Medical Technology in Australia:
Key facts and figures 2014
Acknowledgements
The information in this factbook has been obtained from a variety of sources. These include Medical Technology Association of Australia (MTAA) members, the Australian Bureau of Statistics (ABS), Australian Institute of Health and Welfare (AIHW), Therapeutic Goods Administration (TGA), Australian New Zealand Clinical Trials Registry (ANZCTR), Eucomed, EvaluateMedTech, Medicare Benefits Schedule (MBS), Private Health Insurance Administration Council (PHIAC) and Independent Hospital Pricing Authority (IHPA). In some cases where direct data is not available extrapolations have been made (and noted where this is the case).
Suggested Citation
Medical Technology in Australia: Key facts and figures 2014, Occasional Paper Series: Sydney. Medical Technology Association of Australia Limited (2014).
International Standard Serial Number (ISSN) ISSN 2200-5668 (Print)
Contact Details
E: reception@mtaa.org.au
All correspondence: Medical Technology Association of Australia, PO Box 2016, North Sydney NSW 2059, Australia.
Disclaimer
Every effort has been made to ensure the accuracy, correctness and reliability of the information provided in this paper. MTAA does not claim that the information is free of errors.
Copyright © 2014 Medical Technology Association of Australia Limited (MTAA)
To the extent permitted by law, all rights are reserved and no part of this publication covered by copyright may be reproduced or copied in any form or by any means except with the written permission of MTAA Limited.
Contents
1. Introduction
2
2. About MTAA
4
3. What is medical technology?
6
Benefits of medical technology 7
4. General health trends in Australia
85. The Australian health system
10The Australian hospital system 11
Funding for public hospital services 12
Caring for patients in the community 12
National Disability Insurance Scheme 14
Telehealth and remote monitoring trends in Australia 14
Health expenditure in Australia 15
International health expenditure and trends 16
Relative costs of medical technology 17
6. The medical technology industry in Australia
18Historical timeline of entrants to the Medical Technology sector 19
Industry structure growth 19
Products supplied by the industry 19
Size of industry 19
Geographical locations of medical technology companies (head offices) 19
Employment 19
Imports and exports 20
Industry value in Australia 20
Industry value globally 20
7. Medical technology regulation and reimbursement in Australia
22Medical device inclusions in the Australian Register of Therapeutic Goods 23
Medical technology listed on the Prostheses List 23
8. Clinical research and innovation in Australia
26Medical technology and clinical research in Australia 27
Research and development 27
Patent applications 28
2 Medical Technology in Australia: Key facts and figures 2014
1. Introduction
The fourth edition of the MedicalTechnology in Australia: Key facts and figures booklet provides updated
data and statistics from 2014. The Medical Technology Association of Australia (MTAA) has been publishing this resource since 2011 to summarise available information on the medical technology industry. The factbook provides a valuable resource for those wanting to gain a better understanding of the medical technology industry in Australia and globally.
The Australian medical technology industry, which includes medical devices, diagnostics and medical imaging equipment, comprises a diversity of manufacturers and suppliers of medical technology: • Australian companies and Australian
affiliates of multinational companies, which undertake manufacturing in Australia for the domestic market and for export
• Australian companies which manufacture off-shore for import to Australia and for overseas markets • Affiliates of multinational
companies, which import to Australia and from time to time undertake clinical investigations in Australia and collaborations with Australian research institutions • Independent distributors which
import and distribute medical technologies.
Medical technology saves and improves lives by detecting diseases earlier, monitoring progress and by providing more effective treatment options for patients and the healthcare system.
The industry is characterised by a high level of innovation, resulting in short life cycles for many products. Many medical devices undergo constant development based on feedback from medical practitioners and their patients, and advances in other sciences relevant to medical technology.
The Australian medical technology industry:
• had turnover of approximately $10.2 billion (2012-13)
• imported goods to the value of $5.59 billion and exported goods to the value of $2.23 billion
• was responsible for approximately 44,000 medical devices listed in the Australian Register of Therapeutic Goods (ARTG, 2014) with up to a million different devices linked to them
• included over 500 medical technology companies with products listed in the ARTG • was mainly located in NSW (55%)
followed by Victoria (24%) and Queensland (12%)
• employed more than 19,000 people.
Globally the medical technology market
was valued at US$349 billion in 2012 and
is forecasted to grow to US$455 billion in
2018 with a compound annual growth rate
of 4.5% between 2012-18
1.
