LV-Based Cell and Gene Therapy Products Market Products Transforming Global Healthcare

Revenue, 2025

USD 5.48 Billion

Forecast, 2035

USD 26.94 Billion

CAGR, 2026-2035

17.27%

Report Coverage

Global

LV-Based Cell and Gene Therapy Products Market Size, Opportunities with Key Players

The global LV-based cell and gene therapy products market size was estimated at USD 5.48 billion in 2025 and is predicted to increase from USD 6.42 billion in 2026 to approximately USD 26.94 billion by 2035, expanding at a CAGR of 17.27% from 2026 to 2035.

The growing chronic diseases are increasing the demand for LV-based cell and gene therapies globally, where the use of AI technologies is accelerating their innovations. Additionally, the growing investments are also increasing their R&D activities, where the advanced healthcare, regulatory standards, and expanding industries are also increasing their use across various regions. Furthermore, companies are launching new products, promoting market growth.

Key Takeaways

• LV-based cell and gene therapy products industry poised to reach USD 6.42 billion by 2026.
• Forecasted to grow to USD 26.94 billion by 2035.
• Expected to maintain a CAGR of 17.27% from 2026 to 2035.
• North America held the major revenue share of 48.90% in the global LV-based cell and gene therapy products market in 2025.
• Asia Pacific is expected to grow with the fastest CAGR of 14.40% between 2026 and 2035.
• By product type, the ex vivo LV-modified cell therapies segment held a 38.60% share in the market in 2025.
• By product type, the in vivo LV gene therapies segment is expected to grow with the fastest CAGR of 14.90% during the forecast period.
• By therapeutic area type, the oncology segment held a 42.30% share in the market in 2025.
• By therapeutic area type, the rare genetic disorders segment is expected to grow with the fastest CAGR of 13.80% during the forecast period.
• By indication type, the monogenic disorders segment held a 46.70% share in the market in 2025.
• By indication type, the autoimmune disorders segment is expected to grow with the fastest CAGR of 14.20% during the forecast period.
• By end user, the pharmaceutical & biotechnology companies segment held a 44.80% share in the LV-based cell and gene therapy products market in 2025.
• By end user, the contract development & manufacturing organizations (CDMOs) segment is expected to grow with the fastest CAGR of 15.10% during the forecast period.
• By vector production type, the GMP-grade lentiviral vectors segment held a 63.40% share in the market in 2025 and is expected to grow with the fastest CAGR of 13.60% during the forecast period.

Key Indicators and Highlights

What are the LV-Based Cell and Gene Therapy Products?

The LV-based cell and gene therapy products market is driven by the clinical success of CAR T cell therapies and new approvals for rare genetic disorders. The LV-based cell and gene therapy products refer to lentiviral therapies used to deliver therapeutic genes into the patient’s cells. They are used for the treatment of cancer, genetic disorders, autoimmune diseases, etc.

What is the Use of AI in the Market?

The use of AI in the LV-based cell and gene therapy products is increasing for their design and optimization. They are also used for the identification of the targets and biomarkers , and to monitor their manufacturing process. They also detect the off-target effects and reduce the risk associated with them, where they are also used in the design of clinical trials and personalized medication development.

What are the Trends & Future Outlook of the Market?

Growing applications

There is a rise in the research and development of the LV-based cell and gene therapies to enhance their application beyond cancer, which is increasing their clinical trials.

Flourishing Technological Advancements

The companies are developing self-activating LV vectors along with new lentiviral platforms to enhance their accuracy and efficiency to provide precise gene corrections.

Increasing Personalized Medication Demand

The industries are focusing on offering personalized medications, with the use of individual genetic profiles, which is increasing their acceptance rates, promoting their innovations.

What are the Major Investments in the Market?

• In December 2025, a total of 20 million US dollars was received by T-CURX GmbH in the first financing round from Würzburg, which will be used to develop non-viral CAR-T therapies for the treatment of acute myeloid leukaemia (AML) and solid tumours.
• In December 2025, $25M in Series B financing was secured by Vyriad, Inc., which will be used to support the imminent first-in-human testing of VV169, which is an in vivo CAR-T candidate of the company.

Segmental Insights

By Product Type Insights

Why Did the Ex vivo LV-modified Cell Therapies Segment Dominate in the Market in 2025?

The ex vivo LV-modified cell therapies segment held the largest share of 38.60% in the LV-based cell and gene therapy products market in 2025, due to their stable and long-lasting therapeutic effect. This increased their use across diving and non-diving cells, where they were also used in the CAR-T cell therapies development, which enhanced their adoption rates.

