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Chapter- 1: INTRODUCTION

STUDY GOALS AND OBJECTIVES
REASONS FOR DOING THIS STUDY AND ITS IMPORTANCE
INTENDED AUDIENCE
SCOPE AND FORMAT OF REPORT
METHODOLOGY AND INFORMATION SOURCES
ANALYST CREDENTIALS
BCC ONLINE SERVICES
DISCLAIMER

Chapter-2: EXECUTIVE SUMMARY

SCOPE OF THE INDUSTRY
DRUG-DEVICE COMBINATIONS: THE GLOBAL MARKET
TECHNOLOGY AND PATENT ACTIVITY
THE CENTRAL ROLE OF THE FDA
SUMMARY TABLE SALES OF DRUG DEVICE COMBINATION PRODUCTS, THROUGH 2014 ($ BILLIONS)
SUMMARY FIGURE SALES OF DRUG DEVICE COMBINATION PRODUCTS, 2008-2014 ($ BILLIONS)

Chapter-3: CURRENT STATUS OF THE DRUG DEVICE COMBINATION INDUSTRY

OVERVIEW
ROLE OF THE FDA
TABLE 1 RECENT EXAMPLES OF FDA APPROVED COMBINATION PRODUCTS
OFFICE OF COMBINATION PROUCTS ORGANIZATIONAL STRUCTURE
HIGHLY ADVANCED TECHNOLOGIES ARE A MARKET CORE
EXAMPLES OF THE MOST PATH-BREAKING PRODUCTS
FDA CLASSIFICATION SCHEME FOR INDIVIDUAL SEGMENTS
TABLE 2 FDA CLASSIFICATION SCHEME FOR COMBINATION PRODUCTS
THE RELATION BETWEEN NANOTECHNOLOGY AND COMBINATION PRODUCTS
FDA TRENDS IN REVIEWING COMBINATION PRODUCTS
FIGURE 1 COMBINATION PRODUCT APPLICATIONS AT FDA, 2003-2007 (NUMBER OF SUBMISSIONS)
TABLE 3 FDA COMBINATION PRODUCT CATEGORIES, FY 2004
TABLE 4 FDA COMBINATION PRODUCT CATEGORIES, FY 2005 (NUMBERS AND TYPES OF COMBINATION PRODUCTS)

Chapter-4: REGULATORY PROCESS AND ISSUES

OVERVIEW
SCOPE OF FDA ACTION
TREATMENT OF DEVICES
CLASS I DEVICES
CLASS II DEVICES
CLASS III DEVICES
CURRENT STATUS OF FDA AND NANOTECHNOLOGY INITIATIVES
FDA NANOTECH PRODUCT APPROVALS
OTHER RELEVANT HEALTH OR REGULATORY AGENCIES
TYPICAL REGULATORY MILESTONES IN COMBINATION PRODUCT APPROVALS
CLINICAL TRIALS

Chapter-5: NANOTECH COMBINATION PRODUCTS

OVERVIEW
NATIONAL NANOTECHNOLOGY INITIATIVE (NNI)
NANOTECH REGULATORY ENVIRONMENT
COMBINATION NANOTECHNOLOGY PRODUCT RESEARCH
NANODIAMOND DRUG DEVICES FOR CANCER TREATMENT
NANOTECHNOLOGY-MAGNETISM COMBINATION IN TINY IMPLANTABLE DEVICE FOR DRUG DELIVERY
IMPLANTS USING CONDUCTING POLYMER NANOTUBES
CALCIUM PHOSPHATE NANOPARTICLES FOR DRUG DELIVERY
NANO-SCALE DELIVERY OPTIMIZES CHEMOTHERAPY REGIMES
DRUG INFUSED NANOPARTICLES
ENCAPSULATION OF DRUG TREATMENTS IN NANOPARTICLES
SILICON NANOWIRES FOR DRUG DELIVERY
MINUTE ANTIBACTERIAL PARTICLES DESTROY DRUG-RESISTANT GERMS
BIODEGRADABLE CATIONIC CORE-SHELL NANOPARTICLES FOR CO-DELIVERY OF DRUGS AND GENES
STIMULI-SENSITIVE CORE-SHELL NANOPARTICLES FOR CANCER THERAPY
POLYMER-BASED NON-VIRAL GENE CARRIERS
POTENTIAL HEALTH EFFECTS: IMPACT ON NANO INDUSTRY
TABLE 5 REVENUES ATTRIBUTABLE TO NANOTECHNOLOGY-BASED DRUG-DEVICE COMBINATIONS, THROUGH 2014 $ MILLIONS

