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ACMI Corporation
American Medical Systems
BioSphere Medical
Boston Scientific Corporation
C.R. Bard
CooperSurgical
Cytyc
GE Healthcare
Johnson & Johnson
Karl Storz Endoscopy
Microsulis
Olympus America
Richard Wolf Medical Instruments
Siemens Medical Solutions
EXECUTIVE SUMMARY
Diagnosis
Drug Therapy
Surgical Interventions
Product Markets
Companies
Summary Exhibit 1: Overview of Major Benign Uterine Pathologies
Summary Exhibit 2: Techniques Used to Diagnose Benign Uterine Conditions
Summary Exhibit 3: Hormonal Pharmacologic Approaches to Management of Benign Uterine Lesions
Summary Exhibit 4: Surgical and Other Interventions for Benign Uterine Lesions
Summary Exhibit 5: Comparison of Global Endometrial Ablation Technologies, 2004
Summary Exhibit 6: Surgical Interventions for Benign Uterine Conditions, Procedure Forecast, 2002-2008
Summary Exhibit 7: Products Used to Manage Benign Uterine Conditions, Market Forecast, 2002-2008
1.0 OVERVIEW OF BENIGN UTERINE CONDITIONS
1.1 Fibroids
1.1.1 Prevalence and Causes
1.1.2 Symptoms and Diagnosis
1.1.3 Treatment
1.2 Polyps
1.2.1 Prevalence
1.2.2 Symptoms
1.2.3 Diagnosis
1.2.4 Treatment
1.3 Endometriosis
1.3.1 Prevalence and Causes
1.3.2 Symptoms, Diagnosis and Staging
1.3.3 Treatment
1.4 Menorrhagia
1.4.1 Prevalence
1.4.2 Causes
1.4.2.1 Hormonal Imbalance
1.4.2.2 Fibroids
1.4.2.3 Coagulation Disorders
1.4.3 Diagnosis
1.4.4 Treatment
1.5 Adenomyosis
1.6 Chronic Pelvic Pain
Exhibit 1-1: Overview of Major Benign Uterine Pathologies
Exhibit 1-2: Types of Uterine Fibroids
Exhibit 1-3: Principal Locations of Endometrial Implants
Exhibit 1-4: Comparison of Endometriosis and Native Endometrium
Exhibit 1-5: Pictures of Endometriosis
Exhibit 1-6: Staging System for Endometriosis
Exhibit 1-7: Types of Abnormal Uterine Bleeding.
Exhibit 1-8: Major Causes of Menorrhagia
Exhibit 1-9: Major Tests Used to Diagnose Menorrhagia
Exhibit 1-10: Current and Emerging Treatments for Menorrhagia, 2004
Exhibit 1-11: Potential Causes of Chronic Pelvic Pain
2.0 DIAGNOSIS OF BENIGN UTERINE LESIONS
2.1 Pelvic Exam
2.2 Pelvic Ultrasound
2.2.1 Indications
2.2.2 Approaches
2.2.3 Equipment
2.2.4 Installations
2.2.5 Market Analysis
2.3 Dilation and Curettage
2.4 Endometrial Biopsy
2.5 Diagnostic Hysteroscopy
2.5.1 Indications
2.5.2 Contraindications
2.5.3 Uterine Distention
Absolute Contraindications:
Relative Contraindications:
2.5.3.1 CO2 Insufflation
2.5.3.2 Fluid Distention
2.5.4 Equipment
2.5.4.1 Hysteroscopes
2.5.4.2 Distention Equipment
2.5.5 Procedures
2.5.6 Market Analysis
2.6 Diagnostic Laparoscopy
2.6.1 Procedure
2.6.2 Complications
2.6.3 Application to Benign Uterine Lesions
2.6.4 Equipment
2.6.4.1 Laparoscopes
2.6.4.1.1 Product Trends
2.6.4.1.2 Suppliers
2.6.4.2 Trocars
2.6.4.2.1 Product Trends
2.6.4.2.2 Suppliers
2.6.4.3 Other Products
2.6.5 Procedure Forecast
2.6.6 Market Analysis
2.6.6.1 Gynecologic Laparoscopes
2.6.6.2 Gynecologic Trocars
2.7 Gynecologic Markers
2.8 Electrohysterography
