Cell and Gene Therapy Manufacturing Market Size, Share 2024 To 2033

Cell and Gene Therapy Manufacturing Market Size and Growth 2024 To 2033

The global cell and gene therapy manufacturing market size was accounted at USD 9.23 billion in 2023 and is estimated to reach around USD 98.54 billion by 2033, growing at a compound annual growth rate (CAGR) of 26.71% from 2024 to 2033.

The cell and gene therapy manufacturing market involves the production of innovative therapies that modify genes or cells to treat various diseases, particularly genetic disorders, cancers, and chronic conditions. This market includes the development, scaling, and commercialization of therapies, encompassing complex processes like viral vector production, cell culture, and gene editing. With the growing approval of advanced therapies and increasing investment in biotechnology, the market is rapidly expanding. Key factors driving growth include technological advancements, increased funding, and the rising demand for personalized medicine. Challenges include regulatory hurdles and high production costs.

• “Genezen will acquire uniQure's commercial gene therapy manufacturing operations in Lexington, MA. Steve Favaloro, President and CEO of Genezen, expressed excitement about the acquisition, highlighting the addition of a state-of-the-art, licensed viral vector manufacturing facility as a significant enhancement to their capabilities.”
• ” Bristol Myers Squibb has signed a $380 million deal with Cellares to manufacture CAR T-cell therapies for cancer, reflecting growing demand for outsourced cell therapy manufacturing. Cellares, which raised $255 million in Series C funding in August 2023 with BMS as an investor, will produce these therapies.”
• “Ori Biotech introduced its IRO® cell and gene therapy manufacturing platform at ISCT 2024 in Vancouver. The next-generation platform aims to address current manufacturing challenges in CGT by enhancing efficiency and scalability, marking a significant advancement in the industry.”

Report Highlights

• By region, the North America region has dominated the market by holding revenue share of 47.9% in 2023.
• By region, The Asia Pacific is experiencing significant growth by generating market revenue share of 19.63% in 2023.
• By scale, The pre-commercial/ R&D scale manufacturing segment has reported highest revenue share of 73.24% in 2023.
• By therapy type, In 2023 the cell therapy type segment has captured revenue share of 60.2%.
• By mode, The Contract manufacturing segment has registered highest revenue share of 66.5% in 2023.

Cell and Gene Therapy Manufacturing Market Growth Factors

• Advancements in Gene Editing Technologies: Breakthroughs in gene editing technologies, such as CRISPR-Cas9, are revolutionizing cell and gene therapy manufacturing. These advancements enable more precise modifications of genes, enhancing the effectiveness and safety of therapies, thereby driving market growth.
• Increased Funding and Investment: Growing interest from venture capitalists, pharmaceutical companies, and government agencies is fueling significant investment in cell and gene therapy manufacturing. This financial backing supports research, clinical trials, and the commercialization of new therapies, accelerating market expansion.
• Rising Prevalence of Chronic Diseases: The increasing incidence of genetic disorders, cancers, and chronic diseases is boosting demand for innovative treatments. Cell and gene therapies offer promising solutions for conditions with limited treatment options, propelling the market forward as more therapies gain regulatory approval.
• Regulatory Support and Accelerated Approvals: Regulatory agencies like the FDA and EMA are providing support through fast-track designations and orphan drug status for cell and gene therapies. These accelerated approval processes encourage innovation and bring new treatments to market more quickly, contributing to market growth.
• Expansion of Manufacturing Capabilities: The rapid expansion of manufacturing infrastructure, including new facilities and advanced bioprocessing technologies, is enabling the production of complex cell and gene therapies at scale. This scalability is critical for meeting growing demand and reducing costs, further driving market growth.

Cell and Gene Therapy Manufacturing Market Trends

• Integration of Single-Use Technologies: The adoption of single-use technologies in cell and gene therapy manufacturing is on the rise. These disposable systems offer flexibility, reduce contamination risks, and lower operational costs by eliminating the need for extensive cleaning and sterilization processes. This trend supports more agile and cost-effective production, particularly for small-batch or personalized therapies.
• Growing Focus on Personalized Medicine: The market is increasingly focusing on personalized cell and gene therapies tailored to individual patients' genetic profiles. This trend is driving advancements in manufacturing techniques that enable customization at scale, meeting the rising demand for therapies that address specific patient needs and offer improved outcomes.
• Regenerative Medicine Applications: The expanding field of regenerative medicine presents a significant opportunity for cell and gene therapy manufacturing. As research progresses in areas like tissue engineering and stem cell therapy, manufacturers can explore new applications for their technologies, addressing unmet medical needs in areas such as wound healing, organ repair, and degenerative diseases.
• Technological Innovation in Viral Vector Production: Innovations in viral vector production offer a substantial opportunity for growth. As viral vectors are crucial for delivering genetic material in gene therapies, improving production efficiency, scalability, and safety can significantly enhance the availability and affordability of these therapies, opening new markets and expanding treatment options.

