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Global Markets for Drug-Device Combinations

Global Markets for Drug-Device Combinations

REPORT HIGHLIGHTS

The sales of drug-device combination products reached $21.4 billion in 2013 and $22 billion in 2014. This market is expected to grow to $31 billion in 2019, with a compound annual growth rate (CAGR) of 7.1% from 2014 to 2019.

This report provides:

An overview of the global market for drug-device combinations.

Analyses of global market trends, with data from 2013 and 2014, and projections of CAGRs through 2019.

Detailed coverage of such product categories as drug-eluting stents (DES), drug-eluting beads (DEB), antimicrobial catheters, antibiotic-loaded bone cements, glass ionomer cements, bone graft substitutes, antibacterial-releasing dental restorative materials, biologic wound care products such as collagen-based dressings as therapeutic agents for wound healing, drug-device combination products for ocular applications, and photodynamic therapy.

Detailed patent analysis and research and development updates.

Comprehensive company profiles of major players.


SCOPE AND FORMAT

In preparing this report, an overall study of the drug-device combination market was undertaken.

The report covers the following product categories:
Drug-eluting stents (DES).
Drug-eluting beads (DEB).
Transdermal patches.
Antimicrobial catheters.
Antibiotic-loaded bone cements.
Glass ionomer cements.
Bone graft substitutes.
Antibacterial-releasing dental restorative materials.
Biologic wound care products, such as collagen-based dressings as therapeutic agents for wound healing.
Drug-device combination products for ocular applications.
Photodynamic therapy.
Many nanotechnology applications.

Devices that do not combine a drug with the delivery mechanism are not covered; for example, insulin pumps are not covered.

Related areas, such as drug delivery systems and nanotechnology, were key to the analysis as well, as these newer areas such as nanotechnology foreshadow likely product developments in the years ahead. All major aspects of the drug-device combination market are addressed including identification of current and future technologies, products, market segments/end markets, and government and regulatory involvement. Participating companies are discussed in light of technological strengths and weakness, relative market share, marketing strengths, and innovative marketing practices. Included is a detailed discussion of the current regulatory environment for drug-device combination products and how it is affecting development and approval of such products.

