Global Gene Therapy Market – Industry Trends and Forecast to 2031

Gene Therapy Market Analysis and Size

In the gene therapy market, innovative treatments harness genetic material to address diseases at their root, offering potential cures rather than symptom management. This transformative approach holds promise across various ailments, from genetic disorders to cancers, revolutionizing healthcare by providing personalized and targeted interventions, ultimately improving patients' quality of life and prognosis.

For instance, in December 2022, Japan's Ministry of Health, Labour and Welfare approved Yescarta, a CAR T-cell therapy by Kite Pharma, Inc. and Daiichi Sankyo Co., Ltd., for treating relapsed/refractory large B-cell lymphoma. Exclusive to patients without prior treatment with CAR T cells targeting CD19.                 

Data Bridge Market Research analyses that the global gene therapy market size was valued at USD 8.68 billion in 2023, is projected to reach USD 33.31 billion by 2031, with a CAGR of 18.3% during the forecast period 2024 to 2031. This indicates that the market value. In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Gene Therapy Market Scope and Segmentation

Market Definition

Gene therapy is a medical approach to treating genetic disorders by introducing, removing, or modifying specific genes within a patient's cells. This therapeutic method holds the potential for addressing inherited diseases such as cystic fibrosis or cancer by targeting the root genetic cause. It offers promise for personalized medicine and has shown encouraging results in clinical trials.            

Global Gene Therapy Market Dynamics

Drivers

• Rising Prevalence of Genetic Disorders

The surge in genetic disorders such as cystic fibrosis, sickle cell anemia, and muscular dystrophy is driving the need for gene therapy treatments. This rising incidence underscores the demand for innovative therapeutic approaches. Gene therapy offers potential solutions by targeting the root causes of these disorders, presenting a promising avenue for addressing unmet medical needs in affected populations.

• Advancements in Gene Editing Technologies

Innovations such as hemophilia gene therapy and CRISPR-Cas9 have revolutionized gene editing, improving precision, efficiency, and affordability. This transformation propels growth in the gene therapy market by facilitating targeted genetic modifications for disease treatment. These advancements offer more effective therapies, spurring investment and driving the creation of innovative gene therapy solutions for diverse medical conditions.

For instance, in March 2021, the USFDA approved Abecma (idecabtagene vicleucel), a pioneering cell-based gene therapy for adults with multiple myeloma who haven't responded to or relapsed after at least four prior treatments. It marks the FDA's first approval of a cell-based gene therapy for this form of cancer, offering a new treatment avenue.

Opportunities

• Growing Personalized Medicine Approach

Gene therapy facilitates personalized treatment by targeting genetic mutations and offering tailored solutions for individual patients. This approach, honing in on the unique genetic makeup of each person, drives market expansion by providing highly effective and customized therapies, thus revolutionizing the landscape of medical treatment.

• Rise in Strategic Acquisition and Partnership Among Organizations

Organizations are increasingly forming strategic partnerships to develop gene therapy products for detecting genetic disorders. Collaborations facilitate the development of new technologies and platforms for disease detection. Long-term agreements enable companies to offer dynamic pricing of gene therapy products, catering to consumer demand. These partnerships create opportunities for mutual growth and benefit in the market.

For instance, in January 2023, Spark Therapeutics and Neurochase initiated a strategic collaboration to integrate Neurochase's specialized delivery technology with Spark's AAV platform for selected gene therapies targeting rare CNS disorders. Neurochase brings expertise in direct drug delivery, enhancing Spark's capabilities for effective treatment development.

Restraints/Challenges

• Concern About Immune Responses

Immune responses to viral vectors or foreign gene products can impede gene therapy efficacy and cause adverse events. Strategies to address this challenge include immunomodulatory interventions and engineered vectors designed to evade immune detection. Overcoming these responses is crucial for ensuring the safety and effectiveness of gene therapy treatments. 

• High Development Costs

Gene therapy's substantial research and development costs stem from intricate manufacturing, extensive clinical trials, and stringent regulatory demands. These financial hurdles pose challenges for companies, limiting investment capacity and potentially hindering innovation and market accessibility. Overcoming the high costs of gene therapy is essential for progressing the field and ensuring wider accessibility for patients.