Report Scope

Cell and Gene Therapy Manufacturing Market Dynamics

Drivers

Shift Toward Automation and Digitalization:

• The cell and gene therapy manufacturing market is increasingly embracing automation and digital technologies to enhance production efficiency and ensure consistent quality. Automation reduces the risk of human error, while digital tools like data analytics and AI improve process monitoring and optimization, driving more reliable and scalable manufacturing.

Adoption of Allogeneic Therapies:

• There is a growing trend toward the development and adoption of allogeneic cell therapies, which use donor cells that can be mass-produced and stored for off-the-shelf use. This shift offers the potential for broader patient access, reduced costs, and streamlined production compared to autologous therapies, which are patient-specific.

Restraints

High Production Costs:

• The complex and resource-intensive nature of cell and gene therapy manufacturing results in significantly high production costs. From the need for specialized facilities and equipment to the labour-intensive processes involved in ensuring product safety and efficacy, these costs can limit the accessibility of therapies, restraining market growth and posing challenges for scaling up production.

Complex Regulatory Landscape:

• Navigating the complex and evolving regulatory landscape for cell and gene therapies is a significant restraint. The stringent requirements for safety, quality, and efficacy, coupled with variations in regulatory frameworks across different regions, can lead to delays in product approval and commercialization. This complexity adds to development costs and timelines, making market entry challenging for new players.

Opportunities

Emerging Markets:

• Expanding into emerging markets presents a significant growth opportunity for cell and gene therapy manufacturers. Countries in Asia-Pacific and Latin America are investing in biotechnology and healthcare infrastructure, offering a fertile ground for market entry and expansion, especially as regulatory frameworks in these regions evolve to support advanced therapies.

Collaboration and Partnerships:

• The growing complexity of cell and gene therapy manufacturing creates opportunities for strategic collaborations between biotech companies, academic institutions, and contract manufacturing organizations (CMOs). These partnerships can accelerate innovation, share expertise, and optimize production processes, leading to faster commercialization and market penetration of new therapies.

Challenges

Supply Chain Management:

• Managing the supply chain for cell and gene therapy manufacturing presents a significant challenge. These therapies often require highly specialized materials, such as viral vectors and specific cell lines, which must be sourced, transported, and stored under strict conditions. Any disruption or delay in the supply chain can impact production timelines and therapy quality, making efficient and reliable supply chain management critical but difficult.

Scalability of Manufacturing Processes:

• Scaling up manufacturing processes for cell and gene therapies is a complex challenge. Unlike traditional pharmaceuticals, these therapies often require individualized production, making it difficult to achieve economies of scale. Additionally, maintaining consistent quality and efficacy during scale-up can be problematic, particularly when moving from small-scale clinical production to large-scale commercial manufacturing.

Cell and Gene Therapy Manufacturing Market Segmental Analysis

Therapy Type Analysis

Cell Therapy: Cell therapy involves the administration of living cells to treat or cure diseases. These cells can be derived from the patient (autologous) or a donor (allogeneic). In the manufacturing market, the trend is toward improving scalability and automation to meet growing demand. The cell therapy segment has generated highest market share of 60.2% in 2023. Innovations in cell expansion, cryopreservation, and quality control are driving market growth, alongside the development of off-the-shelf allogeneic therapies, which offer broader patient accessibility.

Gene Therapy: Gene therapy focuses on modifying or replacing defective genes to treat genetic disorders and diseases. This segment is witnessing advancements in viral vector production, which is crucial for delivering therapeutic genes. Trends include the shift towards more efficient and safer vectors, such as adeno-associated viruses (AAVs), and the rise of ex vivo gene editing techniques. Regulatory support and increasing clinical success are also boosting the market for gene therapy manufacturing. This segment has acquired market share of 39.8% in 2023.

Application Analysis

Oncology: Oncology in cell and gene therapy targets cancers through therapies like CAR-T, modifying patient cells or introducing therapeutic genes to target cancer. Growth is driven by CAR-T therapy approvals and personalized treatments, with ongoing research to overcome tumor resistance.

Cardiovascular Diseases: Therapies for cardiovascular diseases focus on regenerating heart tissue or enhancing function through cell and gene modification. Innovations in stem cells and gene editing are advancing treatments, with emphasis on improving delivery methods and outcomes.

Neurological Disorders: This segment involves therapies for neurological conditions like Parkinson’s and Alzheimer’s, aiming to restore or replace damaged neurons. Increased focus on gene therapy and overcoming blood-brain barrier challenges, with promising clinical trial results.

Ophthalmic Disorders: Cell and gene therapies for eye conditions aim to repair or replace retinal cells to restore vision. Growth driven by successful gene therapy approvals and advancements in gene delivery techniques for various eye disorders.

