Published January 2007 | 420 Pages | 136 Exhibits | Forecasts Through 2011
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AirSep Corporation
Covidien Ltd
DeVilbiss Healthcare
Fisher & Paykel Healthcare Corporation Ltd
Flaga Group hf
Hill-Rom (Hillenbrand Industries, Inc.)
Invacare Corporation
Medical Graphics Corporation/Angeion
nSpire Health, Inc
Olympus America, Inc
ResMed, Inc
Respironics, Inc
Viasys Healthcare, Inc
Executive Summary
Major Pulmonary Diseases
Non-Sleep Pulmonary Diagnostic Technologies
Non-Sleep Device-Based Pulmonary Therapeutics
Traditional Products
Emerging Technologies
Sleep Apnea Products
Diagnostic Segment
Therapeutics Segment
Suppliers
Summary Exhibit 1: Pulmonary Device Markets by Major Category, 2005-2011
Summary Exhibit 2: Overview of Major Pulmonary Conditions
Summary Exhibit 3: Non-Sleep Pulmonary Diagnostic Technologies, 2005-2011
Summary Exhibit 4: Non-Sleep Pulmonary Therapy Technologies, 2005-2011
Summary Exhibit 5: Emerging Pulmonary Device Therapies, 2008-2015
Summary Exhibit 6: Sleep Apnea Technologies by Category, 2005-2011
1.0 Overview and Epidemiology
1.1 Major Obstructive Pulmonary Diseases
1.1.1 Chronic Obstructive Pulmonary Disease
1.1.1.1 Risk Factors
1.1.1.2 Symptoms
1.1.1.3 Diagnosis and Staging
1.1.1.4 Heterogenous versus Homogenous Emphysema
1.1.1.5 Treatment
1.1.1.6 Prevalence
1.1.1.7 Morbidity and Mortality
1.1.2 Asthma
1.1.2.1 Risk Factors
1.1.2.2 Symptoms
1.1.2.3 Types
1.1.2.4 Diagnosis
1.1.2.5 Severity
1.1.2.6 Treatment
1.1.2.7 Statistics
1.2 Lung Cancer
1.2.1 Risk Factors
1.2.2 Symptoms
1.2.3 Diagnosis
1.2.4 Staging
1.2.5 Treatment
1.2.6 Prognosis
1.2.7 Incidence
1.3 Mechanical Ventilation Patients
1.3.1 Complete Quadriplegia
1.3.2 Amyotrophic Lateral Sclerosis
1.3.3 Intensive Care Patients
1.4 Sleep Apnea
1.4.1 Mechanics of Nocturnal Breathing
1.4.2 Types of Sleep Apnea
1.4.2.1 Obstructive Sleep Apnea
1.4.2.1.1 Pathophysiology
1.4.2.1.2 Diagnosis and Staging
1.4.2.1.3 Risk Factors
1.4.2.2 Central Sleep Apnea
1.4.2.2.1 Pathophysiology
1.4.2.2.2 Risk Factors
1.4.2.3 Complex Sleep Apnea
1.4.3 Prevalence of Sleep Apnea
1.4.4 Associated Comorbidities
1.4.4.1 Diabetes
1.4.4.2 Hypertension
1.4.4.3 Other Cardiovascular Disorders
1.4.4.4 Daytime Sleepiness and Cognitive Dysfunction
1.4.5 Diagnosis
1.4.6 Treatment
1.4.6.1 Positive Airway Pressure Devices
1.4.6.2 Oral Appliances
1.4.6.3 Surgery and Surgical Implants
Exhibit 1-1: Overview of Chronic Obstructive Pulmonary Disease
Exhibit 1-2: Characteristics of Patients Dying with COPD
Exhibit 1-3: Staging of COPD Severity
Exhibit 1-4: Prevalence of COPD by Disease Severity, Patient Forecast, 2005-2011
Exhibit 1-5: Staging of Asthma Severity
