There is no disputing that respiratory disease is on the rise, with asthma and chronic obstructive pulmonary disease (COPD) in particular representing a significant worldwide burden. Globally, 300 million people have asthma, a figure which is set to rise to 400 million by 2025, and it is responsible for 250,000 deaths globally each year, of which 90% are preventable.
Furthermore, with key drugs and delivery devices soon to come off-patent in the asthma and COPD space, it is predicted that the emerging markets offer considerable potential for inhaled generics. Asia Pacific is expected to display the fastest growth, driven by the rapidly-evolving healthcare industry that has led to an increasing patient pool in need of treatments for asthma and COPD.
India in particular is expected to benefit from the increasing efforts from its government to reduce overall healthcare costs. The country has seen the rise of the middle class with more disposable income, as have a number of nations in Latin America, Middle East and Africa, who are seeing improved access to healthcare – one of the positive results of rapid urbanization.
This has led to the increased usage of asthma inhalers in these regions and while the inhaled market has been dominated by metered dose inhalers (MDIs), the dry powder inhaler (DPI) has become the fastest-growing segment.
However, while most DPIs have been designed for developed markets, with multiple components and complex mechanics, the demand for respiratory treatments is also growing rapidly in developing markets. Interestingly, the message from the customers I speak to is that while they want DPIs that can deliver reliable performance, they also need to be easy to use and come at a reduced cost.
While the pharmaceutical industry has made extraordinary technological advances with inhalation devices, it is also important to make sure that we are not also adding complexity that makes them more difficult to use and expensive to make - manufacturers must not lose sight of the importance of device usability as well as functionality.
A well-designed inhaler which is easy to use can help remove the risk of errors that may affect a treatment’s efficacy and one of them - poor inhaler technique - is still a huge problem. A 2016 large independent study summarized 144 articles reporting on 54,354 subjects and concluded that “incorrect inhaler technique is unacceptably frequent and has not improved over the past 40 years, pointing to an urgent need for new approaches to education and drug delivery”1. Earlier this month, the Asthma Society of Ireland unveiled figures which show that up to 60% of the 300,000 asthmatics in the country do not have their disease under control 2.
Those figures are from a European country and the statistics from developing markets are equally concerning. In Latin America, COPD deaths have increased by 65% in the last decade and in India, a study collecting data without spirometry assessment suggested that 12 million people were affected by the disease - in China, chronic respiratory diseases are the second leading cause of death.
There is clearly unmet medical need in the developing markets and a major opportunity for generic manufacturers of respiratory medicines. DPIs represent the strongest opportunity for these markets, especially capsule-based DPIs, which offer significant cost and flexibility benefits. However, while cost is clearly an important factor, companies looking to tap into this market need to be able to deliver quality product guarantees.
H & T Presspart has over 45 years’ heritage in the assembly and manufacture of respiratory drug delivery components, producing parts for over 75% of the world’s MDIs. This year we have moved into the DPI space through a pact with Portugal’s Hovione and launched PowdAir Plus, which is designed principally for the developing world.
PowdAir Plus, a capsule-based DPI, was designed to maximize simplicity and ease of use and to minimize manufacturing assembly and production costs, for example with no metal and separate parts, and was designed to be robust to withstand the mechanical stresses of frequent use. A particularly novel design feature is the way the device opens the capsule once the tray is closed, removing the need for patients to actively pierce the capsule and reducing the number of operational steps.
However, being easy to use and efficacious is not enough for medical devices nowadays - it has to look good too and that applies to inhalers in both developed and emerging markets.
A decade ago, the focus was on functionality but as the industry becomes more customer-focused, the importance of aesthetics has grown. If patients are going to use a tool all the time, it has to look nice and be neat and portable. Essentially, to tick all the boxes requires real design discipline.
The generic DPI segment in developing markets shows a lot of promise for manufacturers who provide products that meet the needs of patients and payers in those countries. Affordable manufacturing and assembly are a prerequisite for success, but don’t make the mistake of cutting costs at the expense of quality and design. Expectations are changing and patients, payers and healthcare professionals don’t want inferior products. It may cost less than a mature-market equivalent, but it has to serve the purpose just as well. That means making it simple to use, easy to carry, robust and reliable – and great to look at.
References
1 Joaquin Sanchis, Ignasi Gich, and Soren Pedersen, Aerosol Drug Management Improvement Team (ADMIT), CHEST 2016; 150(2): 394
2 https://www.asthma.ie/news/300000-irish-asthmatics-not-using-inhalers-correctly-world-asthma-day-asthma-week-2017
