The respiratory disposables and reusable respiratory accessories market is undergoing a dramatic change caused in part by a recent government regulation that bans the use of chlorofluorocarbon in inhalers.
According to a new report from Kalorama Information, inhalers make up a dominant amount (45 percent) of the $36 billion market for respiratory devices and are expected to enjoy a strong 9.8 percent growth rate through 2012, spurred in part by new product innovations following a ban on CFC-based inhalers.
More than 95 percent of inhalers contain ozone-depleting CFC as a propellant. In order to abide by international environmental guidelines, the United States released a policy in 2005 that CFCs must be removed from inhalers by December 31, 2008 and replaced with hydrofluoroalkane, or HFA.
All HFA inhalers had to undergo extensive clinical development and new drug applications to the FDA. These new non-CFC inhalers will not see generic competition until they begin coming off patent starting in 2010 and therefore cost about twice as much as CFC inhalers.
The report, titled "World Market for Respiratory Equipment and Disposables, 3rd Edition," suggests that compliance could be a "blessing in disguise" for inhaler companies.
"Until December 2007, companies with CFC-based products were allowed to market their product, so they have had sufficient time to take the necessary steps to shift towards HFA based products," said Kalorama Information analyst Joe Constance. "And the companies did not need to make any significant changes in their manufacturing processes in order to abide by this new government regulation."
Constance said inhaler equipment suppliers and pharmaceutical companies have been collaborating to face the phase-out and preparing themselves by installing the capabilities for HFA-based products in terms of stability testing and product compatibility tests.