Exhibit 1-6: Selected Asthma Statistics
Exhibit 1-7: Overview of Lung Cancer
Exhibit 1-8: Stage Distribution of Lung Cancer by Type at Diagnosis, 1996-2002
Exhibit 1-9: Five-Year Survival Rates by Lung Cancer Type and Stage, 1996-2002
Exhibit 1-10: States With Highest Incidence of Lung Cancer by Sex, 1999-2003
Exhibit 1-11: Ventilator-Dependent Quadriplegics, Patient Forecast, 2005-2011
Exhibit 1-12: Amyotrophic Lateral Sclerosis, New Diagnoses, 2005-2011
Exhibit 1-13: Intensive Care Mechanical Ventilation, Patient Forecast, 2005-2011
Exhibit 1-14: Types of Sleep Apnea
Exhibit 1-15: Risk Factors for Obstructive Sleep Apnea
Exhibit 1-16: Selected Studies of OSA in the General Population
Exhibit 1-17: Obstructive Sleep Apnea (OSA) Prevalence by Severity, 2005-2011
Exhibit 1-18: Central Sleep Apnea (CSA) Prevalence, 2006-2011
Exhibit 1-19: Complex Sleep Apnea (CompSA) Prevalence, 2006-2011
Exhibit 1-20: Selected Studies of Obstructive Sleep Apnea and Type 2 Diabetes
Exhibit 1-21: Selected Studies of Hypertension and Obstructive Sleep Apnea
Exhibit 1-22: Selected Studies of Cardiovascular Disease in OSA Patients
Exhibit 1-23: Selected Studies of OSA and Cognitive Impairment
Exhibit 1-24: Treatment of Sleep Apnea by Type
2.0 Pulmonary Diagnostic Technologies
2.1 Pulmonary Screening Recommendations
2.1.1 Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial
2.1.2 National Lung Screening Trial
2.2 Current Diagnostic Technologies
2.2.1 Spirometry
2.2.1.1 Variables Measured
2.2.1.2 Sensing Methods
2.2.1.3 Sites of Use
2.2.1.4 Configurations
2.2.1.4 Technology Trends
2.2.1.5 Suppliers and Products
2.2.1.5 Market Analysis
2.2.2 Pulmonary Function Testing Systems
2.2.2.1 Tests and Measurements
2.2.2.3 Technology Trends
2.2.2.4 Products and Supliers
2.2.2.5 Market Analysis
2.2.3 Bronchoscopy
2.2.3.1 Physicians and Labs
2.2.3.2 Products
2.2.3.3 Technology Trends
2.2.3.3.1 Autofluorescence Bronchoscopy
2.2.3.3.2 Optical Coherence Tomography
2.2.3.3.3 Endobronchial Ultrasonography
2.2.3.3.4 Electromagnetic Navigation Bronchoscopy
2.2.3.4 Procedures
2.2.3.5 Market Analysis
2.3 Emerging Diagnostic Technologies
2.3.1 Digital Chest X-Rays
2.3.2 Computer-Aided Detection
2.3.2.1 Clinical Goals
2.3.2.2 Protocols
2.3.2.3 Current Barriers to Use
2.3.2.4 Clinical Experience
2.3.2.5 Suppliers
2.3.2.5.1 CAD Sciences/Saphenia LLC
2.3.2.5.2 EDDA Technology
2.3.2.5.3 GE Healthcare
2.3.2.5.4 Hologic/R2 Technology
2.3.2.5.5 Infinnitt
2.3.2.5.6 Kodak Health Group
2.3.2.5.7 Median Technologies
2.3.2.5.8 Merge Healthcare
2.3.2.5.9 MGT Capital/Medicsight
2.3.2.5.10 Philips Medical Systems
2.3.2.5.11 Riverain Medical
2.3.2.5.12 Siemens Medical Solutions
2.3.2.6 Market Analysis
