Abstract
Introduction
Using Target Product Profiles in Your Market Strategy
Our Target Product Profiles qualitatively predict the market potential of a
drug fulfilling a key unmet need. This information is critical for evaluating
the impact of clinical attributes on physician prescribing of emerging agents,
whether the emerging drug is your own or a competitor' s. Examples of how to
use the information you will find in this report are highlighted below:
- For companies who are developing a drug with some of the characteristics
we are testing, our survey results reveal the standards that surveyed
physicians expect the remainder of the drug' s clinical profile to meet. Our
analysis begins to uncover physician-expected drug attributes as well as
acceptable trade-offs in emerging therapies. Our primary research with
practicing physicians includes this emerging therapy' s anticipated patient
share, projected use by line of therapy, and forecasted sales.
- For companies that already have a drug launched for the indication in
question, our data and analysis show the impact an emerging drug would have on
their brand' s market. Not only does our research reveal which existing brands
would be replaced by a drug meeting the Target Product Profile, but it also
clearly outlines whether any drugs in the pipeline will meet the criteria laid
out by physicians to challenge the existing sales leader. This knowledge gives
existing brands the information they need to protect their share, either
through new clinical trials aimed at end points physicians say are critical
differentiators or by aggressive marketing of brand attributes that emerging
agents will not be able to beat.
- For companies looking to enter a disease through licensing or acquisition,
the challenge of sifting through tens or hundreds of early-stage candidates
can be daunting. Our Target Product Profiles can quickly show business
development teams the clinical attributes that are unique versus products
already on the market, and our primary research with physicians quickly
identifies likely share and market potential to give a first glimpse at
valuation. Because all of our Target Product Profiles are designed to be
attainable within the next decade, our research can be a fast and efficient
way to whittle the field of potential licensing candidates down to the most
valuable few.
Report Contents
The Target Product Profile reports are divided into two sections. The first
section, “Etiology and Pathophysiology,” offers a high-level view
of the genetic and environmental causes of the disease under study, as well as
the subsequent symptoms and clinical effects that result. This section is
intended to give the reader a clear view of the physical and biochemical
pathways that are known, or suspected, to be causative to disease onset or
progression. These pathways, therefore, are common targets for drug therapy;
where possible, we identify the molecular targets against which current or
emerging drugs act.
The second section, “Target Product Profile Summary,” begins with
an overview of the drug development landscape and the attributes on which
investigators are focusing. Based on this analysis, as well as the clinical
end points that practicing physicians say are most influential in their
prescribing decision, our analysts define a key unmet need that could be
addressed within the next ten years. Our Target Product Profiles are a set of
quantified performance measures against key clinical end points and attributes
that physicians build themselves. Our analysis of physician-desired attributes
identifies areas of potential trade-offs versus those attributes that are
either expected in new agents or are fully satisfied by current therapies.
This section concludes with an analysis of high profile agents currently in
the pipeline (“Competitors to Watch” and “Emerging Product
Profiles”). Using surveyed physicians' estimates of these agents' usage
as inputs, our analysis integrates our extensive knowledge of the competitive
landscape and non-clinical market hurdles to determine the market potential of
these agents and their threat to current brands.
Target Product Profile Methodology
Our Target Product Profiles are made up of two physician-defined Profiles that
highlight physicians' expectations of emerging therapies in terms of how much
better or worse the therapy performs relative to a comparator drug on key
measures of efficacy, safety and tolerability, and delivery. The Profiles also
provide physician insight on estimated uptake and use (i.e., patient share) of
drugs matching the Target Product Profiles as well as key drugs already in the
pipeline. Interviews with key thought leaders are used to identify a key drug
development opportunity that is realistic and obtainable within the next ten
years. To complete the Profile of a product that is able to fulfill the key
drug development opportunity and determine the product' s potential uptake, we
conduct two surveys for every disease we cover, each with at least 60 U.S.
physicians who have large clinical practices.
The first survey asks physicians how they would expect a therapy fulfilling
the key drug development opportunity to perform on various measures of
efficacy, safety, and delivery. To qualify physicians' willingness to accept
varying trade-offs in efficacy, safety, or delivery, price points above and
below a comparator therapy (generally the sales-leading agent in the disease)
are used. Price is used to force physicians to make choices between must-have
drug attributes and acceptable trade-offs. These prices do not necessarily
reflect the potential cost or reimbursement of a novel agent fulfilling the
key drug development opportunity. With these price points in mind, physicians
are asked to Profile two theoretical therapies:
- “Minimal Acceptable,” defined as a therapy that satisfies the
key drug development opportunity being tested and is priced lower than the
comparator drug.
- “Major Achievement,” defined as a therapy that satisfies
the key drug development opportunity being tested and is priced higher than
the comparator drug.
All physician survey responses are averaged together to create the two final
Target Product Profiles, each of which has clearly quantified performance
measures against efficacy, safety, and delivery end points.
The second survey presents these two Target Product Profiles to a new set of
at least 60 physicians and asks for their opinion on the market potential of
each Profile. Survey results reveal both Target Product Profiles' market
potential in terms of prescription patterns (how many patients physicians
would consider prescribing the theoretical product Profiles), the line of
therapy such theoretical products would be used, and which current drug(s) the
theoretical products would replace.
The results of each of these surveys are presented and analyzed in the Target
Product Profiles section of this report.
Table of Contents
- Introduction
- Using Target Product Profiles in Your Market Strategy
- Report Contents
- Target Product Profile Methodology
- Etiology and Pathophysiology
- Etiology
- Thrombosis
- Embolism
- Small Penetrating Artery Disease
- Pathophysiology
- The Therapeutic Time Window
- Ischemic Cascade
- Toxic Events Following Prolonged Ca++ Influx
- Target Product Profile Discussion - Acute Ischemic Stroke
- Target Product Profile Summary for Acute Ischemic Stroke - 2011
- Assessing Drug Development Opportunities
- Physician Survey Results
- Efficacy
- Safety and Tolerability
- Delivery
- Estimated Patient Share
- Pricing Potential
- Forecasted 2016 Pricing Environment
- Competitors to Watch
- Emerging Product Profiles
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