Frost & Sullivan Asia Pacific

By Rae Sita Massie – Industry Manager, Medical Devices & Diagnostics, FROST & SULLIVAN ASIA PACIFIC

Diabetes has reached epidemic levels - around the world it is estimated that at least 140 million people have diabetes, with the number of new cases on the rise every year. According to the World Health Organization, the three countries with the highest incidence of diabetes are India, China and USA. Overall, Pan Asian countries recorded the highest incidence of diabetes with approximately 96 million diabetics in 2000. By 2010, the number is expected to increase to 139 million. The rising incidence of diabetes has prompted a flourishing market, not only for the pharmaceutical manufacturers, but also for companies producing diabetes monitoring devices and drug delivery systems.

In year 2000, Frost & Sullivan estimated that the total market for blood glucose strips and meters in Pan Asia (excluding China), US and Europe reached above $2.89 billion, with a Compound Annual Growth Rate (CAGR) from 2000 to 2005 of 15.6 percent. By 2005, we predict that the combined markets will be over $5.97 billion. Although Pan Asia is the smallest revenue contributor in the combined markets, its CAGR is the highest, nearly reaching 20 percent. In addition, as Pan Asian countries have the highest diabetes incidence rate, the region offers potential in the untouched/underdeveloped markets.

Around the globe, the giants in this industry are Johnson & Johnson’s Lifescan, Roche Diagnostics, Abbott Diagnostics’ Medisense and Bayer Diagnostics. These manufacturers are in a constant race to top one another, with occasional spurts of competition from local manufacturers in various countries. A serious competitor in Asia is Korean-based Allmedicus. The group is expanding its grip in Asia by increasing its GlucoDr exports to China and the South East Asian countries, positioning itself as one of the more potent threats to the global giants.

Despite the high incidence of diabetes, only half of the individuals with diabetes in Asia are diagnosed with the ailment. The main challenge for medical professionals in diagnosing and treating their diabetic patients is the lack of understanding among the patients regarding the disease, which usually leads to problems with treatment compliance and monitoring.

Monitoring glucose levels present issues for the majority of patients in Asia. In the less developed countries, such as India and Indonesia, some of the physicians prefer that the patient come in to clinics to have their glucose levels checked. This does not mean that the doctors are against blood glucose self-monitoring; most are unsure that the patient can perform the self-monitoring correctly. In addition, the high cost of glucometers deters patients from purchasing their own monitoring device. As a result, the frequency of glucose monitoring in these countries is low - on average the patients only monitor their blood sugar levels once a day, compared with 4 to 7 times per day in other parts of the world.

In developed countries in Pan Asia, such as Japan and Australia, the challenge faced by the manufacturers is in convincing patients to purchase particular glucometer brands. However, one similarity, in both developed and the less developed countries, is the patients’ dislike of pricking their fingers to obtain the blood sample for the meter.

THE QUEST FOR INNOVATION

Realizing the opportunity in the painless glucose-monitoring segment, companies are competing to invent technologies for non-invasive or minimally invasive monitoring devices. More than 40 companies are noted to have joined the search for this niche technology.

One of the first companies to begin development of an innovative technology for painless monitoring was Futrex Inc. The company’s Dream Beam Analyzer was based on technology designed to measure ‘a person’s blood glucose levels by passing infra red lights through his or her fingers’. However, the US Securities and Exchange Commission in 1996 charged Futrex with fraud, claiming that there was no evidence that the Dream Beam worked. The company settled the lawsuit in 1999 without admitting or denying the charges.

Another product that created much hope but ended up with no significant result was the Diasensor 1000 by Biocontrol Technology, Inc. (Bico). Similar to the Dream Beam Analyzer, the Diasensor technology passed infra red light through the patient’s skin and through the blood, which was then reflected back to the sensor. In 1996, the US FDA delayed the final recommendation for this product pending the company’s data on the production model. However, in Europe, the Diasensor 1000 obtained the CE mark, and was believed to have gone on sale in 1998. But an article in the Pittsburgh Post Gazette in March 2001 revealed Bico’s statement that there were no buyers for Diasensor in Europe in 2000.

DRAWING BLOOD - Minimally Invasive Glucose Monitoring Devices

Some companies ‘settled’ on developing minimally invasive monitoring devices, based on various technologies such as interstitial fluid testing. Other technologies used, although they tend to be lancet replacements, are silicon microtechnology and laser technology.

Georgia based SpectRx Inc. is developing a ‘painless, bloodless, alternative for conventional finger stick personal glucose meters.’ The device is like a skin patch that ‘measures the glucose level in the interstitial fluid (ISF)’. This could enable diabetic patients to monitor their glucose levels without multiple finger pricks for blood samples. The company received a grant from the US Center for Disease Control and Prevention (CDC) for clinical studies. Currently the product is undergoing clinical studies at the Barbara Davis Center for Childhood Disease in Denver, Colorado.

Kumatrex Inc. is developing a silicon micro-needle that could enable users to draw blood painlessly. The micro-needle is expected to be about the size of a mosquito sting and able to draw a small amount of blood. Many believe that this technology can be adapted and incorporated in various diagnostics applications, including blood glucose monitoring.

The US Food & Drug Administration (FDA) has approved Cell Robotics Inc.’s Lassette Plus. It is a lancing device that uses the laser beam to prick the finger and draw blood. The procedure is not as painful as when using the conventional lancing device. However, some say that because the device burns the skin, it may also burn the blood; hence the quality of blood would not be adequate for analysis. In addition, there is an odor of burned flesh that may cause discomfort for some users.

