Drug-Device Combinations

Publication Date	January 2005
Publisher	BCC Research
Product Type	Report
Pages	211
ISBN Number	not applicable
Product Code	BCC00112

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Summary

Therapeutic drug-device combination products are an area of intense interest and unlimited potential from a clinical as well as an investment point of view. Devices, in general, are used to treat conditions rather than cure them. Drugs and biologics also generally treat disease, although some products provide cures. The combining of two treatment approaches, drugs/biologics and devices, should enhance the quality of treatment by increasing efficacy and reducing side effects. In some cases, the one-two treatment punch may, in fact, effect a cure.

The purpose of drug-device combination products either is to augment a device's efficacy and/or safety through the use of a drug coating, or to use a device to deliver a drug locally. This BCC report covers devices that serve a therapeutic function and have a drug component incorporated into them.

The study provides an overview of the current drug-device combination product market and an insight into the emerging market. The categories for this report were chosen because they represent areas for which therapeutic drug-device combination products recently have been introduced and/or are emerging.

Scope Of Study

The report contains:

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 for these products with forecasts to 2010
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.

Report Highlights

The total market for drug-device combinations worldwide was valued at $5.4 billion in 2004 and is expected to rise at an average annual growth rate (AAGR) of 13.6% to $11.5 billion in 2010.
The star category is drug-eluting stents that will continue to show average annual growth of 11.5%. This will result in the market doubling to $8 billion in 2010.
With the exception of bone graft substitutes and antibiotic bone cements, all categories will show double-digit growth.
The U.S. dominates the market for drug-device combination products, mainly because the largest-selling drug-eluting stents have been enthusiastically accepted in this market and consequently are penetrating the market more quickly than in Europe.