4 Medical Technology in Australia: Key facts and figures 2014
The MTAA is the national association representing companies in the medical technology industry. The MTAA’s objective is to ensure the benefits of modern, innovative and reliable medical technology are delivered effectively to provide better health outcomes to the Australian community.
MTAA represents manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and management of disease and disability. The variety of medical technology is diverse with products ranging from consumable items such as syringes and wound dressings, through to high-technology implanted devices such as cardiac pacemakers, defibrillators, hip and other orthopaedic devices. Products also include hospital equipment, surgical equipment and diagnostic imaging equipment such as ultrasounds and magnetic resonance imaging machines.
MTAA members distribute the majority of the
non-pharmaceutical products used in the diagnosis and treatment of disease and disability in Australia. Our member companies also play a vital role in providing healthcare professionals with essential education and training to ensure safe and effective use of medical technology.
The medical technology industry is a positive contributor to science, research and innovation, improved health outcomes, the economy, trade, manufacturing, employment, education and training, and society through its philanthropy.
The Medical Technology Association of Australia (MTAA)
is the national association representing companies in
the medical technology industry. MTAA aims to ensure
the benefits of modern, innovative and reliable medical
technology are delivered effectively to provide better health
6 Medical Technology in Australia: Key facts and figures 2014
3. What is medical
technology?
The term medical technology is used to describe a broad range of products used in the diagnosis, prevention, treatment and management of disease and disability, such as medical devices, including in vitro diagnostic devices (IVDs), imaging equipment, and dental equipment.
A medical device is any instrument,
apparatus, appliance, material or similar other articles which, without chemical action within or on the body, can diagnose, prevent, or treat a disease or other condition. Examples range from bandages, syringes and disposable gloves, to pacemakers, hip and knee prostheses and surgical instruments.
IVDs are considered
medical devices, and are used to perform
diagnostic tests on human specimens in vitro (outside the human body), for the purpose of diagnosing or monitoring
a disease or other condition. Examples include home pregnancy test kits, blood glucose monitoring devices, and IVD systems used in the diagnosis of genetic diseases.
Imaging equipment is used to
capture medical images of patients for the purpose of diagnosing a disease or other condition.
Examples include radiography (x-ray), ultrasound, computed tomography (CT), and magnetic resonance imaging (MRI).
Dental equipment includes products
such as dentistry tools, alloys and resins that are used by dentists and allied oral healthcare professionals, as well as over-the-counter products used by consumers such as floss and brushes.
For the full legislative definitions of a medical device and IVD, see the Therapeutic Goods Administration (TGA) website2.
For a more detailed comparison between medical devices and pharmaceuticals please access the MTAA website www.mtaa.org.au
Medical
Technology
Medical Devices
IVDs EquipmentImaging
Dental Equipment
Medical technologies benefit lives in many ways, for example3:
• Telehealth and remote monitoring systems can link rural communities to top-class specialist care units via video conferencing services, eliminating unnecessary visits and reducing travel time for patients and health care professionals.
• Patients with insulin pumps and glucose monitors manage disease better with greater adherence to regimes and less daily pain than those who use conventional treatments.
• The use of communication technologies such as mobile health applications can replace face-to-face consultations e.g. Swedish doctors are able to carry out teledermoscopic evaluations of skin lesions by using an iPhone app, camera and customised dermoscope, with an accuracy rate comparable to face-to-face consultations.
• Ophthalmologists can review photographs of the eye to check for diabetes and glaucoma in Indigenous people without the need for them to leave their remote communities.
Benefits of medical technology
Minimally-invasive surgical techniques, which are now used to treat aneurysms, can reduce recovery time to around four weeks, compared with more than a year for older procedures.
Patients with cardiovascular disease treated with drug-eluting stents have been shown to require fewer repeat revascularisation procedures (6.6% versus 16.6%) and incur lower average costs for supplemental medical care.
Medical technology comprises 2% - 5% of national health expenditure; however, appropriate use of medical technology reduces hospital stays by an average of 13%.
8 Medical Technology in Australia: Key facts and figures 2014
4. General health
trends in Australia
Australia faces a rapidly ageing population, with the number of people aged 85 and over projected to more than quadruple by 2050; increasing from 400,000 in 2010 to 1.8 million (5.1% of the total population). By 2050 it is expected that over 3.5 million older people will access aged care services each year, with 80% of services delivered in the community4. Public aged care expenditure, currently $15 billion (including informal care support), will be driven by demography, expansion in planned supply, and unit cost changes. By 2050 it is projected to rise from 0.8% of GDP to 2.2%, but will remain below the OECD average5. The anticipated increase in expenditure is driven by a rise in demand due to an ageing population with growing levels of chronic disease and not by increasing levels of reimbursement for medical technology.
