The US urological device market will experience moderate growth over the
forecast period, largely fueled by the aging population in the US, which will
promote a greater need for the devices covered in this report. The market for
urinary incontinence (UI) devices generated the largest revenues in 2011 and
is characterized by its large amount of competitors (many of which are
multinational firms) and the presence of competing alternatives. Reimbursement
changes that took effect in 2008 will continue to fuel unit growth in the
intermittent catheter segment of the UI device market. The adoption of new
devices that are less invasive and/or offer superior efficacy will promote
growth in all device segments over the forecast period. Physicians and
patients prefer minimally invasive procedures because of the fast recovery
times, shorter hospital stays, and reduced pain associated with these
procedures. Despite competition from pharmaceuticals that treat conditions
such as UI, kidney stones, benign prostatic hyperplasia (BPH), and erectile
dysfunction, the US urological device market will experience moderate growth
through 2016.
METHODOLOGY
RESEARCH METHODOLOGY
This report uses a number of methodologies to gather and present data and
analysis. At the outset, a large survey of secondary sources is conducted.
These sources act as the basis for the primary research stage, which builds
and enhances the quantitative and qualitative attributes of the early research.
Secondary sources include
Government sources:
Securities and Exchange Commission filings
Food and Drug Administration and patent filings
National Center for Health Statistics data
Urological device companies:
Annual reports, product brochures, corporate profiles, etc.
Internal databases and reports:
Previous reports on similar/related sources
General Internet searches, medical literature, and newspaper/magazine
searches:
Identifying various centers of specialization and articles that might
provide leads for primary research
The secondary research stage builds the foundation for the primary research.
The primary research methodology has four steps:
Step 1: The first step involves an impartial scan of all the
information gathered during the secondary research stage to determine its
utility based on the specific requirements of this report. Each piece of
information is either discarded or marked as high- or low-priority and then
organized appropriately as determined by the structure and sectioning of the
report.
Step 2: At this stage, early assumptions are formed as to the
implications of the information for the various urological device market
segments. These assumptions are then used to determine hypotheses using both
inductive and deductive approaches. On the quantitative front, these
hypotheses result in full historical and projected market data sets (market
sizes - unit sales, average selling prices [ASPs], and revenues - as well as
market shares).
Step 3: At this stage, the research is in position for its most
important primary phase - expert interviews. Throughout the secondary research
phase, industry and medical experts are identified.
These experts are then contacted by telephone and asked to participate in
interviews on recent trends and developments in the industry. Interviews are
either conducted at the time of the initial call or scheduled at the
convenience of the expert. Interview questions are tailored to the expertise
of each particular interviewee, although in most cases, the most important
questions are asked of all experts.
The questions are largely based on the assumptions and hypotheses developed in
Step 2, which are then augmented, discarded, or adjusted based on the views
and positions put forth. Attempts are made, whenever possible, to cross-check
the views of various experts against each other and to reach positions of
consensus on issues and market numbers.
Step 4: The final stage of primary research involves individual and
group analysis by Millennium Research Group. All research results are assessed
and cross-checked thoroughly to determine their validity, relevance, and
weight. From this process, qualitative conclusions are reached and data points
finalized.
MARKETRACK METHODOLOGY
Millennium Research Group's Marketrack methodology involves recruiting
hospital personnel responsible for the management of urological devices and
procedures to participate by providing procedure volumes, device usage data,
and brand-level pricing information on an ongoing basis. Hospital respondents
include facility managers, nurses, administrators, and physicians.
FORECAST METHODOLOGY
In addition to the research methodology outlined above, the following
“bottom-up” methodology is used to develop forecast assumptions
for the report.
A comprehensive breakdown of various urological device procedures and unit
sales is prepared using data from several sources, including professional
associations, government statistics, and private research/media sources.
Industry experts and practitioners are consulted to ensure accuracy and verify
observed trends. As a cross-check, total industry revenues available through
annual reports and other sources are compared against modeled industry
revenues.
