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Regenerative Medicine - Global Strategic Business Report Product Image

Regenerative Medicine - Global Strategic Business Report

  • Published: November 2012
  • Region: Global
  • 392 Pages
  • Global Industry Analysts, Inc

This report analyzes the worldwide markets for Regenerative Medicine in US$ million. The report provides separate comprehensive analytics for the US, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2010 through 2018. A six-year historic analysis is also provided for these markets.

The report profiles 93 companies including many key and niche players such as:

- BioVest International Inc.
- Curis Inc.
- Cytori Therapeutics Inc.
- Evotec AG
- Forticell Bioscience Inc.
- Geron Corporation
- Integra LifeSciences Corporation
- LifeCell Corporation
- Osiris Therapeutics Inc.
- Tengion Inc.
- Tepha Inc.
- TiGenix N.V.

Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.

Please note: Reports are sold as single-site single-user licenses. Electronic versions require 24-48 hours as each copy is customized to the client with digital controls and custom watermarks.

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REGENERATIVE MEDICINE - A GLOBAL STRATEGIC BUSINESS REPORT

CONTENTS

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-2
Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3

II. Executive Summary

1. INDUSTRY OVERVIEW II-1
A Primer II-1
Current and Future Analysis II-1
Current Global Market for Regenerative Medicine II-2
Therapeutic Companies and Products in Regenerative Medicine -
Current Status II-2
Select Therapeutic Regenerative Medicine Products in the
Global Market II-3
Market Potential II-3

2. REGENERATIVE MEDICINE IN BONE AND JOINT APPLICATIONS II-5
An Overview of Regenerative Medicine in Bone and Joint
Applications II-5
Bone Graft Substitutes - Penetration in Foot and Ankle Surgeries II-5
Repair of Non-Healing Bones - High Market Potential II-5
Market Potential of Bone Graft Substitutes (BGSs) II-6
Table 1: Global Bone Graft Substitute Market (2010):
Percentage Share Breakdown of Sales for DePuy, OrthoVita,
ApaTech/Baxter, Wright Medical, Medtronic/RTI, Biomet, and
Others (includes corresponding Graph/Chart) II-6
Synthetic Bone Graft Substitutes to Replace Traditional
Autografts and Allografts II-6
Select Synthetic Products in Orthobiologics II-7
Bone Morphogenic Proteins (BMPs) Gaining Popularity II-7
Bone Morphogenic Protein products in Orthobiology II-7
Table 2: Global Bone Morphogenic Protein Market (2010):
Percentage Share Breakdown of Sales for Medtronic/RTI, and
Stryker (includes corresponding Graph/Chart) II-7
Demineralized Bone Matrices (DBMs) Market Getting Crowded II-8
Table 3: Global Demineralized Bone Matrix Market (2011):
Percentage Share Breakdown of Value Sales for Medtronic/RTI,
Synthes/MTF, Integra LifeSciences, Altiva, Bacterin, and
Others (includes corresponding Graph/Chart) II-8
Select DBM products in Orthobiologics market II-8
Biomaterials Market - Promising Opportunities for Cost-
Effective Products II-8
Existing Bone Graft Procedures - Limitations and Concerns II-9
Autograft Procedures II-9
Allograft - DBM and Other Allografts II-9
BMPs and Other Synthetic Growth Factors II-9
Medical Devices and Implants for Orthopedics II-10
Expanding Opportunities in Hip and Knee Market II-10
Extremity Reconstruction - A Growing Market II-10
Tissue Engineered Cartilage Market - An Overview II-11
Tissue Engineered Cartilages - A Promising Solution for
Cartilage Repair II-11
Market Potential of Tissue Engineered Cartilage Products II-11
Potential Applications of Tissue Engineered Cartilage Products II-11
Commercially Available tissue engineered cartilage products II-12
Challenges in Clinical Application of Tissue Engineered
Cartilage Products II-13
Bone Marrow Transplants (BMTs) II-13
Market Potential for BMTs II-14
Companies Engaged in CBSC Research for BMTs II-14
Table 4: Global Orthobiologics Market (2010): Percentage
Share Breakdown of Value Sales for Medtronic/RTI,
Synthes/MTF, DePuy, Osteotech, Orthofix, and Others
(includes corresponding Graph/Chart) II-14

