Opportunities in Non-Surgical Bio-Implants: Marketed injectable biomaterials, applications, and leading players

Injectable bio-implants provide rapid non-surgical treatments and offer effective replacement, restoration, or modulation of function to lost, damaged, or dysregulated physiology. Market opportunities for injectable bio-implants are high in an increasingly aging population that demands fast, effective, and safe treatments for age-related conditions. Both medical and aesthetic applications for biomaterials make the market opportunities for injectable bio-implants highly attractive for drug and device manufacturers. However, biocompatibility is crucial for any implantable biomaterial to integrate into the host anatomy and prevent an immunogenic response.
This report provides a comprehensive assessment and analysis of the current market for viscoaugmentation and viscosupplementation products and shows how research and development has expanded product choice and diversity among the relatively limited injectable medical devices that are approved.
The report also shows promising next-generation bio-implants and those in preclinical research and clinical development. It details the challenges of achieving biocompatibility and the technologies that have successfully emerged from biomaterials research. Additionally, the report details the major players, market opportunities, and emerging sectors of the field that are changing the landscape of injectable treatments with major applications in cosmetic dermatology and orthopedics. The report also shows how reformulation and product line extensions may be needed to succeed in an increasingly saturated market sector.

Key features of this report

• Analysis of current biomaterials that have been developed as injectable medical devices
• Evaluation of the barriers and problems associated with biocompatibility for developed biomaterial types
• Identification of the current trends in injectable bio-implants for aesthetic and medical indications and how companies have expanded indications to increase revenues and portfolios
• Analysis of next-generation products and how companies are reformulating products to improve clinical performance and patient attractiveness.
• Assessment of approved injectable viscoaugmentation and viscosupplementation devices and the strategies employed to expand product lines

Scope of this report

• Understanding of the key obstacles in research for biocompatibility in the development of injectable medical devices
• Rationale for injectable device development and how biomaterials R&D has evolved to meet unmet needs in aesthetics and orthopedics
• Up-to-date information on the marketed viscoaugmentation and viscosupplementation product sectors
• Evaluates the key recent developments and activities of companies who are developing and licensing injectable bio-implant technologies.


Key Market Issues

• Biocompatibility is a critical issue for commercial development of injectable bio-implants. Products that are not safe and biocompatible will fail in the marketplace.
• Medical technology and device developers need to develop next-generation products that offer greater clinical benefits, value, and patient and physician preference.
• Demand for more durable and adaptable formulations of bio-implants has led to expanded brands and indications in the market.
• Reimbursement issues for injectable bio-implants in orthopedics is driving innovation to reformulate products that are more durable and hence more cost-effective.
• Development efforts are underserved and focus on limited repertoire of biomaterials that reach the clinic.

Key findings from this report

• Biocompatibility is a critical issue that challenges research and development of injectable bio-implants. Commercialized products are limited to collagens, hyaluronic acids, polymer formulations, and ceramics.
• Demand for safer, more effective treatment options has stimulated R&D to produce a variety of same-type products differentiated by type, size, indication, and unmet needs mainly in cosmetic dermatology and orthopedics.
• Commercial opportunities are evident for approved viscoaugmentation and viscosupplementation products in crossover fields where injectable bio-implants may be developed for a variety of diverse conditions.
• Research and development themes are limited and few novel biomaterials have reached the clinic indicating upside potential for R&D in the field.
• Companies are increasingly licensing and re-marketing products across therapeutic areas to maximize sales revenues, novelty, and product choice.

Key questions answered

• What are key challenges in developing an injectable biomaterial and bio-implant?
• What are the current commercialized product types and how have they evolved?
• What are the key viscoaugmentation and viscosupplementation products and what key indications are they used for?
• What are the trends in product development for approved injectable products?
• How are companies optimizing their product lines?



