Cell And Gene Therapy CDMO Market Size, Share & Trends Analysis Report By Phase (Pre-clinical, Clinical), By Product Type (Gene Therapy, Gene-Modified Cell Therapy, Cell Therapy), By Indication (Oncology, Infectious Diseases), By Region, And Segment- Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2024-2033

The global Cell And Gene Therapy CDMO market size was estimated at USD 5.90 billion in 2023 and is projected to hit around USD 69.11 billion by 2033, growing at a CAGR of 27.9% during the forecast period from 2024 to 2033.

Key Takeaways:

• North America accounts for the largest share of 40.18% in 2023.
• Asia Pacific, on the other hand, is anticipated to register a lucrative CAGR of 29.1% during the forecast period.
• The oncology segment dominated the cell and gene therapy CDMO market and held the largest revenue share of 49.11% in 2023.
• On the other hand, the rare diseases segment is anticipated to witness a lucrative CAGR of 28.5% during the forecast
• The pre-clinical segment held the largest revenue share of 66.3% in 2023
• The clinical segment is anticipated to witness a considerable CAGR of 27.15% during the analysis period.
• The cell therapy segment dominated the market and held the largest revenue share of 41.9% in 2023.
• The gene-modified cell therapy segment, on the other hand, is anticipated to witness a lucrative CAGR of 28.9% during the analysis period.

Market Overview

The Cell and Gene Therapy CDMO (Contract Development and Manufacturing Organization) market has become an essential and dynamic component of the biopharmaceutical industry, driven by the explosive growth in demand for personalized, regenerative, and precision medicine. Contract manufacturers serve as vital enablers for biotech firms by offering a range of services including process development, scale-up, analytical testing, GMP manufacturing, and regulatory support. As cell and gene therapies (CGTs) progress from clinical to commercial stages, the complexities involved in their development and manufacturing necessitate a specialized, compliant, and scalable infrastructure—precisely the capabilities that CDMOs are equipped to provide.

Unlike traditional pharmaceuticals, CGTs involve highly sensitive biological materials that require bespoke handling, cold chain logistics, and contamination-free environments. CDMOs not only bridge this gap for emerging biotechs lacking the capital to build in-house facilities but also allow large pharmaceutical companies to maintain agile, decentralized supply chains. As of 2024, the market has shown strong momentum, buoyed by an increasing number of clinical trials, favorable regulatory initiatives, and high-profile therapy approvals like Luxturna and Zolgensma. Major pharmaceutical players are forging strategic partnerships or acquiring CDMOs to internalize capabilities and reduce time-to-market.

As investment in CGT R&D continues to soar and more therapies enter late-stage trials, the global CDMO landscape is rapidly evolving, characterized by technological innovation, geographical expansion, and an arms race for production capacity.

Major Trends in the Market

• Integration of AI and automation technologies for improving process efficiency and predictive quality control.

• Surging demand for viral vector production, especially AAV and lentivirus, due to the growing number of gene therapies.

• Rise of modular and flexible manufacturing facilities that allow CDMOs to adapt quickly to diverse client needs.

• Increased outsourcing by biotechs owing to capital constraints and focus on core competencies.

• Mergers and acquisitions involving large pharmaceutical companies and niche CDMOs.

• Adoption of single-use bioreactors and closed-system processing to minimize contamination and streamline operations.

• Expansion into emerging markets to reduce manufacturing costs and support clinical trials in Asia-Pacific and Latin America.

• Capacity expansion initiatives led by CDMOs to cater to the commercial-scale production of late-stage therapies.