During 2012-13 the Australian Government provided almost $1.5 billion to the Commonwealth Home and Community Care (HACC) Program, which delivered services to 967,092 people, of which 78% were aged 65 years and over. With a budget allocation of $2 billion in 2015-16, the program represents a substantial investment by the government to support independence of older people at home and in the community4.
Compared with other countries, Australia performs strongly across a range of important health indicators. Life expectancy for Australian women is the third highest globally at 84 years, and for men it is the fourth highest at 80 years. More than half of Australian adults rate their health as excellent or very good6.
Coronary heart disease (CHD) is still the leading cause of death, with 20,064 deaths (14% of all deaths) in 2012. However, this has fallen steadily from 19% in 2003 influenced by advances in medical and surgical treatment. For people with established CHD, significant reductions in coronary events and deaths have been achieved through revascularisation procedures that restore good blood supply to the heart by either reducing or bypassing coronary artery blockages7.
There were 10,779 deaths from cerebrovascular disease (including haemorrhages, strokes, infarctions and blocked arteries of the brain), making these the second most common cause of death followed by dementia and Alzheimer’s disease, accounting for 10,369 (7% of all deaths) in 2012. The majority (95%) of these deaths occurred in people aged 75 or over8.
In 2004 almost 23% of Australians aged 65 or over had three or more chronic diseases. By 2007 more than 80% of people in that age group had three or more long-term health conditions. The combined costs of chronic diseases and an ageing population are expected to exceed $200 billion by 20459.
Aboriginal and Torres Strait Islander people continue to have a greater burden of ill health. They have a lower life expectancy than other Australians (7.5 years less for females and 8.8 years less for males), higher incidence of chronic diseases and are more likely to experience disability and reduced quality of life. The leading cause of death amongst Aboriginal and Torres Strait Islander people is heart disease, with diabetes ranked as the second leading cause. Many lower income earning Australians and people living in remote areas of Australia also experience poorer health compared to those on higher incomes or living in major cities. The hospitalisation rate from chronic diseases in remote areas of Australia is more than double that for major cities. In remote Australia there are only 589 nurses and 58 GPs per 100,000 residents, compared to almost 1000 nurses and nearly 200 GPs in major cities10.
The combined costs of chronic diseases and an ageing population are expected to exceed $200 billion by 2045. Coronary heart disease is the leading cause of death, with 20,064 deaths (14% of all deaths) in 2012.
The hospitalisation rate from chronic diseases in remote areas of Australia is more than double that for major cities.
10 Medical Technology in Australia: Key facts and figures 2014
5. The Australian
health system
The Australian hospital
system
Australia has a universal health care system, with private health funding and services operating alongside the public health system. The private healthcare industry comprises 34 private health insurers and continues to be dominated by a small number of large insurers (top five insurers represent 82% of national policies); the remaining 18% of the market is distributed between 29 insurers. In 2012-13, 55% of the Australian population was privately insured, of which 47% held a cover for private hospital treatment and 55% were covered by a general treatment policy. Private hospital cover can ease potentially long waiting lists in the public system and provide patients with a choice of doctors11.
Australia has 1,338 hospitals, 55% public and 45% private. In 2012-13 there were almost 9.4 million separations (episodes of care) for admitted patients (5.5 million in public and 3.8 million in private hospitals). In the last 4 years, the number of separations increased by 3.1% on average for public and by 4.1% for private hospitals. In 2012-13 the average length of hospital stay excluding same-day separations was 5.6 days (5.8 days in public and 5.2 in private hospitals), a slight reduction since 2008-09.
Same-day admissions for public and private hospitals are rising at a rate faster than overnight admissions. Between 2008-09 and 2012-13 same-day admissions rose by approximately 3.6% each year, compared with 2.7% for overnight admissions. Continued improvements in medical technologies and techniques will enable procedures to be provided as a single day treatment, which means that same day service utilisation will likely continue to increase11. Subacute and non-acute admissions (such as rehabilitation, palliative and maintenance care) rose by an average of 13.7% each year for private and 8.2% for public hospitals12. The majority of privately insured acute hospital episodes (66%) were provided in private hospitals, 15% in private day facilities, and 3% were provided as Hospital Substitute Treatment (HST). The proportion of episodes attributable to public hospitals increased to 16%, which indicates an increase in private health cover utilisation in a public hospital setting.
