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Gene Therapy Market Size 2024-2028

The gene therapy market size is forecast to increase by USD 6.74 billion, at a CAGR of 23.31% between 2023 and 2028.

The market is experiencing significant growth, driven by the increasing number of special drug designations granted to gene therapy products. This trend signifies regulatory approval and validation of gene therapy as a viable treatment modality, encouraging further investment and innovation. Another key driver is the expanding research in gene therapy applications for cardiovascular diseases (CVDs) and orphan diseases, which hold immense potential for addressing unmet medical needs and improving patient outcomes. Its applications span diverse fields, including ophthalmology in Japan, where vision-restoring treatments are gaining traction, and infectious disease research in Asia, addressing global health challenges. 
Companies must navigate this obstacle by exploring cost reduction strategies, collaborating with payers and insurers, and demonstrating the long-term value of these therapies to secure reimbursement and patient access. Effective management of these challenges, alongside continued innovation and regulatory support, will enable market players to capitalize on the promising opportunities in the market.

What will be the Size of the Gene Therapy Market during the forecast period?

Explore in-depth regional segment analysis with market size data - historical 2018-2022 and forecasts 2024-2028 - in the full report.
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The market continues to evolve, driven by advancements in various sectors. Gene replacement therapies, utilizing viral vectors to deliver functional genes, are gaining traction in the treatment of genetic disorders. Gene silencing, a modality that manipulates the expression of mutated genes, is also making strides in healthcare, particularly for chronic conditions. The therapeutic areas spanning from neurology indications to orphan diseases are witnessing significant progress. Gene therapy's mechanism of action, which can include gene augmentation, molecular carriers, and advanced targeted therapies, is revolutionizing precision medicine. Startup companies and biotechnology firms are spearheading innovation, developing delivery systems and preclinical testing for gene therapy products.

Regulatory approval processes, including drug designations and patent portfolio strength, are adapting to accommodate these emerging technologies. Advanced technologies, such as hybrid vector systems and non-viral vectors, are extending the shelf life and commercialization strategies of gene therapy products. Big pharma players are increasingly investing in gene editing therapies, further fueling market growth. Clinical research initiatives, including clinical trials and investment funding, are paving the way for the development of new gene therapy products. Gene therapy's role in cancer treatment and genome sequencing is also expanding, reflecting the vast potential of this dynamic field. The regulatory landscape is evolving to accommodate these medical advancements, with regulatory approval processes becoming more streamlined.

Temperature control and route of administration are crucial considerations in the development of gene therapy products. In the genomics field, gene therapy is playing a pivotal role in the manipulation of genes and biological therapies, leading to therapeutic innovation and improved patient outcomes. The market is a continually unfolding landscape, with ongoing research and development initiatives shaping its future.

How is this Gene Therapy Industry segmented?

The gene therapy industry research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in 'USD million' for the period 2024-2028, as well as historical data from 2018-2022 for the following segments.

Delivery Mode

  In vivo
  Ex vivo


Therapy Area

  Oncology
  CNS
  Ophthalmology
  Rare diseases
  Others


Vector Type

  Viral Vectors
  Non-viral Vectors


Indication

  Genetic Disorders
  Cancer
  Infectious Diseases


Application

  Oncology
  Orphan Diseases
  Neurological Disorders
  Cardiovascular Diseases
  Infectious Diseases
  Hematological Disorders


Geography

  North America

    US
    Canada


  Europe

    France
    Germany
    Italy
    UK


  Middle East and Africa

    Egypt
    KSA
    Oman
    UAE


  APAC

    China
    India
    Japan


  South America

    Argentina
    Brazil


  Rest of World (ROW)

By Delivery Mode Insights

The in vivo segment is estimated to witness significant growth during the forecast period.

In the realm of medical innovation, in vivo gene therapy represents a groundbreaking technique that delivers genetic material directly into target cells to effect therapeutic change. This approach, which employs various vectors to transfer functional genes i

The global gene therapy market is calculated at a value of US$ 10.34 billion in 2024. Increasing cases of rare diseases is contributing to the rising need for cell and gene therapies. Expanding at a CAGR of 14.1%, the market is forecasted to reach US$ 38.52 billion by the end of 2034.