2.3.3 New Imaging Technologies
2.3.3.1 Deep Breeze Medical
2.3.3.2 Vital Images
2.3.3.3 Market Analysis
2.4 Sleep Apnea Diagnosis
2.4.1 Referral Pathways
2.4.2 Evaluations
2.4.3 Diagnostic Protocol
2.4.3.1 Scoring the Severity of Sleep Apnea
2.4.3.2 Titration, Split-Night Sleep & Follow-Up Studies
2.4.3.3 Home-Based Diagnosis and Unattended Studies
2.4.4 Diagnostic Technologies
2.4.4.1 PSG Technologies
2.4.4.2 Non-PSG Technologies
2.4.5 Trends in Sleep Diagnostics
2.4.5.1 Home Diagnosis
2.4.5.2 Sleep Labs
2.4.6 Products and Suppliers
2.4.6.1 Advanced Brain Monitoring
2.4.6.2 Bio-Logic Systems (Natus Medical)
2.4.6.3 Compumedics
2.4.6.4 Covidien
2.4.6.5 Embla (Flaga Group)
2.4.6.6 Grass Technologies (Astro-Med)
2.4.6.7 Nihon Kohden America
2.4.6.8 Respironics
2.4.6.9 Viasys Healthcare
2.4.7 Market Analysis
2.4.7.1 PSG Technologies
2.4.7.2 Non-PSG Technologies
2.4.7.3 Supplier Shares
Exhibit 2-1: Selected Diagnostic Spirometers, 2007
Exhibit 2-2: Spirometry Products, Market Forecast, 2005-2011
Exhibit 2-3: Spirometry Products, Market Forecast by Segment, 2005-2011
Exhibit 2-4: Spirometry Products, Supplier Shares, 2006
Exhibit 2-5: Comparison of Obstructive and Restrictive Pulmonary Disease
Exhibit 2-6: Selected Pulmonary Function Testing Systems, 2007
Exhibit 2-7: Pulmonary Function Testing Systems, Market Forecast, 2005-2011
Exhibit 2-8: Pulmonary Function Testing Products, Supplier Shares, 2006
Exhibit 2-9: Rigid and Flexible Bronchoscopy
Exhibit 2-10: Selected Flexible Bronchoscopes, 2007
Exhibit 2-11: Selected Emerging Adjunctive Bronchoscopic Technologies, 2007
Exhibit 2-12: Selected Autofluorescence Bronchoscopy Systems, 2007
Exhibit 2-13: Olympus Endobronchial Ultrasound Products
Exhibit 2-14: Comparison of Lung Biopsy Methods
Exhibit 2-15: superDimension Bronchus Electromagnetic Navigation Technology
Exhibit 2-16: Bronchoscopy, Procedure Forecast, 2005-2011
Exhibit 2-17: Flexible Bronchoscopes, Market Forecast, 2005-2011
Exhibit 2-18: Flexible Bronchoscopes, Supplier Shares, 2006
Exhibit 2-19: Selected Approaches to Optimizing Pulmonary Diagnosis, 2007
Exhibit 2-20: Benefits and Limitations of Digital X-Ray Technology
Exhibit 2-21: Major Drivers and Barriers to Adoption of Lung CAD Technology
Exhibit 2-22: Selected Lung Computer-Aided Detection Systems, 2007
Exhibit 2-23: Lung CAD Systems, Market Forecast, 2005-2011
Exhibit 2-24: Lung CAD Systems, Supplier Shares, 2006
Exhibit 2-25: Selected New Lung Imaging Technologies, 2007
Exhibit 2-26: Deep Breeze Medical VRIxp Technology
Exhibit 2-27: Vibration Response Imaging, Market Forecast, 2007-2011
Exhibit 2-28: Epworth Sleepiness Scale
Exhibit 2-29: Severity of Disease by Apnea-Hypopnea Index (AHI)