This market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Recent Development

• In December 2023, Libmeldy received approval from the Swiss Agency for Therapeutic Products to treat early-onset metachromatic leukodystrophy, marking a significant advancement in addressing this rare disorder's therapeutic needs
• In May 2023, Krystal Biotech's VYJUVEK gene therapy gained approval for treating Dystrophic Epidermolysis Bullosa, offering hope to patients with this debilitating condition
• In January 2023, Voyager Therapeutics and Neurocrine Biosciences initiated a strategic collaboration to commercialize and develop Voyager's GBA1 program and other innovative gene therapies targeting neurological disorders, promising advancements in this critical field of medicine
• In August 2022, the USFDA approved Zynteglo (betibeglogene autotemcel) as the first cell-based gene therapy for treating beta-thalassemia in adults and children. The approval of Zynteglo gene therapy is driving market growth, fueled by heightened research and development in gene therapy. This breakthrough promises innovative treatments for genetic disorders, marking a significant advancement in the field of medical science
• In December 2022, Ferring Pharmaceuticals saw FDA approval for Adstiladrin, a gene therapy for high-risk, BCG-unresponsive non-muscle invasive bladder cancer. This novel therapy, based on an adenovirus vector, targets adult patients with carcinoma in situ, with or without papillary tumors, bolstering the company's product range and therapeutic options

Gene Therapy Market Scope

The market is segmented on the basis of vector type, method, gene type, application, and end user. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Vector Type

• Viral Vector
• Non-Viral Vector

 Method

• Ex-Vivo
• In-Vivo

 Gene Type

• Antigen
• Cytokine
• Tumor Suppressor
• Suicide
• Deficiency
• Growth factors
• Receptors
• Others

 Application

• Oncological Disorders
• Cardiovascular Diseases
• Infectious Diseases
• Rare Diseases
• Neurological Disorders
• Other Diseases

 End User

• Cancer Institutes
• Hospitals
• Research institutes
• Others

Global Gene Therapy Market Regional Analysis/Insights

The market is analysed and market size insights and trends are provided by country, vector type, method, gene type, application, and end user as referenced above.

The countries covered in the market report are U.S., Canada, Mexico, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific, Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa, Brazil, Argentina, and Rest of South America.

North America is expected to dominate the market, propelled by rising R&D investments. The U.S., led by key players such as Novartis AG and Kite Pharma, holds significant regional control, fostering market growth and innovation.

Europe is expected to be fastest growing in the gene therapy market, propelled by Germany's mass production and emerging market demand. Expansion initiatives bolster its dominance, meeting the growing need for innovative treatments and solidifying its position as a global leader in biotechnology.

Asia-Pacific is expected to dominate the gene therapy market, led by China's prominence. Increasingly, customers favor minimally invasive medical procedures, propelling the region's growth. This trend aligns with gene therapy's promise of advanced treatments, fostering a favorable environment for its adoption.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points like down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.   

Healthcare Infrastructure growth Installed base and New Technology Penetration

The market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipment, installed base of different kind of products for global autoimmune disease diagnosis market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the market. The data is available for historic period 2016-2021.

Competitive Landscape and Global Gene Therapy Market Share Analysis

The market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to market.

Some of the major players operating in the market are:

• Novartis AG (Switzerland)
• Gilead Sciences, Inc. (U.S.)
• uniQure NV (Netherlands)
• Oxford Biomedica PLC (U.K.)
• Spark Therapeutics, Inc. (U.S.)
• SIBONO (China)
• bluebird bio, Inc. (U.S.)
• Shanghai Sunway Biotech Co., Ltd. (China)
• Biogen (U.S.)
• Dendreon Pharmaceuticals LLC (U.S.)
• Amgen Inc. (U.S.)
• AnGes, Inc. (Japan)
• Enzyvant Therapeutics GmbH  (Switzerland)
• Epeius Biotechnologies Corp.  (U.S.)
• Astellas Pharma, Inc.  (Japan)
• American Gene Technologies (U.S.)
• BioMarin (U.S.)

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