Cell and Gene Therapy Manufacturing Market

Market Overview

The global cell and gene therapy manufacturing market size was valued at USD 20.23 billion in 2022. It is estimated to reach USD 95.35 billion by 2031, growing at a CAGR of 18.8% during the forecast period (2023–2031). The anticipated increase in demand for cell and gene therapy manufacturing services is attributed to the implementation of government programs that aim to provide support in this area.

Cell and gene therapy disciplines overlap in biomedical research and treatment. Both treatments can lessen the underlying cause of hereditary and acquired diseases and aim to treat, prevent or cure disorders. Cell therapy seeks to treat diseases by restoring or modifying specific cell populations or using cells to transport therapy throughout the body. Before being administered to the patient, cells are cultivated or modified outside the body as part of cell therapy. The cells may be derived from the patient (autologous) or a donor (allogeneic).

Gene therapy seeks to treat disease by replacing, inactivating, or introducing genes into cells, either within the body (in vivo) or outside of it (ex vivo). Some treatments qualify as both cell and gene therapies. These therapies modify and introduce DNA in specific cell types into the body.

Market Dynamics

Market Drivers

Growing Pipeline of Cell and Gene Therapy

In recent years, the ratio of clinical success to the number of clinical trials has increased due to a greater scientific and clinical understanding of the safety hazards associated with using gene and cell therapy products to treat various diseases. This includes understanding  Cell and Gene Therapyhe pattern of viral vectors, immunogenicity, modified delivery mechanisms, and improved technology. In addition, advancements in manufacturing include improved accuracy of oligo synthesis, new chemistry, manufacturing, and control regulations. Therefore, the cell and gene therapy marketplace has grown tremendously in the past few years.

According to a March 2020 article, there were 289 cell and gene therapies in phase III studies in the United States at the start of 2019 and 362 at the same time in 2020. The number is expected to increase by twofold if the preclinical pipeline is considered. This growing number indicates the high demand for manufacturing services for cell and gene therapies, thereby boosting market expansion.

Supportive Regulatory Bodies

The number of cell and gene therapies going to clinical trials and gaining marketing authorization from regulatory bodies is increasing yearly. By the end of 2019, the U.S. FDA approved 17 cell and gene therapy products for commercial use. It was anticipated by the Food and Drug Administration (FDA) that an annual influx of more than 200 Investigational New Drug applications (INDs) pertaining to gene and cell therapy will be received starting from the year 2020. The regulatory body also plans to approve up to 20 products annually from 2025. Such supportive government initiatives are expected to surge the need for cell and gene therapy manufacturing services soon.

Market Restraint

High Cost of Manufacturing

The high cost of cell and gene therapy manufacturing is a major concern for manufacturers. The cost of manufacturing these nonconventional biologics is significantly more than conventional biologics, such as recombinant proteins and monoclonal antibodies. According to an article published in 2019, manufacturing single gene therapy costs can range between USD 500,000 and USD 1 million, excluding R&D expenditure, clinical trial costs, and commercial infrastructure costs. Such high costs hamper the market growth.

Market Opportunities

Rising Pressure on Drug Developers/Manufacturers

Due to the surging incidence of hereditary disorders and chronic and fatal diseases like cancer and diabetes, rapid and extensive R&D on advanced therapeutics, like cell and gene therapies, is an emerging trend. The market for such advanced therapies is still in its infancy and constantly changing. Owing to the long-term benefits of such novel therapeutic modalities and the potential for transforming patient care and single-dose cures, many pharmaceutical and biopharmaceutical companies exhibit interest in cell and gene therapies to fulfill consumer demand for therapeutics. This further creates opportunities for small biotech and biopharmaceutical firms to enter the market by undertaking various strategies, such as collaborations with global companies and licensing agreements to provide technology.

Currently, the market is witnessing limitations in capacity, with the number of ongoing clinical trials reaching 1,052 by the third quarter of 2019. Therefore, the surge in clinical activity in the cell and gene therapy space is anticipated to increase the number of companies entering this market.

