Opportunities in the COPD market

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The increasing elderly population and increases in diagnosis and drug treatment will fuel a steady 4.6% annual growth in the chronic obstructive pulmonary disease (COPD) drug market, says a new report.


The COPD drug market, which totalled nearly US$8.4 billion in 2009, is expected to reach more than US$13 billion in 2019 in France, Germany, Italy, Japan, Spain, UK and the US. The report also reveals that the number of people treated for COPD will increase by nearly six million over the next decade.

Just a few players currently dominate the COPD market. The biggest selling drug for the treatment of COPD is GlaxoSmithKline’s (GSK) Seretide/Advair (fluticasone+salmeterol) with sales of GBP 4,977 million (US$ 7,794 million) in 2009. The next best sellers are Boehringer Ingelheim’s Spiriva (tiotropium), with sales of Euros 2,400 million (US$ 3,478 million) in 2009 and AstraZeneca’s Symbicort (budesonide+formoterol), with sales of US$ 2,294 million in 2009.

GSK’s patent on Seretide/Advair will expire in the US in September 2010 and in most European markets in 2013. The UK patent has already been revoked. Patents covering Symbicort have already been revoked in Europe, and AstraZeneca’s data exclusivity ends in August 2010. The US patents for Symbicort begin to expire in 2011. The US patents for Spiriva begin to expire from December 2012, although there are patents running right up to 2023.

Here’s where the generic opportunity arises. Makers of lower-priced generics will capitalise on the loss of market exclusivity of Seretide/Advair, Spiriva and Symbicort in the US and Europe, with generic versions of these drugs expected to become available in Europe by 2019.

The EMA recently granted marketing authorisation for the first new substance class in the area of COPD in more than a decade, Daxas (roflumilast), an oral, once-daily phosphodiesterase 4 enzyme inhibitor, manufactured by German-based manufacturer Nycomed. The drug is indicated for maintenance treatment of severe COPD associated with chronic bronchitis in adults.

With high-profile COPD drugs coming off patent, the prospects for the generic sector look promising and with such a healthy and increasing annual growth in the number of people being treated for COPD, this is definitely a drug market worth investing in.

(see also Opportunities for generic inhalation and nasal spray drugs)


Decision Resources. News and Events. An expanding aging population and increases in diagnosis and drug treatment will fuel steady 4.6 percent annual growth in the chronic obstructive pulmonary drug market. 31 August 2010

Espicom, Emerging Opportunities in Inhalation & Nasal Spray Generic Drugs 2008. 12 March 2010

Nycomed Press Releases. From Oranienburg to the rest of the world: global market launch of Daxas® (Roflumilast) kicks off in Germany. 1 September 2010

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