To serve a surging patient population, companies will need a robust product and intellectual property portfolio to maximise growth.
Diabetes mellitus has become a growing global worldwide healthcare concern. It is the fifth leading cause of death in the majority of developed countries and is becoming an increasingly larger issue in emerging economies. The International Diabetes Federation (IDF) estimates the prevalence of diabetes to be 366 million people worldwide in 2011, and projects the disease to affect 550 million people and cost over US$500 billion annually by 2030. UBM TechInsights, in conjunction with Espicom, a noted medical market research firm, recently completed an analysis that included not just a market overview, but also a deep dive into the technology and intellectual property (IP) associated with the state of medical device treatment for this growing epidemic.
The analysis focused specifically on medical devices, with exclusions for drugs, transplants/cell replacement and generic chronic illness monitoring systems. Even so, the expenditure on device technologies and related systems needed to address the diabetes pandemic will reach US$18 billion in less than five years. Key findings include:
The remainder of this article will focus on the technology and IP analysis results, providing a glimpse into past and future technology areas. To supplement the information presented around the IP analysis, TechInsights has an active teardown programme that has evaluated and analysed a number of the popular blood glucose monitors (BGMs), continuous glucose monitors (CGMs) and insulin pumps. Examples of the internals of some of those products will be presented as well as additional perspectives.
Figure 1: Diabetes patents timeline.
A framework was devised to partition the problem into manageable segments that would facilitate an analysis of the products and technologies associated with diabetes. This approach resulted in 17 categories ranging from simple blood tests to an artificial pancreas. The IP, more specifically the patents, associated with each of these partitions was then collected, assessed and evaluated for relevance to the category. Finally, the technical and IP analyses were correlated against the marketing assessment, permitting a top-to-bottom connection between the companies, products, technology and medical device IP associated with the monitoring and treatment of diabetes.
A fairly generic search of diabetes-related patents in which the keyword diabetes was found in the patent claims generated more than 100,500 patents with patent activity beginning as early as 1969. The top 10 categories by International Patent Classification (IPC) code are all essentially drug-related patents and account for more than 51,000 of them. A screening process, including limiting the data set to medical device patents, resulted in almost 5900 unique patents (the data set) that were placed into the technology subcategories for individual review and analysis. Before diving into the details of one of these categories, a look at some of the characteristics of the overall data set is in order.
Figure 2: BGM and test strip top assignees (Green—further analysis in report).
The timing and distribution of the priority dates for the 100,000-plus patents associated with diabetes are detailed in Figure 1. The late 1990s saw a dramatic increase in the number of patents, with a peak occurring in 2005. This rapid increase followed a long period of stasis and very slow technology adoption from the development of long-acting insulin in the 1940s to the 1980s. The advent of small BGMs in the 1980s accelerated testing by the individual patient, providing a more efficient method of monitoring and treating this chronic illness. These events also prompted the development of specialists who could focus on treatment of the disease. The first insulin pumps were created in 1979. They were large and had to be carried in a backpack and, consequently, were quite inconvenient. Finally, the Diabetes Control and Complications Trial (DCCT) was conducted from 1983 to 1993, demonstrating that people who could manage their glucose level were less likely to contract long-term complications. Thus, a number of developments converging in the 1980s and 1990s spurred new thinking in the treatment of diabetes and triggered greater innovation across the technology groups. The peak in 2005 and 2006 reflects the large increase in innovation that had occurred during this timeframe with new products built on preceding technology. However, the drop in the number of patents since that time probably corresponds to several factors, including:
|Figure 3: BGM and test strip—priority date by top assignees.|
Emerging markets drive demand for SMBG
To illustrate how the integration of IP, technology and product teardowns can facilitate the setting of a strategic product development direction, one of the 17 technology categories will serve as an example. By far the most common form of blood glucose monitoring is self-monitoring blood glucose (SMBG). Currently, SMBG accounts for 97% of the diabetes monitoring market, as these products are widely reimbursed and approved, as well as relatively cheap and simple to use. These are the traditional finger-stick and blood test instruments.
|Figure 4: Abbott FreeStyle blood glucose meter.|
Although a well-established market, growth in this area is being driven by strong demand in emerging markets, while new products that enhance ease-of-use, improve accuracy and facilitate data management and sharing are providing growth opportunities in the developed world. An analysis of this technology category reveals that many of the leading IP assignees also are among the leading product providers. Figure 2 displays the top 20 assignees in this category. While a number of them are also leading sellers of products in the category, it is interesting, as well, to see the other companies in this area. In addition, further analysis of the target area from a time perspective as shown in Figure 3 often can reveal not only where a company (or technology) has been but where it may be going.
As mentioned previously, a solid technology evaluation programme includes the analysis of a physical product. In the diabetes product space, UBM TechInsights has analysed products
|Figure 5: Inside the FreeStyle BGM.|
ranging from blood glucose meters to insulin pumps and smartphone accessories. By integrating the market information, technology and IP with the product itself, a thorough picture of where things may be going begins to appear. Figures 4 and 5 provide a “look under the hood” of a popular BGM, the Abbott FreeStyle. However, the impact of the consumer upon the evolution of medical design can be seen in Figure 6, which shows the AgaMatrix iBGStar, a BGM designed to interface directly with an iPhone.
So what has this analysis indicated about the state of diabetes medical device technology today? Consumer demand for reduced levels of discomfort indicates a strong pull for noninvasive monitoring technology with a great deal of patent activity in this area. However, the commercialisation of minimally invasive or noninvasive products remains
a challenge. There are a number of active smaller companies in these emerging areas with potential for significant market disruption. We expect the large companies to be watching this space closely. While medical device advances will certainly continue and developments in monitoring technology of the chronically ill will make diabetes treatment more manageable, the promise of more comfortable and effective treatments through medical device technology continues to be a goal on the horizon.
|Figure 6: AgaMatrix iBGStar blood glucose monitor.|
The pace of fundamental development in the areas of monitoring and treatment of diabetes appears to have slowed while the overall market continues to grow as the prevalence of the disease increases. The emphasis today tends to be on patient compliance, driven primarily by ease of use, and consumer product influences, which is leading to devices that emphasise look and feel as opposed to performance. Finally, the ultimate medical device solution—the artificial pancreas—continues to be a much sought technology limited by technical, biological and regulatory issues that prevent it from being viable in the foreseeable future. In the interim, emphasis on disease management via improved monitoring and compliance will continue to dominate the device side while the search for biological solutions continues.