Cell And Gene Therapy Manufacturing Market Size, Share & Trends Report

Cell And Gene Therapy Manufacturing Market Size, Share & Trends Analysis Report By Therapy Type, By Scale (R&D), By Mode, By Workflow (Vector Production, Cell Banking), By Region, And Segment Forecasts, 2023 - 2030

  • Report ID: GVR-4-68038-289-1
  • Number of Report Pages: 130
  • Format: PDF, Horizon Databook
  • Historical Range: 2018 - 2021
  • Forecast Period: 2023 - 2030 
  • Industry: Healthcare

Research Methodology

A three-pronged approach was followed for deducing the cell and gene therapy manufacturing market estimates and forecasts. The process has three steps: information procurement, analysis, and validation. The whole process is cyclical, and steps repeat until the estimates are validated. The three steps are explained in detail below:

Information procurement: Information procurement is one of the most extensive and important stages in our research process, and quality data is critical for accurate analysis. We followed a multi-channel data collection process for cell and gene therapy manufacturing market to gather the most reliable and current information possible.

  • We buy access to paid databases such as Hoover’s and Factiva for company financials, industry information, white papers, industry journals, SME journals, and more.
  • We tap into Grand View’s proprietary database of data points and insights from active and archived monitoring and reporting.
  • We conduct primary research with industry experts through questionnaires and one-on-one phone interviews.
  • We pull from reliable secondary sources such as white papers and government statistics, published by organizations like WHO, NGOs, World Bank, etc., Key Opinion Leaders (KoL) publications, company filings, investor documents, and more.
  • We purchase and review investor analyst reports, broker reports, academic commentary, government quotes, and wealth management publications for insightful third-party perspectives.

Analysis: We mine the data collected to establish baselines for forecasting, identify trends and opportunities, gain insight into consumer demographics and drivers, and so much more. We utilized different methods of cell and gene therapy manufacturing market data depending on the type of information we’re trying to uncover in our research.

  • Market Research Efforts: Bottom-up Approach for estimating and forecasting demand size and opportunity, top-down Approach for new product forecasting and penetration, and combined approach of both Bottom-up and Top-down for full coverage analysis.

  • Value-Chain-Based Sizing & Forecasting: Supply-side estimates for understanding potential revenue through competitive benchmarking, forecasting, and penetration modeling.

  • Demand-side estimates for identifying parent and ancillary markets, segment modeling, and heuristic forecasting.

  • Qualitative Functional Deployment (QFD) Modelling for market share assessment.

Market formulation and validation: We mine the data collected to establish baselines for forecasting, identify trends and opportunities, gain insight into consumer demographics and drivers, and so much more. We utilize different methods of data analysis depending on the type of information we’re trying to uncover in our research.

  • Market Formulation: This step involves the finalization of market numbers. This step on an internal level is designed to manage outputs from the Data Analysis step.

  • Data Normalization: The final market estimates and forecasts are then aligned and sent to industry experts, in-panel quality control managers for validation.

  • This step also entails the finalization of the report scope and data representation pattern.

  • Validation: The process entails multiple levels of validation. All these steps run in parallel, and the study is forwarded for publishing only if all three levels render validated results.

Cell And Gene Therapy Manufacturing Market Categorization:

The cell and gene therapy manufacturing market was categorized into five segments, namely therapy type (Cell therapy manufacturing, Gene therapy manufacturing), scale (Pre-commercial/ R&D scale manufacturing, Commercial scale manufacturing), mode (Contract manufacturing, In-house manufacturing), workflow (Cell processing, Cell banking, Process development, Fill & finish operations, Analytical and quality testing, Raw material testing, Vector production), and region (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa).

Segment Market Methodology:

The cell and gene therapy manufacturing market was segmented into therapy type, scale, mode, workflow, and regions. The demand at a segment level was deduced using a funnel method. Concepts like the TAM, SAM, SOM, etc., were put into practice to understand the demand. We at GVR deploy three methods to deduce market estimates and determine forecasts. These methods are explained below:

Market research approaches: Bottom-up

  • Demand estimation of each product across countries/regions summed up to from the total market.

  • Variable analysis for demand forecast.

  • Demand estimation via analyzing paid database, and company financials either via annual reports or paid database.

  • Primary interviews for data revalidation and insight collection.

Market research approaches: Top-down

  • Used extensively for new product forecasting or analyzing penetration levels.

  • Tool used invoice product flow and penetration models Use of regression multi-variant analysis for forecasting Involves extensive use of paid and public databases.

  • Primary interviews and vendor-based primary research for variable impact analysis.

Market research approaches: Combined

  • This is the most common method. We apply concepts from both the top-down and bottom-up approaches to arrive at a viable conclusion.

