Drug-device Combinations: The Global Market

Published by: BCC Research

Published: Jan. 1, 2010 - 263 Pages

Table of Contents

CHAPTER ONE: 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 TWO: 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 THREE: 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 FOUR: 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 FIVE: 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 DRUGRESISTANT 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 NANOTECHNOLOGYBASED DRUG-DEVICE COMBINATIONS, THROUGH 2014 $ MILLIONS

CHAPTER SIX: 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 SEVEN: 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 EIGHT: 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 NINE: 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 TEN: 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 DRUGELUTING 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 DRUGELUTED BEADS, THROUGH 2014 ($ MILLIONS)

CHAPTER ELEVEN: 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 TWELVE: 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

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 THIRTEEN: 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 FOURTEEN: 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 DRUGDEVICE COMBINATION PRODUCTS, THROUGH 2014 ($ MILLIONS)

CHAPTER FIFTEEN: 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 SIXTEEN: 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 SEVENTEEN: 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 EIGHTEEN: 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

Interpore Cross International (Continued)

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.

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

LIST OF TABLES

SUMMARY TABLE SALES OF DRUG DEVICE COMBINATION

PRODUCTS, THROUGH 2014 ($ BILLIONS)

TABLE 1 RECENT EXAMPLES OF FDA APPROVED COMBINATION

PRODUCTS

TABLE 2 FDA CLASSIFICATION SCHEME FOR COMBINATION

PRODUCTS

TABLE 3 FDA COMBINATION PRODUCT CATEGORIES, FY 2004

TABLE 4 FDA COMBINATION PRODUCT CATEGORIES, FY 2005

(NUMBERS AND TYPES OF COMBINATION PRODUCTS)

TABLE 5 REVENUES ATTRIBUTABLE TO NANOTECHNOLOGY-BASED

DRUG-DEVICE COMBINATIONS, THROUGH 2014 $ MILLIONS

TABLE 6 MARKETS FOR CORONARY STENTS, THROUGH 2014 $

BILLIONS

TABLE 7 EXAMPLES OF STENTS APPROVED FOR CLINICAL USE

TABLE 8 PHOTODYNAMIC THERAPY MARKETS, THROUGH 2014

($BILLIONS)

TABLE 9 REVENUES ATTRIBUTABLE TO ANTIMICROBIALS

THROUGH 2014 ($ BILLIONS)

TABLE 10 REVENUES ATTRIBUTABLE TO MEDICAL DEVICE

COATINGS THROUGH 2014 ($ MILLIONS)

TABLE 11 MEDICAL DEVICE PRODUCTS RELYING ON

ANTIMICROBIAL COATINGS

TABLE 12 CATHETER MARKET FORECASTS, BY PRODUCT TYPE,

THROUGH 2014 ($ BILLIONS)

TABLE 13 CURRENT CLINICAL TRIALS INVOLVING DRUG-ELUTING

BEADS

TABLE 14 R&D AND REVENUES ATTRIBUTABLE TO DRUG-ELUTED

BEADS, THROUGH 2014 ($ MILLIONS)

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

TABLE 20 SELECTED DBM PRODUCT AND PERCENTAGE OF

DEMINERALIZED BONE MATRIX

TABLE 21 THE U.S. MARKET FOR PRECISION-MACHINED

ALLOGRAFTS, THROUGH 2014 ($ MILLIONS)

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)

TABLE 24 IDENTIFICATION OF COLLAGEN-BASED PRODUCTS

TABLE 25 EXAMPLES OF SKIN SUBSTITUTE PRODUCTS

TABLE 26 TOTAL SALES OF ENGINEERED SKIN GRAFTS AND

REPLACEMENTS, THROUGH 2014 ($ MILLIONS)

TABLE 27 EXAMPLES OF ALGINATE-BASED PRODUCTS

TABLE 28 EXAMPLE ENZYMATIC DEBRIDING AGENTS

TABLE 29 MARKETS FOR BIOLOGICAL WOUND CARE PRODUCTS

THROUGH 2014 ($ BILLIONS)

TABLE 30 MARKETS FOR OCCULAR APPLICATIONS IN DRUG-DEVICE

COMBINATION PRODUCTS, THROUGH 2014 ($ MILLIONS)

TABLE 31 IMPLANTABLE DRUG DEVICE COMBINATIONS THROUGH

2014 ($ MILLIONS)

TABLE 32 MARKETS FOR RELATED DRUG-DEVICE COMBINATION

PRODUCTS, THROUGH 2014 ($ MILLIONS)

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

LIST OF FIGURES

SUMMARY FIGURE SALES OF DRUG DEVICE COMBINATION

PRODUCTS, 2008-2014 ($ BILLIONS)

FIGURE 1 COMBINATION PRODUCT APPLICATIONS AT FDA, 2003-

2007 (NUMBER OF SUBMISSIONS)

Abstract

• Analysis of the technologies for five areas of drug-device combination products, including antimicrobial catheters, biologic wound care products, bone graft substitutes and bone cements, drug-eluting stents and photodynamic therapy (PDT)
• Analysis of global markets with data for 2008, estimates for 2009, and projections of 5-year compound annual growth rates through 2014
• Detailed discussion of the current regulatory environment for drug-device combination products and how this is affecting development and approval of such devices
• Further analysis of overall market trends and competitors, and profiles of selected competitors in the category.

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