Industry Analysis

Global Cell and Gene Therapy Manufacturing QC Market to Reach $5.92 Billion by 2030

The global cell and gene therapy manufacturing QC market is projected to reach $5.92 billion by 2030,according to CRI’s new report. The study also highlights that the market is set to witness a CAGR of 22.80% during the period between 2020 and 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

The comprehensive study of the cell and gene therapy manufacturing QC market extensively covers the following:

• Market numbers on micro-segments that are influencing the market
• More than 200 products and services present in the market
• Over 30 brands were evaluated
• Market share analysis for more than 15 analytical methods
• Technological information on more than 10 extensively used technologies
• Detailed global and regional market share analysis including the scrutiny of more than 17 countries
• Study of data of more than 30 companies

Besides these parameters, the study also encompasses the market growth drivers, opportunities, market restraining factors, competition mapping, segmental analysis, and a visual dashboard of 200+ products and services.

This report indicates that 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.

The market intelligence additionally throws a spotlight on the opportunities existing in the market, such as drug approvals and a strong pipeline of cell and gene therapies worldwide, and multiple investments in the expansion of cGMP units, among others.

To gain a holistic view of the market, data from different segments of the market has been analyzed minutely. These segments include types of products and services, processes, analytical methods, technologies, and regions. The analytical methods and the region segments have been further sub-segmented to offer an in-dept analysis of the global cell and gene therapy manufacturing QC market.

The product and ecosystem analysis of the global market include data analysis on the type of offerings available in the market. Pertaining to the market segmentation, the product segment is segmented into products and services, with the product segment further being sub-segmented into kits and assays, instruments, reagents, and software. The processes segment has been segmented into starting material preparation, upstream processing, and downstream processing. The analytical methods segment has been segmented into safety testing, purity testing, potency testing, identity testing, and stability testing. Further, safety testing has been sub-segmented into sterility testing, endotoxin testing, mycoplasma and spiroplasma testing, replication-competent virus testing, and toxicity testing. The purity segment has been sub-segmented into process-related impurity testing, host cell-related impurity testing, and capsid content testing. The potency segment has been sub-segmented into physical titer value testing, functional titer value testing, and transfection and expression testing. The stability testing segment has been sub-segmented into pH testing, osmolality testing, and aggregate formation testing. The technology segment has been analyzed pertaining to offerings in the market for both products and services, such as 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.

Emphasizing the dominance of the North America region in the global genomic data analysis and interpretation market in 2020 and 2030, “The scalability of cell and gene therapies has always been an issue with manufacturing since most of these therapies are targeting a very small group. Since the group is too small, the cost of manufacturing is too high, and vice-versa. Pharmaceutical companies and manufacturers should typically collaborate on bringing down the cost of manufacturing in order to offer the therapies at a lower cost, which would also require the pharmaceutical companies to compromise on their current profit margins. North America is traditionally where this needs to be an area of focus since the region has close to half of the global cell and gene clinical trials.”

Key insights are drawn from in-depth interviews with the key opinion leaders of more than 15 leading companies, market participants, and vendors. The key players profiled in the report include 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.

The study also offers strategic recommendations that can help organizations in tracking various products and trends that are changing the dynamics of the market. The recommendations also offer bespoke research services to help organizations meet their objectives.

Who should buy this report?

• CDMOs and CMOs who are actively participating in the manufacture and scale up of cell and gene therapies, worldwide.
• Cell and gene therapy innovators looking forward to creating synergies with CDMOs and CMOs.
• Pharmaceutical companies looking to enter the cell and gene therapy market.
• Regulators of regenerative medicine products, looking for specific quality control areas to focus on.

How can market intelligence on cell and gene therapy manufacturing QC add value to an organization’s decision-making process?

• Aid in product development
• Help in targeting a segment for launching a new product or service
• Offer go to market access strategies
• Support in diversifying the product portfolio basis risk and progression of underlying technologies
• Help in analyzing specifications
• Aid in understanding the analytical method landscape
• Gain holistic views pertaining to the regions and understand the market potential of the countries
• Support in analyzing the competitive landscape to gain an understanding of the business strategies incorporated by the companies

Insightful Questions Covered to Enable Companies take Strategic Decisions

• 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?

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