Exhibit 2-30: Reimbursement for Sleep Studies
Exhibit 2-31: Overview of Sleep Diagnostic Technologies
Exhibit 2-32: Sleep Labs and Beds, Facility Forecast, 2005-2011
Exhibit 2-33: Selected PSG Suppliers and Systems, 2007
Exhibit 2-34: Selected Non-PSG Home Screening and Diagnostic Products, 2007
Exhibit 2-35: Polysomnograph Systems & Accessories, Market Forecast, 2005-2011
Exhibit 2-36: U.S. Market for Non-PSG Diagnostic Products, 2005-2011
Exhibit 2-37: U.S. Sleep Diagnostics, Supplier Shares, 2006
3.0 Pulmonary Disease Therapies
3.1 Drug Therapy
3.1.1 Bronchodilators
3.1.2 Anti-Inflammatory Agents
3.1.3 Other Medications
3.1.4 Emerging Drugs
3.2 Pulmonary Rehabilitation
3.2.1 Therapeutic Goals
3.2.2 Therapeutic Tools
3.3 Oxygen Therapy
3.3.1 Therapeutic Goals
3.3.2 Delivery Modalities
3.3.2.1 Compressed Oxygen
3.3.2.2 Liquid Oxygen Systems
3.3.2.3 Oxygen Concentrators
3.3.3 Oxygen Conserving Devices
3.3.4 Oxygen Concentrator Market Analysis
3.4 Peak Flow Monitoring
3.4.1 Monitoring Process and Readings
3.4.2 Peak Flow Meters
3.4.2.1 Product Trends
3.4.2.2 Products and Suppliers
3.4.3 Market Analysis
3.5 Noninvasive Ventilation
3.5.1 Devices
3.5.2 Clinical Applications
3.5.3 Advantages and Limitations
3.5.4 Market Analysis
3.6 Emerging Pulmonary Therapies
3.5.1 Artificial Lung and Lung Assist Technologies
3.5.1.1 ALung Technologies
3.5.1.2 Haemair
3.5.1.3 MC3/Novalung
3.5.1.4 NovaLung
3.5.1.5 Market Analysis
3.5.2 Bronchial Thermoplasty (Asthmatx)
3.5.2.1 Procedure
3.5.2.2 Clinical Experience
3.5.2.3 Company History
3.5.2.4 Market Forecast
3.5.3 Chest Compression Systems
3.5.3.1 Dymedso
3.5.3.2 Electromed
3.5.3.3 Hill-Rom
3.5.3.4 RespirTech
3.5.3.5 Market Analysis
3.5.4 Diaphragm Pacing (Synapse Biomedical)
3.5.4.1 NeuRx DPS System
3.5.4.2 Clinical Experience
3.5.4.3 Ventilator-Associated Pneumonia Prophylaxis
3.5.4.4 Product Pricing
3.5.4.5 Company History
3.5.4.6 Market Forecast
3.5.5 Lung Volume Reduction
3.5.5.1 Aeris Therapeutics
3.5.5.2 Emphasys Medical
3.5.5.3 Johnson & Johnson Closure Medical
3.5.5.4 Novatech
3.5.5.5 PneumRx
3.5.5.6 Pulmonx
3.5.5.7 Spiration
3.5.5.7.1 VALR System
3.5.5.7.2 Intra-Bronchial Valve (IBV)
3.5.5.8 Uptake Medical
3.5.5.9 Market Forecast
3.5.6 Airway Bypass
3.5.6.1 Broncus Technologies
3.5.6.2 Market Forecast
3.5.7 Shunt Technologies (Rox Medical)
Exhibit 3-1: Overview of Major Treatment Approaches to Pulmonary Disease
Exhibit 3-2: Drug Therapy For Asthma
Exhibit 3-3: Drug Therapy for COPD
Exhibit 3-4: Home Oxygen Therapy Formats
Exhibit 3-5: Selected Oxygen Concentrators, 2007
Exhibit 3-6: Selected Transfilling Systems, 2007
Exhibit 3-7: Oxygen Conserving Technologies and Approaches
Exhibit 3-8: Oxygen Concentrators, Market Forecast by Type, 2005-2011
Exhibit 3-9: Oxygen Concentrators, Supplier Shares, 2006
Exhibit 3-10: Selected Peak Flow Meters, 2007
Exhibit 3-11: Peak Flow Meters, Market Forecast, 2005-2011
Exhibit 3-12: Peak Flow Meters, Supplier Shares, 2006
