Gene Therapy Market Size, Share, Trends, Industry Analysis Report: By Therapeutic Area (Autoimmune Disorders, Cardiovascular Diseases, Dermatological Disorders, Hematological Disorders, Metabolic Disorders, Muscle-Related Diseases, Oncological Disorders,

The gene therapy market size is expected to reach USD 27,250.20 million by 2034, according to a new study by Polaris Market Research. The report “Gene Therapy Market Size, Share, Trends, Industry Analysis Report: By Therapeutic Area (Autoimmune Disorders, Cardiovascular Diseases, Dermatological Disorders, Hematological Disorders, Metabolic Disorders, Muscle-Related Diseases, Oncological Disorders, and Others), Vector Type, Approach, Route of Administration, and Region (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa) – Market Forecast, 2025–2034” 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, along with an increasing understanding of molecular biology, have propelled gene therapy from experimental stages to real-world clinical applications. Researchers and biopharmaceutical companies are investing heavily in developing safe and effective therapies, while regulatory bodies are streamlining approval processes to accelerate gene therapy market 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 cause of these diseases at the genetic level. This targeted approach enhances treatment efficacy and offers the potential for long-term or even permanent relief. In recent years, significant breakthroughs in gene-editing technologies, such as CRISPR-Cas9 and zinc finger nucleases (ZFNs), have enabled more precise and efficient gene modifications.

The rising number of regulatory approvals for gene-based treatments is propelling the gene therapy market growth. Government agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have 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, 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 leads the gene therapy market share in 2024 due to the prevalence of significant physical and psychological impacts of the disease and its treatment.

By vector type, the viral segment leads gene therapy market revenue share due to its effective and efficient delivering genes to the targeted cells for various cancers, monogenic and infectious diseases.

North America leads the gene therapy market due to its robust research infrastructure, advanced healthcare system, significant funding for clinical trials, and a supportive regulatory framework, particularly from the FDA, which allows for rapid development and approval of new gene therapies.

A few global key market players are 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.

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

By Type Therapeutic Area Outlook (Revenue, USD Million, 2020–2034)

Autoimmune Disorders

Cardiovascular Diseases

Dermatological Disorders

Hematological Disorders

Metabolic Disorders

Muscle-Related Diseases

Oncological Disorders

Others

By Vector Type Outlook (Revenue, USD Million, 2020–2034)

Viral

Non-Viral

By Approach Outlook (Revenue, USD Million, 2020–2034)

Gene Augmentation

Oncolytic Viral Therapy

Immunotherapy

Other Approaches

By Route of Administration Outlook (Revenue, USD Million, 2020–2034)

Intraarticular

Intracerebellar

Intradermal

Intramuscular

Intratumoral

Intravenous

Intravesical

Intravitreal

Subretinal

Others

By Regional Outlook (Revenue, USD Million, 2020–2034)

North America

  • US
  • 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


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 Prevalence of Target Diseases
4.1.1.3 Growing Geriatric Population Base
4.1.2 Restraints and Challenges
4.1.2.1 Manufacturing and logistics challenges
4.1.2.2 High Procedure Costs and Presence of Ambiguous Regulatory Framework
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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