Cell and Gene Therapy Manufacturing QC Market - Industry Analysis, Trends & Forecast 2030

Market Research Report

A quick peek into the report

1.1   Inclusion and Exclusion
1.2   Scope of Work
1.3   Key Questions Answered in the Report

2.1   Primary Data Sources
2.2   Secondary Data Sources
2.3   Market Estimation Model
2.4   Criteria for Company Profiling

3.1   Clinical Importance of Cell and Gene Therapies
3.2   Cell and Gene Therapy Manufacturing QC: Industry Overview
3.3   Market Footprint
3.4   Impact of COVID-19

4.1   Impact Analysis
4.2   Market Drivers
4.2.1   Increasing Prevalence of Cancer and Chronic Diseases
4.2.2   Rising Number of Clinical Trials
4.2.3   Steady Investment and Consolidation in the Cell and Gene Therapy Market
4.2.4   Favorable Regulatory Environment
4.3   Market Restraints
4.3.1   Lack of Reliable Vector Production for Cell and Gene Therapy
4.3.2   Lack of Therapy Specific Assays
4.4   Opportunities
4.4.1   Drug Approvals and Strong Pipeline of Cell and Gene Therapies
4.4.2   Multiple Investments in Expansion of cGMP Units

5.1   Role of Regulatory Bodies and Consortium in Cell and Gene Therapy
5.1.1   Regulatory Challenges
5.1.2   Successful Regulatory Strategies
5.2   Regulatory Framework
5.2.1   Chemistry, Manufacturing, and Control (CMC) Requirements by the FDA
5.2.1.1   Product Testing
5.2.1.1.1   Microbial Testing
5.2.1.1.2   Identity
5.2.1.1.3   Purity
5.2.1.1.4   Potency
5.2.1.1.5   Viability
5.2.1.1.6   Cell Number/Dose
5.2.2   Quality Aspects of Cell and Gene Therapy Products by the EMA
5.2.2.1   Characterization
5.2.2.1.1   Identity Testing
5.2.2.1.2   Purity Testing
5.2.2.1.3   Potency Testing
5.2.2.1.4   Release Criteria
5.2.3   Quality Control Requirements for Cell and Gene Therapies in China
5.2.3.1   CAR-T Cell Therapy
5.2.3.2   Gene Therapy
5.3   Cost Analysis for Cell and Gene Therapy QC

6.1   Overview
6.2   Synergistic Activities
6.3   Expansion Activities
6.4   Product and Service Launches
6.5   Acquisitions
6.6   Other Developments
6.7   Market Share Analysis, 2019-2020
6.8   Growth Share Analysis
6.8.1   Growth Share Analysis (by Company)
6.8.2   Growth Share Analysis (by Technology)
6.8.3   Growth Share Analysis (by Analytical Method)

7.1   Overview
7.2   Service
7.3   Product

8.1   Overview
8.2   Starting Material Preparation
8.3   Upstream Processing
8.4   Downstream Processing

9.1   Overview
9.2   Safety Testing
9.3   Purity Testing
9.4   Potency Testing
9.5   Identity Testing
9.6   Stability Testing

10.1   Overview
10.2   Polymerase Chain Reaction
10.3   Flow Cytometry
10.4   Limulus Amebocyte Lysate (LAL)
10.5   Enzyme-Linked Immunosorbent Assay (ELISA)
10.6   Chromatography
10.7   Mass Spectrometry
10.8   Western Blotting
10.9   Next-Generation Sequencing
10.10 Electrophoresis
10.11   Other Technologies

11.1   Overview
11.2   North America
11.2.1   U.S.
11.2.2   Canada
11.3   Europe
11.3.1   Germany
11.3.2   U.K.
11.3.3   France
11.3.4   Italy
11.3.5   Spain
11.3.6   Netherlands
11.3.7   Russia
11.3.8   Rest-of-Europe
11.4   Asia-Pacific
11.4.1   China
11.4.2   Japan
11.4.3   South Korea
11.4.4   Australia
11.4.5   India
11.4.6   Singapore
11.4.7   Rest-of-Asia-Pacific
11.5   Latin America
11.5.1   Brazil
11.5.2   Mexico
11.5.3   Rest-of-Latin America
11.6   Rest-of-the-World (RoW)

