Global Regenerative Medicine (RM) Market Report 2019: Big Pharma is Demonstrating an Interest in Regenerative Medicine

DUBLIN, June 20, 2019 /PRNewswire/ -- The "Global Market for Regenerative Medicine (RM), 2019" report has been added to ResearchAndMarkets.com's offering.

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
• And More

As the first and only market research firm to specialize in the stem cell industry, the publisher has an exceptional and unique understanding of the Regenerative Medicine (RM) Industry. Founded in 2006, the publisher has collected over 13 years of historical data on the RM industry, providing it with a robust historical database of data on which to make future market projections. Headquartered in Washington, DC, the publisher is strategically positioned near industry lawmakers, the National Institutes of Health (N.I.H.), the U.S. FDA, and the Maryland Biotech Corridor, among other critical resources.

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. To date, the publisher has interviewed leadership from FUJIFILM, Pluristem Therapeutics, Cynata Therapeutics, RooserBio, Celularity, Hemostemix, Glycostem, Accellta, ORIG3N, Gamida Cell, Nohla Therapeutics, Fortuna Fix, Avery Therapeutics, Stem Cell Medicine Ltd., Minerva Biotechnologies, Celyad, Universal Cells, Rhemastem, and hundreds of others.

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

3. CELL THERAPY (CT): AN OVERVIEW
3.1 Cell Therapy Timeline
3.2 Types of Stem Cells Used in Cell Therapy
3.3 Neural Stem Cells (NSCs)
3.4 Embryonic Stem Cells (ESCs)
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)
9.11.5 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
10.2 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

