Table of Content



Chapter 1 Executive Summary
1.1 Market Outlook
1.2 Competitive Milieu
1.3 Segment Outlook
1.4 Market Summary
Chapter 2 Research Methodology
2.1 Information Procurement
2.2 Information or Data Analysis
2.3 Market Scope & Definition
2.3.1 ATMP definition as per EU regulatory body:
2.3.2 ATMP definition as per the U.S. FDA:
2.4 Market Model
2.4.1 Historic and base year estimates
2.4.2 Forecast analysis
2.4.2.1 Case study
2.4.2.1.1 MACI (Vericel Corporation):
2.4.2.1.2 LAVIV (Azficel-T) (Fibrocell Technologies):
Chapter 3 Market Variables, Trends, & Scope
3.1 Market Segmentation
3.2 Market Dynamics
3.2.1 Market driver analysis
3.2.1.1 Benefits over conventional therapies
3.2.1.2 Growing competition among market players
3.2.1.3 Increase in number of clinical trials for ATMP
3.2.2 Market Restraint Analysis
3.2.2.1 Absence of effective diagnosis framework
3.2.2.2 Affordability and financial sustainability
3.2.3 Market Opportunity Analysis
3.2.3.1 Increased financing for gene and cell therapy
3.2.3.2 Facility expansion for cell and gene therapies
3.2.3.3 Technological advancements in manufacturing vectors
3.2.4 Market Challenge analysis
3.2.4.1 Challenges in developing generics/biosimilar market for ATMPs
3.2.4.2 Current challenges of on-market gene therapies
3.3 Regulatory Landscape, by Geography
3.3.1 U.S.
3.3.2 Europe
3.3.3 China
3.3.4 Japan
3.4 Payment & Pricing Models
3.4.1 Payment models for innovative therapies
3.5 Patent Landscape
3.6 Deals, Funding’s, Partnerships and Collaborations
3.6.1 Merger & acquisition deals
3.6.2 Collaboration & partnerships
3.7 Pipeline Analysis
3.8 Advanced Therapy Medicinal Products (ATMP) Market-SWOT Analysis, by Factor (Political & Legal, Economic, and Technological)
