Report Scope:
The scope of this study encompasses an investigation of cell and gene therapy manufacturing services. BCC Research analyzes the manufacturing services based on therapy type, application, disease, and end user. BCC determines the current market status in each segment, examines its impact on future markets, and presents growth forecasts over the next six years. The recent report provides a detailed analysis of the market's drivers, challenges, and opportunities. The report also covers market projections to 2028 and market share for key market players. The report includes the company profiles of the key players with detailed information about their business segments, financials, product portfolios, and recent developments. The report also provides the ESG perspective, emerging technologies, and investment outlook.
Report Includes:
- 34 data tables and 18 additional tables
- An overview of the global cell and gene therapy manufacturing services market
- Analyses of global market trends, with data from 2020-2022, estimates for 2023, and projections of compound annual growth rates (CAGRs) through 2028
- Highlights of the market potential and quantification of market based on therapy type, application, disease, and end-user
- A look into current technologies underlying the market as well as the effects new technologies will have on the market
- Coverage of clinical trials pipeline, partnership between pharmaceutical companies, and Contract Development & Manufacturing Organization (CDMO)
- Insights into investments from multiple stakeholders, and discussion on increasing focus on personalized medicine for rare and chronic conditions
- Information on recent mergers, acquisitions, collaborations, agreements, product launches, and expansions in the market and a relevant patent analysis
- Company profiles of major players within the industry, including Catalent, Charles River Laboratories, Lonza, Merck KGaA, and Thermo Fisher Scientific
Summary:
The pharmaceutical industry is changing and moving away from a one-size-fits-all approach to a targeted and personalized approach, in which patients' own genetic information and immune systems are used to treat previously incurable diseases. Cell and gene therapies are different from the traditional biopharma products. Cell and gene therapies (CGT) are a novel therapeutic modality for a range of chronic and age-related conditions. These provide a fundamental treatment option for disease conditions that do not have a cure or cannot be treated with conventional drugs. Initially, cell and gene therapies were highly explored for oncology. However, the research is expanding into other disease areas.
Demand for cell and gene therapies is high and there is a lot of R&D in this segment supported by huge investments and funding for CGTs. According to the Alliance for Regenerative Medicine 2022 report, CGT research raised nearly $REDACTED billion in 2020, $REDACTED billion in 2021 and $REDACTED billion in the first half of 2022 (H1 2022) and overall investment of $REDACTED billion. The number of clinical trials and regulatory approvals for cell and gene therapies will increase over the coming years. The FDA estimates that by 2025, it will approve 10-20 cell and gene therapy products per year, and it is forecasted that by 2030 there will be around REDACTED approved therapies.
Notably, even though awareness and demand are increasing, there is a lack of supply. This is mainly due to limited manufacturing capacity and complex supply chain. Hence, it is important that the organizations scale-up to meet the supply chain requirements. Also, due to stringent, expensive, and complex manufacturing processes, most of the small and medium sized pharma and biotech companies are engaging with contract development and manufacturing organizations (CDMO). This is a contributing factor to the growth of the CGT CDMO's.
Increasing investments, capacity expansions for clinical and commercial manufacturing, increasing prevalence of chronic diseases and focus on rare diseases, and increased healthcare expenditure drive the cell and gene therapy manufacturing services market. Accelerated approvals in recent years, coupled with technological advancements (development of off-the-shelf products, automations, application of advanced gene editing techniques like CRISPR), will lower the complexities involved around manufacturing CGTs and will attract many pharma and biotech companies to enter the market, thus contributing to the market in the forecast period.
The global market for cell and gene therapy manufacturing services was estimated to be $REDACTED billion in 2022 and is expected to increase to $REDACTED billion by 2028, growing at a CAGR of REDACTED%. The cell and gene therapy manufacturing services market is segmented based on application, type, disease, end user, and region. Major players in the market are Lonza, FUJIFILM Diosynth, Charles River, Thermo Fisher, and Merck KGaA.
The North American region has the highest share, followed by Europe. Extensive R&D activities take place in the region, there are major players present, plentiful funding, and increasing prevalence of chronic diseases. All these factors contribute to growth in the market. Based on application, the cancer segment has the highest share.