Table 5: Global Orthobiologics Market (2010): Percentage
Share Breakdown of Value Sales by Product Type for Growth
Factors, Synthetics, DMBs, Allografts, and Stem Cells
(includes corresponding Graph/Chart) II-15

Table 6: Global Machined Bone and Allograft Market (2010):
Percentage Share Breakdown of Value Sales for Synthes/MTF,
DePuy, Medtronic/RTI, Osteotech, RTIX, and Others (includes
corresponding Graph/Chart) II-15

Table 7: Global Stem Cell Orthobiologics Market (2010):
Percentage Share Breakdown of Value Sales for Nuvasive, and
Otrhofix includes corresponding Graph/Chart) II-15

Table 8: Global Bone Growth Stimulation Market (2010):
Percentage Share Breakdown of Value Sales for Orthofix,
Biomet, DJO and Smith & Nephew (includes corresponding
Graph/Chart) II-16

Table 9: Global Spinal Stimulation Market (2010): Percentage
Share Breakdown of Value Sales for Orthofix, Biomet and DJO
(includes corresponding Graph/Chart) II-16

Table 10: Global Long Bone Stimulation Market (2010):
Percentage Share Breakdown of Value Sales for Smith& Nephew,
DJO, Biomet and Orthofix (includes corresponding
Graph/Chart) II-16
Regenerative Medicine in Other Areas II-16
Wound Healing - The Second Largest Segment II-16
Cardiology - Promising Opportunities II-17
Diabetes - Highly Effective Innovative Treatments II-17
Neurodegenerative Diseases - Great Potential II-17
Body Sculpting/Cosmetics - High Potential II-18
Table 11: Global Market for Regenerative Medicine in Body
Reconstruction and Cosmetics (2014): Value Sales by Target
Area (in US$ Million) (includes corresponding Graph/Chart) II-18
Regenerative Medicine - the Past, the Present, & the Future II-18
Another Revolution in the Making? II-20
Conventional Chemical Medicine Vs Regenerative Medicine II-20
Regenerative Medicine - The Need of Modern Era II-21
Regenerative Medicine Throws in Several New Therapies II-21
What's in Store? II-21
Regenerative Medicine to Arrest Ageing? II-21
Thriving on an Aging World Population II-22
Faster Healing Process II-22
Regenerative Medicine to Overcome Donor Organs Shortage II-23
Possible Scenarios II-23
Stem Cell Research - Not Just Another Medical Advancement II-23
Sources of Stem Cells II-24
Japanese Technology in the Area of Stem Cells II-24
Progenitor Cell Therapy to Witness No Holds Barred Growth II-25
Key Issues at Play II-25
Ethical Angle of Embryonic Stem Cell Research II-25
Growth Drivers for Regenerative Medicine II-26
A Combination of Factors to Drive Regenerative Medicine Market II-26
Aging Population Provides a Ready Market for Innovative
Therapies II-26
Scientific and Technological Advances in Associated Areas II-26
Government Support and Increased Private Sector Participation II-26
Investment and Funding Landscape II-27