Exhibit 2-1: Techniques Used to Diagnose Benign Uterine Conditions
Exhibit 2-2: Selected Office-Based Gynecologic Ultrasound Systems, 2004
Exhibit 2-3: Selected Office-Based OB/GYN Ultrasound Systems, 2004
Exhibit 2-4: OB/GYN Office-Based Diagnostic Ultrasound Systems, Market Forecast, 2002-2008
Exhibit 2-5: OB/GYN Office-Based Diagnostic Ultrasound Systems, Supplier Shares, 2003
Exhibit 2-6: Diagnostic Hysteroscopy
Exhibit 2-7: Indications for Diagnostic Hysteroscopy
Exhibit 2-8: Contraindications to Diagnostic Hysteroscopy
Exhibit 2-9: Comparison of Uterine Distention Approaches for Hysteroscopy
Exhibit 2-10: Selected Diagnostic Hysteroscopes, 2004
Exhibit 2-11: Diagnostic Hysteroscopy, Procedure Forecast, 2002-2008
Exhibit 2-12: Diagnostic Laparoscopy
Exhibit 2-13: Trends in Laparoscope Technology, 2004
Exhibit 2-14: Olympus and Fujinon Surgical Videolaparoscopes, 2004
Exhibit 2-15: Radial Dilation Trocar Technology
Exhibit 2-16: Applied Medical Separator Abdominal Access System
Exhibit 2-17: Selected Laparoscopic Trocar Systems, 2004
Exhibit 2-18: Gynecologic Laparoscopy, Procedure Forecast, 2002-2008
Exhibit 2-19: Gynecologic Laparoscopes and Trocars, Market Forecast, 2002-2008
Exhibit 2-20: Gynecologic Laparoscopes, Market Forecast, 2002-2008
Exhibit 2-21: Laparoscopes, Supplier Shares, 2003
Exhibit 2-22: Disposable Gynecologic Trocars, Market Forecast, 2002-2008
Exhibit 2-23: Gynecologic Disposable Laparoscopic Trocars, Supplier Shares, 2003
Exhibit 2-24: Major Markers Used to Diagnose Gynecologic Conditions
3.0 DRUG THERAPY
3.1 Hormonal Drug Treatment Options
3.1.1 Gonadotropin-Releasing Hormone Agents
3.1.1.1 Current Products
3.1.1.2 Pipeline Products
3.1.1.2.1 Balance Pharmaceutical (Libra)
3.1.1.2.2 Mediolanum Farmaceutici Group (Avorelin)
3.1.1.2.3 Nektar/Enzon (Inhaled Leuprolide)
3.1.1.2.4 Neurocrine (NBI-42902)
3.1.1.2.5 Praecis Pharmaceutical (Plenaxis)
3.1.1.2.6 Taketa (Sufugolix)
3.1.1.2.7 Zentaris (Cetrotide)
3.1.2 Progestins/Antiprogestins
3.1.2.1 Endometrion (Schering)
3.1.2.2 Nestorone (Population Council)
3.1.2.3 Intrauterine Levonorgestrel (Berlex, Contrel)
3.1.2.4 Antiprogestins
3.1.3 Contraceptives
3.1.4 Androgenic Agents
3.1.5 Selective Progesterone Receptor Modulator
3.1.5.1 Asoprosnil (TAP, Schering AG)
3.1.5.2 Progenta (Zonagen)
3.1.5.3 CBD-2914 (NICHD)
3.1.6 Selective Estrogen Receptor Modulators
3.1.7 Aromatase Inhibitors
3.1.8 Pirfenidone
3.2 Blood Clotting Therapies
3.2.1 Hormonal Therapies
3.2.2 Desmopressin Acetate (DDAVP)
3.2.3 Blood Factor Replacement Therapy
3.2.4 Tranexamic Acid (TXA)
3.3 Anti-Inflammatory Therapies
3.4 Patient Forecast
3.5 Market Analysis
3.5.1 Oral Contraceptives
3.5.2 Progestins
3.5.3 Androgenic Agents
3.5.4 GnRH Agonists
3.5.5 Other Drug Products
Exhibit 3-1: Hormonal Pharmacologic Approaches to Management of Benign Uterine Lesions
Exhibit 3-2: Summary for Pipeline GnRH Agents, 2004
Exhibit 3-3: Selected Emerging Progestins Targeting Endometriosis, 2004
Exhibit 3-4: Selected Levonorgestrel-Releasing Intrauterine Systems, 2004
