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New Biotechnology Report: Regenerative Medicine Markets

June 25, 2013

MarketResearch.com announces the addition of a new market research report in Biotechnology to their product offering:Regenerative Medicine Markets; http://www.marketresearch.com/land/product.asp?productid=7458272&progid=85536

Rockville, MD (PRWEB) June 25, 2013

Regenerative Medicine Markets

TriMarkPublications.com cites in its newly published “Regenerative Medicine Markets” report that the regenerative medicine market will catapult to over $35 billion by 2019.

Regenerative medicine is a way of treating injured and diseased human tissue by using laboratory-grown or therapeutically-induced human tissue as a replacement. As such, astounding new advancements in the ability to repair or replace damaged human tissue and organ functions are being made. Whereas before, remedies for damaged tissue or organ functions due to congenital deformities, injuries, diseases or simple wear-and-tear relied upon either the body's ability to repair itself (or not), or a surgeon's skilled hands.

Now, the area of regenerative medicine promises to revolutionize humanity's ability to remediate countless physical maladies that have perpetually afflicted humans and other animals. Compared to a select few life forms–like the starfish–man-made solutions for tissue repair and organ replacement haven't come close to nature's solutions. And where there once was no solution even offered by nature, researchers are now at the cusp of overcoming such limitations by literally regrowing damaged tissue and restoring organ functions through the use of tissue engineering and stem cell therapy. This is the promise of regenerative medicine.

Regenerative medicine (RM) can be categorized into three main modalities: tissue engineering, biomaterials and biomolecules, e.g., scaffolds, growth factors and stem cell therapy. Tissue-engineered bone products in the orthopedic segment will see steady growth, from $7.5 billion in 2012 to $3.29 billion in 2019. The up-and-coming cardiology and vascular products segment will also see substantial growth, reaching a market value of $3.29 over the forecast period.

“Regenerative Medicine Markets” discusses the current state of regenerative medicine. The study provides a thorough overview of regenerative medicine sector together with analyses of the funding trends, intellectual property, market opportunities, therapeutic pipeline, research collaborations, partnership activities, and guidelines for establishing new ventures.

The report enables the reader gain in-depth knowledge about ongoing tissue engineering and stem cell therapy research programs carried out in universities and other research centers. Moreover, this analysis profiles the leading companies developing regenerative medicine solutions. Detailed charts with sales forecasts and market share data are included.

Regenerative Medicine Markets – Table of Contents:

