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, 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 despite opportunities for growth. The uptake of the first once-daily long-acting beta2 agonist (LABA)/inhaled corticosteroid (ICS) fixed-dose combination (vilanterol/fluticasone furoate [GlaxoSmithKline’s Breo/Relvar]), the introduction of the first anticholinergic in asthma due to the label extension of a leading chronic obstructive pulmonary disorder agent (tiotropium [Boehringer Ingelheim/Pfizer’s Spiriva]) to asthma, and the launches of five novel anticytokine therapies within the next ten years will offset the market constraints. Despite the high number of effective asthma therapies for mild to moderate asthma cases, considerable opportunity still exists for the development of new agents that target the heterogeneous population of asthma patients who experience severe symptoms and who are resistant to LABA/ICS combination therapies. Any emerging therapy that serves even a small fraction of this underserved segment of the asthma market will have considerable sales potential.

Questions Answered in This Report:

  • At the outset of the forecast period, the first once-daily LABA/ICS combination, vilanterol/fluticasone furoate, will join the LABA/ICS combination class, the leading drug class in the asthma market. How will vilanterol/fluticasone furoate fare in this competitive market space? Will vilanterol/fluticasone furoate increase the patient share of the LABA/ICS class or mainly replace treatments from the same class of 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 and montelukast (Merck/Kyorin’s Singulair, generics) during the study period. How will the loss of brand exclusivity affect the asthma market? What key therapies in development will sustain sales?

  • The first anticholinergic option, the long-acting muscarinic antagonist tiotropium (Boehringer Ingelheim/Pfizer’s Spiriva), was approved for asthma in Europe in September 2014 and is expected to soon be approved in other markets under study. Although tiotropium is already used off-label, the approval in asthma will increase tiotropium’s usage widely, particularly for difficult-to-treat asthma populations. How will tiotropium fare in this competitive market? Will tiotropium compete directly with available and emerging biologics by delaying patient access to these expensive biologics?

  • Asthma treatment will move toward a more personalized medicine approach beginning with the launch of five novel anticytokines during the forecast period. How do thought leaders view these emerging agents? Will the unmet need among 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 (Roche/Novartis’s Xolair)?

Scope:

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

Primary research: 34 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: 13 drugs; Phase III: 7 drugs; preregistration: 1 drug; registration: 1 drug. Coverage of 1 Phase I product.

Author(s): Eun-Jin Yang, Ph.D.
Kimberly Martin, Ph.D.

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