[Research Report] The gene therapy market is projected to reach US$ 25.69 billion by 2031 from US$ 5.11 billion in 2023; the market is estimated to record a CAGR of 14.3% during 2023–2031.

Market Insights and Analyst View:

Gene therapy is a process for the treatment of diseases by inactivating a disease-causing gene, replacing a disease-causing gene with a healthy copy of the gene, or introducing a new or modified gene into the body to help treat and prevent the disease. Gene therapy can be classified into in vivo and ex vivo gene therapy. Gene therapy aims to replace or correct faulty genes with normal ones, allowing the body to produce the correct proteins or enzymes needed for normal function, which can potentially cure the underlying cause of the diseases. The growing prevalence of genetic diseases and cancer worldwide and the increasing number of FDA approvals of gene therapies favor the gene therapy market growth. In addition, the gene therapy market trends include advancements in gene therapy technologies that will favor the growth of the market in the future.

Growth Drivers:

The advancements in biotechnology have led to the development of treatments for a wide range of indications. Gene therapies are being used to treat various diseases, such as cancer, neurological disorders, and genetic disorders. Globally, gene therapies are widely being adopted owing to the availability of US Food and Drug Administration (FDA) approved products. Following are a few examples of gene therapy products approved by the FDA in recent years:

• In December 2023, the FDA approved two cell-based gene therapies for sickle cell disease. Bluebird Bio’s Lyfgenia (lovotibeglogene autotemcel) was cleared for sickle cell disease patients aged 12 and older with a history of vaso-occlusive events. It was approved along with Casgevy (exagamglogene autotemcel), from Vertex Pharmaceuticals and CRISPR Therapeutics.
• In June 2023, the FDA approved Roctavian, an adeno-associated virus vector-based gene therapy for treating adults with severe hemophilia A without pre-existing antibodies to adeno-associated virus serotype 5. Hereditary hemophilia A is a serious bleeding disorder that happens due to a gene mutation, which is responsible for the production of factor VIII (FVIII), a protein that enables blood clotting. Roctavian is a one-time gene therapy product that contains a viral vector carrying a gene for clotting Factor VIII.
• In June 2023, the FDA approved Elevidys, the first gene therapy for treating Duchenne muscular dystrophy in pediatric patients aged 4 to 5 years with a confirmed mutation in the Duchenne muscular dystrophy gene and who do not have a pre-existing medical condition that prevents treatment with this therapy.
• In November 2022, the FDA approved HEMGENIX, manufactured by CSL Behring LLC, a recombinant Adeno-associated virus type 5 gene therapy to treat adult patients with certain kinds of Hemophilia B.

Therefore, the increasing approval of these gene therapies is fueling the gene therapy market growth.

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Gene Therapy Market: Strategic Insights

Market Size Value in	US$ 5.11 billion in 2023
Market Size Value by	US$ 25.69 billion by 2031
Growth rate	CAGR of 14.3% from 2023 to 2031
Forecast Period	2023-2031
Base Year	2023

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Report Segmentation and Scope:

The gene therapy market analysis has been carried out by considering the following segments: vectors, indication, delivery mode, and geography. Based on vectors, the market is categorized into non-viral vectors and viral vectors. In terms of indication, the market is classified into neurological diseases, cancer, Duchenne muscular dystrophy, hepatological diseases, and other indications. In terms of delivery mode, the market is bifurcated into in-vivo and ex-vivo. The scope of the gene therapy market report covers North America (the US, Canada, and Mexico), Europe (France, Germany, the UK, Spain, Italy, and the Rest of Europe), Asia Pacific (China, Japan, India, Australia, South Korea, and the Rest of Asia Pacific), the Middle East & Africa (Saudi Arabia, South Africa, the UAE, and the Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and the Rest of South & Central America).

Segmental Analysis:

The gene therapy market, by vectors, is categorized into non-viral vectors and viral vectors. The viral vectors segment held a significant market share in 2023. It is anticipated to record a higher CAGR in the market during 2023–2030.

Based on indication, the market is classified into neurological diseases, cancer, Duchenne muscular dystrophy, hepatological diseases, and other indications. The cancer segment held a significant gene therapy market share in 2023 and is estimated to register the highest CAGR during 2023–2030.

Based on delivery mode, the market is segmented into in-vivo and ex-vivo. The in-vivo segment held a significant gene therapy market share in 2023 and is expected to register a higher CAGR during 2023–2030. In vivo gene therapy enables systematic treatment, implying that it can reach multiple sites and organs throughout the body. This is especially helpful for diseases that affect multiple areas or have systematic signs, allowing for a comprehensive therapeutic approach. In addition, the development of advanced delivery technologies, such as viral vectors, nanoparticles, and lipid-based carriers, has improved the effectiveness and specificity of in vivo therapy. These advancements boost the targeted delivery of genetic material and improve the therapy's safety and efficacy.

Regional Analysis:

Geographically, the gene therapy market is segmented into North America, Europe, Asia Pacific, South & Central America, and the Middle East & Africa. In 2023, North America captured a significant share of the market. In 2023, the US dominated the gene therapy market in this region. The market growth in North America is attributed to the growing prevalence of genetic disorders, rising number of cancer patients, increasing government funding, rising adoption of advanced gene therapy for disease treatment, and growing product approval.

According to the Centers for Disease Control and Prevention (CDC), ~1,603,844 new cancer cases were diagnosed in 2020, with 602,347 cancer deaths in the US. For every 100,000 individuals, 403 new cancer cases were reported. Additionally, as per the International Agency for Research on Cancer, new cancer cases were projected to reach 30.2 million by 2040. As per the estimates of the US Government Accountability Office published in October 2021, ~25 to 30 million of the population suffers from rare diseases in the country; nearly 50% of patients with rare diseases are children. Rare diseases are often the result of a genetic mutation; it is estimated that 80% of rare diseases are genetic.

According to an October 2021 update by the National Institutes of Health, 10 pharmaceutical companies and 5 non-profit organizations have collaborated to accelerate the development of gene therapies for the 30 million American people suffering from rare illnesses. The US FDA has approved 7 cell and gene therapy drugs, with the pipeline of new products reaching ~1,200 experimental therapies. Half of these are in Phase 2 clinical trials, with estimates of annual sales growth accounting for 15% for cell therapies and ~30% for gene therapies, as per the Chemical & Engineering News report 2023 estimates. All these factors mentioned above contribute to the growing gene therapy market size in the region.

Gene Therapy Market Report Scope

Industry Developments and Future Opportunities:

A few initiatives taken by market players operating in the global gene therapy market are listed below:

• In January 2022, Ori Biotech Ltd secured over US$ 100 million in an oversubscribed Series B funding round to introduce an innovative cell and gene therapy manufacturing platform in the market.
• In January 2020, Astellas Pharma Inc. acquired Audentes Therapeutics, Inc. The acquisition enables the combined company to become a global leader in AAV-based genetic medicine.

Competitive Landscape and Key Companies:

The gene therapy market forecast can help stakeholders plan their growth strategies. Novartis AG, Astellas Pharma Inc., Bristol-Myers Squibb Company, Bluebird Bio Inc., CSL Behring, Sanofi, F. Hoffmann-La Roche Ltd, Daiichi Sankyo, Biogen, and Oxford Biomedica are among the prominent players profiled in the gene therapy market report. These companies focus on introducing new high-tech products, advancements in existing products, and geographic expansions to meet the growing consumer demand worldwide.