U.S. Cell And Gene Therapy Manufacturing Market (By Therapy Type: Cell Therapy Manufacturing, Gene therapy manufacturing; By Scale; By Mode; By Workflow) - Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2024-2033

The U.S. Cell and gene therapy manufacturing market size was estimated at around USD 3.91 billion in 2023 and it is projected to hit around USD 43.12 billion by 2033, growing at a CAGR of 27.13% from 2024 to 2033.

Key Pointers

• By Therapy Type, the cell therapy manufacturing segment held the largest revenue share of 57% in 2023.
• By Therapy Type, the gene therapy segment is anticipated to grow at the noteworthy CAGR from 2024 to 2033.
• By Scale, the pre-commercial and R&D scale manufacturing generated the maximum market share of 73% in 2023.
• By Mode, the contract manufacturing segment contributed the largest market share of 66% in 2023.
• By Mode, the in-house manufacturing segment is anticipated to grow at the noteworthy CAGR during the forecast period.
• By Workflow, the process development segment held the largest revenue share of 17% in 2023.

U.S. Cell and Gene Therapy Manufacturing Market Growth Factors

The growth of the U.S. cell and gene therapy manufacturing market is propelled by an advancement in biotechnology and genetic engineering have enabled the development of novel therapies with the potential to address previously untreatable diseases. Additionally, increasing investment from both public and private sectors is driving research and development efforts, leading to a pipeline of innovative cell and gene therapies. Moreover, regulatory initiatives aimed at streamlining approval processes and ensuring product safety are facilitating market growth by expediting the commercialization of new therapies. Furthermore, growing awareness among healthcare providers and patients about the potential benefits of cell and gene therapies is driving demand and adoption. Finally, strategic collaborations between industry players, academic institutions, and regulatory agencies are fostering innovation and knowledge exchange, further fueling market expansion.

U.S. Cell and Gene Therapy Manufacturing Market Trends:

• Increasing Investment: Growing investment from both public and private sectors is driving research and development efforts in cell and gene therapy manufacturing, leading to the emergence of innovative therapies and technologies.
• Advancements in Biotechnology: Rapid advancements in biotechnology and genetic engineering are enabling the development of more sophisticated cell and gene therapies with improved efficacy and safety profiles.
• Regulatory Streamlining: Regulatory initiatives aimed at streamlining approval processes for cell and gene therapies are facilitating market growth by reducing barriers to entry and expediting commercialization timelines.
• Growing Pipeline of Therapies: The expanding pipeline of cell and gene therapies targeting a diverse range of diseases and disorders is fueling market growth and diversification, offering new treatment options for patients.
• Increasing Adoption: Growing awareness among healthcare providers and patients about the potential benefits of cell and gene therapies is driving demand and adoption, particularly for diseases with high unmet medical needs.

U.S. Cell and Gene Therapy Manufacturing Market Challenges

• Regulatory Complexity: The regulatory landscape for cell and gene therapies is complex and evolving, presenting challenges related to compliance, approval processes, and navigating regulatory requirements across different jurisdictions.
• Scalability: Achieving scalable manufacturing processes for cell and gene therapies remains a significant challenge, particularly for autologous therapies that require customized production for each patient. Scaling up production while maintaining product consistency and quality is crucial for meeting market demand and ensuring cost-effectiveness.
• Supply Chain Vulnerabilities: Cell and gene therapy manufacturing relies on a complex global supply chain for raw materials, equipment, and specialized reagents. Vulnerabilities in the supply chain, such as shortages or disruptions, can impact manufacturing timelines, product quality, and patient access.
• Infrastructure and Expertise: Establishing specialized manufacturing facilities and expertise for cell and gene therapies requires substantial investment and resources. Limited availability of qualified personnel, specialized equipment, and infrastructure poses challenges for scaling up production capacity and ensuring consistent manufacturing processes.                                                           

Therapy Type Insights

In 2023, the cell therapy manufacturing segment took the lead in the market, commanding a revenue share of 57%. This dominance is attributed to the escalating number of ongoing clinical trials and the influx of products entering the market, thereby elevating the significance of cell therapy, particularly in immuno-oncology. Despite limited U.S. FDA approvals for CAR T-cell therapies, the landscape is rapidly evolving, with over 250 clinical trials exploring CAR T-cell and other cell therapies across a spectrum of indications, spanning both solid and liquid tumors. Consequently, there is a burgeoning demand for advanced cell manufacturing services anticipated in the forthcoming years, fueled by the projected market expansion of allogeneic cell therapy products. As these products are poised to attain sizable market shares, the imperative for commercial-scale production amplifies.

