The global gene therapy market size was USD 7.4 Bn in 2022 and is likely to reach USD 17.3 Bn by 2031, expanding at a CAGR of 18.7% during, 2023–2031. High investments in research & development of gene therapy is expected to boost the market in the coming years.
Gene therapy is the method that uses a gene to prevent and treat a disease or disorder. It involves the addition of new copies of genes, or replacing a defective gene in a patient’s cells. This therapy is used in the treatment of blood disorders, cancer, chronic disease, and infectious disease. The two types of gene therapy include somatic gene therapy and germline gene therapy, based on the location of the target gene on a chromosome.
Gene therapy is the partial or full replacement of defective genes in a patient's body with healthy genes to prevent disease proliferation. Healthy gene is transferred into the host cell by biological vectors, such as liposome, virus, and plasmids. Viral vector consists of retrovirus, adenovirus, lentivirus, and adeno-associated vector. The non-viral vector includes transposons, liposomes, and plasmids.
Physical methods are available for gene transfer, such as sonication, electroporation, gene gun, and photoporation. It can be applied for the treatment of several diseases, such as Parkinson’s, cystic fibrosis, hemophilia, Alzheimer’s, AIDS, SCID, brain tumors, cancer, and others. Moreover, the development of the technology has opportunities for curing untreatable chronic diseases.
The research report finds that the COVID-19 pandemic hampered various industries. The gene therapy market has experienced severe disruption due to the significant challenges faced by the supply chain industry. For instance, several companies face prolonged delivery for some components. Later, these companies were short on clinical trial supplies when a partner contract manufacturing company was facing a shutdown.
Gene Therapy Market Dynamics
Key Trends
Emerging countries are using advanced treatment options for rising chronic diseases. Advanced treatment is widely used compared to conventional treatment. Conventional therapy has side effects, for instance, chemotherapy has severe side effects and long-term implications. Moreover, the use of viral vectors is increasing in therapy development for lower toxicity and high immunogenicity.
Major Drivers
Rising number of cancer cases globally is likely to fuel the market. According to World Health Organization (WHO) and Globocan, the total five-year prevalence of cancer is around 43 million globally. Gene therapy has immense importance in cancer treatment as it prevents a certain type of cancer. Patient suffering from disorder through genetic mutation passed down from previous generations is cured with the help of gene therapy.
The prevalence of rare genetic disorders is growing among children and adults and is expected to boost the market in the coming years. As per the National Organization for Rare Diseases (NORD), the estimated incidence of spinal muscular atrophy is 1 in 10,000 live births in the US annually. Researchers have found a cure for diseases that were previously deemed untreatable.
Existing Restraints
The high cost of gene therapy is projected to hinder market during the forecast period. Some insurance companies are reluctant to offer reimbursement for costly therapies. Cancer treatment method is expensive. As per the Novartis AG, a single dose of Kymriah, the therapy cancer drug costs a whopping USD 475,000 while the same drug is priced at USD 306,000 in Japan. The therapy is known as a single-dose treatment that reverses the genetic dysfunction in the patient’s body.
Emerging Opportunities
The rising drug approvals for treating rare disease is anticipated to create lucrative opportunities for market players. Novartis and Gilead continue to expand their customer base in several regions for Kymriah and Yescarta, designed to treat large B-cell lymphoma. In 2019, it has been witnessed that Novartis receive approval to sell its products in Japan. Moreover, in 2017, about 51% of patients who received Yescarta treatment achieved remission.
Scope of Gene Therapy Market Report
The market report includes an assessment of the market trends, segments, and regional markets. Overview and dynamics have also been included in the report.
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Attributes
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Details
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Report Title
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Gene Therapy Market - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast
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Base Year
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2022
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Historic Data
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2016–2021
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Forecast Period
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2023–2031
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Segmentation
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Application (Oncological Disorders, Neurological Disorders, Hepatological Diseases, and Rare Diseases), Vector Type (Retroviral Vector, Herpes Virus Vector, Adeno Virus Vector, Adeno-associated Virus Vector, Lentiviral Vector, and Others), and Therapy Type (Ex Vivo Therapy and In Vivo Therapy)
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Regional Scope
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Asia Pacific, North America, Latin America, Europe, and Middle East & Africa
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Report Coverage
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Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, Market Trends, and Revenue Forecast
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Key Players Covered in the Report
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Novartis AG; Bristol-Myers Squibb.; Amgen Inc.; Pfizer, Inc.; Shenzhen SiBiono GeneTech; Shanghai Sunway Biotech Co. Ltd.; Adaptimmune Therapeutics plc; Adverum Biotechnologies Inc.; Gilead Sciences.; Jazz Pharmaceuticals; Biogen Inc; and Orchard Therapeutics
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Gene Therapy Market Segment Insights
On the basis of application, the market is segmented into oncological disorders, neurological disorders, hepatological diseases, and rare diseases. The neurological disorders segment is projected to expand at a considerable CAGR during the forecast period, due to the high cost of the drug used in neurological disorder treatment. The rising number of neurology patients suffering from spinal muscular atrophy is likely to propel the market during the forecast period.