Exhibit 3-5: Selective Progesterone Receptor Modulators Under Development, 2004
Exhibit 3-6: Pharmacologic Options for Coagulation-Based Menorrhagia, 2004
Exhibit 3-7: Drug Therapy for Benign Uterine Conditions, Patient Forecast, 2002-2008
Exhibit 3-8: Drug Therapy for Benign Uterine Lesions, Market Forecast, 2002-2008
Exhibit 3-9: Oral Contraceptives Employed for Benign Uterine Conditions, Supplier Shares, 2003
Exhibit 3-10: Progestin Products Used to Treat Benign Uterine Conditions, Supplier Shares, 2003
Exhibit 3-11: GnRH Agonists Used to Treat Benign Uterine Conditions, Supplier Shares, 2003
Exhibit 3-12: Other Drugs Used to Treat Benign Uterine Conditions, Market Forecast, 2002-2008
4.0 SURGICAL AND OTHER INTERVENTIONS
4.1 Techniques
4.1.1 Dilation and Curettage
4.1.2 Hysterectomy
4.1.3 Hysteroscopic Endometrial Ablation
4.1.3.1 Hysteroscopy
4.1.3.2 General Complications
4.1.3.3 Fluid Management
4.1.3.4 Ablation Technologies
4.1.3.5 Surgeons Performing Hysteroscopy
4.1.3.6 Costs
4.1.3.7 Procedures
4.1.4 Global Endometrial Ablation
4.1.4.1 Technique
4.1.4.2 Ablation Approaches
4.1.4.3 Reimbursement
4.1.4.4 Procedure Forecast
4.1.5 Fibroid Removal
4.1.5.1 Myomectomy
4.1.5.1.2 Laparoscopic Myomectomy
4.1.5.1.1 Myomectomy via Laparotomy
4.1.5.1.3 Hysteroscopic Resection
4.1.5.1.4 Laparoscopically-Assisted Myomectomy
4.1.5.2 Myolysis and Cryomyolysis
4.1.5.3 Procedure Forecast
4.1.6 Uterine Artery Embolization
4.1.6.1 Procedure
4.1.6.2 Indications
4.1.6.3 Outcomes and Professional Endorsement
4.1.6.4 Costs and Reimbursement
4.1.6.5 Procedures
4.1.7 High Intensity Focused Ultrasound
4.1.8 Resection of Endometriosis
4.1.8.1. Standard Ablation Approaches
4.1.8.2 Helium Plasma Technology
4.1.8.3 Light-Based Approaches
4.1.8.3.1 Photodynamic Therapy
4.1.8.3.2 Laparoscopic Spectral Analysis
4.2 Products
4.2.1 Uterine Manipulators
4.2.2 Operative Hysteroscopes
4.2.3 Hysteroscopic Insufflators
4.2.4 Fluid Management Systems
4.2.4.1 ACMI Corporation (Dolphin, Disten-U-Flo)
4.2.4.2 Bard Davol (AquaSens)
4.2.4.3 Johnson & Johnson Gynecare (VeriStat)
4.2.4.4 Karl Storz Endoscopy (Equimat)
4.2.4.5 Olympus America (Uteromat)
4.2.4.6 Richard Wolf Medical Instruments (Fluid Manager)4-61
4.2.4.7 World of Medicine (IUR)
4.2.5 Global Endometrial Ablation Systems
4.2.5.1 American Medical Systems/CryoGen
4.2.5.2 Atos Medical
4.2.5.3 Boston Scientific/BEI Medical Systems
4.2.5.4 Cytyc Corporation/Novacept
4.2.5.5 Impres Medical
4.2.5.6 Johnson & Johnson Gynecare
4.2.5.7 Lumenis
4.2.5.8 Microsulis
4.2.5.9 Tyco/U.S. Surgical/InnerDyne/ValleyLab
4.2.5.10 Wallsten Medical
4.2.6 Laparoscopes
4.2.7 Autofluorescence Systems
4.2.8 Embolic Agents
4.2.8.1 PVA Particles
4.2.8.2 Microspheres
4.3 Product Markets
4.3.1 Hysteroscopes
4.3.2 Fluid Management Systems
4.3.3 Disposable Uterine Manipulators
4.3.4 Global Endometrial Ablation Systems
4.3.5 Embolic Agents
Exhibit 4-1: Surgical and Other Interventions for Benign Uterine Conditions
Exhibit 4-2: Interventions for Benign Uterine Conditions, Procedure Forecast, 2002-2008