CHAPTER 1 INTRODUCTION
STUDY GOALS AND OBJECTIVES
THE IMPORTANCE OF THIS STUDY
INTENDED AUDIENCE
SCOPE AND FORMAT
METHODOLOGY AND INFORMATION SOURCES
ANALYST'S CREDENTIALS
RELATED BCC RESEARCH REPORTS
BCC RESEARCH WEBSITE
DISCLAIMER
CHAPTER 2 EXECUTIVE SUMMARY
SCOPE OF THE INDUSTRY
DRUG-DEVICE COMBINATIONS: THE GLOBAL MARKET
SUMMARY TABLE SALES OF DRUG-DEVICE COMBINATION PRODUCTS, THROUGH 2019 ($ BILLIONS)
SUMMARY FIGURE SALES OF DRUG-DEVICE COMBINATION PRODUCTS, 2013-2019 ($ BILLIONS)
TECHNOLOGY AND PATENT ACTIVITY
THE CENTRAL ROLE OF THE FDA
CHAPTER 3 CURRENT STATUS OF THE DRUG-DEVICE COMBINATION
INDUSTRY
OVERVIEW
ROLE OF THE FDA
TABLE 1 EXAMPLES OF FDA APPROVED COMBINATION PRODUCTS
OFFICE OF COMBINATION PRODUCTS 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
TABLE 3 COMPANIES INVOLVED IN DRUG RELATED NANOTECHNOLOGY
R&D OR MANUFACTURING
FDA TRENDS IN REVIEWING COMBINATION PRODUCTS
TABLE 4 TRENDS IN COMBINATION PRODUCT APPLICATIONS AT FDA, 2003-2012 (NO. OF PRODUCT SUBMISSIONS)
TABLE 5 FDA COMBINATION PRODUCT CATEGORIES, FY2010-FY2012
CHAPTER 4 REGULATORY PROCESS AND ISSUES
REGULATORY FUNDING
OVERSEAS AND WORLD REGULATION
FDA OFFICE OF COMBINATION PRODUCTS
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
REPRESENTATIVE COMPANIES
TABLE 6 COMPANIES WITH SIGNIFICANT SPECIALIZATION IN NANOMEDICINE, 2014 ($ MILLIONS)
NATIONAL NANOTECHNOLOGY INITIATIVE
NANOTECH REGULATORY ENVIRONMENT
COMBINATION NANOTECHNOLOGY PRODUCT RESEARCH
PRODUCTS
PERMANENT MRI CONTRAST AGENTS
NANOPARTICLE IMAGING AGENTS
NANOPARTICLE TO SEQUENCE DRUG DELIVERY
VACCINE DELIVERY VIA NANOPARTICLES
NANODIAMOND DRUG DEVICES FOR CANCER TREATMENT
WAX NANOPARTICLES ENHANCE IMMUNE RESPONSE
BRAIN-PENETRATING NANOPARTICLES
COMBINED POLYETHYLENE GLYCOL-HYDROPHILIC CARBON CLUSTERS
NANO-SYRINGES
NANOPARTICLES PROTECT AGAINST SEXUALLY TRANSMITTED INFECTIONS
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
MAGNETICALLY TARGETED NANOPARTICLES TO TREAT PERIPHERAL ARTERY
DISEASE
POTENTIAL HEALTH EFFECTS: IMPACT ON NANO INDUSTRY
TABLE 7 REVENUES ATTRIBUTABLE TO NANOTECHNOLOGY-BASED DRUG-DEVICE COMBINATION PRODUCTS, THROUGH 2019 ($MILLIONS)
CHAPTER 6 DRUG-ELUTING CORONARY STENTS
OVERVIEW
MECHANISM OF ACTION
CLINICAL TRIALS
DEFINITION AND SIZE OF TARGET MARKET
TABLE 8 MARKETS FOR CORONARY STENTS, THROUGH 2019 ($ BILLIONS)
FDA REGULATORY ROLE WITH REGARD TO STENTS
FDA STENT APPROVAL HISTORY
STENT APPROVALS IN 2011-2013
Medtronic
Boston Scientific
Medtronic
Abbott
TABLE 9 STENT APPROVAL ACTIVITY AT FDA, 2012-2013
PRINCIPAL DRUG ELUTED STENT PRODUCERS
STENT DESIGN
PRODUCT LINES
