Gene Therapy Market Size, Share, Growth, and Industry Analysis, By Type (Viral Gene Therapy, Non-Viral Gene Therapy), By Application (Neurological Diseases, Cancer, Other), and Regional Forecast to 2035

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GENE THERAPY MARKET OVERVIEW

The global Gene Therapy Market is estimated to be valued at approximately USD 11.52 Billion in 2025, and is expected to grow to USD 14.7 Billion by 2026. The market is projected to reach USD 105.24 Billion by 2035, expanding at a CAGR of 27.6% from 2025 to 2035.

Gene therapy is an inventive clinical method that includes adjusting the qualities inside a singular's cells to treat or forestall illness. By utilizing various techniques, for example, viral vectors or non-viral strategies, gene therapy intends to fix, supplant, or alter damaged qualities answerable for causing infections. It holds the possibility to treat hereditary problems, Cancer, and different sicknesses that are impervious to conventional treatments. This progressive methodology is changing the scene of medication by giving customized medicines the potential for long haul adequacy and even fix. With huge progressions in gene altering advances, including CRISPR, gene therapy is making ready for designated, accurate medication that tends to be the main driver of illnesses as opposed to simply overseeing side effects.

The gene therapy market has encountered vigorous development as of late, powered by huge headways in hereditary exploration, gene altering apparatuses, and viral and non-viral vector improvement. As the interest for customized and designated treatments builds, the market for gene therapy is extending quickly, drawing in significant speculation from both public and confidential areas. The developing pervasiveness of hereditary issues and persistent illnesses like Cancer and neurological infections has additionally determined the market's extension. A few significant drug organizations and biotech firms are putting vigorously in gene therapy innovative work, prompting a rising number of gene therapy items arriving at clinical preliminaries and administrative endorsement. With the possibility to reform the manner in which we approach the treatment of perplexing sicknesses, the market is ready for additional development as advancements advance and administrative systems adjust to the new headways in the field.

KEY FINDINGS

COVID-19 IMPACT

Gene Therapy Industry Had a Negative Effect Due to Upset Clinical Preliminaries during COVID-19 Pandemic

The global COVID-19 pandemic has been unprecedented and staggering, with the market experiencing lower-than-anticipated demand across all regions compared to pre-pandemic levels. The sudden market growth reflected by the rise in CAGR is attributable to the market’s growth and demand returning to pre-pandemic levels.

The Coronavirus pandemic fundamentally influenced the worldwide medical services area, including the gene therapy market. At first, the pandemic upset clinical preliminaries, research exercises, and the store network of gene therapy items, as numerous medical services assets were diverted to battle the infection. Be that as it may, the pandemic likewise sped up development inside the biotech business, featuring the significance of gene-based treatments in tending to a great many illnesses, including viral diseases. The pandemic pointed out the capability of mRNA antibodies, which depend on comparative standards as gene therapy, making more noteworthy mindfulness and interest in gene therapy research.

LATEST TRENDS

Rising Spotlight on Customized Medication to Drive Market Growth

The gene therapy market is seeing a few key patterns that are forming its development and future bearing. One of the most striking patterns is the rising spotlight on customized medication, which means to fit medicines to individual patients in light of their hereditary profiles. This approach takes into account more powerful and designated treatments, diminishing the gamble of incidental effects and further developing treatment results. As gene therapy innovations develop, there is a developing emphasis on the improvement of gene altering instruments like CRISPR, which empower exact and precise changes of hereditary material. This pattern is prompting the rise of new gene therapies that offer the possibility to address hereditary transformations at their source.

• According to the American Society of Gene & Cell Therapy Q3 2024 report, ~3,700 gene, cell, and RNA therapy programs were active in clinical or preclinical development.

• According to a Nature review (2024), 29 in-vivo and 14 ex-vivo gene therapies have obtained approval across major regulatory jurisdictions.

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GENE THERAPY MARKET SEGMENTATION

By Type

Based on Type, the global market can be categorized into Viral Gene Therapy, Non-Viral Gene Therapy.

• Viral Gene Therapy: Viral gene therapy uses adjusted infections as vectors to convey restorative qualities to target cells. The most regularly utilized infections in gene therapy incorporate adenoviruses, retroviruses, and lentiviruses, which are designed to convey and embed qualities into the patient's cells. This technique has been effective in different clinical preliminaries and is the most broadly involved approach in gene therapy because of its proficiency in gene conveyance.

• Non-Viral Gene Therapy: Non-Viral Gene Therapy includes the utilization of engineered materials, like liposomes or nanoparticles, to convey remedial qualities into target cells without the requirement for infections. Non-viral vectors are less inclined to incite a safe reaction, which makes them an appealing option in contrast to viral vectors. Be that as it may, the test lies in guaranteeing productive gene conveyance and stable articulation in the objective cells.

By Application

Based on application, the global market can be categorized into Neurological Diseases, Cancer, Other.