3. TRENDS & ISSUES II-28
A Promising Outlook II-28
Increased Activity in the Field of Regenerative Medicine II-28
Recent Advancements in the Science of Regenerative Medicine II-28
Nanotechnology in Regenerative Medicine II-29
Advances in Nanotechnology Assist Regenerative Medicine II-29
Players Embrace Automation in Production Facilities II-30
Contract Manufacturing - A Growing Sector II-30
Issues to be Sorted Out II-30
Need for New Scientific and Technological Standards II-30
Standardized Guidelines II-31
Clinical Translation - Collaboration of Multidisciplinary
Skills is Essential II-31
The Question of Apt Business Models - The Service and
Product Approach II-32
Table 12: Percentage Breakdown of Autologous and Allogeneic
Approach by Therapeutic Firms Across Select Countries (2011)
(includes corresponding Graph/Chart) II-32
Autologous or Service Approach Preferred by European Firms II-33
Allogeneic or Product Approach - Slow to Develop II-33
Regenerative Medicine Requires Improved Biomaterials II-33
Assessment of Worldwide R&D Activities in the Area of
Biomaterials II-34
Investors Wary of Funding Regenerative Medicine II-34
Regenerative Medicine Field Lags Behind due to Segregated Focus II-35
Challenges Encountered by Regenerative Medicine II-35
Scientific and Technological Challenges II-35
Barriers in Sharing Intellectual Property Rights II-36
Viable Manufacturing Technologies and Skilled Personnel Crucial II-36
Strict Regulations Push up Operational Costs II-37
Scientific and Technological Challenges in Orthopedics II-37
Bone Regeneration II-37
Clinical Approaches in Bone Regeneration and Their Limitations II-37

4. PRODUCT OVERVIEW II-39
Regenerative Medicine Advances in Four Phases II-39
Human Substances II-39
Tissue Engineering II-39
Therapeutic Cloning II-39
Nanotechnology-Driven Biomaterials II-39
Types of Regenerative Medicine II-40
Type I - Regenerative Medicine II-40
Human Proteins and Genes are Drugs in Regenerative Medicine II-40
Type-2 Regenerative Medicine II-40
Therapies Based on Human Cells and Tissues II-40
Type-3 Regenerative Medicine II-42
Based on Embryonic Stem Cells II-42
The Opponents of the ESC Theory II-43
Embryonic Stem Cells - Shortcomings II-43
Type-4 Regenerative Medicine II-44
Based on Novel Materials / Material Science Advancements II-44
Overview of Major Regenerative Medicine Techniques II-45
Natural Regenerative Proteins II-45
Tissue Engineering Capable of Culturing Replacement Organs II-45
All About Stem Cells II-46
Adult Stem Cells II-46
Adult Stem Cell Research Eludes Ethical Dispute II-46
hESC - Highly Capable of Differentiating and Multiplying II-47
Stem Cell Research in Development of Regenerative Medicine II-47
Neural Stem Cell to Restore Memory Functioning II-47
Pancreatic Islet Cells to Control Blood Sugar in Diabetics II-48
Therapeutic Cloning to Cure Parkinson's II-48

5. REGULATORY ENVIRONMENT II-49
Global Regulatory Landscape II-49
US II-49
EU II-49
Japan II-49
Regulatory Norms Governing ES Cell Research II-50
Milestones in the Human Embryonic Stem Cell Research: 2001 II-50
Legality of ES Cell Use in Major Developed Nations II-50

6. TECHNOLOGICAL INNOVATIONS/ BREAKTHROUGHS II-51
BioMimetic Therapeutics to Launch Augmatrix™ Biocomposite
Bone Graft II-51
TEI Biosciences Introduces PriMatrix™ Ag Antimicrobial Dermal
Repair Scaffold II-51

7. TECHNOLOGICAL INNOVATIONS IN RECENT PAST A PERSPECTIVE BUILDER II-52
SANUWAVE Health Introduces orthoPACE™ in Europe II-52
Kensey Nash's Medeor ECM Receives Approval from US FDA II-52
Celling Technologies Unveils Res-Q Device II-52
Kinetic Wins FDA Approval for LifeCell Tissue Matrix II-53