The gene therapy segment is poised for significant growth throughout the forecast period. With numerous products advancing through clinical trials, there arises a pressing need for enhancements in the production processes within the gene therapy manufacturing domain. Bolstered by heightened investments from industry players and the mounting clinical successes of various products, several gene therapy companies are directing their efforts towards manufacturing and commercialization endeavors. When designing the manufacturing process for gene therapy products, critical considerations include the evaluation of existing processes and their scalability, alongside the strategic determination of in-house versus outsourced manufacturing options.

Scale Insights

In 2023, pre-commercial and R&D scale manufacturing claimed a substantial revenue share of 73%. This dominance is primarily attributed to the rapidly evolving market landscape for cell and gene therapies, which drives innovation in research and development concerning gene and cell therapy. As the market continues to evolve, with more positive data emerging from ongoing clinical trials, the pre-commercial manufacturing segment is poised for further growth. Notably, over 400 companies in North America are actively engaged in the development of cell and gene therapy products targeting various diseases.

Concurrently, the commercial-scale manufacturing segment is forecasted to exhibit the fastest compound annual growth rate (CAGR) during the forecast period. Major biopharmaceutical companies such as Bristol-Myers Squibb (BMS), Novartis AG, and Merck KGaA are making substantial investments in cell and gene therapy programs and manufacturing infrastructure. Leveraging their capabilities, resources, and skilled workforce, these companies can expedite entry into clinical trials and accelerate time to market. Consequently, the market for commercial-scale manufacturing is expected to be propelled by the increasing number of products entering the market through these established players.

Mode Insights

In 2023, the contract manufacturing segment claimed the highest revenue share at 66%. The escalating demand for cell and gene therapies has brought forth challenges related to sufficient manufacturing capacity, thereby creating opportunities for contract manufacturing service providers. As the industry undergoes rapid transformation, outsourcing services are anticipated to provide market participants with a competitive advantage, offering expertise and experience vital for navigating complex manufacturing processes.

Conversely, the in-house manufacturing segment is forecasted to demonstrate the fastest compound annual growth rate (CAGR) during the forecast period. Establishing a small-scale in-house manufacturing facility may be a viable option for gene therapy companies encountering difficulties in securing contract manufacturing service partners or obtaining production time slots within required timelines. However, the associated capital investment for constructing a manufacturing facility tailored to a single cell or gene therapy product can pose challenges for emerging and small pharmaceutical or biotechnology firms.

Workflow Insights

In 2023, the process development segment accounted for a significant revenue share of 17%. This growth is primarily attributed to the increasing number of therapies transitioning from clinical trials to regulatory approvals, thereby driving demand for robust process development methodologies in cell therapy production. The development of efficient and organized processes is crucial for ensuring the safety and quality of candidate programs, thus enhancing their overall profiles.

Concurrently, the vector production segment is poised to register the fastest compound annual growth rate (CAGR) during the forecast period. Viral vectors are witnessing a surge in adoption for the treatment of diverse health conditions, spanning metabolic, muscular, infectious, cardiovascular, hematologic, ophthalmologic, and various types of cancer. Among the widely utilized viral vectors are adenoviral, lentiviral, adeno-associated viral (AAV), retroviral, and herpes simplex virus vectors. Manufacturing viral vectors involves utilizing different cell lines characterized by unique growth and transfection characteristics.

U.S. Cell And Gene Therapy Manufacturing Market Key Companies

• Lonza
• Bluebird Bio Inc.
• Catalent Inc.
• F. Hoffmann-La Roche Ltd
• Samsung Biologics
• Boehringer Ingelheim
• Cellular Therapeutics
• Hitachi Chemical Co., Ltd.
• Takara Bio Inc.
• Miltenyi Biotec
• Thermo Fisher Scientific
• Novartis AG
• Merck KGaA
• Wuxi Advanced Therapies

U.S. Cell and Gene Therapy Manufacturing Market Segmentations:

By Therapy Type

• Cell therapy manufacturing
  • Stem cell therapy
  • Non-stem cell therapy
• Gene therapy manufacturing

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