U.S. Opportunities in the Management of Benign Uterine Conditions

Companies Covered

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

Table of Contents

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