Cell and Gene Therapy Manufacturing Isolators Market Future Demand

Revenue, 2025

USD 140.16 Million

Forecast, 2035

USD 321.3 Million

CAGR, 2026-2035

8.65%

Report Coverage

Global

Cell and Gene Therapy Manufacturing Isolators Market Size, Trends and Key Players with Dynamics

The global cell and gene therapy manufacturing isolators market size is expected to be worth around USD 321.3 million by 2035, from USD 140.16 million in 2025, growing at a CAGR of 8.65% during the forecast period from 2026 to 2035.

Volume Table (Units Produced/Installed Globally)

• This table shows the projected volume of cell and gene therapy manufacturing isolators produced and installed globally.
• It estimates the growth in isolator demand as the cell and gene therapy market expands.

The cell and gene therapy manufacturing isolators market is experiencing robust growth, driven by the increasing development of cell and gene therapy (CGT) products, rising investments, and technological advancements. The increasing collaboration among key players enables them to access advanced technologies and manufacture proprietary products. Regulatory agencies and manufacturers make constant efforts to fulfill global patient needs, accelerating CGT manufacturing.

Key Takeaways

• Cell and gene therapy manufacturing isolators sector pushed the market to USD 152.28 million by 2026.
• Long-term projections show USD 321.3 million valuation by 2035.
• Growth is expected at a steady CAGR of 8.65% in between 2026 to 2035.
• North America held a major revenue share of the market in 2025.
• Asia-Pacific is expected to grow at the fastest CAGR in the upcoming years.
• By isolator type, the negative pressure isolators segment dominated the cell and gene therapy manufacturing isolators market in 2025.
• By isolator type, the dual-pressure/flexible isolators segment is expected to grow with the highest CAGR in the market during the studied years.
• By application process, the aseptic processing segment accounted for the highest revenue share of the market in 2025.
• By application process, the viral vector production segment is expected to witness the fastest growth in the market over the forecast period.
• By technology/design feature, the glovebox isolators segment held a dominant revenue share of the cell and gene therapy manufacturing isolators market in 2025.
• By technology/design feature, the restricted-access barrier systems (RABS) segment is expected to grow at the fastest CAGR in the market during the forecast period.
• By end-use facility, the contract development and manufacturing organizations (CDMOs) segment contributed the biggest revenue share of the market in 2025.
• By end-use facility, the academic & research institutes segment is expected to expand rapidly in the market in the coming years.

Quick Facts Table

Sterility at the Core: CGT Manufacturing Isolators

The cell and gene therapy manufacturing isolators market refers to the development and distribution of tailored isolators for large-scale manufacturing of CGT. CGT isolators provide closed environments and enhance sterility by reducing manual intervention and minimizing contamination risks. They offer modular, sterile, automation-compatible environments that support both autologous and allogeneic product manufacturing at clinical sites. They lower facility requirements and enable real-time quality control (QC) testing.

Smart Containment: AI in the Cell and Gene Therapy Manufacturing Isolators Market

Integrating artificial intelligence (AI) into isolators introduces automation and leads to smarter, data-driven manufacturing. AI and machine learning (ML) algorithms transform CGT production by reducing errors, streamlining workflows, and making life-changing therapies more accessible. They enable real-time monitoring of CGT manufacturing, enabling manufacturers to get real-time updates. AI-based predictive analytics allow manufacturers to detect errors and make proactive decisions.

Manufacturing Price Range Table (Manufacturer Selling Price)

Rationale for ranges:

• Lower range reflects basic aseptic isolators used in research/early manufacturing.
• Higher range reflects advanced CGT manufacturing isolators with automation, RABS, and compliance features.

Selling Price Range Table (End‑User Price Including Services/Installation)

Key Considerations:

• End‑user prices include validation, qualification, compliance documentation (IQ/OQ/PQ) a significant cost driver in CGT manufacturing.
• Contract manufacturing adoption accelerates uptake of higher‑end isolators

Trends and Future Outlook in the Market

• Demand for Personalized Medicines: The growing demand for personalized medicines necessitates researchers to develop innovative CGT.
• Technological Advancements: The integration of AI and ML in CGT isolators drives innovation and presents future opportunities for market players.
• Increasing Investments: Government and private organizations provide funding and subsidies to adopt advanced tools in manufacturing facilities.

