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Cell and Gene Therapy Infrastructure Market Growth Forecast 2025 to 2034

Cell and Gene Therapy Infrastructure Market Ignites Global Expansion

The cell and gene therapy infrastructure market is growing due to advances in gene editing technology and the increasing prevalence of genetic and chronic diseases. North America is dominant in the market due to the robust public and private spending.

Category: Therapeutic Area Insight Code: 6301 Format: PDF / PPT / Excel

Cell and Gene Therapy Infrastructure Market Size, Key Players with Growth and Forecast

The cell and gene therapy infrastructure market is on an upward trajectory, poised to generate substantial revenue growth, potentially climbing into the hundreds of millions over the forecast years from 2025 to 2034. This surge is attributed to evolving consumer preferences and technological advancements reshaping the industry.

The cell and gene therapy infrastructure market is growing because of increasing government approval, increasing demand for advanced therapies, and increasing awareness among people of genetic diseases, which increases the demand for cell and gene therapy infrastructure. North America dominated as growing government support in healthcare solutions, while the Asia Pacific is the fastest growing, with increasing partnerships with contract research organizations and advancements in technology.

Key Takeaways

  • By region, the North America segment was dominant in the cell and gene therapy infrastructure market in 2024.
  • By region, the Asia Pacific segment is expected to be the fastest-growing over the forecast period, 2025 to 2034.
  • By therapy type, the gene-modified cell therapy segment was dominant in 2024.
  • By therapy type, the gene therapy segment is expected to be the fastest-growing over the forecast period, 2025 to 2034.
  • By infrastructure component, the manufacturing facilities segment was dominant in 2024.
  • By infrastructure component, the supply chain & logistics segment is expected to be the fastest-growing over the forecast period, 2025 to 2034.
  • By delivery model, the centralized manufacturing & delivery segment was dominant in 2024.
  • By delivery model, the hybrid models segment is expected to be the fastest-growing over the forecast period, 2025 to 2034.
  • By end user, the biotech & pharmaceutical companies segment was dominant in the cell and gene therapy infrastructure market in 2024.
  • By end user, the contract development and manufacturing organizations (CDMOs) segment is expected to be the fastest-growing over the forecast period, 2025 to 2034.

What is Europe Cell and Gene Therapy?

The cell and gene therapy infrastructure market is expanding as this infrastructure has massive potential to offer innovative treatments for complex health conditions, and rapid advancements in gene-editing technology. Cell and gene therapies significantly improve patient outcomes and reduce the ongoing burden on the healthcare system. More than 6,000 diseases could be significantly treated by cell and gene therapies, affecting more than 350 million people globally. Cell and gene therapy (CGT) infrastructure refers to the whole multifaceted network of services, services, tools, and technology required to research, manufacture, develop, and deliver these modern therapies.

Cell and Gene Therapy Infrastructure Market Outlook

  • Industry Growth Overview: Between 2025 and 2030, the market is expected to grow, driven by the requirement for infrastructure for research, delivery, and development. This is experiencing fast growth, with a focus on treating and potentially curing diseases such as cancer and genetic disorders.
  • Sustainability Trends:  Sustainability and environmental considerations are significant for the long-term success of the cell and gene therapy sector. By tolerant energy-efficient technologies, lowering plastic waste, enhancing logistics, and partnering in industry-wide initiatives, CGT corporations reduce their environmental impact.
  • Major Investors: Major investors include pharmaceutical companies, biotechnology firms, venture capital firms, investment firms, government bodies, and funds. This includes Novartis, Gilead Sciences, and Bristol-Myers Squibb.

What is the role of AI in the Market?

AI-driven technologies enable the advancement of a new therapy through the R&D value chain in different stages, including payload design optimization, target identification, translational and clinical development, and end-to-end (E2E) digitization. AI-driven technology in gene therapy efficacy and safety prediction by participating in different datasets. It constructs predictive models to assess treatment results.

AI and analytics are altering CGT production by lowering challenges, streamlining workflows, and making life-changing therapies accessible.  This includes leveraging AI-driven algorithms to analyse genetic data and predict drug responses, eventually leading to more efficient and tailored treatment approaches. AI-driven technology delivers substantially greater efficacies in cell and gene therapy manufacturing and allows more patients to benefit from significant treatments, which contributes to the growth of the cell and gene therapy infrastructure market.

Market trends

Increasing biotech approval to high-performance biomanufacturing, such as cell and gene therapies, contributes to the growth of the market.

