Gene Therapy Market - By Vector {Viral (Retro, Adeno-associated, Lentiviral), Non-viral (Oligonucleotide)}, Delivery Method (In vivo, In vitro), Gene (Antigen, Tumor Suppressor, Cytokine), Indication (Cancer, Neurological), Global Forecast, 2024 – 2032

Gene Therapy Market - By Vector {Viral (Retro, Adeno-associated, Lentiviral), Non-viral (Oligonucleotide)}, Delivery Method (In vivo, In vitro), Gene (Antigen, Tumor Suppressor, Cytokine), Indication (Cancer, Neurological), Global Forecast, 2024 – 2032

Gene Therapy Market Size

Gene Therapy Market size was estimated at USD 9 billion in 2023 and is anticipated to register a CAGR of over 19.4% between 2024 and 2032. Due to the expansion of advanced medicines and gene delivery technologies such as gene vectors, increased funding for gene therapy research, increasing incidence of cancer and other target diseases for gene therapy, increasing availability of cell & gene therapy manufacturing services, and increasing number of product approval and launches.
 

Furthermore, increased regulatory supporting presents a development opportunity for the gene therapy industry throughout the projection period. The FDA has made substantial progress in its efforts to address the rapidly evolving technology equated with the manufacture of CAR specific T-cell therapies. Specifically in phase II and III investigations, authorities are permitting flexibility in the traditional hierarchy of clinical trials. In addition, the FDA estimated that by 2025, 10 to 20 innovative cell and gene therapies will approve each year.
 

COVID-19 Impact

The COVID-19 pandemic had an immense effect on the gene therapy market, including clinical trial disruptions, manufacturing and supply chain challenges, and regulatory flexibility. The pandemic led to disruptions in ongoing and planned clinical trials for gene therapies. Clinical trial enrolment was impacted due to restrictions on patient visits, reduced access to healthcare facilities, and prioritization of resources for COVID-19 patients. This resulted in delays in trial timelines, data collection, and regulatory submissions.
 

Moreover, the market faced disruptions in manufacturing and supply chains due to lockdown measures, travel restrictions, and reduced workforce. This led to delays in the production and distribution of gene therapy products. The availability of raw materials, reagents, and specialized equipment was also affected, impacting the overall manufacturing capacity.
 

Gene Therapy Market Trends

Some key trends in the market includes advancements in gene editing technologies, increasing number of clinical trials, and expansion of gene therapies into rare diseases. The development and refinement of gene editing technologies, such as CRISPR-Cas9, zinc finger nucleases (ZFNs), and TALENs, have revolutionized the field of gene therapy. These technologies enable precise and targeted modifications to the genetic material, opening up new possibilities for treating genetic disorders and other diseases.
 

Gene Therapy Vector Market Analysis

Based on vector type, the gene therapy market is segmented as viral vectors and non-viral vectors. The viral vectors segment further divided into retro viral vectors, adeno-associated virus vectors, lentiviral vectors, and other viral vectors. In 2022, the non-viral vector segment accounts for the majority of the market size and is expected to grow at the fastest rate throughout the forecast period.
 

Owing to lower risk of pre-existing immunity and broad range of delivery methods, as many individuals have pre-existing immunity to certain viral vectors due to prior exposure to the viruses. This can limit the effectiveness of viral vector-based gene therapies. Non-viral vectors, on the other hand, are not subject to pre-existing immunity issues, making them more widely applicable across patient populations.
 

Moreover, non-viral vectors are generally considered safer compared to viral vectors. They do not carry the risk of viral replication or integration into the host genome, which can cause unintended effects. Non-viral vectors are less likely to trigger immune responses and are associated with lower toxicity, making them attractive for clinical use.
 

Based on delivery method, the gene therapy market is segmented as in vivo gene therapy, and ex vivo gene therapy. The in vivo gene therapy held a dominant market share of around 71.2% in 2022 and is expected to grow at a significant pace during the analysis period. In vivo gene therapy enables systemic treatment, meaning it can reach multiple sites or organs throughout the body. This is particularly beneficial for diseases that affect multiple areas or have systemic manifestations, allowing for a comprehensive therapeutic approach.
 

In addition, the development of advanced delivery systems, such as viral vectors, nanoparticles, or lipid-based carriers, has improved the efficiency and specificity of in vivo gene therapy. These advancements enhance the targeted delivery of genetic material and improve the safety and efficacy of the therapy.
 