8. RECENT INDUSTRY ACTIVITY II-54
BioMimetic Therapeutics Secures CE Mark Approval for GEM 21S®
in EU II-54
WFIRM and Nantong University Set-up China-US Regenerative and
Translational Medicine Research Center II-54
EMD Millipore Collaborates with Centre for Commercialization
of Regenerative Medicine II-54
American CryoStem Associates with Alliance for Regenerative
Medicine II-55
TAP Biosystems Collaborates with a leading Regenerative
Medicine Company II-55
Cytomedix Acquires Aldagen II-55
Centre for Commercialization of Regenerative Medicine Sets Up
Industry Consortium II-56
Tengion Conducts Preclinical Study for Small Intestine
Regeneration II-56
TiGenix Inks Agreement with Cellerix for Combining Business
Operations II-56
La Jolla Pharmaceutical Acquire Rights to Regenerative
Immunophilin Ligands from GliaMed II-57
Medtronic Acquires Minority Stake in Tengion II-57
ImageIQ to Enter into Partnership with CCBC, NCRM and
Cleveland Clinic II-58
Centre for Commercialization of Regenerative Medicine
Collaborates with McEwen Centre for Regenerative Medicine II-58
LifeNet Health Sets Up Institute of Regenerative Medicine II-59
UK Government Sets Out Plan for Regenerative Medicine II-59

9. CORPORATE ACTIVITY IN RECENT PAST - A PERSPECTIVE BUILDER II-60
Healthpoint Acquires Cell-based Technologies and Allied
Assets from Intercytex II-60
Astellas Pharma to Acquire Equity Stake in Cytori Therapeutics II-60
Cephalon Enters into Partnership with Mesoblast II-61
BioTime and California Institute for Regenerative Medicine
Ink Agreement II-61
The Automation Partnership Extends Partnership with EPSRC
Centre for Innovative Manufacturing in Regenerative Medicine II-61
The Alliance for Regenerative Medicine Introduces
Regenerative Medicine Promotion Act II-62
Power3 Medical Inks Definitive Agreement to Acquire StemTroniX II-62
Healthpoint Acquires CYZACT™ and ICX-SKN Technologies from
Intercytex II-62
Stem Cell Therapy International Merges with Histostem II-63
TiGenix Acquires Orthomimetics II-63
Integra Inks Licensing Deal with Organogenesis II-63
DePuy Spine Collaborates with ATRM II-63
Epistem Enters into Partnership with Novartis II-63
Athersys Inks Agreement with Pfizer II-64
Beike Biotechnology Signs Investment Agreement with Biomaster II-64
Fujifilm Establishes New Drug Discovery Labs II-64

10. FOCUS ON SELECT GLOBAL PLAYERS II-65
BioVest International, Inc. (US) II-65
Curis, Inc. (US) II-65
Cytori Therapeutics, Inc. (US) II-66
Evotec AG (Germany) II-67
Forticell Bioscience, Inc. (US) II-67
Geron Corporation (US) II-68
Integra LifeSciences Corporation (US) II-68
LifeCell Corporation (US) II-69
Osiris Therapeutics, Inc. (US) II-69
Tengion, Inc. (US) II-70
Tepha Inc. (US) II-70
TiGenix N.V. (Belgium) II-71

11. GLOBAL MARKET PERSPECTIVE II-73
Table 13: World Recent Past, Current & Future Market Analysis
for Regenerative Medicine Products for Bone and Joint
Applications by Geographic Region - US, Europe and Rest of
World Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) II-73

Table 14: World Historic Review for Regenerative Medicine
Products for Bone and Joint Applications by Geographic Region -
US, Europe and Rest of World Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2004
through 2009 (includes corresponding Graph/Chart) II-74

Table 15: World 15-Year Perspective for Regenerative Medicine
Products for Bone and Joint Applications by Geographic Region -
Percentage Breakdown of Dollar Sales for US, Europe and Rest
of World Markets for Years 2004, 2011 & 2018 (includes
corresponding Graph/Chart) II-75
Regenerative Medicine Market by Application II-76
Table 16: World Recent Past, Current & Future Market Analysis
for Regenerative Medicine Products for Bone and Joint
Applications by Application - Bone Replacements, Bone
Stimulators, and Tissue Replacements Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2010 through 2018 (includes corresponding Graph/Chart) II-76