1. Overview

1.1 Statement of Report

1.2 Scope of this Report

1.3 Methodology

1.4 Executive Summary

2. Regenerative Medicines: An Overview of Segments

2.1 Tissue Engineering

2.1.1 Tissue-Engineered Skin

2.1.2 Tissue-Engineered Cartilage

2.1.3 Tissue-Engineered Bone

2.1.4 Tissue-Engineered Peripheral Nerves

2.1.5 Tissue-Engineered Cornea

2.1.6 Tissue-Engineered Blood Vessels

2.1.7 Progress and Promises for Tissue Engineering Industry

2.1.7.1 Key Positioning Strategies in Tissue Engineering Industry

2.1.7.2 Tissue Engineering Industry Participants

2.1.7.3 Tissue Engineering Firms by their Product Applications

2.1.7.4 Number of TEFs Focused on Skin, Cartilage, Bone and Urological Products

2.1.7.5 Number of Tissue Engineering Firms Focused on Cardiovascular Products

2.1.7.6 Number of Tissue Engineering Firms Focused on Neurological Products

2.1.7.7 Number of Tissue Engineering Firms Focusing on Pancreas, Liver and Kidney

2.1.7.8 Tissue Engineering Firms Focused on Ophthalmic Products

2.1.7.9 Tissue Engineering Firms Involved in Dental Products

2.1.7.10 Number of TEFs Involved in Autologous and Allogenic Products

2.1.7.11 Geographic Distribution of Tissue Engineering Firms in Major Markets

2.2 Cell Therapy

2.2.1 Progress in Cell Therapy Product Research

2.2.2 Commercially Available Cell Therapy Products

2.2.3 Major Cell Therapy Companies

2.2.4 Locations of Cell Therapy Companies

2.2.5 Disease Focus by Cell Therapy

2.2.6 Cell Therapy Products and Companies

2.2.6.1 Autologous Structural Products for Cartilage, Skin, Bone, etc.

2.2.7 Potential Patients for Cell Therapy in the U.S.

2.2.8 Number of Patients Treated Between 1988 and 2010 by Cell Therapy

2.2.9 Cell Therapy Pipeline

2.2.10 Cell Therapy Clinical Trials by Indication

2.2.10.1 Major Cell Therapy Clinical Trials for Diabetes

2.2.10.2 Progress in Clinical Trials for Diabetes

2.2.10.3 Estimated Completion Dates for Cell Therapy Clinical Trials in Diabetes

2.2.11 Major Four Targeted Disease Conditions for Clinical Trials

2.2.12 Commercial Success of Cell Therapies in Europe

2.2.13 Deals in Cell Therapy, 2007-2011

2.2.14 Commercial-Stage Cell Therapy Companies and Products

2.2.15 Cell Therapy Clinical Trials in the U.K.

2.2.15.1 Clinical Trials Involving Allogeneic vs. Autologous Products in the U.K.

2.2.15.2 Cell Types Involved in the U.K. Clinical Trials

2.2.15.3 U.K. Cell Therapy Clinical Trials by Indication

2.3 Cell Culture Products

2.3.1 Market for Reagents Used in Cell Culture

2.3.2 Cell Culture Media

2.3.3 Market for Sera Used in Cell Culture

2.3.3.1 Suppliers of Culture Media and Reagents

2.3.3.2 In Vitro Test Kits

2.3.3.3 Suppliers of Cells and Tissues

2.3.3.4 Equipment for Stem Cell Research

2.3.3.5 Computer Software for Stem Cell Research

2.4 Scaffolding Biomaterials

2.5 Growth Factors

3. Regenerative Medicine: The Next Evolution of Medical Treatment

3.1 Scope of this Chapter

3.2 Need for Regenerative Medicine

3.3 Current State of Regenerative Medicines

3.4 Future of Regenerative Medicine

3.4.1 Number of Products in Pipeline

3.5 Projected Timeline for Regenerative Medicine

3.6 Selected Regenerative Medicine Products in the Market

3.6.1 Medtronic’s Infuse Bone Graft and LT-Cage Device

3.6.2 Genzyme’s Corticel

3.6.3 OP-1 from Stryker

3.6.4 Osteocel from Osyris/Nuvasive

3.6.5 Spinal Implants from RTI Biologics

3.6.6 Apligraf from Organogenesis

3.6.7 Dermograft from Advanced BioHealing

3.6.8 Integra’s Bilayer Matrix for Wound Dressing

3.6.9 Alloderm from LifeCell

3.6.10 Celution from Cytori Therapeutics

3.6.11 Other Products of Importance in Regenerative Medicine

3.6.12 Tissue-Engineered Wound Healing Products

3.6.12.1 Oasis

3.6.12.2 Permacol

3.6.12.3 EZ-Derm

3.6.12.4 Matriderm

3.6.12.5 TransCyte

3.6.12.6 ICX-SKN

3.6.12.7 OrCel

3.6.12.8 Epicel

3.6.12.9 Myskin

3.6.12.10 VCT01

3.6.13 ICX-TRC—Hair Regeneration Therapy

3.6.14 Cartilage Regeneration

3.6.14.1 Novocart

3.6.14.2 BioSeed-C

3.6.14.3 BioSeed—Oral Bone

3.6.14.4 Chondrotissue

3.6.14.5 co.don Chondrotransplant

3.6.14.6 co.don Chondrotransplant DISC

3.6.14.7 co.don Chondrosphere

3.6.14.8 co.don Osteotransplant DENT

3.6.14.9 MACI Implant

3.6.14.10 Cartilink-3

3.6.14.11 Accell Evo3 Demineralized Bone Matrix

3.6.14.12 OsSatura BCP

3.6.15 Mozobil

3.7 Clinical Milestones in RM Sector, 2011-2012

3.7.1 GINTUIT (March 2012)

3.7.2 Ixmyelocel-T (February 2012)

3.7.3 Autologous CD34+ Stem Cells (February 2012)

3.7.4 HuCNS-SC (February 2012)

3.7.5 DeNovo ET (February 2012)

3.7.6 Retinal Pigment Epithelium Cells (January 2012)

3.7.7 AMR-001 (January 2012)

3.7.8 Avance Nerve Graft (January 2012)

3.7.9 Adipose-Derived Stem Cells to Treat Myocardial Ischemia (January 2012)

3.7.10 T-Cells Resistant to HIV (January 2012)