Report Attribute	Detail
Gene Therapy Market Size (2024E)	US$ 10.34 Billion
Forecasted Market Value (2034F)	US$ 38.52 Billion
Global Market Growth Rate (2024 to 2034)	14.1% CAGR
South Korea Market Value (2034F)	US$ 2 Billion
India Market Growth Rate (2024 to 2034)	22.4% CAGR
Key Companies Profiled	American Gene Technologies BioMarin Bluebird Bio Inc. Orchard Therapeutics Limited uniQure NV BioNTech Oxford Biomedica Plc. Celgene Corporation Shanghai Sunway Biotech Co., Ltd. Sibiono GeneTech Co. Ltd. Biogen Dendreon Pharmaceuticals LLC Spark Therapeutics Inc. Amgen Inc. Gilead Sciences Inc. Enzyvant Therapeutics GmbH Novartis AG Astellas Pharma, Inc.

Country-wise Analysis

Attribute	United States
Market Value (2024E)	US$ 3.14 Billion
Growth Rate (2024 to 2034)	13.4% CAGR
Projected Value (2034F)	US$ 11.05 Billion

Attribute	India
Market Value (2024E)	US$ 569.9 Million
Growth Rate (2024 to 2034)	22.4% CAGR
Projected Value (2034F)	US$ 4.30 Billion

Category-wise Analysis

Attribute	Adeno-Associated Virus
Segment Value (2024E)	US$ 2.6 Billion
Growth Rate (2024 to 2034)	15.9% CAGR
Projected Value (2034F)	US$ 11.37 Billion

Attribute	Spinal Muscular Atrophy (SMA)
Segment Value (2024E)	US$ 3.6 Billion
Growth Rate (2024 to 2034)	8.9% CAGR
Projected Value (2034F)	US$ 8.43 Billion

The global gene therapy market is projected to grow at a significant CAGR of 20% from 2024 to 2029. This growth is driven by advancements in gene-editing technologies, a surge in research funding, an increasing prevalence of genetic disorders, and rising demand for personalized medicine. However, high costs associated with gene therapies and limited accessibility […]

Gene Therapy Market Outlook

According to our latest research, the global gene therapy market size reached USD 12.8 billion in 2024, driven by a robust wave of regulatory approvals, technological advancements, and expanding therapeutic applications. The market is demonstrating an impressive growth trajectory, with a projected compound annual growth rate (CAGR) of 22.4% from 2025 to 2033. By the end of the forecast period in 2033, the gene therapy market is expected to attain a value of USD 67.2 billion. This rapid expansion is fueled by the increasing prevalence of genetic and rare diseases, rising investments in biotechnology research, and a growing number of successful clinical trials that underscore the efficacy and safety of gene therapies.

One of the primary growth factors for the gene therapy market is the escalating incidence of rare and genetic disorders worldwide. Conditions such as cystic fibrosis, sickle cell anemia, and Duchenne muscular dystrophy, which previously had limited or no effective treatment options, are now at the forefront of gene therapy applications. The ability of gene therapies to address the root cause of these diseases at the molecular level, rather than merely alleviating symptoms, has attracted significant attention from both healthcare providers and patients. Additionally, the expansion of newborn screening programs and advancements in genetic diagnostics have led to earlier and more accurate detection of genetic anomalies, further increasing the eligible patient population for gene therapy interventions.

Another significant driver is the technological innovation in vector development and delivery systems. The evolution of both viral and non-viral vectors has markedly improved the efficiency, specificity, and safety of gene transfer techniques. Innovations such as CRISPR-Cas9, adeno-associated viral vectors (AAV), and lentiviral vectors have revolutionized the field, making gene editing more precise and reducing the risk of off-target effects. These advancements have not only accelerated the pace of clinical trials but have also broadened the spectrum of treatable conditions, including various cancers, cardiovascular diseases, and neurological disorders. The convergence of genomics, bioinformatics, and synthetic biology continues to drive the pipeline of novel gene therapies, ensuring sustained growth in the coming years.