3.9 Industry Analysis - Porter’s
Chapter 4 COVID-19 Impact Analysis
4.1 COVID-19 Impact Analysis
4.2 Challenges Analysis
4.2.1 Manufacturing & supply challenges
4.2.2 Other challenges
4.3 Opportunities analysis
4.3.1 Need for development of new therapies against SARS-CoV-2
4.3.1.1 T-cell Therapy
4.3.1.2 Cell Therapy
4.3.1.3 Gene Therapy
4.3.1.4 Tissue engineering
4.3.2 Rise in demand for supply chain management solutions
4.4 Challenges in Manufacturing T-cell Therapies Against COVID-19
4.5 Clinical Trial Analysis
4.6 Key Market Initiatives
4.7 Conclusion
Chapter 5 Therapy Type Business Analysis
5.1 Advanced Therapy Medicinal Products (ATMP) Market: Therapy Type Movement Analysis
5.2 Cell Therapy
5.2.1 Global cell therapy market, 2017 - 2028 (USD Million)
5.2.2 Stem cell therapy
5.2.2.1 Global stem cell therapy market, 2017 - 2028 (USD Million)
5.2.3 Non-stem cell therapy
5.2.3.1 Global non-stem cell therapy market, 2017 - 2028 (USD Million)
5.3 Gene Therapy
5.3.1 Global gene therapy market, 2017 - 2028 (USD Million)
5.4 CAR-T Therapy
5.4.1 Global CAR-T therapy market, 2017 - 2028 (USD Million)
5.5 Tissue-Engineered Products
5.5.1 Global tissue-engineered products market, 2017 - 2028 (USD Million)
Chapter 6 Regional Business Analysis
6.1 Market: Regional Movement Analysis
6.2 North America
6.2.1 Market estimates and forecast, by therapy type, 2017 - 2028 (USD Million)
6.2.2 U.S.
6.2.2.1 Market estimates and forecast, by therapy type, 2017 - 2028 (USD Million)
6.2.3 Canada
6.2.3.1 Market estimates and forecast, by therapy type, 2017 - 2028 (USD Million)
6.3 Europe
6.3.1 Market estimates and forecast, by therapy type, 2017 - 2028 (USD Million)
6.4 Asia Pacific
6.4.1 Market estimates and forecast, by therapy type, 2017 - 2028 (USD Million)
6.4.2 Japan
6.4.2.1 Market estimates and forecast, by therapy type, 2017 - 2028 (USD Million)
6.4.3 China
6.4.3.1 Market estimates and forecast, by therapy type, 2017 - 2028 (USD Million)
6.4.4 Russia
6.4.4.1 Market estimates and forecast, by therapy type, 2017 - 2028 (USD Million)
6.4.5 Australia
6.4.5.1 Market estimates and forecast, by therapy type, 2017 - 2028 (USD Million)
6.4.6 India
6.4.6.1 Market estimates and forecast, by therapy type, 2017 - 2028 (USD Million)
6.5 Rest of World (RoW)
6.5.1 Market estimates and forecast, 2017 - 2028 (USD Million)
Chapter 7 Company Profiles
7.1 Strategy Framework
7.2 Market Participants Categorization
7.3 F. Hoffmann-La Roche Ltd.
7.3.1 Company overview
7.3.2 Financial performance
7.3.3 Spark Therapeutics, Inc.
7.3.3.1 Company overview
7.3.3.2 Financial performance
7.3.4 Product benchmarking
7.3.5 Strategic initiatives
7.4 Bluebird Bio, Inc.
7.4.1 Company overview
7.4.2 Financial performance
7.4.3 Product benchmarking
7.4.4 Strategic initiatives
7.5 Novartis AG
7.5.1 Company overview
7.5.2 Financial performance
7.5.3 AveXis, Inc.
7.5.3.1 Financial performance (AveXis, Inc.)
7.5.4 Product benchmarking
7.5.5 Strategic initiatives (Novartis AG)
7.5.5.1 Strategic initiatives (AveXis, Inc.)
7.6 UniQure N.V.
7.6.1 Company overview
7.6.2 Financial performance
7.6.3 Product benchmarking
7.6.4 Strategic initiatives
7.7 Bristol-Myers Squibb Company
7.7.1 Company overview
7.7.2 Financial performance
7.7.3 Celgene Corporation
7.7.3.1 Company overview
7.7.3.2 Financial performance
7.7.4 Product benchmarking
7.7.5 Strategic initiatives
7.8 Gilead Lifesciences, Inc.
7.8.1 Company Overview
7.8.2 Financial Performance
7.8.3 Product Benchmarking
7.8.4 Strategic initiatives
7.9 Kolon TissueGene, Inc.
7.9.1 Company overview
7.9.2 Financial performance
7.9.3 Product benchmarking
7.9.4 Strategic initiatives
7.10 JCR Pharmaceuticals Co., Ltd.
7.10.1 Company overview
7.10.2 Financial performance
7.10.3 Product benchmarking
7.10.4 Strategic initiatives
7.11 MEDIPOST
7.11.1 Company overview
7.11.2 Financial performance
7.11.3 Product benchmarking
7.11.4 Strategic initiatives
7.12 Vericel Corporation
7.12.1 Company overview
7.12.2 Financial performance
7.12.3 Product benchmarking
7.12.4 Strategic initiatives
7.13 PHARMICELL Co., Ltd.
7.13.1 Company overview
7.13.2 Financial performance
7.13.3 Product benchmarking
