Cell And Gene Therapy Manufacturing Market is Rising Rapidly

The global cell and gene therapy manufacturing market size was evaluated at USD 9.95 billion in 2023 and is expected to attain around USD 106.03 billion by 2033, growing at a CAGR of 26.7% from 2024 to 2033.North America accounted for the highest revenue share of 48.32% in 2023.

Global Cell and Gene Therapy Manufacturing Market Overview

Cell and gene therapy manufacturing stands at the forefront of medical innovation and is poised to revolutionize the treatment landscape for various diseases. This cutting-edge field harnesses the power of cellular and genetic engineering to develop personalized and targeted therapies, holding immense promise for addressing unmet medical needs.

Unlike traditional pharmaceuticals, these therapies involve manipulating patients’ own cells or genes to combat diseases at their root causes. Convergence of advanced biotechnology, precision medicine, and manufacturing expertise has paved the way for these therapies to become a reality, with remarkable successes observed in conditions such as cancer and genetic disorders.

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Key Takeaways:

• North America accounted for the highest revenue share of 48.32% in 2023.
• Asia Pacific is anticipated to be a growing market for cell and gene therapy manufacturing. The region accounted for a 21.11% revenue share in 2023
• The cell therapy manufacturing segment dominated the market with a revenue share of 60.19% in 2023.
• The gene therapy segment is expected to expand by a significant CAGR during the forecast period.
• The pre-commercial/R&D scale manufacturing segment captured a significant revenue share of 73.34% in 2023.
• The commercial-scale manufacturing segment is projected to have the highest CAGR during the forecast period.
• The contract manufacturing mode segment held the highest revenue share of 67.13% in 2023.
• The in-house manufacturing segment is likely to register a considerable CAGR during the forecast period.
• On the basis of workflow, the process development segment accounted for a significant revenue share of 17.57% in 2023.
• The vector development segment is estimated to register the fastest CAGR during the forecast period.

The exponential progress of the clinical pipeline, coupled with a rising number of regulatory approvals for advanced therapies, which has majorly driven the growth of the market.

Significant investments by government authorities and key market players are other factors fueling the growth of cell and gene therapy manufacturing. Around USD 2.3 billion was invested in gene therapies by companies over the last decade. Major service providers, including CDMOs/CMOs and in-house manufacturers, consider these therapies as an active area of investment. For instance, in May 2020, Thermos Fisher Scientific also invested USD 180 million to scale up its viral vector manufacturing capacity twofold. These players are investing significant amounts either in building and/or expanding manufacturing capabilities or forming strategic alliances with competitors to boost their market presence. Thus, these factors are anticipated to act as primary driving factors for this market.

The number of cell and gene therapies entering clinical trials and later gaining marketing authorization from regulatory bodies is increasing every year. By the end of 2019, 17 cell and gene therapy products were approved by the U.S. FDA for commercial use. The U.S. FDA is expecting to receive over 200 gene and cell treatment INDs annually from the beginning of 2020. The regulatory body is also planning to approve up to 20 products per year from 2025. Such supportive government initiatives are expected to increase the demand for cell and gene therapy manufacturing services in the near future.

Following an article published in March 2020, in the U.S., the number of cell and gene therapies in the pipeline (phase III trials) was 289 at the beginning of 2019, which reached 362 in early 2020. The number is expected to increase twofold if the preclinical pipeline is considered. This growing number indicates the high demand for manufacturing services for cell and gene therapies. According to a report by America’s Biopharmaceutical Companies, gene and cell therapies range from early to late stages of clinical development with a focus on a wide spectrum of diseases, including neurologic conditions, genetic disorders, and cancer.

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Regional Insights

The U.S cell and gene therapy manufacturing Market size reached USD 4.10 billion in 2023 and is projected to hit around USD 45.46 billion by 2033, expanding at a CAGR of 27.2% during the forecast period from 2024 to 2033.

North America accounted for the highest revenue share of 48.32% in 2023. This can be attributed to the growing engagement of entities in research and product development in gene and cell therapy, coupled with a substantial number of contract development organizations in the region. In addition, homegrown companies are expanding their manufacturing facilities in the region.

Asia Pacific is anticipated to be a growing market for cell and gene therapy manufacturing. The region accounted for a 21.11% revenue share in 2023 and is estimated to witness the fastest growth with a significant CAGR from 2024 to 2033. Over the past several years, the cell therapy market has gained momentum in Asia. This can be attributed to the establishment of accelerated approval pathways, increasing healthcare needs, and growing private and government investments.

Segments Insights:

Therapy Type Insights

The cell therapy manufacturing segment dominated the market with a revenue share of 60.19% in 2023. The higher market share is attributed to the increasing number of products entering the marketplace and the high number of ongoing clinical trials. More than 360 clinical trials focusing on CAR-T cell therapies and other cell-based therapies are being studied to decipher the potential of these therapies for the treatment of various disease indications. Thus, the demand for advanced therapy manufacturing services is expected to increase in the coming years.