Content

Introduction
- Study Goal And Objectives
- Reasons For Doing The Study
- Contributions Of The Study And For Whom
- Scope And Format
- Methodology
- Information Sources
- Author's Credentials
- Related BCC Work Credentials
- BCC Online Services
- Disclaimer
Summary
- Summary Table: Market For Drug-Device Combination Products By Geographic Area, Through 2010 ($ Millions)
- Summary Figure: Market For Drug-Device Combination Products By Geographic Area, 2004-2010 ($ Millions)
Overview
- The Promise Of Drug-Device Combination Products
- Exciting Concept, Difficult Execution
- Manufacturer And Investor Interest In Drug-Device Combinations
- Drug-Device Combination Products Capitalize On A Variety Of New Technologies
- History Of The Development Of Drug-Device Combination Products
- Definition Of A Combination Product
- Applications For Drug-Device Combination Products
- Challenges To Market Entry
- The Market For Drug-Device Combination Products
- Future Directions For Drug-Device Combination Products
- New Partnering Opportunities
  - Patent Advantages
- The Customer Base For Drug-Device Combination Products
- Pricing Strategies
- Regulatory Issues
  - The Standard Operating Procedure And Policy On Intercenter Consultation/Collaboration
  - Office Of Combination Products
  - What A Difference A Review Center Makes
    - Request For Designation
  - Separate User Fees
  - Amended "mode Of Action" Definitions
  - Clinical Endpoints And Trial Designs For Drug-Device Combination Products
  - Regulation Of Drug-Device Combination Products Outside The U.S.
    - Regulatory Situation In The European Union
Antimicrobial Catheters
- Overview
  - Catheter-Related Infection
- Antimicrobial Agents Applicable To Catheters
  - Silver
- The Market For Antimicrobial Catheters
- Products
  - Arrowg+Ard Blue And Arrowg+Ard Blue Plus
  - Spectrum And Spectrum Glide
  - Vantex Cvc With Oligon
  - Product Comparison
  - Products Available Outside The U.S.
  - Manufacturers Of Antimicrobial Coatings
- Controversy About The Efficacy Of Antimicrobial-Impregnated Catheters
- Company Profiles
  - Agion Technologies, Inc.
    - Overview
    - Financial Information
    - Products
    - Corporate Strategy
  - Arrow International
    - Overview
    - Financial Information
    - Products
    - Corporate Strategy
  - Cook Critical Care, Inc.
    - Overview
    - Products
  - Edwards Lifesciences Corp.
    - Overview
    - Financial Information
    - Products
    - Corporate Strategy
Wound-Care Products
- Overview
- Applications For Drug-Device Combination Products
- Definition Of Wound-Care Products That Qualify As Drug-Device Combinations
- The Need For Biological Or Active Wound-Care Products
  - Reimbursement Environment
- Marketed Products
  - Antibiotic-Enhanced Wound-Care Products
    - Products Incorporating Silver
    - Acticoat
    - Actisorb Silver 220
    - Aquacel Ag
    - Avance
    - Contreet Products
    - Hydroferra Blue
    - Iodosorb Gel And Iodoflex Pad
    - Kerlix A.M.D.
    - Silvasorb
    - Silvercel
    - Urgotul Ssd
    - Product Comparison
    - The Market For Traditional And Advanced Wound-Care Products
    - The Market For Antimicrobial Wound-Care Products
  - Artificial Skin/Skin Replacement Products
    - Alloderm
    - Apligraf
    - Biobrane
    - Bioseed-S And Bioseed-M
    - Cymetra
    - Dermagraft
    - Epicel
    - Integra Matrix Wound Dressing
    - Laserskin
    - Oasis
    - Orcel
    - Transcyte
  - Other Biologic Therapies
    - Collagen
    - Antibiotic Collagen Sponges
    - Dressskin
    - Graftjacket
    - Matrix Collagen
    - Promogran
    - Growth Factors
- Manufacturers Of Biologic Dressings
- Products In Development
  - Activetex
  - Other Biological Dressing Products In Development
- Market Analysis
- Company Profiles
  - Collagen Matrix, Inc.
    - Overview
    - Products
    - Corporate Strategy
  - Integra Lifesciences Holdings Corp.
    - Overview
    - Products
  - Lifecell Corp.
    - Overview
    - Financial Information
    - Products
    - Corporate Strategy
  - Organogenesis, Inc.
    - Overview
    - Products
    - Corporate Strategy
  - Ortec International, Inc.
    - Overview
    - Products
    - Corporate Strategy
  - Nucryst Pharmaceuticals, Inc.
    - Overview
    - Financial Information