In 2012-13, 2.5 million hospital admissions involved surgery. The majority (2 million) were through elective admissions and of these 67% occurred in private hospitals. Almost 1 in 4 of public hospital patients was admitted for general surgery (surgery on organs of the abdomen) and 1 in 7 was admitted for orthopaedic surgery (surgery on bones, joints, ligaments and tendons, including knee and hip replacements). Indigenous Australians had a lower rate of elective surgery admissions compared with other Australians, 58 per 1,000 people compared with 88 per 1,000. In 2012 half of all patients waited up to 36 days for public elective surgery, an increase from 33 days in 2008-09 and unchanged since 2011-12. The surgical specialties with the longest median waiting times in 2012-13 were ophthalmology, ear, nose and throat surgery and orthopaedic surgery (76, 68 and 65 days, respectively). Cardiothoracic surgery had the shortest median waiting time (17 days). Coronary artery bypass graft was the procedure with the shortest median waiting time (16 days), while total knee replacement had the longest median waiting time with 196 days13. In 2012-13, 55% of the Australian population was privately insured. In 2012-13 the average length of hospital stay excluding same-day separations was 5.6 days
The surgical specialties with the longest median waiting times in 2012-13 were ophthalmology, ear, nose and throat surgery and orthopaedic surgery (76, 68 and 65 days, respectively).
12 Medical Technology in Australia: Key facts and figures 2014
Funding for public hospital
services
The Commonwealth and States share the responsibility for funding of public hospitals. In 2011 they agreed to a new funding deal, Activity Based Funding (ABF), and from July 2014 funding changed from a capped to an uncapped basis. The Commonwealth pays 45% of the National Efficient Price (NEP) for growth in volume of services relative to the previous year. The NEP is set by the Independent Hospital Pricing Authority (IHPA), is based on the National Hospital Costing Data Collection (NHCDC) and is set at the average cost of care across the country. This type of funding model aims to improve the value of the public investment in hospital care and ensures a sustainable and efficient network of public hospital services.
IHPA has completed three rounds of pricing review for public hospital services under the National Health Reform Agreement. The NEP for 2014-15 was set at $5,007 per National Weighted Activity Unit (NWAU) based on Round 16 NHCDC, which included data from 429 public hospitals. Comparing the national average cost per weighted separation ($4,812) both the territories are noticeably above ($5,934 in the NT and $6,496 in the ACT). The only state below the national average is Victoria with $4,087 per weighed separation14.
In the 2014-15 Budget, the Australian Government announced that ABF will end in June 2017, and that from 1 July 2017 efficient growth funding will be replaced with indexation for CPI and population growth. In addition, subject to consultation, the Government will work with the States and Territories to create a new Health Productivity and Performance Commission, by merging the Australian Commission on Safety and Quality in Health Care, AIHW, IHPA, the National Health Performance Authority, the National Health Funding Body and the Administrator of the National Health Funding Pool15.
Caring for patients in the
community
Medical aids, appliances, and consumables are essential for people with impairments or disabilities, and assist them with day-to-day living and participation in the community. These products are provided through over 100 stand alone Commonwealth, state and territories’ aids and equipment schemes. A plurality of schemes tends to result in ad-hoc and inequitable allocation to consumers and act as a barrier to economies of scale for suppliers16.
Accurately estimating the relevant expenditure on aids and equipment products in Australia is difficult due to the large number of consumers and products, multiple sources and types of supply, along with different definitions of aids and appliances. Based on the Australian government definition, aids and appliances are durable medical goods that are not implanted surgically but are external to the user of the appliance (glasses, hearing aids, wheelchairs and orthopaedic appliances and prosthetics). In 2011-12 an estimated $3.7 billion was spent on aids and appliances. Federal and state/territory schemes are listed below17.
