Introduction:
Last Updated 12 May 2010 The large and growing
population of patients with type 2 diabetes, coupled with an unmet need for
drugs that can effectively control the disease in the long term, signals
tremendous commercial potential in the type 2 diabetes market through 2018.
However, new agents face major challenges, including differentiating themselves
from the multitude of existing and emerging therapies and navigating an
increasingly stringent regulatory environment.
Questions Answered in This Report:
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2009 and early 2010 saw the
launch of a second GLP-1 analogue (Novo Nordisk’s Victoza) and a third DPP-IV
inhibitor (Bristol-Myers Squibb/AstraZeneca’s Onglyza). More agents in these
drug classes are expected to launch over our forecast period.
In this
increasingly crowded market, how will these drugs differentiate themselves?
Which will be the most successful, and why?
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The inexpensive generic biguanides and sulfonylureas still
dominate the first two lines of therapy in the management of type 2 diabetes.
Will
any emerging drugs challenge this paradigm? What are the key barriers
preventing new drugs from being more widely prescribed?
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Several novel insulin formulations—including an inhaled
version—are in late-stage development.
In the aftermath of Exubera’s
discontinuation, are physicians still willing to prescribe inhaled insulins?
What is the commercial potential for this drug class? How will other novel
formulations of insulin fare against established insulin and insulin analogues?
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The recent FDA guidance on cardiovascular safety requirements
for novel antidiabetic drugs has the potential to seriously delay the launch of
several drugs that are close to entering the market.
Which drugs are most
likely to be affected, and what impact will this policy have on the U.S. type 2
diabetes market over the next ten years?Scope:
Markets covered: United
States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 25 country-specific interviews with experts.
Epidemiology: Prevalence of
type 2 diabetes; prevalence of prediabetes (impaired glucose tolerance).
Population segments in market
forecast: Type 2 diabetes.
Emerging therapies: Phase
II: 39 drugs; Phase III: 19 drugs; preregistration: 5 drugs. Coverage of 24
select preclinical and Phase I products.
Market forecast features:
Using a patient-based model, we forecast population sizes and drug sales for
type 2 diabetes through 2018.
Alternative market scenarios: (1) Further, more-conclusive data are released that strengthen the association between insulin glargine and certain types of cancer, (2) exenatide LAR must undergo additional premarketing cardiovascular safety testing, (3) pancreatitis is found to be a genuine adverse event and class effect among GLP-1 analogues, (4) once-weekly GLP-1 analogues are not approved in the United States because preclinical carcinogenicity data suggest a thyroid tumor risk, and (5) tagatose achieves 10% uptake among the prediabetic population in the United States.