Using the best estimates of industry experts, practitioners, private
research/media sources, and inhouse experts, year-by-year growth rates and
ASPs are applied individually to each subcategory to derive forecasts. These
estimates are cross-checked by industry experts (marketing managers, product
managers, CEOs, etc.) and further refined.
Overall findings are compared against market and procedure forecasts published
by other sources to ensure reasonable estimates.
Companies mentioned in this report:
AbbeyMoor Medical
AllMed Systems
AMS (acquired by Endo Pharmaceuticals)
Amsino
Applied Medical
Astra Tech
Best Medical
Biocompatibles
BioDerm
Boston Scientific
Caldera Medical
Cardinal Health
CL Medical
Coloplast
Convergent Laser Technologies
Cook Urological
Core Oncology
Covidien
C. R. Bard
DirexGroup
Dornier MedTech
DraxImage
Eckert & Ziegler BEBIG
EDAP TMS
ETHICON
FMD
Fossa Medical
Galil Medical
HealthTronics
Hollister
IsoAid
IsoRay
KARL STORZ
Kitalpha Med
Laser Peripherals
LISA laser products
Lumenis
Medispec
Medline Industries
Medtronic
Mpathy Medical
Neomedic International
New Star Lasers
NORTECH
Nucletron
Olympus/Gyrus-ACMI
Oncura
PENTAX Medical
PercSys
Promedon
ProSurg
Quanta Systems
Richard Wolf
Rochester Medical
RUSCH (a Teleflex Medical company)
Siemens Healthcare
Theragenics
Trimedyne
UROCARE Products
Urologix
Uroplasty
Table of Contents
Table of Contents
TABLE OF CONTENTS
LIST OF FIGURES AND TABLES
EXECUTIVE SUMMARY
1.0 CLINICAL LANDSCAPE
1.1. Background
1.1.1. Urinary Incontinence
1.1.2. Urinary Stones
1.1.3. Prostate Cancer
1.1.4. Benign Prostatic Hyperplasia
1.1.5. Erectile Dysfunction
1.2. Diagnosis and Referral Patterns
1.2.1. Urinary Incontinence
1.2.2. Urinary Stones
1.2.3. Prostate Cancer
1.2.4. Benign Prostatic Hyperplasia
1.2.5. Erectile Dysfunction
1.3. Procedure Overview
1.3.1. Urological Device Procedures
1.3.1.1. Urinary Incontinence Treatments
1.3.1.2. Stone Management Procedures
1.3.1.3. Prostate Cancer Treatments
1.3.1.4. Benign Prostatic Hyperplasia Treatments
1.3.1.5. Erectile Dysfunction Treatments
1.3.2. Competing Treatments
1.3.2.1. Urinary Incontinence
1.3.2.2. Urinary Stones
1.3.2.3. Prostate Cancer
1.3.2.4. Benign Prostatic Hyperplasia
1.3.2.5. Erectile Dysfunction
1.4. Clinical Guidelines
1.5. Country Overview
1.5.1. Demographics and Economy
1.5.2. Health Care System
1.5.3. Regulatory Environment
2.0 PRODUCTS
2.1. Overview
2.1.1. Products Covered
2.2. Urinary Incontinence Devices
2.2.1. Functions
2.2.1.1. Urinary Catheters
Intermittent Catheters
Male External Catheters
Foley Catheters
2.2.1.2. Urine Drainage Bags
2.2.1.3. Vaginal Slings
By Material Group
Commercial Vaginal Slings
Autologous Vaginal Slings
By Technique
Midurethral Vaginal Slings
Bladder-Neck (Traditional) Vaginal Slings
2.2.1.4. Artificial Urinary Sphincter
2.2.1.5. Male Slings
2.2.1.6. Urethral Bulking Agents
2.2.2. Differentiating Features
2.2.3. Emerging Products
2.2.3.1. Electrical Stimulation and Magnetic Innervation Devices