3.7.11 Tissue-Engineered Windpipe (November 2011)

3.7.12 Revascor (November 2011)

3.7.13 ReN001 Stem Cell Therapy (September 2011)

3.7.14 HP802-247 Allogeneic Cell Suspension for Leg Ulcers (August 2011)

3.7.15 ALD-301 for Critical Limb Ischemia (May 2011)

3.7.16 JVS-100 for Heart Failure (April 2011)

3.7.17 MultiStem for Ulcerative Colitis (March 2011)

3.7.18 HuCNS-SC Human Neural Stem Cells (March 2011)

3.8 Accelerated Pace of Deals in RM Sector

3.8.1 Acquisitions and Partnerships

3.8.1.1 Shire’s Acquisition of Advanced BioHealing, Inc. (May 2011)

3.8.1.2 Terumo Americas Holding’s Acquisition of Harvest Technologies (April 2011)

3.8.1.3 Sanofi’s Acquisition of Genzyme Corporation (February 2011)

3.8.1.4 NeoStem’s Acquisition of Progenitor Cell Therapy, LLC (January 2011)

3.8.1.5 Strategic Alliance between Mesoblast and Cephalon, Inc. (December 2011)

3.8.2 Notable Financings

3.8.2.1 Financing to AlloCure, Inc. (April 2012)

3.8.2.2 Financing to Promethera Biosciences (March 2012)

3.8.2.3 Financing to In Vivo Therapeutics Holdings Corp. (February 2012)

3.8.2.4 Financing to Organovo (March 2012)

3.8.2.5 Financing to Cytomedix, Inc. (February 2012)

3.8.2.6 Financing to Fate Therapeutics, Inc. (May 2011)

3.8.2.7 Financing to Cellular Dynamics International, Inc. (April 2011)

3.8.2.8 Financing to Cytori Therapeutics (December 2010)

3.8.2.9 Overview of Capital Formation in RM Industry

4. Recent Advances in Regenerative Medicine and Stem Cell Research

4.1 Bioengineered Autologous Vein

4.2 Stem Cell Treatment for Spinal Cord Injury

4.3 Repairing Damaged Retina

4.4 A Possible Cure for Deafness

4.5 Clinical Trials for Stem Cell Therapies for CNS Disorders by StemCells, Inc.

4.6 First Clinical Use of Bioengineered Vascular Graft Made from Autologous Stem Cells

4.6.1 Recent Developments in Stem Cell Therapy in Cardiology

4.6.2 Recent Developments in Acute MI

4.6.3 Chronic Ischemic Cardiomyopathy and Heart Failure

4.6.4 Stem Cells and Neurodegenerative Diseases

4.7 Disease Modeling: The Use of Inducible Cells

4.7.1 Modeling Disease with iPS Cells

4.7.2 Modeling Disease with Direct Neuronal Conversion

4.8 Stem Cell Transplants

4.8.1 Recent Developments in Ophthalmologic Stem Cell Transplantation Therapies

4.8.2 Stem Cell Types for Eye Disease Clinical Trials

4.8.2.1 Pluripotent Stem Cells

4.8.2.2 Neural Stem Cells

4.8.2.3 RPE Stem Cells

4.8.2.4 Limbal Stem Cells

4.8.2.5 Umbilical Cord Stem Cells

4.8.2.6 Bone Marrow Stem Cells

4.8.2.7 Pluripotent Stem Cells for Retinal and RPE Degeneration

4.8.2.8 Patch of hESC-Derived RPE Monolayer

4.8.2.9 Patient-Derived RPE

4.8.2.10 NSCs for AMD

4.8.2.11 UCSCs for RP and AMD

4.8.2.12 Bone Marrow Stem Cells for Photoreceptor Diseases

4.8.2.13 Corneal Repair

4.8.2.14 Bioengineered Eye Tissues

4.9 Regenerative Strategies in the Treatment of Diabetes

4.9.1 Cell-Based Therapy for Diabetes

4.9.2 Embryonic Stem Cells and Induced Pluripotent Cells

5. Stem Cell Industry Highlights, 2012

5.1 Business Development

5.2 Clinical Trials

5.3 Market Authorization

5.4 Regulations

5.5 Capital Market and Finances

5.6 Investments in Xeno-Cell Therapy

5.7 Collaborations in Stem Cell Science

5.7.1 California Institute for Regenerative Medicine (CIRM)

5.7.2 The International Translational Regenerative Medicine Center

6. Regenerative Medicines: A Brief Update from Selected Countries

6.1 U.S.

6.1.1 Key Institutions

6.1.1.1 California Institute for Regenerative Medicine

6.1.1.2 The New York Stem Cell Foundation

6.1.1.3 NIH Center for Regenerative Medicine

6.1.2 Innovative Company

6.1.2.1 Aastrom Biosciences

6.2 Canada

6.2.1 Key Institutions

6.2.1.1 Institute of Biomaterials & Biomedical Engineering, University of Toronto

6.2.1.2 Terry Fox Research Institute

6.2.1.3 Institute for Research in Immunology and Cancer, University of Montreal

6.2.2 Innovative Companies

6.2.2.1 Northern Therapeutics

6.2.2.2 Octane Biotech

6.3 U.K.

6.3.1 Key Institutions

6.3.1.1 Loughborough University

6.3.1.2 U.K. Stem Cell Foundation

6.3.1.3 University College, London

6.3.2 Innovative Companies

6.3.2.1 Intercytex

6.3.2.2 Azellon Cell Therapeutics

6.3.2.3 Cell Medica

6.4 Sweden

6.4.1 Key Institutions

6.4.1.1 Karolinska Institutet

6.4.1.2 The University of Lund

6.4.2 Innovative Companies

6.4.2.1 Vitrolife

6.4.2.2 Cellartis

6.4.2.3 Biolamina

6.5 Brazil

6.5.1 Key Institutions

6.5.1.1 Universidade de SaoPaulo

6.5.1.2 Fiocruz and Hospital Sao Rafael

6.5.1.3 Universidade Federal do Rio de Janeiro

6.5.1.4 Pontificia Universidade Catolica do Parana

6.5.2 Innovative Company

6.5.2.1 Excellion & CellPraxys

7. Market Analysis for Regenerative Medicine Sector

7.1 Scope of this Chapter

7.2 Opportunities for RM Products

7.3 Commercial RM Products

