Gene Therapy Market Size Anticipated to Reach USD 16.5 Billion by 2035

Rise in Inherited and Rare Disorders to Drive Gene Therapy Market Growth; Anticipated to Cross US$ 16.5 billion by 2035 | Roots Analysis

According to a recently published report by Roots Analysis, the rising incidence of congenital / inherited disorders along with increase in demand for targeted and highly effective personalized medicines is driving the gene therapy market growth

Gene Therapy Industry Overview

The global gene therapy market is anticipated to grow at a CAGR of 19.25% during the forecast period 2024-2035, reaching USD 16.5 billion by 2035.

Gene therapies are a class of biologic products designed to alter the genetic material of an individual to treat rare diseases caused by inherited genetic mutations. These therapies are developed to address the underlying genetic cause of a disease, either by introducing a healthy version of the mutated gene or by inactivating the functions of disease-causing genes within the body. Currently, 20 gene therapies are commercially available for the treatment of various genetic disorders, including spinal muscular atrophy and sickle cell disease. Additionally, more than 370 candidates are currently being evaluated across various phases of clinical trials and around 920 gene therapies are being developed across preclinical and discovery stages of development. Further, it is worth highlighting that these therapies have demonstrated tremendous potential in revolutionizing the treatment of chronic conditions, with promising results in achieving complete disease remission. As such, the demand for gene therapies is increasing substantially, thereby encouraging gene therapy companies and non-industry players to enhance their R&D capabilities in order to develop and advance a greater number of therapies towards the commercial market. Driven by the growing demand for targeted therapies, the gene therapy market size is poised to experience a noteworthy increase during the forecast period.

Browse 270+ figures and 455+ market data tables spread across 970+ pages and detailed Table of Content on “Gene Therapy Market by Therapeutic Area, Type of Vector, Type of Therapy, Type of Gene Delivery Method, Route of Administration, Geographical Regions, Leading Players and Sales Forecast, till 2035” here: https://www.rootsanalysis.com/reports/gene-therapies-market/268.html

Market Drivers

Several factors are propelling the growth of the gene therapy market. One of the key factors driving the future of the global gene therapy market is the growing preference for personalized healthcare wherein treatments are tailored to selectively correct the mutated, disease-causing genes of individual patients. Further, the advent of advanced gene editing technologies, such as base editing and prime editing has enhanced the precision of gene therapies by allowing targeted alterations in specific genetic material within cells or organs, while minimizing the risk of off-target effects. Additionally, it is worth highlighting that regulatory bodies have introduced several expedited drug approval pathways, including orphan drug designation and accelerated approval processes, to facilitate the approval of effective gene therapies. In fact, the number of USFDA approved gene therapies are increasing each year, consequently strengthening the funding and start-up activity in the domain.

Market Restraints

While the gene therapy market is experiencing substantial growth, there are various restraints that can hinder the growth of the industry. One of the primary restraints in this domain is the relatively high cost of gene therapies which limits the affordability and accessibility of these therapies. Further, several ethical concerns, including eugenics and mosaicism are known to be associated with the application of gene therapies, consequently resulting in slower adoption of these therapies and eventually impacting the gene therapy market growth.

Growth Factors

Despite the challenges and various market restraints, several growth factors continue to drive the gene therapy market. According  to a recently published study, one of the key growth factors is the rising incidence of genetic disorders, which accounts for over 40% of infant deaths in the US. Notably, gene therapies have demonstrated tremendous potential in treating these conditions and have emerged as a strategic approach to alleviate the burden of genetic disorders. Moreover, these therapies have also emerged as a promising treatment for a myriad of other chronic indications (including infectious diseases, ophthalmic disorders, rare diseases and oncological disorders), thereby targeting a larger patient population. As a result, the demand for these therapies is increasing and is likely to present lucrative opportunities for gene therapy companies to establish their presence in the domain.

Gene Therapy Market Segments

Based on the therapeutic area, the market is segmented into cardiovascular disorders, dermatological disorders, genetic disorders, hematological disorders, metabolic disorders, muscle disorders oncological disorders, ophthalmic disorders and other disorders

• The muscle disorders segment captures the largest revenue share of more than 70% in the gene therapy market, in 2024.
• The cardiovascular disorders segment is anticipated to witness the highest market growth rate of 47.98%, during the forecast period.

Based on the type of vector, the market is segmented into adeno-associated virus vectors, adenovirus vectors, herpes simplex virus vectors, lentivirus vectors, non-viral vectors, retroviral vectors and other vectors

• Adeno-associated virus vectors segment captures the largest revenue share of close to 80% in the gene therapy market, in 2024.
• Non-viral vectors segment is anticipated to be the fastest growing segment in gene therapy market with a CAGR of 73.26%, during the forecast period.

Based on the type of therapy, the market is segmented into gene augmentation, gene editing, gene regulation, oncolytic immunotherapy and other therapies

• The gene augmentation segment captures the largest revenue share of 94% in the gene therapy market, in 2024.
• The gene regulation segment is anticipated to witness a higher CAGR of 53.10%, during the forecast period.

Based on the type of gene delivery method, the market is segmented into ex vivo gene delivery and in vivo gene delivery

• The in vivo gene delivery segment captures the largest revenue share of 91% in the gene therapy market, in 2024.
• The ex vivo gene delivery segment is anticipated to witness the highest market growth rate of 30.67%, during the forecast period.

Based on the route of administration, the market is segmented into intramuscular route, intratumoral route, intravenous route, subretinal route and other routes of administration

• The intravenous route segment captures the largest revenue share of close to 85% in the gene therapy market, in 2024.
• The intramuscular route segment is anticipated to witness a higher market growth rate of 31.98%, during the forecast period.

Based on the geographical regions, the market is segmented into North America, Europe, Asia-Pacific, Latin America and Rest of the World

• North America dominates the gene therapy market and accounts for the largest revenue share of more than 60% in 2024.
• In Europe, the gene therapy market is anticipated to witness a higher growth rate of 20.79%, during the forecast period.

Key Companies Profiled

The gene therapy market report also includes profiles of key players (listed below) that are involved in the development of gene therapies:

• Amgen
• Artgen Biotech
• BioMarin Pharmaceutical
• bluebird bio
• CRISPR Therapeutics
• CSL Behring
• Ferring Pharmaceuticals
• Kolon TissueGene
• Krystal Biotech
• Novartis
• Orchard Therapeutics
• Pfizer
• PTC Therapeutics
• Sarepta Therapeutics
• Shanghai Sunway Biotech
• Sibiono GeneTech
• Spark Therapeutics

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