In vivo LV Gene Therapies

The in vivo LV gene therapies segment is expected to show the fastest growth with a CAGR of 14.90% during the upcoming years, due to their direct delivery. Moreover, their growing applications are also increasing their use in the treatment of a wide range of diseases, promoting new innovations.

By Therapeutic Area Insights

How the Oncology Segment Dominated the Market in 2025?

The oncology segment led the LV-based cell and gene therapy products market with a 42.30% share in 2025, driven by its proven effectiveness. At the same time, the growth in unmet medical needs also increased their acceptance rates. Moreover, a rise in R&D investments also increased their innovation and adoption rates.

Rare Genetic Disorders

The rare genetic disorders segment is expected to show the highest growth with a CAGR of 13.80% during the upcoming years, due to their growing incidence rates. This, in turn, is increasing the use of LV-based cell and gene therapies for target-specific action, where they are also being used in their early and accurate diagnosis.

By Indication Type Insights

Which Indication Type Segment Held the Dominating Share of the Market in 2025?

The monogenic disorders segment held the largest share of 46.70% share in the LV-based cell and gene therapy products market in 2025, due to their single gene defects, which provided ideal targets for LV-based cell and gene therapy products. This, in turn, increased the cure rates and enhanced the successful treatment, which increased the acceptance rates.

Autoimmune Disorders

The autoimmune disorders segment is expected to show the fastest growth rate with a CAGR of 14.20% during the upcoming years, due to their growing incidence rates. Furthermore, the growing awareness is also increasing their early diagnosis, and driving the use of LV-based cell and gene therapies.

By End User Insights

What Made Pharmaceutical & Biotechnology Companies the Dominant Segment in the Market in 2025?

The pharmaceutical & biotechnology companies segment led the LV-based cell and gene therapy products market with 44.80% share in 2025, due to the presence of robust R&D infrastructure. This, in turn, increased their innovation and production rate. Additionally, R&D investments also increased their advancements.

Contract Development & Manufacturing Organizations (CDMOs)

The contract development & manufacturing organizations (CDMOs) segment is expected to show the highest growth with a CAGR of 15.10% during the predicted time, due to growing outsourcing trends. At the same time, the presence of expertise and well-developed GMP facilities is also increasing their production rates.

By Vector Production Type Insights

Why GMP-grade Lentiviral Vectors Segment Dominated the Market?

The GMP-grade lentiviral vectors segment held the largest share of 63.40% share in the market in 2025 and is expected to show the fastest growth rate with a CAGR of 13.60% during the predicted time, driven by their high approval rates. Moreover, they also offered enhanced safety and potency, which increased their use and promoted their innovations.

Regional Distribution

• North America held the dominance in the LV-based cell and gene therapy products market in 2025. 
• The U.S. led the market by capturing the largest revenue share of the market in 2025. 
• Asia Pacific is expected to be a significantly growing region in the studied years.
• China is anticipated to grow at a rapid CAGR during the forecast period.
• Europe is expected to grow at a notable CAGR in the market during the forecast period.
• The UK is anticipated to grow at a rapid CAGR during the forecast period. 

Advanced Industries Drives North America

North America dominated the LV-based cell and gene therapy products market with 48.90% in 2025, due to the presence of well-developed industries. This increased the innovation rates of these products, promoting their clinical trials. Additionally, the presence of a robust healthcare system also increased their use to tackle various chronic diseases, which contributed to the market growth.

Due to growing focus on the development of curative treatment options, the development of the LV-based therapies is increasing across the U.S. At the same time, the growth in investments and funding is also increasing their manufacturing and adoption rates. Moreover, growing collaborations also increased their R&D activities.

Expanding Healthcare Boosts the Asia Pacific

Asia Pacific is expected to host the fastest-growing LV-based cell and gene therapy products market with a 14.40% CAGR during the forecast period, due to the expanding healthcare sector. This is increasing the adoption and R&D of these products, which are backed by government initiatives. Moreover, the growing diseases are also increasing their demand, which is enhancing the market growth.

The industries in China are experiencing a rapid expansion, which is driving the LV-based cell and gene therapy product innovations. At the same time, the growing government initiatives and disease burden are also increasing their demand. Furthermore, the presence of a well-developed healthcare infrastructure is also increasing its use.

Europe Driven by Robust Regulatory Framework

Europe is expected to grow significantly in the LV-based cell and gene therapy products market during the forecast period, due to the robust regulatory framework. This, in turn, is promoting the development of safe and effective LV-based therapies, driving their clinical trials and approvals. New collaborations are also increasing their innovations, promoting market growth.

