Global Market for Cell Therapy & Tissue Engineering, 2019: The Arrival of Regenerative Medicine (RM) has been Propelled by Advances Across the Cell Therapy (CT) and Tissue (TE) Engineering Industries


Dublin, April 30, 2019 (GLOBE NEWSWIRE) -- The "Market for Cell Therapy and Tissue Engineering - Market Size, Forecasts, Technologies & Trends" report has been added to ResearchAndMarkets.com's offering.

This report contains an analysis of developments across the rapidly evolving fields of cell therapy (CT) and tissue engineering (TE), with a focus on competitive dynamics and commercial successes and failures.

This report highlights important issues across these interrelated fields, including market challenges, economic evaluation, policy improvements, pricing and reimbursement, and rates of global adoption. Because several of the developments in cell therapy and regenerative medicine (RM) are closely related, the report also gives an overview of the regenerative medicine industry.

One of the earliest examples of cell therapy was the transplantation of hematopoietic stem cells (HSCs) in the 1950s from a donor to a recipient to create a bone marrow transplant, which today represents a well-established type of cell therapy practiced worldwide. Newer forms of cell therapy involve the delivery of other cell types to a patients, including CAR-T and CAR-NK cells, mesenchymal stem cells (MSCs), neural stem cells (NSCs), and to a lesser degree, induced pluripotent stem cells (iPSCs), embryonic stem cells (ESCs), directly reprogrammed cells, and other pluripotent and differentiated cell types.

Because tissue engineering (TE) integrates cellular products with scaffolds, it is integral to the field of cell therapy. These scaffolds are often made using naturally occurring proteins or biocompatible synthetic polymers. Some TE products are made using a protein-based extracellular matrix (ECM) obtained from a donor. The ECM is prepared by removing the cells by a process called decellularization. Cells and growth factors are seeded on to the ECM to develop a tissue or organ.

Cell therapy, gene-modified cell therapy, gene therapy, and tissue engineering are the four pillars of regenerative medicine (RM). These therapies have the potential to favorably change the quality of life and improve the health status of patients suffering from cellular defects, genetic diseases, neurodegenerative diseases, tissue malignancies, and other medical conditions. The combined efforts of research and clinical scientists in academic, translational and industry settings have led us to the development of several approved commercial firsts, such as Glybera, Kymriah, Yescarta, Holoclar, and Luxturna.

Today, the healthcare environment is under great pressure to develop therapies capable of reversing or significantly impacting the progression of serious illnesses. The arrival of regenerative medicine (RM) has been propelled by advances across the cell therapy (CT) and tissue (TE) engineering industries. Regenerative medicines have the potential to transform the healthcare landscape by providing transformative, durable and potentially curative outcomes to human injuries, diseases, and genetic disorders.

With the number of regenerative medicine firms expanding exponentially, over a thousand clinical trials ongoing worldwide (>50% in oncology), and key strategic alliances underway among industry and academic partners, the success of regenerative medicine therapies seems to be a certainty.

This report reports the market for regenerative medicine (RM) products approved worldwide, including 44 approvals across the U.S., Europe, South Korea, India, China, Japan, Australia and New Zealand. Additionally, the RM sector saw venture capital investment grow from a mere $200 million in 2010 to a massive $14.6 billion in 2018. This massive investment and market growth in the RM space indicates a future with heavy competition.

Thus, the main objectives of this cell therapy (CT) and tissue engineering (TE) report are to provide the reader with the following details:

