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Global Markets for Drug-Device Combinations

  • January 2015
  • -
  • BCC Research
  • -
  • 331 pages

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.

Table Of Contents

Global Markets for Drug-Device Combinations

Chapter- 1: INTRODUCTION - Complimentary 4

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 4

SCOPE OF THE INDUSTRY
DRUG-DEVICE COMBINATIONS: THE GLOBAL MARKET
TECHNOLOGY AND PATENT ACTIVITY
THE CENTRAL ROLE OF THE FDA

Chapter- 3: CURRENT STATUS OF THE DRUG-DEVICE COMBINATION INDUSTRY 12

OVERVIEW
ROLE OF THE FDA
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
THE RELATION BETWEEN NANOTECHNOLOGY AND COMBINATION PRODUCTS
FDA TRENDS IN REVIEWING COMBINATION PRODUCTS

Chapter- 4: REGULATORY PROCESS AND ISSUES 7

REGULATORY FUNDING
OVERSEAS AND WORLD REGULATION
FDA OFFICE OF COMBINATION PRODUCTS
SCOPE OF FDA ACTION
TREATMENT OF 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 23

OVERVIEW
REPRESENTATIVE COMPANIES
NATIONAL NANOTECHNOLOGY INITIATIVE
NANOTECH REGULATORY ENVIRONMENT
COMBINATION NANOTECHNOLOGY PRODUCT RESEARCH
PRODUCTS
POTENTIAL HEALTH EFFECTS: IMPACT ON NANO INDUSTRY

Chapter- 6: DRUG-ELUTING CORONARY STENTS 18

OVERVIEW
MECHANISM OF ACTION
CLINICAL TRIALS
DEFINITION AND SIZE OF TARGET MARKET
FDA REGULATORY ROLE WITH REGARD TO STENTS
FDA STENT APPROVAL HISTORY
PRINCIPAL DRUG ELUTED STENT PRODUCERS
STENT DESIGN
PRODUCT LINES
STENT PRODUCT INNOVATIONS AND RandD: BIOABSORBABLE STENTS
MARKETS FOR STENT RELATED TECHNOLOGIES

Chapter- 7: PHOTODYNAMIC THERAPIES 15

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
OTHER MEDICAL APPLICATIONS
OPTOGENETICS
PDT MARKET GROWTH DRIVERS
EXAMPLES OF PDT PRODUCTS
RESEARCH AND DEVELOPMENT
EQUIPMENT PRODUCERS

Chapter- 8: ANTIMICROBIALS AND OTHER MEDICAL DEVICE COATINGS 9

OVERVIEW: REGULATORY TREATMENT
DRIVING FORCE IN DEVELOPMENT OF ANTIMICROBIALS
MARKET CONTEXT AND PREVALENCE OF INFECTIONS
EXAMPLES OF USE
TRENDS IN FDA APPLICATIONS FOR ANTIMICROBIALS
ANTIMICROBIAL AND OTHER MEDICAL DEVICE COATINGS
MARKET CATEGORIES FOR MEDICAL DEVICE COATINGS IN COMBINATION PRODUCTS
EXAMPLE PRODUCTS

Chapter- 9: ANTIMICROBIAL CATHETERS 12

MARKET OVERVIEW
CLINICAL TRIALS
APPLICATIONS
MARKET SIZE
CATHETER INNOVATIONS
ANTIMICROBIAL CATHETER CONCEPTS
EXAMPLE PRODUCTS
RandD INITIATIVES

Chapter- 10: DRUG-ELUTING BEADS 15

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
RandD AND OTHER NOVEL APPLICATIONS OF BEADS
CONTROLLED DELIVERY OF TUMOR-KILLER DRUGS
RADIATION AND IMMUNOTHERAPY COMBINATIONS
POLYMERIC MICROCAPSULES

Chapter- 11: BONE CEMENTS INCLUDING ANTIBIOTIC 8

GENERAL APPLICATIONS
ANTIBIOTIC APPLICATIONS
EARLY HISTORY
APPLICATIONS
MARKET SIZE
COMPOSITION
NEW TECHNOLOGIES
EXAMPLE PRODUCTS
RELATED PRODUCTS: TYPES OF CERAMICS
CEMENTS IN DENTAL APPLICATIONS: GLASS IONOMER CEMENTS

Chapter- 12: BONE GRAFT SUBSTITUTES 38

OVERALL SIZE OF BONE GRAFT BUSINESS
RECENT DEVELOPMENTS
OVERVIEW OF APPLICATIONS
BONE GRAFT SUBSTITUTES
OSTEOBIOLOGICS AND OSTEOINDUCTIVE GROWTH FACTORS
BONE GRAFTS
THE MARKET FOR BONE GRAFT PRODUCTS
REGENERATIVE MEDICINE PRODUCTS IN DEVELOPMENT FOR BONE APPLICATIONS

