Global Regenerative Medicine Industry

• Publication date: November 2012
• Report size: 392 pages

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 The...

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., and 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.

Global Blood Supply, Tissue Banking And Transplantation Industry

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)