Collaboration Landscape: Cell and Gene Therapy Manufacturing Isolators Market

• In June 2025, STEMCELL Technologies announced the acquisition of Cellular Highways Ltd. to integrate Cellular Highways’ Highway1 instrument for faster cell sorting in a closed, sterile system through microfluidic vortices.
• In January 2025, Trenchant Biosystems, Inc. and Autolomous collaborated to integrate Autolomous’ autoloMATE digital solution into Trenchant’s automated CGT manufacturing platform.
• In April 2024, Multiply Labs collaborated with GenScript Biotech to introduce the first fully automated solution for bead-based cell isolation phase using Multiply Labs’ cell therapy robotic cluster and GenScript’s cell isolation solution, CytoSinct 1000. 

Global Count of Approved CGT Products

Segmental Insights

Isolator Type Insights

Which Isolator Type Segment Dominated the Market?

The negative pressure isolators segment held a dominant position in the cell and gene therapy manufacturing isolators market in 2025, due to the high demand for operator protection. Negative pressure isolators provide personnel or environmental protection by containing hazardous substances. They minimize airborne toxins from escaping into the cleanroom equipment. The increasing development of highly potent active pharmaceutical ingredients (HPAPIs) potentiates the demand for negative pressure isolators.

Dual-Pressure/Flexible Isolators

The dual-pressure/flexible isolators segment is expected to grow at the fastest CAGR in the market during the forecast period. Dual-pressure/flexible isolators possess the characteristics of both types of isolators, providing superior benefits. They protect products, personnel, and the environment, eliminating the need for different isolators.

Application Process Insights

How the Aseptic Processing Segment Dominated the Market?

The aseptic processing segment held the largest revenue share of the cell and gene therapy manufacturing isolators market in 2025, due to the growing need to prevent contamination. Isolators help maintain sterility throughout the complex, multi-step processes, where terminal sterilization isn’t possible. Closed aseptic systems or isolators offer advantages, such as greater process scalability, robustness, flexibility, and consistency with fewer batch failures. They minimize the risk of cross-contamination with microbes.

Viral Vector Production

The viral vector production segment is expected to grow with the highest CAGR in the market during the studied years. Isolators are increasingly used in viral vector production, especially in aseptic fill-finish procedures. This helps manufacturers maintain the sterility of CGT products and maintain a closed environment throughout their manufacturing. Viral vectors are essential components of gene therapy to deliver modified genes directly to the targeted site.

Technology/Design Feature Insights

Why Did the Glovebox Isolators Segment Dominate the Market?

The glovebox isolators segment contributed the biggest revenue share of the cell and gene therapy manufacturing isolators market in 2025, due to the ability to manipulate processes without human interference. Glovebox isolators enable manufacturers to conduct the desired operations within a controlled microenvironment. They are specifically designed to thwart contamination from the environment or operator. They allow manual handling of the objects with minimal filtration.

Restricted-Access Barrier Systems (RABS)

The restricted-access barrier systems (RABS) segment is expected to expand rapidly in the market in the coming years. The demand for RABS is increasing due to the presence of safety-locked doors, a rigid machine enclosure, and glove ports. RABS are easy to install, easy to validate, and control temperature and humidity across stringent conditions. They also provide full operator protection, minimizing contamination risk from and to the operator.

End-Use Facility Insights

Which End-Use Facility Segment Led the Market?

The contract development and manufacturing organizations (CDMOs) segment led the cell and gene therapy manufacturing isolators market in 2025, due to the presence of favorable infrastructure and increasing collaboration with biotech companies. CDMOs invest heavily in adopting specialized equipment for CGT manufacturing. Large companies collaborate with CDMO to expand their product pipelines, focusing on their core competencies. Small companies can have access to equipment and expertise.

Academic & Research Institutes

The academic & research institutes segment is expected to witness the fastest growth in the market over the forecast period. Academic & research institutions receive funding from the government and private organizations to conduct advanced research. Funding also helps them purchase CGT isolators for experiments focusing on CGT development. The growing research and development activities and the increasing public-private partnerships propel the segment’s growth.

Regional Distribution

• North America registered dominance in the market in 2025.
• The U.S. led the market by capturing the largest revenue share in 2025.
• Asia Pacific is expected to be the fastest-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 significant CAGR during the forecast period.
• The UK is anticipated to grow at a rapid CAGR over the upcoming years.

Which Factors Drive the Market in North America?

North America dominated the global cell and gene therapy manufacturing isolators market in 2025. The availability of a robust manufacturing infrastructure, the presence of key players, and favorable regulatory support are factors that drive the market in North America. Countries like the U.S. and Canada are home to multiple biotech companies that focus on producing innovative CGT products. They adopt advanced technologies, supporting biotech innovation and strengthening their position in the global CGT market.