The gene therapy segment is expected to expand by a significant CAGR during the forecast period. With a large number of products currently in clinical trials, production process improvement has become a major need for the gene therapy manufacturing market. With an increase in investments from players and the clinical success of more products, several gene therapy companies are focusing on manufacturing and commercialization. Evaluating the existing process and its scalability, as well as for deciding on in-house or outsourced manufacturing, are some of the major factors to be considered while designing the manufacturing process for gene therapy products. Some of the key global companies are undertaking various strategic initiatives to boost their presence in the gene therapy manufacturing market. For instance, in September 2020, Pfizer collaborated with Vivet Therapeutics to manufacture Wilson’s disease candidate.

Scale Insights

The pre-commercial/R&D scale manufacturing segment captured a significant revenue share of 73.34% in 2023. Certain factors such as the robust and constantly growing pipeline of gene and cell therapies along with the rise in investments are expected to have a positive impact on the segment growth. Till 2022, more than 2,073 clinical trials were ongoing for various cell therapies. Furthermore, according to an article published in September 2021, over 200 gene therapies are under clinical trials, which could translate to up to 40 new products being approved for clinical use in the next decade.

The commercial-scale manufacturing segment is projected to have the highest CAGR during the forecast period. With the increasing number of regulatory approvals for gene and cell therapy products, the demand for commercial production of these therapies is increasing rapidly. The major market players such as Thermo Fisher Scientific and AGC Biologics are undertaking various strategic initiatives to fulfill the changing market demands. For instance, in February 2022, Thermo Fisher Scientific launched new Patheon Commercial Packaging Services for cell and gene therapy across the U.S. and Europe. This integrated solution combines logistics, serialization compliance, and distribution globally. Such factors are expected to offer a favorable environment for segment growth by 2033.

Mode Insights

The contract manufacturing mode segment held the highest revenue share of 67.13% in 2023. With the growing demand for cell and gene therapies, the shortage of manufacturing capacity is creating growth opportunities for contract manufacturing service providers. As the market for cell and gene therapies is non-standardized and rapidly changing, outsourcing to a contract manufacturing service provider is expected to provide a competitive advantage in terms of experience and expertise. According to an article published in March 2020, approximately 35% of the process is outsourced with traditional biologics and more than 65% of the manufacturing process for cell and gene therapies is outsourced. This can be attributed to the fact that around two-thirds of the innovation in this space is achieved by small firms that lack the capacity, expertise, and resources for the commercialization of these products. The constantly growing clinical pipeline is another contributing factor expected to accelerate segment growth.

The in-house manufacturing segment is likely to register a considerable CAGR during the forecast period. The academic institutes with personalized patient treatment programs, as well as the presence of a substantial number of entities with large capital, are the largest contributors to this segment. Moreover, advantages over contract manufacturing are also expected to boost segment growth. Small biotechnology companies developing cell and gene therapies lack resources, capacity, and infrastructure, leading to strategic partnerships with contract manufacturers. This factor is expected to boost segment growth in the coming years. Moreover, the investments in this area are expanding by 30-35% per year, further propelling the market growth.

Workflow Insights

On the basis of workflow, the process development segment accounted for a significant revenue share of 17.57% in 2023. With an increasing number of therapies advancing from clinical trials to regulatory approval, the development of well-characterized and robust methods for cell therapy production has become increasingly important. Process development strategies provide efficiency while improving the quality and safety profiles of candidate programs. Process development can be applied to all process elements, such as cell characterization, cell isolation, optimization of cell culture media, removal of impurities, and scale-up.

The vector development segment is estimated to register the fastest CAGR during the forecast period. The high penetration of manufacturing services in this space is the major factor contributing to the segment growth. With a growing market for gene therapies, the demand for viral vectors is increasing. Viral vectors have been used for the treatment of various disorders, such as metabolic, cardiovascular, muscular, infectious, hematologic, and ophthalmologic, as well as various types of cancer. The most widely used viral vectors are adenoviral, retroviral, AAV, lentiviral, and herpes simplex virus.

Key Developments in Global Cell and Gene Therapy Manufacturing Market

• In July 2023, MaxCyte and Vittoria Biotherapeutics entered into a strategic platform license to propel advancements in next-generation cellular therapies. Under the terms of the agreement, Vittoria would obtain non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation technology and ExPERT platform. In return, MaxCyte is entitled to receive platform licensing fees and program-related revenue.
• In March 2023, Thermo Fisher Scientific, Inc. and the University of California, San Francisco (UCSF) teamed up to expedite the development of advanced cell therapies for challenging medical conditions such as cancer, rare diseases, and other ailments. This collaboration involves the utilization of a newly established cGMP bio-manufacturing facility located near the UCSF Medical Center’s Mission Bay campus.

Each of these players has been profiled in the cell and gene therapy manufacturing market research report based on parameters such as company overview, financial overview, business strategies, product portfolio, business segments, and recent developments.

Key Companies & Market Share Insights

The key entities in the market are undertaking several strategic initiatives such as licensing, partnership, and mergers and acquisitions to expand their market presence. Over the last few years, the market witnessed various remarkable mergers and acquisitions. For instance, in January 2022, Thermo Fisher acquired PeproTech, a manufacturer of recombinant proteins such as growth factors and cytokines, for USD 1.85 billion:

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

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

By Region

• North America
• Europe
• Asia-Pacific
• Latin America

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