Exhibit 4-3: Dilation & Curettage, Procedure Forecast, 2002-2008
Exhibit 4-4: Hysterectomy, Procedure Forecast, 2002-2008
Exhibit 4-5: Hysteroscopic Endometrial Ablation Methods
Exhibit 4-6: Cost Comparison of Surgical Endometrial Ablation and Hysterectomy for the Treatment of Menorrhagia
Exhibit 4-7: Operative Hysteroscopy, Procedure Forecast, 2002-2008
Exhibit 4-8: Comparison of Global Endometrial Ablation Modalities
Exhibit 4-9: Global Endometrial Ablation, Procedure Forecast by Type, 2002-2008
Exhibit 4-10: Approaches Used for Uterine Fibroid Removal
Exhibit 4-11: Comparison of Laparoscopic versus Abdominal Myomectomy
Exhibit 4-12: Uterine Artery Embolization
Exhibit 4-13: Uterine Artery Embolization versus Myomectomy—2 Studies
Exhibit 4-14: Advantages & Limitations of Photodynamic Therapy for Endometriosis
Exhibit 4-15: Comparison of Uterine Manipulators
Exhibit 4-16: Application of Uterine Manipulator
Exhibit 4-17: Selected Disposable Uterine Manipulators, 2004
Exhibit 4-18: Selected Reusable and Disposable Uterine Manipulators, 2004
Exhibit 4-19: Selected Operative Hysteroscopes, 2004
Exhibit 4-20: Selected Hysteroscopic Fluid Management Systems, 2004
Exhibit 4-21: Hysteroscopic Fluid Monitoring Systems, 2004
Exhibit 4-22: Selected Global Endometrial Ablation Technologies, 2004
Exhibit 4-23: American Medical Systems' Her Option System
Exhibit 4-24: Atos Medical MenoTreat System
Exhibit 4-25: Application of Boston Scientific HTA System
Exhibit 4-26: Cytyc Corporation NovaSyre System
Exhibit 4-27: Comparison of NovaSure and Cavaterm Outcomes at 12 Months
Exhibit 4-28: Johnson & Johnson Gynecare ThermaChoice III System
Exhibit 4-29: Microsulis MEA System
Exhibit 4-30: Wallsten Medical Cavaterm System
Exhibit 4-31: Selected Embolic Agents Employed for Uterine Artery Embolization
Exhibit 4-32: Products Used to Treat Benign Uterine Conditions, Market Forecast, 2002-2008
Exhibit 4-33: Hysteroscopes by Type, Market Forecast, 2002-2008
Exhibit 4-34: Hysteroscopes, Supplier Shares, 2003
Exhibit 4-35: Hysteroscopic Fluid Management Systems, Market Forecast, 2002-2008
Exhibit 4-36: Hysteroscopic Fluid Management Systems, Supplier Shares, 2003
Exhibit 4-37: Disposable Uterine Manipulators, Market Forecast, 2002-2008
Exhibit 4-38: Disposable Uterine Manipulators, Supplier Shares, 2003
Exhibit 4-39: Global Endometrial Ablation Systems, Market Forecast, 2002-2008
Exhibit 4-40: Global Endometrial Ablation Consumables, Market Forecast by Technology, 2002-2008
Exhibit 4-41: Global Endometrial Ablation Systems, Supplier Shares, 2002 & 2003
Exhibit 4-42: UAE Embolic Agents, Market Forecast, 2002-2008
Exhibit 4-43: UAE Embolic Agents, Supplier Shares, 2003
5.0 COMPANY PROFILES
5.1 ACMI Corporation
5.2 American Medical Systems
5.3 C.R. Bard
5.4 BioSphere Medical
5.5 Boston Scientific Corporation
5.6 CooperSurgical
5.7 Cytyc
5.8 GE Healthcare
5.9 Johnson & Johnson
5.10 Microsulis
5.11 Olympus America
5.12 Siemens Medical Solutions
5.13 Karl Storz Endoscopy
5.14 Richard Wolf Medical Instruments