7.13.4 Strategic initiatives
7.14 Organogenesis Inc.
7.14.1 Company overview
7.14.2 Financial performance
7.14.3 Product benchmarking
7.14.4 Strategic initiatives



List of Figures



Fig. 1 Key stakeholders constituting the ATMP ecosystem
Fig. 2 Classification of companies
Fig. 3 Market segmentation & scope
Fig. 4 Gene therapy market snapshot, 2019 (USD Million)
Fig. 5 Market research process
Fig. 6 Information procurement
Fig. 7 Industry pyramid analysis
Fig. 8 Industry pyramid analysis
Fig. 9 Market research approaches
Fig. 10 Value-chain-based sizing & forecasting
Fig. 11 Industry pyramid analysis
Fig. 12 Industry pyramid analysis
Fig. 13 Definition of ATMP by EU regulatory body
Fig. 14 Definition of ATMP by the U.S. FDA
Fig. 15 Revenue model for ATMP market
Fig. 16 Commodity flow analysis for historic and base year estimates
Fig. 17 Commodity flow analysis for forecast analysis
Fig. 18 Initiatives by Vericel Corporation to sustain market and boost revenue through its ATMPs
Fig. 19 Market trends & outlook
Fig. 20 Advanced Therapy Medicinal Products (ATMP) therapy market driver impact
Fig. 21 Conventional therapies versus ATMP Advanced Therapy Medicinal Products (ATMP)
Fig. 22 ATMPs’ value to healthcare systems, patients, & society
Fig. 23 Key strategies by market players to drive success in gene therapy arena
Fig. 24 Number of ongoing clinical trials, 2017 & 2018
Fig. 25 Some major industry sponsors of CAR T cell clinical trials, as of September 2019
Fig. 26 Distribution of the sponsors of ATMP clinical trials, 2016
Fig. 27 Distribution of the non-commercial sponsors of ATMP clinical trials, 2016
Fig. 28 Gene therapies in clinical trials at the end of 2019 globally
Fig. 29 Advanced Therapy Medicinal Products (ATMP) market restraint impact
Fig. 30 Uncertainties identified in this field with respect to magnitude and effect duration
Fig. 31 Global financings for ATMPs
Fig. 32 U.K. cell and gene therapy manufacturing capacity, 2016 to 2019
Fig. 33 Number of gene therapy sites across gene therapy and multifunctional facilities in the U.K., 2019
Fig. 34 Challenges in gene therapy arena by degree of difficulty to overcome
Fig. 35 Number of gene and cell therapy patents, 2003 - 2017
Fig. 36 CAR T-cell patent landscape, by Derwent World Patents Index (DWPI), 2018
Fig. 37 Major players in CAR T space with respect to patent filing, by Derwent World Patents Index (DWPI)
Fig. 38 Number of CAR T-Cell patent by operating players, by Derwent World Patents Index (DWPI), 2018
Fig. 39 Patents for CAR T-cell therapy, 2016 - 2019
Fig. 40 Total M&A transactions values in cell therapy, gene therapy, & tissue engineered products, by year
Fig. 41 SWOT analysis, by factor (Political & legal, economic, and technological)
Fig. 42 Porter’s Five Forces Analysis
Fig. 43 Advanced Therapy Medicinal Products (ATMP) market: Therapy type outlook and key takeaways
Fig. 44 Advanced Therapy Medicinal Products (ATMP) market: Therapy type movement analysis (USD Million)
Fig. 45 Cell therapy clinical trials, 2018
Fig. 46 Global financings in cell therapy, 2016 - 2018
Fig. 47 Global cell therapy market, 2017 - 2028 (USD Million)
Fig. 48 Global stem cell therapy market, 2017 - 2028 (USD Million)
Fig. 49 Global non-stem cell therapy market, 2017 - 2028 (USD Million)
Fig. 50 Volume of gene therapies in development, by companies; as of August 2018
Fig. 51 Global gene therapy market, 2017 - 2028 (USD Million)
Fig. 52 Annual investment in CAR T space
Fig. 53 Number of CAR-T related publications from 2015 to 2018
Fig. 54 Global CAR-T therapy market, 2017 - 2028 (USD Million)
Fig. 55 Global tissue-engineered products market, 2017 - 2028 (USD Million)
Fig. 56 ATMP market: Regional outlook and key takeaways
Fig. 57 Advanced Therapy Medicinal Products (ATMP) market: Regional movement analysis
Fig. 58 North America ATMPs market estimates and forecast, 2017 - 2028 (USD Million)
Fig. 59 U.S. ATMPs market estimates and forecast, 2017 - 2028 (USD Million)
Fig. 60 Canada ATMPs market estimates and forecast, 2017 - 2028 (USD Million)
Fig. 61 Registered cell therapy contract manufacturing organization (CMO) locations in the EU
