Gene Therapy Market Size, Share by Gene Therapy Type (Germline Gene Therapy and Somatic Gene Therapy), By Type of Vector (Viral Vector and Non-viral Vector), By Disease Indication (Cardio Vascular Diseases, Cancer, Genetic Disorders, Neuro Disorders, Infectious Diseases, and Others), and By Region – Market Trends, Analysis and Forecast till 2034

Gene Therapy Market Size was valued at USD10.73 Billion in 2024 and is expected to reach USD 58.90 Billion by 2034, growing at a CAGR of 20.6%

Genes are the composition of an acid, which consists of essential information used in protein production necessary for the best possible functioning of the body. This acid is deoxyribonucleic. When proteins are imperfect, they are termed gene mutations, resulting in a genetic disorder. Gene therapy is projected to introduce healthy genes within the damaged cells that are used to counteract various abnormal genes. They are also intended to make proteins of interest.

Tisagenlecleucel became the first gene therapy the FDA ever approved to treat relapsed or refractory pediatric and young adult B-cell acute lymphoblastic leukemia. Several breakthroughs with different gene therapies have been realized within the past two decades. In 2020, Libmeldy™, an ex vivo gene therapy, acquired approval for treating metachromatic leukodystrophy. Additional context will be provided by the treatment course of such therapies, which involves correcting mutated genes in patients through molecular carriers, including viral and non-viral vectors.

 Furthermore, since the COVID-19 pandemic, there has been a linear increase in investigational new drug applications for cell and gene therapies. In 2021, over 200 gene therapies were under phase II and III evaluation processes. Furthermore, in 2022, six gene therapies are predicted to gain the USFDA market approval. The promising results from ongoing clinical research initiatives have motivated government and private firms to invest in supporting therapy product development initiatives in this domain.

Key Drivers of Target Market:   

Increasing prevalence of genetic disorders

• Millions of people across the globe are suffering from various genetic disorders, and their demand for effective treatment is also increasing. Gene therapy can be a hopeful concept in treating such illness conditions by rectification of genetic defects at the root level.

Advancements in gene editing technologies

• With the discovery, several gene editing tools, such as the much-talked-about CRISPR-Cas9 system, have surfaced to alter the face of gene therapy. These technologies facilitate more precise and efficient manipulation of genes; hence, safer and more efficient therapies are being made possible.

Increased regulatory approvals

• The FDA and EMA, leading regulatory bodies, are slowly opening their doors to gene therapy. Rather, there is a growing trend regarding the two regulatory bodies' approval for gene therapy products. It provides a clear way for new gene therapies to make it to the market.

Increase in R&D investments

• Pharmaceutical companies, biotech startups, and government agencies are increasing their investments in gene therapy R&D. This increases funding for the same manyfold and gives a fillip to the innovation cycle, creating new treatments for many more diseases.

Increasingly strong demand for personalized medicine

• Because gene therapy addresses the specific genetic cause of a given disease in an individual, it generally offers highly personalized treatments. This kind of disposition has become quite attractive in the field of medicine.

Restrains:

High cost of gene therapy

• Gene therapies are developed and produced through a very complex, expensive procedure. This generally makes the treatment very costly, which might keep many patients away from this line of therapy.

Low efficacy and safety concerns

• Gene therapy is a relatively new field; some gene therapies' long-term efficacy and safety are still under investigation. More clinical trials should be conducted to show that these therapies are safe and effective in the long term.

Ethical Considerations

• Gene therapy has several ethical concerns, like possible unintended consequences of gene manipulation and editing in the germline. If this process is to be developed and applied responsibly, any ethical concerns over gene therapy must be pursued rigorously.

Delivery challenges

• The efficient and safe delivery of gene therapy vectors to target cells is still challenging. New delivery systems are being developed to improve the process of gene therapy.

Limited gene therapy expertise

• Gene therapy is a highly specialized activity that requires extensive expertise. The limited availability of health professionals who have received gene therapy training is one of the major barriers to its extensive application.

 Opportunities:

The expanding treatment landscape

• Gene therapy has the potential to treat a wide plethora of diseases beyond what is currently possible, such as inherited genetic disorders like cystic fibrosis and hemophilia, infectious diseases like HIV and Hepatitis B, and even complex diseases like cancer and neurodegenerative disorders like Alzheimer's and Parkinson's. With sophisticated gene editing tools, this will only continue to grow in the spectrum of diseases that can be treated.

Personalized Medicine

• Gene therapy is an ultramodern approach to personalized medicine since it gets to the root of the disease by targeting its cause at gene levels. Hence, gene therapy can offer great efficiency and longevity of treatment over conventional therapies that only alleviate symptoms. Moreover, gene therapies can be tailored to the specific genetic makeup of individual patients, maximizing the efficacy of the treatment while reducing side effects.