7.3.1 Leading Commercial Cell Therapy Products

7.3.2 FDA Approved Cell-Based Products

7.3.3 Growth Spurt by Regenerative Medicine (RM)

7.4 Global Market for Tissue-Engineered Products

7.4.1 Tissue Engineering and Stem Cell Industry

7.5 Market for Stem Cell Therapy in Cardiology

7.6 Market for RM Products in Orthopedics

7.6.1 No Strong Alternatives for Medtronic’s INFUSE

7.6.2 Demineralized Bone Matrix (DBM)

7.6.3 The Unproven Stem Cells in Orthopedics

7.6.4 Future of Bone Replacement Market

7.7 Global RM Market for Neurology Products

7.8 Market for RM Dental Products

7.9 Market for RM Cancer Products

7.10 RM Market for Urology Products

7.11 Global Market for Skin Products

7.12 Overall Global RM Market

7.13 U.S. Market for Tissue-Engineered Skin

7.14 U.S. RM Market for Orthopedic/Spine Products

7.15 U.S. RM Market for Nerve Repair Products

7.16 U.S. RM Market for Cardiovascular and Stroke Products

7.17 U.S. Market for Anti-Inflammatory RM Products

7.18 U.S. Market for RM Products in Diabetes

7.19 Overall U.S. Regenerative Medicine Market

7.19.1 U.S. RM Market by Segment

8. Stem Cell Industry

8.1 Global Market for Stem cells

8.2 Stem Cell Use in the U.S.

8.2.1 Autologous Stem Cell Use in the U.S.

8.2.2 U.S. Stem Cell Market Overview

8.2.2.1 Potential U.S. Population for Cell-Based Therapies

8.2.3 U.S. Market for Stem cells

8.3 European Market for Stem Cells

8.3.1 Autologous and Allogeneic Cell Therapy Companies in Europe

8.4 Asia-Pacific Market for Stem Cells

8.5 Autologous Cell Therapy

8.5.1 Commercially Available Autologous Treatments

8.5.1.1 Autologous Cell Therapy for Alzheimer’s disease

8.5.1.2 Autologous Cell Therapy for Multiple Sclerosis

8.5.1.3 Autologous Cell Therapy for Wound Healing

8.5.1.4 Autologous Therapy for Cosmetic Surgery

9. Business Models and Requirements for a Successful Regenerative Medicine Industry

9.1 Scope of this Chapter

9.2 Business Models in Regenerative Medicine

9.2.1 Current Model for Autologous Cell Therapies

9.2.2 Current Models for Allogeneic Cell Therapies

9.3 Key Factors for Successful Business Models for Cell Therapies

9.4 Requirements for Commercial Manufacturing of Cell Therapy Products

9.4.1 Elements of Commercial Manufacturing

9.4.1.1 Regulatory Requirements

9.4.1.2 Manufacturing Process Scale

9.4.1.3 In-House Manufacturing

9.4.1.4 Contract Manufacturing: Commercial and Academic

10. Company Profiles

10.1. Aastrom Biosciences, Inc.

10.1.1 Aastrom’s Cellular Therapy and Ixmyelocel-T

10.1.1.1 Advantages of Patient’s Bone Marrow and Ixmyelocel-T

10.1.2 Aastrom’s Clinical Trials

10.1.2.1 REVIVE-CLI

10.1.2.2 RESTORE-CLI

10.2 Advanced Cell Technology, Inc. (ACT)

10.2.1 ACT’s Human ES Cell Programs

10.2.2 ACT’s Human Embryonic Stem Cell Technologies

10.2.3 ACT’s Cell Therapy Research Program

10.2.3.1 Retinal Pigment Epithelium Program

10.2.3.2 Hemangioblast Program

10.2.3.3 Adult Stem Cell Program

10.2.4 ACT’s Intellectual Property

10.3 AlloCure, Inc.

10.3.1 AlloCure’s Technology

10.3.2 AlloCure’s Clinical Trials

10.3.2.1 Acute Kidney Injury

10.3.2.2 Epidemiological Study of AKI

10.3.2.3 Phase I Clinical Trial in AKI

10.3.2.4 Phase II Clinical Trial in AKI

10.4 Altrika Ltd.

10.4.1 Myskin

10.4.2 Cryoskin

10.5 American Type Culture Collection, Inc. (ATCC)

10.5.1 ATCC’s Cell Lines and Hybridomas

10.5.2 ATCC’s Media, Sera and Reagents

10.5.3 MTT Cell Proliferation Assay

10.5.4 XTT Cell Proliferation Assay Kit

10.5.5 Universal Mycoplasma Detection Kit

10.5.6 DNA and RNA

10.5.7 STR Profile Database

10.5.8 hTERT Immortalized Cell Lines

10.5.9 Embryonic Stem Cell Products

10.5.10 Bacteria and Phages

10.5.11 Fungi and Yeast

10.5.12 Protozoa and Algae

10.5.13 Viruses and Related Reagents

10.5.14 Microbial DNA and RNA

10.5.15 ATCC’s Tissue Biology Products

10.6 Avita Medical Limited

10.6.1 ReCell

10.7 Amorcyte, LLC

10.7.1 AMR-001

10.8 Ars Arthro AS

10.8.1 CaReS

10.8.2 Fibrocell

10.8.3 Fibroplus

10.9 Axiogenesis AG

10.9.1 Human iPS Cell-Derived Cardiomyocytes

10.9.2 Murine Cardiomyocytes ES

10.9.3 Murine Cardiomyocytes iPS

10.9.4 Murine Endothelial Cells

10.9.5 Murine Smooth Muscle Cells

10.10 AxoGen, Inc.

10.10.1 Avance Nerve Graft

10.10.2 AxoGuard Nerve Protector

10.10.3 AxoGuard Nerve Connector

10.11 Bellicum Pharmaceuticals, Inc.

10.11.1 Bellicum’s Technology

10.11.2 Bellicum’s Pipeline

10.12 BetaStem Therapeutics, Inc.

10.12.1 BetaStem’s Technology

10.13 Bioheart, Inc.

10.13.1 MyoCell

10.13.2 MyoCell SDF-1

10.13.3 MyoCath

10.13.4 LipiCell

10.14 Biomet, Inc.

10.14.1 Endobon Xenograft Granules

10.14.2 RegenerOss Allograft

10.14.3 Ground Cancellous Bone

10.15 BioMimetic Therapeutics, Inc.

10.15.1 Augment Bone Graft

10.15.2 Augmatrix Biocomposite Bone Graft

