In 2012, the 10 biggest selling respiratory drugs generated combined sales of $25 billion, with GlaxoSmithKline’s Advair (sold as Seretide outside of the US) accounting for nearly a third of this total.
Commercial evolution of this drug – which is indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD) – will play an integral role in shaping the broader respiratory market over the next five years. Two particular trends will be key: how successful GlaxoSmithKline is in shifting patients to its newer therapies Breo Ellipta and Anoro Ellipta, and whether substitutable generic competition for Advair enters the market and when.
GlaxoSmithKline’s strategy in the respiratory space appears to be to enhance its industry leading position via a more diversified portfolio offering. Clearly the success of Breo – effectively a once-daily version of Advair – and the potential launch of generic Advair are interlinked; the sooner generics are launched the less time GlaxoSmithKline will have to switch patients to Breo without the disruption that the availability of cheaper competition will cause.
That said, switching patients may prove a challenge even prior to the availability of generic competition, particularly with regard to convincing payers. See Spotlight On: Express Scripts joins CVS Caremark in publishing list of formulary excluded drugs for 2014 as pharmacy benefit managers look to tackle pharma co-pay schemes and ViewPoints: GlaxoSmithKline's Q2 conference call sheds further light on Breo Ellipta launch/respiratory strategy.
Mapping the possible route to market for generic versions of Advair remains difficult, despite the FDA having recently published draft guidance that appears to have lowered the regulatory barriers to entry - see Spotlight On: FDA shifts landscape for generic respiratory products – is GlaxoSmithKline's $8 billion Seretide/Advair franchise in the firing line?
Mylan, for example, has indicated that it could be in a position to file a substitutable generic by 2015, thus facilitating a potential launch in 2016 when patent exclusivity on GlaxoSmithKline’s Diskus device expires. Teva, on the other hand, argued last week that it is difficult to see generic manufacturers delivering an AB-rated generic to the market anytime before 2018 - see ViewPoints: Teva makes u-turn in generic Advair chase, but can it catch rivals?
With analysts having generally taken the view that ‘true’ generic Advair is unlikely to reach the market before the end of the decade, consensus forecasts for GlaxoSmithKline’s flagship franchise may well be revised downwards as more information is provided by the FDA relating to regulatory requirements, and developers reveal more details about their generic products. At this point in time, however, forecasts point to a steady erosion of Advair sales (driven primarily by cannibalisation from Breo and, to a lesser extent, Anoro and branded competition). See In Focus: GlaxoSmithKline's Anoro – can physicians be convinced sufficiently to drive drug towards blockbuster aspirations.
Robust consensus forecasts point to both of GlaxoSmithKline’s new respiratory products generating 2018 sales of around $2 billion (although Breo forecasts may be liable to revision given its relationship with Advair). Equally – if not more – impressive is the long-term sustainability of key GlaxoSmithKline franchises in the respiratory market such as Ventolin and Flovent/Flixotide, which are both expected to retain blockbuster status by 2018.
Boehringer Ingelheim is the second largest player in the global respiratory market, generating combined sales of $5.7 billion from its Spiriva and Combivent franchises in 2012. Consensus forecast sales are unavailable for Boehringer Ingelheim given its private ownership status, but its mid-term performance will likely be shaped by how successfully Spiriva performs in the face of potential generic competition and the opportunity offered by new combination products. Critically, the company recently presented positive data for its Respimat inhaler device, which should strengthen Boehringer Ingelheim’s own efforts to develop its portfolio, note analysts - see ViewPoints: Will new data remove overhang on Boehringer Ingelheim's Respimat device and intensify competition with GlaxoSmithKline, Novartis in the COPD market?
With Merck & Co. expected to become increasingly less focused on the respiratory space given the loss of Singulair patent exclusivity last year, AstraZeneca – already a leading player in the sector via its Symbicort franchise – and Novartis – a more emergent player in respiratory despite its co-commercialisation of the Xolair franchise – will be the other key players by 2018 - see also In Focus: Can Pearl Therapeutics support AstraZeneca's late dash in the respiratory market? - FirstWord speaks to CEO Charles Bramlage.
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