Cell and Gene Therapy Manufacturing Services Market
Table of Contents
Chapter 1 Introduction
Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Information Sources
Methodology
Geographic Breakdown
Chapter 2 Summary and Highlights
Market Overview
Chapter 3 Market Overview and Technology Background
Overview
Gene Addition or Augmentation
Gene Correction
Gene Silencing
Manufacturing
Supply Chain
Regulatory Landscape
U.S. (FDA)
Europe
Outsourcing of Manufacturing
Chapter 4 Market Dynamics
Factors Affecting the Market
Market Drivers
Increasing Investment and Funding for CGT Development
Capacity Expansions for Clinical and Commercial Manufacturing
Rising Prevalence of Chronic Diseases and Focus on Rare Diseases
Increasing Strategic Collaborations and Acquisitions
Market Restraints
Complex Manufacturing and Supply Chain
Lack of Skilled Workforce
Regulatory Hurdles
Market Opportunities
Chapter 5 Emerging Technologies
Introduction
Emerging Technologies
Automation
Digitalization
Single-Use Technologies
Emerging Manufacturing Models
Chapter 6 Market Breakdown by Type
Overview
Cell Therapy
Gene Therapy
Cell Therapy Types
Autologous Cell Therapy
Allogeneic Cell Therapy
Cell and Gene Therapy Types Based on Vector Type
Viral Vectors
Nonviral Vectors
Chapter 7 Market Breakdown by Application
Overview
Clinical Manufacturing
Commercial Scale Manufacturing
Chapter 8 Market Breakdown by Disease
Overview
Cancer
Rare Diseases
Other Diseases
Chapter 9 Market Breakdown by End User
Overview
Pharmaceutical and Biotechnology Companies
Academic and Research Institutes
Others
Chapter 10 Market Breakdown by Region
Overview
North America
U.S.
Canada
Europe
U.K.
Germany
France
Rest of Europe
Asia-Pacific
China
Japan
Australia
Rest of Asia-Pacific
Rest of the World
Chapter 11 Sustainability: An ESG Perspective
Overview
ESG Practices in the CGT Manufacturing Industry
Case Studies: Examples of Successful ESG Implementation
Conclusion
Chapter 12 M&A, Funding Outlook and Competitive Landscape
Investments Outlook
Mergers and Acquisitions
Strategic Initiatives
Competitive Analysis
Chapter 13 Company Profiles
CATALENT INC.
CELL AND GENE THERAPY CATAPULT
CHARLES RIVER LABORATORIES
FUJIFILM DIOSYNTH BIOTECHNOLOGIES
LONZA GROUP AG
MERCK KGAA
MILTENYI BIOTEC
NIKON CELL INNOVATION CO. LTD.
TAKARA BIO INC.
THERMO FISHER SCIENTIFIC
WUXI ADVANCED THERAPIES
List of Tables
Summary Table A : Global Market for Cell and Gene Therapy Manufacturing Services, Through 2028
Summary Table B : Global Market for Cell and Gene Therapy Manufacturing Services, by Region, Through 2028
Table 1 : Global Cancer Statistics, 2020
Table 2 : Global Market for Cell and Gene Therapy Manufacturing Services, by Type, Through 2028
Table 3 : Global Market for Cell Therapy Manufacturing Services, by Region, Through 2028
Table 4 : Global Market for Gene Therapy Manufacturing Services, by Region, Through 2028
Table 5 : Global Market for Cell Therapy Manufacturing Services, by Type, Through 2028
Table 6 : Global Market for Autologous Cell Therapy Manufacturing Services, by Region, Through 2028
Table 7 : Global Market for Allogeneic Cell Therapy Manufacturing Services, by Region, Through 2028
Table 8 : Global Market for Gene-Modified Cell and Gene Therapy Manufacturing Services, by Vector, Through 2028
Table 9 : Global Market for Gene-Modified Cell and Gene Therapy Manufacturing Services for Viral Vectors, by Region, Through 2028
Table 10 : Global Market for Gene-Modified Cell and Gene Therapy Manufacturing Services for Nonviral Vectors, by Region, Through 2028
Table 11 : Global Market for Cell and Gene Therapy Manufacturing Services, by Application, Through 2028
Table 12 : Global Market for Clinical Cell and Gene Therapy Manufacturing Services, by Region, Through 2028
Table 13 : Global Market for Commercial Cell and Gene Therapy Manufacturing Services, by Region, Through 2028
Table 14 : Global Market for Cell and Gene Therapy Manufacturing Services, by Disease, Through 2028
Table 15 : Global Market for Cell and Gene Therapy Manufacturing Services for Cancer, by Region, Through 2028
Table 16 : Global Market for Cell and Gene Therapy Manufacturing Services for Rare Diseases, by Region, Through 2028
Table 17 : Global Market for Cell and Gene Therapy Manufacturing Services for Other Diseases, by Region, Through 2028