For instance, 

  • In September 2024, the Union Cabinet approved the proposal ‘BioE3 Policy for Fostering High-Performance Biomanufacturing’ of the Department of Biotechnology. BioE3 Policy, the Union Cabinet also merged three schemes of the Science & Technology Ministry into a single scheme, called Vigyan Dhara, with a financial outlay of Rs 10,579 crore until 2025-26.

Increasing multi-state initiatives to enhance access to cell and gene therapies, which drive the growth of the market.

For Instance,

  • In July 2025, the Centers for Medicare & Medicaid Services Search company has launched a groundbreaking multi-state initiative to improve access to gene therapies for sickle cell disease, addressing the significant barriers that have limited patient uptake of these transformative but expensive treatments since their approval. The Centers for Medicare & Medicaid Services unveiled a new outcomes-based payment model with 33 states to expand Medicaid access to gene therapies for sickle cell disease.

Government Approval for Cell and Gene Therapy Infrastructure in 2025

Company Approval
Integra Therapeutics The company successfully closed a €10.7 million pre-Series A funding round in September 2025 to develop its gene writing platform for CAR-T therapies.
Akadeum Life Sciences Closed a $20 million+ financing round in June 2025, led by Michigan Capital Network, to advance its cell separation technology.
Isomorphic Labs The AI drug discovery company, which partners with major pharmaceutical firms, secured $600 million in financing in April 2025.

Segmental Insights

Why the Gene-Modified Cell Therapy Segment Dominated the Market?

In therapy type, the gene-modified cell therapy segment led the cell and gene therapy infrastructure market, as this type of used to treat, prevent, or manage certain inherited disorders, like cystic fibrosis, alpha-1 antitrypsin deficiency, hemophilia, beta thalassemia, and sickle cell disease. They also used to treat cancers or infections, including HIV. Genetic engineering of stem cells can be effective for cumulative cell survival when transplanted, specifically into an aggressive environment. They modified to deliver proteins to neighbouring cells, reduce graft-host rejection, or kill cancer cells.

On the other hand, the gene therapy segment is projected to experience the fastest CAGR in the cell and gene therapy infrastructure market from 2025 to 2034, as it provides a novel hope for people with genetic health conditions. It has the power to target the root cause of a disease. Gene therapy has massive potential to remove and prevent genetic diseases, like cystic fibrosis, and is a possible cure for heart disease, cancer, and AIDS. For gene therapy to be recognised as a permanent cure for any disorder, it has to be confirmed that the therapeutic DNA introduced into the target cells experiences expression for long and the cells expressing the therapeutic DNA are long-lived and stable.

Why the Manufacturing Facilities Segment Dominated the Market?

By infrastructure component, the manufacturing facilities segment led the cell and gene therapy infrastructure market in 2024, as manufacturing facilities such as academic medicine serve to advance the scientific field and offer the highest quality of medical care. Hospital-driven Good Manufacturing Practice (GMP) facilities, which support mainly investigator-initiated clinical trials, are progressively involved in integration with industry. Cell and gene therapy clinical development impacts downstream progress to commercialization and patient access.

On the other hand, the supply chain & logistics segment is projected to experience the fastest CAGR in the cell and gene therapy infrastructure market from 2025 to 2034, as cell and gene therapies use rapid manufacturing processes to enhance production and delivery efficacy and avoid spoilage.  It widely extends product shelf life as compared to refrigerated storage. Increase effectiveness by orchestrating the cell or gene therapy supply chain. In a limited time supply chain diminutions warehousing needs diminish, spoilage concerns, inventory valuation, and increase the flow of therapies and resulting in more effective, lean manufacturing techniques.

Why the Centralized Manufacturing and Delivery Segment Dominated the Market?

By delivery model, the centralized manufacturing & delivery segment led the cell and gene therapy infrastructure market in 2024, as centralized manufacturing benefits from a recognized supply chain. Centralized manufacturing allows businesses to take advantage of economies of scale. Combining production in a single facility often leads to inferior production expenses per unit. Bulk buying of raw materials, efficient production processes, and effective utilization of resources result in price savings.

On the other hand, the hybrid models segment is projected to experience the fastest CAGR from 2025 to 2034, as this drug delivery model creates an opportunity for novel technologies in a wide range of applications. The significant advantages of hybridization are to eliminate biological obstacles in the delivery of medicines. The design of hybrid gene delivery agents encompassing both virally derived and synthetic materials shows a promising strategy for the development of safe and efficient gene therapy vectors.

