Pharmacor

Introduction:

Last Updated 30 August 2010
The sizeable therapeutic market for chronic obstructive pulmonary disease (COPD), a disease that is closely affiliated with smoking, continues to expand. More and more patients are diagnosed with COPD every year as populations age, efforts to promote awareness of the disease continue, and the use of spirometry to diagnose COPD becomes more widespread. The expanding COPD patient population has great unmet need because truly disease-modifying pharmacotherapies are lacking; current treatments merely alleviate symptoms and do not slow or reverse the progression of COPD. However, large gains are possible in the COPD market for therapies that offer incremental improvements in existing treatment modalities. For example, improving COPD patients’ compliance with their medications by offering more convenient dosing will lead to better treatment outcomes as well as market growth.

Questions Answered in This Report:

  *   Aging demographics and increasing diagnosis rates will lead to an expanded drug-treated population through 2019. What are the emerging opportunities in the expanding COPD drug-treated population? How can marketers attract new COPD patients entering the market?

  *   Five new long-acting beta₂ agonist (LABA)/inhaled corticosteroid combinations will be launched in the major markets under study in 2019, including several once-daily agents. Will new entrants, such as GlaxoSmithKline/Theravance’s vilanterol/fluticasone furoate (Relovair), Novartis’s indacaterol/mometasone, and Chiesi Farmaceutici’s carmoterol/budesonide, displace key established agents such as GlaxoSmithKline’s salmeterol/fluticasone (Advair/Seretide/Adoair) and AstraZeneca’s salmeterol/budesonide (Symbicort)? Will physicians favor inhalers with established molecules or favor the dosing convenience offered by once-daily agents comprising new molecules?

  *   The next drug class to emerge for COPD will be fixed-dose combinations of LABAs and long-acting muscarinic antagonists (LAMAs). Will physicians consider twice-daily agents in this class, such as formoterol/aclidinium, or will they insist upon agents with once-daily dosing? To what degree will sales for COPD of Boehringer Ingelheim’s olodaterol/tiotropium cannibalize sales for COPD of Boehringer Ingelheim/Pfizer’s tiotropium (Spiriva)? 

  *   Nycomed/Forest/Merck/Mitsubishi Tanabe’s roflumilast (Daxas) is the first oral anti-inflammatory medication to receive market authorization for COPD. How will roflumilast’s side-effect profile affect the agent’s uptake? Will roflumilast ultimately gain access to the lucrative U.S. market, or are barriers to FDA approval insurmountable? Will roflumilast’s price prevent the agent’s widespread use in Europe?

Scope:

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

Primary research: 25 country-specific interviews with thought-leading pulmonologists.

Epidemiology: Prevalence of COPD in patients aged 40 or older; subpopulations by severity (mild, moderate, severe/very severe); growth potential of the COPD population over the 2009-2019 study period.

Emerging therapies: Phase II: 21 drugs; Phase III: 6 drugs; preregistration: 0 drugs; registered: 52 drugs. Coverage of 12 select preclinical and Phase I products.

Market forecast features: We reconciled our 2009 COPD sales estimations based on epidemiological data, number of treated days, compliance, annual pricing, and country-specific prescribing trends with reported COPD sales and used our patient-based model to forecast sales through 2019. We included estimates of symptomatic COPD (i.e., patients diagnosed with COPD who have normal spirometry data).

Alternative market scenarios: We provide several alternative market scenarios. One scenario assumes the emergence of generic inhalers in the U.S. market. Another scenario assumes the launch of GlaxoSmithKline/Theravance’s GW-642444/fluticasone furoate, Novartis’s indacaterol/mometasone, and GlaxoSmithKline’s fluticasone furoate into markets with restrictive pricing policies (France, Italy, Spain). A third alternative market scenario assumes that Nycomed/Forest Laboratories/Merck/Mitsubishi Tanabe Pharma’s roflumilast (Daxas) secures a commercialization partner in the United States and the drug obtains approval in this region.