Global Regenerative Medicine Industry

NEW YORK, March 20, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Global Regenerative Medicine Industry

http://www.reportlinker.com/p090567/Global-Regenerative-Medicine-Industry.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Blood_Supply,_Tissue_Banking_and_Transplantation

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.

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONSStudy Reliability and Reporting Limitations I-1Disclaimers I-2Data Interpretation & Reporting Level I-2Quantitative Techniques & Analytics I-3Product Definitions and Scope of Study I-3II. 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-5An Overview of Regenerative Medicine in Bone and JointApplications II-5Bone Graft Substitutes - Penetration in Foot and Ankle Surgeries II-5Repair of Non-Healing Bones - High Market Potential II-5Market Potential of Bone Graft Substitutes (BGSs) II-6Table 1: Global Bone Graft Substitute Market (2010):Percentage Share Breakdown of Sales for DePuy, OrthoVita,ApaTech/Baxter, Wright Medical, Medtronic/RTI, Biomet, andOthers (includes corresponding Graph/Chart) II-6Synthetic Bone Graft Substitutes to Replace TraditionalAutografts and Allografts II-6Select Synthetic Products in Orthobiologics II-7Bone Morphogenic Proteins (BMPs) Gaining Popularity II-7Bone Morphogenic Protein products in Orthobiology II-7Table 2: Global Bone Morphogenic Protein Market (2010):Percentage Share Breakdown of Sales for Medtronic/RTI, andStryker (includes corresponding Graph/Chart) II-7Demineralized Bone Matrices (DBMs) Market Getting Crowded II-8Table 3: Global Demineralized Bone Matrix Market (2011):Percentage Share Breakdown of Value Sales for Medtronic/RTI,Synthes/MTF, Integra LifeSciences, Altiva, Bacterin, andOthers (includes corresponding Graph/Chart) II-8Select DBM products in Orthobiologics market II-8Biomaterials Market - Promising Opportunities for Cost-Effective Products II-8Existing Bone Graft Procedures - Limitations and Concerns II-9Autograft Procedures II-9Allograft - DBM and Other Allografts II-9BMPs and Other Synthetic Growth Factors II-9Medical Devices and Implants for Orthopedics II-10Expanding Opportunities in Hip and Knee Market II-10Extremity Reconstruction - A Growing Market II-10Tissue Engineered Cartilage Market - An Overview II-11Tissue Engineered Cartilages - A Promising Solution forCartilage Repair II-11Market Potential of Tissue Engineered Cartilage Products II-11Potential Applications of Tissue Engineered Cartilage Products II-11Commercially Available tissue engineered cartilage products II-12Challenges in Clinical Application of Tissue EngineeredCartilage Products II-13Bone Marrow Transplants (BMTs) II-13Market Potential for BMTs II-14Companies Engaged in CBSC Research for BMTs II-14Table 4: Global Orthobiologics Market (2010): PercentageShare 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 (includescorresponding 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 correspondingGraph/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 correspondingGraph/Chart) II-16Regenerative Medicine in Other Areas II-16Wound Healing - The Second Largest Segment II-16Cardiology - Promising Opportunities II-17Diabetes - Highly Effective Innovative Treatments II-17Neurodegenerative Diseases - Great Potential II-17Body Sculpting/Cosmetics - High Potential II-18Table 11: Global Market for Regenerative Medicine in BodyReconstruction and Cosmetics (2014): Value Sales by TargetArea (in US$ Million) (includes corresponding Graph/Chart) II-18Regenerative Medicine - the Past, the Present, & the Future II-18Another Revolution in the Making? II-20Conventional Chemical Medicine Vs Regenerative Medicine II-20Regenerative Medicine - The Need of Modern Era II-21Regenerative Medicine Throws in Several New Therapies II-21What's in Store? II-21Regenerative Medicine to Arrest Ageing? II-21Thriving on an Aging World Population II-22Faster Healing Process II-22Regenerative Medicine to Overcome Donor Organs Shortage II-23Possible Scenarios II-23Stem Cell Research - Not Just Another Medical Advancement II-23Sources of Stem Cells II-24Japanese Technology in the Area of Stem Cells II-24Progenitor Cell Therapy to Witness No Holds Barred Growth II-25Key Issues at Play II-25Ethical Angle of Embryonic Stem Cell Research II-25Growth Drivers for Regenerative Medicine II-26A Combination of Factors to Drive Regenerative Medicine Market II-26Aging Population Provides a