TABLE 10 EXAMPLES OF STENTS APPROVED FOR CLINICAL USE
STENT PRODUCT INNOVATIONS AND R&D: BIOABSORBABLE STENTS
COMPETITIVE SITUATION
TABLE 11 RECENT BIOABSORBABLE STENT PATENTS, 2009-2014
R&D STATUS
BIODEGRADABLE COATINGS
MARKETS FOR STENT RELATED TECHNOLOGIES
LIPISCAN CORONARY IMAGING SYSTEM
CHAPTER 7 PHOTODYNAMIC THERAPIES
OVERVIEW
TREATMENT LIMITATIONS
TECHNOLOGY HISTORY
FIRST GENERATION 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
OPTOGENETICS
PDT MARKET GROWTH DRIVERS
EXAMPLES OF PDT PRODUCTS
VISUDYNE (NOVARTIS)
LEVULAN
PHOTOFRIN (PORFIMER SODIUM)
APTOCINE
VISONAC
CEVIRA
LUMACAN
RESEARCH AND DEVELOPMENT
INTERVENTIONAL CARDIOLOGY
Cardiac Ablation
DERMATOLOGY
AUTOIMMUNE DISEASES
CANCER
Mesothelioma
Prostate Cancer
ANTIMICROBIAL APPLICATIONS
EQUIPMENT PRODUCERS
TABLE 12 PHOTODYNAMIC THERAPY MARKETS, THROUGH 2019 ($ BILLIONS)
CHAPTER 8 ANTIMICROBIALS AND OTHER MEDICAL DEVICE COATINGS
OVERVIEW: REGULATORY TREATMENT
DRIVING FORCE IN DEVELOPMENT OF ANTIMICROBIALS
MARKET CONTEXT AND PREVALENCE OF INFECTIONS
EXAMPLES OF USE
CLINICAL TRIALS WITH COPPER AS AN ANTIMICROBIAL
RELATED PRODUCTS
TRENDS IN FDA APPLICATIONS FOR ANTIMICROBIALS
TABLE 13 REVENUES ATTRIBUTABLE TO ANTIMICROBIALS THROUGH 2019 ($ BILLIONS)
ANTIMICROBIAL AND OTHER MEDICAL DEVICE COATINGS
MARKET CATEGORIES FOR MEDICAL DEVICE COATINGS IN COMBINATION
PRODUCTS
TABLE 14 REVENUES ATTRIBUTABLE TO MEDICAL DEVICE COATINGS, THROUGH 2019 ($ BILLIONS)
EXAMPLE PRODUCTS
TABLE 15 MEDICAL DEVICE PRODUCTS INCORPORATING AN ANTIMICROBIAL FUNCTION
CHAPTER 9 ANTIMICROBIAL CATHETERS
MARKET OVERVIEW
CLINICAL TRIALS
TABLE 16 CURRENT FDA APPROVED CLINICAL TRIALS FOCUSED ON NEW ANTIMICROBIAL CATHETER CONCEPTS (AS OF JULY 2014)
APPLICATIONS
MARKET SIZE
TABLE 17 PROJECTED CATHETER MARKET BY PRODUCT TYPE, INCLUDING ANTIMICROBIAL PRODUCTS, THROUGH 2019 ($ BILLIONS)
CATHETER INNOVATIONS
ANTIMICROBIAL CATHETER CONCEPTS
SMART CATHETER CONCEPTS
SELENIUM NANOPARTICLES ON CATHETERS AND IMPLANTS
EXAMPLE PRODUCTS
5-FLUOROURACIL-COATED CENTRAL VENOUS CATHETER
ZURAGEN
DRUG - DEVICE COMBINATION CATHETER LOCK/FLUSH SOLUTIONS
R&D INITIATIVES
DIALYSIS CATHETERS
URINARY CATHETERS
OTHER DELIVERY TECHNIQUES
CHAPTER 10 DRUG-ELUTING BEADS
OVERVIEW
EXAMPLE OF THERAPY
COMPANY ACTIVITY
BEAD APPLICATIONS IN ORTHOPEDICS
BEAD APPLICATIONS IN STROKE
BEAD APPLICATIONS IN ALLERGY AND ASTHMA ATTACKS
RECENT FDA APPROVALS
RECENT OVERSEAS APPROVALS FOR CLINICAL TRIALS
CLINICAL TRIALS
TABLE 18 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
POLYETHYLENE-GLYCOL (PEG) COATED NANOPARTICLES
CONTROLLED DELIVERY OF TUMOR-KILLER DRUGS
