Regenerative Medicine: Market Research Report

December 2017 | 303 pages | ID: R9C9DD9D391EN
Global Industry Analysts, Inc

Abstracts

This report analyzes the worldwide markets for Regenerative Medicine in US$ Million. The report provides separate comprehensive analytics for the US, Japan, Europe, Asia-Pacific, and Rest of World. Annual estimates and forecasts are provided for the period 2015 through 2022.

Also, a six-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research.

Company profiles are primarily based on public domain information including company URLs.

The report profiles 52 companies including many key and niche players such as -

• AlloSource
• Anika Therapeutics, Inc.
• Bioventus LLC
• DePuy Synthes Companies
• Exactech, Inc.

Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

II. EXECUTIVE SUMMARY

1. OUTLOOK

Regenerative Medicine: A Preface
An Overview of Regenerative Medicine in Bone and Joint Applications
Current and Future Analysis
Developed Markets Dominate, Developing to Drive Growth

2. REGENERATIVE MEDICINE – A MACRO PERSPECTIVE

Regenerative Medicine – Past, Present & Future
Another Revolution in the Making?
Conventional Chemical Medicine Vs Regenerative Medicine
Regenerative Medicine – Bypassing the Ethical Concerns
Regenerative Medicine Throws Up Several New Therapies
Current Global Market for Regenerative Medicine
Market Potential
Therapeutic Companies and Products in Regenerative Medicine – Current Status
Growth Drivers for Regenerative Medicine
A Combination of Factors to Drive Regenerative Medicine Market
Burgeoning Global Population Offers Significant Growth Opportunities

Table 4. Top 25 Countries Worldwide in Terms of Population: 2015 & 2016 (includes corresponding Graph/Chart)

Aging Global Population: Need for New Effective Treatments

Table 5. Global Population Statistics for the 65+ Age Group (2015) (includes corresponding Graph/Chart)

Table 6. Comparison of Aging Population by Country (1980, 2015 & 2050): Percentage Share of Population Aged Above-65 Years of the Overall Population for Select Countries (includes corresponding Graph/Chart)

Table 7. Life Expectancy for Select Countries in Number of Years: 2015E (includes corresponding Graph/Chart)

Increasing Healthcare Spending in Emerging Markets: Opportunities in Store

Table 8. Healthcare Spending as a Percentage of GDP by Region (2016E) (includes corresponding Graph/Chart)

Table 9. Per-Capita Healthcare Expenditure in US$ for Select Countries/Regions (2014) (includes corresponding Graph/Chart)

Government Support and Increased Private Sector Participation
Investment and Funding Landscape
Recent Advancements in the Science of Regenerative Medicine
Advanced Ceramics Gaining Preeminence in Regenerative Medicine Field

Table 10. Global Medical Ceramics Market (2015 & 2020): Percentage Breakdown of Value Sales by Application (includes corresponding Graph/Chart)

3D ORGAN & TISSUE PRINTING: STILL IN EARLY STAGES
Nanotechnology in Regenerative Medicine
Issues to be Sorted Out
Need for New Scientific and Technological Standards
Standardized Guidelines
Clinical Translation – Collaboration of Multidisciplinary Skills is Essential
The Question of Apt Business Models – The Service and Product Approach
Autologous or Service Approach Preferred by European Firms
Allogenic or Product Approach – Slow to Develop
Regenerative Medicine Requires Improved Biomaterials
Investors Wary of Funding Regenerative Medicine
Regenerative Medicine Field Lags Behind Due to Segregated Focus
Challenges Encountered by Regenerative Medicine
Scientific and Technological Challenges
Barriers in Sharing Intellectual Property Rights
Viable Manufacturing Technologies and Skilled Personnel Crucial
Strict Regulations Push up Operational Costs
Challenges Facing Autologous Cell Therapies