Chapter-6: DRUG-ELUTING CORONARY STENTS

OVERVIEW
DEFINITION AND SIZE OF TARGET MARKET
TABLE 6 MARKETS FOR CORONARY STENTS, THROUGH 2014 $ BILLIONS
STENT MARKET REINFORCED BY CURRENT RESEARCH FINDINGS
PRINCIPAL DRUG-ELUTED STENT PRODUCERS
STENT DESIGN
PRODUCT LINES
MECHANISM OF ACTION
DEVELOPMENT OF THE INDUSTRY
FDA REGULATORY ROLE WITH REGARD TO STENTS
TABLE 7 EXAMPLES OF STENTS APPROVED FOR CLINICAL USE
STENT PRODUCT INNOVATIONS AND R&D: BIOABSORBABLE STENTS
BIODEGRADABLE COATINGS
HYDROXYAPATITE COATINGS
MARKETS FOR STENT RELATED TECHNOLOGIES
LIPISCAN CORONARY IMAGING SYSTEM

Chapter-7: PHOTODYNAMIC THERAPY

OVERVIEW
TREATMENT LIMITATIONS
TECHNOLOGY HISTORY
RECENT DEVELOPMENTS
SECOND GENERATION PDT SENSITIZERS
PDT MARKETS FOR CANCER
PDT MARKETS FOR MACULAR DEGENERATION
PDT MARKETS FOR PSORIASIS
TYPES OF UVB THERAPY FOR PSORIASIS
PUVA PHOTOCHEMOTHERAPY
TARGETED PHOTOTHERAPY (EXCIMER LASER)
OTHER MEDICAL APPLICATIONS
PDT MARKET GROWTH DRIVERS
EXAMPLE PDT PRODUCTS
VISUDYNE (NOVARTIS)
LEVULAN
PHOTOFRIN (PORFIMER SODIUM)
VISONAC
CEVIRA
LUMACAN
RESEARCH AND DEVELOPMENT
INTERVENTIONAL CARDIOLOGY
DERMATOLOGY
AUTOIMMUNE DISEASES
EQUIPMENT PRODUCERS
TABLE 8 PHOTODYNAMIC THERAPY MARKETS, THROUGH 2014 ($BILLIONS)

Chapter-8: ANTIMICROBIALS AND OTHER MEDICAL DEVICE COATINGS

OVERVIEW: REGULATORY TREATMENT
DRIVING FORCE IN DEVELOPMENT OF ANTI-MICROBIALS
MARKET CONTEXT AND PREVALENCE OF INFECTIONS
EXAMPLES OF USE
TRENDS IN FDA APPLICATIONS FOR ANTIMICROBIALS
TABLE 9 REVENUES ATTRIBUTABLE TO ANTIMICROBIALS THROUGH 2014 ($ BILLIONS)
ANTI-MICROBIAL AND OTHER MEDICAL DEVICE COATINGS
MARKET CATEGORIES FOR MEDICAL DEVICE COATINGS IN COMBINATION PRODUCTS
TABLE 10 REVENUES ATTRIBUTABLE TO MEDICAL DEVICE COATINGS THROUGH 2014 ($ MILLIONS)
EXAMPLE PRODUCTS
TABLE 11 MEDICAL DEVICE PRODUCTS RELYING ON ANTIMICROBIAL COATINGS

