Clinica Article: Inside China: Seeing the relevance in prevalence

Screen Shot 2013-10-18 at 11.30.07 AMOne size does not fit all when you’re developing medical devices for China. Ignoring the physiological and epidemiological differences between the Chinese (and other East Asians) and the West can be disastrous, while understanding and capitalizing on these differences can create significant opportunity, writes Michael Alper

February 2014: Inside China – Seeing the relevance in prevalence

Currently, most major medical device innovations are developed in the US and Europe based on the epidemiology and physiology of those (mostly Caucasian) populations.   This process largely leads to products that also work well among East Asian populations since for many disease conditions the epidemiology and physiology is sufficiently similar. However, there are many areas that have significant differences where those differences either create significant challenges or significant opportunities.  Some examples I have seen are in the areas of diabetes, neurovascular disease, end-stage renal disease and vascular disease.

Diabetes

Due to changes in diet and lifestyle, diabetes is an area that has exploded in China over the past 15 years.  The current estimate is that there are over 100 million people suffering from diabetes in China today. Insulin manufacturers such as Novo Nordisk and Sanofi-Aventis have capitalized very well on this trend with China becoming the second largest market in the world for their products. Blood glucose meter companies have also done relatively well in China, although they have met a few difficulties due to lack of reimbursement, limited affordability and low patient education.  The story is different, however, for insulin pumps. Those pumps that have been doing very well in the US and Europe have hit significant challenges in uptake in China. This is because these products are fundamentally designed for Type I diabetes, which is largely a European disease.  The prevalence of Type I diabetes in China is roughly 1/20th to 1/40th of that of the US, with only around 100,000-200,000 Type I patients in China versus one million or so in the US.  Recently there have been simple, economical pumps designed for Type II diabetes released in the US such as the V-Go.  Assuming these products are well accepted in the US, there would likely be a good opportunity for them in China.

Neurovascular disease

Despite the market challenges faced by insulin pump makers, there are many areas where the potential prevalence rate is larger in China (and other East Asian countries) than the West and thus create even bigger opportunities than would be assumed just given China’s large population. For instance, neurovascular aneurysms have a much higher prevalence among East Asians than those of European decent.  Neurovascular coils are a typical therapy for such disease.  The US has around 25,000 coil procedures while Japan with a population of about one third the US has around 20,000 procedures.  Though China right now also has around 20,000 procedures, if diagnosis and access issues could be resolved, China has the potential to have around 200,000+ procedures or roughly eight times the US market.

End-stage renal disease (ESRD)

In addition to existing prevalence rates, manufacturers should look at prevalence trends.  The current ESRD population comprises around 400,000 patients.  ESRD is a complication of advanced stage diabetes usually after someone has had diabetes (type II) for quite a number of years.  As the sharp incline in diabetes incidence only started a little over 10 years ago, it is only now that we are seeing a significant increase in chronic kidney disease (CKD), a pre-cursor to ESRD.  As the prevalence rates of ESRD in other East Asian regions such as Japan and Taiwan are even greater than the US following the diabetes and CKD trends, we expect the population to explode to over two million people in the next 15 years with the influx of new ESRD patients from China, which would be a boom for dialysis equipment suppliers.

Vascular disease

Also, there are certain disease conditions that are very prevalent in China but not so much in the US and Europe.  Not surprisingly, these conditions are not yet being addressed by Western medical device companies.  For instance, thoracic aortic dissection is a common problem among East Asian populations that is much less common in the West.  Most commonly, stent graft systems originally designed for thoracic aortic aneurysms (TAA) are used to treat this problem.  However, aortic dissection causes a narrowing of the aorta by the introduction of a false lumen.  TAA stent graft systems are not designed for such a narrowing of the aorta and can sometimes lead to complications because of this.  A Chinese manufacturer called Grikin took advantage of this unmet need.  They designed the only stent graft system to specifically address aortic dissection by utilizing a conical shape to avoid this problem thus gaining significant market share.

Though some large multinationals are already putting resources to address market differences in China, a majority of the market still looks at China and East Asia as an after thought in their R&D process.  Western companies would best be vigilant as to what the current epidemiological situation and trends are in China is for their products as early as possible to ensure they understand the potential opportunity and appropriately take advantage of it or make better use of their resources elsewhere.

On February 15, 2014, posted in: News by

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