Fueled by an expanding aging population and increases in diagnosis and drug treatment, sales of drugs to treat chronic obstructive pulmonary disease (COPD) in seven major markets will grow 4.6% a year to reach more than $13 billion in 2019, says a new study.

The COPD drug market in France, Germany, Italy, Japan, Spain, the UK and the USA was worth nearly $8.4 billion last year says the study, from Decision Resources, which forecasts that the drug-treated COPD population will increase by nearly six million patients over the next decade.

Two maintenance therapies currently dominate the COPD market; they are GlaxoSmithKline’s Advair/Seretide/Adoair (salmeterol/fluticasone) - whose sales in emerging markets and Japan soared 12% and 23%, respectively, in second-quarter 2010 - and Boehringer Ingelheim/Pfizer’s Spiriva  (tiotropium), for which turnover was up 16.2% to 2.40 billion euros last year, with US sales topping 1 billion euros for the first time. However, the near-term market will become fractured owing to the launch of new agents and generic erosion of key brands, says the report. Moreover, it adds that the makers of lower-priced branded generics will capitalize on the loss of market exclusivity of Advair/Seretide/Adoair and Spiriva in the US and Europe, and generic versions of these drugs will become available in Europe by 2019.

“Challenging regulatory environments, uncertain pricing and reimbursement restrictions and the loss of patent protection and/or market exclusivity for many top-selling COPD products will constrain the COPD market,” comments Benjamin Guikema, an analyst at Decision Resources Analyst. However, he also points out that manufacturers of generic products “will face great barriers to entering the COPD market, given the lack of clear regulatory pathways and the difficulty of creating a device that is acceptable to regulators, physicians and patients.”

The report’s findings also reveal that the launch of fixed-dose combination inhalers containing a long-acting beta2 agonist (LABA) and a long-acting muscarinic antagonist (LAMA) will offer more potent bronchodilation than the treatments which are currently available. “Thought leaders hope that LABA/LAMA combinations will also be more effective than currently-available treatments in reducing the frequency of COPD exacerbations,” notes Dr Guikema.