Just Breathe: COPD, Asthma Future

June 1, 2010

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-06-01-2010, Volume 0, Issue 0

Updates on the respiratory therapeutic market.

The respiratory therapeutic market comprises various diseases including asthma, bronchial disease, cystic fibrosis, a genetic disease with respiratory and digestive disease components, COPD, and the common cold. Of these, asthma and COPD comprise a $32 billion global market according to IMS 2009 data, with asthma valued at $15 billion in the United States and COPD valued at $4 billion to $5 billion. However, current asthma and COPD products are facing a patent protection expiry by 2016, and include Advair (GlaxoSmithKline), Symbicort (AstraZeneca), Singulair (Merck), and Spiriva (Boehringer Ingelheim).

In 2016, many therapeutic areas and pharmaceutical companies will be affected by the same patent cliff. However, Advair is projected to retain a number nine for global sales that year, with a negative (-)6% annual growth between 2009 and 2016, the year of its expiration.

Respiratory Studies Snapshot

Future market growth in asthma and COPD will be driven by a growing disease awareness, and thus patient pool, and the launch of newer, more expensive therapies. This growth will be tempered by new generics and the decrease of monotherapy product sales by combination drugs. This market information comes from a press release issued by Sandoz on its announcement of acquiring Oriel Therapeutics, a privately held U.S.-based pharmaceutical company focusing on respiratory products.

In the meantime, in regard to clinical trials, issues around data collection are important, as in any therapeutic area. OmniComm Systems recently reported successful use of its EDC and trial management software for medical device company Asthmatx. Its AIR2 Trial collected nearly 6GB of data and included 30 active sites in six countries. Two hundred ninety-seven adult subjects were enrolled and the trial collected over 77,000 forms from 12 office visits and 31 phone contacts per subject. Case Report Form (CRF) design included 1869 edit specifications. The system was also required to import data from electronic daily diaries maintained by study subjects. This electronic patient reported outcomes (ePRO) was fulfilled by PHT.

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