Global Regenerative Medicine Markets, 2010-2018 - Market Driven by Kymriah and Yescarta

Dublin, July 22, 2019 (GLOBE NEWSWIRE) -- The "Global Market for Regenerative Medicine (RM), 2019" report has been added to ResearchAndMarkets.com's offering.

The Regenerative Medicine (RM) Industry also saw venture capital investment expand from a mere $200 million in 2010 to a stunning $14.6 billion in 2018.

The Regenerative Medicine (RM) Industry has been rapidly expanding in recent years, making it a high-value, fast-growth market. Key drivers for the market include high rates of clinical trials, accelerated pathways for product approvals, new technologies to support cell and gene therapy manufacturing, and the potential for cell therapies to revolutionize healthcare.

There are now accelerated pathways for advanced therapy medicinal products (ATMPs) in several countries worldwide, including the U.S., Japan, and South Korea. The legislation took effect in Japan in late 2014, in South Korea in 2016, and in the United States in 2017. Additionally, the EU has a program for product acceleration - Adaptive Pathways. These historic events demonstrate to investors, the public, and funding providers alike that regenerative medicine is a sector that has emerged, no longer one that is evolving in the future.

Big Pharma is also demonstrating a snowballing interest in regenerative medicine. At its core, this is a strategic way for pharmaceutical companies to diversify their product development pipeline. Much of this interest has been driven by progress with immunotherapy treatments, such as CAR-T cell therapies, most notably, Kymriah and Yescarta. After attaining FDA approvals, these two products achieved historic approvals across varied geographic markets, providing hope to millions of cancer patients worldwide.

This upsurge in venture capital investment represents growth of 7,300% over an eight-year period. The aggressive construction of cell and gene therapy manufacturing facilities is also being undertaken by biotech companies seeking their own production capabilities, as well as by CDMOs planning to serve third-party clients from across the RM sector. With more than 900+ brave companies composing the marketplace, regenerative medicine advances are truly disrupting healthcare.

The Regenerative Medicine (RM) Industry includes companies that are developing:

• Stem cell therapies
• Cellular therapies
• Gene therapies
• Tissue engineering
• Direct cell reprogramming
• Exosome therapies
• Cellular scaffolds and matrices
• 3D bioprinting
• Biomaterials
• Combination Products
  

In addition to leveraging an experienced team of analysts, this experience provides the publisher with access to Key Opinion Leaders (KOLs) from across the RM sector, including dozens of executives who were interviewed for this report.

Claim this global strategic report to learn:

• Rates of Regenerative Medicine (RM) Industry Patents, Grants, and Scientific Publications
• RM Clinical Trial Activity by Type, Stage, Sponsor, and Geography
• Market Size Determinations with 5-Year Projections
• Emerging Market Opportunities and Threats
• Approved RM Products, including Dates of Approval and Market Pricing
• Geographic Forces Impacting the RM Industry
• Regulatory Pathways and Accelerated Approval Programs
• Profiles for Leading Market Competitors

Key Topics Covered:

1. REPORT OVERVIEW
1.1 Statement of the Report
1.2 Executive Summary

2. REGENERATIVE MEDICINE (RM): AN INTRODUCTION
2.1 A Bird's Eye View of the RM Industry
2.1.1 Number of RM Companies
2.1.2 Major Therapeutic Platforms and Enabling Technologies in RM Industry
2.1.3 RM Product Approvals in 2017/2018
2.1.4 Total RM Clinical Trials
2.1.5 Total RM Clinical Trials by Technology Type
2.1.6 Patient Impact of Three U.S.-Approved RM Products, 2018
2.1.7 Select Anticipated RM Industry Clinical Trial Data Readouts: 2019
2.2 RM Industry-Total Global Financings: 2018
2.2.1 Total Financings to RM Industry by Type and Year, 2016-2018
2.2.2 Corporate Partnerships (Upfront Payments) in RM Industry, 2018
2.2.3 Private Placements and Venture Financings in RM Industry, 2018
2.2.4 Public Offerings (IPOs & Follo-Ons) in RM Industry, 2018
2.2.5 Total Merger & Acquisition within RM Industry by Year, 2016-2018
2.3 Market Access for Regenerative Medicines as of January 2019
2.4 Anticipated RM Product Launches
2.4.1 Predicted RM Treated Patient Numbers
2.5 Top 20 RM Companies by Pipeline Size
2.6 RM Research Institutes
2.6.1 RM Research Institutes in the U.S.
2.6.2 RM Research Institutes in Europe
2.6.3 RM Research Institutions in Australia
2.6.4 University Research to Products in the Market

3. CELL THERAPY (CT): AN OVERVIEW
3.1 Cell Therapy Timeline
3.2 Types of Stem Cells Used in Cell Therapy
3.2.1 Hematopoietic Stem Cells (HSCs)
3.2.2 Induced Pluripotent Stem Cells (iPSCs)
3.2.3 Mesenchymal Stem Cells (MSCs)
3.2.3.1 Number of MSCs in Clinical Trials
3.2.3.2 Indications for which MSCs are tested in Clinical Trials
3.3 Neural Stem Cells (NSCs)
3.3.1 Indications Addressed by NSCs in Clinical Trials
3.4 Embryonic Stem Cells (ESCs)
3.4.1 Clinical Trials using Human Embryonic Stem Cells (hESCs)
3.4.2 Number of Clinical Trials using hESC-Derived Cells in 2018
3.5 NoTable Events in Cell Therapy Space in 2018
3.6 Top 15 Cell Therapy Companies

