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薬剤と医療機器の併用:世界市場

Global Markets for Drug-Device Combinations

発行 BCC Research 商品コード 112016
出版日 ページ情報 英文 331 Pages
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薬剤と医療機器の併用:世界市場 Global Markets for Drug-Device Combinations
出版日: 2015年01月01日 ページ情報: 英文 331 Pages
担当者のコメント
BCC Research社のレポートは、Reuter、Wall Street Journal、Fortuneなどで引用されることも多く、それぞれの業界の識者の意見として重きを置かれています。同社レポートを複数冊ご購入の場合年間パッケージのご契約がお得です。詳細は右の担当者のおすすめ商品よりご覧下さい。
概要

当レポートでは、薬剤と医療機器の併用製品を5つの分野にわけ、それぞれの技術動向、実績と成長率予測、法規制環境と将来の動向、主要企業のプロファイルなどを織り交ぜてお届けいたします。

第1章 イントロダクション

第2章 エグゼクティブサマリー

第3章 薬剤と医療機器の併用業界の現状

  • 概要
  • FDAの役割
  • ナノテクノロジーと併用製品の関係
  • 併用製品確認におけるFDAの動向 他

第4章 規制プロセスと課題

  • 概要
  • 海外の規制
  • 併用製品のFDA事務局
  • FDA措置の範囲
  • 装置の取り扱い
    • クラス1
    • クラス2
    • クラス3
  • 現在の動向とナノテクノロジーへの取組み
  • FDAの承認
  • その他の関連機関
  • 一般的規制事項
  • 治験

第5章 ナノテクノロジーの併用製品

第6章 薬剤溶出冠動脈ステント

第7章 光力学的治療

第8章 抗菌およびその他の医療機器コーティング

第9章 抗菌カテーテル

第10章 薬剤溶出ビーズ

第11章 抗生物質を含む骨セメント

第12章 代用骨

第13章 生物学的被覆剤を含む創傷ケア製品

第14章 眼科用薬剤・デバイス併用製品

第15章 インプラント製品

第16章 関連する薬剤・デバイス併用

第17章 特許分析

第18章 業界の構造と企業プロファイル

第19章 付録1

第20章 付録2

図表

このページに掲載されている内容は最新版と異なる場合があります。詳細はお問い合わせください。

目次
Product Code: PHM045D

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.

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REPORT SCOPE

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.

ANALYST'S CREDENTIALS

Research analyst Kevin Gainer holds both B.A. and M.A. degrees in quantitative economic analysis and forecasting, and has 26 years of economic forecasting, industry intelligence and market research experience. He is the author of six published books and more than 100 magazine articles, technical papers, analyses, and studies published in conference proceedings, including many unpublished within corporations. He has worked as a Research Editor and Project Analyst at BCC Research since 1985, and has authored numerous BCC Research technology market research reports.

Table of Contents

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 148
      • 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