• Neurological Diseases: gene therapy holds critical commitment in the therapy of neurological problems like Parkinson's illness, Alzheimer's illness, and spinal solid decay (SMA). By focusing on the fundamental hereditary reasons for these illnesses, gene therapy offers the potential for long haul upgrades in understanding results, making it an imperative area of innovative work in the area of neuroscience.

• Cancer: gene therapy is progressively being investigated as a therapy for different sorts of disease, including strong cancers and hematological tumors. By presenting qualities that either prompt disease cell demise or upgrade the invulnerable reaction against Cancer cells, gene therapy means to work on the viability of customary Cancer treatments, like chemotherapy and radiation, offering a more designated and less poisonous therapy choice.

• Other: gene therapy is likewise being investigated for the treatment of different sicknesses, including cardiovascular illnesses, eye problems, and immune system infections. With the capacity to straightforwardly modify the hereditary material in impacted cells, gene therapy offers the possibility to address a large number of conditions that are challenging to treat with ordinary strategies.

MARKET DYNAMICS

Market dynamics include driving and restraining factors, opportunities and challenges stating the market conditions.

Driving Factors

Rising Predominance of Hereditary Problems to Boost the Market

The gene therapy market growth is basically determined by the rising predominance of hereditary problems and ongoing illnesses, which are frequently challenging to treat utilizing customary treatments. As mindfulness develops with respect to the capability of gene therapy to offer long haul, even healing, arrangements, more patients are searching out these medicines. Propels in hereditary exploration, including the disclosure of new gene altering devices, have likewise assumed a pivotal part in driving the market's development. Also, the progress of beginning phase gene therapies, like those used to treat interesting hereditary issues, has demonstrated the way that gene therapy can give unmistakable outcomes, further speeding up market development.

• According to the U.S. FDA product listings, 36 cellular and gene therapy products were documented among approved OTP products, reflecting regulatory momentum.

• According to an industry landscape summary, ~1,894 ongoing gene therapy clinical trials existed recently, indicating strong R&D program volume.

Technological Progressions to Expand the Market

The gene therapy market share is quickly extending, powered by technological progressions, more prominent administrative acknowledgment, and developing industry ventures. Organizations engaged with gene therapy innovative work are utilizing associations, coordinated efforts, and acquisitions to reinforce their market position. This is bringing about the improvement of a more extensive pipeline of gene therapy items that can treat a scope of sicknesses, from hereditary problems to tumors and neurological circumstances. As more gene therapies arrive at clinical preliminaries and administrative endorsement, their market share keeps on developing, prompting a profoundly cutthroat scene in the gene therapy industry.

Restraining Factor

Significant Expense to Potentially Impede Market Growth

Regardless of the promising capability of gene therapy, a few elements are limiting its boundless reception. One of the essential obstructions is the significant expense related with the turn of events, assembling, and organization of gene therapy items. These treatments require complex innovations, for example, gene altering devices and viral vectors, which are costly to deliver. Subsequently, the expense of treatment can be restrictively high, making it blocked off for some patients, especially in low-and center pay nations. Furthermore, the significant expense represents a test for medical care frameworks and insurance agencies, who should choose whether to subsidize these costly therapies.

• According to peer-reviewed analyses, ~70% of trials rely on viral vectors, creating manufacturing scale and immunogenicity constraints.

• According to sector reports, only a small double-digit count of gene therapy trials have reached Phase III, highlighting late-stage development bottlenecks.

Rising Interest for Medicines Focusing on Uncommon and Orphan Diseases to Create Opportunity for the Product in the Market

Opportunity

A critical open door in the gene therapy market lies in the rising interest for medicines focusing on uncommon and orphan diseases. Large numbers of these circumstances have restricted treatment choices, and customary treatments frequently give deficient or no drawn-out solutions. Gene therapy can possibly address the underlying driver of these illnesses by remedying the hereditary transformations answerable for them. With administrative motivations, for example, quick track endorsements and vagrant medication status, gene therapy organizations have an extraordinary chance to zero in on uncommon illnesses, offering possibly life-saving medicines to patients who in any case have not many choices. As mindfulness and examination here develop, the gene therapy market is supposed to see a flood in speculation and improvement for treatments focusing on uncommon hereditary problems, making ready for forward leaps in beforehand untreatable circumstances.

• According to clinical pipeline trackers, approvals of novel gene-editing therapies have opened in-hospital treatment pathways, with multiple new platforms progressing to registrational stages.

• According to regulatory and research summaries, broader non-oncology trial starts represent over 50% of newly initiated programs, expanding addressable indications.

Unconventionality Of Gene Therapy Methodology Could Be a Potential Challenge for Consumers

Challenge

While the gene therapy market presents huge open doors, a few difficulties persevere that could slow its development and reception. One of the essential difficulties is the intricacy and unconventionality of gene therapy methodology. Creating successful, solid, and versatile strategies for conveying remedial qualities to the right cells in the body stays a critical obstacle. Viral vectors, albeit broadly utilized, have restrictions, for example, resistant responses and difficulties in accomplishing stable gene reconciliation. Non-viral techniques, while promising, still face issues connected with conveyance proficiency and long-haul gene demeanor.