Key players, such as Thermo Fisher Scientific, Bio-Rad Laboratories, and Akadeum Life Sciences, are major providers of CGT isolators in the U.S. The U.S. conducts the highest number of clinical trials related to CGT. As of December 2025, a total of 513 clinical trials were registered from the U.S. on the clinicaltrials.gov website.

Burgeoning Biotech Sector Promotes Asia-Pacific Growth

Asia-Pacific is expected to witness the fastest growth in the cell and gene therapy manufacturing isolators market during the predicted timeframe. The rising prevalence of chronic disorders, the growing geriatric population, and the increasing awareness of early intervention augment the market. Countries like China, India, Japan, and South Korea have a suitable manufacturing infrastructure due to their favorable geographical location and affordable workforce, encouraging foreign companies to set up their facilities in the region. The increasing emphasis on domestic production of pharmaceutical products and biologics necessitates the use of CGT isolators.

The biotech sector in China is booming at a rapid pace, with evolving regulatory landscapes, government initiatives, and a maturing startup ecosystem. More than 130 companies are estimated to produce CGT products in China. As of 2025, the National Medical Products Administration (NMPA) has approved 5 CAR-T cell therapies in China.

Venture Capital Investment to Drive Europe

Europe is expected to grow at a considerable CAGR in the cell and gene therapy manufacturing isolators market in the upcoming period. European nations are emerging as global hubs for clinical trials and manufacturing of advanced therapy medicinal products (ATMPs). The European Medicines Agency (EMA) regulates the manufacturing and approval of CGTs in Europe. It establishes a favorable regulatory framework to accelerate the development of CGTs. The presence of key biotech companies and the increasing investments also contribute to market growth.

The UK ranks second in Europe in having the largest number of startups for cancer research after France, accounting for 290 companies. Most of the cancer therapeutics’ innovations are in cellular immunotherapy, gene therapy, and image analysis in oncology. The UK also witnessed a surge in equity financing in Q1 2025, reaching £924 million across venture capital and follow-on funding.

Final Regulatory Stretch: Pre-Registration Gene Therapy Pipeline

Top Companies & Their Offerings

SWOT Analysis in the Cell and Gene Therapy Manufacturing Isolators Market

Strengths

• The rising prevalence of genetic or rare disorders leads to an increase in the global patient population base, facilitating large-scale manufacturing of CGT.
• Government organizations launch initiatives to encourage the prevention, diagnosis, and treatment of chronic diseases using advanced biologics.
• Stringent regulatory frameworks facilitate the approval of novel CGTs and the adoption of advanced manufacturing technologies.

Weaknesses

• Several underdeveloped and developing countries lack trained workforces to operate CGT isolators and develop CGT products.
• CGT isolators are relatively expensive, ranging from several hundred thousand to millions of U.S. dollars. This limits the affordability of numerous small- and mid-sized companies.

Opportunities

• Emerging technologies, such as automated closed-system bioreactors and digitalized QC workflows, are increasingly used.
• Strategic coordination among regulators, hospitals, and developers is essential to overcome operational and compliance hurdles.
• Manufacturers adopt harmonized operational standards to ensure product safety and consistency.

Threats

• CGT isolators face technical limitations, such as uncontrollable temperature and the influence of the on/off state of the isolator on the pressure difference in the clean room.
• Developers need to comply with stringent GMP regulations for enhanced product safety.

Recent Developments

• In October 2025, Jubilant HollisterStier LLC launched its New Sterile Fill & Finish line at its Spokane manufacturing facility in the U.S. The new line features advanced isolator technology to deliver enhanced sterility assurance, throughput, and operational precision, accelerating its ability to support complex injectable programs.
• In July 2025, BLOCK Technology announced the development of its prototype system to create a real-time monitoring solution for the aseptic production of gene therapy medicines in isolators. The system leverages advanced methods of image analysis and real-time 3D modeling of the production process.

Segments Covered in the Report

By Isolator Type

• Negative Pressure Isolators
• Dual-Pressure/Flexible Isolators
• Positive Pressure Isolators

By Application Process

• Aseptic Processing
• Viral Vector Production
• Cell Isolation & Harvesting
• Formulation & Fill-Finish
• Cryopreservation & Storage Integration

By Technology/Design Feature

• Glovebox Isolators
• Restricted-Access Barrier Systems (RABS)
• Integrated Monitoring & Automation Isolators
• Single-Use Isolator Systems
• Modular/Skid-Mounted Isolators

By End-Use Facility

• Contract Development and Manufacturing Organizations (CDMOs)
• Academic & Research Institutions
• Pharmaceutical & Biotech Companies
• Hospitals & Clinical Manufacturing Units
• Cell & Gene Therapy Startups

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