12.1   Overview
12.2   bioMérieux SA
12.2.1   Company Overview
12.2.2   Role of bioMérieux SA in Global Cell and Gene Therapy Manufacturing QC Market
12.2.3   Financials
12.2.4   Key Insights About Financial Health of the Company
12.2.5   SWOT Analysis
12.3   Bio-Techne Corporation
12.3.1   Company Overview
12.3.2   Role of Bio-Techne Corporation in Global Cell and Gene Therapy Manufacturing QC Market
12.3.3   Financials
12.3.4   Key Insights About Financial Health of the Company
12.3.5   SWOT Analysis
12.4   Catalent, Inc.
12.4.1   Company Overview
12.4.2   Role of Catalent, Inc. in Global Cell and Gene Therapy Manufacturing QC Market
12.4.3   Financials
12.4.4   Key Insights About Financial Health of the Company
12.4.5   SWOT Analysis
12.5   Charles River Laboratories International Inc.
12.5.1   Company Overview
12.5.2   Role of Charles River Laboratories International Inc. in the Global Cell and Gene Therapy Manufacturing QC Market
12.5.3   Financials
12.5.4   SWOT Analysis
12.6   Eurofins Scientific SE
12.6.1   Company Overview
12.6.2   Role of Eurofins Scientific SE in the Global Cell and Gene Therapy Manufacturing QC Market
12.6.3   Financials
12.6.4   SWOT Analysis
12.7   F. Hoffmann-La Roche Ltd
12.7.1   Company Overview
12.7.2   Role of F. Hoffmann-La Roche Ltd. in the Global Cell and Gene Therapy Manufacturing QC Market
12.7.3   Financials
12.7.4   Key Insights About Financial Health of the Company
12.7.5   SWOT Analysis
12.8   Intertek Group plc
12.8.1   Company Overview
12.8.2   Role of Intertek Group plc in the Global Cell and Gene Therapy Manufacturing QC Market
12.8.3   Financials
12.8.4   Key Insights About Financial Health of the Company
12.8.5   SWOT Analysis
12.9   Lonza Group AG
12.9.1   Company Overview
12.9.2   Role of Lonza Group AG in the Global Cell and Gene Therapy Manufacturing QC Market
12.9.3   Financials
12.9.4   SWOT Analysis
12.10 Merck KGaA
12.10.1   Company Overview
12.10.2   Role of Merck KGaA in the Global Cell and Gene Therapy Manufacturing QC Market
12.10.3   Financials
12.10.4   Key Insights About Financial Health of the Company
12.10.5   SWOT Analysis
12.11   Sartorius AG
12.11.1   Company Overview
12.11.2   Role of Sartorius AG in the Global Cell and Gene Therapy Manufacturing QC Market
12.11.3   Financials
12.11.4   Key Insights About Financial Health of the Company
12.11.5   SWOT Analysis
12.12   SGS S.A.
12.12.1   Company Overview
12.12.2   Role of SGS S.A. in the Global Cell and Gene Therapy Manufacturing QC Market
12.12.3   Financials
12.12.4   SWOT Analysis
12.13   Sistemic Scotland Limited
12.13.1   Company Overview
12.13.2   Role of Sistemic Scotland Limited in Global Cell and Gene Therapy Manufacturing QC Market
12.13.3   SWOT Analysis
12.14   Thermo Fisher Scientific Inc.
12.14.1   Company Overview
12.14.2   Role of Thermo Fisher Scientific Inc. in the Global Cell and Gene Therapy Manufacturing QC Market
12.14.3   Financials
12.14.4   Key Insights About Financial Health of the Company
12.14.5   SWOT Analysis
12.15   Vigene Biosciences, Inc.
12.15.1   Company Overview
12.15.2   Role of Vigene Biosciences, Inc. in Global Cell and Gene Therapy Manufacturing QC Market
12.15.3   SWOT Analysis
12.16   WuXi AppTec
12.16.1   Company Overview
12.16.2   Role of WuXi AppTec in Global Cell and Gene Therapy Manufacturing QC Market
12.16.3   Financials
12.16.4   SWOT Analysis