• According to technical reviews, Immune responses against viral vectors cause treatment setbacks in 15–20% of patients, according to the National Institutes of Health.

• According to healthcare access reports, Manufacturing scalability remains limited, with current facilities producing less than 1,000 doses per month for high-demand therapies.

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GENE THERAPY MARKET REGIONAL INSIGHTS

• North America

The North American gene therapy market is one of the biggest and most developed, driven by the presence of driving biotech and drug organizations, state of the art research establishments, and good administrative conditions. The US, specifically, assumes a crucial part in the market's development because of its hearty medical services framework, critical interests in innovative work, and the endorsement of a few gene therapies by the Food and Drug Administration (FDA). The U.S. government has additionally upheld gene therapy research through financing and public-private associations. This, alongside a popularity for cutting edge treatment choices, positions North America as a central member in the worldwide gene therapy market.

• Europe

In Europe, the gene therapy market is likewise encountering huge development, driven by expanding interests in biotechnology, cooperative examination drives, and a steady administrative climate. The European Medicines Agency (EMA) has endorsed a few gene therapy items lately, demonstrating a developing acknowledgment of gene therapies inside the district. Also, European nations are progressively embracing customized medication draws near, which supplement the advantages of gene therapy. Nonetheless, administrative obstacles, cost difficulties, and aberrations in medical care foundation across European countries might slow the far-reaching reception of gene therapy in specific districts.

• Asia

Asia presents huge open doors for gene therapy market development because of the developing pervasiveness of hereditary illnesses and ongoing circumstances, alongside expanding medical services interests in nations like China, Japan, and India. The interest for cutting edge medicines is ascending as these nations center around further developing medical care access and framework. Gene therapy is still in the beginning phases of improvement in numerous Asian business sectors, however progressions in clinical preliminaries, neighborhood coordinated efforts, and good government arrangements are supposed to drive market development before very long. The development of the gene therapy market in Asia could be advanced rapidly by the rising accessibility of hereditary testing and customized medicines.

KEY INDUSTRY PLAYERS

Key Industry Players Shaping the Market Through Innovation and Market Expansion

A few conspicuous players are driving the gene therapy market, driving advancement, exploration, and improvement. These industry monsters are not just putting resources into state-of-the-art gene altering advancements but at the same time are fashioning vital organizations and joint efforts to put up gene therapies for sale to the public all the more rapidly.

• Biogen: According to public filings and company data, Biogen reported ~7,600 employees globally in 2024 and maintains programs targeting neurological rare diseases.

• Novartis: According to corporate announcements, Novartis’ onasemnogene abeparvovec (Zolgensma) received U.S. approval in 2019, marking a major commercial gene therapy milestone.

Organizations like Novartis, Gilead Sciences, Sarepta Therapeutics, and Flash Therapeutics are at the forefront, creating treatments for a scope of hereditary and persistent illnesses, including intriguing problems and Cancer. These organizations are taking critical steps in clinical preliminaries and administrative endorsements, for certain treatments currently accessible to patients.

List Of Top Gene Therapy Companies

• Biogen (U.S.)
• Novartis (Switzerland)
• Gilead Sciences (U.S.)
• Sarepta Therapeutics (U.S.)
• Alnylam Pharmaceuticals (U.S.)
• Amgen (U.S.)
• Spark Therapeutics (U.S.)
• Akcea Therapeutics (U.S.)
• bluebird bio (U.S.)
• Sunway Biotech (China)
• SIBIONO (China)
• AnGes (Japan)
• Orchard Therapeutics (U.K.)
• Human Stem Cells Institute (Russia)

KEY INDUSTRY DEVELOPMENT

August 2024: A gene therapy platform called "GeneWave" is sent off, using progressed conveyance frameworks to improve the accuracy and productivity of gene altering, with the possibility to successfully treat a large number of hereditary problems more. This inventive platform is supposed to speed up the improvement of treatments for conditions that have for some time been viewed as untreatable.

REPORT COVERAGE

The study encompasses a comprehensive SWOT analysis and provides insights into future developments within the market. It examines various factors that contribute to the growth of the market, exploring a wide range of market categories and potential applications that may impact its trajectory in the coming years. The analysis takes into account both current trends and historical turning points, providing a holistic understanding of the market's components and identifying potential areas for growth.

The gene therapy is seeing huge development, powered by expanding attention to its advantages, rising consumer interest in sustainable solutions, and persistent technological headways. In spite of the fact that it faces difficulties like supply limitations and increasing costs, the continuous interest for innovative and excellent choices is driving extension and progress across the area. Key industry players are driving advancement through essential developments and market extensions, improving both supply and appeal. As purchaser inclinations shift towards better and more different choices, the market is supposed to thrive, upheld by progressing developments and a developing acknowledgment of its contributions.