    - Products
    - Company Strategy
  - Smith & Nephew, Plc
    - Overview
    - Financial Information
    - Products
    - Corporate Strategy
  - Tei Biosciences, Inc.
    - Overview
    - Products
    - Corporate Strategy
  - Wright Medical Group, Inc.
    - Overview
    - Financial Information
    - Products
    - Corporate Strategy
Bone Graft Substitutes
- Overview
- Types Of Bone Grafts
  - Autografts
  - Allografts
    - Risks Associated With Allografts
    - Demineralized Bone Matrix Products
- Increased Usage Of Bone Graft Substitutes
- Drug-Device Combination Bone Graft Substitutes
  - Factor-Based Bone Graft Substitutes
    - Bone Morphogenic Proteins
    - Healos
    - Inductos
    - Infuse Bone Graft
    - Ne-Osteo
    - Op-1 Implant
    - Skelite
  - The Market For Bone Graft Products
Bone Cements
- Drug-Device Combination Bone Cements And Puttys
- The History Of Antibiotic Bone Cement
- The Composition Of Bone Cements
- The Growing Need For Bone Cements
- Orthopedic Procedure Volumes In The U.S.
- Sources Of Infection
- Prevention Of Infection
  - Applicable Antibiotics
    - Mechanism Of Action
- Products
  - Cemex Genta
  - Interspace Hip Spacer
  - Interspace Knee Spacer
  - Palacos G And Refobacin-Palacos R
  - Simplex P With Tobramycin Bone Cement
  - Smartset Ghv Gentamycin Bone Cement
  - Product Comparison
- The Market For Bone Cements And Antibiotic Bone Cements
- New Directions In Drug-Device Combination Bone Cements
- Company Profiles
  - Biomet Orthopedics, Inc.
    - Overview
    - Financial Information
    - Products
    - Corporate Strategy
  - Exactech, Inc.
    - Overview
    - Financial Information
    - Products
    - Corporate Strategy
  - Medtronic, Inc.
    - Overview
    - Financial Information
    - Products
    - Corporate Strategy
  - Millenium Biologix, Inc.
    - Overview
    - Products
    - Osteo
    - Actes
    - Corporate Strategy
  - Stryker Corp.
    - Overview
    - Financial Information
    - Products
    - Op-1
    - Corporate Strategy
Drug-Eluting Stents
- The Rapid Revolution In Percutanous Transluminal Coronary Angioplasty Technology
  - Percutaneous Transluminal Coronary Angioplasty
    - Trends In Ptca
- History Of Stents
- Procedure For Placing Stents
- Costs Of Ptca, Stenting, And Cabg
- Composition Of Drug-Eluting Stents
  - Drugs Used In Marketed And In-Development Stents
    - Abt-578
    - Dexamethasone
    - Everolimus
    - Paclitaxel
    - Prostaglandin E-1
    - Sirolimus
    - Tacrolimus
- The Worldwide Market For Drug-Eluting Stents
  - The U.S. Market For Drug-Eluting Stents
  - The European Market For Drug-Eluting Stents
  - The Japanese Market For Drug-Eluting Stents
- Drug-Eluting Stents On The Market
  - Cook V-Flex Plus Ptx
  - Cypher And Cypher Select
  - Dexamet
  - Taxus Express2
  - Taxus Liberte
- Leading Competitors In The Drug-Eluting Stent Market
- Profit Margins For Drug-Eluting Stents
- Impact Of Drug-Eluting Stents On The Interventional Cardiology Market
- Regulation Of Drug-Eluting Stents
- Cardiologists And Patient Response To The Cost Of Drug-Eluting Stents
  - The High Cost Of Drug-Eluting Stents Does Not Decrease Patient Demand
  - Reimbursement For Drug-Eluting Stents
- Drug-Eluting Stents In Development
  - Angiogenix-Coated Biodegradable/Resorbable Stent
  - Champion
  - Challenge And Spirit
  - Devax Axxess Bifurcation Stent System
  - Endeavor (Abt-578) Drug-Eluting Stent
  - Gtu X-Stent, Gtu X2-Stent
  - R Stent
  - Reva Resorbable Stent
  - Zilver Paclitaxel-Eluting Peripheral Stent
  - Zomaxx I
- New Applications And Technologies For Drug-Eluting Devices
- Company Profiles
  - Angiotech Pharmaceuticals, Inc.
    - Overview
    - Financial Information
    - Products
    - Corporate Strategy
  - Boston Scientific Corp.
    - Overview
    - Financial Information
    - Leading Cardiac Products
  - Cordis Corp.
    - Overview
    - Drug-Eluting Stents
    - Corporate Strategy
  - Endovasc, Inc.
    - Overview
    - Financial Information
    - Stents And Other Products
    - Corporate Strategy
    - Overview
    - Financial Information
    - Corporate Strategy
  - Surmodics, Inc.
    - Overview
    - Financial Information
    - Products
    - Corporate Strategy
Photodynamic Therapy
- Definition
- The Two Stages Of Pdt Treatment
