Gene Therapy Market Opportunity, Growth Drivers, Industry Trend Analysis, and Forecast 2024

Description

The Global Gene Therapy Market was valued at USD 9 billion in 2024 and is estimated to grow at a CAGR of 19.4% to reach USD 51.3 billion by 2034.

This significant growth trajectory is being fueled by advances in gene delivery systems, rising investments in gene therapy development, the growing prevalence of diseases targeted by gene therapy, such as cancer and rare genetic disorders, and an increasing number of regulatory product approvals. Expanding access to contract manufacturing for gene and cell therapies, along with strategic developments in delivery technology, are further enhancing the market outlook. Regulatory agencies are streamlining approval processes for promising gene therapies, and governments are boosting funding toward innovative genetic medicine platforms. As healthcare systems focus on personalized and targeted treatments, gene therapy is gaining traction for its potential to address complex diseases at the molecular level. Market players are also leveraging digital platforms to share data, accelerate clinical trials, and optimize drug discovery pipelines. Meanwhile, broader integration of precision medicine and bioinformatics is helping gene therapies achieve better treatment efficacy, reduced side effects, and long-term therapeutic benefits. These trends are positioning gene therapy as a disruptive force in the next phase of modern medicine.

Market Scope
Start Year	2024
Forecast Year	2025-2034
Start Value	$9 Billion
Forecast Value	$51.3 Billion
CAGR	19.4%

In 2024, the viral vectors segment held an 85.1% share, underscoring their continued dominance as the most effective delivery vehicles. These vectors, including adeno-associated viruses and lentiviruses, are widely used due to their superior ability to deliver genetic material accurately and maintain consistent gene expression over time. Their broad clinical application and proven success in approved treatments have reinforced their commercial viability, making them a cornerstone of gene therapy development. Robust manufacturing protocols and scalable production also support their widespread deployment across therapeutic pipelines.

The in vivo gene therapy segment accounted for USD 5.8 billion in 2024, owing to its systemic approach to treating complex and multi-organ diseases. In vivo methods enable direct gene delivery into the body, eliminating the need for cell extraction and reinfusion. This method supports broader therapeutic access and reduces procedural complexity. Advances in non-viral and hybrid delivery systems-such as nanoparticles and lipid-based formulations are further enhancing targeting precision and treatment outcomes.

North America Gene Therapy Market held a 51.2% share in 2024, making it the dominant region for gene therapy innovation and commercialization. This leadership is supported by a robust investment environment, favorable regulatory frameworks, and a sophisticated healthcare infrastructure. With leading biotech firms, prominent academic institutions, and high R&D activity, the region, particularly the U.S., continues to push the boundaries of gene therapy science. Strong public-private collaborations and a deep talent pool are accelerating clinical development and commercial adoption of cutting-edge therapies.

Prominent players in the Global Gene Therapy Market include Sangamo Therapeutics, Amgen, Spark Therapeutics (Roche), Beam Therapeutics, Krystal Biotech, Sarepta Therapeutics, AGTC, Orchard Therapeutics, bluebird bio, Bristol-Myers Squibb Company, Gilead Sciences, Novartis, Helixmith, Pfizer, Intellia Therapeutics, Bayer, UniQure N.V., BioMarin Pharmaceutical, CRISPR Therapeutics, and Audentes Therapeutics (Astellas Pharma). To strengthen their foothold, leading companies in the gene therapy sector are prioritizing strategic mergers and acquisitions to enhance their technology platforms and expand product pipelines. Many firms are entering collaborative R&D partnerships with academic institutions and smaller biotech innovators to access novel therapies and accelerate clinical timelines. Increasing investment in in-house manufacturing capabilities and global supply chain infrastructure ensures faster scaling and regulatory compliance. Companies are also intensifying their focus on securing fast-track, orphan drug, and breakthrough therapy designations to reduce time-to-market.

Product Code: 5883

Chapter 1 Methodology and Scope

1.1 Market scope and definition
1.2 Research design
- 1.2.1 Research approach
- 1.2.2 Data collection methods
1.3 Data mining sources
- 1.3.1 Global
- 1.3.2 Regional/Country
1.4 Base estimates and calculations
- 1.4.1 Base year calculation
- 1.4.2 Key trends for market estimation
1.5 Primary research and validation
- 1.5.1 Primary sources
1.6 Forecast model
1.7 Research assumptions and limitations

Chapter 2 Executive Summary

2.1 Industry 360° synopsis
2.2 Key market trends
- 2.2.1 Regional trends
- 2.2.2 Vector trends
- 2.2.3 Delivery method trends
- 2.2.4 Gene type trends
- 2.2.5 Indication trends
- 2.2.6 End Use trends
2.3 CXO perspectives: Strategic imperatives
- 2.3.1 Key decision points for industry executives
- 2.3.2 Critical success factors for market players
2.4 Future outlook and strategic recommendations