Table 17: World Historic Review for Regenerative Medicine
Products for Bone and Joint Applications by Application - Bone
Replacements, Bone Stimulators, and Tissue Replacements
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2004 through 2009 (includes
corresponding Graph/Chart) II-77

Table 18: World 15-Year Perspective for Regenerative Medicine
Products for Bone and Joint Applications by Application -
Percentage Breakdown of Dollar Sales for Bone Replacements,
Bone Stimulators, and Tissue Replacements Markets for Years
2004, 2011 & 2018 (includes corresponding Graph/Chart) II-78

III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Current and Future Analysis III-1
US to Retain Leadership Position III-1
The Strength of US in Regenerative Medicine - A Glance III-1
Factors Driving the US Market of Regenerative Medicine III-2
Millions of American Patients Put their Hope in Stem Cell
Research III-2
Table 19: Prevalence of Various Diseases in the US
(includes corresponding Graph/Chart) III-3
High Potential for Regenerative Medicine in Orthopedics III-3
Regenerative Medicine in Bone and Joint Applications III-3
Regenerative Therapy - Best Fit for Joint Problems III-4
Table 20: US Market for Regenerative Medicine Products for
Bone and Joint Applications (2011, 2015 & 2018):
Percentage Breakdown of Value Sales for Bone Replacement
Grafting, Bone Growth Stimulators, and Tissue Engineering
Cartilage (includes corresponding Graph/Chart) III-5

Table 21: US Demineralized Bone Matrices Market (2011):
Percentage Share Breakdown of Value Sales for Leading
Players (includes corresponding Graph/Chart) III-5

Table 22: US Cartilage Procedure Market by Volume:
2012-2018 (in Million Procedures) (includes corresponding
Graph/Chart) III-6
Regenerative Medicine - Other Areas of Application III-6
Regenerative Medicine - Face of Future Revolution in
Cardiology III-6
Regenerative Medicine in Wound Healing - The Most
Widespread Application III-6
Regenerative Medicine in Diabetes - A Number of Emerging
Applications III-7
Regenerative Medicine - A Ray of Hope for
Neurodegenerative Disease Patients III-7
Major Scientific Breakthroughs and Developments in
Regenerative Medicine III-7
CBI's Human Tissue Products for Treating Liver Failure and
Diabetes III-8
Market for Liver and Pancreas Transplantation III-8
Implantable Regenerative Products Take Over Sports Medicine III-8
Challenges in the Area of Product Development III-9
Process of Integration Continues III-9
Legal Entangles in the Field of Regenerative Medicine -
Cause for Concern III-9
Scientific and Technological Challenges to be Tackled III-10
Dominant Patents a Cause of Concern III-10
Technological Innovations/Breakthroughs III-11
Strategic Corporate Developments III-12
Key Players III-13
B.Market Analytics III-21
Table 23: US Recent Past, Current & Future Analysis for
Regenerative Medicine Products for Bone and Joint
Applications Market with Annual Sales Figures in US$ Million
for Years 2010 through 2018 (includes corresponding
Graph/Chart) III-21

Table 24: US Historic Review for Regenerative Medicine
Products for Bone and Joint Applications Market with Annual
Sales Figures in US$ Million for Years 2004 through 2009
(includes corresponding Graph/Chart) III-22

