Regulatory Intelligence on Medical Device Recalls - Ineffective Process Control, Defects in Design of Device, Software or Other Components are the Major Reasons for Recall
- Language: English
- 73 Pages
- Published: April 2012
Many are concerned that the global economic downturn is blunting the rapid growth in the BRICS countries. Is this a time of exciting opportunity or commercial danger for medical manufacturers and how is the economic turmoil affecting each market? These reports separate fact from fiction and are essential in making sound, impartial business judgements.
These leading emerging economies represent a total medical market of US$26.8 billion. But how might the impact of the economic downturn affect them? Where do commercial opportunities exist for medical device companies now, and what are the future prospects?
Putting things in perspective
With a combined population of 3.0 billion people and with significant unmet medical need, the challenges and opportunities of the BRIC markets are considerable. The economic downturn has affected these markets varyingly; for example, the Brazilian import market may be affected by disadvantageous US$ exchange rates, but China is affected more by a weak economy in the USA, its major market. Significant growth rates are impressive, but the low starting point – along with a range of other operational issues – means companies must be targeted in the opportunities they pursue.
Opportunities do exist
There are, of course, wide regional differences in expenditure levels within the BRIC countries, far more so than in developed countries where health systems have evolved to provide a more uniform level of coverage. All four countries have a relatively wealthy urban population with a far greater spending power than their respective national average. These urban populations have grown rapidly, and number hundreds of millions. The challenge for these countries is to extend this level of wealth to the rest of the population, in order that better levels of healthcare become affordable.
A long haul
The prevailing economic woes have to be seen over the long term. This is evolution not revolution, and change will be incremental. Short-term opportunities exist in meeting the health demands of the burgeoning middle classes, and future prospects are bright, where steady growth in BRIC markets will erode commercial differences with the established markets in North America, Japan and Europe.
Highlights from the Region
Brazil has the largest economy and medical device market in Latin America, but per capita medical expenditure is still very low. The highest expenditure is in the large cities, such as Sao Paulo or Rio de Janeiro, but producers are moving into regional markets outside the major state capitals. Dilma Roussef, who took office as President on 1st January 2011, has largely followed in the footsteps of former president Lula da Silva, maintaining market-friendly policies and ensuring broad policy continuity. The next elections will be held in 2014. GDP is forecast to grow 3.5% in 2013 and at an average of 4.1% through to 2018. With a growing economy, if inflation is kept in check, there will be more money available to spend on healthcare both in the public and private sectors.
In 2012, the Russian market for medical equipment and supplies is estimated at US$5,455.7 million. Per capita spending is low by European standards at US$39 per capita. This is despite rapid growth, especially of imported products, in the 2007-11 period. Russian medical device manufacturers are generally small and under-capitalised, and tend to produce obsolete products; they can only compete with Western products in terms of cost. The country has a strong scientific research base but has no experience of commercialising new products. Exports are low and centred on other former USSR markets. In November 2010, the government developed a strategy that will help the medical device industry to attract investment, create new jobs and produce competitive, safe, good quality and affordable products to fulfil the healthcare system’s requirements. Currently, the bulk of high-tech medical equipment comes from abroad. If the objectives of the plan are realised, by 2020, the local industry will be able to meet 50% of the local demand for medical devices.
The Indian market for medical equipment and supplies ranks among the world’s top 20 but, despite strong growth rates, the market remains disproportionately small with per capita spending of US$2.4. The private sector is the dominant healthcare provider, particularly in urban areas, and as such is the major end-user of medical equipment. High quality, high tech products are sought after, particularly by facilities run by corporate groups such as Apollo Hospitals and Fortis Healthcare. The latest Five Year Plan (2012-17) proposes an ambitious expansion of healthcare services including doubling the level of public health spending to 2.5% of GDP and increasing health insurance coverage from 25% to 75%. Given the lack of healthcare infrastructure, the government’s plans mark an opportunity for private investors, and manufacturers of medical devices, as new facilities are constructed and existing ones are upgraded. Detailed regulation of medical devices is still under consideration. New regulations were to have been published as the Drugs, Cosmetics and Medical Device bill in the winter 2012 parliamentary session, but implementation has been further delayed.
For 2012, The analyst estimates market growth to be in the region of 21.4%; one of the fastest growing markets in the world. High rates of growth are not uncommon in the Asian region, but on the back of a huge market size, China’s growth is particularly pronounced. Latest annual data to December 2012 show that imports have grown very strongly during the period, rising by 20.8% to reach US$10,329 million. All product categories posted strong growth during the period, with orthopaedic & prosthetic products leading the way with a rise of 51.4% over the previous year. All other categories achieved at least 15% growth during the period. The prospects for medical device spending is huge; the government has committed heavily in the construction of thousands of hospitals, healthcare centres, clinics and this will inevitably lead to spending on capital goods, most notably medical devices, equipment and furniture at an unprecedented rate in a relatively short space of time. In addition, the government is actively encouraging the development of the private sector to cater for the growing needs of China's middle classes and restrictions on foreign investors operating hospitals have been lifted.
South Africa has a particularly low provision of doctors at less than one doctor (0.7) per thousand population. In 2008, of the total 34,687 doctors or medical practitioners registered with the Health Professions Council of South Africa (HPCSA), only 30.7%, or 10,653, were working in the public sector with the majority working in the private sector. This means the provision rate for doctors in the public sector is just 0.2 per thousand population.
The long term growth prospects of the South African medical device market will be strongly influenced by the ANC government’s policies in regards to the new National Health Insurance (NHI) scheme, the promotion of public-private partnerships to develop and upgrade hospitals, the serious shortage of healthcare personnel and an urgent need to effectively address the AIDS crisis in the country.
The government has committed itself to increasing the level of healthcare spending and has launched a 14-year programme to implement universal healthcare coverage.
A key driver of growth is expected to be the public-private partnerships to develop hospitals in South Africa but this could be tempered slightly, by a depreciating rand against the US dollar and the general state of the South African economy.
The medium term prospects for the medical device industry look encouraging; based on current trends, the market, of which over 90% is supplied by imports, is expected to grow at a CAGR of 8.7% from 2012-2017.
Imports reached a new record high of US$1,178.9 million in 2011, rising by 20.3% over the previous year and expanding at a CAGR of 8.1% during the 2007-2011 period. Imports fell in 2009 following poor economic conditions but bounced back with two consecutive years of growth.
These Quarterly Updated Reports Analyse the Issues
The Outlook for Medical Device Markets in Brazil, Russia, India, China and South Africa is published by Espicom. Each report provides an individual and highly-detailed analysis of each market, looking at the key regulatory, political, economic and corporate developments in the wider context of market structure, service and access. The reports are available individually or as a discounted collection, and the price includes 4 completely updated reports sent quarterly and details of local medical equipment distributors.
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BRICS Medical Device Market Reports
With the BRICS Medical Device Market Reports you can easily evaluate these markets. Each report provides individual and highly-detailed analysis of the market, looking at the key regulatory, political, economic and corporate developments in the wider context of market structure, service and access. The reports are available individually or as a discounted collection. SHOW LESS READ MORE >
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