Table 3.1:   Key Products of Cell and Gene Therapy Market
Table 4.1:   Impact Analysis
Table 4.2:   Key Cell and Gene Therapies with FDA Expedited Review
Table 5.1:   Product Class Inclusions in EU and U.S. Regulatory Pathway
Table 7.1:   List of Key Services
Table 7.2:   List of Key Products Offered
Table 9.1:   Key Safety Testing Offerings
Table 9.2:   Key Purity Testing Offerings
Table 9.3:   Key Potency Testing Offerings
Table 9.4:   Key Identity Testing Offerings
Table 9.5:   Key Stability Testing Offerings
Table 10.1:   Key PCR-Based Offerings
Table 10.2:   Key Flow Cytometry-Based Offerings
Table 10.3:   Key LAL-Based Offerings
Table 10.4:   Key ELISA-Based Offerings
Table 10.5:   Key Chromatography-Based Offerings
Table 10.6:   Key Mass Spectrometry-Based Offerings
Table 10.7:   Key Western Blotting-Based Offerings
Table 10.8:   Key NGS-Based Offerings
Table 10.9:   Key Electrophoresis-Based Offerings

Figure 1:   Global Clinical Landscape for Regenerative Medicine, 2019
Figure 2:   Impact Analysis on the Global Cell and Gene Therapy Manufacturing QC Market
Figure 3:   Global Cell and Gene Therapy Manufacturing QC Market (by Product and Service), $Million, 2019 and 2030
Figure 4:   Global Cell and Gene Therapy Manufacturing QC Market (by Process), $Million, 2019 and 2030
Figure 5:   Global Cell and Gene Therapy Manufacturing QC Market (by Analytical Method), $Million, 2019 and 2030
Figure 6:   Global Cell and Gene Therapy Manufacturing QC Market (by Technology), $Million, 2019 and 2030
Figure 7:   Global Cell and Gene Therapy Manufacturing QC Market (by Region), Market Snapshot
Figure 1.1:   Global Cell and Gene Therapy Manufacturing QC Market Segmentation Primary Research Methodology
Figure 2.1:   Bottom-Up Approach (Segment-Wise Analysis)
Figure 2.2:   Top-Down Approach (Segment-Wise Analysis)
Figure 3.1:   Clinical Trials by Therapeutic Category, Cell and Gene Therapy, 2019
Figure 3.2:   Global Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 3.3:   Impact of COVID-19 on Global Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 4.1:   Number of Clinical Trials for ATMP (by Phase), 2019
Figure 5.1:   Cost of Manufacturing Cell Therapies
Figure 6.1:   Share of Key Developments and Strategies, January 2018-Januray 2021
Figure 6.2:   Synergistic Activities Share (by Company), January 2018-January 2021
Figure 6.3:   Expansion Activities Share (by Company), January 2018-January 2021
Figure 6.4:   Product and Services Launches Share (by Company), January 2018- January 2021
Figure 6.5:   Product and Services Launches Share (by Company), January 2018- January 2021
Figure 6.6:   Market Share Analysis for Global Cell and Gene Therapy Manufacturing QC Market, 2019 and 2020
Figure 6.7:   Growth Share Analysis for Global Cell and Gene Therapy Manufacturing QC Market (by Company), 2020
Figure 6.8:   Growth Share Analysis for Global Cell and Gene Therapy Manufacturing QC Market (by Technology), 2019-2030
Figure 6.9:   Growth Share Analysis for Global Cell and Gene Therapy Manufacturing QC Market (by Analytical Method), 2019-2030
Figure 7.1:   Global Cell and Gene Therapy Manufacturing QC Market (by Product and Service), $Million, 2019 and 2030
Figure 7.2:   Global Cell and Gene Therapy Manufacturing QC Market (by Service), $Million, 2019-2030
Figure 7.3:   Global Cell and Gene Therapy Manufacturing QC Market (by Product), $Million, 2019-2030