10.16 BioTissue Technologies AG

10.16.1 BioSeed-C

10.16.2 Chondrotissue

10.16.3 BioSeed-Oral Bone

10.17 Biovest International, Inc.

10.17.1 Autovaxid

10.17.2 Xcellerator

10.17.3 Maximizer

10.17.4 Minimax

10.18 BrainStorm Cell Therapeutics, Inc.

10.18.1 NurOwn

10.19 California Stem Cell, Inc.

10.19.1 Clinical Pipeline

10.19.1.1 MotorGraft

10.19.1.2 Cancer Stem Cell

10.19.2 Cell Products

10.19.2.1 MotorPlate and MotorVial

10.19.2.2 NeuroPlate and NeuroVial

10.19.2.3 OPCVial

10.19.2.4 HepatoPlate

10.19.3 Cell Culture Products

10.19.3.1 StemBlast

10.19.3.2 MotorBlast

10.19.3.3 NeuroBlast

10.19.3.4 OPC Media

10.19.3.5 Cellular Transplant Solution

10.20 Cardio3 Biosciences SA

10.20.1 Products Pipeline

10.20.1.1 C3BS-CQR-1 (C-Cure)

10.20.1.2 Positive Phase II Results for C-Cure

10.20.1.3 C3BS-CQR-1 (Protein)

10.20.1.4 C-CATHez (Medical Device)

10.21 Cellartis AB (Cellectis)

10.21.1 iPS Engineering Hub

10.21.2 Hepatocytes hiPS-HEP

10.21.3 Cardiomyocyte Clusters hES-CMC

10.21.4 Stem Cell Culture System DEF-CS

10.22 CellSeed, Inc.

10.22.1 Epithelial Cell Sheet for Corneal Regeneration

10.22.2 Regenerated Cardiac Patch

10.22.3 Epithelial Cell Sheet for Esophageal Regeneration

10.22.4 Cell Sheet for Periodontal Regeneration

10.22.5 Regenerated Cartilage Sheet

10.23 Cellular Dynamics International, Inc.

10.23.1 iCell Cardiomyocytes

10.23.2 iCell Endometrial Cells

10.23.3 iCell Hepatocytes

10.23.4 iCell Neurons

10.23.5 MyCell Products

10.24 Chromocell Corporation

10.24.1 Chromovert Technology

10.24.2 Chromovert Applications

10.24.2.1 Pain Relief

10.24.2.2 Anxiety Treatments

10.24.2.3 Respiratory Disorders

10.25 Cognate Bioservices, Inc.

10.25.1 Process Development

10.25.2 Regulatory Services

10.25.3 Assay Development

10.25.4 Preclinical Services

10.25.5 Stem Cell Services

10.26 Cook Biotech, Inc.

10.26.1 Cook’s Technology

10.26.2 Biodesign Dural Graft

10.26.3 Dynamatrix Extracellular Membrane

10.26.4 tarSys

10.26.5 Oasis Wound Matrix

10.26.6 Biodesign Staple Line Reinforcement

10.26.7 Biodesign Hiatal Hernia Graft

10.26.8 CorMatrix ECM

10.26.9 ECM for Cardiac Tissue Repair

10.26.10 Biodesign Incision Graft

10.26.11 Biodesign Inguinal Hernia Graft

10.26.12 Biodesign Parastomal Reinforcement Graft

10.26.13 Biodesign Umbilical Hernia Graft

10.26.14 Biodesign Anterior Pelvic Floor Graft

10.26.15 Biodesign Fistula Plug

10.26.16 LIFT with Biodesign

10.26.17 Biodesign Posterior Pelvic Floor Graft

10.26.18 Biodesign Peyronie’s Repair Graft

10.26.19 Biodesign Tension-Free Urethral Sling

10.27 Cytomedix, Inc.

10.27.1 Cytomedix’s AutoloGel System

10.27.1.1 The Working of AutoloGel System

10.27.1.2 Balancing Effect of AutoloGel System

10.27.1.3 Formulation of AutoloGel System

10.27.2 Cytomedix’s Angel PRP

10.28 Cytonet, LLC

10.28.1 Cytonet’s Liver Cell Therapy

10.28.2 SELICA III Clinical Trial

10.29 Cytori Therapeutics, Inc.

10.29.1 Cytori’s Commercial Activities and Markets

10.29.2 Cytori’s Pipeline

10.29.2.1 Celution System for Cardiovascular Disease

10.29.2.2 Other Applications of Celution System

10.29.2.3 PureGraft

10.29.2.4 StemSource

10.30 DanDrit Biotech A/S

10.30.1 Dendritic Cell

10.30.1.2 Colorectal Cancer Trial Phase II in Singapore

10.30.1.3 Non-Small-Cell Lung Cancer, Phase II

10.31 Fibrocell Science, Inc.

10.31.1 Fibrocell’s Technology

10.31.2 Pipeline

10.32 Forticell Bioscience, Inc.

10.32.1 OrCel

10.33 Gamida Cell Ltd.

10.33.1 Gamida’s Technology

10.33.1.1 Copper Chelator Based Technology

10.33.1.2 NAM Based Technology

10.33.1.3 StemEx

10.33.1.4 NiCord

10.33.1.5 CordBridge

10.33.1.6 NK Cell Product

10.34 Harvest Technologies Corporation

10.34.1 Smart PReP2 APC+

10.34.2 SmartPReP 2 BMAC

10.35 Histogenics Corporation

10.35.1 NeoCart

10.35.2 VeriCart

10.36 Humacyte, Inc.

10.36.1 Humacyte Grafts

10.37 Integra Lifesciences Holdings Corporation

10.37.1 Integra’s Products Overview

10.37.2 Integra’s Orthopedics Product Portfolio

10.37.3 Integra’s Extremity Reconstruction Product Portfolio

10.37.3.1 Skin and Wound

10.37.3.2 Bone and Joint Fixation Devices and Instruments

10.37.3.3 Lower Extremity Products

10.37.3.4 Upper Extremity Products

10.37.3.5 Bone Graft Substitutes for Extremity Reconstruction

10.37.3.6 Nerve and Tendon

10.37.4 Integra’s Spine Product Portfolio

10.37.4.1 Integrated Interbody Fusion Devices

10.37.4.2 Minimally Invasive Solutions

10.37.4.3 Deformity Correction

10.37.4.4 Orthobiologics

10.37.4.5 Integra’s Research and Development in Regenerative Medicine

10.38 Intercytex Ltd.

10.38.1 VAVELTA

10.38.2 Epidermolysis Bullosa

10.38.3 Scar Contractures

10.38.4 Acne Scarring

10.38.5 International Stem Cell Corporation

10.38.6 Therapeutic Programs

10.39 iPierian, Inc.