Improved Gene Editing Techniques

• Gene editing tools, especially the famous CRISPR-Cas9, are becoming increasingly precise and efficient in altering genes. Developing gene therapies that are safer and more effective with reduced unintended consequences becomes possible. Moreover, these tools are constantly evolving and can provide opportunities for new gene therapy strategies, such as gene silencing or correcting faulty regulatory genes.

Growing Investments and Partnerships

• Acknowledging the potential, vast amounts of investment are pumped into gene therapy from major pharmaceutical companies, biotech startups, and government agencies. The surge in funding thus speeds up the research and development work, and new gene therapies are brought to the pipeline at an accelerated rate. Additionally, academia-industry-patient advocacy group combos make innovation possible and drastically smoothen the way, leading to clinical trials and, eventually, commercialization.

The market is segmented based on By Gene Therapy Type, By Type of Vector, By Disease Indication and Region.

Gene Therapy Type Insights

• Germline Gene Therapy - this changes genes in germline cells, that is, sperm and egg cells; changes are then passed down through generations. While politically and ethically complex, it has the potential to cure hereditary diseases.
• Somatic Gene Therapy - This modifies genes in the body cells, excluding reproductive cells. It is the only approved gene therapy type to date since germline editing introduces associated safety concerns.

Type of Vector Insights

• Viral Vectors—this vectors use modified viruses to get the therapeutic genes into the target cells. The viral vector is highly efficient and hence an obvious choice. However, it has limitations due to potential immune response and insertional mutagenesis.
• Non-Viral Vectors - These include plasmids, nanoparticles, and other modes in gene delivery. They generally are safer but might have a reduced extent of delivery efficiency compared to viral vector.

Disease Indication Insights

• Cardiovascular Diseases - Gene therapy is being developed to cure heart diseases, stroke, and other blood vessel problems. The change of genes would increase blood flow, decrease inflammation in organs, or even enhance the development of healthy heart tissue. This venue has only recently been opened for investigation, but it does open up a new spectrum of treatment options against cardiovascular diseases.
• Cancer - Gene therapy can revolutionize the concept of treating cancers without crutches. Several modalities are under exploration. Some of them involve the alteration of genes responsible for developing cancer. Yet another uses gene therapy to make the body's immune system better target and destroy the cancer cells. This segment has remarkable growth driven by the rise in cancer cases and expectations of more efficient and site-directed therapies.
• Genetic Disorders—This forms the largest share of this market simply because it shows a well-defined genetic cause for most inherited diseases. Gene therapy can give hope to the patients here for a one-time correction of the underlying defect that may lead to a cure—for example, cystic fibrosis, haemophilia, sickle cell disease, metabolic disorders like Tay-Sachs disease, etc.
• Neurological Disorders: Several neurodegenerative diseases are currently being explored for gene therapy. These include Alzheimer's disease, Parkinson's disease, Huntington's disease, and amyotrophic lateral sclerosis. In essence, these diseases are caused by malfunctioning nerve cells or nerve cells that constituents die. Gene therapy can supply neuroprotective factors, repair gene defects, or even replace damaged nerve cells. This field of research is still in the early phase of development but has some promising future treatments.
• Infectious diseases—Gene therapy is being explored for a variety of diseases caused by viruses such as HIV and Hepatitis B. Gene therapy will provide genetic material that interferes with the ability of the virus to replicate or enables the immune system to recognize and kill infected cells. This segment remains in pre-clinical stages but has strong growth potential by transforming the treatment for chronic viral infections.
• Others - include gene therapies for treating blindness due to retinal degeneration, skin disorders like Netherton syndrome, or even autoimmune diseases such as rheumatoid arthritis. These represent the smaller fractions as of now but have high potential in projected applications of gene therapy against a wide array of diseases.

Regional Insights:

• North America Currently dominates the gene therapy market with the highest share. There are a variety of factors for this. First and foremost, North America has an advanced, well-rooted healthcare structure with top-end research institutions and leading hospitals engaged in the research and development of gene therapy. Government support in the form of requisite funding for research and development, coupled with a favorable regulation that accelerates clinical trial approvals, has also helped strengthen the position of North America. Likewise, the high prevalence of chronic diseases and large pools of patients willing to volunteer for clinical trial studies contribute towards market growth in this region.
• Asia Pacific: The region will continue to grow at the fastest growth rate in the gene therapy market. These macro- and micro-drivers will increase the demand for gene therapy: a growing burden of genetic disorders and chronic diseases, a large patient population, and growing awareness about gene therapy as a potential treatment. Economically developing Asian countries are increasing investments in infrastructure for healthcare and research into gene therapy. Much of the growth will come from China, South Korea, and India; each country is showing an increasing government interest and private support for biotechnology.
• Europe: Europe holds a mature gene therapy market, underpinned by a robust healthcare infrastructure and probably greater emphasis on life sciences research. Much like North America, Europe has government funding initiatives and a encouraging regulatory framework for gene therapy innovation. The presence of big pharma and significant research centers further cements this geography's position in this market. Although the market size is comparatively smaller than that in North America, this region will continue to register progressive growth in the near future with higher investment in R&D and greater acceptance of new gene treatments.
• Latin America: Gene therapy belongs to the emerging markets in Latin America, holding substantial further development potential. Factors like the rapid rise in the prevalence of genetic disorders and chronic diseases create a gigantic need for novel treatment options.
• Middle East & Africa: Such factors include changing lifestyles, environmental factors, and the ill-availability of early detection and screening programs. In addition, this creates an enormous demand for treatment approaches related to novel gene therapy.