Figure 7.4:   Global Cell and Gene Therapy Manufacturing QC Market (by Product), $Million, 2019 and 2030
Figure 8.1:   Global Cell and Gene Therapy Manufacturing QC Market (by Process), $Million, 2019 and 2030
Figure 8.2:   Global Cell and Gene Therapy Manufacturing QC Market (by Starting Material Preparation), $Million, 2019-2030
Figure 8.3:   Global Cell and Gene Therapy Manufacturing QC Market (by Upstream Processing), $Million, 2019-2030
Figure 8.4:   Global Cell and Gene Therapy Manufacturing QC Market (by Downstream Processing), $Million, 2019-2030
Figure 9.1:   Product Characterization Tests for Cell and Gene Therapy Manufacturing
Figure 9.2:   Global Cell and Gene Therapy Manufacturing QC Market (by Analytical Method), $Million, 2019 and 2030
Figure 9.3:   Global Cell and Gene Therapy Manufacturing QC Market (by Safety Testing), $Million, 2019-2030
Figure 9.4:   Global Cell and Gene Therapy Manufacturing QC Market (by Safety Testing Type), $Million, 2019 and 2030
Figure 9.5:   Global Cell and Gene Therapy Manufacturing QC Market (by Purity Testing), $Million, 2019-2030
Figure 9.6:   Global Cell and Gene Therapy Manufacturing QC Market (by Purity Testing Type), $Million, 2019 and 2030
Figure 9.7:   Global Cell and Gene Therapy Manufacturing QC Market (by Potency Testing), $Million, 2019-2030
Figure 9.8:   Global Cell and Gene Therapy Manufacturing QC Market (by Potency Testing Type), $Million, 2019 and 2030
Figure 9.9:   Global Cell and Gene Therapy Manufacturing QC Market (by Identity Testing), $Million, 2019-2030
Figure 9.10: Global Cell and Gene Therapy Manufacturing QC Market (by Stability Testing), $Million, 2019-2030
Figure 9.11: Global Cell and Gene Therapy Manufacturing QC Market (by Stability Testing Type), $Million, 2019 and 2030
Figure 10.1:   Global Cell and Gene Therapy Manufacturing QC Market (by Technology), $Million, 2019 and 2030
Figure 10.2:   Global Cell and Gene Therapy Manufacturing QC Market (PCR), $Million, 2019-2030
Figure 10.3:   Global Cell and Gene Therapy Manufacturing QC Market (Flow Cytometry), $Million, 2019-2030
Figure 10.4:   Global Cell and Gene Therapy Manufacturing QC Market (LAL), $Million, 2019-2030
Figure 10.5:   Global Cell and Gene Therapy Manufacturing QC Market (ELISA), $Million, 2019-2030
Figure 10.6:   Global Cell and Gene Therapy Manufacturing QC Market (Chromatography), $Million, 2019-2030
Figure 10.7:   Global Cell and Gene Therapy Manufacturing QC Market (Mass Spectrometry), $Million, 2019-2030
Figure 10.8:   Global Cell and Gene Therapy Manufacturing QC Market (Western Blotting), $Million, 2019-2030
Figure 10.9:   Global Cell and Gene Therapy Manufacturing QC Market (NGS), $Million, 2019-2030
Figure 10.10:   Global Cell and Gene Therapy Manufacturing QC Market (Electrophoresis), $Million, 2019-2030
Figure 10.11:   Global Cell and Gene Therapy Manufacturing QC Market (Other Technologies), $Million, 2019-2030
Figure 11.1:   Global Cell and Gene Therapy Manufacturing QC Market (by Region), Market Snapshot
Figure 11.2:   North America: Market Dynamics
Figure 11.3:   North America Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.4:   North America Cell and Gene Therapy Manufacturing QC Market (by Country), $Million, 2019 vs. 2030
Figure 11.5:   U.S. Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.6:   Canada Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.7:   Europe: Market Dynamics
