Asthma

Pharmacor -- May 2008

  Introduction:

The asthma market is saturated with a variety of therapies that are safe and effective, yet opportunity exists for the development of agents for the highly heterogeneous patient population. Because the asthma market is one of the largest markets in the pharmaceutical industry, drug developers stand to gain blockbuster or near-blockbuster earnings with an emerging therapy that serves even a niche segment.

  Questions Answered in This Report:

The long-acting beta₂ agonist (LABA)/inhaled corticosteroid (ICS) combination salmeterol/fluticasone (GlaxoSmithKline’s Advair/Seretide/Adoair) has earned blockbuster sales in the asthma market alone. Five other LABA/ICS agents will reach the market in the coming decade, for a total of eight competitors by 2017. How will entry of these new LABA/ICS agents affect the sales of the current class leader, salmeterol/fluticasone?

Generic and/or branded-generic versions of the most lucrative therapies--salmeterol/fluticasone, fluticasone propionate (GlaxoSmithKline’s Flovent/Flixotide/Flutide), budesonide nebulizer (AstraZeneca’s Pulmicort Respules), and montelukast (Merck/Kyorin’s Singulair), among others--will enter the market during the study period. How will entry of generic and/or branded-generic versions of leading agents affect sales of the branded agents?

Thought-leading physicians tell us that they value therapies that improve patient compliance. How are developers continuing to capitalize on this need? How will entry of the more convenient therapies affect the sales of existing agents?

Among the seven major markets under study, the United States is the last country to implement compliance with the Montreal Protocol, which bans chlorofluorocarbon (CFC)-containing inhalers from the market. How will the removal of CFC-containing inhalers from the market by end of 2008 affect short-acting beta₂ agonist (SABA) class sales? Which agents will receive extensions to this deadline and how will the extension affect their product sales?

  Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 38 country-specific interviews with thought leaders.

Epidemiology: Diagnosed 12-month prevalent asthma and diagnosed current asthma; prevalence of four subpopulations: mild intermittent, mild persistent, moderate persistent, and severe persistent asthma.

Emerging therapies: Phase II: 18 drugs; Phase III: 4 drugs; preregistration: 0 drugs; registered: 0 drugs. Coverage of 3 select preclinical and Phase I products.

Market forecast features: Our market analysis evaluates more than 10 drug classes and more than 35 key therapies.

Alternative market scenarios: (1) If the FDA excludes Boehringer Ingelheim’s albuterol/ipratropium (Combivent) from the mandatory withdrawal of chlorofluorocarbon (CFC)-propelled agents with essential use designation.