Chapter-9: ANTIMICROBIAL CATHETERS

MARKET OVERVIEW
APPLICATIONS
MARKET SIZE
CATHETER INNOVATIONS
ANTIMICROBIAL CATHETER CONCEPTS
EXAMPLE PRODUCTS
5-FLUOROURACIL-COATED CENTRAL VENOUS CATHETER
DRUG - DEVICE COMBINATION CATHETER LOCK/FLUSH SOLUTIONS
R&D INITIATIVES
DIALYSIS CATHETERS
URINARY CATHETERS
OTHER DELIVERY TECHNIQUES
TABLE 12 CATHETER MARKET FORECASTS, BY PRODUCT TYPE, THROUGH 2014 ($ BILLIONS)

Chapter-10: DRUG-ELUTING BEADS

OVERVIEW
EXAMPLE OF THERAPY
COMPANY ACTIVITY
BEAD APPLICATIONS IN STROKE
BEAD APPLICATIONS IN ALLERGY AND ASTHMA ATTACKS
RECENT FDA APPROVALS
RECENT OVERSEAS APPROVALS
CLINICAL TRIALS
TABLE 13 CURRENT CLINICAL TRIALS INVOLVING DRUG-ELUTING BEADS
R&D AND OTHER NOVEL APPLICATIONS OF BEADS
USING FLUORESCENT SILICA BEADS TO DETECT MALIGNANT CERVICAL CELLS
ANTIBODY COATED MAGNETIC BEADS TO COMBAT INFECTION
FUMAGILLIN NANOPARTICLES
CONTROLLED DELIVERY OF TUMOR-KILLER DRUGS
POLYMERIC MICROCAPSULES
TABLE 14 R&D AND REVENUES ATTRIBUTABLE TO DRUG-ELUTED BEADS, THROUGH 2014 ($ MILLIONS)

Chapter-11: BONE CEMENTS INCLUDING ANTIBIOTIC

OVERVIEW
EARLY HISTORY
APPLICATIONS
MARKET SIZE
COMPOSITION
EXAMPLE PRODUCTS
RELATED PRODUCTS: TYPES OF CERAMICS
ALPHA-BSM
BIOGRAN
BIO-OSS
BONESOURCE
CALCIGEN S
CEMENTS IN DENTAL APPLICATIONS: GLASS IONOMER CEMENTS
OTHER OSTEOCONDUCTIVE BONE GRAFT SUBSTITUTES

Chapter-12: BONE GRAFT SUBSTITUTES

OVERALL SIZE OF BONE GRAFT BUSINESS
BONE GRAFT SUBSTITUTES
ALLOGRAFT TISSUE
OTHER OSTEOCONDUCTIVE BONE-GRAFT SUBSTITUTES
HYDROGELS IN BONE GRAFTING
Composition and Method for Self-Assembly and Mineralization of Peptide Amphiphiles
Chondroitinase ABC I Polynucleotides
Transdiscal Administration of Cycline Compounds
Composition and Method for Preparing Biocompatible Surfaces
Spinal Mobility Preservation Apparatus Having an Expandable Membrane
OSTEOBIOLOGICS AND OSTEOINDUCTIVE GROWTH FACTORS
BONE GRAFTS
TABLE 15 CHARACTERISTICS OF IDEAL BONE GRAFT MATERIAL
TABLE 16 BONE GRAFT PROCEDURE VOLUMES BY APPLICATION IN THE U.S., THROUGH 2014
TABLE 17 BONE GRAFT PROCEDURE VOLUMES BY TYPE OF GRAFT IN THE U.S., THROUGH 2014
TABLE 18 COMPARISON OF BONE GRAFT MATERIALS
TABLE 19 TYPES OF SUBSTITUTE BONE GRAFTS
AUTOGRAFTS
BioSeed Grafts
Allografts
Demineralized Bone Matrix Products
TABLE 20 SELECTED DBM PRODUCT AND PERCENTAGE OF DEMINERALIZED BONE MATRIX
Accell
AlphaGRAFT
Allomatrix
Grafton DBM
DBX
DynaBlast and DynaGraft-D
Graftech
Grafton
Opteform
OrthoBlast II
Osteofil
Solo Cervical Allograft
Xenografts
THE MARKET FOR ALLOGRAFTS
TABLE 21 THE U.S. MARKET FOR PRECISION-MACHINED ALLOGRAFTS, THROUGH 2014 ($ MILLIONS)
CELL-BASED BONE GRAFT SUBSTITUTES
FACTOR-BASED BONE GRAFT SUBSTITUTES
BONE MORPHOGENIC PROTEINS
InductOs
INFUSE Bone Graft
OP-1 Implant
CERAMIC-BASED BONE GRAFT SUBSTITUTES
TYPES OF CERAMICS
Alpha-BSM
BioGran
Bio-Oss
BoneSource
Calcigen S
Collagraft Strip Bone Graft Matrix
Conduit TCP Granules
IsoTis Products
Mimix Bone Substitute Material
Norian SRS
OsteoGraf
Osteoset
Osteostim Resorbable Bone Graft Substitute
PerioGlas
Pro Osteon Implant
Vitoss
POLYMER-BASED BONE GRAFT SUBSTITUTES
Cortoss
Healos
Immix Extenders and Immix CB
THE MARKET FOR BONE GRAFT PRODUCTS
TABLE 22 THE WORLDWIDE MARKET FOR BONE REPLACEMENT PRODUCTS, THROUGH 2014 ($ MILLIONS)
TABLE 23 THE U.S. MARKET FOR BONE REPLACEMENT PRODUCTS, THROUGH 2014 ($ MILLIONS)
REGENERATIVE MEDICINE PRODUCTS IN DEVELOPMENT FOR BONE APPLICATIONS
BIOLOGIC/SYNTHETIC GRAFTS
CHRYSALIN

