The global cell and gene therapy manufacturing market size is expected to be worth around US$ 67.4 billion by 2030, according to a new report by Vision Research Reports.
The global cell and gene therapy manufacturing market size is expected to be worth around US$ 67.4 billion by 2030, according to a new report by Vision Research Reports.
The global cell and gene therapy manufacturing market size was valued at US$ 16.1 billion in 2020 and is anticipated to grow at a CAGR of 20.10% during forecast period 2021 to 2030.
Growth Factors
An exponential rise in clinical pipeline coupled with a rising number of regulatory approvals for advanced therapies has majorly driven the market.
Considering promising growth opportunities in the contract development of cellular and gene-modified therapies, market participants are making focused efforts to boost their market presence. Also, bio manufacturers are signing strategic alliances with contract manufacturers to accelerate the R&D of their candidate programs. Rising demand for CMOs/CDMOs services has led to the entry of several new players as well as expansion of product development capabilities, thereby positively impacting market revenue.
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Several novel methods are being introduced to advance cell and gene therapy manufacturing. For instance, the manufacturers are exploring the potential of single-use technology in production workflows. This technique is gaining increasing attention in this arena to speed the development process while reducing the overall cost and production timeline. Such technological advancements in space are anticipated to bolster market growth in the coming years.
Report Highlights
The cell therapy manufacturing segment dominated the market for cell and gene therapy manufacturing and accounted for the largest revenue share of 58.0% in 2020. The growth is owing to the high number of ongoing clinical trials and the increasing number of products entering the marketplace. More than 250 clinical trials focusing on CAR T cell therapies and other are studied to decipher the potential of cell therapies for the treatment of various cancer indications. Furthermore, allogeneic CAR T cell therapies are receiving traction as a more profitable business by biopharma companies, compared to existing manufacturing and business models.
Owing to the low immunogenicity, tissue repair capabilities, and immunosuppressive properties of mesenchymal stem cells, the implantation of allogeneic MSCs serves as a promising tool for the development of cell-based therapy. Furthermore, process automation is considered a suitable option to reduce the costs and time required for large-scale manufacturing of cell therapies. Such technological evolution to advance therapy manufacturing is anticipated to greatly benefit the growth of the market for cell and gene therapy manufacturing.
Since the first U.S. FDA approval for gene therapy in 2017, this space is growing at a tremendous pace. With the increased investments from the operating entities coupled with the clinical success of these products, many gene therapy companies are focusing on the manufacturing and commercialization of their products. The key manufacturers are undertaking various strategic initiatives to bolster their presence in the gene therapy manufacturing market space.
The pre-commercial/ R&D scale manufacturing segment dominated the market for cell and gene therapy manufacturing and accounted for the largest revenue share of 73.0% in 2020. This can be attributed to the strong and constantly growing pipeline of cell and gene therapies across the globe. As of March 2020, more than 1,000 clinical trials are underway for various cell therapies. Furthermore, according to the Journal of Gene Medicine, the number of gene therapy clinical trials has reached 3,025 as of 2019. This high number depicts the growing demand for manufacturing services in pre-clinical stage product candidates.
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The recent outbreak of SARS-CoV-2 is expected to positively impact the growth of this segment. According to the U.S. FDA official, the regulatory agency is receiving an increased number of applications for the use of cell therapies to treat COVID-19. For instance, in June 2021, Cartesian Therapeutics has initiated the recruitment for the clinical trial of its RNA cell therapy, Descartes-30 for COVID-19 Related ARDS.
Supportive regulatory bodies are playing a crucial role in driving the market for commercial upstream manufacturing. As of July 2020, the U.S. FDA has approved 18 cellular and gene therapy products for commercial production and use. The regulatory body has expected to receive over 200 gene and cell therapy INDs annually from the beginning of 2020 and planning to approve up to 20 products per year from 2025. Such advances in the segment are anticipated to drive the commercial scale manufacturing segment.
The in-house manufacturing segment dominated the market for cell and gene therapy manufacturing and accounted for the largest revenue share of 85.0% in 2020. The presence of a substantial number of companies with large capital, as well as academic institutes with personalized patient treatment programs is the largest contributor to this segment. Greater agility in process troubleshooting, ownership of supply channels, and efficient development of a corporate knowledge base to help future in-house scale-up are key factors accelerating segment growth.
The rising popularity of advanced therapies has intensified market competition among players. Cell therapy manufacturing companies and CDMOs are signing contracts and deals to speed up their product development and gain a competitive edge. Also, ongoing clinical research initiatives have fueled the revenue generation for the contract manufacturing segment. Besides, 65% or more of the cell and gene therapy manufacturing process is outsourced, in turn, supporting segment growth.
Small biotech firms developing cell and gene therapies lack resources, infrastructure, and capacity leading to strategic alliances with contract manufacturers. This has propelled the market growth in this segment. In addition, the investments in this space are expanding 30-35% per year further driving the market.
The process development segment dominated the market and accounted for the largest revenue share of 17.0% in 2020. With the 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.
On the other hand, owing to the high penetration of manufacturing services in vector production space, this segment is expected to witness the fastest growth throughout the forecast period. The viral vectors have been employed for the treatment of various diseases such as cardiovascular, metabolic, hematologic, muscular, infectious diseases, and ophthalmologic and different types of cancer indications.
CDMOs and bio manufacturers such as Thermo Fisher Scientific, Lonza, Merck KGaA, and others are investing a significant amount to expand their viral vector capabilities and meet the changing market demands. For instance, on 15th June 2021, French CDMO Yposkesi invested USD 71 Million to expand its viral vector production capacity. The company announced its plans to build a second commercial gene and cell therapy manufacturing plant.
North America dominated the cell and gene therapy manufacturing market and accounted for the largest revenue share of 43.0% in 2020. A substantial number of ongoing clinical trials coupled with the rising engagement of companies in the R&D of gene and cell therapy is the major driving factor for regional market growth. North America pegged the first rank for exhibiting the highest number of gene therapy clinical trials with the presence of more than 400 companies in the region actively engaged in the development of cell and gene therapy products for various diseases.
In Europe, multiple new collaborative research and innovation projects were launched, under Horizon 2020 initiative. These projects include viral vector-based gene therapy trials for rare conditions. This is expected to drive the growth of cell and gene therapy manufacturing services across the European nations. A strong facility network coupled with a strong workforce in European countries is anticipated to further fuel the market growth.
Key Players
- Thermo Fisher Scientific
- Merck KGaA
- Lonza
- Catalent Inc.
- Takara Bio Inc.
- F. Hoffmann-La Roche Ltd
- Wuxi Advanced Therapies
- Samsung Biologics
- BoehringerIngelheim
- Novartis AG
- Hitachi Chemical Co., Ltd.
- Cellular Therapeutics
- MiltenyiBiotec
- Bluebird Bio Inc.
Market Segmentation
- Therapy Type Outlook
- Cell Therapy Manufacturing
- Stem Cell Therapy
- Non-Stem Cell Therapy
- Gene Therapy Manufacturing
- Cell Therapy Manufacturing
- Scale Outlook
- Pre-commercial/ R&D Scale Manufacturing
- Commercial Scale Manufacturing
- Mode Outlook
- Contract Manufacturing
- In-house Manufacturing
- Workflow Outlook
- Cell Processing
- Cell Banking
- Process Development
- Fill & Finish Operations
- Analytical And Quality Testing
- Raw Material Testing
- Vector Production
- Others
- Regional Outlook
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East Africa (MEA)
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