Last Updated 21 September 2015

The asthma market has historically been one of the most lucrative drug markets in the pharmaceutical industry owing to a large and growing patient population. However, despite a robust pipeline in asthma with a substantial growth potential, generic and/or branded-generic price erosion, increased product competition, and an increasingly difficult pricing and reimbursement environment will stabilize the asthma market over the forecast period. The uptake of the first once-daily long-acting beta2 agonist (LABA)/inhaled corticosteroid (ICS) fixed-dose combination (vilanterol/fluticasone furoate [GlaxoSmithKline/Theravance’s Breo/Relvar]), introduction of the first anticholinergic in asthma due to the label extension of a leading COPD agent (tiotropium [Boehringer Ingelheim’s Spriva]) to asthma, and launches of six different novel anticytokine therapies and a new class of two LABA/long-acting muscarinic antagonist (LAMA)/ICS combination therapies within the next ten years will offset the market constraints. Despite the high number of effective asthma therapies for mild to moderate asthma patients, considerable opportunity exists for the development of new agents that target the heterogeneous population of asthma patients with severe symptoms and who are resistant to LABA/ICS combination therapies. Any emerging therapy that serves even a fraction of this underserved segment of the asthma market will have considerable sales potential.

Questions Answered in This Report:

  • 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)?

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.

Author(s): Eun-Jin Yang, Ph.D.
Lade Ayodele, M.B.B.S., M.P.H.

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