Abstract:

Owing to the large diagnosed prevalent population, relatively high rates of drug treatment across patients of all disease severities, and high rates of polypharmacy—particularly among the moderate/severe population—the asthma market totaled almost $18 billion in 2016 in the seven major pharmaceutical markets under study (United States, France, Germany, Italy, Spain, United Kingdom, and Japan). The uptake of recently approved and emerging biologics in the severe, refractory segment of the market, the launch and uptake of more-convenient LABA/ICS and LABA/LAMA/ICSFDCs, along with entry of a small-molecule oral agent, fevipiprant, will fuel the growth of the market. At the same time, generic and/or branded-generic erosion of the leading inhaler therapies, increased product competition within many drug classes, and an increasingly difficult pricing and reimbursement environment will constrain the expansion of the market.Questions Answered: The entry and uptake of premium-priced biologics Nucala (GlaxoSmithKline), Cinqair/Cinqaero (Teva), benralizumab (AstraZeneca), and Dupixent (Sanofi/Regeneron), as well as launch and uptake of a small-molecule agent, fevipiprant (Novartis), during our forecast period will further expand the available armamentarium of therapies used to treat severe, refractory asthma. How much market growth will be driven by these agents? How do interviewed thought leaders perceive the safety and efficacy of these agents? What factors will influence the choice of treatment in moderate/severe patients who remain uncontrolled despite the use of medium or high doses of LABA/ICSFDCs? Multiple additional branded/branded-generic/generic LABA/ICSFDCs continue to enter the market in the United States and Europe. What will be the impact of these launches? How will the entry of branded-generic/generic LABA/ICSFDCs erode the sales and patient share of currently marketed branded products? Will the current market leaders in the LABA/ICSFDC class be able to withstand the competition from the newer, more- convenient once-daily agents from the less-expensive products in the class, and from the branded-generic/generic agents? Several LABA/LAMA/ICS triple FDCs are starting to gain approval and launch for COPD, with the approvals for asthma expected to follow. What are key opinion leaders’ perceptions of these novel agents? How do physicians view the utility of these “closed” triple combinations compared with “open” combinations (a LABA/ICSFDC and a LAMA in separate inhalers)? How much will LABA/LAMA/ICSFDCs erode sales of LABA/ICSFDC and LAMA drug classes? Which emerging triple therapies are likely to be the most successful in gaining uptake?Scope:Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, and Japan.Primary research: 34 country-specific interviews with thought leaders.Epidemiology: Number of diagnosed and drug-treated prevalent cases of asthma; number of diagnosed and drug-treated prevalent cases of intermittent/mild persistent and moderate/severe persistent asthma.Emerging therapies: Preregistered: 1 drug; Phase III: 6 drugs; Phase II: 12 drugs; coverage of 1 select preclinical/Phase I product.

Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.Primary research: 26 country-specific interviews with thought-leading pulmonologists, allergists, and respiratory specialists.Epidemiology: Diagnosed prevalent cases of active asthma; four subpopulations within diagnosed prevalent active asthma: intermittent, mild persistent, moderate persistent, and severe persistent asthma.Emerging therapies: Phase II: 17 drugs; Phase III: 6 drugs; preregistration: 3 drugs. Coverage of 1 select Phase I product. 

Questions Answered:

  • The first once-daily LABA/ICS combination, vilanterol/fluticasone furoate, has launched in Europe and Japan, at the outset of the forecast period, it received approval in asthma in the U.S. The agent’s initial uptake has been slow in Europe and Japan to date. How will vilanterol/fluticasone furoate fare in this competitive market space, and whether the approval in the U.S. strongly boost patient shares of LABA/ICS class or mainly replace patients who are already treated with the same class therapy?
  • How will entry of vilanterol/fluticasone furoate affect the sales of the current class leader, salmeterol/fluticasone propionate (GlaxoSmithKline’s Advair/Seretide/Adoair)?
  • Continued generic and/or branded-generic erosion will negatively impact sales of market-leading therapies, including salmeterol/fluticasone propionate, formoterol/budesonide and montelukast (Merck/Kyorin’s Singulair, generics) during the study period. How will the loss of brand exclusivity impact the asthma market?
  • What are the key therapies recently launched or in development that will sustain sales?
  • The first anticholinergic (long-acting muscarinic antagonist), tiotropium (Boeringer Ingelheim’s Spiriva) has gained approvals in asthma in Europe and Japan in 2014, and is expected to be approved in the U.S. at the outset of the forecast period. Although already used off-label, the approval in asthma will increase the tiotropium’s usage particularly for difficult-to-treat asthma populations. How will tiotropium fare in this competitive market?
  • Will tiotropium directly compete with an available and several emerging biologic(s) by delaying patient access to these expensive biologics?Asthma treatment will move toward a more personalized medicine approach beginning with the launch of six novel anticytokine during the forecast period. How do thought leaders view these emerging agents? Will the unmet need amongst severe asthmatics drive uptake of this new class of medications? How will these emerging agents compete against each other and the only approved biologic to date, omalizumab (Genentech/Novartis’s Xolair)?
     

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