Ready Market for InnovativeTherapies II-26Scientific and Technological Advances in Associated Areas II-26Government Support and Increased Private Sector Participation II-26Investment 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-39Regenerative Medicine Advances in Four Phases II-39Human Substances II-39Tissue Engineering II-39Therapeutic Cloning II-39Nanotechnology-Driven Biomaterials II-39Types of Regenerative Medicine II-40Type I - Regenerative Medicine II-40Human Proteins and Genes are Drugs in Regenerative Medicine II-40Type-2 Regenerative Medicine II-40Therapies Based on Human Cells and Tissues II-40Type-3 Regenerative Medicine II-42Based on Embryonic Stem Cells II-42The Opponents of the ESC Theory II-43Embryonic Stem Cells - Shortcomings II-43Type-4 Regenerative Medicine II-44Based on Novel Materials / Material Science Advancements II-44Overview of Major Regenerative Medicine Techniques II-45Natural Regenerative Proteins II-45Tissue Engineering Capable of Culturing Replacement Organs II-45All About Stem Cells II-46Adult Stem Cells II-46Adult Stem Cell Research Eludes Ethical Dispute II-46hESC - Highly Capable of Differentiating and Multiplying II-47Stem Cell Research in Development of Regenerative Medicine II-47Neural Stem Cell to Restore Memory Functioning II-47Pancreatic Islet Cells to Control Blood Sugar in Diabetics II-48Therapeutic 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-51BioMimetic Therapeutics to Launch Augmatrix™ BiocompositeBone Graft II-51TEI Biosciences Introduces PriMatrix™ Ag Antimicrobial DermalRepair 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-54BioMimetic Therapeutics Secures CE Mark Approval for GEM 21S®in EU II-54WFIRM and Nantong University Set-up China-US Regenerative andTranslational Medicine Research Center II-54EMD Millipore Collaborates with Centre for Commercializationof Regenerative Medicine II-54American CryoStem Associates with Alliance for RegenerativeMedicine II-55TAP Biosystems Collaborates with a leading RegenerativeMedicine Company II-55Cytomedix Acquires Aldagen II-55Centre for Commercialization of Regenerative Medicine Sets UpIndustry Consortium II-56Tengion Conducts Preclinical Study for Small IntestineRegeneration II-56TiGenix Inks Agreement with Cellerix for Combining BusinessOperations II-56La Jolla Pharmaceutical Acquire Rights to RegenerativeImmunophilin Ligands from GliaMed II-57Medtronic Acquires Minority Stake in Tengion II-57ImageIQ to Enter into Partnership with CCBC, NCRM andCleveland Clinic II-58Centre for Commercialization of Regenerative MedicineCollaborates with McEwen Centre for Regenerative Medicine II-58LifeNet Health Sets Up Institute of Regenerative Medicine II-59UK 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-65BioVest International, Inc. (US) II-65Curis, Inc. (US) II-65Cytori Therapeutics, Inc. (US) II-66Evotec AG (Germany) II-67Forticell Bioscience, Inc. (US) II-67Geron Corporation (US) II-68Integra LifeSciences Corporation (US) II-68LifeCell Corporation (US) II-69Osiris Therapeutics, Inc. (US) II-69Tengion, Inc. (US) II-70Tepha Inc. (US) II-70TiGenix 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 MedicineProducts for Bone and Joint Applications by Geographic Region -US, Europe and Rest of World Markets Independently Analyzedwith Annual Sales Figures in US$ Million for Years 2004through 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 MedicineProducts for Bone and Joint Applications by Application - BoneReplacements, Bone Stimulators, and Tissue ReplacementsMarkets Independently Analyzed with Annual Sales Figures inUS$ Million for Years 2004 through 2009 (includescorresponding 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 LeadingPlayers (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 MedicineProducts for Bone and Joint Applications Market with AnnualSales 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 MedicineProducts for Bone and Joint Applications Market with AnnualSales 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 RegenerativeMedicine Products for Bone and Joint Applications Marketwith Annual Sales Figures in US$ Million for Years 2004through 2009 (includes corresponding Graph/Chart) III-47IV. 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)

To order this report:Blood Supply, Tissue Banking and Transplantation Industry: Global Regenerative Medicine Industry

Contact Clare: [email protected]
US:(339) 368 6001
Intl:+1 339 368 6001

SOURCE Reportlinker