U.S. Opportunities in Prostate Disease Management

Published December 2003 | 479 Pages | 123 Exhibits | Forecasts Through 2008


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Companies Covered

Abbott Laboratories 

ACMI Corporation

American Medical Systems 

AstraZeneca plc 

Beckman Coulter (Hybritech)

B-K Medical Corporation 

C.R. Bard 

EDAP Technomed 


Focus Surgery 

Gyrus Medical

Laborie Medical Technologies 




Mentor Corporation 

Oakwood Laboratories

Oncura (Amersham Health, Galil Medical)

Praecis Pharmaceuticals


TAP Pharmaceuticals



Varian Medical Systems

Table of Contents




Benign Prostatic Hyperplasia

Prostate Cancer 



Summary Exhibit 1: Prostate Diseases, Patient Forecasts, 2001-2008

Summary Exhibit 2: Prostate Diagnosis, Procedure & Market Forecast, 2001-2008 

Summary Exhibit 3: Patients Treated for BPH by Modality, 2001-2008

Summary Exhibit 4: Prostate Cancer Treatments, Patient Forecast, 2001-2008

Summary Exhibit 5: Prostate Cancer Products, Market Forecast, 2001-2008 



1.1 Overview of Prostate Anatomy, Function and Disorders

1.2 Prostatitis 

1.2.1 Types

1.2.2 Incidence and Prevalence

1.2.3 Symptoms 

1.2.4 Theories of Etilogy Bacterial Causes Quinolone-Resistance of E.coli Role of Chlamydial Infections Role of Biofilms Neuromuscular Dysfunction of Pelvic Floor Muscles Expression of Nerve Growth Factor Pudendal Nerve Entrapment Voiding Dysfunction Bladder Neck Hyperplasia Urine Reflux into Prostatic Ducts Autoimmune Other Potential Causes

1.2.5 Diagnosis 

1.2.6 Treatment 

1.3 Benign Prostatic Hyperplasia

1.3.1 Causes 

1.3.2 Symptoms 

1.3.3 Diagnosis 

1.3.4 Treatment 

1.3.5 Prevalence 

1.4 Prostate Cancer 

1.4.1 Symptoms 

1.4.2 Incidence and Deaths 

1.4.3 Etiology

1.4.4 Prevention 

1.4.5 Diagnosis 

1.4.6 Treatment 


Exhibit 1-1: The Male Prostate 

Exhibit 1-2: Comparison of Major Prostate Diseases 

Exhibit 1-3: NIH Classification System for Prostatitis Syndromes 

Exhibit 1-4: NIH Chronic Prostatitis Symptom Index

Exhibit 1-5: Selected Theories of Etiology of Chronic Prostatitis and CPPS

Exhibit 1-6: Biofilm Theory of Chronic Prostatitis 

Exhibit 1-7: Potential Neuromuscular Causes of Chronic Prostatitis 

Exhibit 1-8: Potential Voiding Dysfunction Causing Chronic Prostatitis 

Exhibit 1-9: Prostate Cancer Incidence and Deaths, 2000-2003

Exhibit 1-10: Prostate Cancer Relative Survival Rates, 2003 

Exhibit 1-11: Prostate Cancer Risk Factors 



2.1 Diagnostic Guidelines and Protocols 

2.1.1 Prostate Disease Patient Outcomes Research Team 

2.1.2 Prostate, Lung Colorectal and Ovarian Trial 

2.1.3 American Urological Association Guidelines 

2.1.4 National Institutes of Health 

2.2 Protocols by Condition 

2.2.1 Prostate Cancer Screening and Diagnosis Cancer Grading Cancer Staging Partin Tables DNA Test for Prostate Cancer 

2.2.2. Benign Prostatic Hyperplasia

2.2.3 Prostatitis 

2.3 Prostate Disease Diagnostic Tools

2.3.1 Patient History 

2.3.2 Digital Rectal Exam

2.3.3 Urinanalysis or Culture 

2.3.4 PSA Tests PSA Values and Refinements Free PSA Test Complexed PSA Test RT-PCR Assays Suppliers of PSA Test Equipment and Assays Clinical Laboratory Testing Point-of-Care Segment PSA Tests Performed PSA Test Market Analysis

2.3.5 Diagnostic Ultrasound Technique Equipment and Suppliers Installations and Procedures Diagnostic Ultrasound Market Analysis

2.3.6 Urodynamic Studies Equipment and Suppliers Reimbursement Installations & Specialists Performing Procedures Procedures Market Analysis 