Regional Analysis

Based on region, the global cell and gene therapy manufacturing market is bifurcated into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global cell and gene therapy manufacturing market shareholder and is anticipated to exhibit a CAGR of 18.81% during the forecast period. The dominance of this area can be attributed to the soaring engagement of companies in research and development in gene and cell therapy, along with a significant number of contract development organizations in the region. In addition, homegrown players are expanding their manufacturing facilities in the region. For instance, a US-based pharmaceutical company, Pfizer, expanded its gene therapy production facility in North Carolina. The construction of this facility commenced in 2018 and has been operational since January 2020. Such initiatives are anticipated to expedite market growth in the region.

On the other hand, more than 400 regional companies are actively developing cell and gene therapy products for various diseases. North American region has the highest number of clinical trials in the gene therapy segment. Thus, the region's demand for cell and gene therapy manufacturing is growing, which will aid significant market growth in the coming years.

Europe is predicted to exhibit a CAGR of 16.7% over the forecast period. Growing investments in gene and cell therapy companies across European countries are a major driving factor for the European region's cell and gene therapy manufacturing market. Process development and manufacturing for gene and cell therapies are growing at a constant pace in Europe. Moreover, the European region is at the forefront of providing funds for developing and commercializing cell and gene therapy products and R&D activities. For instance, in January 2019, an international research team received funding of approximately USD 7.7 million from the European Union under the Horizon 2020 research and innovation program for the development of nonviral gene delivery technology. In addition, Apceth Biopharma GmbH and Hitachi Chemical Advanced Therapeutic Solutions signed an agreement with Bluebird Bio in May 2020 to expand production capacity for Lenti-D for CALD. Such initiatives are anticipated to accelerate market growth in the region.

Asia Pacific is estimated to be a growing cell and gene therapy manufacturing market. Asia's cell therapy market has acquired momentum over the past few years. This is due to the establishment of expedited approval pathways, the growth of private and government investments, and the rise in healthcare needs. Besides, unmet needs in personalized medicine drive research for regenerative medicine technologies, leading to increased demand for cell and gene therapy manufacturing services. The availability of funding grants, especially for cell and gene therapy manufacturing, is expected to accelerate market growth further. For instance, in September 2020, Terumo Blood and Cell Technologies announced Advanced Therapy Manufacturing and Innovation (ATMI) Grant 2020 to boost development and manufacturing in the Asia Pacific region.

Latin American region has low cell and gene therapy manufacturing market penetration. However, developing biotechnology and biopharmaceutical industries in Latin American countries are anticipated to increase the region's demand for cell and gene therapy manufacturing. The region is witnessing increasing attention and fast growth in stem cell research. Scientists from several Latin American countries, such as Mexico, Uruguay, Chile, Brazil, and Argentina, are working on stem cell research. Therefore, active engagement in this space is expected to boost market growth. In addition, Latin America is considered a growing market for cell and gene therapy products, as the incidence of chronic diseases is high in Latin American countries, which, in turn, is expected to drive demand for manufacturing services.

In the Middle East, regenerative medicine is used for wound and skin repair, sports medicine, or orthopedics. Compared to these fields, fewer products are available for treating cardiac diseases, cancers, and diabetes. Over the last few years, clinics and hospitals in the region have been showing a growing interest in the cellular therapy space. For instance, in March 2019, Israel-based Sheba Medical and Lonza collaborated to manufacture genetically engineered human CAR-T cells. Lonza provides a manufacturing platform to bolster Sheba's in-house cell manufacturing processes as part of this collaboration. Such collaborative efforts are anticipated to fuel the region's cell and gene therapy manufacturing growth.

Segmental Analysis

The global cell and gene therapy manufacturing market is segmented by therapy type, scale, mode, and workflow.

Based on therapy type, the global market is segmented into cell therapy manufacturing and gene therapy manufacturing. 