10.39.1 Technology

10.39.2 Product Development

10.40 Japan Tissue Engineering Co., Ltd.

10.40.1 Autologous Cultured Epidermis

10.40.2 Autologous Cultured Cartilage

10.40.3 Autologous Cultured Corneal Epithelium

10.41 Kensey Nash Corporation

10.41.1 Medeor Matrix

10.41.2 Meso BioMatrix Scaffold

10.41.3 Epi-Guide Bioresorbable Barrier Matrix

10.41.4 OsseoFit Porous Tissue Matrix

10.41.5 Vitoss Scaffold Foam Products

10.42 Kiadis Pharma B.V.

10.42.1 Kiadis’ Pipeline

10.42.1.1 ATIR

10.42.1.2 Reviroc

10.42.1.3 Rhitol

10.43 Living Cell Technologies Limited (LCT)

10.43.1 Diabecell

10.43.2 Ntcell

10.44 Life Cell Corporation

10.44.1 AlloDerm

10.44.2 Cymetra Micronized AlloDerm Tissue

10.44.3 Strattice Reconstructive Tissue Matrix

10.44.4 SPY Elite System

10.45 MaxCyte, Inc.

10.45.1 MaxCytes Technology Platform

10.45.2 Drug Discovery Applications

10.45.2.1 GPCRs

10.45.2.2 Ion Channels

10.45.3 Antibody Production

10.45.4 General Protein Production

10.45.5 Viral Vector and VLP Production

10.45.6 Insect Cell Transfection

10.45.7 Cell Therapy

10.45.7.1 Dendritic Cell Vaccines

10.45.7.2 Regenerative Medicine

10.45.7.3 Chimeric Antigen Receptor (CAR) Immunotherapy

10.46 MediStem, Inc.

10.46.1 Intellectual Property

10.46.1.1 Method for Expansion of Stem Cells

10.46.1.2 Compositions of Placentally-Derived Stem Cells for the Treatment of Cancer

10.46.1.3 Transcatheter Tumor Immunoembolization

10.46.1.4 Stem Cell Therapy for Cardiac Valvular Dysfunction

10.46.1.5 Treatment of Erectile Dysfunction by Stem Cell Therapy

10.46.1.6 Allogeneic Stem Cell Transplants in Non-Conditioned Recipients

10.46.1.7 Stem Cell Mediated Treg Activation for Therapeutic Immune Modulation

10.46.1.8 Cellular Therapy for Lower Back Pain

10.46.1.9 Compositions and Methods of Stem Cell Therapy for Autism

10.46.1.10 Stem Cell Therapy for Weight Loss

10.46.1.11 Menstrual Blood Cellular Populations, Isolation, and Use Thereof

10.46.1.12 Endometrial Derived Reparative/Regenerative Cells

10.46.1.13 Treatment of Insulin Resistance and Diabetes

10.46.1.14 Combination Treatment of Cardiovascular Disease

10.46.1.15 Stem Cell Therapy for Autism

10.46.2 Product Pipeline

10.46.2.1 Endometrial Regenerative Cell Platform

10.46.2.2 Angiostem Platform

10.46.2.3 Tolerostem Platform

10.47 Mesoblast Ltd.

10.47.1 Revascor

10.47.2 MPCs for Diabetics

10.47.3 Bone Marrow Derived Allogeneic MPCs

10.47.4 Macular Degeneration

10.47.5 Diabetic Macular Edema

10.47.6 Intervertebral Disc Repair Product

10.47.7 Lumbar and Cervical Spinal Fusion Product

10.47.8 Fracture Repair Product

10.47.9 Arthritis Product

10.48 MolMed S.p.A.

10.48.1 MolMed’s Technological Platforms

10.49 NanoCor Therapeutics, Inc.

10.49.1 Carfostin

10.50 Neuralstem, Inc.

10.50.1 Neuralstem’s Technology Platforms: Stem Cells

10.50.2 Pharmaceutical Compounds

10.50.3 Neuralstem’s Clinical Trials for Stem Cells

10.50.4 Clinical Trials for Neuralstem’s Pharmaceutical Compound

10.51 NeuroNova AB

10.51.1 Neurogenesis Qualifier

10.51.2 NeuroNova’s Projects

10.52 Olympus Terumo Biomaterials Corp.

10.52.1 OSferion60

10.52.2 Terudermis

10.52.3 OSferion

10.52.4 Teruplug

10.52.5 Bone Cream

10.53 NewLink Genetics Corporation

10.54 OncoMed Pharmaceuticals, Inc.

10.54.1 OncoMed’s Research on Cancer Stem Cells

10.54.2 OncoMed’s Platform

10.54.3 OncoMed’s Development Pipeline

10.55 Opexa Therapeutics, Inc.

10.55.1 T-Cell Platform

10.56 Organogenesis, Inc.

10.56.1 Apligraf

10.56.2 Gintuit

10.57 Orthovita, Inc.

10.57.1 Vitoss

10.58 Osiris Therapeutics, Inc.

10.58.1 Osiris’ Technologies

10.58.1.1 Stem Cell Source

10.58.1.2 Manufacturing Process

10.59 Osteotech, Inc.

10.59.1 MagniFuse

10.59.2 Plexur P

10.59.3 Plexur M

10.59.4 FacetLinx Fusion Technology

10.59.5 Grafton

10.59.6 Xpanse Bone Inserts

10.59.7 GraftCage TLX and GraftCage ACX

10.60 Pervasis Therapeutics, Inc.

10.61 Pluristem Therapeutics, Inc.

10.62 Proneuron Biotechnologies, Inc.

10.62.1 Spinal Cord Technology

10.63 RegeneRx

10.63.1 Tß4 Peptide Research

10.64 ReNeuron Group PLC

10.64.1 ReN001

10.64.2 ReN009

10.64.3 ReNcell VM and ReNcell CX

10.65 Revivicor, Inc.

10.65.1 Xenotransplantation Technology

10.66 SanBio, Inc.

10.66.1 SanBio’s Product Pipeline

10.66.1.1 SB623

10.66.1.2 SB618

10.66.1.3 SB308

10.67 Saneron CCEL Therapeutics, Inc.

10.67.1 U-Cord Cell Program

