The US heart valve device market will experience substantial growth from 2011
to 2016, driven primarily by the growth of transcatheter heart valve (THV)
devices, particularly transcatheter aortic valve replacement (TAVR) devices,
which will be rapidly adopted to treat patients who would previously not have
been eligible for or able to undergo surgical heart valve procedures. In
addition, THV devices are priced at a premium compared to conventional heart
valve devices and will therefore spur average selling price (ASP) and will
drive revenue growth. The growth of tissue heart valve and annuloplasty
procedures faces competition from THV devices, which will increasingly
subtract from them as the use of THV devices becomes more widespread.
Mechanical heart valve implantations will decline as a result of greater
competition from not only THV devices but also annuloplasty devices and
increasingly durable tissue heart valves. Cost reduction pressures on health
care facilities following the economic recession will push market players to
increasingly compete on price, reducing ASPs. As a whole, the US heart valve
device market will grow robustly over the forecast period.
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 publications, such as documentation from securities
commissions, health care and statistical agencies, and regulatory and patent
authorities;
material provided by medical technology companies, including annual
reports, product brochures, and corporate profiles;
internal databases and reports, including previous reports on similar or
related topics; and
general Internet searches, medical literature, and newspaper and magazine
searches to identify 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 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,
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.
In some cases, a sample of relevant physicians is surveyed or interviewed.
Physicians are asked to comment on various issues and trends, both in their
own practice and in the overall market. The responses provided are then used
to strengthen or augment the assumptions and hypotheses developed during the
primary research phase.
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 medical equipment 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. Information
is generally collected on a quarterly basis and includes, but is not limited
to, numbers and types of procedures performed and devices used.
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 procedures and device 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, company executives, etc.) and further refined.
Overall findings are compared against market and procedure forecasts published
by other sources to ensure reasonable estimates.
