Worldwide Cell & Gene Therapy Market Outlook, 2019 to 2025 - Focus on Products, Applications, Regions, and Competitive Landscape


Dublin, Aug. 27, 2019 (GLOBE NEWSWIRE) -- The "Global Cell and Gene Therapy Market: Focus on Products, Applications, Regions and Competitive Landscape - Analysis and Forecast, 2019-2025" report has been added to ResearchAndMarkets.com's offering.

  • What are the major market drivers, challenges, and opportunities in the global cell and gene therapy market?
  • What are the underlying structures resulting in the emerging trends within the global cell and gene therapy market?
  • How is each segment of the global cell and gene therapy market expected to grow during the forecast period and what is the estimated revenue to be generated by each of the segments by the end of 2025?
  • What is the expected compound growth rate to be witnessed by the leading players in the market during the forecast period 2019-2025?
  • What are the key applications in global cell and gene therapy market? What are the major segments of these applications?
  • Who are the key manufacturers and service providers in the global cell and gene therapy market, and what are their contributions?

The cell and gene therapy Industry analysis projects the market to grow at a significant CAGR of 36.52% during the forecast period, 2019-2025. The cell and gene therapy market generated $1,017.2 million revenue in 2018, in terms of value.

The cell and gene therapy growth has been primarily attributed to the major drivers in this market such as 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.

The market is expected to grow at a significant growth rate due to the opportunities that lie within its domain, which include drug approvals and strong pipeline of cell and gene therapies. However, there are significant challenges which are restraining the market growth. These challenges include high cost of therapy and lack of therapy specific assays.

Expert Quote

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Scope of the Market Intelligence

The cell and gene therapy market research provides a holistic view of the cell and gene therapy market in terms of various factors influencing it, including regulatory reforms, and technological advancements.

The scope of this report is centered upon conducting a detailed study of the products and services allied with the therapeutics market. In addition, the study also includes exhaustive information on the unmet needs, perception on the new products, competitive landscape, market share of leading manufacturers, growth potential of each underlying sub-segment, and company, as well as other vital information with respect to global cell and gene therapy market.

Key Companies

The key manufacturers who have been contributing significantly to the cell and gene therapy market include Amgen Inc., bluebird bio, Inc. Dendreon Pharmaceuticals LLC., Fibrocell Science, Inc., Human Stem Cell Institute, Kite Pharma, Inc., Kolon TissueGene, Inc., Novartis AG, Orchard Therapeutics plc., Organogenesis Holdings Inc., Pfizer, Inc., Spark Therapeutics, Inc., Vericel Corporation, and ViroMed Co., Ltd., among others.

Key Topics Covered

1 Research Scope and Methodology
1.1 Scope of the Study
1.2 Research Methodology
1.3 Data Sources
1.4 Assumptions and Limitations
1.5 Data and Prediction Modelling

2 Global Cell and Gene Therapy Market: Global Prospective
2.1 Introduction
2.2 Cell and Gene Therapy and Their Clinical Importance
2.3 Cell and Gene Therapy Development and Commercialization Landscape
2.4 Global Cell and Gene Therapy Market Size, 2018-2025
2.5 Role of Regulatory Bodies and Consortium in Cell and Gene Therapy
2.6 Reimbursement and Market Access
2.7 Key Companies in Cell and Gene Therapy Market and their Contributions

3 Global Cell and Gene Therapy Market Overview (Addressable Market Size and Growth Potential), 2018-2025
3.1 Cell and Gene Therapy Industry
3.2 Key Successful Cell and Gene Therapy Commercialization
3.3 Addressable Market and Growth Potential
3.4 North America
3.5 Europe
3.6 Asia-Pacific
3.7 Latin America
3.8 Rest-of-the-World

4 Industry Insights
4.1 Mergers and Acquisitions
4.2 Product Approvals
4.3 Partnerships, Collaborations and Joint Ventures
4.4 Business Expansion Activities and Others
4.5 Legal Requirements and Regulations
4.5.1 Overview of Regulatory Pathway for Cell and Gene Therapy
4.5.2 FDA Expedited Approval Designations
4.5.2.1 Fast Track Designation
4.5.2.2 Breakthrough Therapy
4.5.2.3 Accelerated Approval
4.5.2.4 Priority Review
4.5.2.5 Regenerative Medicine Advanced Therapy Designation:
4.5.3 Expedited Designation vs. Traditional Approval Timelines:
4.5.4 Regulatory Challenges
4.5.5 Successful Regulatory Strategies

