Respiratory diseases impose a tremendous health burden on society. As countries industrialise rising pollution and changes in lifestyle have contributed to increased levels of respiratory disease. According to the World Health Organization (WHO), in 2000, the top five respiratory accounted for 17.4 per cent of all deaths worldwide. Worryingly, death and disability due to Chronic Obstructive Pulmonary Disorder (COPD) was identified as being on the increase.
WHO defines COPD as encompassing two groups of lung disease, chronic bronchitis and emphysema. Chronic bronchitis refers to a productive cough for at least 3 months of each of 2 successive years for which other causes have been excluded. Emphysema describes destruction of the lung architecture with enlargement of the airspaces and loss of alveolar surface area. As the two conditions can coexist the terminology COPD is often used.
COPD effectively damages lung tissue over a prolonged period of time and impairs the flow of air in and out of the lungs and causes breathlessness. As the disease progresses it can cause sever limitations for the patient in their daily life. In some cases, they may require oxygen and could even eventually depend on mechanical respiratory assistance.
Action needed
WHO is particularly concerned with the link between smoking and COPD. Although the risk of COPD increases with age, there is a dramatic synergy with smoking. For example, cigar smokers are reported to have a 45 per cent higher risk of COPD when compared to nonsmokers.
Unlike cardiovascular disease, quitting smoking does not lead to a substantial reversal of the COPD-related damage caused by tobacco, once the disease is established. As death rates due to cardiovascular conditions fall in industrialised regions of the world, the rates of COPD are increasing.
Another area of concern is that smoking is becoming much more popular in developing regions of the world and thus COPD is on the rise. For example, India is estimated to have around 184 million smokers. In 2001, a population-based study was carried out in India to examine the gross burden of COPD and its association with smoking. The authors concluded that the smoker-nonsmoker ratio of COPD in males was 82.3 per cent, which is similar to that described in foreign studies of the disease.
Using financial indicators, a French study revealed that patients with COPD required considerable healthcare resources and that the disease had a heavy impact on society in economic terms. COPD had annual direct costs estimated at €530 per patient and as COPD-related illness or disability prevented many patients from working, there was an estimated annual indirect cost of €1078 per patient. As in other studies, the French study revealed an under diagnosis of the condition and poor treatment options being made available to patients, which led to inadequate symptom control. Furthermore the failure to recognize and treat COPD appropriately had an economic impact on the health system. The cost of unscheduled care (€151 per patient) was almost double the cost of scheduled visits to healthcare professionals (€82), reiterating the need for a more proactive strategy to deal with COPD.
The pharmaceutical market
In 2002, Boehringer Ingelheim launched Spiriva (tiotropium bromide), which was the first COPD-specific drug. Co-marketed with Pfizer, Spiriva's sales exceeded analysts' expectations and this has led to optimistic expectations for the COPD pharmaceutical market as a whole. Spiriva has now been launched in more than 40 countries and further approvals are anticipated through 2005.
However, poor public awareness has meant that a variety of treatments have been used for COPD, such as those primarily for asthmatic conditions. Therefore, although the market has potential for growth it currently features a range of different types of products and is still considered to be a relatively new type of pharmaceutical market.
According to IMS Health, the value of the COPD pharmaceutical market is currently around US$3 billion, but could increase to over US$9 billion by 2010. Perhaps the main influence on the market will be the attention that COPD is beginning to receive in the United States, the world's leading pharmaceutical market. If safer and more effective medicines become available and awareness of the disease grows patient demand will rise.
The Pharmaceutical Research and Manufacturers of America (PhRMA) recently surveyed its pharmaceutical and biotech company members and found that 17 COPD compounds were at various stages of clinical development. A new R&D focus in the pharmaceutical industry is the class of drugs known as phosphodiesterase-IV inhibitors. There are still a variety of safety issues to be resolved, but many companies have reported this class of drug as exhibiting great promise for the treatment of COPD.
Outlook
Many in the public are relatively unaware of the existence of COPD. As the disease progresses slowly, many sufferers do not seek medical attention until the disease is fairly advanced thus limiting treatment options. Many smokers in their 30s often attribute their symptoms to a 'smoker's cough' and thus fail to recognize the seriousness of the condition.
Whilst appropriate treatments for COPD need to be developed, governments and health agencies also have an important role to play. Yet, as the country-wide study of COPD in India revealed, it is far from easy to produce a national picture of the disease and tremendous human and financial resources are required. So far there are few signs that countries have the considerable political will required to take action in response to the rise in COPD, particularly when they are faced with numerous other healthcare concerns. Governments must also do more to counter the prevailing attitudes to smoking amongst some young people and the high profile that cigarettes continue to enjoy in the media.
It is difficult to determine which class of drugs will have the most success in the emerging COPD pharmaceutical market. What is clear though is that there will be a high demand for effective medicines and so COPD should be an area of interest for pharmaceutical companies who have an interest in the respiratory therapeutic field.
- (The author is with Chiltern International, a Clinical Research Organisation based in Slough)