Tim Noakes has been Medical Propellants Business Expert at Mexichem over the last 20+ years and has developed unique access to and insight into pressurized metered dose inhaler manufacturing around the world. He gives OINDPnews.com his perspective on how the industry has been evolving, especially in the developing world.
Q: What trends are you seeing in the MDI business worldwide?
A: To an aspiring developing world MDI manufacturer, the prices these products can command in some Western countries – especially the USA – is a seductive siren song. While a 200 dose MDI of salbutamol sulfate (albuterol) costs about $2 in US dollars in their home markets, that same MDI costs about $4 in the UK and between $30 and $50 in the US.
The exceptional US price is a result of two factors, namely patents (which expire mid 2014) and what might be termed the “FDA Effect.” It is widely recognized that regulatory standards of the US pharma market are the toughest in the world, and this has – and does – have the effect of limiting competition, especially in these more hi-tech medications.
It remains to be seen what price albuterol MDIs will drop to in the US after 2014, but previous manufacture of generic CFC albuterol inhalers provides an indication; when generics were available in the US, they retailed at around $12 per aerosol. So, in a couple of years, I think it’s possible that we could see albuterol HFA at $12 in the US.
To an Indian manufacturer, the EU, never mind the US, looks very attractive, and indeed Indian manufacturers already have many medications on these markets, albeit only a few in these complex respiratory dosage forms. So there is a real push in a number of developing world, particularly Indian, companies, to dip into this attractive pool in the developed world markets.
Demand for asthma medications is also increasing steadily in the developing world. Until recently, reports of the incidence of asthma in these regions represented only a tiny fraction of that reported in the developed world. This gap between developed and developing world disease incidence is now rapidly changing, and one consequence is a greater demand for inhalers.
Q:Have you seen anything to explain this trend?
A:If you look at the percentage of population reported with the condition as follows:
Ir% = Ia% x P%/100 x D%/100:
(where Ir% = % population reported with the condition
Ia% = % population actually with the condition
P% = % of actual asthma suffers presenting to a medical practitioner
D% = % of presenting asthma sufferers achieving diagnosis at practitioner
Numerous factors can cause the number of patients seeing medical practitioners and receiving diagnoses to differ from country to country and change with time.
For example, in some developing countries there has been a large social stigma attached to being caught using any form of inhaler. Wives will conceal their inhaler from their husbands, for example, and the sight of someone taking an inhaler in many developing countries may lead to loss of employment, under the confusion of this respiratory condition with tuberculosis and the incorrect belief that the condition can in some way be transmitted to other employees. So why bother visiting the doctor if you fear the consequences of being seen with the medication?
However, in some countries, the stigma may now be lessening, and more patients are receiving diagnoses.
In addition, it may be that as a country develops, a greater percentage of the population actually suffers from asthma due to changing environmental conditions. There is evidence that a move away from a rural, agrarian lifestyle to a more modern, urbanised one can, on its own, cause a substantial increase in diseased incidence. However, this is proving to be an exceptionally difficult story to understand, and I am sure we have much more to uncover.