Fig. 62 Europe ATMPs market estimates and forecast, 2017 - 2028 (USD Million)
Fig. 63 Drivers for rapid growth of cell therapy in Asia Pacific
Fig. 64 Asia Pacific ATMPs market estimates and forecast, 2017 - 2028 (USD Million)
Fig. 65 Japan ATMPs market estimates and forecast, 2017 - 2028 (USD Million)
Fig. 66 China ATMPs market estimates and forecast, 2017 - 2028 (USD Million)
Fig. 67 Russia ATMPs market estimates and forecast, 2017 - 2028 (USD Million)
Fig. 68 Australia ATMPs market estimates and forecast, 2017 - 2028 (USD Million)
Fig. 69 India ATMPs market estimates and forecast, 2017 - 2028 (USD Million)
Fig. 70 Rest of World (RoW) ATMP market estimates and forecast, 2017 - 2028 (USD Million)
Fig. 71 Strategy framework
Fig. 72 Market participants categorization


List of Tables



Table 1 Approved therapies that are considered in the revenue modeling
Table 2 Gene therapy buyouts and associated premiums
Table 3 Suggested payment models for innovative therapies
Table 4 Pipeline analysis: Cell therapy
Table 5 Pipeline analysis: Gene therapy
Table 6 Pipeline analysis: CAR-T therapy
Table 7 Pipeline analysis: NK Cell therapy
Table 8 Pipeline analysis: Tissue engineered products
Table 9 CAR-T cell resources and potential disruptions during a pandemic
Table 10 Ongoing regenerative medicine clinical trials to treat COVID-19 & related complications, as of April 14, 2020
Table 11 Collaborations between Japanese players and global (Mesenchymal Stem Cell) MSC biotechs
Table 12 North America Advanced Therapy Medicinal Products (ATMP) market estimates & forecasts, by therapy type, 2017 - 2028 (USD Million)
Table 13 North America cell therapy market estimates & forecasts, by cell type, 2017 - 2028 (USD Million)
Table 14 U.S. Advanced Therapy Medicinal Products (ATMP) market estimates & forecasts, by therapy type, 2017 - 2028 (USD Million)
Table 15 U.S. cell therapy market estimates & forecasts, by cell type, 2017 - 2028 (USD Million)
Table 16 Canada Advanced Therapy Medicinal Products (ATMP) market estimates & forecasts, by therapy type, 2017 - 2028 (USD Million)
Table 17 Canada cell therapy market estimates & forecasts, by cell type, 2017 - 2028 (USD Million)
Table 18 Europe Advanced Therapy Medicinal Products (ATMP) market estimates & forecasts, by therapy type, 2017 - 2028 (USD Million)
Table 19 Europe cell therapy market estimates & forecasts, by cell type, 2017 - 2028 (USD Million)
Table 20 Asia Pacific Advanced Therapy Medicinal Products (ATMP) market estimates & forecasts, by therapy type, 2017 - 2028 (USD Million)
Table 21 Asia Pacific cell therapy market estimates & forecasts, by cell type, 2017 - 2028 (USD Million)
Table 22 Collaborations between Japanese players and global (Mesenchymal Stem Cell) MSC biotechs:
Table 23 China Advanced Therapy Medicinal Products (ATMP) market estimates & forecasts, by therapy type, 2017 - 2028 (USD Million)
Table 24 China cell therapy market estimates & forecasts, by cell type, 2017 - 2028 (USD Million)
Table 25 Japan Advanced Therapy Medicinal Products (ATMP) market estimates & forecasts, by therapy type, 2017 - 2028 (USD Million)
Table 26 Japan cell therapy market estimates & forecasts, by cell type, 2017 - 2028 (USD Million)
Table 27 Russia Advanced Therapy Medicinal Products (ATMP) market estimates & forecasts, by therapy type, 2017 - 2028 (USD Million)
Table 28 Russia cell therapy market estimates & forecasts, by cell type, 2017 - 2028 (USD Million)
Table 29 Australia Advanced Therapy Medicinal Products (ATMP) market estimates & forecasts, by therapy type, 2017 - 2028 (USD Million)
Table 30 Australia cell therapy market estimates & forecasts, by cell type, 2017 - 2028 (USD Million)
Table 31 India Advanced Therapy Medicinal Products (ATMP) market estimates & forecasts, by therapy type, 2017 - 2028 (USD Million)
Table 32 India cell therapy market estimates & forecasts, by cell type, 2017 - 2028 (USD Million)
Table 33 RoW Advanced Therapy Medicinal Products (ATMP) market estimates & forecasts, by therapy type, 2017 - 2028 (USD Million)
Table 34 RoW cell therapy market estimates & forecasts, by cell type, 2017 - 2028 (USD Million)