RADIATION AND IMMUNOTHERAPY COMBINATIONS
POLYMERIC MICROCAPSULES
OHIO STATE UNIVERSITY RESEARCH
TECHNION-ISRAEL INSTITUTE OF TECHNOLOGY
TABLE 19 R &D AND REVENUES ATTRIBUTABLE TO DRUG-ELUTED BEADS, THROUGH 2019 ($ MILLIONS)
CHAPTER 11 BONE CEMENTS INCLUDING ANTIBIOTIC
GENERAL APPLICATIONS
ANTIBIOTIC APPLICATIONS
EARLY HISTORY
APPLICATIONS
MARKET SIZE
TABLE 20 ANNUAL SALES OF BONE CEMENTS, INCLUDING COMBINATION
PRODUCT ANTIBIOTIC BONE CEMENTS, THROUGH 2019 ($ MILLIONS)
COMPOSITION
NEW TECHNOLOGIES
EXAMPLE PRODUCTS
RELATED PRODUCTS: TYPES OF CERAMICS
BIOGRAN
BIO-OSS
BONESOURCE
CALCIGEN S
CEMENTS IN DENTAL APPLICATIONS: GLASS IONOMER CEMENTS
CHAPTER 12 BONE GRAFT SUBSTITUTES
OVERALL SIZE OF BONE GRAFT BUSINESS
TABLE 21 PRINCIPAL COMPANIES IN THE BONE GRAFT BUSINESS
RECENT DEVELOPMENTS
OVERVIEW OF APPLICATIONS
BONE GRAFT SUBSTITUTES
TABLE 22 PATENT ACTIVITY IN BONE GRAFT SUBSTITUTES FROM AUGUST
2010 TO JULY 2014
INFUSE
AUGMENT
CARRIGEN POROUS BONE SUBSTITUTE MATERIAL
ALLOGRAFT TISSUE
OTHER OSTEOCONDUCTIVE BONE-GRAFT SUBSTITUTES
HYDROGELS AND NANOTUBES IN BONE GRAFTING
Hydrogel Bone Void Filler
Amphiphilic Peptides and Hydrogel Matrices Thereof for Bone Repair
Hydrogel Bioscaffold and Coating for Bone and Tooth Repair
Injectable Composite Material Suitable for Use as a Bone Substitute
Bone Filling Complex and Method for Fabricating the Same
Composite Material
Device for Regeneration of Articular Cartilage and Other Tissue
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 23 CHARACTERISTICS OF IDEAL BONE GRAFT MATERIAL
TABLE 24 BONE GRAFT PROCEDURE VOLUMES BY APPLICATION IN THE U.S., THROUGH 2019
TABLE 25 BONE GRAFT PROCEDURE VOLUMES BY SOURCE OF GRAFT IN THE U.S., THROUGH 2019
TABLE 26 COMPARISON OF BONE GRAFT MATERIALS
TABLE 27 TYPES OF SUBSTITUTE BONE GRAFTS
AUTOGRAFTS
Bioseed Grafts
ALLOGRAFTS
Demineralized Bone Matrix Products
TABLE 28 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
Xenografts
THE MARKET FOR ALLOGRAFTS
TABLE 29 THE U.S. MARKET FOR PRECISION-MACHINED ALLOGRAFTS, THROUGH 2019 ($ 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
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 30 THE WORLDWIDE MARKET FOR BONE REPLACEMENT PRODUCTS, THROUGH 2019 ($ MILLIONS)
TABLE 31 THE U.S. MARKET FOR BONE REPLACEMENT PRODUCTS, THROUGH 2019 ($ MILLIONS)
REGENERATIVE MEDICINE PRODUCTS IN DEVELOPMENT FOR BONE
APPLICATIONS
NANO/MACROPOROUS BONE TISSUE
BIOLOGIC/SYNTHETIC GRAFTS
CHAPTER 13 WOUND CARE PRODUCTS INCLUDING BIOLOGICAL
DRESSINGS
WOUND CARE GENERALLY
TABLE 32 GLOBAL COMPANIES WITH A SIGNIFICANT FOCUS IN WOUND
CARE PRODUCTS
PRODUCT EFFICACY