2.3.7 Prostate Biopsy Potential for Cancer Seeding Products and Suppliers Procedures Market Analysis 

2.3.8 Staging Studies Imaging Studies Pelvic Lymph Node Dissection 

2.3.9 Emerging and Investigational Diagnostic Modalities Differentiation of Prostate Cancer from BPH Kallikrein Enzyme Prostatic Intraepithelial Neoplasia Prostate Cancer Oncogene Photodynamic Laser Blood Analysis Improved Staging and Characterization of Prostate Cancer Prostascint 12-Lipoxygenase Prostate Cancer Staging Oncogenes DNA Ploidy Analysis Chromosome 8p22 Deletion Optical Molecular Imaging SELDI Protein Profiling Other Biomarker Technologies


Exhibit 2-1: Sample Questions from the AUA BPH Symptom Index

Exhibit 2-2: Screening and Diagnosis of Prostate Cancer 

Exhibit 2-3: Comparison of Recommendations for Prostate Cancer Screening 

Exhibit 2-4: Prostate Cancer Staging 

Exhibit 2-5: Whitmore-Jewett versus TNM Prostate Cancer Staging Systems

Exhibit 2-6: Illustrations of Prostate Cancer Stages 

Exhibit 2-7: Partin Tables 

Exhibit 2-8: Diagnostic and Screening Tools for Prostate Disease 

Exhibit 2-9: Factors Potentially Affecting PSA Levels 

Exhibit 2-10: Types and Characteristics of Serum PSA

Exhibit 2-11: Probability of Cancer: Total PSA versus Free PSA Testing 

Exhibit 2-12: Current and Emerging PSA Tests, 2003

Exhibit 2-13: PSA Testing, Forecast by Application, 2001-2008 

Exhibit 2-14: PSA Test Products, Market Forecast by Segment, 2001-2008

Exhibit 2-15: PSA Tests, Supplier Shares, 2002 

Exhibit 2-16: Selected Diagnostic Ultrasound Urology Scanners, 2003

Exhibit 2-17: TRUS, Installed Base and Procedure Forecast, 2001-2008

Exhibit 2-18: Portable TRUS Scanners, Market Forecast, 2001-2008

Exhibit 2-19: Transrectal Ultrasound Scanners, Supplier Shares, 2002

Exhibit 2-20: Overview of Major Urodynamic Studies

Exhibit 2-21: Selected Urodynamic Systems, 2003 

Exhibit 2-22: Medicare Reimbursement for Urodynamic Studies, 2003 

Exhibit 2-23: Urodynamic Studies, Procedure Forecast, 2001-2008 

Exhibit 2-24: Urodynamic Products by Major Category, Market Forecast, 2001-2008 

Exhibit 2-25: Urodynamic Systems and Consumables, Supplier Shares, 2002 

Exhibit 2-26: Selected Prostate Biopsy Systems, 2003 

Exhibit 2-27: Prostate Biopsies, Procedure Forecast, 2001-2008

Exhibit 2-28: Prostate Biopsy Products, Market Forecast, 2001-2008

Exhibit 2-29: Prostate Biopsy Products, Supplier Shares, 2002

Exhibit 2-30: Selected Prostate Cancer Diagnostic Technologies in Development, 2003 

Exhibit 2-31: High Grade Prostatic Intraepithelial Neoplasia (PIN) 

Exhibit 2-32: Selected Programs Targeting Improved Staging and Characterization of Prostate Cancer 



3.1 Treatment Challenges 

3.2 Treatment Options 

3.2.1 Drug Therapy Antibiotic Therapy Fluoroquinolones Trimethoprim/Sulfamethoxazole Doxycycline Nitrofurantoin Narcotic Drugs Analgesic and Anti-Inflammatory Agents Alpha Blockers Intraprostatic Delivery 

3.2.2 Other Medical Therapy

3.2.3 Surgical Therapy

3.2.4 Hyperthermia Therapies Microwave Therapy Transrectal Hyperthermia TUMT Radiofrequency Ablation Interstitial Laser Coagulation Water-Induced Thermotherapy

3.2.5 Neuromuscular Therapies Neurotransmitter Blocker Therapy Sacral Nerve Stimulation 

3.2.6 Pelvic Floor Physical Therapy 

3.3 Potential Patient Caseload 

3.4 Product Opportunities 


Exhibit 3-1: Prostatitis Treatment Issues and Implications

Exhibit 3-2: Current and Emerging Treatment Options for Prostatitis, 2003 

Exhibit 3-3: Studies of Microwave Thermal Therapy in the Treatment of Chronic Nonbacterial Prostatitis

