Drug-Device Combinations

Summary

Report Highlights:

• 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.

Study Goals and Objectives

This report discusses key markets for drug device combination products. IT provides descriptions of technologies and products, a review of the status of R&D initiatives and a forecast of the market through 2014. Company profiles and a patent analysis are provided as well. Example product categories that are covered include 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, photodynamic therapy, and other important niches.

Reasons for Doing This Study and Its Importance

Products that combine a drug or biologic with a device, such as drug-eluting stents and drug-delivery systems, can offer valuable approaches for treating diseases. in addition, developments in cell-based therapeutics, progenitor cell exploitation, growth factor delivery and advanced formulation strategies are becoming the basis of even more advanced combination device strategies. Technology advancements in the drug device combination market have been of considerable import in recent years and the pace of activity seems to be quickening with the appearance of many development-stage companies.

Especially since the approval of Johnson & Johnson's Cypher drug-eluting stent in 2003 and Boston Scientific's Taxus drug-eluting stent in 2004, drug-device combination products have attracted significant medical and media attention. but, combination products are subject to intense regulatory scrutiny for the issues of safety and effectiveness. Teams of device and drug product reviewers at a number of FDA centers are dedicated to evaluating such products. Thus, the bar is very high for FDA product approvals and consequently some combination products in certain categories are very small in number. for example, the entire fibrin sealant market is shared by only five FDA-approved products. beyond drug-eluting stents and other categories noted above, combination products subject to FDA scrutiny include innovative drug-delivery systems, hemostatic sealants, photodynamic-therapy systems, gene-therapy systems, and products for many other investigational treatments.

The development of the market for combination products is closely related to another dynamic and fast growing healthcare segment generally termed ""drug-delivery systems"". ""Delivery systems"" represents a vast area of research and development within biomaterials and medicine and the demand for sophisticated drug-delivery devices is behind many novel product developments. Advanced drug-delivery devices offer increased efficiency, improved performance and convenience.

Intended Audience

with its broad scope and in-depth analyses, this study will prove to be a valuable resource, particularly for anyone involved with or interested in the future of the fast growing drug device combination market. This study will be particularly useful for researchers, laboratory and government personnel working in research or company settings, as well as business professionals involved with drug and device development. IT also will be of value to potential investors and members of the general public interested in acquiring a business-oriented view of a key health care sector in the economy. The projections, forecasts, and trend analyses found in this report provide readers with the necessary data and information for decision-making.

Scope and Format of Report

in preparing this report, an overall study of the drug device combination market was undertaken. Related areas, such as drug delivery systems and nanotechnology, were key to the analysis as well, as 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 agencies. 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 this is affecting development and approval of such products.

Methodology and Information Sources

Data for this study were collected using both primary and secondary data research techniques. A literature search was conducted covering scientific, medical, business and technical documents, as well as patents. since most segments of the drug device combination market are not routinely measured, BCC derived estimates from a variety of sources. Whenever market estimates are derived, they are fully noted. All forecasts are in current (nominal) dollars, unadjusted for inflation.

Contents

• Chapter- 1: Introduction -- Complimentary
  • 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
  • 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
  • The Relation between Nanotechnology and Combination Products
  • Fda Trends in Reviewing 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
• Chapter-6: Drug-Eluting Coronary Stents
  • Overview
  • Definition and Size of Target Market
  • 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
  • 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
• 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
  • Anti-Microbial and Other Medical Device Coatings
  • Market Categories for Medical Device Coatings in Combination Products
  • Example Products
• 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
• 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
  • 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
• 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
  • Autografts
    • BioSeed Grafts
    • Allografts
    • Demineralized Bone Matrix Products
    • Accell
    • Alphagraft
    • Allomatrix
    • Grafton Dbm
    • DBX
    • DynaBlast and DynaGraft-D
    • Graftech
    • Grafton
    • Opteform
    • OrthoBlast II
    • Osteofil
    • Solo Cervical Allograft
    • Xenografts
  • The Market for Allografts
  • 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
  • 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
  • Specific Collagen Products
    • Tenomendtm Collagen Tendon Wrap
    • CosmoDerm and CosmoPlast Human-Based Collagen
  • Tissue Engineering
  • Skin Substitutes: Cells and Tissues
  • Artificial Skin
  • Skin-like Tissue Developed from Human Embryonic Stem Cells
  • Alginates
  • 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
• 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
• Chapter-15: Implantables as Drug Device Combinations
  • Miniature Neurostimulators
  • Biodegradable Circuits
  • Steroid Eluting Pacemaker Leads
  • Market Size
• Chapter-16: Related Drug Device Combinations of Relevance
  • Overview
  • Market Size
  • 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 1: Recent Fda Approvals of Devices, Including Combination Devices
  • Appendix 2: Glossary of Relevant Terminology
• List of Tables
  • 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
  • Figure 1 Combination Product Applications at Fda, 2003-2007 (Number of Submissions)