- Choosing The Correct Wavelength
- The Role Of Singlet Oxygen
- Dual-Control Mechanisms Of Pdt
- Mechanisms Of Pdt-Induced Cell Death
  - Direct Cell Kill
  - Indirect Cell Kill Via Vascular Damage
  - Immunological Response To Pdt
- Role Of The Immune System In Pdt Of Cancer
  - Tumor-Targeted Pdt Results In An Enhanced Immune Response
  - Immunosuppressive Effects Of Pdt
  - Pdt For Immunomodulation
- History Of Photodynamic Therapy
  - The Fda Approves Pdt
  - Early Problems With Pdt
  - Technology Breakthroughs
    - Improved Photosensitizing Agents
    - New Light Sources
- Applications
  - Cancer
    - Barrett's Esophagus
    - Bladder Cancer
    - Cervical Cancer
    - Gastric Cancer
    - Head And Neck Cancer
    - Lung Cancer
  - Dermatologic Conditions
    - Actinic Keratoses
  - Ophthalmic Conditions
    - Age-Related Macular Degeneration
    - Pathologic Myopia
    - Presumed Ocular Histoplasmosis
  - Applications In Development
    - Autoimmune And Related Diseases/Disorders
    - Infectious Diseases
    - Aids
    - Photoangioplasty
    - Vascular Access
- Photosensitizing Agents Market
  - Market Share By Company
- Photosensitizing Agents And Photodynamic Therapy
  - Porphyrins
  - Location Of The Photosensitizer In The Cell
  - Improving Photosensitizer Targeting
  - Characteristics Of Photosensitizing Agents
  - Second-Generation Photosensitizers
  - Pdt Used With Other Therapies
  - Approved Photosensitizers For Pdt
    - Foscan
    - Levulan Kerastick
    - Metvix
    - Photofrin/Photobarr
    - Visudyne
    - Medicare Reimbursement Increased For Visudyne
    - Emerging Competition
  - Products In Development
    - Categories Of Products In Development
    - Anthracyclines
    - Benzoporphyrin And Benzoporphyrin Derivatives
    - Chlorins And Bacteriochlorins
    - Phorbides
    - Phthalocyanines
    - Porphycenes
    - Psoralens
    - Purpurins
    - Synthetic Nonporphyrin Compounds
    - Products Currently In Development
    - Antrin
    - Levulan
    - Litx
    - Mono-L-Aspartyl Chlorin E6
    - Photofrin/Photobarr
    - Photopoint Mv0633
    - Photopoint Mv2101
    - Photopoint Mv6401
    - Photopoint Mv9411
    - Photrex (Photopoint Snet2)
    - Qlt 0074
    - Theralux
    - Visudyne
  - The Ideal Photosensitizer
  - Marketers Of Drugs Used In Pdt
- Lasers And Other Light Sources Used In Pdt
  - Lasers
  - Light-Emitting Diodes
  - Blu-U
  - Levia
  - Metalas-M
  - Marketers Of Lasers And Other Light Sources For Pdt
  - Lasers And Other Related Devices In Development For Pdt
    - Lumacare Model Lc-122
    - V-Star
- Industry Structure
- Company Profiles
  - Axcan Pharma, Inc.
    - Overview
    - Financial Information
    - Products
    - Corporate Strategy
  - Celmed Biosciences
    - Overview
    - Products
  - Cynosure, Inc.
    - Overview
    - Products
  - Dusa Pharmaceuticals, Inc.
    - Overview
    - Financial Information
    - Products
    - Corporate Strategy
  - Miravant Medical Technologies
    - Overview
    - Financial Information
    - Products
  - Qlt, Inc.
    - Overview
    - Financial Information
    - Products
    - Corporate Strategy
  - Pharmacyclics, Inc.
    - Overview
    - Financial Information
    - Products
    - Corporate Strategy
Other Applications
- Antimicrobial Sutures
- Antimicrobial Vascular Grafts
- Heat-Activated Drugs
List Of Figures
- Summary Table: Market For Drug-Device Combination Products By Geographic Area, Through 2010 ($ Millions)
- Table 1 Estimated Worldwide Market For Drug-Device Combination Products By Type, Through 2010 ($ Millions)
- Table 2 Estimated Worldwide Market For Drug-Device Combination Products By Geographic Area, Through 2010 ($ Millions)
- Table 3 Devices Amenable To Drug-Eluting Coatings
- Table 4 Potential Drug-Device Combination Products
- Table 5 Application, Prescribing And Customer Differences Between Drugs And Devices
- Table 6 Estimated Worldwide Market For Antimicrobial Catheters, Through 2010 ($ Millions)
- Table 7 Estimated U.S. Market For Antimicrobial Catheters, Through 2010 ($ Millions)
- Table 8 Data Comparing Arrowg+Ard Blue Vs. Spectrum Antimicrobial Catheters
- Table 9 Estimated Worldwide Market For Traditional And Advanced Wound-Care Products, Through 2010 ($ Millions)