Exhibit 3-4: Sacral Nerves and Contiguous Structures

Exhibit 3-5: Potential Candidates for New Prostatitis Therapies, 2001-2008 



4.1 Overview of Treatment Protocols

4.1.1 Factors Influencing Treatment Choice

4.1.2 General Trend in BPH Treatment 

4.2 Watchful Waiting

4.3 Drug Therapy

4.3.1 5-Alpha-Reductase Inhibitors Merck (Proscar) Glaxo SmithKline (Avodart) 

4.3.2 Alpha Blockers Abbott Laboratories (Hytrin) Boehringer-Ingelheim/Abott Laboratories (Flomax) Pfizer (Cardura) Sanofi-Synthelabo (Uroxatral) Synaptic Pharmaceutical

4.3.3 Plant-Based Derivatives (Phytotherapy)

4.3.4 Clinical Comparison of Drug Options 

4.3.5 Patient Forecast

4.3.6 Market Analysis 

4.4 Balloon Dilatation

4.5 Surgical Interventions (Prostatectomy)

4.5.1 Transurethral Resection of the Prostate Products Traditional Devices Bipolar Products Reimbursement Procedures Market Analysis 

4.5.2 Transurethral Incision of the Prostate Equipment Reimbursement and Procedures

4.5.3 Electrosurgical Vaporization of the Prostate Benefits and Limitations Equipment and Supplies Procedures Market Analysis 

4.5.4 Laser-Assisted Prostatectomy Visual Laser-Assisted Prostatectomy (VLAP) Holmium Laser Resection of the Prostate (HoLRP) Clinical Experience Potential Drawbacks Procedures Photoselective Vaporization of Prostate (PVP) Development History Clinical Experience Benefits and Limitations Reimbursement Settings Long-Term Outcomes Product Requirements/Installations Procedures Market Analysis 

4.6 Minimally Invasive Treatments 

4.6.1 Transurethral Microwave Thermotherapy (TUMT) Benefits and Challenges Clinical Experience Products and Suppliers Urologix TherMatrx ProstaLund/ACMI Celsion Corp/Boston Scientific Reimbursement Procedures Market Analysis 

4.6.2 Transurethral Needle Ablation (TUNA) Reimbursement Procedures Market Analysis 

4.6.3 Interstitial Laser Coagulation (ILC) Advantages and Limitations Procedures Market Analysis 

4.6.4 Water-Induced Thermotherapy (WIT) Clinical Experience Products and Suppliers Procedures and Market Analysis 

4.6.5 High-Intensity Focused Ultrasound Technique Advantages and Limitations Products and Suppliers Procedures and Market Analysis 

4.6.6 Chemical Ablation Technique Advantages and Limitations Clinical Experience Products and Suppliers Procedure and Market 

4.6.7 Transurethral Volume Reduction of Prostate (TUVOR) 

4.6.8 Prostatic Stents Clinical Outcomes Products and Suppliers AbbeyMoor Medical Allium American Medical Systems Bionx Implants Boston Scientific ContiCare Medical Endocare Engineers & Doctors Global Precision Medical Harmonia Medical Technologies InjecTx Mentor Urology Patients and Procedures Market Analysis 


Exhibit 4-1: Benigh Prostatic Hyperplasia, Patient Forecast, 2001-2008

Exhibit 4-2: Overview of Treatment Options for Benign Prostatic Hyperplasia, 2002

Exhibit 4-3: Characteristics of Major Treatments for Benign Prostatic Hyperplasia 

Exhibit 4-4: Comparison of Selected BPH Drugs, 2003 

Exhibit 4-5: Summary of MTOPS Study Findings

Exhibit 4-6: BPH Drug Therapy, Patient Forecast by Category, 2001-2008

Exhibit 4-7: BPH Drugs, Market Forecast by Type, 2001-2008 

Exhibit 4-8: BPH Drugs, Supplier Shares, 2002

Exhibit 4-9: Transurethral Prostatectomy Techniques, 2003

Exhibit 4-10: Surgical Interventions for BPH, Procedure Forecast by Type, 2001-2008 

Exhibit 4-11: TURP Cutting Loops, Market Forecast, 2001-2008

Exhibit 4-12: TURP Cutting Loops, Supplier Shares, 2002

Exhibit 4-13: Electrovaporization of Prostate Disposables, Market Forecast, 2001-2008 