• 4D Molecular Therapeutics, LLC
• Abeona Therapeutics, Inc.
• Adaptimmune Therapeutics plc
• Admedus Ltd.
• Advanced Bioscience Laboratories, Inc.
• Adverum Biotechnologies, Inc.
• Akouos, Inc.
• Aldevron, LLC
• Allogene Therapeutics, Inc.
• AlloSource, Inc.
• Amarna Therapeutics B.V.
• Ambys Medicines, Inc.
• American Gene Technologies International, Inc.
• Amgen, Inc.
• Amicus Therapeutics, Inc.
• Anterogen Co., Ltd.
• APAC Biotech Pvt., Ltd.
• apceth Biopharma GmbH
• AskBio/Asclepios Biopharmaceutical, Inc.
• Asterias Biotherapeutics, Inc.
• Atara Biotherapeutics, Inc.
• Athersys, Inc.
• ATVIO Biotech Ltd.
• Audentes Therapeutics, Inc.
• AveXis, Inc.
• Avita Medical Ltd.
• AVROBIO, INC.
• Batavia Bioscience B.V.
• Bellicum Pharmaceuticals, Inc.
• Benitec Biopharma Limited
• Betalin Therapeutics
• BioCardia, Inc.
• Biomay AG
• BioReliance Corporation
• Biosolution Co., Ltd.
• Biostage, Inc.
• Bioverativ, Inc.
• Biovian Oy
• bluebird bio, Inc.
• BlueRock Therapeutics
• Bone Therapeutics SA
• Brainstorm Cell Therapeutics, Inc.
• Brammer Bio, LLC
• Caladrius Biosciences, Inc.
• Carina Biotech
• CARsgen Therapeutics, Ltd.
• Casebia Therapeutics
• Cell Cure Neurociences Ltd.
• Cell Medica Limited
• Cell Therapy Catapult, Ltd.
• Cellerant Therapeutics, Inc.
• Cellular Biomedicine Group, Inc.
• Cellular Dynamics International, Inc.
• Celonic AG
• Celyad SA
• Cevec Pharmaceuticals GmbH
• co-don AG
• Cobra Biologics Ltd.
• CombiGene AB
• Corestem, Inc.
• CRISPR Therapeutics AG
• CureVac
• Cynata Therapeutics, Ltd.
• CytomX Therapeutics, Inc.
• Cytori Therapeutics, Inc.
• Delphi Genetics S.A.
• Dendreon Pharmaceuticals, Inc.
• DNAlite Therapeutics, Inc.
• Editas Medicine, Inc.
• Elixirgen Therapeutics, LLC
• Enzyvant, Inc.
• Eukarys
• Eureka Therapeutics, Inc.
• Farmaceutici S.p.A.
• Fate Therapeautics, Inc.
• Fibrocell Technologies, Inc.
• FinVector Vision Therapies Oy
• Freeline Therapeutics Ltd.
• FUJIFILM Diosynth Biotechnologies, Inc.
• Gamida Cell Ltd.
• GC Cell
• GEG Tech
• Gemini Therapeutics, Inc.
• Generation Bio Co.
• Genethon
• Genzyme Corporation
• Glycostem Therapeutics BV
• Hemostemix, Inc.
• Histogenics Corporation
• Homology Medicines, Inc.
• Horama SAS
• Humacyte, Inc.
• Immune Design Corporation
• Immusoft Corporation
• Innovative Cellular Therapeutics Co., Ltd.
• Intellia Therapeutics, Inc.
• Iovance Biotherapeutics, Inc.
• J-TEC
• JCR Pharmaceuticals Co., Ltd.
• JW CreaGene Co., Ltd.
• Kadimastem Ltd.
• Kaneka Eurogentec S.A.
• KBI Biopharma, Inc.
• Kiadis Pharma N.V.
• Kite Pharma, Inc.
• Kolon Lifescience, Inc.
• Krystal Biotech, Inc.
• LakePharma
• Lion TCR Pte. Ltd.
• Lonza Group Ltd.
• Lysogene S.A.
• Magenta Therapeutics, Inc.
• MassBiologics
• MaxCyte, Inc.
• Medigene AG
• MEDIPOST CO., Ltd.
• MeiraGTx Holdings plc
• Mesoblast Limited
• Miromatrix Medical, Inc.
• MolMed S.p.A
• multimmune GmbH
• Mustang Bio, Inc.
• Myonexus Therapeutics, Inc.
• NantKwest, Inc.
• Neuralstem, Inc.
• NexImmune, Inc.
• Nightstar Therapeutics plc
• Nohla Therapeutics, Inc.
• Novartis AG
• Novasep Holding SAS
• Noveome Biotherapeutics, Inc.
• NuVasive, Inc.
• Orchard Therapeutics plc
• Orgenesis, Inc.
• Orthocell Limited
• Orthofix Medical, Inc.
• Osiris Therapeutics, Inc.
• Oxford BioMedica plc
• Oxford Genetics Ltd.
• Paragon Bioservices, Inc.
• Pharmicell Co., Ltd.
• Pluristem Therapeutics, Inc.
• Posedia Therapeutics, Inc.
• Precision BioSciences, Inc.
• Prevail Therapeutics, Inc.
• PROMETHERA Biosciences S.A.
• PTC Therapeutics, Inc.
• Quethera Ltd.
• Recipharm AB
• Regenerative Medical System (RMS)
• REGENXBIO, Inc.
• ReNeuron Group plc
• Renova Therapeutics, Inc.
• Richter-Helm BioLogics GmbH & Co. KG.
• Rocket Pharmaceuticals, Inc.
• RoosterBio, Inc.
• RoslinCT
• Rubius Therapeutics, Inc.
• Sangamo Therapeutics, Inc.
• Sarepta Therapeutics, Inc.
• SCM Lifesciences Co., Ltd.
• Semma Therapeutics Inc.
• Sentien Biotechnologies, Inc.
• Sibiono GeneTech Co., Ltd.
• Sirion Biotech GmbH
• Solid Biosciences, Inc.
• Spark Therapeutics, Inc.
• SQZ Biotechnologies
• Stempeutics Research Pvt., Ltd.
• Synpromics Ltd.
• Takara Bio, Inc.
• Terumo Corporation
• The Cell and Gene Therapy Catapult
• Translate Bio, Inc.
• Triumvira Immunologics USA, Inc.
• TxCell S.A.
• Ultragenyx Pharmaceutical, Inc.
• uniQure N.V.
• Vericel Corporation
• Vertex Pharmaceuticals, Inc.
• VGXI, Inc.
• ViaCyte, Inc.
• Vibalogics GmbH
• Vigene Biosciences
• Virovek, Inc.
• Vivebiotech SL
• Vivet Therapeutics
• Voyager Therapeutics, Inc.
• Vybion, Inc.
• Waisman Biomanufacturing
• WindMIL Therapeutics, Inc.
• Wuxi App Tec, Inc.
• Xalud Therapeutics, Inc.

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