10.67.2 Sert-Cell Program

10.68 Sangamo Biosciences, Inc.

10.68.1 SB-728

10.68.2 SB-313

10.68.3 Hemophilia

10.69 Stem Cell Authority Ltd.

10.69.1 MIRACHYMAL Stem Cells

10.70 StemCells, Inc.

10.70.1 StemCells’ Research Collaborations

10.70.1.1 Stanford University and Stanford School of Medicine

10.70.1.2 UC Irvine

10.70.1.3 OHSU Casey Eye Institute

10.70.1.4 McLaughlin Research Institute

10.70.2 StemCells’ Therapeutic Programs

10.70.3 Cells and Cell Lines

10.70.4 Cell Culture Products

10.70.5 Antibody Detection Reagents

10.70.6 Purified Whole Stem Cell Lysates

10.71 Stemline Therapeutics, Inc.

10.71.1 Cancer Stem Cells

10.71.2 Stemline Therapeutics’ Platform

10.72 Stratetech Corporation

10.72.1 Stratatech’s Core Technology

10.73 Synthecon, Inc.

10.73.1 Rotary Cell Culture Systems

10.73.2 Biofelt (Bioabsorbable Scaffold)

10.73.3 Biomerix 3D Scaffolds

10.73.4 RollerCell 40

10.74 Tengion, Inc.

10.74.1 Tengion’s Scientific Platform

10.74.2 Tengion’s Pipeline

10.75 TiGenics NV

10.75.1 ChondroCelect

10.75.2 CX601

10.75.3 Cx611

10.75.4 Cx621

10.76 Tissue Genesis, Inc.

10.76.1 Clinical Therapies from Tissue Genesis

10.76.1.1 Icellator

10.76.1.2 Adipase

10.77 Thermogenesis Corp.

10.77.1 AXP System

10.77.2 MXP System

10.77.3 Manual Systems

10.77.4 Res-Q 60 BMC System

10.77.5 BioArchive System

10.78 ViaCyte, Inc.

10.78.1 Technology Overview

10.79 Vistagen Therapeutics, Inc.

10.79.1 Vistagen’s Technology

10.79.2 CardioSafe 3D

10.79.3 LiverSafe 3D

10.80 Zen-Bio, Inc.

Appendix 1: Allogeneic vs. Autologous Stem Cell Therapy

Appendix 1.1: Manufacturing Process

Appendix 1.2: Cost Differential

Appendix 1.3: Donor Screening and Testing

Appendix 1.4: Release Testing

Appendix 1.5: Overall Analysis

INDEX OF FIGURES

Figure 2.1: Geographic Distribution of Tissue Engineering Firms in Major Markets

Figure 2.2: The Potential Uses of Embryonic Stem Cells

Figure 2.3: Progress of Cell Therapy Product Research, 2012

Figure 2.4: Commercially Available Cell Therapy Products, 2012

Figure 2.5: Disease Focus by Regenerative Medicine

Figure 2.6: Estimated Completion Dates for Stem Cell Based Clinical Trials Targeting Type 1 Diabetes, 2009-2015

Figure 2.7: Number of Clinical Trials by Targeted Condition, 2005-2011

Figure 2.8: Concentration of European Cell Therapy Firms, 2012

Figure 2.9: European Stem Cell Platforms by Cell Source

Figure 2.10: Autologous vs. Allogeneic Stem Cell Therapy Firms in Europe, 2012

Figure 2.11: Autologous and Allogeneic Somatic Cell Therapy Firms in Europe, 2012

Figure 2.12: Sponsors of Cell Therapy Clinical Trials in the U.K., 2012

Figure 2.13: Clinical Trials Involving Allogeneic vs. Autologous Cell Therapy

Products in the U.K., 2012

Figure 2.14: Cell Types Involved in the U.K. Cell Therapy Clinical Trials, 2012

Figure 2.15: U.K. Cell Therapy Clinical Trials by Indication, 2012

Figure 2.16: Cell Culture Products Market by Segment, 2012

Figure 2.17: Market for Reagents Used in Cell Culture, 2012-2019

Figure 2.18: Market for Media Used in Cell Culture, 2012-2019

Figure 2.19: Market for Serum Used in Cell Culture, 2012-2019

Figure 5.1: CIRM’s Grants for Disease Types by Funding Level, 2012

Figure 7.1: Commercially Available Regenerative Products

Figure 7.2: Global Market for Tissue Engineering Products, 2012-2019

Figure 7.3: Global RM Market for Cardiology and Vascular Products, 2012-2019

Figure 7.4: Alternatives for Medtronic’s Infuse

Figure 7.5: Global Market for RM Products in Orthopedics, Musculoskeletal and Spine, 2012-2019

Figure 7.6: Global RM Market for Neurology Products, 2012-2019

Figure 7.7: Global RM Market for Dental Products, 2012-2019

Figure 7.8: Global Tissue Engineering and Cell Therapy Market for Cancer Products, 2012-2019

Figure 7.9: Global Market for RM Products in Urology, 2012-2019

Figure 7.10: Global Market for RM Products in Skin/Integument, 2012-2019

Figure 7.11: Global Tissue Engineering and Cell Therapy Market, 2012-2019

Figure 7.12: U.S. Market for Tissue Engineered Skin Replacement and Substitutes, 2012-2019

Figure 7.13: U.S. Market for RM Products in Orthopedic/Spine, 2012-2020

Figure 7.14: U.S. Market for RM Products in Nerve Repair, 2012-2020

Figure 7.15: U.S. Market for RM Products in Cardiovascular Therapies, 2012-2020

Figure 7.16: U.S. Market for RM Products in Anti-Inflammatory Therapies, 2012-2020