Report Highlights

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Table of Contents
Opportunities in Non-surgical Bio-implants Executive summary 10
Injectable biomaterials 10
Viscoaugmentation 11
Viscosupplementation 12
Alloplastic injectable biomaterials: R&D 13
Chapter 1 Injectable biomaterials 16
Summary 16
Introduction 17
Development issues 18
Problems with biocompatibility 18
Design factors 20
Rationale for development of injectable biomaterials 22
Types of injectable biomaterials 22
Collagen 23
Hyaluronic acid 24
Hydrogels 25
Hydroxyapatite 26
Calcium phosphate ceramic pastes 27
Biopolymers 27
Adverse reactions associated with current injectable biomaterials 28
Ideal properties of injectable biomaterials 29
Chapter 2 Viscoaugmentation 32
Summary 32
Soft tissue viscoaugmentation bio-implants 33
Trends in injectable cosmetic treatments in the US 33
Primary indications for soft-tissue augmentation products 34
Collagen 35
Companies, products, and market activities 36
Allergan’s Zyderm-Zyplast/Cosmoderm-Cosmoplast range 36
Recent industry activities: Evolence discontinued 37
Hyaluronic acid 38
Companies, products, and market activities 39
Adoderm 39
Allergan 39
Anteis 41
Anika Therapeutics 42
BioPolymer GmbH & Co. KG 43
Coapt Systems 45
Fidia Farmaceutici 46
KuhraVital Dermapharma 46
Laboratoires Filorga 46
L&M Aesthetic Equipment/Parpas Group 47
LCA Pharmaceutical 47
Hangzhou Gallop Biological Products 48
Novatex Bioengineering/Laboratoires Orgév 49
Johnson & Johnson/Mentor Corp. 50
Puragen 50
Merz Pharma/Merz Aesthetics 51
Q-Med 52
Nordic Aesthetics 54
Prollenium Medical Technologies 55
Rofil Medical/Philoderm Aesthetics 56
Teoxane Laboratoires 56
Biopolymers 57
Dimethicone/silicone oil 57
Companies, products, and market activities 58
Contura International 58
FzioMed 60
Polymekon 60
Suneva 61
ProCytech 62
Sanofi-Aventis 63
Generic polymeric soft tissue fillers 63
Ceramics/hybrid technologies 64
Companies, products, and market activities 64
BioForm Medical 64
Stiefel Laboratories/GlaxoSmithKline 65
Chapter 3 Viscosupplementation 68
Summary 68
Intra-articular injectable bio-implants 69
Marketed injectable products and company activities 70
Anika Therapeutics 70
Anteis 71
BioPolymer 71
Curasan 72
Ferring Pharmaceuticals 72
Fidia Farmaceutici 73
Genzyme Corp 73
LCA Pharmaceutical 74
Novatex Bioengineering 75
Ortho Biotech/Johnson & Johnson/Anika Therapeutics 76
Q-Med/Smith & Nephew 76
Sanofi-Aventis 77
Seikagaku/Smith & Nephew 77
TRB Chemedica 78
Generic sodium hyaluronate 79
Chapter 4 Alloplastic injectablebiomaterials: R&D 82
Summary 82
Alloplastic injectable biomaterials: current R&D 83
Viscoaugmentation: cosmetic applications 83
Albiorex 83
FibroGen 84
Kythera Pharmaceuticals 84
Moma Therapeutics 84
Novatex Bioengineering 85
Prollenium Medical Technologies 85
Viscosupplementation: medical/surgical applications 85
Anika Therapeutics 86
Barrow Neurological Institute at St. Joseph’s Hospital and Medical
Center, US 86
Biotechnology Institute IMASD 87
Genzyme Corp 87
Pioneer Surgical Technology 87
Prollenium Medical Technologies 88
Seikagaku 88
Considerations, insights, and recommendations 89
Appendix 91
Scope 91
Methodology 91
Glossary 92
Index 94
List of Figures
Figure 1.1: Potential adverse responses to implanted biomaterials 19
Figure 1.2: Essential design components for biocompatibility of implantable biomaterials 20
Figure 1.3: Types of marketed injectable biomaterials 23
Figure 1.4: Medical applications and benefits of hydrogels 26
Figure 1.5: Potential adverse reactions associated with injectable biomaterials 29
Figure 2.6: Trends in injectable treatments in the US, 2003–2009 34
Figure 2.7: Primary indications for soft tissue dermal fillers 35
List of Tables
Table 1.1: Basic properties and medical applications of biomaterials 18
Table 1.2: Medical applications of hyaluronic acid 25
Table 1.3: Medical applications of biopolymers 28
Table 2.4: Marketed collagen-based injectable products 36
Table 2.5: Main indications for Allergan’s collagen-based injectable products 37
Table 2.6: Adoderm’s hyaluronic acid-based injectable products 39
Table 2.7: Allergan’s hyaluronic acid-based injectable products 41
Table 2.8: Anteis’ hyaluronic acid-based injectable products 42
Table 2.9: Anika Therapeutics’ hyaluronic acid-based injectable products 43
Table 2.10: Biopolymer’s marketed hyaluronic acid-based injectable products 44
Table 2.11: Coapt Systems’ marketed hyaluronic acid-based injectable products 45
Table 2.12: KuhraVital’s marketed hyaluronic acid-based injectable products 46
Table 2.13: Laboratoires Filorga’s marketed hyaluronic acid-based injectable products 47
Table 2.14: L&M Aesthetic’s marketed hyaluronic acid-based injectable products 47
Table 2.15: LCA Pharma’s marketed hyaluronic acid-based injectable products 48
Table 2.16: HGBP’s marketed hyaluronic acid-based injectable products 49
Table 2.17: Novatex’s hyaluronic acid-based injectable products 50
Table 2.18: J&J’s marketed hyaluronic acid-based injectable products 50
Table 2.19: Merz Pharma’s marketed hyaluronic acid-based injectable products 51
Table 2.20: Q-Med’s marketed hyaluronic acid-based injectable products 52
Table 2.21: Nordic Aesthetics’ marketed hyaluronic acid-based injectable products 54
Table 2.22: Prollenium’s marketed hyaluronic acid-based injectable products 55
Table 2.23: Rofil Medical/Philiderm Aesthetics’ marketed hyaluronic acid-based injectable products 56
Table 2.24: Teoxane’s marketed hyaluronic acid-based injectable products 57
Table 2.25: Contura’s marketed polymer-based injectable products 59
Table 2.26: FzioMed’s marketed polymer-based injectable products 60
Table 2.27: Polymekon’s marketed polymer-based injectable products 60
Table 2.28: Suneva’s marketed polymer-based injectable products 62
Table 2.29: ProCytech’s marketed polymer-based injectable products 62
Table 2.30: Sanofi-Aventis’ marketed polymer-based injectable products 63
Table 2.31: BioForm Medical’s injectable ceramic-based products 65
Table 2.32: Stiefel Laboratories/GSK’s injectable ceramic-based products 66
Table 3.33: Application of biomaterials for orthopedic applications 69
Table 4.34: Selected allosteric viscoaugmentation products in development 83
Table 4.35: Selected allosteric viscosupplementation products in development 86


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