Gene Therapy Market to Cross USD 16.5 billion by 2035 | Roots Analysis

The global market is witnessing robust growth, driven by several key factors such as 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.

According to Roots Analysis, the global gene therapy market size is projected to reach USD 16.5 billion by 2035 from USD 2.4 billion in 2024, growing at a CAGR of 19.25% in the forecast period 2024-2035.

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 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 global market, in 2024.

Non-viral vectors segment is anticipated to be the fastest growing segment in the 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 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 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 market and accounts for the largest revenue share of more than 60% in 2024.

In Europe, the market is anticipated to witness a higher growth rate of 20.79%, during the forecast period. 

Key Report Takeaways

§  Presently, 345 developers worldwide, are engaged in manufacturing gene therapies; over to 95% of these players are headquartered in the North America

§  60% of developers were established between 2011 and 2020, whereas 8% of the developers are startups that are established post 2020

§  Over 40% of the marketed and clinical stage gene therapies are currently delivered using adeno-associated virus vectors

§  Close to 30% of the gene therapies are administered via intravenous route of administration

§  The gene therapy market is anticipated to grow at a CAGR of 19.25%

Key Players

Examples of key companies in gene therapy market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Amgen, Artgen Biotech, BioMarin Pharmaceutical, bluebird bio, CRISPR Therapeutics, CSL Behring, Ferring Pharmaceuticals, Kolon TissueGene, Krystal Biotech, Novarti, Orchard Therapeutics, Pfizer, PTC Therapeutics, Sarepta Therapeutics, Shanghai Sunway Biotech, Sibiono GeneTech, Spark Therapeutics and Thermo Fisher Scientific.

About Roots Analysis 

Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights. All reports provided by us are structured in a way that enables the reader to develop a thorough perspective on the given subject. Apart from writing reports on identified areas, we provide bespoke research / consulting services dedicated to serve our clients in the best possible way.

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