Rare Diseases: Targeting genetic disorders with therapies that address the underlying genetic causes of rare diseases. Expanding due to orphan drug designations and targeted therapies, with a focus on long-term efficacy and safety.

Infectious Diseases: Developing therapies to combat infections by enhancing immune responses or targeting pathogens’ genetic material. Accelerated by the COVID-19 pandemic, with innovative approaches like CRISPR-based antivirals gaining attention.

Others: Includes therapies for conditions like autoimmune diseases and metabolic disorders, focusing on immune modulation or tissue repair. Expanding as researchers explore diverse applications, driven by advances in gene editing and stem cell technology.

Scale Analysis

Pre-commercial/ R&D Scale Manufacturing: Pre-commercial or R&D scale manufacturing involves small-scale production focused on developing and validating cell and gene therapies. Trends in this segment include increased investment in early-stage research, advancements in cell culture technologies, and the use of automated systems to streamline R&D processes. This phase is crucial for proving feasibility and optimizing manufacturing processes before transitioning to larger-scale production. This segment has reported dominating market share of 73.24% in the year of 2023. 

Commercial Scale Manufacturing: Commercial scale manufacturing refers to large-scale production intended for widespread distribution and commercial use of cell and gene therapies. Trends include the expansion of manufacturing facilities, adoption of advanced technologies for increased efficiency, and implementation of robust quality control measures. As therapies move from clinical trials to market, scaling up processes while maintaining consistency and regulatory compliance is a key focus. The commercial scale manufacturing segment has confirmed market share of 26.76% in 2023.

Workflow Analysis

Cell Processing: Cell processing involves the isolation, activation, and expansion of cells for therapy. Trends include advancements in automated cell processing technologies that enhance efficiency and reduce variability. The cell processing semgment has accounted market share of 15.57% in 2023. The shift towards personalized medicine is driving the need for scalable, high-throughput cell processing solutions to meet growing demand.

Cell Banking: Cell banking refers to the long-term storage of cells for future use, ensuring their viability and integrity. Trends include the use of advanced cryopreservation techniques and automated systems to improve cell quality and reduce contamination risks. This segment has captured market share of 14.28% in 2023. Increasing regulatory requirements are also driving improvements in cell banking practices.

Process Development: Process development encompasses designing and optimizing manufacturing processes for cell and gene therapies. Current trends focus on enhancing process efficiency and scalability through innovations in bioprocessing and automation. There is also a growing emphasis on developing robust, reproducible processes to meet regulatory standards and reduce production costs. The process development segment has registered market share of 17.81% in the year of 2023.

Fill & Finish Operations: Fill & finish operations involve the final steps of product formulation, including filling, capping, and packaging. Trends include the adoption of advanced aseptic filling technologies and automated systems to ensure high-quality, contamination-free products. There is a growing demand for flexible, scalable solutions to accommodate varying production volumes. This segment has covered market share of 13.88% in 2023.

Analytical and Quality Testing: Analytical and quality testing ensures the safety, efficacy, and consistency of cell and gene therapies. Trends include the integration of advanced analytical technologies, such as high-throughput sequencing and real-time PCR, to enhance testing accuracy and efficiency. The analytical and quality testing segment has achieved market share of 12.8% in 2023. There is a growing focus on ensuring compliance with stringent regulatory standards.

Raw Material Testing: Raw material testing involves evaluating the quality and safety of materials used in therapy production. Trends include increased use of rigorous testing methods and traceability systems to ensure material consistency and reduce risks. Enhanced regulatory scrutiny is driving improvements in raw material testing protocols. The raw material testing segment has calculated 8.93% market share in 2023.

Vector Production: Vector production involves creating viral vectors used to deliver therapeutic genes into cells. Trends include the development of more efficient and scalable vector production methods, such as cell-based and cell-free systems. Advances in vector engineering are improving delivery efficiency and reducing production costs. This segment has recorded market share of 10.93% in 2023.

Others: "Others" includes additional processes and technologies that support cell and gene therapy manufacturing, such as logistics, supply chain management, and data management. The others segment has captured market share of 5.8% in 2023. Trends in this segment focus on improving overall operational efficiency and integrating digital solutions to streamline manufacturing workflows and enhance data integration.

Cell and Gene Therapy Manufacturing Market Regional Analysis

Why North America is leading in the cell and gene therapy manufacturing market?

North America leads in the cell and gene therapy manufacturing market due to advanced technological infrastructure and significant investments in R&D. U.S market size is estimated to reach around USD 37.76 billion by 2033 increasing from USD 4.48 billion in 2024 with a CAGR of 24.68%. The U.S. and Canada are at the forefront of clinical trials and regulatory approvals, with a growing emphasis on personalized medicine and innovative manufacturing techniques. Increased collaboration between biotech firms and contract manufacturing organizations (CMOs) is also driving growth. North America market size is expected to reach around USD 47.20 billion by 2033 increasing from USD 5.60 billion in 2024 with a CAGR of 26.94%.