The regulatory landscape has also become increasingly supportive, contributing to the market’s momentum. Agencies like the US FDA and the European Medicines Agency (EMA) have established clear pathways for the approval of gene therapies, including accelerated review processes and special designations such as Orphan Drug and Breakthrough Therapy. This regulatory clarity has encouraged substantial investments from both public and private sectors, fostering a conducive environment for innovation. Furthermore, the formation of strategic partnerships between academic institutions, biotechnology firms, and pharmaceutical giants has expedited the translation of laboratory discoveries into commercially viable therapies, thereby enhancing market accessibility and adoption.

Regionally, North America continues to dominate the gene therapy market, accounting for the largest share in 2024, thanks to its advanced healthcare infrastructure, significant R&D funding, and a high concentration of leading market players. Europe follows closely, benefiting from strong government support and a vibrant research ecosystem. Meanwhile, the Asia Pacific region is emerging as a high-growth market, propelled by rising healthcare expenditure, increasing awareness about genetic diseases, and expanding clinical trial activities. Latin America and the Middle East & Africa, while still nascent, are witnessing gradual improvements in healthcare infrastructure and regulatory frameworks, setting the stage for future market expansion.

Therapy Type Analysis

The gene therapy market is broadly segmented by therapy type into in vivo&

As of November 2019, 55 percent of clinical trials in cell and gene therapy development were in phase two, and 30 percent were in phase one of clinical trials. This statistic shows the proportion of clinical trials for cell and gene therapies worldwide as of late-2019, by clinical trial phase.

Of the ***** active clinical trials for cell and gene therapies as of 2022, *** were in phase 1/1b. This statistic depicts the number of active trials for cell and gene therapies in the global pipeline, by trial phase.

The Gene Therapy Market Report Segments the Industry Into by Vector Type (Adeno Virus Vector, and More), Indication (Oncology, Rare Metabolic Disorders, and More), Delivery Mode (In Vivo Gene Delivery and Ex Vivo Gene Delivery), End User (Hospitals and Clinics, and More), and Geography (North America, Europe, Asia-Pacific, Middle-East and Africa, South America). The Market Forecasts are Provided in Terms of Value (USD)

The global market for CGT manufacturing is forecast to grow from USD 32,117.1 Million in 2025 to USD 403,548.1 Million by 2035, at a compound annual growth rate (CAGR) of 28.8% during that period.

Key Market Metrics

Metric	Value
Market Size in 2025	USD 32,117.1 Million
Projected Market Size in 2035	USD 403,548.1 Million
CAGR (2025 to 2035)	28.8%

Country-Wise Outlook

Country	CAGR (2025 to 2035)
United States	29.3%

Country	CAGR (2025 to 2035)
United Kingdom	28.1%

Country	CAGR (2025 to 2035)
European Union	28.8%

Country	CAGR (2025 to 2035)
Japan	27.6%

Country	CAGR (2025 to 2035)
South Korea	29.0%

Segmentation Outlook

Therapy Type	Market Share (2025)
Gene Therapy Manufacturing	63.9%

Scale	Market Share (2025)
Commercial Scale Manufacturing	67.5%

Competitive Outlook

Company Name	Estimated Market Share (%)
Lonza Group	14-17%
Thermo Fisher Scientific	11-14%
Catalent Inc.	9-12%
WuXi Advanced Therapies	7-10%
Fujifilm Diosynth Biotechnologies	6-9%
Other Providers	38-45%

The Gene Therapy in CNS Disorder Market is projected to reach USD 13.86 billion by 2025. As per FMI's analysis, the gene therapy in CNS disorder will grow at a CAGR of 30% and reach USD 191.04 billion by 2035. The worldwide gene therapy market for CNS disorders is growing at a fast pace, spurred by progress in genetic studies, rising incidence of neurological disorders, and growing investments in biotech advancements.

Metric	Value
Industry Size (2025E)	USD 13.86 Billion
Industry Size (2035F)	USD 191.04 Billion
CAGR (2025 to 2035)	30%

BCC Research Market Report provides an overview of Cell and Gene Therapy Market is segmented into rare diseases, oncology, hematology, cardiovascular, neurology and others based on application.

