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Gene Therapy Market Size, Share, Trends, Industry Analysis Report : By Therapeutic Area, Vector Type (Viral, Non-Viral), Approach, Route of Administration, and Region – Market Forecast 2026–2035

Publisher Polaris Market Research & Consulting LLP
Published Dec 01, 2025
Length 130 Pages
SKU # PLRS20702965

Description

The gene therapy market size is expected to reach USD 29.01 billion by 2035, according to a new study by Polaris Market Research. The report “Gene Therapy Market Size, Share, Trends, Industry Analysis Report: By Therapeutic Area, Vector Type (Viral, Non-Viral), Approach, Route of Administration, and Region – Market Forecast 2026–2035” gives a detailed insight into current market dynamics and provides analysis on future market growth.

Gene therapy involves modifying or replacing unhealthy genes within a patient’s cells to treat or prevent disease. Rapid advancements in genetic engineering and an increasing understanding of molecular biology are propelling gene therapy from experimental stages to real-world clinical applications. Researchers and biopharmaceutical companies invest heavily in developing safe and effective therapies. Also, regulatory bodies streamline approval processes, which accelerates gene therapy industry expansion.

The demand for gene therapy has surged due to the increasing prevalence of genetic disorders, such as Duchenne muscular dystrophy (DMD), sickle cell disease, hemophilia, and cystic fibrosis. Unlike traditional treatment methods that primarily focus on symptom management, gene therapy targets the underlying genetic cause of these diseases. This targeted approach enhances treatment efficacy. It also offers the potential for long-term or even permanent relief. Significant breakthroughs in gene-editing technologies, such as CRISPR-Cas9 and zinc finger nucleases (ZFNs), have enabled precise and efficient gene modifications.

The rising number of regulatory approvals for gene-based treatments drives the gene therapy market growth. Government agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) recognized the transformative potential of these therapies. They are expediting the approval process for promising candidates. Therapies such as Zolgensma for spinal muscular atrophy (SMA) and Luxturna for inherited retinal disease have demonstrated remarkable clinical success. This approach is paving the way for broader adoption of gene-based therapies or treatments.

Gene Therapy Market Report Highlights

Based on therapeutic area, the oncological disorders segment led the gene therapy market share in 2025. The prevalence of significant physical and psychological impacts of the disease and its treatment contributed to the dominance.

By vector type, the viral segment dominated the revenue share in 2025. The leading position is attributed to its effective and efficient delivering genes to the targeted cells for various cancers, monogenic and infectious diseases.

North America held the largest revenue share in 2025. The regional industry growth is driven by robust research infrastructure and advanced healthcare system. Also, significant funding for clinical trials and a supportive regulatory framework, particularly from the FDA, allows for rapid development and approval of new gene therapies. This factor also boosts the North America gene therapy industry growth.

Abeona Therapeutic, Novartis AG, Spark Therapeutics LLC, Gilead Sciences Inc., Bristol Myers Squibb, Adverum Biotechnologies, Alnylam Pharmaceuticals, American Gene Technologies, Applied Genetic Technologies Corporation, Biogen, and Ultragenyx are among the global market players.

Request a free sample copy or read the full market insights : gene therapy market Report

Where is the Gene Therapy Market Headed?

According to our research on gene therapy industry, the market is expected to grow in the coming years due to rising approvals for therapies and technological evolution. Also, venture capital firms and large pharma companies are increasingly investing in vector technologies and delivery mechanisms. Such strategies will boost innovation and capacity expansion in the coming years.

What Does Gene Therapy Report Reveal?

What is the market size and CAGR for the market during 2026–2035?

What are the market drivers, trends, opportunities, and challenges?

Who are the key industry players? What is their relative position in terms of competitive positioning?

What are the leading candidates and technologies?

How do different treatment approaches, such as gene augmentation, oncolytic viral therapy, and immunotherapy, influence the market landscape?

How does the industry differ in terms of therapeutic area, vector type, approach, route of administration, and geography? Which is the leading vector type?

Among North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa, which region shows growth potential?

Polaris Market Research has segmented the market report on the basis of therapeutic area, vector type, approach, route of administration, and region:

By Type Therapeutic Area Outlook (Revenue, USD Billion, 2022–2035)

Autoimmune Disorders

Cardiovascular Diseases

Dermatological Disorders

Hematological Disorders

Metabolic Disorders

Muscle-Related Diseases

Oncological Disorders

Others

By Vector Type Outlook (Revenue, USD Billion, 2022–2035)

Viral

Non-Viral

By Approach Outlook (Revenue, USD Billion, 2022–2035)

Gene Augmentation

Oncolytic Viral Therapy

Immunotherapy

Other Approaches

By Route of Administration Outlook (Revenue, USD Billion, 2022–2035)

Intraarticular

Intracerebellar

Intradermal

Intramuscular

Intratumoral

Intravenous

Intravesical

Intravitreal

Subretinal

Others

By Regional Outlook (Revenue, USD Billion, 2022–2035)

North America

U.S.

