Introduction:Last Updated 15 August 2013
As one of the most prevalent diseases in the major
pharmaceutical markets we cover (United States, France, Germany, Italy, Spain,
United Kingdom, and Japan), dyslipidemia represents a compelling commercial
opportunity for the manufacturers of both new and existing drugs. While the
excellent efficacy and safety profile of statins, and their increasing
availability as generics, mean that this class will continue to dominate early
lines of therapy, substantial opportunity awaits nonstatin drugs that can convincingly
show clinical benefit on a statin background, and thereby address the residual
cardiovascular risk that continues to represent a significant unmet need.
However, the barriers to market entry for novel drugs are higher than ever,
with premarketing cardiovascular outcomes trials, in which agents are tested in
combination with a statin, are now a normal regulatory requirement along with
ever-tighter healthcare payer budgets pushing physicians to prescribe generics.
The dearth of nonstatin therapies that target HDL-C and triglycerides and
possess convincing CV outcomes data means that the greatest commercial
potential exists for novel drugs that target the growing population of mixed
dyslipidemia—as long as these novel drugs are supported by positive outcomes
data. Therefore, the potential rewards of successfully developing such drugs
more than outweigh the associated increased cost and risk.
Questions Answered in This Report:
Of the emerging agents set to launch for dyslipidemia during
our forecast period, thought leaders are most interested in the CETP
inhibitors, anacetrapib (Merck) and evacetrapib (Eli Lilly). In light of
dalcetrapib’s failure during interim analysis of Phase III outcomes data, do
thought leaders expect the remaining CETP class members to show CV outcomes
benefit? In what patients do they foresee these drugs being used and how
widely? Do thought leaders expect these drugs to be significantly
differentiated from one another?
Several drugs—including Sanofi/Isis’s mipomersen (Kynamro),
Sanofi/Regeneron’s alirocumab (REGN-727), Amarin’s Vascepa (AMR-101), and
AstraZeneca/Omthera Pharmaceuticals’ Epanova—are in development for niche,
severe dyslipidemic populations, such as familial hypercholesterolemia and
severely elevated triglycerides. What do thought leaders think of the
clinical profiles of these drugs? Do they think these drugs have any potential
to be used in the wider dyslipidemic population? How much commercial success
can the developers of drugs for these niche indications expect?
One of the greatest factors affecting the dyslipidemia market
over the next ten years will be generic erosion, with the blockbuster brands
atorvastatin (Pfizer’s Lipitor [generic since November 2011 in the United
States]), rosuvastatin (AstraZeneca/Shionogi’s Crestor), ezetimibe (Merck’s
Zetia/Ezetrol), ezetimibe/simvastatin (Vytorin/Inegy), the emerging drug
ezetimibe/atorvastatin (Merck), and ER niacin (AbbVie’s Niaspan) all set to
face generics competition over the 2012-2022 forecast period. How will
generic erosion affect the dyslipidemia market at large? Now that atorvastatin
has lost patent protection, how will rosuvastatin maintain its market share
during its remaining years of exclusivity? Will the results of the SATURN trial
affect the relative patient shares of these two drugs?
The completion of IMPROVE-IT
for ezetimibe should help answer the question of how efficacious cholesterol
absorption inhibitors actually are at reducing cardiovascular risk and
will have implications for emerging LDL-C reducing agents. Will the
completion of IMPROVE-IT change thought-leader perception and/or prescribing of
these drugs? Will the availability of outcomes data be sufficient to stave off
the dual challenges of increasing genericization in the market and the launches
of novel drugs with outcomes data?
Markets covered: United States, France, Germany, Italy,
Spain, United Kingdom, Japan.
Primary research: 14 country-specific interviews with
lipidologists, cardiologists, endocrinologists, and PCPs.
Epidemiology: Prevalence of dyslipidemia; prevalence of
low-to-moderate CV risk, prevalence of coronary heart disease (CHD)/CHD risk
equivalent patients; prevalence of dyslipidemia segmented by lipid profile
(high LDL-C [low-to-moderate CV risk LDL-C ≥ 130 mg/dL, high CV risk
LDL-C ≥ 100 mg/dL], and TG concentration [250-499 mg/dL and ≥ 500
Population segments in market forecast: Low-to-moderate
risk patients and CHD/CHD risk-equivalent patients.
Emerging therapies: Phase II: 13 drugs; Phase III: 6
drugs; preregistration: 2 drugs; registered: 4 drugs; coverage of
19 selected preclinical and Phase I products.
Market forecast features: Using an epidemiology-based
methodology, we estimate the number of patients receiving treatment each year,
and forecast drug sales for each of the markets covered, and for combined
markets for each year through 2022.