Introduction:
Biomarkers have significantly changed patient care and the
therapeutic markets in oncology and infectious diseases. Central nervous system
(CNS) disorders are the next therapeutic area where biomarkers will make such
an impact. Given the emerging promise of personalized medicine, regulators have
designated biomarker discovery a priority, which is reflected in the large
number of ongoing initiatives that involve industry, academia, and regulatory
agencies. However, many obstacles remain to be overcome before biomarkers can
realize their full potential. Historically, drug developers have been wary of
biomarkers because they threaten to reduce use of their drugs, because
regulators are warning of increased oversight of the field, and payer
reimbursement for novel tests remains problematic. Nevertheless, select
neurological and psychiatric indications offer great opportunity for
biomarkers.
We present the first report on the impact of biomarkers in
neurological and psychiatric markets to include extensive primary research with
physicians, payers, and biomarker specialists in the
United States and
Europe. We analyze physician and payer attitudes toward biomarkers, the
regulatory and reimbursement landscapes biomarkers will face, developmental
strategies, biomarker technologies, and indication-specific analysis of current
and emerging biomarkers to provide a comprehensive view of biomarkers and their
impact on the current and future market.
Questions Answered in This Report:
*
Thought leaders are enthusiastic about novel biomarkers and
believe that some have the potential to provide earlier, more accurate
diagnosis and increase diagnosis and treatment rates.
Which biomarkers have
generated the most excitement from experts? What is their opinion of in vitro
and in vivo biomarkers in CNS, including imaging, EEG, genetic, and biochemical
biomarkers?
*
Surveyed physicians and payers require specific biomarker
characteristics in order to accept and reimburse novel tests.
What
attributes are necessary to earn physician acceptance and payer reimbursement?
Which patients will be the best candidates for biomarker-based diagnostics in
the indications covered? What will be the major obstacles to biomarkers’
gaining physician and payer acceptance?
*
Reimbursement is one of the greatest challenges to entering the
market with a novel diagnostic test.
What are the issues and obstacles in
the current pricing and reimbursement structures of the major payers? How will
changes in Medicare reimbursement policies affect diagnostic developers?
*
Diagnostics developers face several regulatory hurdles before
bringing a biomarker to market.
What are the regulatory processes available
for diagnostics approval? How is this regulatory environment changing? How do
payers and physicians rank these pathways?
*
Delays in diagnosis and difficulties in choosing optimal
treatment cause delays in effective treatment and increased cost and morbidity.
Novel diagnostics and theranostics may decrease this delay, thereby increasing
the duration of effective drug treatment.
Which physicians will be early
adopters of biomarkers? How will the launch of novel diagnostics change the
diagnostic and treatment paradigm?
*
CNS indications present enormous opportunity for drug and
diagnostics developers.
What are the advantages and disadvantages of
biomarker development strategies? Which indications have the greatest unmet
need for biomarkers? What type of biomarker will be most useful in each
indication? When are the first biomarkers likely to launch in CNS?Scope:
Markets covered: United States, France, Germany, Italy,
Spain, United Kingdom.
Indications covered: In-depth coverage of current and
emerging biomarkers in four neurological indications—Alzheimer’s disease,
Parkinson’s disease, multiple sclerosis, and epilepsy—and five psychiatric
indications—schizophrenia, bipolar disorder, major depression, autism, and
attention-deficit/hyperactivity disorder.
Primary research: Country-specific interviews with 19
thought-leading neurologists, psychiatrists, and biomarker experts. Surveys
of 50 physicians (25 neurologists and 25 psychiatrists) and 25 payers (pharmacy
and medical directors).
Includes:
- Regulatory framework and issues for biomarkers and diagnostics.
- Considerations in using biomarkers in drug development.
- Background and analysis of the technologies used in current and
emerging biomarker diagnostics.
- Coverage of 78 current and emerging biomarkers and
diagnostics in neurological and psychiatric indications, background and context
of biomarkers within each indication, analysis of market impact, and obstacles
facing biomarkers and diagnostics.
- U.S. and European specialists’ perspectives on the current
environment for biomarkers, anticipated adoption of biomarkers, expected impact
of biomarkers, reactions to biomarker diagnostic product profiles, and
biomarker diagnostic development considerations.
- Reimbursement issues and obstacles for biomarkers and
diagnostics.
- A comprehensive list of CNS diagnostic collaborations for the
last several years.