Chapter- 13: WOUND CARE PRODUCTS INCLUDING BIOLOGICAL DRESSINGS 19

WOUND CARE GENERALLY
PRODUCT EFFICACY
MARKET SEGMENTS
TISSUE ENGINEERING

Chapter- 14: DRUG-DEVICE COMBINATION PRODUCTS FOR OCULAR APPLICATIONS 10

OVERVIEW
FDA APPROVED OPHTHALMIC IMPLANTS
CONTACT LENSES
COMBINATION DRUGS
INTRAOCULAR LENS PRODUCTS (IOL)
MARKET POTENTIAL

Chapter- 15: IMPLANTABLES AS DRUG-DEVICE COMBINATIONS 6

OVERVIEW
NEUROMODULATION
MINIATURE NEUROSTIMULATORS
BIODEGRADABLE CIRCUITS
BIORESORBABLE DEVICES
STEROID ELUTING PACEMAKER LEADS
MICROELECTRONIC CONTROL OF DRUG DELIVERY
MARKET SIZE

Chapter- 16: RELATED DRUG-DEVICE COMBINATIONS OF RELEVANCE 17

OVERVIEW
MARKET SIZE
INJECTABLE BIODEGRADABLE HYDROGELS FOR DRUG DELIVERY AND TISSUE ENGINEERING
IN VIVO FLEXIBLE ELECTRONICS
HEAT ACTIVATED DRUGS
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

Chapter- 17: PATENT ANALYSIS 41

PATENT VOLUMES
COMPETITIVE ASPECTS
INTELLECTUAL PROPERTY ISSUES
EXAMPLES OF DRUG-DEVICE COMBINATION PATENTS: 2012 TO 2014
EXAMPLES OF DRUG-DEVICE COMBINATION PATENTS: 2011 TO 2012
EXAMPLES OF DRUG-DEVICE COMBINATION PATENTS: 2008 TO 2009

Chapter- 18: INDUSTRY STRUCTURE AND COMPANY PROFILES 62

OVERVIEW
INVESTMENT OVER THE LAST 10 YEARS
REVENUES AND PROFITABILITY
GLOBAL MARKET COMPETITION
COMPANY PROFILES

Chapter- 19: APPENDIX 1: RECENT FDA APPROVALS OF DEVICES, INCLUDING COMBINATION PRODUCTS 10

OVERVIEW

Chapter- 20: APPENDIX 2: GLOSSARY OF RELEVANT TERMINOLOGY 1


List of Tables

Summary Table : SALES OF DRUG-DEVICE COMBINATION PRODUCTS, THROUGH 2019
Table 1 : EXAMPLES OF FDA APPROVED COMBINATION PRODUCTS
Table 2 : FDA CLASSIFICATION SCHEME FOR COMBINATION PRODUCTS
Table 3 : COMPANIES INVOLVED IN DRUG RELATED NANOTECHNOLOGY RandD OR MANUFACTURING
Table 4 : TRENDS IN COMBINATION PRODUCT APPLICATIONS AT FDA, 2003-2012
Table 5 : FDA COMBINATION PRODUCT CATEGORIES, FY2010-FY2012
Table 6 : COMPANIES WITH SIGNIFICANT SPECIALIZATION IN NANOMEDICINE, 2014
Table 7 : REVENUES ATTRIBUTABLE TO NANOTECHNOLOGY-BASED DRUG-DEVICE COMBINATION PRODUCTS, THROUGH 2019
Table 8 : MARKETS FOR CORONARY STENTS, THROUGH 2019
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
Table 13 : REVENUES ATTRIBUTABLE TO ANTIMICROBIALS THROUGH 2019
Table 14 : REVENUES ATTRIBUTABLE TO MEDICAL DEVICE COATINGS, THROUGH 2019
Table 15 : MEDICAL DEVICE PRODUCTS INCORPORATING AN ANTIMICROBIAL FUNCTION
Table 16 : CURRENT FDA APPROVED CLINICAL TRIALS FOCUSED ON NEW ANTIMICROBIAL CATHETER CONCEPTS
Table 17 : PROJECTED CATHETER MARKET BY PRODUCT TYPE, INCLUDING ANTIMICROBIAL PRODUCTS, THROUGH 2019
Table 18 : CURRENT CLINICAL TRIALS INVOLVING DRUG-ELUTING BEADS
Table 19 : RandD AND REVENUES ATTRIBUTABLE TO DRUG-ELUTED BEADS, THROUGH 2019
Table 20 : ANNUAL SALES OF BONE CEMENTS, INCLUDING COMBINATION PRODUCT ANTIBIOTIC BONE CEMENTS, THROUGH 2019
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
Table 30 : THE WORLDWIDE MARKET FOR BONE REPLACEMENT PRODUCTS, THROUGH 2019
Table 31 : THE U.S. MARKET FOR BONE REPLACEMENT PRODUCTS, THROUGH 2019
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
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
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
Table 41 : IMPLANTABLE DRUG-DEVICE COMBINATIONS, THROUGH 2019
Table 42 : MARKETS FOR RELATED DRUG-DEVICE COMBINATION PRODUCTS, THROUGH 2019
Table 43 : WORLD'S LARGEST MANUFACTURERS OF MEDICAL DEVICES
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

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