5 Patent Landscape

6 Cell and Gene Therapy Manufacturing
6.1 Viral Vector Manufacturing
6.1.1 Upstream Manufacturing
6.1.1.1 Cost Consideration and Timelines
6.1.1.2 Process Design and Regulatory Burdens
6.1.1.3 Other Considerations
6.1.1.4 Viral vector Manufacturing
6.1.1.4.1 Retrovirus
6.1.1.4.2 Lentivirus
6.1.1.4.3 AAV
6.1.1.4.4 Adenovirus
6.1.2 Downstream Manufacturing
6.1.2.1 Viral Vector Manufacturing
6.1.2.1.1 Retrovirus
6.1.2.1.2 Lentivirus
6.1.2.1.3 AAV
6.1.2.1.4 Adenovirus
6.1.2.2 Cost Considerations and Timelines
6.1.2.3 Challenges in Downstream
6.1.2.4 Scale-up of Downstream from Research to Clinical Manufacturing
6.2 Non-Viral Vector Manufacturing
6.2.1 Non-Viral, Plasmid-Free Manufacturing
6.2.2 Plasmid
6.2.3 Naked DNA
6.2.4 Physical-Mediated Methods
6.3 Cell and Gene Therapy Manufacturing Capacity, by Company

7 Market Dynamics
7.1 Impact Analysis
7.2 Market Drivers
7.2.1 Increasing Prevalence of Cancer and Chronic Diseases
7.2.2 Rising Number of Clinical Trials
7.2.3 Steady Investment and Consolidation in the Cell and Gene Therapy Market
7.2.4 Favorable Regulatory Environment
7.3 Market Restraints
7.3.1 Lack of Reliable Vector Production for Cell and Gene Therapy
7.4 Opportunities
7.4.1 Drug Approvals and Strong Pipeline of Cell and Gene Therapies
7.5 Market Challenges
7.5.1 High Cost of Therapy
7.5.2 Lack of Therapy Specific Assays

8 Global Cell and Gene Therapy Market (by Product)
8.1 Therapeutic Market
8.1.1 Yescarta
8.1.2 Provenge
8.1.3 Luxturna
8.1.4 Kymriah
8.1.5 Imlygic
8.1.6 Gintuit
8.1.7 MACI
8.1.8 Laviv
8.1.9 Gendicine
8.1.10 Oncorine
8.1.11 Neovasculgen
8.1.12 Strimvelis
8.1.13 Invossa
8.1.14 Others
8.2 Pipeline Analysis
8.2.1 Phase 1
8.2.2 Phase 2
8.2.3 Phase 3
8.2.4 Phase 4

9 Global Cell and Gene Therapy Market (by Therapeutic Class)
9.1 Rare Diseases
9.2 Oncology
9.3 Hematology
9.4 Cardiovascular
9.5 Ophthalmology
9.6 Neurology
9.7 Other Therapeutic Classes

10 Global Cell and Gene Therapy Market (by Region), 2018-2025 ($Million)
10.1 Overview
10.2 North America
10.2.1 U.S.
10.2.1.1 Approved Products
10.2.1.2 Market Size and Forecast
10.2.1.3 Key Developments
10.2.1.4 Competitive landscape
10.2.2 Canada
10.2.2.1 Approved Products
10.2.2.2 Market Size and Forecast
10.2.2.3 Key Developments
10.2.2.4 Competitive landscape
10.3 Europe
10.4 Asia-Pacific
10.5 Latin America
10.6 Rest-of-World

11 Competitive Landscape
11.1 Market Share Analysis
11.2 Growth Share Analysis

12 Company Profiles
12.1 Overview
12.2 Amgen Inc.
12.3 bluebird bio, Inc.
12.4 Dendreon Pharmaceuticals LLC
12.5 Fibrocell Science, Inc.
12.6 Human Stem Cells Institute
12.7 Kite Pharma, Inc.
12.8 Kolon TissueGene, Inc.
12.9 Novartis AG
12.10 Orchard Therapeutics PLC
12.11 Organogenesis Holdings Inc.
12.12 Pfizer, Inc.
12.13 Renova Therapeutics
12.14 Shanghai Sunway Biotech Co. Ltd.
12.15 Sibiono GeneTech Co. Ltd.
12.16 Spark Therapeutics, Inc.
12.17 Vericel Corporation
12.18 ViroMed Co. Ltd.

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