Figure 11.8:   Europe Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.9:   Europe Cell and Gene Therapy Manufacturing QC Market (by Country), $Million, 2019 vs. 2030
Figure 11.10:   Germany Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.11:   U.K. Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.12:   France Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.13:   Italy Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.14:   Spain Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.15:   Netherlands Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.16:   Russia Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.17:   Rest-of-Europe Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.18:   Asia-Pacific: Market Dynamics
Figure 11.19:   Asia-Pacific Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.20:   Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Country), $Million, 2019 vs. 2030
Figure 11.21:   China Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.22:   Japan Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.23:   South Korea Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.24:   Australia Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.25:   Italy Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.26:   Singapore Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.27:   Rest-of-Europe Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.28:   Latin America: Market Dynamics
Figure 11.29:   Latin America Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.30:   Latin America Cell and Gene Therapy Manufacturing QC Market (by Country), $Million, 2019 vs. 2030
Figure 11.31:   Brazil Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.32:   Mexico Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.33:   Rest-of-Latin America Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 11.34:   Rest-of-the-World Cell and Gene Therapy Manufacturing QC Market, $Million, 2019-2030
Figure 12.1:   Total Number of Companies Profiled
Figure 12.2:   bioMérieux SA: Overall Product Portfolio
Figure 12.3:   bioMérieux SA: Overall Financials, 2017-2019
Figure 12.4:   bioMérieux SA: Revenue (by Segment), 2017-2019
Figure 12.5:   bioMérieux SA: Revenue (by Region), 2017-2019
Figure 12.6:   bioMérieux SA: R&D Expenditure, 2017-2019
Figure 12.7:   bioMérieux SA: SWOT Analysis
Figure 12.8:   Bio-Techne Corporation: Overall Product Portfolio
Figure 12.9:   Bio-Techne Corporation: Overall Financials, 2018-2020
Figure 12.10:   Bio-Techne Corporation: Revenue (by Segment), 2018-2020
Figure 12.11:   Bio-Techne Corporation: Revenue (by Region), 2018-2020
Figure 12.12:   Bio-Techne Corporation: R&D Expenditure, 2018-2020
Figure 12.13:   Bio-Techne Corporation: SWOT Analysis
Figure 12.14:   Catalent, Inc.: Overall Product Portfolio
Figure 12.15:   Catalent, Inc.: Overall Financials, 2018-2020
Figure 12.16:   Catalent, Inc.: Revenue (by Segment), 2018-2020
Figure 12.17:   Catalent, Inc.: Revenue (by Region), 2018-2020
Figure 12.18:   Catalent, Inc.: R&D Expenditure, 2018-2020
Figure 12.19:   Catalent, Inc.: SWOT Analysis
Figure 12.20:   Charles River Laboratories International Inc.: Overall Service Portfolio
Figure 12.21:   Charles River Laboratories International Inc.: Overall Financials, 2017-2019
Figure 12.22:   Charles River Laboratories International Inc.: Revenue (by Segment), 2017-2019
Figure 12.23:   Charles River Laboratories International Inc.: Revenue (by Region), 2017-2019