The cell therapy manufacturing segment owns the highest market share and is estimated to exhibit a CAGR of 18.2% during the forecast period. With the growing number of ongoing clinical trials and products entering the market, cell therapy is gradually gaining importance in immuno-oncology. Only a few CAR T-cell therapies have been approved by the U.S. FDA. In addition, more than 250 clinical trials studying CAR T-cell therapies and additional cell therapies indicate that potential indications are broadening to include solid and liquid tumors. Thus, the demand for advanced cell manufacturing services will increase in the coming years.

As many cell therapy products are allogeneic and expected to have large market sizes, there is a growing need for commercial-scale production. Large-scale manufacturing of cell therapies includes careful maintenance of cell identity and potency, recovery of functional cells, and inability to sterile filter the final drug product.

Based on the scale, the global market is bifurcated into pre-commercial/R&D scale manufacturing and commercial scale manufacturing. 

The pre-commercial/R&D scale manufacturing segment dominates the global market and is projected to exhibit a CAGR of 6.3% over the forecast period. The pre-commercial manufacturing segment is anticipated to witness healthy growth as the market witnesses more positive data from ongoing clinical trials. As of May 2020, more than 400 companies in North America were actively developing cell and gene therapy products for various diseases. In addition, the number of ongoing clinical trials for advanced therapies increased by more than twofold from 2015 to 2019. At the beginning of 2015, the number of clinical trials was 486, which reached 1,066 by the end of 2019. This growing number indicates the increasing demand for pre-commercial cell and gene therapy manufacturing services.

Furthermore, according to an article published in March 2020, 80% of the currently available CDMO capacity supports the pre-commercial stage. Around 40% of this capacity was being used for academic research. Thus, the pre-commercial manufacturing base for cell and gene therapy products is stronger than the commercial base.

Based on mode, the global market is divided into contract manufacturing and in-house manufacturing. 

The in-house manufacturing segment is the most significant contributor to the market and is estimated to exhibit a CAGR of 17.9% over the forecast period. In-house manufacturing has advantages over contract manufacturing, including ownership of supply channels, greater agility in process troubleshooting, and efficient development of a corporate knowledge base to aid in future in-house scaling. These factors play an important role in manufacturing allogeneic CAR T-cell therapies. Owing to this, Precision BioSciences opened a new center for manufacturing advanced therapies in 2019. This was the first in-house cGMP-compliant manufacturing facility for CAR T-cell therapy products.

Furthermore, in-house manufacturing services are more suitable for speedy clinical trials. The advantages of in-house GMP facilities for a hospital are a rapid supply of products, lower costs, optimal organization, and flexibility in batch planning. Therefore, in-house manufacturing is expected to significantly contribute to the global market share.

Based on workflow, the global market is divided into cell processing, cell banking, process development, fill and finish operations, analytical and quality testing, raw material testing, vector production, and others.

The process development segment is the largest revenue contributor to the market and is expected to exhibit a CAGR of 17.8% over the forecast period. Establishing well-characterized and reliable procedures for producing cell therapies has become more crucial as more treatments move from clinical trials to regulatory approval. Process development solutions increase candidate programs' effectiveness while raising quality and safety standards. In addition, process development can be applied to all process elements, like cell characterization, cell isolation, cell culture media optimization, impurities removal, and scale-up. The Target Product Profile (TPP) is a tool that helps align manufacturing process requirements. After defining the potential therapy, TPP is generated. It includes all elements in the process workflow and encompasses all product aspects, including manufacturing, regulatory, and clinical.

Recent Developments

• August 2023- GeneFab, a biofoundry specializing in contract manufacturing and synthetic biology concentrating on cell and gene therapies, signed an agreement with Senti Biosciences to sublease Senti Bio's cGMP facility. GeneFab would also acquire Senti Bio's chemistry, manufacturing, and controls (CMC) capabilities for approximately USD 38 million.
• August 2023- AGC Biologics expanded its manufacturing facility at the Milan Cell and Gene Center of Excellence. The expansion, which was first announced in 2021, adds 1x50L, 2x200L, and 2x1,000L suspension single-use bioreactors and permits up to 4 iCellis500 adherent single-use bioreactors to meet the needs of future GMP viral vector manufacturing projects.