3. BONE AND JOINT REGENERATIVE MEDICINE – AN OVERVIEW

Bone Regenerative Medicine Presents Need for Advanced Therapies
Limitations and Drawbacks for Different Bone Grafts
Key Growth Drivers
Rising Incidences of Degenerative Intervertebral Disc Diseases

Table 11. Global Osteoporosis Prevalence by Country/Region (2012 & 2022P): Number of People with Osteoporosis in Millions for US, EU, Japan, China and India (includes corresponding Graph/Chart)

Table 12. % of Women Affected by Osteoporosis (includes corresponding Graph/Chart)

Increase in Prevalence of Arthritis and Other Orthopedic Disorders
Rise in Revision Orthopedic Surgeries
Increase in Spinal Fusions in Private Healthcare
Bone Grafts Market Maintains Positive Momentum
Applications of Bone Grafts: A Review
What Drives Physicians’ Choice of Bone Grafts?
Bone Graft Substitutes (BGSs) Market: Showing Promising Potential
Synthetic Bone Graft Substitutes to Replace Traditional Autografts and Allografts
Orthobiologics Gain Traction in the Bone Grafts Market

Table 14. Leading Players in the Global Orthobiologics Market (2016E): Percentage Breakdown of Value Sales for AlloSource, DePuy, Integra, Medtronic, MTF, RTI Biologics, Sanofi, Sekagaku, Stryker, Zimmer Biomet and Others (includes corresponding Graph/Chart)

Histroical Data for Additional Perspective

Table 15. Global Orthobiologics Market (2012): Percentage Breakdown of Value Sales for Allograft & DBM, Blood & Marrow-based Products, Growth Factors, Hemostasis, Synthetic Bone Graft Substitutes and Viscosupplements (includes corresponding Graph/Chart)

Table 16. Global Stem Cell Orthobiologics Market (2012): Percentage Breakdown of Value Sales for Alphatec, NuVasive and Orthofix (includes corresponding Graph/Chart)

Increasing Visibility of Orthobiological Products to Spur Grafting Options
Autograft: Gold Standard for Bone Grafting Procedures
Allograft: Leading the Race over Autografts
Allografts Encroach into the Use of Autografts in Surgical Procedures
Technological Advancements Drive the Market for Bone Grafts
Foot and Extremity Reconstruction – Promising Market for Bone Grafts
Precision Machined Allograft Gain Surgeon Preference
Unmet Clinical Needs to Foster R&D Engine
Biological Solutions in Sports Medicine – Beyond Bone Grafting
What Ails the Market?
BMPs and Other Synthetic Growth Factors
Bone Morphogenic Proteins (BMPs): Safety Concerns Led to Downfall
Demineralized Bone Matrices (DBMs) Market: Strong Growth but Tough Competition

Table 17. Global Demineralized Bone Matrix Market (2012): Percentage Breakdown of Value Sales for Altiva, Bacterin, Integra LifeSciences, Medtronic, Synthes/MTF and Others (includes corresponding Graph/Chart)

Biomaterials Market – Promising Opportunities for Cost-Effective Products
Tissue Engineered Cartilage Market – An Overview
Stem Cells to Support Tissue Engineering
Market Potential of Tissue Engineered Cartilage Products
Potential Applications of Tissue Engineered Cartilage Products
Challenges in Clinical Application of Tissue Engineered Cartilage Products
Bone Marrow Transplants (BMTs)
Companies Engaged in CBSC Research for BMTs
Stem Cell Research – Not Just Another Medical Advancement
Sources of Stem Cells
Stem Cell Based Bone Grafts – Fastest Growing Bone Graft Substitute Segment
Progenitor Cell Therapy to Witness No Holds Barred Growth
Stem Cell Market on the Verge of Rapid Growth
Clinical Development in Adult stem cells Moves Ahead, Lurches in hESCs
Teratomas – No Longer an Impediment to Stem Cell Therapy Development
Induced Pluripotent – A Potential Competitor to hESCs?
Mesenchymal Stem Cells for Regenerative Medicine
Scientific and Technological Challenges in Orthopedic Regenerative Market
Bone Regeneration
Clinical Approaches in Bone Regeneration and Their Limitations