Why the Biotech & Pharmaceutical Companies Segment Dominated the Market?

By end-user, the biotech & pharmaceutical companies segment led the cell and gene therapy infrastructure market in 2024, as cell and gene therapy infrastructure provides many advantages to the major healthcare companies, such as lower cost, quick supply of manufactured products in response to medical demand, and optimal organization and transport of cellular material. These therapies precisely eliminate or even replace a targeted gene by application of vectors to deliver novel genetic material. It provides convenience to cell collection services and manufacturing capabilities.

On the other hand, the contract development and manufacturing organizations (CDMOs) segment is projected to experience the fastest CAGR from 2025 to 2034, as CDMO efficiently manages labor, operations, materials, and quality of manufacturing cell and gene therapy, resulting in well cost control for drug manufacturers. Outsourcing CGT production to CDMOs enables companies to save expenses by removing the requirement to build in-house infrastructure. CDMO digital alteration is reshaping how cell and gene therapies (CGT) are produced. These therapies have emerged with ground-breaking potential and unprecedented difficulty.

Regional Insights

Why is North America dominant in the Market?

North America is dominant in the cell and gene therapy infrastructure market in 2024, due to an increasing robust public and private investment, strong regulatory support and government frameworks, and an impenetrable ecosystem of biotech firms and research institutions. Rising government support, such as organizations like the National Institutes of Health (NIH), awards major grants to speed up research into gene-editing technologies and various CGT applications, which contributes to the growth of the market.

For Instance,

  • In October 2025, Matica Biotechnology, Inc., a U.S.-based Contract Development and Manufacturing Organization (CDMO) specializing in cell and gene therapies (CGT), announced that it had secured over 10 new manufacturing projects in the first half of 2025. The new projects span preclinical to commercial stages and reflect growing demand from a diverse range of biotech companies, from foundations, emerging startups, to publicly traded firms.

U.S. Cell and Gene Therapy Infrastructure Market Trends

In the U.S. significant spending, scientific innovations, and supportive government initiatives.  Recent innovations in gene-editing tools such as CRISPR, next-generation viral vectors, and non-viral delivery systems, which drive the growth of the market.

In April 2025, Global pharmaceutical company Novartis announced a $23 billion investment plan over the next five years to build and expand its healthcare infrastructure in the U.S. The move aims to ensure that all key Novartis medicines for U.S. patients are manufactured domestically.

Canada Cell and Gene Therapy Infrastructure Market Trends

Canada has strong government support and a robust research ecosystem for advanced healthcare manufacturing. This country is developing as a significant player, with its commercialization infrastructure, specifically in healthcare manufacturing, which drives the growth of the market.

In March 2025, OmniaBio’s expanded facility in Hamilton seeks to drive a 5X increase in manufacturing efficiency while reducing production and supply costs by up to 50%, facilitating patient access to life-saving treatments for chronic diseases, including cancer.

Why is Asia Pacific the fastest-growing region in the Cell and Gene Therapy Infrastructure Market?

Asia Pacific is the fastest-growing region in the cell and gene therapy infrastructure market in the forecast period, due to the presence of a large aging population base, which increases the innovation ecosystem in healthcare. Major countries in the Asia Pacific, such as China, Japan, South Korea, and Singapore, have established dedicated funding to accelerate CGT development, driving the growth of the market. This expansion is with increased investments and specialized regulatory frameworks. For instance, South Korea created a $1.3 billion fund to help the sector, which contributes to the growth of the market.

For instance,

  • In March 2025, Bharat Biotech International Limited (BBIL), a pioneer in affordable indigenous vaccine development and manufacturing, announced its foray into Cell & Gene Therapy (CGT) & Viral Vector Production at Genome Valley - expanding its expertise from vaccine innovation to leading-edge regenerative and personalised therapies that promise hope for millions.

Cell and Gene Therapy Infrastructure Market – Value Chain Analysis

R&D

The research and development (R&D) process involves emerging robust and scalable manufacturing processes, confirming stringent quality control, and integrating advanced technologies to meet government requirements

Key Players: Novartis and CRISPR Therapeutics

Clinical Trials

The infrastructure for cell and gene therapy (CGT) clinical trials contributes complex, multi-stage methods that bridge preclinical research with human application. These trials need a highly specialized structure and a robust operational framework, from advancing the therapy in a lab to obtaining government approval

Key Players: Krystal Biotech and Intellia Therapeutics

Patient Services

The patient services processes in cell and gene therapy (CGT) infrastructure are extremely specialized and span the complete patient journey, from initial diagnosis to long-term follow-up.