Chapter 3 Industry Insights

3.1 Industry ecosystem analysis
3.2 Industry impact forces
- 3.2.1 Growth drivers
  - 3.2.1.1 Advancements in gene editing technologies
  - 3.2.1.2 Increasing prevalence of rare genetic and inherited diseases
  - 3.2.1.3 Rising investments and collaborations
  - 3.2.1.4 Growing awareness and improved genetic diagnostics
- 3.2.2 Industry pitfalls and challenges
  - 3.2.2.1 High development and manufacturing costs
  - 3.2.2.2 Complexity of gene therapy delivery and potential side effects
- 3.2.3 Market opportunities
  - 3.2.3.1 Development of personalized and precision gene therapies
  - 3.2.3.2 Expansion in emerging markets with growing healthcare infrastructure
3.3 Growth potential analysis
3.4 Regulatory landscape
- 3.4.1 North America
  - 3.4.1.1 U.S.
  - 3.4.1.2 Canada
- 3.4.2 Europe
- 3.4.3 Asia Pacific
- 3.4.4 Latin America
- 3.4.5 Middle East and Africa
3.5 Technology landscape
- 3.5.1 Current trends
- 3.5.2 Emerging technologies
3.6 Pipeline analysis
3.7 Future market trends
3.8 Porter's analysis
3.9 PESTEL analysis

Chapter 4 Competitive Landscape, 2024

4.1 Introduction
4.2 Company market share analysis
- 4.2.1 Global
- 4.2.2 North America
- 4.2.3 Europe
- 4.2.4 Asia Pacific
4.3 Company matrix analysis
4.4 Competitive analysis of major market players
4.5 Competitive positioning matrix
4.6 Key developments
- 4.6.1 Merger and acquisition
- 4.6.2 Partnership and collaboration
- 4.6.3 New product launches
- 4.6.4 Expansion plans

Chapter 5 Market Estimates and Forecast, By Vector, 2021 - 2034 ($ Mn)

5.1 Key trends
5.2 Viral vectors
- 5.2.1 Retro viral vectors
- 5.2.2 Adeno-associated virus vectors
- 5.2.3 Lentiviral vectors
- 5.2.4 Other viral vectors
5.3 Non-viral vectors
- 5.3.1 Plasmid DNA
- 5.3.2 Lipid nanoparticles (LNPs)
- 5.3.3 Oligonucleotides
- 5.3.4 Other non-viral vectors

Chapter 6 Market Estimates and Forecast, By Delivery Method, 2021 - 2034 ($ Mn)

6.1 Key trends
6.2 In vivo gene therapy
6.3 Ex vivo gene therapy

Chapter 7 Market Estimates and Forecast, By Gene Type, 2021 - 2034 ($ Mn)

7.1 Key trends
7.2 Antigen-encoding genes
7.3 Cytokine-encoding genes
7.4 Tumor suppressor genes
7.5 Suicide genes
7.6 Gene replacement (for deficiency)
7.7 Growth factor genes
7.8 Receptor-encoding genes
7.9 Other gene types

Chapter 8 Market Estimates and Forecast, By Indication, 2021 - 2034 ($ Mn)

8.1 Key trends
8.2 Oncology
- 8.2.1 Acute Lymphoblastic Leukemia (ALL)
- 8.2.2 Large B-cell lymphoma
- 8.2.3 Head & neck squamous cell carcinoma
- 8.2.4 Melanoma
8.3 Neurological disorders
- 8.3.1 Duchenne muscular dystrophy (DMD)
- 8.3.2 Spinal muscular atrophy (SMA)
8.4 Hemophilia A & B
8.5 Hepatological diseases
8.6 Inherited retinal disease
8.7 Peripheral arterial disease
8.8 Other indications

Chapter 9 Market Estimates and Forecast, By End Use, 2021 - 2034 ($ Mn)

9.1 Key trends
9.2 Hospitals
9.3 Specialty clinics and gene therapy centers
9.4 Academic and research institutions
9.5 Other End uses

Chapter 10 Market Estimates and Forecast, By Region, 2021 - 2034 ($ Mn)

10.1 Key trends
10.2 North America
- 10.2.1 U.S.
- 10.2.2 Canada
10.3 Europe
- 10.3.1 Germany
- 10.3.2 UK
- 10.3.3 France
- 10.3.4 Spain
- 10.3.5 Italy
- 10.3.6 Netherlands
10.4 Asia Pacific
- 10.4.1 China
- 10.4.2 India
- 10.4.3 Japan
- 10.4.4 Australia
- 10.4.5 South Korea
10.5 Latin America
- 10.5.1 Brazil
- 10.5.2 Mexico
- 10.5.3 Argentina
10.6 Middle East and Africa
- 10.6.1 South Africa
- 10.6.2 Saudi Arabia
- 10.6.3 UAE

Chapter 11 Company Profiles

11.1 Amgen
11.2 Applied Genetic Technologies Corporation (AGTC)
11.3 Audentes Therapeutics, Inc. (Astellas Pharma)
11.4 Bayer
11.5 Beam Therapeutics
11.6 BioMarin Pharmaceutical
11.7 bluebird bio
11.8 Bristol-Myers Squibb Company
11.9 CRISPR Therapeutics
11.10 Gilead Sciences
11.11 Helixmith
11.12 Intellia Therapeutics
11.13 Krystal Biotech
11.14 Novartis
11.15 Orchard Therapeutics
11.16 Pfizer
11.17 Sangamo Therapeutics
11.18 Sarepta Therapeutics
11.19 Spark Therapeutics (Roche)
11.20 UniQure N.V.

Gene Therapy Market Opportunity, Growth Drivers, Industry Trend Analysis, and Forecast 2024 - 2032