Cell And Gene Therapy Manufacturing Market (Therapy Type: Cell, Gene Therapy Manufacturing; By Scale: Pre-commercial/ R&D Scale, Commercial Scale Manufacturing; By Mode: Contract, In-house Manufacturing; By Workflow: Cell Processing, Cell Banking, Process Development, Fill & Finish Operations) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2021-2030

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.

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.

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
• Boehringer Ingelheim
• Novartis AG
• Hitachi Chemical Co., Ltd.
• Cellular Therapeutics
• Miltenyi Biotec
• Bluebird Bio Inc.

Market Segmentation

Therapy Type Outlook 

• Cell Therapy Manufacturing
  • Stem Cell Therapy
  • Non-Stem Cell Therapy
• Gene 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
  • U.S.
  • Canada
• Europe
  • Germany
  • U.K.
  • France
  • Italy
  • Spain
• Asia Pacific
  • Japan
  • China
  • India
  • South Korea
• Latin America
  • Brazil
  • Mexico
• Middle East Africa (MEA)
  • South Africa
  • Saudi Arabia

The Cell And Gene Therapy Manufacturing market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.

The report provides size (in terms of volume and value) of Cell And Gene Therapy Manufacturing market for the base year 2020 and the forecast between 2021 and 2030. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.

This report focuses on the global Cell And Gene Therapy Manufacturing market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Cell And Gene Therapy Manufacturing market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted Cell And Gene Therapy Manufacturing market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.

In terms of production side, this report researches the Cell And Gene Therapy Manufacturing capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.

In terms of consumption side, this report focuses on the consumption of Cell And Gene Therapy Manufacturing by regions (countries) and application.

Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Cell And Gene Therapy Manufacturing market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2030. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.

With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Cell And Gene Therapy Manufacturing market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Cell And Gene Therapy Manufacturing market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.

The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.

Overall, this is an in-depth research report specifically for the Cell And Gene Therapy Manufacturing industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.

The Cell And Gene Therapy Manufacturing market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Cell And Gene Therapy Manufacturing market.

Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Cell And Gene Therapy Manufacturing market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.

Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Cell And Gene Therapy Manufacturing market. These factors have benefited the growth of the global market for Cell And Gene Therapy Manufacturing. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.

New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Cell And Gene Therapy Manufacturing. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).

In this study, the years considered to estimate the market size of Cell And Gene Therapy Manufacturing are as follows:

• Historic Year: 2017-2020
• Base Year: 2021
• Forecast Year 2021 to 2030

Reasons to Purchase this Report:

- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects

- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.

- Market value USD Million and volume Units Million data for each segment and sub-segment

- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years

- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Research Methodology:

In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

Market Size Estimation

Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).

The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.

Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.

All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.

Market Breakdown and Data Triangulation

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.

Secondary Sources

Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.

Primary Sources

 In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.

The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.

The study objectives of this report are:

• To analyze and study the global market capacity, production, value, consumption, status (2017-2020) and forecast (2021-2030);
• Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
• Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
• To define, describe and forecast the market by type, application and region.
• To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
• To identify significant trends and factors driving or inhibiting the market growth.
• To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
• To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
• To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
• To strategically profile the key players and comprehensively analyze their growth strategies.