Market Segmentation

• By Product Type: Yescarta, Provenge, Luxtura, Kymriah, Imlygic, Gintuit, MACI, Laviv, Gendicine, Oncorine, Neovasculgen, Strimvelis, Invossa, Zolgenesma, Tecartus, Liso-Cel, Zyntelego, Others
• By Therapeutic Class: Rare Diseases, Oncology, Hematology, Cardiovascular, Ophthalmology, Neurology and Other Therapeutic Classes
• By Region: North America, Europe, Asia-Pacific, Latin America, and Rest-of-the-World

Regional Segmentation

• North America – U.S., Canada
• Europe – Germany, France, Italy, U.K., Spain,The Netherlands, Russia, and Rest-of-Europe
• Asia-Pacific – China, Japan, India, Singapore, Australia, South Korea and Rest-of-Asia-Pacific (RoAPAC)
• Latin America – Brazil, Mexico, and Rest-of-the-Latin America
• Rest-of-the-World

Growth Drivers

• Increasing Incidences of Cancer and other Chronic Diseases
• Rising Number of Clinical Trials
• Increasing Funding and Investments in Cell and Gene Therapy Market
• Favorable Regulatory Environment and FDA Approvals for Cell and Gene Therapy Products

Market Challenges

• Lack of Reliable Vector Production for Cell and Gene Therapy
• Complex Manufacturing and Distribution Setup
• Tedious Process of Therapeutic Commercialization

Market Opportunities

• Drug Approvals and Strong Pipeline of Cell and Gene Therapies
• Increasing Number of Mergers and Acquisitions within the Cell and Gene Industry

Key Cell and Gene Therapy Companies Profiled

Amgen Inc., bluebird bio, Inc., Castle Creek Pharmaceutical Holdings., Kite Pharma, Inc., Novartis AG, Orchard Therapeutics plc., Pfizer, Inc., Spark Therapeutics, Inc., Vericel Corporation, Dendreon Pharmaceuticals LLC., Human Stem Cells Institute, Kolon TissueGene, Inc., Organogenesis Holdings Inc., Pfizer, Inc., RENOVA THERAPEUTICS, Shanghai Sunway Biotech Co. Ltd., and Sibiono GeneTech Co. Ltd.

Key Questions Answered in this Report:

• What are the different types of approved cell and gene therapies available in the respective market?
• What are the key development strategies implemented by the key players to stand out in this market?
• What are the various manufacturing considerations within the cell and gene therapy market?
• How have the strategic collaborations among the key players providing a push to product development within the global cell and gene therapy market?
• What are the regulations pertaining to the global cell and gene therapy market in different regions?
• What are the initiatives implemented by different government bodies regulating the development and commercialization of cell and gene therapy products and associated platforms?
• How has COVID-19 impacted the cell and gene therapy market?
• How will the urgency of the pandemic influence the global cell and gene therapy market?
• What are the leading companies dominating the global cell and gene therapy market?
• What is the reimbursement scenario of the products offered in the global cell and gene therapy market?
• Based on the product type, which therapy in the global cell and gene therapy market is anticipated to witness a massive rise in demand in the forecast period?
• How is each segment of the global cell and gene therapy market expected to grow during the forecast period, and what is the revenue expected to be generated by each of the segments by the end of 2027?

Market Overview

Cell and gene therapy are overlapping fields of biomedical research having similar therapeutic goals, which target DNA or RNA inside or outside the body. Both therapies aim at modifying genetic material for treatment of a disease. Gene therapy uses genetic material, or DNA, to manipulate a patient’s cells for the treatment of an inherited or acquired disease. Cell therapy is the introduction of new cells into a patient’s body to grow, replace or repair damaged tissue to treat a disease. The cell and gene therapies are categorized into several therapeutic class, such as rare diseases, oncology, hematology, cardiovascular, ophthalmology, neurology, and others.

The global cell and gene therapy market was valued at $2,599.7 million in 2020, and it is expected to grow at an impressive double-digit rate of 33.82% and reach a value of $25,002.1 million in 2027.

The existing cell and gene therapy market is favored by multiple factors, which include increasing incidences of cancer and other chronic diseases, rising number of clinical trials, increasing funding and investments in the cell and gene therapy market, and favorable regulatory environment and FDA Approvals for cell and gene therapy products.

Within the research report, the market is segmented on the basis of product type (Yescarta, Provenge, Luxtura, Kymriah, Imlygic, Gintuit, MACI, Laviv, Gendicine, Oncorine, Neovasculgen, Strimvelis, Invossa, Zolgenesma, Tecartus, Liso-cel, Zyntelego, Others), therapeutic class type (Yescarta, Provenge, Luxtura, Kymriah, Imlygic, Gintuit, MACI, Laviv, Gendicine, Oncorine, Neovasculgen, Strimvelis, Invossa, Zolgenesma, Tecartus, Liso-cel, Zyntelego, Others), and region (North America, Europe, Asia Pacific, Latin America, and Rest-of-the-World). This segmentation highlights value propositions and business models useful for industry leaders and stakeholders. The research also comprises country-level analysis, go-to-market strategies of leading players, and future opportunities, among other analyses, to detail the scope and provide a 360-coverage of the domain.

Competitive Landscape

The global cell and gene therapy market witnessed 14 mergers and acquisitions, 14 product launches and approvals, 13 joint ventures, and nine business expansions. 14 mergers and acquisitions, 14 product launches and approvals, 13 joint ventures, and nine business expansions.

Major players within the cell and gene therapy market are Amgen Inc., bluebird bio, Inc., Castle Creek Pharmaceutical Holdings., Kite Pharma, Inc., Novartis AG, Orchard Therapeutics plc., Pfizer, Inc., Spark Therapeutics, Inc., Vericel Corporation, Dendreon Pharmaceuticals LLC., Human Stem Cells Institute, Kolon TissueGene, Inc., Organogenesis Holdings Inc., Pfizer, Inc., RENOVA THERAPEUTICS, Shanghai Sunway Biotech Co. Ltd., and Sibiono GeneTech Co. Ltd.

The post Global Cell and Gene Therapy Market: Focus on Product Type, Therapeutic Class, Pipeline, Regional and Country Data (15 Countries) – Analysis and Forecast, 2021-2027 first appeared on CRI Report.

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.

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.

The post 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 first appeared on CRI Report.