Figure 12.24:   Charles River Laboratories International Inc.: SWOT Analysis
Figure 12.25:   Eurofins Scientific SE: Service Portfolio
Figure 12.26:   Eurofins Scientific SE: Overall Financials, 2017-2019
Figure 12.27:   Eurofins Scientific SE: Revenue (by Segment), 2018-2019
Figure 12.28:   Eurofins Scientific SE: Revenue (by Region), 2017-2019
Figure 12.29:   Eurofins Scientific SE.: SWOT Analysis
Figure 12.30:   F. Hoffmann-La Roche Ltd.: Overall Product Portfolio
Figure 12.31:   F. Hoffmann-La Roche Ltd.: Overall Financials, 2018-2020
Figure 12.32:   F. Hoffmann-La Roche Ltd.: Revenue (by Segment), 2018-2020
Figure 12.33:   F. Hoffmann-La Roche Ltd.: Revenue (by Diagnostics), 2018-2020
Figure 12.34:   F. Hoffmann-La Roche Ltd.: Revenue (by Region), 2018-2020
Figure 12.35:   F. Hoffmann-La Roche Ltd.: R&D Expenditure, 2018-2020
Figure 12.36:   F. Hoffmann-La Roche Ltd.: SWOT Analysis
Figure 12.37:   Intertek Group plc: Overall Product Portfolio
Figure 12.38:   Intertek Group plc: Overall Financials, 2017-2019
Figure 12.39:   Intertek Group plc: Revenue (by Segment), 2017-2019
Figure 12.40:   Intertek Group plc: Revenue (by Region), 2017-2019
Figure 12.41:   Intertek Group plc: R&D Expenditure, 2017-2019
Figure 12.42:   Intertek Group plc: SWOT Analysis
Figure 12.43:   Lonza Group AG: Overall Product Portfolio
Figure 12.44:   Lonza Group AG: Overall Financials, 2018-2020
Figure 12.45:   Lonza Group AG: Revenue (by Segment), 2018-2020
Figure 12.46:   Lonza Group AG: Revenue (by Region), 2018-2020
Figure 12.47:   Lonza AG: SWOT Analysis
Figure 12.48:   Merck KGaA: Overall Product Portfolio
Figure 12.49:   Merck KGaA: Overall Financials, 2017-2019
Figure 12.50:   Merck KGaA: Revenue (by Segment), 2017-2019
Figure 12.51:   Merck KGaA: Revenue (by Region), 2017-2019
Figure 12.52:   Merck KGaA: R&D Expenditure, 2017-2019
Figure 12.53:   Merck KGaA: SWOT Analysis
Figure 12.54:   Sartorius AG: Overall Product Portfolio
Figure 12.55:   Sartorius AG: Overall Financials, 2017-2019
Figure 12.56:   Sartorius AG: Revenue (by Segment), 2017-2019
Figure 12.57:   Sartorius AG: Revenue (by Region), 2017-2019
Figure 12.58:   Sartorius AG: R&D Expenditure, 2017-2019
Figure 12.59:   Sartorius AG: SWOT Analysis
Figure 12.60:   SGS S.A.: Overall Product Portfolio
Figure 12.61:   SGS S.A.: Overall Financials, 2018-2020
Figure 12.62:   SGS S.A.: Revenue (by Segment), 2018-2020
Figure 12.63:   SGS S.A.: Revenue (by Region), 2018-2020
Figure 12.64:   SGS S.A.: SWOT Analysis
Figure 12.65:   Sistemic Scotland Limited: Portfolio
Figure 12.66:   Sistemic Scotland Limited: SWOT Analysis
Figure 12.67:   Thermo Fisher Scientific Inc.: Product Portfolio
Figure 12.68:   Thermo Fisher Scientific Inc.: Overall Financials: 2017-2019
Figure 12.69:   Thermo Fisher Scientific Inc.: Sales (by Segment): 2017-2020
Figure 12.70:   Thermo Fisher Scientific Inc.: Revenue (by Region), 2017-2019
Figure 12.71:   Thermo Fisher Scientific Inc.: R&D Expenditure, 2017-2019
Figure 12.72:   Thermo Fisher Scientific Inc.: SWOT Analysis
Figure 12.73:   Vigene Biosciences, Inc.: Portfolio
Figure 12.74:   Vigene Biosciences, Inc.: SWOT Analysis
Figure 12.75:   WuXi AppTec: Product Portfolio
Figure 12.76:   WuXi AppTec: Overall Financials, 2017-2019
Figure 12.77:   WuXi AppTec: Sales (by Segment), 2017-2019
Figure 12.78:   WuXi AppTec: Revenue (by Region), 2017-2019
Figure 12.79:   WuXi AppTec: SWOT Analysis