Gene Therapy Market Report Scope:

Attribute	Details
Market Size 2024	USD 10.73 Billion
Projected Market Size 2034	USD 58.90 Billion
CAGR Growth Rate	20.6%
Base year for estimation	2023
Forecast period	2024-2034
Market representation	Revenue in USD Billion & CAGR from 2024 to 2034
Market Segmentation	By Gene Therapy Type - Germline Gene Therapy and Somatic Gene Therapy By Type of Vector - Viral Vector and Non-viral Vector By Disease Indication - Social Reporting, Environmental Reporting, and Governance Reporting
Regional scope	North America - U.S., Canada Europe - UK, Germany, Spain, France, Italy, Russia, Rest of Europe Asia Pacific - Japan, India, China, South Korea, Australia, Rest of Asia-Pacific Latin America - Brazil, Mexico, Argentina, Rest of Latin America Middle East & Africa - South Africa, Saudi Arabia, UAE, Rest of Middle East & Africa
Report coverage	Revenue forecast, company share, competitive landscape, growth factors, and trends

Segments Covered in the Report:

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2024 to 2034. For the purpose of this study, has segmented the Gene Therapy Market report based on By Gene Therapy Type, By Type of Vector, By Disease Indication and Region:

Segmentation:

By Gene Therapy Types:

• Germline Gene Therapy
• Somatic Gene Therapy

By Type of Vector:

• Viral Vector
• Non-viral Vector

By Disease Indication:

• Cardio Vascular Diseases
• Cancer
• Genetic Disorders
• Neuro Disorders
• Infectious Diseases
• Others

By Region:

• North America

  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Russia
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • GCC
  • Israel
  • South Africa
  • Rest of Middle East & Africa

The key players operating the Gene Therapy Market includes GlaxoSmithKline plc, Bluebird Bio, Inc., Adaptimmune Therapeutics plc, Celgene Corporation, Shanghai Sunway Biotech Co. Ltd., Merck KGaA, Transgene SA, and OncoGenex Pharmaceuticals, Inc

• In April 2024, President Murmu Launched India's First 'Home-Grown Gene Therapy' For Cancer At IIT Bombay. Developed in association with the IIT Bombay and Tata Memorial Hospital, with the industry associate ImmunoACT, a start-up founded by two students, Alka Dwivedi and Atharva Karulkar, along with Professor Rahul Purwar, is India's first CAR-T cell therapy called NexCAR19.
• In June 2023, Vertex previews launch plans for the first CRISPR gene editing therapy ahead of the FDA decision. With a historic FDA submission nearing completion, rare disease specialist Vertex Therapeutics is painting a rosy launch picture for what could be the first gene editing therapy using the revolutionary tool known as CRISPR.
• In June 2023, Shanghai launched a gene therapy action plan targeting a world-class biomed cluster. Shanghai unveiled a 2023 action plan for gene therapy a year after the city initiated a promotion plan for cell therapy. The move sets out the city's ambition to lead the world in cell therapy technology.

• GlaxoSmithKline plc

• Company Overview
• Product Portfolio
• Key Highlights
• Financial Performance
• Business Strategies

• Bluebird Bio, Inc.
• Adaptimmune Therapeutics plc
• Celgene Corporation
• Shanghai Sunway Biotech Co. Ltd.
• Merck KGaA
• Transgene SA
• OncoGenex Pharmaceuticals, Inc.

“*” marked represents similar segmentation in other categories in the respective section.