4. COMPETITIVE LANDSCAPE

Bone Grafts: A Highly Fragmented Market
Bone Growth Stimulation Market

Table 18. Global Bone Growth Stimulation Market (2016): Percentage Breakdown of Value Sales for Bioventus, DJO, Orthofix and Zimmer Biomet (includes corresponding Graph/Chart)

Medtronic’s Infuse BMP Lands into Controversy

5. REGENERATIVE MEDICINE IN OTHER AREAS

Wound Healing – The Second Largest Segment
Tissue Engineered Skin Substitutes: Potential Substitutes for Skin grafts
Cardiology – Promising Opportunities
Select Stem Cell Products in the Development for CV Indications
Diabetes – Highly Effective Innovative Treatments
Regenerative Medicine Products in Development Pipeline for Diabetes
Neurodegenerative Diseases – Great Potential
Body Sculpting/Cosmetics – High Potential
Platelet Rich Plasma Treatment Gains Popularity
Genetic Disorders
Osteoarthritis
Orthopedic Oncology
What’s in Store?
Regenerative Medicine to Arrest Ageing?
Thriving on an Aging World Population
Faster Healing Process
Regenerative Medicine to Overcome Donor Organs Shortage
Possible Scenarios

6. REGULATORY ENVIRONMENT

Global Regulatory Landscape
US
FDA Classification of Bone Products
Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)
Good Tissue Practices
DBM-based Products in US
Synthetic Bone Graft Substitutes
Tissue Banking Regulation
FDA Regulations on Xenograft
EU
Japan
Regulatory Norms Governing Embryonic Stem Cell Research
Human Embryonic Stem Cell Regulation in Select Countries Worldwide
The IP Scenario in the Embryonic Stem Cells Research
Diversity in Patent Regimes Pose Tremendous Challenges
International Divide on Patenting Dents hESC Research

7. A PEEK INTO THE GLOBAL ORTHOPEDIC INDUSTRY

Orthopedic Industry: An Overview

Table 19. Incidence of Fractures by Age Group (2014): Percentage Breakdown of Number of Fractures for Below 45 Years, 45 to 64 Years, and Above 65 Years (includes corresponding Graph/Chart)

Table 20. Global Orthopedic Market by Segment (2015E): Percentage Breakdown of Value Sales for Extremities, Hips, Knees, Orthobiologics, Spine, Trauma and Others (includes corresponding Graph/Chart)

Medical Devices and Implants for Orthopedics
Expanding Opportunities in Hip and Knee Market
Extremity Reconstruction – A Growing Market
Is Consolidation Blowing in the Wind?
Product Mix of Reconstructive Devices Companies
Key Statistics in Global Orthopedics Industry

Table 21. Leading Companies in the Global Orthopedic Market (2016E): Percentage Breakdown of Value Sales for DePuy Synthes, Medtronic, Smith & Nephew, Stryker, Zimmer Biomet and Others (includes corresponding Graph/Chart)

Table 22. Global Orthopedic Market by Application (2016E): Percentage Breakdown of Value Sales for Arthroscopy, Joint Reconstruction, Orthobiologics, Spine, Trauma and Others (includes corresponding Graph/Chart)

Table 23. Leading Players in the Global Trauma and Extremity Products Market (2016E): Percentage Breakdown of Value Sales for DePuy Synthes, Smith & Nephew, Stryker, Zimmer Biomet and Others (includes corresponding Graph/Chart)

Bone Grafts & Joint Revision Arthroplasty

Table 24. Leading Players in the Global Hip and Knee Replacement Market (2016): Percentage Breakdown of Value Sales for DePuy Synthes, Smith & Nephew, Stryker, Zimmer Biomet and Others (includes corresponding Graph/Chart)