  • Total global financings in cell therapy and gene-modified cell therapy space.
  • Corporate partnerships in cell therapy and gene-modified cell therapy space.
  • Private placements and venture financings in cell therapy and gene-modified cell therapy space.
  • The history of cell therapy from 1944 to present.
  • Potential applications of cell therapy.
  • FDA-approved cell therapy products made from human HSCs.
  • Leading induced pluripotent stem cell (iPSC) companies.
  • Potential applications of iPSCs.
  • Various sources of mesenchymal stem cells (MSCs).
  • Various clinical applications of mesenchymal stem cells (MSCs).
  • Various biologically-active substances secreted by mesenchymal stem cells (MSCs).
  • The estimated consumption of MSCs in the cell therapy industry (future projections).
  • Other cell types with the potential to disrupt MSC's demand.
  • Approved MSC-based cell therapy products in the global market.
  • Diseases addressed by neural stem cells in clinical trials.
  • Leading companies in neural stem cells space.
  • Indications addressed by human embryonic stem cells (hESCs) in clinical trials.
  • Leading cell therapy startups.
  • Cell therapies with RMAT designation.
  • Number of gene-modified cell therapy companies.
  • Number of CAR-T cell therapy companies.
  • Number of NK cell therapy companies in the world.
  • Approved TE products in the global market.
  • Number of cell therapy clinical trials.
  • Diseases addressed by MSCs in clinical trials.
  • Number of clinical trials using MSCs.
  • Anticipated clinical events in cell therapy space.
  • Number of clinical trials in gene-modified cell therapy space.
  • Anticipated developments in cell therapy space in 2019.
  • Number of clinical trials in Tissue Engineering (TE) space.
  • Approved cell therapy products by geography.
  • Approved tissue engineering (TE) products by geography.
  • Cell and gene therapy manufacturing capacities in the U.S. and Europe.
  • Select CMOs/CDMOs in cell and gene therapy space.
  • Projected outsourcing market for the manufacture of cell and gene therapy products.
  • Projected growth of cell manufacturing capacity.
  • Global market for cell therapy products by geography.
  • Global market for tissue-engineered products by geography.
  • Profiles of companies that are developing products in cell therapy and tissue engineering spaces.

For companies involved with the commercialization of cell therapy (CT) and tissue engineering (TE) products, this report provides market size determinations, coupled with five-year forecasts and trends. It analyzes emerging market forces, highlights industry partnerships and deal-making, and captures the progression of cell therapy and tissue engineering products across various states of development.

With the rapid evolution of this market sector, this global strategic report is your guide to research advances, clinical breakthroughs, and commercialized successes.

Topics Covered

1. REPORT OVERVIEW
1.1 Statement of the Report
1.2 Executive Summary
1.3 Cell Therapy Industry: An Overview
1.4 Tissue Engineering Industry: An Overview

2. BRIEF OVERVIEW OF REGENERATIVE MEDICINE (RM) INDUSTRY
2.1 Number of RM Companies
2.2 RM Product Approvals in 2017/2018
2.3 RM Products with RMAT Designation
2.4 Total RM Clinical Trials
2.5 RM Industry: Total Global Financings, 2018
2.6 Anticipated RM Product Launches
2.7 Top 20 RM Companies by Pipeline Size

3. CELL THERAPY (CT): AN OVERVIEW
3.1 Cell Therapy Timeline
3.2 Hematopoietic Stem Cells (HSCs)
3.3 Induced Pluripotent Stem Cells
3.4 Mesenchymal Stem Cells (MSCs)
3.5 Neural Stem Cells (NSCs)
3.6 Embryonic Stem Cells (ESCs)
3.7 Notable Events in Cell Therapy Space, 2018
3.8 Top 16 Stem Cell Therapy Startups
3.9 Cell Therapies with RMAT Designation

4. GENE-MODIFIED CELL THERAPY
4.1 Number of Gene-Modified Cell Therapy Companies
4.2 CAR-T Cell Therapy
4.3 Select Events in Cell-Based Immuno-Oncology Space, 2018
4.4 T-Cell Receptor Therapy (TCR Therapy)
4.5 Natural Killer (NK) Cell Therapies
4.6 Tumor Infiltrating Lymphocytes (TILs) Therapy
4.7 Marrow-Infiltrating Lymphocytes (MILs)
4.8 Gamma-Delta T-Cells Therapy
4.9 Dendritic Cell (DC) Therapy

5. TISSUE ENGINEERING
5.1 Smart Biomaterials in Tissue Engineering
5.2 Synthetic and Naturally-Derived Scaffolds
5.3 Tissue Substitutes
5.4 TWO Key Developments in Tissue Engineering Space in 2018

6. CLINICAL TRIAL LANDSCAPE: REGENERATIVE MEDICINE
6.1 Number of Patient Participation in RM Clinical Trials, 2018
6.2 Number of Clinical Trials by Indications in the RM Sector, 2018

7. CELL THERAPY CLINICAL TRIALS
7.1 Cell Therapy Clinical Trials by Indication, 2018
7.2 Mesenchymal Stem Cells (MSCs) in Clinical Trials
7.3 Clinical Trials using hESCs
7.4 Anticipated Clinical Events in Cell Therapy Space

8. CLINICAL TRIALS IN GENE-MODIFIED CELL THERAPIES
8.1 The Most Common Target Antigens for CAR-T Cell Therapies
8.2 Antigens other than CD19 in Clinical Trials Targeted by CAR-T
8.3 Antigens Targeted by CAR-T in Solid Cancers in Clinical Trials
8.4 Anticipated Developments in CAR-T Space