Key Players: Atara Biotherapeutics and Bluebird Bio

Top Vendors and their Offering

  • Catalent Cell & Gene Therapy.: Catalent Cell Therapy provides gene-to-patient integrated solutions for cell therapy development and manufacturing.
  • Lonza: Lonza has significantly expanded its end-to-end manufacturing capabilities to support emerging modalities like mRNA/LNP and microbial-based therapies.
  • WuXi Advanced Therapies: It allows the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies.
  • Thermo Fisher Scientific: It supports cell and gene therapy developers across 15 global sites that offer development, manufacturing, and supply chain services.
  • Charles River Laboratories:  It extensively works in cell and gene therapy manufacturing, as well as end-to-end discovery and development expertise, and provides institutional knowledge.

Top Companies in the Cell and Gene Therapy Infrastructure Market

  • BioLife Solutions
  • TrakCel
  • Vineti
  • Cryoport Systems
  • Be The Match BioTherapies
  • Longevity BioImaging
  • Ori Biotech
  • Miltenyi Biotec
  • Akron Biotech
  • BioSpherix
  • Cellino
  • QuickSTAT
  • Lonza Bioscience
  • Marken
  • SHL Medical

 Recent Developments in the Cell and Gene Therapy Infrastructure Market

  • In July 2025, CMS announced that 33 states, along with the District of Columbia and Puerto Rico, will be participating in the CGT Access Model. Of these, seven states and the District of Columbia have applied for and been awarded Cooperative Agreement funding.
  • In October 2025, Mytos, a biotechnology company automating cell manufacturing, today announced the launch of its automated contract development and manufacturing organization (CDMO) offering, to overcome one of regenerative medicine’s greatest bottlenecks: scalable, affordable manufacturing of stem cell-derived therapies.

Segments Covered in the Report

By Therapy Type

  • Gene-Modified Cell Therapy (e.g., CAR-T, TCR-T, NK cells)
  • Gene Therapy (in-vivo and ex-vivo)
  • Stem Cell Therapy
  • Tissue Engineering

By Infrastructure Component

  • Manufacturing Facilities (GMP-compliant facilities, clean rooms)
  • Supply Chain & Logistics (cold chain, cryopreservation)
  • Quality Control & Testing Laboratories
  • IT & Data Management Platforms (supply chain orchestration, traceability)
  • Automation & Robotics

By Delivery Model

  • Centralized Manufacturing & Delivery
  • Decentralized/Point-of-Care Manufacturing
  • Hybrid Models

By End User

  • Biotech & Pharmaceutical Companies
  • Contract Development and Manufacturing Organizations (CDMOs)
  • Research Institutes & Academic Hospitals
  • Hospitals & Treatment Centers

By Region 

  • North America
    • U.S.
    • Canada
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Thailand
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Sweden
    • Denmark
    • Norway
  • Latin America
    • Brazil
    • Mexico
    • Argentina
  • Middle East and Africa (MEA)
    • South Africa
    • UAE
    • Saudi Arabia
    • Kuwait

Tags

  • Last Updated: 13 October 2025
  • Report Covered: [Revenue + Volume]
  • Historical Year: 2021-2023
  • Base Year: 2024
  • Estimated Years: 2025-2034

Meet the Team

Kesiya Chacko is an accomplished market research professional with over 4+ years of experience in the healthcare industry, known for delivering actionable insights and strategic analysis that empower healthcare organizations.

Learn more about Kesiya Chacko

Aditi Shivarkar is a seasoned professional with over 14 years of experience in healthcare market research. As a content reviewer, Aditi plays a critical role in ensuring the quality and accuracy of all market insights and data presented by the research team.

Learn more about Aditi Shivarkar

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FAQ's

The cell and gene therapy infrastructure market is expected to reach new heights by 2034, driven by technological breakthroughs and changing consumer preferences.

North America is currently leading the cell and gene therapy infrastructure market due to extensive research and development (R&D) investments.

Some key players include Ori Biotech, Miltenyi Biotec, Akron Biotech, BioSpherix, Cellinoand QuickSTAT.

Cell and gene therapy are cutting-edge medical approaches that treat diseases by altering or replacing the genes within a patient cells or by introducing healthy cells to the body.

Ministry of Health and Family Welfare, FDA, WHO, PIB, CDC.