2. EUROPE III-23
A.Market Analysis III-23
Current and Future Analysis III-23
Great Potential for Regenerative Medicine III-23
Challenges Faced by European Regenerative Medicine Industry III-23
Financial Viability - A Growing Concern in the Backdrop of
Euro Crisis III-24
The Need to Embrace Newer Technologies III-24
Complex Regulatory Scenario with Multi-tier Governance System III-24
Need for More Integration III-24
Policies Regarding Egg Procurement Weigh Down Research
Progress III-25
Need for Harmonized Clinical Trial Regulation III-25
International Alliances - Outsourcing Options with
Developing Countries III-26
Patenting Issues in hESC Research III-26
Oral Tissue Regeneration III-27
Table 25: European Oral Tissue Regeneration Market (2011):
Percentage Breakdown of Value Sales for Bone Graft
Material, Membranes, and Tissue Regeneration (includes
corresponding Graph/Chart) III-27
Overview of select regional markets III-27
Germany III-27
United Kingdom III-27
UK Government Sets Out Plan for Regenerative Medicine III-28
Barriers to Commercialization III-28
Strategic Corporate Developments III-28
Key players III-30
B.Market Analytics III-31
Table 26: European Recent Past, Current & Future Analysis
for Regenerative Medicine Products for Bone and Joint
Applications Market with Annual Sales Figures in US$
Million for Years 2010 through 2018 (includes corresponding
Graph/Chart) III-31

Table 27: European Historic Review for Regenerative Medicine
Products for Bone and Joint Applications Market with Annual
Sales Figures in US$ Million for Years 2004 through 2009
(includes corresponding Graph/Chart) III-32

3. REST OF WORLD III-33
A.Market Analysis III-33
Current and Future Analysis III-33
Canada III-33
A Significant Player in the Field of Regenerative Medicine III-33
Regulatory and Legislative Scenario III-33
University of Toronto - Spearheading Regenerative Medicine
Research III-34
Asia-Pacific III-34
Japan III-34
Growth Drivers III-34
Regenerative Medicine Market for Bone and Joint Applications III-35
The Expanding RM market for Cartilage Grafts III-35
Regenerative Bone Grafts - Slow Progress of Research a
Concern III-35
Other Areas in Regenerative Medicine III-35
Skin Transplantation III-35
Pancreas & Liver Transplantation III-35
Research Activity in Regenerative Medicine Field III-35
More Companies Eye the Regenerative Medicine Potential III-36
Competition Heats up Behind Closed Doors III-36
Japanese Firms Need to Catch Up with US and European
Competitors III-37
Science Ministry Rolls Out Regenerative Medicine Project III-37
Regenerative Medicine Exempted from Ban on Human Cloning III-37
Issues and Concerns III-38
Regulatory Issues - Need for Faster Approvals III-38
Need for Participation in International Standardization III-39
China III-39
Substantial Government Support III-39
India III-39
CSIR- Leading the way in Regenerative Medicine Research III-39
High Growth Opportunities III-39
South Korea III-40
Malaysia III-40
Singapore III-40
Latin America III-41
Argentina III-41
Brazil III-41
Highly Promising but Challenges Remain III-41
Inconsistent Government Funding Poses Hurdles for Long-
Term Research III-42
Import Costs and Delays - An Impediment for the RM Sector III-42
Underestimation of Brazilian Innovation - A Concern III-42
Greater Integration Needed the Need of the Hour III-43
Lack of Interest in IP Protection Results in Lesser Patents III-43
Africa III-43
South Africa III-43
Strategic Corporate Developments III-44
Key players III-45
B.Market Analytics III-46
Table 28: Rest of World Recent Past, Current & Future
Analysis for Regenerative Medicine Products for Bone and
Joint Applications Market with Annual Sales Figures in US$
Million for Years 2010 through 2018 (includes corresponding
Graph/Chart) III-46

Table 29: Rest of World Historic Review for Regenerative
Medicine Products for Bone and Joint Applications Market
with Annual Sales Figures in US$ Million for Years 2004
through 2009 (includes corresponding Graph/Chart) III-47

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 93 (including Divisions/Subsidiaries - (98)

The United States (53)
Canada (1)
Japan (12)
Europe (18)
- Germany (5)
- The United Kingdom (7)
- Rest of Europe (6)
Asia-Pacific (Excluding Japan) (10)
Latin America (1)
Africa (1)
Middle East (2)

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