Figure 7.17: U.S. Market for RM Products in Diabetes, 2012-2020

Figure 7.18: U.S. Market for Regenerative Medicines, 2012-2020

Figure 7.19: U.S. Regenerative Medicine Market by Segment, 2020

Figure 8.1: Global Market for Stem Cell Products, 2012-2020

Figure 8.2: U.S. Market for Stem Cell Products, 2012-2020

Figure 8.3: Estimated U.S. Market for Stem Cell Therapy by Type, 2020

Figure 8.4: European Market for Stem Cell Products, 2012-2020

Figure 8.5: Number of Autologous and Allogeneic Cell Therapy Firms in Europe

Figure 8.6: Asia-Pacific Market for Stem Cells, 2012-2019

Figure 8.7: Global Autologous Cell Therapy Market, 2012-2019

Figure 9.1: Cell-Based Business Models

Figure 9.2: Current Autologous Business Models

Figure 9.3: Current Allogeneic Business Models

Figure 10.1: Aastrom’s Cell Expansion Process

INDEX OF TABLES

Table 2.1: Commercially Available Bioengineered Skin Products

Table 2.2: A Partial List of Companies Offering Bioreactor Systems

Table 2.3: Number of Tissue Engineering Companies in the Five Focus Countries

Table 2.4: Number of Tissue Engineering Firms Developing Stem Cells Seeded to Scaffolds

Table 2.5: Number of Tissue Engineering Firms Focusing on Skin, Cartilage, Bone and Urological Products

Table 2.6: Number of Tissue Engineering Firms Focused on Cardiovascular Products

Table 2.7: Number of Tissue Engineering Firms Focusing on Neurological Products

Table 2.8: Number of Tissue Engineering Firms Focusing on Pancreas, Liver and Kidney

Table 2.9: Number of TE Firms Focused on Autologous and Allogenic Products

Table 2.10: Major Cell Therapy Companies

Table 2.11: Geographical Distribution of Cell Therapy Companies

Table 2.12: Cell Therapy Products on the Market

Table 2.13: Cell Therapy Products on the Market by Type and Application

Table 2.14: Potential Patients for Cell Therapy in the U.S.

Table 2.15: Number of Patients Treated with Cell Therapy Between 1988 and 2010

Table 2.16: Cell Therapy Pipeline, 2005-2011

Table 2.17: Number of Stem Cell Clinical Trials by Indication, 2012

Table 2.18: Major Cell Therapy Clinical Trials for Diabetes and Estimated Enrollment Targets, 2012

Table 2.19: Progress in Clinical Trials for Diabetes, 2012

Table 2.20: Cell Therapy Deals, 2007-2011

Table 2.21: Select Cell Therapy Products with FDA/EMA Regulatory Approval, 1998-2010

Table 2.22: Cell Therapy Companies and Products

Table 2.23: Cell Therapy Products Approved in South Korea

Table 2.24: Selected Suppliers of Culture Media and Reagents

Table 2.25: Selected Suppliers of In Vitro Test Kits

Table 2.26: Selected Suppliers of Cells and Tissues

Table 2.27: Selected Suppliers of Equipment for Stem Cell Research

Table 2.28: Selected Companies Offering Computer Software for Stem Cell Research

Table 3.1: Industry Participants in Regenerative Medicine

Table 3.2: Top Ten Regenerative Medicine Products in the Market

Table 3.3: Industry-Sponsored Active Cell Therapy Trials, 2007 and 2012

Table 4.1: Recently Published Stem Cell Therapy Clinical Trials for Ischemic Heart Disease

Table 5.1: CIRM Funding for Projects Moving Towards Disease Therapies, 2012

Table 5.2: List of CIRM Funded Institutions, 2012

Table 7.1: A Sampling of Leading Commercial Cell Therapy Products, 2012

Table 7.2: FDA-Approved Cell-Based Products, 1997-2012

Table 7.3: Ongoing and Reported Clinical Trials in Ischemic Heart Disease

Table 7.4: Human Skin Equivalents for Clinical Skin Replacements and Grafts

Table 7.5: Human Skin Models for Drug Permeability Tests and Toxicity Screening

Table 8.1: Cell Therapy Products Revenue, 2010-2011

Table 8.2: Market Capitalization of Public Stem Cell Companies, 2011 vs. 2010

Table 8.3: Potential U.S. Population for Cell-Based Therapies

Table 8.4: Non-Autologous and Autologous Skin Substitutes and Dermal Treatments for Other Applications

Table 9.1: The Required Elements of a Manufacturing Facility

Table 9.2: Cell Therapy CMO Qualification Audit: Points to Investigate

Table 10.1: ACT’s Pipeline of Therapeutic Programs

Table 10.2: Patents Owned by ACT

Table 10.3: Patents Owned by ACT’s Subsidiary Mytogen, Inc.

Table 10.4: Patents Licensed to ACT by the University of Massachusetts

Table 10.5: Bellicum’s Pipeline

Table 10.6: Bioheart’s Intellectual Property

Table 10.7: Cardio3 Biosciences’ Products Pipeline

Table 10.8: Gamida’s Pipeline Overview

Table 10.9: International Stem Cell Corporation’s Therapeutic Programs

Table 10.10: Kiadis’ Pipeline

Table 10.11: MolMed’s Pipeline

Table 10.12: NeuroNova’s Projects

Table 10.13: NewLink’s Pipeline Overview

Table 10.14: OncoMed’s Development Pipeline

Table 10.15: Vitoss Bone Graft Substitutes

Table 10.16: Osiris’ Product Pipeline

Table 10.17: Pervasis’ Pipeline

Table 10.18: Pluristem’s Product Candidates Pipeline

Table 10.19: Proneuron’s Pipeline

Table 10.20: RegeneRx’s Pipeline/Clinical Trials

Table 10.21: RegeneRx’s T ß Peptide Research

Table 10.22: SanBio’s Product Pipeline

Table 10.23: Sangamo’s Product Pipeline

Table 10.24: StemCells’ Broad Pipeline

Table 10.25: Stemline Therapeutics’ Clinical Programs

Table 10.26: Stemline Therapeutics’ Preclinical Programs

Table 10.27: Stratatech’s Product Pipeline

Table A1.1: Comparison of Autologous and Allogeneic Stem Cell Therapy

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For the original version on PRWeb visit: http://www.prweb.com/releases/2013/6/prweb10858337.htm


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