Table 25. Leading Players in Worldwide Knee Replacement Market (2016): Percentage Breakdown by Value Sales for DePuy Synthes, Smith & Nephew, Stryker, Zimmer Biomet and Others (includes corresponding Graph/Chart)

Table 26. Leading Players in Worldwide Hip Replacement Market (2016): Percentage Breakdown by Value Sales for DePuy Synthes, Smith & Nephew, Stryker, Zimmer Biomet and Others (includes corresponding Graph/Chart)

8. PRODUCT OVERVIEW

9. PRODUCT INNOVATIONS/INTRODUCTIONS

Orthofix’s New Bone Growth Stimulators Obtain FDA and CE Approvals
Anika Therapeutics Obtains CE Approval for ORTHOVISC-T
Zimmer Biomet Rolls Out Bone Allograft PrimaGen
Novastep Introduces biofit Wedge System
Stryker Launches New Hand-held Bone Graft Material Delivery Device
Glidewell Unveils New Range of Dental Bone Grafting Products
AlloSource Launches Two New Demineralized Cortical Fiber Allografts
Exactech Launches Acapella One Cervical Spacer System
Anika Therapeutics Rolls Out Viscosupplement CINGAL in the EU
NuVasive Launches AttraX Putty
Integra LifeSciences to Launch Omnigraft Dermal Regeneration Matrix
Anika Therapeutics Secures Approval for Cingal for Treatment of Osteoarthritic Knee Pain
Bioventus Launches SIGNAFUSE Bioactive Bonegraft Putty
AlloSource Rolls Out ProChondrix Cartilage Restoration Matrix
MIS Implants Releases 4MATRIX Bone Graft Cement
Citagenix Launches PentOS OI Putty
Medtronic’s Infuse Bone Graft Receives Approval for New Indications
Nordson Introduces Bone Graft Delivery System
AmnioLife to Launch New DBM Product Range
BioMimetic Secures FDA Approval for AUGMENT Bone Graft

10. RECENT INDUSTRY ACTIVITY

TheraCell to Secure Patent for DBF Technology
Derma Sciences Acquires BioD
Histogenics Buys Japanese Developmental and Commercialization Rights to NeoCart
Integra LifeSciences Inks Deal with AlloSource
AlloSource Obtains Patent for ProChondrix Cartilage Restoration Matrix
Exactech Divests Dental Biologics Business to Salvin
AlloSource Secures Patent for Acellular Human Dermal Matrix
AlloSource’s AlloStem Cellular Bone Allograft Obtains Patent in the US
Bioventus Takes Over BioStructures
Wright Medical Group Merges with Tornier
Ortho RTi to Acquire Technology from Gestion Univalor and Polytechnique Montréal
Fujifilm Takes Over Cellular Dynamics
Anika Therapeutics Files for IDE for Hyalofast
Zimmer Takes Over ETEX Holdings
Aastrom Biosciences Acquires Cell Therapy and Regenerative Medicine Business of Sanofi
Olympus to Sell the OP-1 Plant
Wright Medical Group Divests OrthoRecon Business

11. FOCUS ON SELECT PLAYERS

AlloSource (US)
Anika Therapeutics, Inc. (US)
Bioventus LLC (US)
DePuy Synthes Companies (US)
DePuy Synthes Spine, Inc. (US)
Exactech, Inc. (US)
Integra LifeSciences Holdings Corp. (US)
LifeNet Health, Inc. (US)
Medtronic, plc (Ireland)
NovaBone Products LLC (US)
NuVasive, Inc. (US)
Orthofix International N. V. (Netherlands)
Osiris Therapeutics, Inc. (US)
Smith & Nephew plc (UK)
Stryker Corporation (US)
Wright Medical Technology, Inc. (US)
Zimmer Biomet Holdings, Inc. (US)