Table 18 : Global Market for Cell and Gene Therapy Manufacturing Services, by End User, Through 2028
Table 19 : Global Market for Cell and Gene Therapy Manufacturing Services for Pharmaceutical and Biotechnology Companies, by Region, Through 2028
Table 20 : Global Market for Cell and Gene Therapy Manufacturing Services for Academic and Research Institutes, by Region, Through 2028
Table 21 : Global Market for Cell and Gene Therapy Manufacturing Services for Other End Users, by Region, Through 2028
Table 22 : Global Market for Cell and Gene Therapy Manufacturing Services, by Region, Through 2028
Table 23 : North American Market for Cell and Gene Therapy Manufacturing Services, by Country, Through 2028
Table 24 : European Market for Cell and Gene Therapy Manufacturing Services, by Country, Through 2028
Table 25 : Asia-Pacific Market for Cell and Gene Therapy Manufacturing Services, by Country, Through 2028
Table 26 : ESG Rating/Metric
Table 27 : Environmental Initiatives by Various CGT Manufacturing CDMOs/Companies
Table 28 : ESG Rankings for Companies in the CGT Manufacturing Services Market, 2023
Table 29 : Mergers and Acquisitions, 2020-2022
Table 30 : Catalent: Financials,2022
Table 31 : Catalent: News
Table 32 : Charles River Laboratories: Financials, 2022
Table 33 : Charles River Laboratories: News
Table 34 : Charles River Laboratories: Cell and Gene Manufacturing Services Offerings
Table 35 : FUJIFILM Diosynth Biotechnologies: Financials, 2022
Table 36 : FUJIFILM Diosynth Biotechnologies: News
Table 37 : Lonza: Financials, 2022
Table 38 : Lonza: News
Table 39 : Lonza: Cell and Gene Services Offerings
Table 40 : Merck KGaA: Financials, 2022
Table 41 : Merck KGaA: Cell and Gene Manufacturing Services Offerings
Table 42 : Merck KGaA: News
Table 43 : Takara Bio: Financials, 2022
Table 44 : Takara Bio: Cell and Gene Services Offerings
Table 45 : Takara Bio.: News
Table 46 : Thermo Fisher Scientific Inc: Financials, 2022
Table 47 : Thermo Fisher: Cell and Gene Services Offerings
Table 48 : Thermo Fisher Scientific Inc.: News
Table 49 : WuXi Advanced Therapies: Financials, 2022
Table 50 : WuXi Advanced Therapies: News
List of Figures
Summary Figure A : Global Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
Summary Figure B : Global Market for Cell and Gene Therapy Manufacturing Services, by Region, 2020-2028
Figure 1 : Cell Therapy Manufacturing Process
Figure 2 : Pharmaceutical Products - Supply Chain
Figure 3 : Cell Therapy Products - Supply Chain
Figure 4 : Cell Therapy Products - Regulatory Pathway
Figure 5 : Centralized Manufacturing Model
Figure 6 : Decentralized Manufacturing Model
Figure 7 : Global Market for Cell and Gene Therapy Manufacturing Services, by Type, 2020-2028
Figure 8 : Global Market Shares of Cell and Gene Therapy Manufacturing Services, by Type, 2022
Figure 9 : Global Market for Cell Therapy Manufacturing Services, by Region, 2020-2028
Figure 10 : Global Market for Gene Therapy Manufacturing Services, by Region, 2020-2028
Figure 11 : Types of Cell Therapies
Figure 12 : Advantages and Disadvantages of Cell Therapy Types
Figure 13 : Global Market for Cell Therapy Manufacturing Services, by Type, 2020-2028
Figure 14 : Global Market for Autologous Cell Therapy Manufacturing Services, by Region, 2020-2028
Figure 15 : Global Market for Allogeneic Cell Therapy Manufacturing Services, by Region, 2020-2028
Figure 16 : Shares of Vectors Used in Clinical Trials on Gene Therapy, 2022
Figure 17 : Global Market for Gene-Modified Cell and Gene Therapy Manufacturing Services, by Vector, 2020-2028
Figure 18 : Global Market for Gene-Modified Cell and Gene Therapy Manufacturing Services for Viral Vectors, by Region, 2020-2028
Figure 19 : Global Market for Gene-Modified Cell and Gene Therapy Manufacturing Services for Nonviral Vectors, by Region, 2020-2028
Figure 20 : Global Market for Cell and Gene Therapy Manufacturing Services, by Application, 2020-2028
Figure 21 : Global Market Shares of Cell and Gene Therapy Manufacturing Services, by Application, 2022
Figure 22 : CGT Clinical Pipeline, by Phase and Type
Figure 23 : Global Market for Clinical Cell and Gene Therapy Manufacturing Services, by Region, 2020-2028
Figure 24 : Global Market for Commercial Cell and Gene Therapy Manufacturing Services, by Region, 2020-2028