Report Description

Market Report Coverage - Cell and Gene Therapy Manufacturing QC
Base Year	2019	Market Size in 2019	$574.8 Million
Forecast Period	2020-2030	Value Projection and Estimation by 2030	$5.92 Billion
CAGR During Forecast Period	22.80%	Number of Tables	20
Number of Pages	238	Number of Figures	167
Research Hours	240
Market Segmentation	• Product – Services and Products (Kits and Assays, Instruments, Reagents, and Software) • Process – Starting Material Preparation, Upstream Processing, and Downstream Processing • Analytical Methods – Safety Testing, Purity Testing, Potency Testing, Identity Testing, and Stability Testing • Technology – Polymerase Chain Reaction (PCR), Flow Cytometry, Limulus Amebocyte Lysate (LAL), Enzyme-Linked Immunosorbent Assay (ELISA), Chromatography, Mass Spectrometry, Western Blotting, Next-Generation Sequencing (NGS), and Electrophoresis, among others
Regional Segmentation	• North America – U.S., and Canada • Europe – Germany, U.K., France, Italy, Spain, Netherlands, Russia, and Rest-of-Europe • Asia-Pacific – China, Japan, India, Australia, South Korea, Singapore, and Rest-of-Asia-Pacific • Latin America – Brazil, Mexico, and Rest-of-Latin America • Rest-of-the-World
Growth Drivers	• Increasing Prevalence of Cancer and Chronic Diseases • Rising Number of Clinical Trials • Steady Investment and Consolidation in the Cell and Gene Therapy Market • Favorable Regulatory Environment
Market Challenges	• Lack of Reliable Vector Production for Cell and Gene Therapy • Lack of Therapy Specific Assays
Market Opportunities	• Drug Approvals and Strong Pipeline of Cell and Gene Therapies • Multiple Investments in Expansion of cGMP Units
Key Companies Profiled	bioMérieux SA, Bio-Techne Corporation, Catalent, Inc., Charles River Laboratories International, Inc., Eurofins Scientific S.E., F. Hoffmann-La Roche Ltd., Intertek Group plc, Lonza Group AG, Merck KGaA, Sartorius AG, SGS S.A, Thermo Fisher Scientific Inc., WuXi AppTec, Sistemic Scotland Limited, and Vigene Biosciences, Inc.

Key Questions Answered in this Report:

•   What are the major market drivers, challenges, and opportunities and their respective impacts in the global cell and gene therapy manufacturing QC market?
•   What is the potential impact of advancement in QC in the contract development and manufacturing organization among the cell and gene therapy innovators?
•   What is the current market demand along with future expected demand for the global cell and gene therapy manufacturing QC market?
•   What are the key regulatory hurdles for industry players looking to enter this highly dynamic market?
•   What are the key development strategies that are implemented by the major players in order to sustain the competitive market?
•   How is each of the following segments of the market expected to grow during the forecast period from 2020 to 2030:
o   product
o   process
o   analytical method
o   technology
o   region, namely, North America, Europe, Asia-Pacific, Latin America, and Rest-of-the-World (RoW)
•   Who are the leading players with significant offerings to the global cell and gene therapy manufacturing QC market? What is the expected market dominance for each of these leading players?
•   Which emerging companies are anticipated to be highly disruptive in the future, and what are their key strategies for sustainable growth in the global cell and gene therapy manufacturing QC market?
•   How is automation expected to change scale up challenges in the market?
•   What is the cost of QC vs production cost for cell and gene therapies and what strategies are leading players undertaking in order to maximize profits?

Market Overview

Our healthcare experts have found the manufacturing QC for cell and gene therapy to be one of the most rapidly evolving and dynamic markets and the global market for cell and gene therapy manufacturing QC is predicted to grow at a CAGR of 22.80% over the forecast period of 2020-2030. The market is driven by certain factors, which include increasing prevalence of cancer and chronic diseases, rising number of clinical trials for cell and gene therapy, steady investment and consolidation in the cell and gene therapy market, and favorable regulatory environment are fueling the growth of the global cell and gene therapy manufacturing QC market.

Figure: Global Cell and Gene Therapy Manufacturing QC Market Snapshot

Manufacturing, being a hallmark of enabling advanced therapies to be disseminated across the patient population, is a consistent driving force behind the growth of overall adoption of innovative therapies. Quality control is a critical aspect of manufacturing, particularly considering advanced therapies such as cell and gene therapies. Profit generation aside, the cost of therapied can primarily be controlled through optimizing manufacturing costs. This will also require the optimization of cost in the underlying factors, including quality control. While a majority of regulators are currently mandating rapid testing technologies, CDMO juggernauts have already begun offering services and products based on advanced technologies such as NGS and PCR. Not only as an attractive promoting tool to gather more cell and gene innovators, but these market leaders are also driving consolidation within the industry by acquiring smaller companies offering unique products and services. As a result, there is tremendous dynamicity in the market, propelling overall access to cell and gene therapies even in smaller developing countries.