The global gene therapy market size was valued at around USD 10.71 billion in 2024 and is projected to grow at a CAGR of over 20.8%, reaching USD 124.93 billion revenue by 2037. Intravenous segment is set to hold 60% share by 2037, attributed to substantial pipeline of IV candidates and the simplicity of intravenous gene delivery for cardiac gene transfer.

The retinal gene therapy market is projected to grow at a compound annual growth rate (CAGR) of 8.8% from 2023 to 2033, increasing from USD 116.0 Million in 2023 to USD 269.6 Million by 2035.

Metric Overview

Metric	Value
Market Size (2025)	USD 116.0 Million
Market Value (2035)	USD 269.6 Million
CAGR (2025 to 2035)	8.8%

Country-wise Outlook

Country	CAGR (2025 to 2035)
United States	9.0%

Country	CAGR (2025 to 2035)
United Kingdom	8.5%

Country	CAGR (2025 to 2035)
European Union	8.6%

Country	CAGR (2025 to 2035)
Japan	8.7%

Country	CAGR (2025 to 2035)
South Korea	8.4%

Segmentation Outlook

By Indication	Market Share (2025)
Leber Congenital Amaurosis (LCA)	40.5%

By Indication	Market Share (2025)
Stargardt Disease	24.2%
X-linked Retinitis Pigmentosa (RP)	19.8%

Competitive Outlook

Company Name	Estimated Market Share (%)
Novartis (Gyroscope Therapeutics)	15 to 20%
Applied Genetic Technologies Corp. (AGTC)	10-15%
Spark Therapeutics	8-12%
Adverum Biotechnologies	5-8%
REGENXBIO Inc.	5-8%
Biogen Inc.	4-7%
MeiraGTx Holdings plc	3-6%
GenSight Biologics	2-5%
Others	30-40%

Gene therapy is a technique involving the delivery of genetic material into a patient’s cells via vectors to remedy the effects of a defective gene. Over the last decade, the gene therapy field has evolved significantly. Owing to the influx of approvals in recent years, neurodegenerative disorders, genetic diseases, and various cancers previously considered incurable may have a path towards treatment. Pharmaceutical companies are now investing significant resources to harness and fulfill the transformative potential of gene therapy products. However, identifying the most efficient gene delivery mechanism proves to be one of the major obstacles affecting the ability to take full advantage of the capabilities of gene therapies. Read More

Gene Therapy Market Outlook

As of 2023, the global gene therapy market size is estimated to be USD 4.2 billion, with a projected growth to USD 32.8 billion by 2032, driven by a remarkable CAGR of 25.9%. The growth in this market can be attributed to several factors including advancements in vector technology, a growing prevalence of genetic disorders, and an increasing number of clinical trials and FDA approvals for gene therapy products.

One of the primary growth factors of the gene therapy market is the significant technological advancements in gene editing tools such as CRISPR-Cas9. These innovations have made it easier to develop therapies that can precisely target and modify specific genes, thereby opening up new avenues for treating previously intractable genetic conditions. Furthermore, the increasing investment by both public and private sectors in research and development has accelerated the pace at which new therapies are being discovered and brought to market. For instance, many biopharmaceutical companies are actively exploring gene therapy solutions for a range of conditions from rare genetic disorders to more common diseases like cancer and cardiovascular diseases.

Another key driver for the market is the rising prevalence of genetic disorders and chronic diseases that can be potentially treated by gene therapy. Conditions such as hemophilia, spinal muscular atrophy, and various forms of cancer are gaining attention as promising candidates for gene therapy treatments. The ability to provide long-lasting or even permanent therapeutic effects through a single administration of gene therapy is a compelling proposition for healthcare providers and patients alike. This growth is further supported by the increasing awareness among the general populace about the potential benefits of gene therapies, which is likely to drive demand in the coming years.