Exhibit 4-14: Roller Ball Devices, Supplier Shares, 2002

Exhibit 4-15: Advantages of Holmium Laser Resection of the Prostate 

Exhibit 4-16: Summary of Published Results of HoLRP, 2003 

Exhibit 4-17: Selected Holmium Lasers Used in Urologic Applications, 2003 

Exhibit 4-18: Comparison of GreenLight PVP versus Minimally Invasive Therapies 

Exhibit 4-19: BPH Laser Systems and Fibers, Market Forecast, 2001-2008 

Exhibit 4-20: BPH Laser Products, Supplier Shares, 2002 

Exhibit 4-21 Current and Emerging Minimally Invasive Treatment Options for BPH

Exhibit 4-22: Minimally Invasive BPH Treatments, Procedure Forecast, 2001-2008 

Exhibit 4-23: Selected Transurethral Microwave Thermotherapy Systems, 2003 

Exhibit 4-24: Benefits of Targis System Express Protocol 

Exhibit 4-25: Transurethral Microwave Thermal Therapy, Market Forecast, 2001-2008 

Exhibit 4-26: Transurethral Microwave Thermal Therapy, Supplier Shares, 2002 

Exhibit 4-27: Summary of Worldwide Results for TUNA Procedure

Exhibit 4-28: Transurethral Needle Ablation, Market Forecast, 2001-2008 

Exhibit 4-29: Interstitial Laser Coagulation, Market Forecast, 2001-2008 

Exhibit 4-30: Water-Induced Thermal Therapy, Market Forecast, 2001-2008 

Exhibit 4-31: High Intensity Focused Ultrasound, Market Forecast, 2001-2008

Exhibit 4-32: Advantages and Limitations of Ethanol Alcohol Ablation of Prostate 

Exhibit 4-33: Ethanol Ablation of the Prostate, Market Forecast, 2001-2008 

Exhibit 4-34: Efficacy of Prostatic Stents

Exhibit 4-35: Current and Emerging Prostatic Urethral Stents, 2003 

Exhibit 4-36: Selected Current and Emerging Prostatic Urethral Stents, 2003

Exhibit 4-37: Potential Obstacles to Broad Adoption of Prostatic Urethral Stents 

Exhibit 4-38: Prostatic Urethral Stents, Procedure & Market Forecast, 2001-2008



5.1 Therapeutic Options

5.2 Watchful Waiting

5.3 Radical Prostatectomy 

5.3.1 Techniques Open Radical Prostatectomy Laparoscopic Radical Prostatectomy Experience Base Learning Curve & Conversion Rate Complications & Techniques Recent Clinical Outcomes Equipment and Products Procedure Costs Selected Observations on Procedure

5.3.2 Procedures

5.4 External Beam Radiation Therapy

5.4.1 Equipment 

5.4.2 Techniques Conventional External Beam Radiation Therapy Three-Dimensional Conformal EBRT Intensity Modulated Radiation Therapy Other Modalities Fractionated Stereotactic Body Radiosurgery Proton Beam Therapy 

5.4.3 Reimbursement 

5.4.4 Procedures

5.5 Brachytherapy

5.5.1 Clinical and Product Developments

5.5.2 Techniques Permanent Implantation Brachytherapy Temporary Implantation Brachytherapy Treatment Protocol Advantages and Limitations Equipment 