Regional Market Methodology:

The cell and gene therapy manufacturing market was analyzed at a regional level. The globe was divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa, keeping in focus variables like consumption patterns, export-import regulations, consumer expectations, etc. These regions were further divided into twenty-three countries, namely, the U.S.; Canada; Germany; the UK; France; Italy; Spain; Denmark, Sweden, Norway, China; Japan; India; Australia; Thailand; South Korea; Brazil; Mexico; Argentina; South Africa; Saudi Arabia; UAE; Kuwait.

All three above-mentioned market research methodologies were applied to arrive at regional-level conclusions. The regions were then summed up to form the global market.

Cell and gene therapy manufacturing market companies & financials:

The cell and gene therapy manufacturing market was analyzed via companies operating in the sector. Analyzing these companies and cross-referencing them to the demand equation helped us validate our assumptions and conclusions. Key market players analyzed include:

  • Thermo Fisher Scientific, Inc. -Thermo Fisher Scientific, Inc. is a publicly held biotechnology company formed by the collaboration of Thermo Electron and Fisher Scientific. Thermo Fisher Scientific, Inc. offers products for life sciences, industrial & applied sciences, and clinical diagnostics sectors. The company offers products through the following brands: Unity Lab Services, Invitrogen, Thermo Scientific, Fisher Scientific, and Applied Biosystems. Its core operations involve development, manufacture, and distribution of laboratory reagents, equipment, analytical instruments, & consumables. The company’s analytical instrument segment provides equipment & instruments, consumables, and services used in production lines, laboratories, & on-field applications. Its solutions segment provides instruments, reagents, and consumables used in disease diagnosis, medical & biological research, as well as novel drug & vaccines discovery. The company has operations in over 50 countries.

  • Merck KGaA -Merck KGaA is a multinational company involved in offering healthcare solutions and materials. It operates in three sectors: healthcare, life sciences, and performance materials. It has worldwide operations, including in North America, Europe, Asia, Latin America, Oceania, and Africa. It offers products for biopharma, consumer health, allergopharma, biosimilars, life science, and performance materials.

  • Lonza - Lonza is a global supplier of biopharmaceuticals. The company offers products in bioresearch, consumer care, pharma & biotech, water treatment, agro-ingredients, industrial solutions, and wood protection. Its market is segmented into pharma & biotech and specialty ingredients. It has worldwide operations, including in North America, Europe, Asia, France, and the UK, with a presence in more than 35 countries through 120 sites & offices.

  • Catalent, Inc. - Catalent, Inc. is a publicly held company that provides delivery technologies, integrated services, and manufacturing solutions to life sciences industry. The company has around 1,000 products in development and launches more than 180 products every year. The company offers more than 7,000 products. It has partnered with biopharmaceutical and pharmaceutical companies across the world. In addition, it has a presence in 5 continents with more than 30 sites and over 50 clinical depots.

  • Takara Bio, Inc. - Takara Bio, Inc. is a publicly held company with expertise in development of research tools for cell & gene therapy, life sciences, and nutraceuticals. The company has three main business units: Genetic Engineering Research, Agribio, and Gene Medicine. The company has business units in China, Japan, Korea, Europe, India, and the U.S. Through its bio-industry business, the company offers research reagents, scientific instruments, and CDMO services. Its gene therapy business includes oncolytic virus and engineered T-cell therapy

  • F. Hoffmann-La Roche Ltd.- F. Hoffmann-La Roche Ltd. is primarily involved in development and supply of diagnostic and pharmaceutical products to support research, healthcare companies, and healthcare providers. It has around worldwide 26 manufacturing sites. It works through two business segments: pharmaceuticals and diagnostics. The pharmaceuticals segment manufactures drugs for infectious, cardiovascular, respiratory, oncology, metabolic disorders, central nervous system, and autoimmune diseases. Roche Diagnostics is involved in market segments ranging from patient self-monitoring to clinical laboratory systems. It is involved in strategic partnerships with various organizations in about 150 countries.

  • Wuxi Advanced Therapies - Wuxi Advanced Therapies is a business unit of WuXi AppTec. It is a global CDMO engaged in development, manufacture, and commercialization of gene, cell, & other advanced therapies. The company has 287,000 square feet of commercial space that incorporates CDMO and testing service platforms. It has expertise in molecular biology, virology, cell biology, QA/QC, analytical, metrology, cell banking, process development, project management, analytical chemistry and regulatory services.

  • Samsung Biologics - Samsung Biologics is a South Korea-based Contract Development and Manufacturing Organization (CDMO) offering the development and manufacturing of biopharmaceutical products. The client base of Samsung Biologics is more than 30 and is spread across the world. The company’s services include CDO, CMO, CRO, and quality testing of biopharmaceutical products. Furthermore, it is planning to expand its manufacturing facility in South Korea by constructing its fourth biopharma manufacturing plant.