12. GLOBAL MARKET PERSPECTIVE

Table 27. World Recent Past, Current & Future Analysis for Regenerative Medicine Products for Bone and Joint Applications by Geographic Region - US, Japan, Europe, Asia-Pacific and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 28. World Historic Review for Regenerative Medicine Products for Bone and Joint Applications by Geographic Region - US, Japan, Europe, Asia-Pacific and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

Table 29. World 14-Year Perspective for Regenerative Medicine Products for Bone and Joint Applications by Geographic Region - Percentage Breakdown of Dollar Sales for US, Japan, Europe, Asia-Pacific and Rest of World Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart)

Regenerative Medicine Market by Segment

Table 30. World Recent Past, Current & Future Analysis for Regenerative Medicine Products for Bone and Joint Applications by Segment - Bone Replacements, Bone Stimulators, and Tissue Replacements Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 31. World Historic Review for Regenerative Medicine Products for Bone and Joint Applications by Segment - Bone Replacements, Bone Stimulators, and Tissue Replacements Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

Table 32. World 14-Year Perspective for Regenerative Medicine Products for Bone and Joint Applications by Segment - Percentage Breakdown of Dollar Sales for Bone Replacements, Bone Stimulators, and Tissue Replacements Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart)

III. MARKET

1. THE UNITED STATES

A. Market Analysis
Current and Future Analysis
US to Retain Leadership Position
The Strength of US in Regenerative Medicine – A Glance
Factors Driving the US Market of Regenerative Medicine
Regenerative Medicine in Bone and Joint Applications
High Potential for Regenerative Medicine in Orthopedics
Regenerative Therapy – Best Fit for Joint Problems
Bone Grafts Market – An Insight
Orthopedic Biomaterials Market – An Overview
Orthobiologics Market – Overview
Competitive Scenario
Stem Cell Market Outlook
Regenerative Medicine – Other Areas of Application
Regenerative Medicine – Face of Future Revolution in Cardiology
Regenerative Medicine in Wound Healing – The Most Widespread Application
Regenerative Medicine in Diabetes – A Number of Emerging Applications
Regenerative Medicine – A Ray of Hope for Neurodegenerative Disease Patients
Implantable Regenerative Products Take Over Sports Medicine
Challenges in the Area of Product Development
Process of Integration Continues
Scientific and Technological Challenges to be Tackled
Dominant Patents a Cause of Concern
Product Approvals/Launches
Strategic Corporate Developments
Key Players
B. Market Analytics

Table 43. US Recent Past, Current & Future Analysis for Regenerative Medicine Products for Bone and Joint Applications Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 44. US Historic Review for Regenerative Medicine Products for Bone and Joint Applications Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

2. JAPAN

A. Market Analysis
Current and Future Analysis
A Peek into Current State of Affairs
Regenerative Medicine to Become A Cost Saving Tool
Japan Takes Steps to Push Forward its RM Science
The Discovery of iPS Cells Lends Traction
Drug Development – A Major Application for iPS
Use of iPS for Regenerative Medicine
Intractable and Congenital Disease Treatments
Research & Development Rife in iPS Cells Space
General Trends in Regenerative Medicine Industry
Research Activity in Regenerative Medicine Field
More Companies Eye the Regenerative Medicine Potential
Competition Heats up Behind Closed Doors
Japanese Firms Need to Catch Up with US and European Competitors
Science Ministry Rolls Out Regenerative Medicine Project
Regenerative Medicine Exempted from Ban on Human Cloning
Regenerative Medicine - Regulatory Overview in Japan
The RM Act
Japanese Pharma Seeks Regenerative Medicine to Gain Competitive Advantage
Strategic Corporate Development
B. Market Analytics

Table 45. Japanese Recent Past, Current & Future Analysis for Regenerative Medicine Products for Bone and Joint Applications Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 46. Japanese Historic Review for Regenerative Medicine Products for Bone and Joint Applications Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