Figure 25 : Global Market for Cell and Gene Therapy Manufacturing Services, by Disease, 2020-2028
Figure 26 : Global Market Shares of Cell and Gene Therapy Manufacturing Services, by Disease, 2022
Figure 27 : CGT Oncology Pipeline, by Phase and Type
Figure 28 : Global Market for Cell and Gene Therapy Manufacturing Services for Cancer, by Region, 2020-2028
Figure 29 : Global Market for Cell and Gene Therapy Manufacturing Services for Rare Diseases, by Region, 2020-2028
Figure 30 : Global Market for Cell and Gene Therapy Manufacturing Services for Other Diseases, by Region, 2020-2028
Figure 31 : Global Market for Cell and Gene Therapy Manufacturing Services, by End User, 2020-2028
Figure 32 : Global Market Shares of Cell and Gene Therapy Manufacturing Services, by End User, 2022
Figure 33 : Global Market for Cell and Gene Therapy Manufacturing Services for Pharmaceutical and Biotechnology Companies, by Region, 2020-2028
Figure 34 : CGT Clinical Pipeline, by Sponsor
Figure 35 : Global Market for Cell and Gene Therapy Manufacturing Services for Academic and Research Institutes, by Region, 2020-2028
Figure 36 : Global Market for Cell and Gene Therapy Manufacturing Services for Other End Users, by Region, 2020-2028
Figure 37 : Global Market for Cell and Gene Therapy Manufacturing Services, by Region, 2020-2028
Figure 38 : Global Market Shares of Cell and Gene Therapy Manufacturing Services, by Region, 2022
Figure 39 : North American Market for Cell and Gene Therapy Manufacturing Services, by Country, 2020-2028
Figure 40 : U.S. Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
Figure 41 : Canadian Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
Figure 42 : European Market for Cell and Gene Therapy Manufacturing Services, by Country, 2020-2028
Figure 43 : U.K. Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
Figure 44 : German Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
Figure 45 : French Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
Figure 46 : Rest of European Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
Figure 47 : Asia-Pacific Market for Cell and Gene Therapy Manufacturing Services, by Country, 2020-2028
Figure 48 : Chinese Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
Figure 49 : Japanese Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
Figure 50 : Australian Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
Figure 51 : Rest of APAC Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
Figure 52 : Rest of the World Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
Figure 53 : ESG in CGT Manufacturing Industry
Figure 54 : Investments, by Year, 2017-2022
Figure 55 : Equity Offering and Venture Financing, 2021 and 2022
Figure 56 : Public and Private Companies Deal Value, 2021 and 2022
Figure 57 : Number of Deals, 2021 and 2022
Figure 58 : M&A Deals, 2021 and 2022
Figure 59 : Strategic Alliance Deals, 2021 and 2022
Figure 60 : Global Market Shares of CGT Manufacturing Services, by Manufacturer, 2022
Figure 61 : Catalent: Financials, 2021 and 2022
Figure 62 : Catalent: Market Share, by Business Segment, 2022
Figure 63 : Charles River Laboratories: Financials, 2021 and 2022
Figure 64 : Charles River Laboratories: Market Share, by Business Segment, 2022
Figure 65 : Charles River Laboratories: Revenue Share, by Region/Country, 2022
Figure 66 : FUJIFILM Diosynth Biotechnologies: Financials, 2021 and 2022
Figure 67 : Lonza: Financials, 2021 and 2022
Figure 68 : Lonza: Market Share, by Business Segment, 2022
Figure 69 : Lonza: Revenue Share, by Region/Country, 2022
Figure 70 : Merck KGaA: Financials, 2021 and 2022
Figure 71 : Merck KGaA Life Sciences: Market Share, by Region, 2022
Figure 72 : Merck KGaA Life Sciences: Market Share, by Business Segment, 2022
Figure 73 : Takara Bio: Financials, 2021 and 2022
Figure 74 : Takara Bio.: Market Share, by Region, 2022
Figure 75 : Takara Bio.: Market Share, by Business Segment, 2022
Figure 76 : Thermo Fisher Scientific Financials, 2021 and 2022
Figure 77 : Thermo Fisher Scientific Inc.: Market Share, by Region, 2022
Figure 78 : Thermo Fisher Scientific Inc.: Market Share, by Business Segment, 2022
Figure 79 : WuXi Advanced Therapies: Annual Revenue, 2021 and 2022
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