Global Cell and Gene Therapy Manufacturing QC Market Report 2021Opportunities in Drug Approvals and Strong Pipeline of Cell and Gene Therapies & Multiple Investments in Expansion of cGMP Units

DUBLIN, March 15, 2021 /PRNewswire/ -- The "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" report has been added to ResearchAndMarkets.com's offering.

One of the most rapidly evolving and dynamic markets, 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.

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.

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:
• 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?

Key Topics Covered:

1 Product Definition and Market Scope

2 Research Methodology

3 Market Overview
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 Market Dynamics
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 Industry Insights
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 Global Cell and Gene Therapy Manufacturing QC Market: Competitive Insights
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 Global Cell and Gene Therapy Manufacturing QC Market (by Product and Service), $Million, 2019-2030
7.1 Overview
7.2 Service
7.3 Product

8 Global Cell and Gene Therapy Manufacturing QC Market (by Process), $Million, 2019-2030
8.1 Overview
8.2 Starting Material Preparation
8.3 Upstream Processing
8.4 Downstream Processing

9 Global Cell and Gene Therapy Manufacturing QC Market (by Analytical Method), $Million, 2019-2030
9.1 Overview
9.2 Safety Testing
9.3 Purity Testing
9.4 Potency Testing
9.5 Identity Testing
9.6 Stability Testing

10 Global Cell and Gene Therapy Manufacturing QC Market (by Technology), $Million, 2019-2030
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
10.1 Electrophoresis
10.11 Other Technologies

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

12 Company Profiles

• Bio-Techne Corporation
• bioMerieux SA
• Catalent, Inc.
• Charles River Laboratories International Inc.
• Eurofins Scientific SE
• F. Hoffmann-La Roche Ltd
• Intertek Group plc
• Lonza Group AG
• Merck KGaA
• Sartorius AG
• SGS S.A.
• Sistemic Scotland Limited
• Thermo Fisher Scientific Inc.
• Vigene Biosciences, Inc.
• WuXi AppTec

For more information about this report visit https://www.researchandmarkets.com/r/dpen0h

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