Cell And Gene Therapy CDMO Market Report Scope

Key Market Driver: Rising Clinical Pipeline for Cell and Gene Therapies

One of the most significant drivers for the Cell and Gene Therapy CDMO market is the ever-growing clinical pipeline of advanced therapies. With over 2,000 cell and gene therapy candidates in various stages of development worldwide, CDMOs are increasingly seen as indispensable partners in bridging the gap between scientific discovery and market delivery. This spike in clinical activity is not only restricted to major pharmaceutical players but also includes a surge in emerging biotechs, particularly those focused on rare diseases and oncology. The increasing number of Phase I and II trials has fueled demand for pre-clinical and clinical manufacturing services, including vector production, fill-finish operations, and process development. CDMOs equipped with GMP-compliant facilities and regulatory expertise offer biotech firms the agility and scalability required to manage the complexity of early-stage development and accelerate their timelines to commercialization.

Key Market Restraint: Limited Viral Vector Manufacturing Capacity

Despite the promising growth, one of the most pressing restraints in the market is the global shortage of viral vector manufacturing capacity. Viral vectors such as adeno-associated viruses (AAV) and lentiviruses are critical components for gene delivery in most in-vivo and ex-vivo therapies. However, their production is technically complex, requires specialized equipment, and must meet stringent quality standards. This bottleneck is further exacerbated by limited global manufacturing infrastructure, long lead times, and high batch-to-batch variability. The scarcity of skilled workforce trained in viral vector bioprocessing adds to the challenges. These capacity constraints can delay clinical timelines, increase development costs, and pose risks to therapy accessibility, especially for smaller biotechs without privileged access to CDMO partnerships.

Key Market Opportunity: Expansion of Commercial Manufacturing Services

The commercial landscape for CGTs is evolving rapidly, creating a strong opportunity for CDMOs to expand their commercial manufacturing services. As more therapies receive FDA and EMA approvals, the need to transition from small-scale clinical manufacturing to large-scale commercial production becomes paramount. CDMOs that can offer integrated, end-to-end solutions ranging from process development to commercial supply, regulatory submissions, and logistics are becoming preferred partners. Companies like Lonza, Catalent, and Thermo Fisher Scientific are making strategic investments in commercial-scale facilities and digital infrastructure to support the shift. Moreover, CDMOs that can deliver flexible batch sizes, real-time data monitoring, and faster turnaround times will be well-positioned to capitalize on the burgeoning market.

Segmental Analysis

By Phase

The clinical phase segment dominates the Cell and Gene Therapy CDMO market, primarily due to the large number of therapy candidates progressing through Phase I and II trials. CDMOs play a crucial role during this stage, offering support in process scale-up, GMP production, quality control, and regulatory compliance. Given the delicate nature of CGTs, CDMOs also ensure robust documentation and validation protocols, helping companies meet FDA and EMA requirements. Clinical trials in areas like oncology and rare diseases often involve patient-specific autologous therapies, making CDMO involvement even more critical. The emergence of allogeneic approaches has further expanded the clinical scope, necessitating customized and scalable solutions from manufacturing partners.

The pre-clinical phase is the fastest-growing segment, driven by the surge in early-stage biotech startups and academic research projects. Startups exploring novel CRISPR-based therapies, gene silencing mechanisms, and new viral vector platforms often lack internal infrastructure and expertise, making them reliant on CDMO support. CDMOs that offer flexible and rapid prototyping capabilities, as well as specialized process development labs, are seeing increased demand. Additionally, the expansion of venture capital funding in biotech is enabling early-stage firms to outsource sophisticated development tasks, further fueling growth in this segment.

By Product Type

Gene-modified cell therapy leads the market, especially CAR T-cell therapies, due to their effectiveness in treating hematological cancers like leukemia and lymphoma. CDMOs supporting these therapies offer a range of specialized services including apheresis, transduction, and cryopreservation. The personalized nature of CAR-T therapies requires a high level of precision and speed, making CDMO capabilities essential for both clinical and commercial supply. Companies like WuXi Advanced Therapies and Charles River are heavily invested in CAR-T manufacturing solutions.

Gene therapy, particularly in-vivo therapies, is the fastest-growing segment, propelled by the increasing approvals and clinical trials for genetic disorders, retinal diseases, and neuromuscular conditions. These therapies often rely on viral vectors delivered directly into the patient’s body, posing unique challenges in vector production and purity. CDMOs are ramping up AAV production capabilities to meet this demand. Moreover, technological advancements in synthetic biology and non-viral delivery methods are expected to further enhance the scalability of in-vivo gene therapies.