Within the research report, the market is segmented on the basis of products, processes, analytical methods, technologies, and region. Each of these segments covers the snapshot of the market over the projected years, the inclination of the market revenue, underlying patterns, and trends by using analytics on the primary and secondary data obtained.

Competitive Landscape

Rapid technological developments and their simultaneous adoption among major companies have made the global cell and gene therapy manufacturing QC market one of the most lucrative opportunities for major companies within the precision therapeutics biosphere. With both market juggernauts and emerging companies playing a significant role in the market, this industry is rapidly evolving into a highly rewarding market for manufacturers and end users. Although mostly based in Europe, market leaders such as Merck KGaA and Lonza Group AG, have been at the forefront in enabling cell and gene manufacturing capabilities across North America and the Asia-Pacific regions.

On the basis of region, North America holds the largest share of the cell and gene therapy manufacturing QC market due to a high number of active cell and gene therapy clinical trials, massive government funding, expansion activities by major companies, and an overall high adoption rate for advancing therapies. Apart from this, Asia-Pacific region is anticipated to grow at the fastest CAGR during the forecast period, 2020-2030.

Global Cell and Gene Therapy Manufacturing QC Market

Focus on Products and Services, Process, Analytical Method, Technology, 17 Countries’ Data and Competitive Landscape - Analysis and Forecast, 2020-2030

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The cell and gene therapy manufacturing QC market is estimated to grow at a CAGR of 22.80% during the forecast period from 2020 to 2030.

Factors responsible for restraining the growth of the market include lack of reliable vector production for cell and gene therapy and lack of therapy specific assays.

The processes covered under cell and gene therapy manufacturing QC market include starting material preparation, upstream processing, and downstream processing.

The different analytical methods covered under the market include safety testing, purity testing, potency testing, identity testing, and stability testing.

The key players operating in the market bioMérieux SA, Bio-Techne Corporation, Catalent, Inc., Charles River Laboratories International, Inc., Eurofins Scientific S.E., F. Hoffmann-La Roche Ltd., Intertek Group plc, Lonza Group AG, Merck KGaA, Sartorius AG, SGS S.A, Thermo Fisher Scientific Inc., WuXi AppTec, Sistemic Scotland Limited, and Vigene Biosciences, Inc.

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A quick peek into the report

Table of Contents

Report Description

Key Questions Answered in this Report:

Market Overview

$5000

Global Cell and Gene Therapy Manufacturing QC Market

Frequently Asked Questions

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Global Cell and Gene Therapy Manufacturing QC Market

A quick peek into the report

Table of Contents

1 Product Definition and Market Scope

2 Research Methodology

3 Market Overview

4 Market Dynamics

5 Industry Insights

6 Global Cell and Gene Therapy Manufacturing QC Market: Competitive Insights

7 Global Cell and Gene Therapy Manufacturing QC Market (by Product and Service), $Million, 2019-2030

8 Global Cell and Gene Therapy Manufacturing QC Market (by Process), $Million, 2019-2030

9 Global Cell and Gene Therapy Manufacturing QC Market (by Analytical Method), $Million, 2019-2030

10 Global Cell and Gene Therapy Manufacturing QC Market (by Technology), $Million, 2019-2030

11 Global Cell and Gene Therapy Manufacturing QC Market (by Region), $Million, 2019-2030

12 Company Profiles

List of Tables

List of Figures

Report Description

Key Questions Answered in this Report:

Market Overview

$5000

Global Cell and Gene Therapy Manufacturing QC Market

Frequently Asked Questions

Q: Q. What is the estimated growth rate for cell and gene therapy manufacturing QC market in the coming years?

Q: Q. What are the possible challenges that can restrict the growth of the cell and gene therapy manufacturing QC market?

Q: Q. What are the different process types of cell and gene therapy manufacturing QC market?

Q: Q. What are the different analytical methods covered under the cell and gene therapy manufacturing QC market?

Q: Q. Which are the top market players operating in the cell and gene therapy manufacturing QC market?

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