MARKET SEGMENTS
COLLAGEN
COLLAGEN IN MEDICAL APPLICATIONS
TABLE 33 IDENTIFICATION OF COLLAGEN-BASED PRODUCTS
SPECIFIC COLLAGEN PRODUCTS
TenoMend Collagen Tendon Wrap
CosmoDerm and CosmoPlast Human-Based Collagen
TachoSil Fibrin Sealant
TISSUE ENGINEERING
SKIN SUBSTITUTES: CELLS AND TISSUES
ARTIFICIAL SKIN
TABLE 34 SKIN SUBSTITUTE PRODUCTS AND THEIR MANUFACTURERS
SKIN-LIKE TISSUE DEVELOPED FROM HUMAN EMBRYONIC STEM CELLS
TABLE 35 TOTAL SALES OF ENGINEERED SKIN GRAFTS AND REPLACEMENTS, THROUGH 2019 ($ MILLIONS)
ALGINATES
TABLE 36 ALGINATE-BASED PRODUCTS AND THEIR MANUFACTURERS
FIBRIN SEALANT PRODUCTS
History of Fibrin Sealants
CLOTBLOCK - LYOPHILIZED FIBRIN SEALANT
FIBRIN MICROTHREADS IN TISSUE REGENERATION
PRODUCTS
Evicel
Artiss
ReCell
RELATED PRODUCTS: FIRST FDA APPROVED SPINE SEALANT
ENZYMATIC DEBRIDING AGENTS
TABLE 37 ENZYMATIC DEBRIDING AGENTS AND THEIR
MANUFACTURERS
NANOSTRUCTURED TEMPERATURE-SENSITIVE MEMBRANES FOR WOUND HEALING AND CELL GRAFTING
TABLE 38 MARKETS FOR BIOLOGICAL WOUND CARE PRODUCTS, THROUGH 2019 ($ MILLIONS)
CHAPTER 14 DRUG-DEVICE COMBINATION PRODUCTS FOR OCULAR
APPLICATIONS
OVERVIEW
FDA APPROVED OPHTHALMIC IMPLANTS
TABLE 39 IMPLANTABLE DRUG-DEVICE OPHTHALMOLOGY COMBINATION PRODUCTS APPROVED BY FDA, 2014
VITRASERT
RETISERT
OZURDEX
CONTACT LENSES
GOOGLE NOVARTIS INITIATIVE IN CONTACT LENSES
COMBINATION DRUGS
INTRAOCULAR LENS PRODUCTS (IOL)
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 40 MARKETS FOR OCULAR APPLICATIONS IN DRUG-DEVICE COMBINATION PRODUCTS, THROUGH 2019 ($ MILLIONS)
CHAPTER 15 IMPLANTABLES AS DRUG-DEVICE COMBINATIONS
OVERVIEW
NEUROMODULATION
TINNITUS
MINIATURE NEUROSTIMULATORS
BIODEGRADABLE CIRCUITS
BIORESORBABLE DEVICES
STEROID ELUTING PACEMAKER LEADS
MICROELECTRONIC CONTROL OF DRUG DELIVERY
MARKET SIZE
TABLE 41 IMPLANTABLE DRUG-DEVICE COMBINATIONS, THROUGH 2019 ($MILLIONS)
CHAPTER 16 RELATED DRUG-DEVICE COMBINATIONS OF RELEVANCE
OVERVIEW
MARKET SIZE
TABLE 42 MARKETS FOR RELATED DRUG-DEVICE COMBINATION PRODUCTS, THROUGH 2019 ($ MILLIONS)
INJECTABLE BIODEGRADABLE HYDROGELS FOR DRUG DELIVERY AND TISSUE
ENGINEERING
SELF-HEALING HYDROGELS
HYDROGELS AND MICRO ROBOTS
HYDROGEL SCAFFOLDING AT NANO SCALE
HYDROGELS AS SMART PILLS
IN VIVO FLEXIBLE ELECTRONICS
HEAT ACTIVATED DRUGS
MEDIFOCUS INC.
PHILIPS/CELSION CORP.
RADIATION/DRUG COMBINATIONS
ANTI-BACTERIAL RELEASING DENTAL RESTORATIVE MATERIALS
COMBINATION DENTAL PROPHYLAXIS PASTES AND DRUG COMPONENTS
BIOMIMETIC CONTROLLED-RELEASE CAPSULES FOR GUM DISEASE
METERED DOSE INHALERS, SPACERS AND OTHER ACCESSORIES
ANTIMICROBIAL SUTURES
ANTIMICROBIAL VASCULAR GRAFTS