Exhibit 3-13: Selected Noninvasive Ventilation Technologies, 2007
Exhibit 3-14: Advantages and Limitations of Noninvasive Ventilation
Exhibit 3-15: Noninvasive Ventilation Technologies, Market Forecast, 2005-2011
Exhibit 3-16: Noninvasive Ventilation Products, Supplier Shares, 2006
Exhibit 3-17: Selected Emerging Approaches to Pulmonary Diseases, 2007
Exhibit 3-18: Selected Artificial Lung and Lung Assist Technologies, 2007
Exhibit 3-19: Hattler Respiratory Assist Catheter and HemoLung Console
Exhibit 3-20: Haemair Respiratory Aid and Prosthetic Lung
Exhibit 3-21: MC3/Novalung Biolung Prosthetic Lung
Exhibit 3-22: Novalung Interventional Lung Assist (iLA) Device
Exhibit 3-23: Artificial Lung/Lung Assist Devices, Market Forecast, 2009-2015
Exhibit 3-24: Asthmatx Alair Bronchial Thermoplasty System
Exhibit 3-25: Bronchial Thermotherapy, Patient & Market Forecast, 2009-2015
Exhibit 3-26: Chest Compression Therapy: Indications and Contraindications
Exhibit 3-27: Selected Chest Compression Systems, 2007
Exhibit 3-28: Chest Compression (HFCWO) Systems, Market Forecast, 2005-2011
Exhibit 3-29: Chest Compression Systems, Supplier Shares, 2006
Exhibit 3-30: Synapse Biomedical NeuRx System
Exhibit 3-31: Advantages of Diaphragm Pacing Stimulation
Exhibit 3-32: Diaphragm Pacing, Market Forecast by Application, 2008-2015
Exhibit 3-33: Minimally Invasive Approaches to Lung Volume Reduction Surgery
Exhibit 3-34: Aeris Therapeutics’ Biological Lung Volume Reduction System
Exhibit 3-35: Emphasys Medical Zephyr Endobronchial Valve
Exhibit 3-36: Spiration VALR Compression-Banding Technology
Exhibit 3-37: Spiration Intra-Bronchial Valve (IBV) Technology
Exhibit 3-38: MI LVR Technologies, Market Forecast, 2008-2015
Exhibit 3-39: Broncus Technologies’ Exhale Stent and Airway Bypass Procedure
Exhibit 3-40: Airway Bypass, Patient and Market Forecast, 2012-2015
4.0 Sleep Apnea Therapy
4.1 Rationale for Treatment
4.2 Behavioral Modification
4.3 Inhaled Carbon Dioxide
4.4 Oxygen Therapy
4.5 Positive Airway Pressure
4.5.1 Continuous Positive Airway Pressure
4.5.2 Bi-Level Positive Airway Pressure Generators
4.5.3 Automatic-Adjustable Positive Airway Pressure Generators
4.5.4 Adaptive Servo-Ventilation
4.5.5 Masks and Interfaces
4.5.6 Humidifiers and Accessories
4.5.7 Reimbursement
4.5.8 Trends in Positive Airway Pressure Therapy
4.5.9 Products and Suppliers
4.5.9.1 Covidien
4.5.9.2 DeVilbiss Healthcare
4.5.9.3 Fisher & Paykel Healthcare
4.5.9.4 Invacare
4.5.9.5 ResMed
4.5.9.6 Respironics
4.5.9.7 Viasys Healthcare
4.5.9.8 Vital Signs
4.5.10 Patient Forecast
4.5.11 Market Analysis
4.5.11.1 Market by Patient Type
4.5.11.2 Market by Technology
4.5.12 Supplier Shares
4.6 Oral Appliances
4.6.1 Mandibular Repositioning Appliances
4.6.2 Tongue Retaining Devices
4.6.3 Clinical Experience
4.6.4 Clinical Trials
4.6.5 Products and Suppliers
4.6.6 Patient Forecast
4.6.7 Market Analysis