Regulatory advancements have also played a crucial role in the market's growth. Regulatory bodies such as the FDA and EMA have been more proactive in approving new gene therapy products, thus enabling quicker market entry. In addition, efforts to streamline the regulatory processes for clinical trials and product approvals have helped to reduce the time to market for new therapies. These regulatory improvements, combined with growing public and private funding, have created a favorable environment for the development and commercialization of gene therapies.

On a regional level, North America continues to dominate the gene therapy market owing to its well-established healthcare infrastructure, high investment in research and development, and strong presence of key market players. Europe follows closely, with significant contributions from countries like Germany, the UK, and France that are heavily involved in gene therapy research. The Asia Pacific region is also anticipated to witness substantial growth due to increasing healthcare expenditure, growing awareness about genetic therapies, and rising prevalence of genetic disorders. Markets in Latin America and the Middle East & Africa show potential for growth, although they currently represent a smaller share of the global market.

Vector Type Analysis

The gene therapy market is segmented by vector type into viral vectors and non-viral vectors. Viral vectors, including adenoviruses, lentiviruses, and adeno-associated viruses (AAV), have been predominantly used in gene therapies due to their high efficiency in delivering genetic material into host cells. These vectors are engineered to be safe and to minimize immune responses, making them suitable for a variety of therapeutic applications. The choice of viral vectors depends on the specific characteristics required for the therapy, such as the size of the gene to be delivered and the type of cells targeted. Despite their advantages, viral vectors face challenges like potential immunogenicity and insertional mutagenesis, which are areas of ongoing research and improvement.

Adeno-Associated Virus (AAV) Gene Therapy has emerged as a pivotal player in the gene therapy landscape due to its unique properties. AAV vectors are known for their ability to deliver genetic material with high precision and minimal immune response, making them an attractive option for therapeutic applications. These vectors are particularly advantageous for targeting non-dividing cells, which is crucial for treating chronic and genetic disorders. The ongoing research and development effor

Gene Therapies & Associated Vectors: Intellectual Property Landscape ; with a focus on current market landscape and future growth opportunities

Gene Therapy Market size reached US$ 4.80 Billion in 2024 and is expected to reach US$ 35.91 Billion by 2033

The global sales of cancer gene therapy is estimated to be worth USD 1,822.2 million in 2024 and anticipated to reach a value of USD 3,142.2 million by 2034. Sales are projected to rise at a CAGR of 5.6% over the forecast period between 2024 and 2034. The revenue generated by oncolytic Virotherapy in 2023 was USD 850.7 million.

Attributes	Key Insights
Historical Size, 2023	USD 1,725.6 million
Estimated Size, 2024	USD 1,822.2 million
Projected Size, 2034	USD 3,142.2 million
Value-based CAGR (2024 to 2034)	5.6%

Semi-annual Market Update for Cancer Gene Therapy Market

Particular	Value CAGR
H1	6.3% (2023 to 2033)
H2	6.0% (2023 to 2033)
H1	5.6% (2024 to 2034)
H2	5.1% (2024 to 2034)

Analysis of Top Countries Developing, Approving, and Administering Cancer Gene Therapies

Countries	Value CAGR (2024 to 2034)
Canada	5.1%
UK	3.4%
France	4.8%
China	9.5%
Japan	3.9%
South Korea	7.5%
Spain	5.5%

Cancer Gene Therapy Industry Analysis by Top Investment Segments

Therapy	Oncolytic Virotherapy
Value Share (2024)	49.3%

Indication	Breast Cancer
Value Share (2024)	24.5%

The gene therapy market size attained a value of USD 7.81 Billion in 2024. The market is anticipated to grow at a CAGR of 22.80% during the forecast period of 2025-2034 to attain a value of USD 60.90 Billion by 2034. The growth of the market is driven by increased funding and investments.

Cell and Gene Therapy Market are estimated to grow at a CAGR of 13.8% from market size of USD 22.7 billion in 2024 to USD 33.3 billion in 2034. Cell therapy and Gene Therapy Industry report classifies global market by share, trend, and on the basis of indication, vector type, and region.

Cell And Gene Therapy Market is estimated to be valued at USD 37.7 Bn in 2023 and is expected to expand at CAGR of 18.5%