Gene Therapy Market is expected to reach US$ 25.69 billion by 2031

Cancer Segment to Lead Gene Therapy Market Based on Indication During 2021–2031

According to our new research study on “Gene Therapy Market Forecast to 2031 – Global Analysis – by Vectors, Indication, Delivery Mode, and Geography,” the market was valued at US$ 5.11 billion in 2023 and is projected to reach US$ 25.69 billion by 2031; it is expected to register a CAGR of 14.3% from 2023 to 2031. Key factors driving the market include the increasing burden of genetic diseases and the rising number of FDA approvals of gene therapies. Moreover, advancements in gene therapy technologies are projected to bring new gene therapy market trends in the coming years. However, the high cost of gene therapy products hinders the market growth.

Gene Therapy Market Analysis Based on Segmental Evaluation:

Based on vectors, the market is categorized into non-viral vectors and viral vectors. The viral vectors segment held a significant gene therapy market share in 2023 and is projected to register a higher CAGR during the forecast period. A viral vector provides the most efficient way to transfer genes to alter a particular cell type or tissue, which can also be used to express therapeutic genes. Due to their ability to transport several copies of therapeutic genes to host cells, viral vectors are the commonly used agents in gene therapy. An extensive range of viral vectors is used in these therapies, including the vectors developed for short-term and permanent long-term gene expression. Adeno-associated viruses (AAV), baculoviruses, and herpes simplex viruses are examples of viral vectors used in gene therapy applications. The effectiveness of transgene expression; ease of production; and safety, toxicity levels, and stability are considered when choosing a virus for routine clinical use.

Gene Therapy Market, by Region, 2023(%)

Source: The Insight Partners Analysis

Viral vectors are mostly used in basic research, vaccine development, and gene therapy due to their relatively high delivery efficiency. AAVs are rapidly becoming the leading viral vectors and are widely used in the development of gene-based advanced therapy medicinal products. With the growing market for gene therapies, the demand for viral vectors is increasing. Viral vectors have been used to deliver therapeutic materials into patients’ bodies to treat muscular, infectious, hematologic, and ophthalmologic diseases and various types of cancer. In addition, viral vectors display low immunogenicity, safety, and long-term transient expression, which is positively influencing the overall gene therapy market size.

Based on indication, the market is categorized into neurological diseases, Duchenne muscular dystrophy, cancer, 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 from 2023 to 2031. According to the World Health Organization, cancer is the biggest cause of death globally, with ~10 million deaths in 2020. The worldwide growing prevalence of various cancers, such as breast, lung, and bowel, is the major driver for this segment. According to the American Cancer Society, ~1.89 million new cancer cases and ~0.61 million cancer deaths occurred in the US in 2021. In addition, as per the International Agency for Research on Cancer, new cancer cases were projected to reach 30.2 million by 2040. According to the study titled "Spotlight on Gene Therapy in China," published in July 2020, over 57 million people suffer from genetic diseases in the country, and ~4 million new cancer cases are recorded per year. Gene therapy allows targeted and accurate delivery of therapeutic genes to cancer cells. By selectively modifying or destroying cancer cells while sparing healthy cells, gene therapy minimizes the off-target effects and reduces the toxicity linked with traditional treatments. With the potential of gene therapy to provide targeted and personalized treatment, it holds significant promise in revolutionizing cancer treatment and improving patients’ outcomes.

The broad field of gene therapy promises many innovative treatments that can potentially prevent cancer deaths. An increasing focus on developing effective therapies for cancer is also supporting the market growth. In December 2022, the FDA approved Adstiladrin, a non-replicating adenoviral vector-based gene therapy, for the treatment of adult patients with high-risk Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors.

The scope of the gene therapy market report entails North America, Europe, Asia Pacific, South & Central America, and the Middle East & Africa. Asia Pacific is likely to register the highest CAGR in the market from 2023 to 2031. The growing need for superior treatment solutions, rising focus on research and development activities, developing healthcare infrastructure, rising genetic diseases and cancer cases, and increasing investments to boost the research activities in genomics are projected to support the Asia Pacific gene therapy market growth during the forecast period.

China and Japan are the major contributors to the growth of the market in Asia Pacific. According to the World Cancer Research Fund International Data, ~1.02 million cases of cancer were diagnosed in 2020 in Japan. The age-standardized rate for all cancers was 282.9 per 100,000 in 2020. According to the article titled "Rare Disease Day: why China's Rare Disease Burden Could be an Opportunity for Innovation," published in February 2023, ~20 million Chinese people suffer from rare diseases. In August 2023, Neurophth Therapeutics, Inc., China's leading gene therapy company for ophthalmic diseases, secured ~US$ 95 million in Series C+ financing. In early 2023, the company’s flagship candidate, NR082 (rAAV2-ND4), achieved an important milestone as the first gene therapy medication to complete patient enrollment for a Phase III clinical study in China. Thus, the above-mentioned factors positively influence the gene therapy market growth in China.

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 leading companies profiled in the gene therapy market report.

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

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