The presence of robust industries in the UK is increasing the R&D of the LV-based cell and gene therapies. Furthermore, the growing disease burden is also increasing their demand and adoption rates. Similarly, the government initiatives, investments, and regulatory support are also encouraging their innovations.

Market Value Chain Analysis

R&D

• The R&D of the LV-based cell and gene therapy products focuses on stable producer cell lines and in vivo delivery systems to improve their scalability and reduce costs.
• Key players: Oxford Biomedica, Rocket Pharmaceuticals.

Clinical Trials and Regulatory Approvals

• Safety and stability are evaluated in the clinical trials and regulatory approval of the LV-based cell and gene therapy products.
• Key players: bluebird bio, Kyverna Therapeutics.

Patient Support and Services

• Real-time monitoring, travel logistics, and financial assistance are provided in the patient support and services of the LV-based cell and gene therapy products.
• Key players: Novartis, bluebird bio.

Top Vendors and Their Offerings

SWOT Analysis

Strengths

• The LV-based cell and gene therapy products provide long-term effectiveness with improved stability, which is increasing their use.
• The growing efficacy of these therapies is driving the demand and acceptance rates of the CART therapies.
• Moreover, these therapies offer targeted action and curative options for the disease, which is increasing their use.
• The growing chronic diseases are increasing the use of these therapies, encouraging new innovations.

Weaknesses

• Complex manufacturing process acts as the major weakness in the LV-based cell and gene therapy products in the market, which limits their innovations.
• The risk of mutagenesis and immunogenicity is increasing the safety concerns, which restricts their acceptance rates.

Opportunities

• The growing number of rare and genetic diseases is increasing the demand for curative options, which is increasing the demand for LV-based cell and gene therapies.
• The companies are focusing on expanding their applications, which is leading to new collaborations among the industries.
• Similarly, the growing technological innovations are also increasing the advancement in the LV vector designs and target-specific action.
• The expanding manufacturing capabilities and emerging startup ecosystem are also leading to the growth and development of these therapies.

Threats

• High manufacturing cost is the major threat, as the development of the LV-based cell and gene therapies requires sophisticated facilities.
• Stringent regulation increases the time of their development and slows down their innovations and approval rates.

Recent Developments in the Market

• In December 2025, the MT027, which is a B7-H3-targeted CAR-T therapy, was announced to have received U.S. FDA IND clearance for the initiation of its Phase II clinical trial in recurrent glioblastoma (rGBM) patients as per T-MAXIMUM Pharmaceutical.
• In December 2025, a Phase I/IIa clinical study of QT-019B, which is an allogeneic CAR-T therapy for refractory systemic lupus erythematosus (rSLE) treatment, was announced to have been initiated by Qihan Biotech.

Segments Covered in the Report

By Product Type

• LV-based Gene Therapy Products
• LV-based Cell Therapy Products
• Ex vivo LV-modified Cell Therapies
• In vivo LV Gene Therapies

By Therapeutic Area

• Oncology
• Rare Genetic Disorders
• Neurological Disorders
• Cardiovascular Diseases
• Immunological & Inflammatory Diseases

By Indication Type

• Monogenic Disorders
• Acquired Diseases
• Infectious Diseases
• Autoimmune Disorders

By End User

• Pharmaceutical & Biotechnology Companies
• Academic & Research Institutes
• Contract Development & Manufacturing Organizations (CDMOs)
• Hospitals & Specialty Clinics

By Vector Production Type

• GMP-grade Lentiviral Vectors
• Research-grade Lentiviral Vectors

By Region

• North America
  • U.S.
  • Canada 
  • Mexico 
  • Rest of North America
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Europe 
  • Western Europe 
    • Germany 
    • Italy
    • France
    • Netherlands
    • Spain
    • Portugal 
    • Belgium
    • Ireland
    • UK 
    • Iceland 
    • Switzerland
    • Poland
    • Rest of Western Europe
  • Eastern Europe 
    • Austria
    • Russia & Belarus 
    • Türkiye
    • Albania 
    • Rest of Eastern Europe 
• Asia Pacific
  • China 
  • Taiwan
  • India 
  • Japan 
  • Australia and New Zealand
  • ASEAN Countries (Singapore, Malaysia)
  • South Korea 
  • Rest of APAC 
• MEA 
  • GCC Countries
    • Saudi Arabia 
    • United Arab Emirates (UAE)
    • Qatar 
    • Kuwait 
    • Oman 
    • Bahrain 
  • South Africa
  • Egypt 
  • Rest of MEA