The global cell and gene therapy manufacturing market size is expected to reach USD 47.1 billion by 2030, according to a new report by Grand View Research, Inc. The market is expected to register a CAGR of 26.6% from 2023 to 2030 owing to 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.
Cell And Gene Therapy Manufacturing Market Report Highlights
- The cell therapy manufacturing segment dominated the 2022 market in terms of revenue. A growing number of ongoing clinical trials and increasing research in this space has resulted in the segment dominance
- A high number of candidate molecules in the pre-commercial scale stage has contributed to the largest revenue share for the pre-commercial scale manufacturing market segment in 2022
- With an increasing number of regulatory approvals for gene and cell therapy products, the demand for commercial production of these therapies is increasing rapidly, thereby increasing the share of the commercial-scale manufacturing segment
- The contract manufacturing segment is expected to witness lucrative growth during the forecast period, as a substantial number of biomanufacturers are turning to CMOs for efficient and rapid product development
- Moreover, the constantly growing clinical pipeline is another contributing factor expected to accelerate contract manufacturing segment growth
- North America dominated the global market in terms of revenue owing to advancements in research and development pertaining to gene therapy and the increasing number of investments by the regional governments
- The Asia Pacific region is anticipated to grow at the fastest rate throughout the forecast period
- This can be attributed to the establishment of accelerated approval pathways, growing private and government investments, and increasing healthcare needs
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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, Thermo 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.
List of Key players in the Cell And Gene Therapy Manufacturing Market
- Lonza
- Bluebird Bio Inc.
- Catalent Inc.
- Hoffmann-La Roche Ltd.
- Samsung Biologics
- Boehringer Ingelheim
- Cellular Therapeutics
- Hitachi Chemical Co., Ltd.
- Bluebird Bio Inc.
- Takara Bio Inc.
We have segmented the global cell and gene therapy manufacturing market on the basis of therapy type, scale, mode, workflow, and region.
Cell And Gene Therapy Manufacturing Therapy Type Outlook (Volume, Number of Doses; Revenue, USD Million, 2018 - 2030)
- Cell therapy manufacturing
- Gene therapy manufacturing
Cell And Gene Therapy Manufacturing Scale Outlook (Volume, Number of Doses; Revenue, USD Million, 2018 - 2030)
- Pre-commercial/ R&D scale manufacturing
- Commercial scale manufacturing
Cell And Gene Therapy Manufacturing Mode Outlook (Volume, Number of Doses; Revenue, USD Million, 2018 - 2030)
- Contract manufacturing
- In-house manufacturing
Cell And Gene Therapy Manufacturing Workflow Outlook (Volume, Number of Doses; Revenue, USD Million, 2018 - 2030)
- Cell processing
- Cell banking
- Process development
- Fill & finish operations
- Analytical and quality testing
- Raw material testing
- Vector production
- Others
Cell And Gene Therapy Manufacturing Regional Outlook (Volume, Number of Doses; Revenue, USD Million, 2018 - 2030)
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East Africa (MEA)
Research Methodology
We employ a comprehensive and iterative research methodology focused on minimizing deviance in order to provide the most accurate estimates and forecasts possible. We utilize a combination of bottom-up and top-down approaches for segmenting and estimating quantitative aspects of the market. Data is continuously filtered to ensure that only validated and authenticated sources are considered. In addition, data is also mined from a host of reports in our repository, as well as a number of reputed paid databases. Our market estimates and forecasts are derived through simulation models. A unique model is created and customized for each study. Gathered information for market dynamics, technology landscape, application development, and pricing trends are fed into the model and analyzed simultaneously.
About Grand View Research
Grand View Research provides syndicated as well as customized research reports and consulting services on 46 industries across 25 major countries worldwide. This U.S. based market research and consulting company is registered in California and headquartered in San Francisco. Comprising over 425 analysts and consultants, the company adds 1200+ market research reports to its extensive database each year. Supported by an interactive market intelligence platform, the team at Grand View Research guides Fortune 500 companies and prominent academic institutes in comprehending the global and regional business environment and carefully identifying future opportunities.
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