9. CLINICAL TRIALS IN TISSUE ENGINEERING SPACE
9.1 Anticipated Clinical Events in Tissue Engineering Space, 2019/2020

10. APPROVED CELL THERAPY PRODUCTS WORLDWIDE
10.1 Number of Cell Therapies Approved by Geography
10.2 Cell Therapy Products by Therapy Type
10.3 Indications Addressed by the Approved Cell Therapy Products
10.4 Approved Cell Therapy Product in Australia
10.5 Cell Therapy Products Approved in Canada
10.6 Approved Cell Therapies in Europe
10.7 Approved Cell Therapy Products in India
10.8 Approved Cell Therapy Product in Japan
10.9 Approved Cell Therapy Product in New Zealand
10.10 Approved Cell Therapy Products in South Korea
10.11 Approved Cell Therapy Products in the U.S

11. APPROVED TISSUE ENGINEERED (TE) PRODUCTS
11.1 Spherox
11.2 HeartSheet
11.3 JACC
11.4 JACE
11.5 Kaloderm
11.6 Holoderm
11.7 MACI
11.8 GINTUIT

12. MANUFACTURING OF CELLS FOR CELL THERAPIES
12.1 Cost of Cell Manufacture
12.2 In-House Gene Therapy Manufacturing Capabilities of Select Big and Mid Pharma
12.3 External Gene Therapy Manufacturing by Big and Mid Pharma
12.4 Cell Manufacturing Capacities in North America
12.5 Cell Manufacturing Capacities in Europe

13. CMOs & CDMOs
13.1 Appropriate Phase for Outsourcing
13.2 Important Points Condirered while Fixing a CMO/CDMO
13.3 In-House vs. Outsourcing
13.4 Number of Cell Gene Therapy CMOs/CDMOs in Europe
13.5 Projected Growth of CMOs and CDMOs
13.6 Projected Growth of Cell Manufacturing Capacity

14. MARKET ANALYSIS
14.1 Global Market for RM Products
14.2 Global Market for Cell Therapy Products
14.3 Global Market for Gene-Modified Cell Therapy Products
14.4 Global Market for Tissue-Engineered Products

15. COMPANY PROFILES
15.1 Adaptimmune Therapeutics plc
15.2 Admedus Ltd
15.3 Advanced Bioscience Laboratories, Inc.
15.4 Allogene Therapeutics, Inc
15.5 AlloSource, Inc.
15.6 Ambys Medicines, Inc.
15.7 Anterogen Co., Ltd.
15.8 APAC Biotech Pvt., Ltd.
15.9 apceth Biopharma GmbH
15.10 Asterias Biotherapeutics, Inc
15.11 Atara Biotherapeutics, Inc.
15.12 Athersys, Inc
15.13 ATVIO Biotech Ltd
15.14 AveXis, Inc.
15.15 Avita Medical Ltd
15.16 Batavia Bioscience B.V.
15.17 Bellicum Pharmaceuticals, Inc.
15.18 Betalin Therapeutics
15.19 BioCardia, Inc
15.20 BioReliance Corporation
15.21 Biosolution Co., Ltd.
15.22 Biostage, Inc
15.23 Biovian Oy
15.24 BlueRock Therapeutics
15.25 Bone Therapeutics SA
15.26 Brainstorm Cell Therapeutics, Inc
15.27 Brammer Bio, LLC
15.28 Caladrius Biosciences, Inc
15.29 Carina Biotech
15.30 CARsgen Therapeutics, Ltd
15.31 Cell Cure Neurociences Ltd
15.32 Cellerant Therapeutics, Inc.
15.33 Cell Medica Limited
15.34 Cell Therapy Catapult, Ltd
15.35 Cellular Biomedicine Group, Inc
15.36 Cellular Dynamics International, Inc
15.37 Celonic AG
15.38 Celyad SA
15.39 Farmaceutici S.p.A
15.40 Cobra Biologics Ltd.
15.41 co-don AG
15.42 Corestem, Inc.
15.43 Cynata Therapeutics, Ltd
15.44 Cytori Therapeutics, Inc
15.45 Dendreon Pharmaceuticals, Inc.
15.46 Enzyvant, Inc.
15.47 Eureka Therapeutics, Inc
15.48 Fate Therapeautics, Inc
15.49 Fibrocell Technologies, Inc.
and many more...

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