  • Boehringer Ingelheim International GmbH - Boehringer Ingelheim International GmbH is involved in research and development of human & veterinary medications. It operates in different regions such as North America, Europe, and Asia. The company operates across various therapeutic areas of respiratory diseases, diseases of the central nervous system, cardiovascular disease, metabolic diseases, oncology, and virological diseases. Boehringer BioXcellence is a subsidiary of the parent group that operates as a contract manufacturer for pharmaceutical and biotechnology companies. The company offers a portfolio of technologies, including the production of nonantibody scaffolds, antibodies, Fab fragments, recombinant proteins, as well as pDNA, from either microbial fermentation systems or mammalian cell culture.

  • Novartis AG - Novartis AG is a publicly owned company formed after the merger of Ciba-Geigy and Sandoz Laboratories. It operates through three divisions—pharmaceuticals, Alcon, and Sandoz. Its pharmaceuticals (innovative medicines) business unit is divided into Novartis pharmaceuticals and Novartis oncology. It offers generics, branded medicines, and eye care devices. 

Value chain-based sizing & forecasting

Supply Side Estimates

  • Company revenue estimation via referring to annual reports, investor presentations, and Hoover’s.

  • Segment revenue determination via variable analysis and penetration modeling.

  • Competitive benchmarking to identify market leaders and their collective revenue shares.

  • Forecasting via analyzing commercialization rates, pipelines, market initiatives, distribution networks, etc.

Demand side estimates

  • Identifying parent markets and ancillary markets

  • Segment penetration analysis to obtain pertinent

  • revenue/volume

  • Heuristic forecasting with the help of subject matter experts

  • Forecasting via variable analysis

Cell And Gene Therapy Manufacturing Market Report Objectives:

  • Understanding market dynamics (in terms of drivers, restraints, & opportunities) in the countries.

  • Understanding trends & variables in the individual countries & their impact on growth and using analytical tools to provide high-level insights into the market dynamics and the associated growth pattern.

  • Understanding market estimates and forecasts (with the base year as 2022, historic information from 2018 to 2021, and forecast from 2023 to 2030). Regional estimates & forecasts for each category are available and are summed up to form the global market estimates.

Cell And Gene Therapy Manufacturing Market Report Assumptions:

  • The report provides market value for the base year 2022 and a yearly forecast till 2030 in terms of revenue/volume or both. The market for each of the segment outlooks has been provided on region & country basis for the above-mentioned forecast period.

  • The key industry dynamics, major technological trends, and application markets are evaluated to understand their impact on the demand for the forecast period. The growth rates were estimated using correlation, regression, and time-series analysis.

  • We have used the bottom-up approach for market sizing, analyzing key regional markets, dynamics, & trends for various products and end-users. The total market has been estimated by integrating the country markets.

  • All market estimates and forecasts have been validated through primary interviews with the key industry participants.

  • Inflation has not been accounted for to estimate and forecast the market.

  • Numbers may not add up due to rounding off.

  • Europe consists of EU-8, Central & Eastern Europe, along with the Commonwealth of Independent States (CIS).

  • Asia Pacific includes South Asia, East Asia, Southeast Asia, and Oceania (Australia & New Zealand).

  • Latin America includes Central American countries and the South American continent

  • Middle East includes Western Asia (as assigned by the UN Statistics Division) and the African continent.

Primary Research

GVR strives to procure the latest and unique information for reports directly from industry experts, which gives it a competitive edge. Quality is of utmost importance to us, therefore every year we focus on increasing our experts’ panel. Primary interviews are one of the critical steps in identifying recent market trends and scenarios. This process enables us to justify and validate our market estimates and forecasts to our clients. With more than 8,000 reports in our database, we have connected with some key opinion leaders across various domains, including healthcare, technology, consumer goods, and the chemical sector. Our process starts with identifying the right platform for a particular type of report, i.e., emails, LinkedIn, seminars, or telephonic conversation, as every report is unique and requires a differentiated approach.

We send out questionnaires to different experts from various regions/ countries, which is dependent on the following factors:

  • Report/Market scope: If the market study is global, we send questionnaires to industry experts across various regions, including North America, Europe, Asia Pacific, Latin America, and MEA.

  • Market Penetration: If the market is driven by technological advancements, population density, disease prevalence, or other factors, we identify experts and send out questionnaires based on region or country dominance.

The time to start receiving responses from industry experts varies based on how niche or well-penetrated the market is. Our reports include a detailed chapter on the KoL opinion section, which helps our clients understand the perspective of experts already in the market space.

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