Based on gene type, the market is segmented as antigen, cytokine, tumor suppressor, suicide, deficiency, growth factors, receptor, and other gene types. The antigen segment is expected to grow at a significant pace of 18.3% by 2032. Antigen-based gene therapies can be employed as immunotherapeutic strategies. By introducing genes encoding specific antigens into the patient's cells, the immune system can be activated or enhanced to recognize and attack tumor cells or pathogens.
 

This approach has shown promise in cancer gene therapy and cancer immunotherapy, where antigens derived from cancer cells can be targeted to elicit an immune response against tumors. Also, antigens can serve as specific targets for gene therapy interventions. By identifying antigens associated with particular diseases or conditions, gene therapies can be designed to specifically target and modulate the expression of these antigens, leading to targeted therapeutic effects.
 

Based on indication, the gene therapy market is segmented as cancer, neurological diseases, DMD (Duchenne Muscular Dystrophy), hepatological diseases, inherited retinal disease, peripheral arterial disease, and other indications. The cancer segment is expected to grow at a significant pace by 2032. Gene therapy allows for targeted and precise delivery of therapeutic genes to cancer cells. By selectively modifying or killing cancer cells while sparing healthy cells, gene therapy minimizes off-target effects and reduces the toxicity associated with traditional treatments.
 

North America gene therapy market is anticipated to grow at 19.2% by 2032. Factors responsible for largest market share in North America such as, favorable regulatory environment, strong financial and investment support, advanced healthcare infrastructure, and robust research and development ecosystem.
 

North America, particularly the United States, has a strong and well-established research and development ecosystem in the field of gene therapy. It is home to leading academic institutions, research centers, and biotechnology companies that actively contribute to advancements in gene therapy research. This ecosystem fosters innovation, attracts investments, and drives the development of novel gene therapies.
 

Furthermore, the prevalence of genetic disorders and complex diseases, such as cancer, in North America has created a significant market demand for innovative treatment options like gene therapy. Also, the willingness of payers to support these therapies through reimbursement programs further fuels market gains.
 

Gene Therapy Market Share

Some of the major market players operating in the gene therapy industry are

• Merck KGaA
• REGENXBIO, Inc.
• Oxford BioMedica plc
• Dimension Therapeutics, Inc.
• Bristol-Myers Squibb Company
• SANOFI
•  Applied Genetic Technologies Corporation
• F. Hoffmann-La Roche Ltd
• bluebird bio, Inc.
• Novartis AG
• Orchard Therapeutics
• Gilead Lifesciences, Inc.
• BENITEC BIOPHARMA
• Sibiono GeneTech Co., Ltd
• Shanghai Sunway Biotech Co., Ltd.

Gene Therapy Industry News

• In May 2023, the FDA approved Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients 6 months and older with dystrophic epidermolysis bullosa (DEB) and mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.
   
• In April 2023, REGENXBIO Inc. announced that the FDA has given fast track designation to RGX-202, a possible one-time gene therapy for the treatment of Duchenne muscular dystrophy (Duchenne).
   
• In December 2022 Kite Pharma, Inc. and Daiichi Sankyo Co., Ltd. announced that the Japan Ministry of Health, Labour and Welfare (MHLW) has approved Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, for the initial treatment of patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, transformed follicular lymphoma, and high-grade B-cell lymphoma. Only patients who have not previously had a transfusion of CAR T cells directed against the CD19 antigen should be treated with Yescarta.
   

The gene therapy market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 to 2032, for the following segments

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By Vector, 2018 - 2032 (USD Million)

• Viral vectors
  • Retro viral vectors
    • Replication-competent vectors
    • Replication-defective vectors
  • Adeno-associated virus vectors
  • Lentiviral vectors
  • Other viral vectors
• Non-viral vectors
  • Oligonucleotides
  • Other non-viral vectors

By Delivery Method, 2018 - 2032 (USD Million)

• In vivo gene therapy
• Ex vivo gene therapy

By Gene type, 2018 - 2032 (USD Million)

• Antigen
• Cytokine
• Tumor suppressor
• Suicide
• Deficiency
• Growth factors
• Receptors
• Other gene types

By Indication, 2018 - 2032 (USD Million)

• Cancer
  • Acute lymphoblastic leukemia (ALL)
  • Large B-cell lymphoma
  • Head & neck squamous cell carcinoma
  • Melanoma (Lesions)
• Neurological diseases
• DMD (Duchenne Muscular Dystrophy)
• Hepatological diseases
• Inherited retinal disease
• Peripheral arterial disease
• Other indications

The above information is provided for the following regions and countries

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Switzerland
  • Netherlands
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific 
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America 
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • Rest of Middle East & Africa