4. GENE-MODIFIED CELL THERAPY & IMMUNOTHERAPIES
4.1 Number of Companies Developing Gene-Modified Cell Therapy Products
4.2 CAR-T Cell Therapy
4.2.1 Global Distribution of CAR-T Cell Therapy Companies
4.2.2 Select Events in Cell-Based Immuno-Onclogy Space, 2018
4.3 T-Cell Receptor (TCR) Therapy
4.4 Natural Killer (NK) Cell Therapies
4.5 Tumor Infiltrating Lymphocytes (TILs) Therapy
4.6 Marrow-Infiltrating Lymphocytes (MILs)
4.7 Gamma-Delta T-Cells Therapy
4.7.1 Big Biopharma's Interest in Gamma-Delta T-Cells Therapy
4.8 Dendritic Cell (DC) Therapy
4.8.1 Cancer Types Targeted by Dendritic Cell Therapy Studies
4.8.2 Ongoing Clinical Trials Testing DC Vaccines

5. GENE THERAPY
5.1 Gene Augmentation Therapy
5.2 Gene Inhibition Therapy
5.3 Suicide Gene Therapy
5.4 The Process of DNA Transfer in Gene Therapy
5.5 Ex vivo vs. in vivo Gene Therapies
5.5.1 Ex vivo Gene Therapy
5.5.2 In vivo Gene Therapy
5.6 Autologous vs. Allogeneic Gene Therapies in Development
5.7 Number of Gene Therapy Companies in the World
5.8 Gene Therapy Pipeline Volumes, 1995-2018
5.9 Big Pharma and Cell Therapy/Gene Therapy Development
5.10 Number of Gene Therapy Products Predicted to be Approved in Next Three Years
5.11 Gene Therapy Product Candidates Granted RMAT Designation
5.12 Gene Therapy Companies Active in Neurodegenerative Disorders (ND)
5.12.1 Gene Therapy Developers for Neurodegenerative Diseases
5.12.2 Neurodegenerative Disorders Addressed by Gene Therapy Studies
5.12.3 Anticipated Events in Neurodegenerative Disease Space of Gene Therapy
5.12.4 Important Events in Gene Therapy Space in 2018
5.13 Leading Gene Therapy StartUps

6. TISSUE ENGINEERING
6.1 Smart Biomaterials in TE
6.1.1 Biosynthetic Materials
6.1.2 3D PrinTable Inks
6.2 Synthetic and Naturally-Derived Scaffolds
6.3 Tissue Substitutes
6.3.1 Cell-Based Tissues
6.3.2 Collagen
6.4 Two Key Developments in Tissue Engineering Space in 2018

7. GENE DELIVERY VEHICLES
7.1 Viral Vectors
7.1.1 Physical Properties of Commonly used Viral Vectors
7.1.2 Retrovirus Vectors
7.1.3 Adenovirus Vectors
7.1.4 Herpes Simplex Viral Vectors
7.1.5 Lentivirus Vectors (LV)
7.1.5.1 Utilization of Lentivirus Vectors by Disease Type in Clinical Trials
7.1.5.2 Companies Developing Lentivirus Vectors
7.1.6 Adeno-Associated Virus Vectors
7.1.6.1 Types of Diseases in Clinical Trials using AAV
7.1.6.2 Genes Transduced by AAV for Specific Diseases
7.1.6.3 Companies Developing AAV Vector
7.1.6.4 The Predominantly-Used Viral Vectors
7.2 Non-Viral Vectors
7.2.1 Microinjection
7.2.2 Particle Bombardment
7.2.3 Laser Iradiation
7.2.4 Electroporation
7.2.5 Magnetofection
7.2.6 Sonoporation

8. RM: CLINICAL TRIAL LANDSCAPE
8.1 Number of People Participating in RM Clinical Trials
8.2 Clinical Trials by Therapeutic Category in the RM Sector, 2018
8.3 Cell Therapy Clinical Trials
8.3.1 Cell Therapy Clinical Trials by Indication
8.3.2 Mesenchymal Stem Cells in Clinical Trials
8.3.3 Anticipated Clinical Events in Cell Therapy Space
8.3.3.1 Remestemcel-L
8.3.3.2 Tab-Cel
8.3.3.3 MultiStem
8.4 Clinical Trials in Gene-Modified Cell Therapies Space
8.4.1 Most Popular Target Antigens for CAR-T Cell Therapies
8.4.2 Antigens other Than CD19 in Clinical Trials Targeted by CAR-T
8.4.3 Antigens Targeted by CAR-T in Solid Cancers in Clinical Trials
8.4.4 Anticipated Developments in CAR-T Space
8.5 Number of Gene Therapy Clinical Trials
8.5.1 Therapy Clinical Trials by Geography
8.5.2 Diseases Targeted by Gene Therapy
8.5.3 Gene Types Transduced in Clinical Trials
8.5.4 Vectors used in Gene Therapy Clinical Trials
8.5.5 Gene Therapy Clinical Trials for Neurodegenerative Indications by Type
8.5.6 Domination of Oncology in Gene Therapy Drug Development
8.5.7 Dominance of Viral Vectors in Gene Therapy
8.5.8 Gene Therapy Alliances Volume and Value, 2012-2018
8.5.9 Anticipated Clinical Events in Gene Therapy Space, 2019/2020
8.6 Number of Tissue Engineering Clinical Trials
8.6.1 Anticipated Clinical Events in Tissue Engineering Space