Chapter-13: WOUND CARE PRODUCTS INCLUDING BIOLOGICAL DRESSINGS

WOUND CARE GENERALLY
MARKET SEGMENTS
COLLAGEN
COLLAGEN IN MEDICAL APPLICATIONS
TABLE 24 IDENTIFICATION OF COLLAGEN-BASED PRODUCTS
SPECIFIC COLLAGEN PRODUCTS
TenoMendTM Collagen Tendon Wrap
CosmoDerm and CosmoPlast Human-Based Collagen
TISSUE ENGINEERING
SKIN SUBSTITUTES: CELLS AND TISSUES
ARTIFICIAL SKIN
TABLE 25 EXAMPLES OF SKIN SUBSTITUTE PRODUCTS
SKIN-LIKE TISSUE DEVELOPED FROM HUMAN EMBRYONIC STEM CELLS
TABLE 26 TOTAL SALES OF ENGINEERED SKIN GRAFTS AND REPLACEMENTS, THROUGH 2014 ($ MILLIONS)
ALGINATES
TABLE 27 EXAMPLES OF ALGINATE-BASED PRODUCTS
FIBRIN SEALANT PRODUCTS
HISTORY OF FIBRIN SEALANTS
PRODUCTS
Evicel
Artiss
ReCell
RELATED PRODUCTS: FIRST FDA APPROVED SPINE SEALANT
ENZYMATIC DEBRIDING AGENTS
NANOSTRUCTURED TEMPERATURE-SENSITIVE MEMBRANES FOR WOUND HEALING AND CELL GRAFTING
TABLE 28 EXAMPLE ENZYMATIC DEBRIDING AGENTS
TABLE 29 MARKETS FOR BIOLOGICAL WOUND CARE PRODUCTS THROUGH 2014 ($ BILLIONS)

Chapter-14: DRUG DEVICE COMBINATION PRODUCTS FOR OCCULAR APPLICATIONS

OVERVIEW
INTRAOCULAR LENS PRODUCTS
LENS MATERIALS
CLEAR LENS EXTRACTION AND REPLACEMENT (CLEAR) SURGERY
VITREOUS SUBSTITUTES
Polymers
Perfluorocarbon Liquids (PFCL)
Silicone Oil
Combination Product: PFCL and Silicone Oil
OCULAR DRUG DELIVERY VIA NANOSTRUCTURED DRUG-LOADED CONTACT LENSES
MARKET POTENTIAL
TABLE 30 MARKETS FOR OCCULAR APPLICATIONS IN DRUG-DEVICE COMBINATION PRODUCTS, THROUGH 2014 ($ MILLIONS)

