Asia-Pacific medical device market gets healthier

The Asia Pacific (APAC) medical devices market will grow more than 10 percent over the next three years. This is higher than the projected global sector growth of 6 percent. APAC’s growth in medical devices will be driven by healthcare service providers’ demand for safe, reliable and cost-effective medical treatments, as well as consumers demanding better medical products.

The APAC medical devices market is estimated at $55 billion. This is about a quarter of the global medical devices market, valued at more than $230 billion. Medical devices manufacturers are expected to increase revenues in APAC from diseases related to diabetes, cardiovascular, orthopedic and infectious diseases.

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To facilitate the growth of medical devices market, most APAC countries are gradually adopting more stringent regulatory policies for production registration and quality local medical devices manufacturing.

An example is Malaysia, which established its first set of medical device regulations under the Medical Device Bill in 2008. Registration of medical devices is not mandatory in Malaysia. Over time, however, more regulations regarding the production and importation of medical devices are expected to increase. The medical devices market in Malaysia is medium-sized and is worth about $600 million. 90 percent of Malaysia’s medical devices are imported. Most of these are from the US, which accounts for more than 25 percent of the total medical device imports.

Rising rates of breast cancer in Japan

The number of breast cancer cases among Japanese women is expected to rise 25 percent from now to year 2020. This is higher than the forecasted 14 percent growth for the US and the EU over the same period. Main causes of this dramatic increase are Japanese environmental pollution and hormonal changes. Physical inactivity and changing diet patterns among Japanese women also play a role.

Breast cancer mortality in Japan has crept up since 1999. Currently, it accounts for about 9 percent of total Japanese female cancer mortality cases, up from 7 percent in 1999. However, this percentage of breast cancer mortality versus other cancer mortalities for women is still lower than that in the US, at 15 percent. Late detection of breast cancer in Japan is a key reason for the rising mortality rate. Breast cancer is most common among Japanese women in their 40s.

The common breast cancer screening method in Japan is mammography. However, mammography screening in Japan is less effective in detecting breast cancer of women in their 40s, vis-à-vis women in their 50s. This is because women in their 40s have more dense breast tissues, which makes detection through mammography more difficult.

Recently, a more effective method increasingly recognized in Japan, as well as the US and Europe, is ultrasound elastography. Using tissue elasticity imaging techniques, this method is used with ultrasound devices to clinically diagnose breast diseases. Research has indicated that ultrasound elastography is more successful than mammography in distinguishing malignant from benign breast lesions. In other parts of Asia, the efficacy of ultrasound elastography for breast cancer diagnosis is believed to be in early stages of study.

China’s new QMP regulations for medical products

• Medical Devices
  As of January 1, 2011, the notifications entitled “Quality Management System Regulations for Medical Devices (interim)” and “Requirements for Medical Device Quality Management System Inspection (interim)” were officially released. Currently, only sterile and implant medical devices are regulated under these new government quality regulations in China.
• Pharmaceuticals
  China’s State Food and Drug Administration (SFDA) first issued the Good Manufacturing Practice (GMP) for Pharmaceutical Products in 1988 to regulate the quality of drugs that are made in China. This regulation was recently revised and the latest GMP regulation is known as the Good Manufacturing Practice for Pharmaceutical Products (2010 revised edition) or the “new version of GMP.” On March 1, 2011, this new version of GMP will be implemented.

  After implementation, new pharmaceutical manufacturers will be required to comply with the new standards. At a later point in time, existing drug manufacturing facilities will need to meet this new regulation. The deadline to comply will be less than five years from the date of the implementation.

  The new version of the GMP has been issued to improve the quality of manufactured drugs. For example, there are more standards that distinguish between GMP hardware and GMP software used by drug manufacturing facilities. More specific clauses have also been added to better enforce the way records on manufacturing procedures are maintained. Other clauses improve the way the concept of risk management is addressed and enhance security measures. Additionally, changes have been made to allow for greater consistency with the World Health Organization’s GMP.

India’s Diagnostics Sector to Grow 20 percent

India’s diagnostics sector is forecasted to grow at about 20 percent over the next three years. The diagnostics sector is estimated to be about $2 billion by the end of 2013.

Five percent of India’s GDP is spent on healthcare. This is significantly lower than in the US, where healthcare spending is 15 percent of GDP. Indian healthcare expenditures, however will grow due to higher government spending and increasing private investment in healthcare. Other healthcare growth drivers are a growing number of affluent middle and upper income earners seeking more comprehensive medical care and an increasing number of health insurance policyholders.

More than two thirds of medical decisions in India’s medical institutions are based on local diagnostic services, which include pathological laboratory tests. There are about 100,000 diagnostic laboratories in India. This is about half the number of those in the US (about 200,000). Test volumes serviced by Indian laboratories vary, from a few hundred tests a day for regional and hospital laboratories, to 2,000 to 3,000 tests per day for larger laboratories.

India’s diagnostic services, including specialized tests such as molecular diagnostics, are generally cheaper than in most developed countries. However, most Indian laboratories in the private sector are not accredited, as accreditation is not mandatory in India.

Ames Gross is president and founder of Pacific Bridge Medical, recognized nationally and internationally as a leader in the Asian medical markets. Founded in 1988 PBM has helped hundreds of medical companies with business development and regulatory issues in Asia. Contact PBM at info@pacificbridgemedical.com.