- Table 10 Estimated U.S. Market For Traditional And Advanced Wound-Care Products, Through 2010 ($ Millions)
- Table 11 Estimated European Market For Traditional And Advanced Wound-Care Products, Through 2010 ($ Millions)
- Table 12 Estimated Worldwide Market For Antimicrobial Wound-Care Products, Through 2010 ($ Millions)
- Table 13 Estimated U.S. Market For Antimicrobial Wound-Care Products, Through 2010 ($ Millions)
- Table 14 Estimated European Market For Antimicrobial Wound-Care Products, Through 2010 ($ Millions)
- Table 15 Manufacturers Of Biologic Dressings, 2005
- Table 16 Biological Dressing Products In Development
- Table 17 Estimated Worldwide Market For Biological Dressings By Product Segment, Through 2010 ($ Millions)
- Table 18 Estimated U.S. Market For Biological Dressings By Product Segment, Through 2010 ($ Millions)
- Table 19 Estimated Worldwide Market For Biological Dressings By Wound Type, Through 2010 ($ Millions)
- Table 20 Estimated U.S. Market For Biological Dressings By Wound Type, Through 2010 ($ Millions)
- Table 21 U.S. Bone Graft Procedure Volumes By Application, Through 2010
- Table 22 U.S. Bone Graft Procedure Volumes By Type Of Graft, Through 2010
- Table 23 Comparison Of Bone Graft Materials
- Table 24 Types Of Substitute Bone Grafts
- Table 25 The Worldwide Market For Bone Graft Products By Type, Through 2010 ($ Millions)
- Table 26 The Worldwide Market For Knee, Hip And Extremity Reconstruction, Through 2010 ($ Millions)
- Table 27 U.S. Total/Partial Hip Replacement Procedures, Through 2010
- Table 28 U.S. Total Hip Revision Procedures, Through 2010
- Table 29 U.S. Primary/Revision Knee Replacement Procedures, Through 2010
- Table 30 The Worldwide Market For Bone Cements And Antibiotic Bone Cements, Through 2010 ($ Millions)
- Table 31 The U.S. Market For Bone Cements And Antibiotic Bone Cements, Through 2010 ($ Millions)
- Table 32 Average Costs Of Ptca, Stenting, And Cabg
- Table 33 Characteristics Of Different Types Of Drug-Eluting Stents
- Table 34 Estimated Worldwide Market For Drug-Eluting Stents, Through 2010 ($ Millions)
- Table 35 Estimated U.S. Sales Of Coronary Stents, Through 2010 ($ Millions, %)
- Table 36 The Estimated U.S. Market For Drug-Eluting Stents, Through 2010 ($ Millions)
- Table 37 The Estimated European Market For Drug-Eluting Stents, Through 2010 ($ Millions)
- Table 38 The Estimated Japanese Market For Drug-Eluting Stents, Through 2010 ($ Millions)
- Table 39 Global Market Shares For Drug-Eluting Stents, By Company, 2004 (%)
- Table 40 U.S. Market Shares For Drug-Eluting Stents By Company, Through 2004 (%)
- Table 41 Medicare Reimbursement Model For Ptca ($)
- Table 42 Angiotech's Marketed And In-Development Products
- Table 43 The Worldwide Market For Photosensitizing Drugs By Indication, Through 2010 ($ Millions)
- Table 44 Cancers Suitable For Treatment By Photodynamic Therapy
- Table 45 The Worldwide Market For Photosensitizing Drugs, Through 2010 ($ Millions)
- Table 46 Approved Photosensitizing Agents For Pdt
- Table 47 Pdt Products In Phase Ii Or Later Development
- Table 48 Dusa Pharmaceuticals Product Pipeline
- Table 49 Qlt, Inc. Marketed Product And Product Pipeline
List Of Figures
- Summary Figure: Market For Drug-Device Combination Products By Geographic Area, 2004-2010 ($ Millions)
- Figure 1 Percentage Of The Worldwide Advanced Wound-Care Market Held By Antimicrobial Products, 2004 And 2010 (%)
- Figure 2 Estimated Worldwide Market For Biological Dressings By Product Segment, 2003-2010 ($ Millions)
- Figure 3 Estimated Worldwide Market For Biological Dressings By Wound Type, 2003-2010 ($ Millions)
- Figure 4 U.S. Bone Graft Procedure Volumes By Type Of Graft, 2003-2010
- Figure 5 The Worldwide Market For Knee, Hip And Extremity Reconstruction, Through 2010 ($ Millions)
- Figure 6 The Worldwide Market For Bone Cements And Antibiotic Bone Cements, 2003-2010 ($ Millions)
- Figure 7 Drug-Eluting Stents: Share Of The Worldwide Coronary Stent Market, 2004 And 2010 (%, Based On Units)
- Figure 8 Drug-Eluting Stents: Share Of The Worldwide Coronary Stent Market, 2004 And 2010 (%, Based On Dollar Volume)
- Figure 9 The Worldwide Market For Photosensitizing Drugs By Indication, 2003-2010 ($ Millions)
- Figure 10 Market Shares By Company For Photosensitizing Drugs, 2004 (%)