Chapter-15: IMPLANTABLES AS DRUG DEVICE COMBINATIONS

MINIATURE NEUROSTIMULATORS
BIODEGRADABLE CIRCUITS
STEROID ELUTING PACEMAKER LEADS
MARKET SIZE
TABLE 31 IMPLANTABLE DRUG DEVICE COMBINATIONS THROUGH 2014 ($ MILLIONS)

Chapter-16: RELATED DRUG DEVICE COMBINATIONS OF RELEVANCE

OVERVIEW
MARKET SIZE
TABLE 32 MARKETS FOR RELATED DRUG-DEVICE COMBINATION PRODUCTS, THROUGH 2014 ($ MILLIONS)
INJECTABLE BIODEGRADABLE HYDROGELS FOR DRUG DELIVERY AND TISSUE ENGINEERING
RADIATION/DRUG COMBINATIONS
ANTI-BACTERIAL RELEASING DENTAL RESTORATIVE MATERIALS
COMBINATION DENTAL PROPHYLAXIS PASTES AND DRUG COMPONENTS
METERED DOSE INHALERS, SPACERS AND OTHER ACCESSORIES
ANTIMICROBIAL SUTURES
ANTIMICROBIAL VASCULAR GRAFTS
HEAT-ACTIVATED DRUGS
BREATH TEST COMBINATION PRODUCTS
MYOCELL THERAPY BY BIOHEART, INC.
OTHER NEW DRUG DELIVERY CONCEPTS

Chapter-17: PATENT ANALYSIS

OVERVIEW
OTHER INTELLECTUAL PROPERTY ISSUES
EXAMPLE DRUG-DEVICE COMBINATION PATENTS: 2008 TO 2009
ELECTROPROCESSED COLLAGEN AND TISSUE ENGINEERING
BIOFUNCTIONAL, ANTIMICROBIAL COATINGS FOR MEDICAL DEVICES
GELATIN DERIVATIVES AND HIGH-MOLECULAR MICELLE COMPRISING THE DERIVATIVES
METHODS AND APPARATUS FOR ACUTE OR CHRONIC DELIVERY OF SUBSTANCES OR APPARATUS TO EXTRAVASCULAR TREATMENT SITES
WOUND COVERING
NANOPARTICLES FOR PROTEIN DRUG DELIVERY
PROCESS FOR PROVIDING ANTIMICROBIAL SURFACES
GROWTH FACTOR MODIFIED PROTEIN MATRICES FOR TISSUE ENGINEERING
METHOD OF COATING IMPLANTABLE MEDICAL DEVICES
ANTIMICROBIAL COATING FOR EROSIVE ENVIRONMENTS
METHOD AND COMPOSITION FOR PRODUCING CATHETERS WITH ANTIBACTERIAL PROPERTY
IMPLANTABLE MEDICAL DEVICE WITH ANTI-INFECTION AGENT
MINIATURE DRUG DELIVERY PUMP WITH A PIEZOELECTRIC DRIVE SYSTEM
IONTOPHORESIS DEVICE
APPARATUS FOR COATING MEDICAL DEVICES
COATINGS FOR DRUG DELIVERY DEVICES
THIN-FILM DRUG DELIVERY ARTICLE AND METHOD OF USE
IMPLANTABLE, TISSUE CONFORMING DRUG DELIVERY DEVICE
IMPLANTABLE DEVICE WITH RESERVOIRS FOR INCREASED DRUG LOADING
STENT ASSEMBLY FOR THE TREATMENT OF VULNERABLE PLAQUE
APPLICATION OF A THERAPEUTIC SUBSTANCE TO A TISSUE LOCATION USING AN EXPANDABLE MEDICAL DEVICE
MULTI-STABLE VALVES FOR MEDICAL APPLICATIONS AND METHODS FOR USE THEREOF
METHOD AND APPARATUS FOR DELIVERING COMBINED ELECTRICAL AND DRUG THERAPIES
HEPARIN PRODRUGS AND DRUG DELIVERY STENTS FORMED THEREFROM
NANOPARTICLE ASSEMBLED HOLLOW SPHERES
METHOD OF STENT MOUNTING TO FORM A BALLOON CATHETER HAVING IMPROVED RETENTION OF A DRUG DELIVERY STENT
STENT HAVING AN ULTRASONIC EMITTER
DRUG-ELUTING INTRAVASCULAR PROSTHESES AND METHODS OF USE
IMPLANTABLE DRUG DELIVERY DEVICE AND USE THEREOF
INTRA-AORTIC RENAL DELIVERY CATHETER
SYSTEM AND METHOD FOR DRUG DELIVERY AND MICROFLUIDIC APPLICATIONS USING MICRONEEDLES
ENCAPSULATED INORGANIC ANTIMICROBIAL ADDITIVE FOR CONTROLLED RELEASE
POLYMER NANOTECHNOLOGY

