The asthma and chronic obstructive pulmonary disease (COPD) therapeutics market in North America is continuing to grow, with most of the momentum coming from COPD, which has remained so far a relatively unknown disease. The figures show that in 2009, 40.3 million Americans were diagnosed with asthma or COPD; of these, 25.1 million had asthma and 15.1 million had COPD. As both asthma and COPD are incurable and chronic, medications that are more effective than the existing ones are needed. Pharmaceutical and biotech companies continue to address this challenge by developing novel medications.

As a result, seven new drugs are expected to be introduced in the market by 2017, driving growth. On the other hand, patent expiry of some of the current top-selling medications will strengthen competition from less expensive generics, eroding the revenue potential of the market. For instance, the second-highest selling medication in this market, Singulair, manufactured by Merck (Whitehouse Station, NJ, USA) loses patent protection in 2012. Similarly, Advair, a product of GlaxoSmithKline (GSK, London, United Kingdom), will lose its last patent in August 2016.

The need for market-specific expertise, however, can inhibit the entry of new participants. For example, most medications for asthma and COPD are inhaled and besides developing a therapeutic compound, entrants must design an inhalation device that meets US Food and Drug Administration (FDA) requirements, and is user friendly. In early 2010, the FDA announced the requirement of a risk management evaluation management strategy (REMS) and a label change for all long-acting bronchodilators. In addition, the FDA changed the treatment guidelines for these medications.

“During the forecast period, four new medications are expected to be approved by the FDA,” commented Frost and Sullivan research spokesperson Britni Myers. “These include a new long-acting anticholinergic medication and a combination of an anti-inflammatory and a long-acting bronchodilator with convenient once-daily dosing.”

Asthma/COPD therapeutics includes bronchodilators (short-acting bronchodilators, long-acting bronchodilators, anticholinergics, and combination bronchodilators), anti-inflammatory drugs such as inhaled corticosteroids, anti-leukotrienes, monoclonal antibodies, and a combination of both. Frost & Sullivan have found that the asthma/COPD therapeutics market earned revenues of US$ 15.4 million in 2009, and estimates this to reach $17.9 million in 2016.

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