4.7 Surgery
4.7.1 Palatal Surgeries
4.7.1.1 Uvulopalatopharyngoplasty
4.7.1.2 Thermal Ablation Palatoplasty
4.7.2 Tongue-Base Surgeries
4.7.2.1 Genioglossus Advancement
4.7.2.2 Hyoid Advancement
4.7.2.3 Maxillomandibular Advancement
4.7.2.4 Maxillomandibular Expansion
4.7.2.5 Radiofrequency Tongue-Base Reductions
4.7.3 Combined Surgical Approaches
4.7.4 Other Surgeries
4.7.4.1 Tracheostomy
4.7.4.2 Bariatric Surgery
4.7.5 Clinical Trials
4.7.6 Products and Suppliers.
4.7.6.1 ArthroCare ENT
4.7.6.2 Gyrus ENT
4.7.7 Surgical Implants
4.7.7.1 Apneon
4.7.7.2 Aspire Medical
4.7.7.3 InfluENT Medical
4.7.7.4 Restore Medical
4.7.8 Market Analysis
Exhibit 4-1: Therapies for Sleep-Related Breathing Disorders
Exhibit 4-2: Types of PAP Generators Used to Treat Sleep Apnea
Exhibit 4-3: Replacement Schedule Allowed by Medicare for Accessories, 2007
Exhibit 4-4: Selected Studies Examining the Effectiveness of PAP Therapy
Exhibit 4-5: Selected Studies of Compliance with PAP Therapy
Exhibit 4-6: Selected Positive Airway Pressure Products and Suppliers, 2007
Exhibit 4-7: Selected Studies of ASV in CSA and CompSA Patients
Exhibit 4-8: Positive Airway Pressure Therapy, Patient Forecast, 2005-2011
Exhibit 4-9: U.S. PAP Therapy Market by Patient Type, 2005-2011
Exhibit 4-10: U.S. Market for PAP Flow Generators by Type, 2005-2011
Exhibit 4-11: U.S. PAP Therapy Market by Technology, 2005-2011
Exhibit 4-12: Positive Airway Pressure Supplier Shares, 2005 and 2006
Exhibit 4-13: Overview of Oral Appliances by Type
Exhibit 4-14: Selected Studies of Oral Appliances in Obstructive Sleep Apnea
Exhibit 4-15: Oral Appliance Products and Suppliers, 2007
Exhibit 4-16: Oral Appliances, U.S. Patient Forecast, 2005-2011
Exhibit 4-17: Oral Appliances for OSA, U.S. Market Forecast, 2005-2011
Exhibit 4-18: Overview of Surgical Approaches to Treat Sleep Apnea
Exhibit 4-19: Selected Studies of Palatal Surgeries for OSA
Exhibit 4-20: Selected Studies of Tongue-Base Surgeries for OSA
Exhibit 4-21: Selected Studies of Combined Surgical Approaches for OSA
Exhibit 4-22: ArthroCare’s Coblation Technology
Exhibit 4-23: Surgical Implants for OSA, Products and Suppliers, 2007
Exhibit 4-24: Apneon Prototyope Magnetic Implant
Exhibit 4-25: Aspire Medical’s Advance System
Exhibit 4-26: Restore Medical’s Pillar System
Exhibit 4-27: Selected Studies of the Pillar System for OSA
Exhibit 4-28: U.S. Market for Surgical Implants to Treat OSA, 2005-2011
Exhibit 4-29: U.S. Surgical Implants for OSA, Supplier Shares, 2006
5.0 Company Profiles
5.1 AirSep Corporation
5.2 Covidien Ltd
5.3 DeVilbiss Healthcare
5.4 Fisher & Paykel Healthcare Corporation Ltd
5.5 Flaga Group hf
5.6 Hill-Rom (Hillenbrand Industries, Inc.)
5.7 Invacare Corporation
5.8 Medical Graphics Corporation/Angeion
5.9 nSpire Health, Inc
5.10 Olympus America, Inc
5.11 ResMed, Inc
5.12 Respironics, Inc
5.13 Viasys Healthcare, Inc
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