LIST OF TABLES

  • TABLE HEADING PAGE NO.
  • SUMMARY TABLE SALES OF DRUG-DEVICE COMBINATION PRODUCTS, THROUGH 2019 ($ BILLIONS)
  • TABLE 1 EXAMPLES OF FDA APPROVED COMBINATION PRODUCTS
  • TABLE 2 FDA CLASSIFICATION SCHEME FOR COMBINATION PRODUCTS
  • TABLE 3 COMPANIES INVOLVED IN DRUG RELATED NANOTECHNOLOGY R&D OR MANUFACTURING
  • TABLE 4 TRENDS IN COMBINATION PRODUCT APPLICATIONS AT FDA, 2003-2012 (NO. OF PRODUCT SUBMISSIONS)
  • TABLE 5 FDA COMBINATION PRODUCT CATEGORIES, FY2010-FY2012
  • TABLE 6 COMPANIES WITH SIGNIFICANT SPECIALIZATION IN NANOMEDICINE, 2014 ($ MILLIONS)
  • TABLE 7 REVENUES ATTRIBUTABLE TO NANOTECHNOLOGY-BASED DRUG-DEVICE COMBINATION PRODUCTS, THROUGH 2019 ($ MILLIONS)
  • TABLE 8 MARKETS FOR CORONARY STENTS, THROUGH 2019 ($ BILLIONS)
  • TABLE 9 STENT APPROVAL ACTIVITY AT FDA, 2012-2013
  • TABLE 10 EXAMPLES OF STENTS APPROVED FOR CLINICAL USE
  • TABLE 11 RECENT BIOABSORBABLE STENT PATENTS, 2009-2014
  • TABLE 12 PHOTODYNAMIC THERAPY MARKETS, THROUGH 2019 ($ BILLIONS)
  • TABLE 13 REVENUES ATTRIBUTABLE TO ANTIMICROBIALS THROUGH 2019 ($ BILLIONS)
  • TABLE 14 REVENUES ATTRIBUTABLE TO MEDICAL DEVICE COATINGS, THROUGH 2019 ($ BILLIONS)
  • TABLE 15 MEDICAL DEVICE PRODUCTS INCORPORATING AN ANTIMICROBIAL FUNCTION
  • TABLE 16 CURRENT FDA APPROVED CLINICAL TRIALS FOCUSED ON NEW ANTIMICROBIAL CATHETER CONCEPTS (AS OF JULY 2014)
  • TABLE 17 PROJECTED CATHETER MARKET BY PRODUCT TYPE, INCLUDING ANTIMICROBIAL PRODUCTS, THROUGH 2019 ($ BILLIONS)
  • TABLE 18 CURRENT CLINICAL TRIALS INVOLVING DRUG-ELUTING BEADS
  • TABLE 19 R &D AND REVENUES ATTRIBUTABLE TO DRUG-ELUTED BEADS, THROUGH 2019 ($ MILLIONS)
  • TABLE 20 ANNUAL SALES OF BONE CEMENTS, INCLUDING COMBINATION PRODUCT ANTIBIOTIC BONE CEMENTS, THROUGH 2019 ($ MILLIONS)
  • TABLE 21 PRINCIPAL COMPANIES IN THE BONE GRAFT BUSINESS
  • TABLE 22 PATENT ACTIVITY IN BONE GRAFT SUBSTITUTES FROM AUGUST 2010 TO JULY 2014
  • 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
  • TABLE 28 SELECTED DBM PRODUCT AND PERCENTAGE OF DEMINERALIZED BONE MATRIX
  • TABLE 29 THE U.S. MARKET FOR PRECISION-MACHINED ALLOGRAFTS, THROUGH 2019 ($ MILLIONS)
  • 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)
  • TABLE 32 GLOBAL COMPANIES WITH A SIGNIFICANT FOCUS IN WOUND CARE PRODUCTS
  • TABLE 33 IDENTIFICATION OF COLLAGEN-BASED PRODUCTS
  • TABLE 34 SKIN SUBSTITUTE PRODUCTS AND THEIR MANUFACTURERS
  • TABLE 35 TOTAL SALES OF ENGINEERED SKIN GRAFTS AND REPLACEMENTS, THROUGH 2019 ($ MILLIONS)
  • TABLE 36 ALGINATE-BASED PRODUCTS AND THEIR MANUFACTURERS
  • TABLE 37 ENZYMATIC DEBRIDING AGENTS AND THEIR MANUFACTURERS
  • TABLE 38 MARKETS FOR BIOLOGICAL WOUND CARE PRODUCTS, THROUGH 2019 ($ MILLIONS)
  • TABLE 39 IMPLANTABLE DRUG-DEVICE OPHTHALMOLOGY COMBINATION PRODUCTS APPROVED BY FDA, 2014
  • TABLE 40 MARKETS FOR OCULAR APPLICATIONS IN DRUG-DEVICE COMBINATION PRODUCTS, THROUGH 2019 ($ MILLIONS)
  • TABLE 41 IMPLANTABLE DRUG-DEVICE COMBINATIONS, THROUGH 2019 ($ MILLIONS)
  • TABLE 42 MARKETS FOR RELATED DRUG-DEVICE COMBINATION PRODUCTS, THROUGH 2019 ($ MILLIONS)
  • TABLE 43 WORLD'S LARGEST MANUFACTURERS OF MEDICAL DEVICES ($ BILLIONS)
  • 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

LIST OF FIGURES

  • SUMMARY FIGURE SALES OF DRUG-DEVICE COMBINATION PRODUCTS, 2013-2019 ($ BILLIONS)
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