9. APPROVED RM PRODUCTS WORLDWIDE
9.1 Number of RM Products Approved by Geography
9.1 Approval of RM Products by Year
9.2 RM Products with MA Worldwide by Therapy Type
9.2.1 Indications Addressed by the Approved RM Products
9.3 Approved RM Products in Australia
9.3.1 Ortho-ACI
9.4 RM Products Approved in Canada
9.5 Gene Therapy Product Approved in China
9.6 Approved RM Products in Europe
9.6.1 Yescarta (Axicabtagene ciloleucel)
9.6.2 Kymriah (Tisagenlecleucel)
9.6.3 Alofisel
9.6.4 Spherox
9.6.5 Zalmoxix
9.6.6 Strimvelis
9.6.7 Imlygic (Talimogene laherparepvec)
9.6.8 Holoclar
9.6.9 RM Products with Withdrawn Approvals in Europe
9.7 Approved RM Products in India
9.7.1 Cartigrow
9.7.2 Ossgrow
9.7.3 Apceden
9.7.4 Stempeucel
9.8 RM Products Approved in Japan
9.8.1 TEMCELL HS Inj.
9.8.2 HeartSheet
9.8.3 JACC
9.9 RM Products Approved in New Zealand
9.9.1 Prochymal
9.10 RM Products Approved in South Korea
9.10.1 KeraHeal-Allo
9.10.2 Neuronata-R
9.10.3 Cupistem
9.10.4 Cartistem
9.10.5 Cellgram-AMI
9.10.6 CureSkin Inj.
9.10.7 Queencell
9.10.8 Kaloderm
9.10.9 RMS Ossron
9.10.10 Immuncell LC
9.10.11 CreaVax-RCC
9.10.12 Kera Heal
9.10.13 Chondron
9.11 Approved RM Products in the U.S.
9.11.1 HPC, Cord Blood
9.11.2 Luxturna (voretigene neparvovec-rzyl)
9.11.2.1 Mechanism of Action
9.11.3 Yescarta (axicabtagene ciloleucel)
9.11.3.1 Mechanism of Action
9.11.4 Kymriah (tisagenlecleucel)
9.11.4.1 Mechanism of Action
9.11.5 MACI
9.11.6 Clevecord
9.11.7 HPC, Cord Blood (Bloodworks)
9.11.8 Imlygic (talimogenelaherparepvec)
9.11.9 HPC, Cord Blood (LifeSouth Community Blood Centers)
9.11.10 Allocord
9.11.11 Ducord
9.11.12 HPC, Cord Blood (Clinimmune Labs)
9.11.13 Gintuit
9.11.14 Hemacord
9.11.15 Laviv (Azficel-T)
9.11.16 Provenge (Sipuleucel-T)
9.12 U.S. RM Products with RMAT Designation
9.13 Pricing of RM Products
9.14 RM Products Expected to be Approved in Late 2019 or 2020

10. MANUFACTURING OF CELLS FOR CELL AND GENE THERAPIES
10.1 Cost of Manufacture
10.1.1 Cost of Manufacture in a Partially-Automated Facility
10.1.2 Cost of Manufacture in a Fully-Automated Facility
10.1.3 Net Present Cost (NPC) of the Three Methods
10.2 In-House Gene Therapy Manufacturing Capabilities of Select Big and Mid Pharma
10.3 External Gene Therapy Manufacturing by Big and Mid Pharma
10.4 Cell and Gene Therapy Manufacturing Capacities in North America
10.5 Cell and Gene Therapy Manufacturing Capacities in Europe

11. CDMOs & CDMOs
11.1 Appropriate Phase for Outsourcing
11.2 Important Points Condirered while Fixing a CMO/CDMO
11.3 In-House vs. Outsourcing
11.4 Number of Cell Gene Therapy CMOs/CDMOs in Europe
11.5 Projected Growth of CMOs and CDMOs
11.6 Projected Growth of Cell Manufacturing Capacity

12. MARKET ANALYSIS
12.1 Global Market for RM Products
12.1.1 Global RM Products Market by Geography
12.2 Global Market for Cell Therapy Products
12.3 Global Market for Gene Therapy Products
12.3.1 Competitive Landscape in Gene-Modified Cell Therapy Products
12.3.2 Global Market for Viral Vector and Plasmid DNA Manufacturing
12.4 Global Market for Tissue-Engineered Products

13. COMPANY PROFILES

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