The oncological disorders segment is anticipated to account for a major market share during the forecast period, owing to the rising number of key market players engaged in developing treatments for different types of cancer. High number of pipeline products in clinical and preclinical stages is expected to fuel market growth.
Based on vector type, the gene therapy market is divided into retroviral vector, herpes virus vector, adeno virus vector, adeno-associated virus vector, lentiviral vector, and others. The retroviral vector segment is expected to hold a significant share of the market in the coming years, as retrovirus is easy to isolate and it is easy to incorporate DNA into the virus. A large number of clinical trials are taking place using retrovirus. Retrovirus is able to convert two copies of single-stranded RNA to double stranded DNA that can be integrated into the host cell chromosomes.
The adeno-associated virus vector segment accounts for a significant market share in the coming years, due to the rising application in clinical trials. Adeno-associated viruses show high efficiency in delivering genes to a specific region. The usage of adeno-associated virus vectors in clinical trials related to the progress of ocular and orthopedic gene therapy treatment witnessed great efficiency.
On the basis of therapy type, the global market is bifurcated into ex vivo therapy and in vivo therapy. The ex vivo therapy segment is anticipated to expand at a substantial CAGR during the forecast period. Ex vivo therapy is the harvesting of cells from the patient in a laboratory. These cells are then genetically modified and amplified in number, then the transduced cells are returned to the patient.
Another way to deliver gene therapy is in-vivo therapy. In vivo gene therapy uses viruses to deliver genes directly into patient cells. Genetic material in the form of DNA is applied to modify the genetic repertoire of target cells for therapeutic goals. In-vivo gene therapy study is done on animal models or human clinical trials. In this therapy the target is specific, thus this property makes it an ideal method.
In terms of region, the global gene therapy market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America is expected to dominate the market during the forecast period, owing to private and government investment to develop advanced gene therapy products and the rising adoption of these products in the region. Moreover, rising disposable income among customers and increasing prevalence of cancer boost the market in the region.
North America is anticipated to become a hotspot for gene therapy, in terms of the number of approvals generated during the forecast period. In 2020, as per the Spinal Muscular Atrophy Foundation, approximately 10,000 to 25,000 adults and children in the US were diagnosed with spinal muscular atrophy. Thus, this disease is known as a common disease.
The market in Asia Pacific is anticipated to expand at a rapid pace during the forecast period, due to government initiatives to improve the healthcare infrastructure and the presence of major market players in the region. The growing population with rising medical needs and high demand for novel technologies in the treatment of increasingly prevalent diseases is projected to propel the market expansion in the coming years.
Segments
The global gene therapy market has been segmented on the basis of
Application
- Oncological Disorders
- Neurological Disorders
- Hepatological Diseases
- Rare Diseases
Vector Type
- Retroviral Vector
- Herpes Virus Vector
- Adeno Virus Vector
- Adeno-associated Virus Vector
- Lentiviral Vector
- Others
Therapy Type
- Ex Vivo Therapy
- In Vivo Therapy
Region
- Asia Pacific
- North America
- Latin America
- Europe
- Middle East & Africa
Key Players
- Novartis AG
- Bristol-Myers Squibb.
- Amgen Inc.
- Pfizer, Inc
- Shenzhen SiBiono GeneTech
- Shanghai Sunway Biotech Co. Ltd.
- Adaptimmune Therapeutics plc
- Adverum Biotechnologies Inc.
- Gilead Sciences.
- Jazz Pharmaceuticals
- Biogen Inc
- Orchard Therapeutics
Competitive Landscape
Key players competing in the global gene therapy market are Novartis AG; Bristol-Myers Squibb.; Amgen Inc.; Pfizer, Inc; Shenzhen SiBiono GeneTech; Shanghai Sunway Biotech Co. Ltd.; Adaptimmune Therapeutics plc; Adverum Biotechnologies Inc.; Gilead Sciences.; Jazz Pharmaceuticals; Biogen Inc; and Orchard Therapeutics.
These companies in the market have adopted various organic growth strategies including product launches, mergers, partnerships, and collaborations to increase their market share and witness significant growth. Key players are actively engaged in R&D programs and aim at the expansion of manufacturing units to expand their consumer base and increase their product portfolio.
- In February 2022, Sarepta Therapeutics collaborated with GenEdit to incorporate latter’s NanoGalaxy platform and former’s gene editing technology. This collaboration is aimed at the development of gene editing therapeutics to treat neuromuscular diseases.
- In April 2022, Pfizer, Inc. announced its plan to introduce its first US site in the phase 3 trials of investigational gene therapy for patients with Duchenne Muscular Dystrophy. This initiative commenced after receiving an approval for restarting the Phase 3 CIFFREO study globally by the regulatory authorities in countries such as Belgium, Canada, Taiwan, the UK, and Spain.
- In May 2022, Novartis AG received FDA approval for KYMRIAH for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
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