By Indication

Oncology remains the dominant indication, owing to the massive investment and clinical activity surrounding cancer immunotherapies. CAR-T, CAR-NK, and TCR-T therapies are at the forefront, with over 500 active trials globally. CDMOs supporting oncology indications must ensure rapid turnaround, tight cold chain logistics, and compliance with stringent regulatory standards. Given the personalized nature of these therapies, speed and reliability are paramount. The success of therapies like Kymriah and Yescarta has paved the way for broader oncology-focused CDMO services.

Rare diseases are emerging as the fastest-growing indication, driven by orphan drug incentives and increasing interest from biotechs in targeting previously untreatable conditions. The U.S. FDA’s Orphan Drug Designation (ODD) and Regenerative Medicine Advanced Therapy (RMAT) statuses are accelerating development timelines. CDMOs involved in rare disease programs must offer highly customizable and small-batch solutions. As many rare disease therapies are gene-based, demand for vector manufacturing and analytical testing has skyrocketed. The opportunity here is immense, especially for CDMOs that can deliver quality with speed.

Regional Analysis

North America dominates the Cell and Gene Therapy CDMO market, primarily led by the United States, which is home to the highest number of CGT clinical trials, a mature regulatory framework, and a high concentration of CDMOs. States like Massachusetts, California, and North Carolina are hubs for advanced therapy manufacturing, supported by proximity to academic institutions and biotech clusters. The FDA’s progressive stance and funding initiatives like the NIH's support for gene therapy trials have created a favorable environment. Leading CDMOs headquartered in North America, such as Catalent, Thermo Fisher, and Resilience, continue to expand capacity to meet domestic and international demand.

Asia-Pacific is the fastest-growing region, fueled by increasing government investment in biotech infrastructure, a rising number of clinical trials, and growing outsourcing from Western pharma companies. Countries like China, South Korea, and Japan are aggressively investing in CGT capabilities, offering cost-effective solutions and regulatory streamlining. Chinese CDMOs such as WuXi AppTec have expanded internationally and are now key players in the global market. Moreover, favorable regulatory reforms and growing local demand for CGTs are expected to bolster APAC’s position further.

Key Cell And Gene Therapy CDMO Companies:

• Lonza
• Catalent, Inc
• Cytiva
• Samsung Biologics
• Thermo Fisher Scientific Inc.
• Novartis AG
• WuXi AppTec
• AGC Biologics
• OmniaBio
• Rentschler Biopharma SE
• Charles River Laboratories

Recent Developments

• March 2024: Catalent announced a $300 million investment in expanding its gene therapy manufacturing site in Maryland, with plans to add new suites for AAV production.

• February 2024: Thermo Fisher Scientific completed the acquisition of a viral vector CDMO in Texas, enhancing its capabilities in gene therapy manufacturing.

• January 2024: Lonza entered a strategic agreement with a U.S.-based biotech company to supply GMP-grade viral vectors for a next-generation in-vivo gene therapy.

• November 2023: WuXi Advanced Therapies launched a new CAR-T cell therapy manufacturing facility in Pennsylvania, equipped with automated cell processing systems.

• September 2023: Charles River Laboratories acquired a viral vector-focused CDMO in Europe to expand its global service offerings for gene-modified therapies.

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Cell And Gene Therapy CDMO market.

By Phase 

• Pre-clinical
• Clinical

By Product Type 

• Gene Therapy
  • Ex-vivo
  • In-vivo
• Gene-Modified Cell Therapy
  • CAR T-cell Therapies
  • CAR-NK Cell Therapy
  • TCR-T Cell Therapy
  • Other
• Cell Therapy

By Indication 

• Oncology
• Infectious Diseases
• Neurological Disorders
• Rare Diseases
• Others

By Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa (MEA)