To date, the US FDA has approved only one minimally invasive glucose-monitoring device. Medtronic Minimed’s Continuous Glucose Monitoring System (CGMS) was approved by the agency in 1999. Using ISF technology, the CGMS sensor is implanted in the abdomen skin for 3 days and will provide readings every 5 minutes over 72 hours. The data can then be downloaded for analysis, providing a complete picture of the patient's glycemic control.

PAINLESS ALTERNATIVES- Totally Non-Invasive Monitoring Devices

To date the US FDA has approved only one device that can be categorized as totally non-invasive. However, even this device does not eliminate the need to draw blood, as this is required to calibrate the device before usage.

The GlucoWatch Biographer by Cygnus Inc. initially received US FDA approval in March 2001 for marketing in the United States. This device is worn like a watch and extracts fluid samples from the skin. Readings are recorded every 20 minutes for 12 hours. The device is only available by prescription and intended for adults 18 years and above.

In August 2002, the Cygnus received another FDA approval for its improved second generation GlucoWatch G2 Biographer. Readings are taken every 10 minutes for up to 13 hours at a time. The G2 Biographer is available only through prescription for children age 7 and above.

Canadian-based CME Telemetrix Inc. is developing the GlucoNIR. This monitoring device uses near infrared light to measure the glucose level. A sophisticated algorithm is used to decipher the ‘relationship between the NIR measurements and the concentration of analytes like glucose’.

Infratec Inc.’s product in development, unlike the technology used in other glucose monitoring prototypes, measures the glucose levels through thermal radiation, using the mid infrared, rather than the near infrared. The technology is based on the understanding that ‘natural mid infrared body emissions change depending on the glucose concentration of the tissue’. Hence, to give out readings the device is simply placed on the ear, like an infrared ear thermometer.

TYING THE KNOT

The bigger manufacturers are already anticipating the future wave of painless glucose monitoring. Keeping watchful eyes towards those companies developing painless technology, many snagged partnerships with them.

Bayer Diagnostics sealed an agreement with Kumetrix Inc. in 2000, giving Bayer the rights to explore potential applications in blood glucose monitoring using Kumetrix’s micro needle technology. Sankyo Co. Ltd., the second largest pharmaceutical manufacturer in Japan, entered a selling agreement with Cygnus Inc., manufacturer of the GlucoWatch, for marketing rights in the United States.

In efforts to keep its competitive advantage, Abbott Laboratories first partnered with CME Telemetrix Inc. at the end of 1997, before it dropped the company for SpectRx Inc., a company developing a continuous blood glucose-monitoring device. However, in January 2003, the company sought termination of agreement with Abbott Laboratories as it felt that the development progress of the minimally invasive monitoring device is not fast enough. Meanwhile, CME Telemetrix Inc. sought alliance with Motorola Inc. for ‘worldwide, royalty bearing, and exclusive license to CME’s non-invasive blood glucose monitoring device and other diabetes-related analytes’.

Keeping up, in 1999 Roche Diagnostics also entered an agreement with SpectRx Inc. to develop its Accu-Check TM D-Tector TM. It is a non-invasive diabetes detection device using optical sensors. The device detects diabetes by ‘shining a blue light into the lens on the eyes’, applying SpectRx proprietary biophotonic technology.

And last but not least, but taking a slightly different route, Johnson & Johnson’s Lifescan entered an agreement with Cygnus Inc. to share market research data regarding the GlucoWatch Bigrapher. Johnson & Johnson has not revealed much regarding its plans to develop a non-invasive/minimally-invasive blood glucose monitor, only that the company is ‘committed to being the first to introduce a non-invasive blood glucose monitoring device that is commercially viable’, although it does not have to be the first company to sell such a device in the market.

Will Non-Invasive and Minimally Invasive Blood Glucose Monitors Replace Meters and Strips?

Currently the market for non-invasive or minimally invasive blood glucose monitors is still in its infancy. Despite the significant breakthroughs that these devices made, especially with the FDA approval of the GlucoWatch, the devices still have a long way to go to replace the conventional strips and meters. Reliability and accuracy of the devices is still an issue, not to mention cost – at first glance this may seem much higher than the current meters and strips. In addition, many of the larger manufacturers are developing new glucometers that require very small blood samples using a near-painless lancing procedure. Hence, users may be more receptive towards these newer models.

Another reason why the non-invasive technology may not replace strips and meters immediately is because there is still much to reap in the current market from the existing technologies. The meters and strips have contributed billions to the manufacturers worldwide, and the logical move is to maximize revenues of the existing technologies before they become completely obsolete.

It will be interesting to see whether the trend evolution is a shift from invasive to minimally invasive or non-invasive technology. The new non-invasive devices will certainly solve one problem: comfort. However, they will present another: the universal issue of cost. One of the major challenges for manufacturers will be to educate the users on the product, and convince them that the price is worth the improvement in comfort - unless the manufacturers can manipulate the cost to be ‘household friendly’.

Sources:

Children with Diabetes - www.childrenwithdiabetes.com CME Telemetrix Inc. - www.cmetele.com Cygnus Inc. - www.cygn.com Diabetes Monitor - www.diabetesmonitor.com Kumetrix Inc. -www.kumetrix.com Medtronic Minimed - www.minimed.com Pittsburgh Post Gazette - www.postgazette.com SpectRx Inc. - www.spectrx.com US Food and Drug Administration - Center for Devices and Radiological Health - www.fda.gov/cdrh/consumer/index/html

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