3. EUROPE

A. Market Analysis
Current and Future Analysis
Great Potential for Regenerative Medicine
Challenges Faced by European Regenerative Medicine Industry
Orthopedic Biomaterials Market – An Overview
Synthetic Bone Graft Market Drives the BGS Market
Dental Biomaterials Market in Europe: An Insight
Key Historical Statistical Data for Additional Perspective

Table 47. European Bone Graft Substitutes Market by Type (2012): Percentage Share Breakdown of Value Sales for Allograft, DBM and Synthetic (includes corresponding Graph/Chart)

Table 48. European Market for Standard Bone Allografts by Leading Companies/ Organizations (2012): Percentage Share Breakdown of Value Sales for LifeNet Health, Medtronic, Musculoskeletal Transplant Foundation, RTI Surgical and Others (includes corresponding Graph/Chart)

Table 49. European Market for Machined Bone Allografts by Leading Companies/ Organizations (2012): Percentage Share Breakdown of Value Sales for Medtronic, Musculoskeletal Transplant Foundation, RTI Surgical and Others (includes corresponding Graph/Chart)

Table 50. European Market for Demineralized Bone Matrix by Leading Companies/ Organizations (2012): Percentage Market Share Breakdown of Value Sales for Medtronic, Musculoskeletal Transplant Foundation, RTI Surgical, Wright Medical Technology and Others (includes corresponding Graph/Chart)

Table 51. European Market for Bone Graft Substitutes by Leading Players (2012): Percentage Share Breakdown of Value Sales for Biomet, Medtronic, Stryker, Wright Medical Technology, Zimmer and Others (includes corresponding Graph/Chart)

The Need to Embrace Newer Technologies
Complex Regulatory Scenario with Multi-tier Governance System
Need for More Integration
Policies Regarding Egg Procurement Weigh Down Research Progress
Need for Harmonized Clinical Trial Regulation
International Alliances – Outsourcing Options with Developing Countries
Patenting Issues in hESC Research
Ageing Population to Drive Demand for MSC based Therapies

Table 52. Population Breakup by Age Group for Select EU-28 Countries: 2015 (as a Percentage of Total Population) (includes corresponding Graph/Chart)

Overview of Select Regional Markets
Germany
United Kingdom
Product Approvals/Launches
Strategic Corporate Developments
Key Players
B. Market Analytics

Table 53. European Recent Past, Current & Future Analysis for Regenerative Medicine Products for Bone and Joint Applications Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 54. European Historic Review for Regenerative Medicine Products for Bone and Joint Applications Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

4. ASIA-PACIFIC

A. Market Analysis
Current and Future Analysis
State of Regenerative Medicine in Asia – An Overview
Dental Bone Graft Substitutes and Biomaterials Market – An Overview

Table 55. Over 65 Years Individuals as % of Total Population in Select Asian Countries: 2015 (includes corresponding Graph/Chart)

Overview of Select Regional Markets
China
India
South Korea
Malaysia
Singapore
New Zealand
Regulatory Developments in the Region
B. Market Analytics

Table 56. Asia-Pacific Recent Past, Current & Future Analysis for Regenerative Medicine Products for Bone and Joint Applications Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 57. Asia-Pacific Historic Review for Regenerative Medicine Products for Bone and Joint Applications Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

5. REST OF WORLD

A. Market Analysis
Current and Future Analysis
Overview of Select Regional Markets
Canada
Latin America
Argentina
Brazil
Middle East
Israel
Product Launch
Strategic Corporate Development
B. Market Analytics

Table 58. Rest of World Recent Past, Current & Future Analysis for Regenerative Medicine Products for Bone and Joint Applications Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 59. Rest of World Historic Review for Regenerative Medicine Products for Bone and Joint Applications Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 52 (including Divisions/Subsidiaries - 54)
The United States (37)
Canada (3)
Japan (1)
Europe (10)
  Germany (2)
  The United Kingdom (2)
  Rest of Europe (6)
Asia-Pacific (Excluding Japan) (1)
Middle East (1)
Africa (1)