BREATH TEST COMBINATION PRODUCTS
MYOCELL THERAPY BY BIOHEART INC.
MICRONEEDLE DRUG AND VACCINE DELIVERY SYSTEMS
VACCINE DELIVERY
SILK-BASED MICRONEEDLE SYSTEM
OPHTHALMIC APPLICATIONS FOR MICRONEEDLES
CHAPTER 17 PATENT ANALYSIS
PATENT VOLUMES
COMPETITIVE ASPECTS
INTELLECTUAL PROPERTY ISSUES
EXAMPLES OF DRUG-DEVICE COMBINATION PATENTS: 2012 TO 2014
THERAPEUTIC AGENT PREPARATIONS FOR DELIVERY INTO A LUMEN OF THE INTESTINAL TRACT USING A SWALLOWABLE DRUG DELIVERY
DEVICE
MANUAL BASAL BOLUS DRUG DELIVERY DEVICE
ASSEMBLY FOR A DRUG DELIVERY DEVICE AND DRUG DELIVERY DEVICE
MEDICAL DEVICE WITH DRUG DELIVERY MEMBER
DEVICE AND METHOD FOR CREATING AEROSOLS FOR DRUG DELIVERY
X-RAY VISIBLE DRUG DELIVERY DEVICE
ORAL TRANSMUCOSAL DRUG DELIVERY DEVICE
DEVICE AND METHOD FOR DELIVERY OF A DRUG DEPOT NEAR THE NERVE
OCULAR DRUG DELIVERY DEVICE
APPARATUS AND METHODS FOR LOADING A DRUG ELUTING MEDICAL
DEVICE
INTRAMEDULLARY DRUG DELIVERY DEVICE AND METHOD OF TREATING
BONE FRACTURES
METHOD OF FORMING A DRUG-ELUTING MEDICAL DEVICE
METHODS TO INCREASE FRACTURE RESISTANCE OF A DRUG-ELUTING
MEDICAL DEVICE
DRUG ELUTING IMPLANTABLE MEDICAL DEVICE WITH HEMOCOMPATIBLE
AND/OR PROHEALING TOPCOAT
MEDICAL DEVICE RAPID DRUG RELEASING COATINGS COMPRISING A
THERAPEUTIC AGENT AND A CONTRAST AGENT
CONTACT LENS DRUG DELIVERY DEVICE
DRUG LOADED IMPLANTABLE MEDICAL DEVICE
EXAMPLES OF DRUG-DEVICE COMBINATION PATENTS: 2011 TO 2012
DRUG-ELUTING STENT AND METHOD OF MAKING THE SAME
DERMAL DELIVERY DEVICE WITH REDUCED LOSS OF ITS VOLATILE
COMPONENTS
METHODS, DEVICES AND FORMULATIONS FOR TARGETED
ENDOBRONCHIAL THERAPY
DRUG RELEASING COATINGS FOR MEDICAL DEVICES
METHOD AND APPARATUS FOR IN SITU DRUG DELIVERY DURING
DISTRACTION OSTEOGENESIS
DRUG FORMULATIONS FOR COATING MEDICAL DEVICES
DRUG DEACTIVATION SYSTEM
LIGHT TRANSMISSION SYSTEM FOR PHOTOREACTIVE THERAPY
DRUG CONDENSATION AEROSOLS AND KITS
IMPLANTABLE DRUG DEPOT FOR WEIGHT CONTROL
DEFORMING SURFACE OF DRUG-ELUTING COATING TO ALTER DRUG
RELEASE PROFILE OF A MEDICAL DEVICE
FLUID MANAGEMENT FLOW IMPLANTS OF IMPROVED OCCLUSION
RESISTANCE
ANTITHROMBOTIC AND ANTI-RESTENOTIC DRUG-ELUTING STENT
SWITCH FOR TRANSDERMAL PATCH
DRUG-ELUTING BALLOON
BIOCOMPATIBLE COATINGS FOR STENTS
IMPLANTABLE DRUG DELIVERY DEVICES HAVING ALTERNATING
HYDROPHILIC AND AMPHIPHILIC POLYMER LAYERS
DEVICE FOR TRANSDERMAL ELECTROTRANSPORT DELIVERY OF FENTANYL
AND SUFENTANIL
METHOD FOR INTRAVESICAL DRUG DELIVERY
DELIVERY OF ANTIPSYCHOTICS THROUGH AN INHALATION ROUTE
NEEDLE-FREE INJECTOR DEVICE WITH AUTOLOADING CAPABILITY
OCULAR DRUG DELIVERY DEVICE
MICRONEEDLE ARRAY PATCH