Chapter-18: INDUSTRY STRUCTURE AND COMPANY PROFILES

OVERVIEW
REVENUES AND PROFITABILITY
COMPANY PROFILES
ACRYMED, INC.
AFFINERGY, INC.
AGION TECHNOLOGIES, INC.
ALEXZA PHARMACEUTICALS
ALLIED MINDS/BIOTECTIX
ANGIOTECH PHARMACEUTICALS, INC.
ARROW INTERNATIONAL
AVITA MEDICAL
AXCAN PHARMA, INC.
BIND BIOSCIENCES, INC.
BIOCOAT, INC.
BIOCOMPATIBLES UK, LTD.
BIOHEART, INC.
BIOMET, INC.
BRONCUS TECHNOLOGIES, INC.
CELSION CORPORATION
CODMAN & SHURTLEFF, INC.
COLLAGEN MATRIX, INC.
COOK MEDICAL, INC.
CORDIS CORPORATION
COVIDIEN, PLC
CYNOSURE, INC.
DUSA PHARMACEUTICALS, INC.
EDWARDS LIFESCIENCES CORP.
ENDOVASC, INC.
ETEX CORPORATION
EXACTECH, INC.
FORTICELL, INC.
INFRAREDX
INTEGRA LIFESCIENCES HOLDINGS CORP.
INTERPORE CROSS INTERNATIONAL
ISTA PHARMACEUTICALS
KENSEY NASH CORPORATION
KIADIS PHARMA B.V.
LIFECELL CORP.
MARTECH MEDICAL PRODUCTS
MILLENIUM BIOLOGIX, INC.
MIRAVANT MEDICAL TECHNOLOGIES
MIV THERAPEUTICS INC.
NOVABONE PRODUCTS, LLC
NUCRYST PHARMACEUTICALS, INC.
OMRIX BIOPHARMACEUTICALS, LTD.
ORGANOGENESIS, INC.
ORTHOVITA, INC.
PHARMACYCLICS, INC.
PHOTOCURE ASA
PHOTOBIOTICS
QLT, INC.
SMITH & NEPHEW, PLC
SORIN S.P.A.
STRYKER CORP.
SURMODICS, INC.
SYNTHES, INC.
SYSTAGENIX WOUND MANAGEMENT
TEI BIOSCIENCES, INC.
WRIGHT MEDICAL GROUP, INC.
W. L. GORE & ASSOCIATES, INC.

Chapter-19: APPENDIX

APPENDIX 1: RECENT FDA APPROVALS OF DEVICES, INCLUDING COMBINATION DEVICES
TABLE 33 MEDICAL DEVICES APPROVED BY THE FDA, 2009
TABLE 34 MEDICAL DEVICES APPROVED BY THE FDA, 2008
TABLE 35 MEDICAL DEVICES APPROVED BY THE FDA, 2007
APPENDIX 2: GLOSSARY OF RELEVANT TERMINOLOGY