Research Objective and Assumption

• Research Objectives
• Assumptions
• Abbreviations

Market Preview

• Report Description
  • Market Definition and Scope
• Executive Summary
  • Market Snippet, By Gene Therapy Type
  • Market Snippet, By Type of Vector
  • Market Snippet, By Disease Indication
  • Market Snippet, By Region
• Opportunity Map Analysis

Market Dynamics, Regulations, and Trends Analysis

• Market Dynamics
  • Drivers
  • Restraints
  • Market Opportunities
• Market Trends
• Product Launch
• Merger and Acquisitions
• Impact Analysis
• PEST Analysis
• Porter’s Analysis

Market Segmentation, Gene Therapy Type, Forecast Period up to 10 Years, (USD Bn)

• Overview
  • Market Value and Forecast (USD Bn), and Share Analysis (%), Forecast Period up to 10 Years
  • Y-o-Y Growth Analysis (%), Forecast Period up to 10 Years
  • Segment Trends
• Germline Gene Therapy
  • Overview
  • Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
• Somatic Gene Therapy
  • Overview
  • Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years

Market Segmentation, Type of Vector, Forecast Period up to 10 Years, (USD Bn)

• Overview
  • Market Value and Forecast (USD Bn), and Share Analysis (%), Forecast Period up to 10 Years
  • Y-o-Y Growth Analysis (%), Forecast Period up to 10 Years
  • Segment Trends
• Viral Vector
  • Overview
  • Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
• Non-viral Vector
  • Overview
  • Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years

Market Segmentation, Disease Indication, Forecast Period up to 10 Years, (USD Bn)

• Overview
  • Market Value and Forecast (USD Bn), and Share Analysis (%), Forecast Period up to 10 Years
  • Y-o-Y Growth Analysis (%), Forecast Period up to 10 Years
  • Segment Trends
• Cardio Vascular Diseases
  • Overview
  • Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
• Cancer
  • Overview
  • Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
• Genetic Disorders
  • Overview
  • Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
• Neuro Disorders
  • Overview
  • Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
• Infectious Diseases
  • Overview
  • Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
• Others
  • Overview
  • Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years

Market Segmentation, By Region, Forecast Period up to 10 Years, (USD Bn)

• Overview
  • Market Value and Forecast (USD Bn), and Share Analysis (%), Forecast Period up to 10 Years
  • Y-o-Y Growth Analysis (%), Forecast Period up to 10 Years
  • Regional Trends
• North America
  • Market Size and Forecast (USD Bn), By Gene Therapy Type, Forecast Period up to 10 Years
  • Market Size and Forecast (USD Bn), By Type of vector, Forecast Period up to 10 Years
  • Market Size and Forecast (USD Bn), By Disease Indication, Forecast Period up to 10 Years
  • Market Size and Forecast (USD Bn), By Country, Forecast Period up to 10 Years
    • U.S
    • Canada
• Asia Pacific
  • Market Size and Forecast (USD Bn), By Gene Therapy Type, Forecast Period up to 10 Years
  • Market Size and Forecast (USD Bn), By Type of Vector, Forecast Period up to 10 Years
  • Market Size and Forecast (USD Bn), By Disease Indication, Forecast Period up to 10 Years
  • Market Size and Forecast (USD Bn), By Country, Forecast Period up to 10 Years
    • India
    • Japan
    • South Korea
    • China
    • Rest of Asia Pacific
• Europe
  • Market Size and Forecast (USD Bn), By Gene Therapy Type, Forecast Period up to 10 Years
  • Market Size and Forecast (USD Bn), By Type of Vector, Forecast Period up to 10 Years
  • Market Size and Forecast (USD Bn), By Disease Indication, Forecast Period up to 10 Years
  • Market Size and Forecast (USD Bn), By Country, Forecast Period up to 10 Years
    • UK
    • Germany
    • France
    • Russia
    • Italy
    • Rest of Europe
• Latin America
  • Market Size and Forecast (USD Bn), By Gene Therapy Type, Forecast Period up to 10 Years
  • Market Size and Forecast (USD Bn), By Type of Vector, Forecast Period up to 10 Years
  • Market Size and Forecast (USD Bn), By Disease Indication, Forecast Period up to 10 Years
  • Market Size and Forecast (USD Bn), By Country, Forecast Period up to 10 Years
    • Brazil
    • Mexico
    • Rest of Latin America
• Middle East and Africa
  • Market Size and Forecast (USD Bn), By Gene Therapy Type, Forecast Period up to 10 Years
  • Market Size and Forecast (USD Bn), By Type of Vector, Forecast Period up to 10 Years
  • Market Size and Forecast (USD Bn), By Disease Indication, Forecast Period up to 10 Years
  • Market Size and Forecast (USD Bn), By Country, Forecast Period up to 10 Years
    • GCC
    • Israel
    • South Africa
    • Rest of Middle East and Africa

Competitive Landscape

• Heat Map Analysis
• Company Profiles

• GlaxoSmithKline plc
• Bluebird Bio, Inc.
• Adaptimmune Therapeutics plc
• Celgene Corporation
• Shanghai Sunway Biotech Co. Ltd.
• Merck KGaA
• Transgene SA
• OncoGenex Pharmaceuticals, Inc.

The Last Word

• Future Impact
• About Us
• Contact