METHODS OF ADMINISTERING TETRAZOLE-CONTAINING RAPAMYCIN
ANALOGS WITH OTHER THERAPEUTIC SUBSTANCES FOR TREATMENT
OF VASCULAR DISORDER
KINASE INHIBITORS
SENSORS HAVING PROTECTIVE ELUTING COATING AND METHOD
THEREFOR
BIODEGRADABLE DRUG-POLYMER DELIVERY SYSTEM
DEVICE AND METHOD FOR TACKING PLAQUE TO A BLOOD VESSEL WALL
METHOD FOR LOADING NANOPOROUS LAYERS WITH THERAPEUTIC AGENT
STENTS WITH DRUG-ELUTING COATINGS
DRUG DELIVERY ENDOVASCULAR GRAFT
MEDICATED COATINGS FOR IMPLANTABLE MEDICAL DEVICES INCLUDING
POLYACRYLATES
COILED WIRE FOR THE CONTROLLED RELEASE OF DRUGS TO THE EYE
APPARATUSES AND MEDIA FOR DRUG ELUTION AND METHODS FOR MAKING AND USING THEM
TRANSDERMAL PATCH
DRUG-ELUTING INTRAVASCULAR PROSTHESES AND METHODS OF USE
PROGENITOR ENDOTHELIAL CELL CAPTURING WITH A DRUG-ELUTING
IMPLANTABLE MEDICAL DEVICE
ONE-STEP PHOSPHORYLCHOLINE-LINKED POLYMER COATING AND DRUG
LOADING OF STENT
SYSTEMS AND METHODS FOR DELIVERING DRUGS TO SELECTED
LOCATIONS WITHIN THE BODY
ENDOTRACHEAL TUBE WITH FEATURE FOR DELIVERING AEROSOLIZED
MEDICATION
METHODS AND SYSTEMS FOR SUBMUCOSAL IMPLANTATION OF A DEVICE
FOR DIAGNOSIS AND TREATMENT WITH A THERAPEUTIC AGENT
STENTS WITH CERAMIC DRUG RESERVOIR LAYER AND METHODS OF MAKING AND USING THE SAME
STENT COATING FOR ELUTING MEDICATION
CONTROLLED RELEASE OF NITRIC OXIDE AND DRUGS FROM
FUNCTIONALIZED MACROMERS AND OLIGOMERS
DEVICE FOR CONTROLLED RELEASE OF CHEMICAL MOLECULES
DRUG ELUTION FOR IMPLANTABLE INCONTINENCE DEVICES
DRUG-ELUTING STENT AND DELIVERY SYSTEM WITH TAPERED STENT IN SHOULDER REGION
DRUG-ELUTING TISSUE MARKER
DELIVERY OF DRUG AMINES THROUGH AN INHALATION ROUTE
ENDOPROSTHESIS COATING
COGNITIVE FUNCTION WITHIN A HUMAN BRAIN
MEDICAL IMPLANT HAVING IMPROVED DRUG-ELUTING FEATURES
DELIVERY OF DRUG ESTERS THROUGH AN INHALATION ROUTE
ELECTRONICALLY-CONTROLLED DEVICE FOR RELEASE OF DRUGS, PROTEINS, AND OTHER ORGANIC OR INORGANIC CHEMICALS
PRELOADING WITH MACULAR PIGMENT TO IMPROVE PHOTODYNAMIC
TREATMENT OF RETINAL VASCULAR DISORDERS
COATED AND IMPRINTED MEDICAL DEVICES AND METHODS OF MAKING
THE SAME
METHOD FOR PHOTOTHERMAL THERAPY USING POROUS SILICON AND NEAR INFRARED RADIATION
EXAMPLES OF DRUG-DEVICE COMBINATION PATENTS: 2008 TO 2009
ELECTROPROCESSED COLLAGEN AND TISSUE ENGINEERING
BIOFUNCTIONAL, ANTIMICROBIAL COATINGS FOR MEDICAL DEVICES
METHOD AND DEVICE FOR DETECTING AND TREATING DEPRESSION
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
TABLE 43 WORLD'S LARGEST MANUFACTURERS OF MEDICAL DEVICES ($ BILLIONS)
INVESTMENT OVER THE LAST 10 YEARS
REVENUES AND PROFITABILITY
GLOBAL MARKET COMPETITION
COMPANY PROFILES
ABBOTT VASCULAR
