: Product Revenue Trend Analysis, 2022 & 2032 (USD Million)
5.2.1. Viral Vectors
5.2.2. Plasmid DNA
5.2.3. Cell Lines
Chapter 6. Global Gene Therapy Starting Materials Market Size & Forecasts by Development Stage 2022 – 2032
6.1. Segment Dashboard
6.2. Global Market: Development Stage Revenue Trend Analysis, 2022 & 2032 (USD Million)
6.2.1. Preclinical
6.2.2. Clinical
6.2.3. Commercial
Chapter 7. Global Gene Therapy Starting Materials Market Size & Forecasts by Application 2022 – 2032
7.1. Segment Dashboard
7.2. Global Market: Application Revenue Trend Analysis, 2022 & 2032 (USD Million)
7.2.1. Gene Editing
7.2.2. Cell Therapy
7.2.3. Genetic Disorders
7.2.4. Oncology
7.2.5. Others
Chapter 8. Global Gene Therapy Starting Materials Market Size & Forecasts by End Use 2022 – 2032
8.1. Segment Dashboard
8.2. Global Market: End Use Revenue Trend Analysis, 2022 & 2032 (USD Million)
8.2.1. Biotechnology and Pharmaceutical Companies
8.2.2. Academic and Research Institutes
8.2.3. CDMOs (Contract Development & Manufacturing Organizations)
8.2.4. Hospitals and Clinics
Chapter 9. Global Gene Therapy Starting Materials Market Size & Forecasts by Region 2022 – 2032
9.1. North America
9.1.1. U.S.
9.1.2. Canada
9.2. Europe
9.2.1. UK
9.2.2. Germany
9.2.3. France
9.2.4. Spain
9.2.5. Italy
9.2.6. Rest of Europe
9.3. Asia Pacific
9.3.1. China
9.3.2. India
9.3.3. Japan
9.3.4. Australia
9.3.5. South Korea
9.3.6. Rest of Asia Pacific
9.4. Latin America
9.4.1. Brazil
9.4.2. Mexico
9.4.3. Rest of Latin America
9.5. Middle East & Africa
9.5.1. Saudi Arabia
9.5.2. South Africa
9.5.3. Rest of Middle East & Africa
Chapter 10. Competitive Intelligence
10.1. Key Company SWOT Analysis
10.1.1. Thermo Fisher Scientific, Inc.
10.1.2. Charles River Laboratories International, Inc.
10.1.3. Catalent, Inc.
10.2. Top Market Strategies
10.3. Company Profiles
10.3.1. Thermo Fisher Scientific, Inc.
10.3.1.1. Key Information
10.3.1.2. Overview
10.3.1.3. Financial (Subject to Data Availability)
10.3.1.4. Product Summary
10.3.1.5. Market Strategies
10.3.2. Charles River Laboratories International, Inc.
10.3.3. Catalent, Inc.
10.3.4. Lonza Group Ltd.
10.3.5. Oxford Biomedica plc
10.3.6. Wuxi AppTec Co., Ltd.
10.3.7. FUJIFILM Diosynth Biotechnologies
10.3.8. Takara Bio Inc.
10.3.9. Aldevron LLC
10.3.10. MilliporeSigma (Merck KGaA)
10.3.11. Bio Techne Corporation
10.3.12. Cobra Biologics (Charles River)
10.3.13. Sarepta Therapeutics, Inc.
10.3.14. GenScript Biotech Corporation
10.3.15. AGC Biologics
Chapter 11. Research Process
11.1. Research Process
11.1.1. Data Mining
11.1.2. Analysis
11.1.3. Market Estimation
11.1.4. Validation
11.1.5. Publishing
11.2. Research Attributes