Canada

Europe

Germany

France

UK

Italy

Spain

Netherlands

Russia

Rest of Europe

Asia Pacific

China

Japan

India

Malaysia

South Korea

Indonesia

Australia

Rest of Asia Pacific

Middle East & Africa

Saudi Arabia

UAE

Israel

South Africa

Rest of Middle East & Africa

Latin America

Mexico

Brazil

Argentina

Rest of Latin America

Table of Contents

130 Pages
Chapter 1. Introduction
1.1 Report Description
1.1.1 Objectives of the Study
1.1.2 Market Scope
1.1.3 Assumptions
1.2 Stakeholders
Chapter 2. Executive Summary
Chapter 3. Research Methodology
3.1 Overview
3.1.1 Data Mining
3.2 Data Sources
3.2.1 Primary Sources
3.2.2 Secondary Sources
Chapter 4. Gene Therapy Market Insights
4.1 Gene Therapy – Industry snapshot
4.1 Gene Therapy Market Dynamics
4.1.1 Drivers and Opportunities
4.1.1.1 Rising Approval and Investments in Gene Therapy Development
4.1.1.2 Growing burden of genetic and rare diseases
4.1.1.3 Regulatory momentum & increasing approvals
4.1.2 Restraints and Challenges
4.1.2.1 High cost per therapy and affordability barriers
4.1.2.2 Manufacturing complexity and supply chain constraints
4.1.2.3 Lack of Healthcare Infrastructure
4.2 Gene Therapy Market – Porter’s Five Forces
4.2.1 Bargaining Power of Suppliers (High)
4.2.2 Threats of New Entrants: (Low)
4.2.3 Bargaining Power of Buyers (Moderate)
4.2.4 Threat of Substitute (Low)
4.2.5 Rivalry among existing firms (High)
4.3 Gene Therapy Market – PEST Analysis
4.4 Covid-19 Impact Analysis & Industry Trends
Chapter 5. Gene Therapy Market Assessment by Therapeutic Area
5.1 Introduction
5.2 Autoimmune Disorders
5.3 Cardiovascular Diseases
5.4 Dermatological Disorders
5.5 Hematological Disorders
5.6 Metabolic Disorders
5.7 Muscle-related Diseases
5.8 Oncological Disorders
5.9 Other Therapeutic Areas
Chapter 6. Gene Therapy Market Assessment by Vector Type
6.1 Introduction
6.2 Viral
6.2.1 Retroviral vectors
6.2.1.1 Gamma-retroviral vectors
6.2.1.2 Lentiviral vectors
6.2.2 Adeno-associated virus vectors
6.2.3 Other viral vectors
6.3 Non-Viral
6.3.1 Oligonucleotides
6.3.2 Other non-viral vectors
Chapter 7. Gene Therapy Market Assessment by Approach
7.1 Introduction
7.2 Gene Augmentation
7.1 Oncolytic Viral Therapy
7.2 Immunotherapy
7.3 Other Approaches
Chapter 8. Gene Therapy Market Assessment by Route of Administration
8.1 Introduction
8.2 Intraarticular
8.3 Intracerebellar
8.4 Intradermal
8.5 Intramuscular
8.6 Intratumoral
8.7 Intravenous
8.8 Intravesical
8.9 Intravitreal
8.10 Subretinal
8.11 Others
Chapter 9. Gene Therapy Market Assessment by Region
9.1 Introduction
9.2 Gene Therapy Market – North America
9.2.1 Gene Therapy Market – U.S.
9.2.2 Gene Therapy Market – Canada
9.3 Gene Therapy Market – Europe
9.3.1 Gene Therapy Market – Germany
9.3.2 Gene Therapy Market – UK
9.3.3 Gene Therapy Market – France
9.3.4 Gene Therapy Market – Italy
9.3.5 Gene Therapy Market – Spain
9.3.6 Gene Therapy Market – Netherlands
9.3.7 Gene Therapy Market – Austria
9.4 Gene Therapy Market – Asia Pacific
9.4.1 Gene Therapy Market – China
9.4.2 Gene Therapy Market – India
9.4.3 Gene Therapy Market – Japan
9.4.4 Gene Therapy Market – South Korea
9.5 Gene Therapy Market – Latin America
9.5.1 Gene Therapy Market – Brazil
9.5.2 Gene Therapy Market – Mexico
9.6 Gene Therapy Market – Middle East & Africa
9.6.1 Gene Therapy Market – Saudi Arabia
9.6.2 Gene Therapy Market – UAE
Chapter 10. Competitive Landscape
10.1 Key Market Players: Categorization
10.2 Strategy Framework
10.3 Vendor Landscape
10.4 Strategies Categorization
10.4.1 Partnerships/Collaborations/Agreements
10.4.2 Expansions/Mergers/Acquisitions
10.4.3 Product Development/New Launch
Chapter 11. Company Profiles
11.1 Sangamo Biosciences
11.1.1 Business Overview
11.1.2 Financial Snapshot
11.1.3 Products and Services
11.1.4 Recent Developments
11.2 Voyager Therapeutics
11.2.1 Business Overview
11.2.2 Financial Snapshot
11.2.3 Products and Services
11.2.4 Recent Developments
11.3 Ultragenyx
11.3.1 Business Overview
11.3.2 Financial Snapshot
11.3.3 Products and Services
11.3.4 Recent Developments
11.4 GlaxoSmithKline
11.4.1 Business Overview
11.4.2 Financial Snapshot
11.4.3 Products and Services
11.4.4 Recent Developments
11.5 Gilead Sciences Inc
11.5.1 Business Overview
11.5.2 Financial Snapshot
11.5.3 Products and Services
11.5.4 Recent Developments
11.6 Bristol Myers Squibb
11.6.1 Business Overview
11.6.2 Financial Snapshot
11.6.3 Products and Services
11.6.4 Recent Developments
11.7 Novartis AG
11.7.1 Business Overview
11.7.2 Financial Snapshot
11.7.3 Products and Services
11.7.4 Recent Developments
11.8 Spark Therapeutics LLC
11.8.1 Business Overview
11.8.2 Products and Services
11.8.3 Recent Developments
11.9 Bluebird Bio
11.9.1 Business Overview
11.9.2 Recent Developments
11.9.3 Products and Services
11.9.4 Recent Developments

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