5.5.3 Radiation Sources Iodine-125 Palladium-103 Iridium-192 Bioabsorbable Radioactive Implants 

5.5.4 Reimbursement 

5.5.5 Procedures

5.5.6 Market Analysis 

5.6 Cryosurgical Ablation

5.6.1 Technique

5.6.2 Complications 

5.6.3 Advantages and Limitations

5.6.4 Indications and Outcomes

5.6.5 Procedure Cost and Reimbursement

5.6.6 Products Endocare Galil Medical/Oncura

5.6.7 Procedures

5.6.8 Market Analysis 

5.7 High Intensity Focused Ultrasound (HIFU) 

5.7.1 Focus Surgery 

5.7.2 EDAP Technomed 

5.7.3 Clinical Experience

5.7.4 Procedures

5.7.5 Market Analysis 

5.8 Photodynamic Therapy 

5.8.1 Technique

5.8.2 Advantages and Limitations 

5.8.3 Clinical Experience in Prostate Cancer

5.8.4 Products and Programs 

5.8.5 Procedures

5.9 Chemotherapy 

5.10 Prophylaxis 

5.10.1 5-Alpha Reductase Inhibitors 

5.10.2 Other Programs 

5.11 Hormone Therapy 

5.11.1 LHRH-A's

5.11.2 Antiandrogens

5.11.3 Other Products 

5.11.4 Developments Praecis Pharmaceuticals Epic Therapeutics Valera Pharmaceuticals Oakwood Laboratories

5.11.5 Market Forecast 

5.12 Emerging Biologic and Other Approaches 

5.12.1 Abbott Laboratories 

5.12.2 Aronex Pharmaceuticals 

5.12.3 Cell Genesys, Inc. 

5.12.4 Cell Pathways/OSI Pharmaceuticals

5.12.5 Dendreon Corporation 

5.12.6 Genentech 

5.12.7 Genta Incorporated

5.12.8 Genistein 

5.12.9 GlycoGenesys 

5.12.10 Introgen Therapeutics 

5.12.11 Medarex 

5.12.12 MGI Pharma

5.12.13 Millenium Pharmaceuticals 

5.12.14 Northwest Biopharmaceuticals 

5.12.15 OncoGenex Technologies

5.12.16 Pharmacia & Upjohn (Sugen)

5.12.17 Sidney Kimmel Comprehensive Cancer Center 

5.12.18 Therion Biologics Corporation 


Exhibit 5-1: Overview of Treatment Options for Prostate Cancer, 2003 

Exhibit 5-2: Comparison of Established Prostate Cancer Treatment Options

Exhibit 5-3: Early Clinical Outcomes of Laparoscopic Radical Prostatectomy 

Exhibit 5-4: Complications Associated with Laparoscopic Radical Prostatectomy

Exhibit 5-5: Cost of Devices Used to Perform Laparoscopic Radical Prostatectomy

Exhibit 5-6: Costs of Open vs Laparoscopic Radical Prostatectomy in France 

Exhibit 5-7: Radical Prostatectomy, Procedure Forecast by Type, 2001-2008 

Exhibit 5-8: Comparison of External Beam Radiation Therapy Modalities, 2003

Exhibit 5-9: External Beam Radiation Therapy, Patient Forecasts, 2001-2008 

Exhibit 5-10: Comparison of Permanent and Temporary Implantation Brachytherapy

Exhibit 5-11: Major Radioisotopes Used for Prostate Brachytherapy

Exhibit 5-12: Suppliers of Prostate Brachytherapy Seeds, 2003 

Exhibit 5-13: Overview of Prostate Brachytherapy Reimbursement 

Exhibit 5-14: Prostate Brachytherapy, Patient Forecasts by Type, 2001-2008 

Exhibit 5-15: Prostate Brachytherapy Products, Market Forecast, 2001-2008 

Exhibit 5-16: Permanent Prostate Brachytherapy, Market Forecast, 2001-2008 

Exhibit 5-17: Temp Prostate Brachytherapy Products, Market Forecast, 2001-2008 

Exhibit 5-18: Prostate Brachytherapy Seeds, Supplier Shares, 2002 

Exhibit 5-19: Overview of Cryosurgical Ablation of the Prostate 

Exhibit 5-20: Cryosurgical Systems Targeting Prostate Cancer

Exhibit 5-21: Cryosurgical Ablation of Prostate, Procedure Forecast, 2001-2008 

Exhibit 5-22: Prostate Cryotherapy Disposables, Market Forecast, 2001-2008

Exhibit 5-23: Prostate Cryotherapy Disposables, Supplier Shares, 2002

Exhibit 5-24: Prostate High Intensity Focused Ultrasound Systems, 2003 

Exhibit 5-25: Prostate Cancer HIFU, Procedure Forecast, 2004-2008

Exhibit 5-26 Prostate Cancer HIFU, Market Forecast, 2001-2008 

Exhibit 5-27 : Clinical Trials of PDT for the Treatment of Prostate Cancer

Exhibit 5-28: Overview of Photosensitizer R&D Targeting Prostate Cancer 

Exhibit 5-29: Prostate Cancer Hormone Therapy, Market Forecast, 2001-2008 

Exhibit 5-30: Prostate Hormonal Therapy, Supplier Shares, 2002

Exhibit 5-31: Approaches to Cancer Gene Therapy 

Exhibit 5-32: Emerging Prostate Cancer Biological Treatment Options



6.1 Abbott Laboratories 

6.2 ACMI Corporation

6.3 American Medical Systems 

6.4 AstraZeneca plc 

6.5 C.R. Bard 

6.6 Beckman Coulter (Hybritech)

6.7 B-K Medical Corporation 

6.8 EDAP Technomed 

6.9 Endocare 

6.10 Focus Surgery 

6.11 Gyrus Medical

6.12 Laborie Medical Technologies 

6.13 Laserscope

6.14 Life-Tech

6.15 Medtronic

6.16 Mentor Corporation 

6.17 Oakwood Laboratories

6.18 Oncura (Amersham Health, Galil Medical)

6.19 Praecis Pharmaceuticals

6.20 ProstaLund 

6.21 TAP Pharmaceuticals

6.22 Theragenics

6.23 Urologix 

6.24 Varian Medical Systems 



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