Why Asia Pacific is experiencing significant growth in the cell and gene therapy manufacturing market?

The Asia-Pacific region is witnessing rapid expansion in cell and gene therapy manufacturing due to increasing investments, a growing patient population, and advancements in biotechnology. Asia Pacific market size is calculated at USD 2.30 billion in 2024 and is projected to grow around USD 19.34 billion by 2033 with a CAGR of 30.17%. Countries like China and Japan are focusing on scaling up production capabilities and improving access to cutting-edge therapies. Regulatory advancements and government support for biotech industries are also key growth drivers.

Europe Cell and Gene Therapy Manufacturing Market Trends

Europe is experiencing growth in cell and gene therapy manufacturing driven by supportive regulatory frameworks and funding initiatives from the European Union. The region is focusing on expanding manufacturing capabilities and enhancing cross-border collaborations to streamline production and access to therapies. Additionally, Europe is a hub for innovative research in gene editing and cell therapies. Europe market size is measured at USD 2.98 billion in 2024 and is expected to grow around USD 25.08 billion by 2033 with a CAGR of 25.45%.

LAMEA Cell and Gene Therapy Manufacturing Market Trends

In the LAMEA(Latin America, Middle East, and Africa) region, cell and gene therapy manufacturing is expanding slowly due to emerging market dynamics and improving healthcare infrastructure. Growth is driven by increasing healthcare investments and rising awareness of advanced therapies. U.S market size is estimated to reach around USD 37.76 billion by 2033 increasing from USD 4.48 billion in 2024 with a CAGR of 24.68%. There is a growing emphasis on building local manufacturing capabilities and partnerships to meet regional healthcare needs and regulatory requirements.

Global Cell and Gene Therapy Manufacturing Market Top Companies

• Novartis AG
• Gilead Sciences, Inc.
• Bluebird Bio, Inc.
• Kite Pharma, Inc. (A Gilead Company)
• Editas Medicine, Inc.
• Celyad Oncology SA
• Celgene Corporation 
• Sangamo Therapeutics, Inc.
• MaxCyte, Inc.
• Kite Pharma, Inc. 
• Takeda Pharmaceutical Company Limited
• Bristol-Myers Squibb Company
• Miltenyi Biotec GmbH
• Inovio Pharmaceuticals, Inc.
• Medigene AG

Companies like Orgenesis Inc. and Poseida Therapeutics, Inc. are emerging in the cell and gene therapy market, focusing on innovative technologies such as advanced gene editing and scalable manufacturing processes. These firms are leveraging novel approaches to address specific therapy challenges and enhance production efficiency. Novartis AG and Gilead Sciences, Inc. lead the market through their extensive portfolios and robust R&D investments. Novartis excels with its Kymriah product, while Gilead dominates with Yescarta, benefiting from established manufacturing capabilities and regulatory expertise.

Recent Developments

• In 2022, Thermo Fisher Scientific acquired PeproTech, a leading manufacturer of recombinant proteins like growth factors and cytokines, for USD 1.85 billion. This acquisition enhances Thermo Fisher's portfolio in cell and gene therapy with advanced protein production capabilities.
• In 2022, Charles River Laboratories acquired Cognate BioServices, a cell and gene therapy CDMO, to expand its manufacturing capabilities. This acquisition strengthens Charles River's position in the cell and gene therapy market by enhancing its production and development capabilities.
• In 2021, Thermo Fisher Scientific acquired Henogen S.A., Novasep's viral vector manufacturing business in Belgium, for approximately USD 859.7 million. This acquisition enhances Thermo Fisher's capabilities in the cell and gene therapy market by expanding its viral vector production capacity.

Market Segmentation

By Therapy Type

• Cell Therapy
  
  • Autologous Cell Therapy
  • Allogeneic Cell Therapy
• Gene Therapy
  
  • In Vivo Gene Therapy
  • Ex Vivo Gene Therapy

By Application

• Oncology
  
  • Hematologic Cancers
  • Solid Tumors
• Cardiovascular Diseases
• Neurological Disorders
• Ophthalmic Disorders
• Rare Diseases
• Infectious Diseases
• Others

By Scale

• Pre-commercial/ R&D scale manufacturing
• Commercial scale manufacturing

By Mode

• Contract manufacturing
• In-house manufacturing

By Workflow

• Cell processing
• Cell banking
• Process development
• Fill & finish operations
• Analytical and quality testing
• Raw material testing
• Vector production
• Others

By Regions

• North America
• APAC
• Europe
• LAMEA