ABL MEDICAL LLC
ACRYMED INC.
ACTAVIS
AFFINERGY INC.
AGILE THERAPEUTICS INC.
ALCON INC.
ALEXZA PHARMACEUTICALS
ALLERGAN INC.
ALLIED MINDS/BIOTECTIX
ANGIOTECH PHARMACEUTICALS INC.
ANTARES PHARMA INC.
APTALIS PHARMA INC.
ARROW INTERNATIONAL
AVITA MEDICAL
BAXTER INTERNATIONAL INC.
BAYER HEALTHCARE
BAUSCH & LOMB INC.
BEZWADA BIOMEDICAL LLC
BIND BIOSCIENCES INC.
BIOCOAT INC.
BIOCOMPATIBLES U.K. LTD.
BIOHEART INC.
BIOMET INC.
BOSTON SCIENTIFIC CORP.
BRONCUS TECHNOLOGIES INC.
CAREFUSION CORORATION
CELSION CORP.
C.R. BARD
CODMAN & SHURTLEFF INC.
COLLAGEN MATRIX INC.
COMBINATION PRODUCTS COALITION
COOK INC.
CORDIS CORP.
COVIDIEN, PLC
CYNOSURE INC.
DELCATH SYSTEMS INC.
DEPUY SYNTHES INC. (JOHNSON & JOHNSON)
DISCOVERY LABORATORIES INC.
DSM BIOMEDICAL HEADQUARTERS
DUSA PHARMACEUTICALS INC.
EDWARDS LIFESCIENCES CORP.
ETEX CORP.
EXACTECH INC.
GE HEALTHCARE
THE HYMED GROUP
INFRAREDX
INTEGRA LIFESCIENCES HOLDINGS CORP.
INTERPORE CROSS INTERNATIONAL
JOHNSON & JOHNSON
KALEO INC.
KIADIS PHARMA B.V.
LIFECELL CORP.
LIGHT SCIENCES ONCOLOGY INC.
LUTONIX INC.
MARTECH MEDICAL PRODUCTS
MEDGENICS INC.
MEDLINE
MEDTRONIC INC.
Medtronic Vascular Inc.
MERIT MEDICAL SYSTEMS INC.
MICROCHIPS INC.
MULTIGENE VASCULAR SYSTEMS (MGVS) LTD.
MYLAN INC.
NOVABONE PRODUCTS LLC
NOVARTIS AG
OMRIX BIOPHARMACEUTICALS LTD.
ORBUSNEICH MEDICAL INC.
ORGANOGENESIS INC.
PHARMACYCLICS INC.
PHOTOCURE ASA
PHOTOBIOTICS
PINNACLE BIOLOGICS
PROTEUS DIGITAL HEALTH INC.
PSIVIDA CORP
PURDUE PHARMA L.P.
REVA MEDICAL INC.
QLT INC.
SCIESSENT
SMITH & NEPHEW, PLC
SORIN S.P.A.
STANMORE IMPLANTS
STRYKER CORP.
SURMODICS INC.
SYSTAGENIX WOUND MANAGEMENT
TEI BIOSCIENCES INC.
TERUMO CORP.
VALERITAS INC.
VISTA SCIENTIFIC LLC
WRIGHT MEDICAL GROUP INC.
W. L. GORE & ASSOCIATES INC.
CHAPTER 19 APPENDIX 1: RECENT FDA APPROVALS OF DEVICES, INCLUDING COMBINATION PRODUCTS
OVERVIEW
TABLE 44 510(K) PREMARKET NOTIFICATIONS (COMBINATION PRODUCT APPROVALS) BY FDA BETWEEN JULY 2013 AND JULY 2014
TABLE 45 510(K) PREMARKET NOTIFICATIONS (COMBINATION PRODUCT APPROVALS) BY FDA BETWEEN AUGUST 2011 AND AUGUST 2012
TABLE 46 PRE-MARKET APPROVAL OF COMBINATION PRODUCTS, JULY 2013-JULY 2014
TABLE 47 PRE-MARKET APPROVAL OF COMBINATION PRODUCTS, AUGUST 2011- AUGUST 2012
TABLE 48 MEDICAL DEVICES APPROVED BY THE FDA IN 2014
TABLE 49 MEDICAL DEVICES APPROVED BY THE FDA IN 2013
TABLE 50 MEDICAL DEVICES APPROVED BY THE FDA IN 2009
TABLE 51 MEDICAL DEVICES APPROVED BY THE FDA IN 2008
TABLE 52 MEDICAL DEVICES APPROVED BY THE FDA IN 2007
CHAPTER 20 APPENDIX 2: GLOSSARY OF RELEVANT TERMINOLOGY

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