25 30 35 40 2012-13 2011-12 2010-11 2009-10 2008-09 2007-08 2006-07 2005-06 2004-05 2003-04 2002-03 2001-02
Median waiting time (days)
Year $6,496 $5,934 $5,384 $5,265 $5,200 $4,892 $4,890 $4,087 $1,000 $2,000 $3,000 $4,000 $5,000 $6,000 $7,000
ACT NT WA TAS SA NSW QLD VIC
Average co st ( $)/ wei ghted sepa rati on States
National average cost per weighted separation $4,812 Figure 1: Median waiting time for elective surgery (days)13
Figure 2: National and state/territory average cost per admitted acute weighted separation in 201414
Federal schemes
Repatriation Pharmaceutical Benefits Scheme (RPBS) Rehabilitation Appliances Program (RAP)
Administered by the Department of Veterans’ Affairs (DVA)
The RPBS provides access to certain medications, dressings and assistive devices for treatment of entitled veterans and war widows
The RAP provides aids and appliances to eligible members of the veteran community to help them maintain their independence. A range of appliances are provided through six product groups
National Diabetes Services Scheme (NDSS)
Administered by Diabetes Australia, this scheme delivers diabetes-related products at subsidised prices, information and support services to over 1 million people with diabetes each year. Products include blood glucose testing strips, insulin pump consumables, sharps and urine testing strips and products
Stoma Appliance Scheme (SAS)
Provides stoma related products (medicines and appliances) to individuals who have undergone either a temporary or permanent surgically created body opening (stoma)
Continence Aids Payments Scheme (CAPS)
Assists individuals with permanent and severe incontinence to meet some of the costs of continence products
Epidermolysis Bullosa Dressing Scheme
The only federal scheme for modern wound care devices assists patients with Epidermolysis Bullosa
Australian Government Hearing Service Program
Provides access to hearing devices and services External breast prostheses
reimbursement program
Assists women who have had a mastectomy due to breast cancer with reimbursement for new or replacement external breast prostheses
Type 1 Diabetes Insulin Pump Programme
The Type 1 Diabetes Insulin Pump Programme is the result of collaboration between the Australian Government and the Juvenile Diabetes Research Foundation (JDRF) to provide subsidies for insulin pumps for people under 18 years of age. Since its inception in 2008, the Programme has provided subsidies for over 600 insulin pumps.
Table 2: State and territory schemes providing medical aids and appliances in Australia
Major state/territory schemes
ACT ACT Equipment Scheme (ACTES) NSW EnableNSW
NT Disability Equipment Program (DEP) QLD Medical Aids Subsidy Scheme (MASS)
SA Department for Communities and Social Inclusion Equipment Program TAS Community Equipment Scheme (CES)
VIC Statewide Equipment program (SWEP)
WA Community Aids and Equipment Program (CAEP)
14 Medical Technology in Australia: Key facts and figures 2014
National Disability Insurance
Scheme
In 2011-12, 4.2 million Australians were living with a disability, of which 1.4 million had a severe or profound disability. The number of people living with a profound or severe disability is estimated to increase to almost 2.3 million people by 203018.
The demand for disability aids and equipment is increasing along with total public and private expenditure on disability, health and aged care. On 1 July 2013 the Federal Government launched the National Disability Insurance Scheme (NDIS) in New South Wales, Victoria, Tasmania and South Australia. Further trials began in the ACT, NT and Western Australia from 1 July 2014.
The government will provide more than $1 billion of funding over four years, which will support people with permanent and significant disability, their families and carers. The scheme is a new way of funding individualised support for people with disability that involves more choice and control. This provides a lifetime approach to a person’s support needs.
As the NDIS is progressively rolled out in Australia, state and territory schemes will continue to work in conjunction with federal departments to streamline and simplify access to government subsidised aids and equipment in a way that will align with the NDIS19.
Telehealth and remote
monitoring trends in Australia
Across the world healthcare systems are recognising the need for innovation and advances in health technologies to meet the challenges of rising demand with increasingly scarce human, capital and operational resources, while at the same time delivering improvements to service quality and availability. The next wave of medical technology will be a drive to design streamlined, smarter, and more personalised devices that are less invasive than existing products and that allow for simplified remote care.
Telehealth and remote monitoring are powerful technologies that allow patients to monitor their health at home, deliver savings by reducing hospitalisation and hospital readmissions, and move many services outside the hospital and into the community setting.
The Australian Government introduced funding for telehealth services in 2011. In Australia, under the universal health insurance scheme Medicare, there is a list of professional services and procedures performed by healthcare providers that attract a Medicare benefit. Medicare benefits are available for video consultations between patients and a variety of health professionals, including specialists, consultant physicians and psychiatrists, medical practitioners, nurse practitioners, midwives, practice
nurses and Aboriginal health workers. Figures from Medicare show that over the period from June 2011 to the end of March 2014, 169,000 services have been provided to more than 62,000 patients by over 9,700 practitioners. The trend is increasing21.
Over 109,000 services were provided by 3,364 specialists including 58,925 services from 6,390 GPs and 680 services from 40 midwives or nurse practitioners. The most popular specialist services were psychiatry (21%) and paediatric services (11%). Queensland and New South Wales offered the majority of telehealth services (50,751 and 50,383
respectively). Victoria provided 26,644 services followed by Western Australia with 15,130, South Australia with 13,943, Tasmania with 10,129, NT with 2,199 and ACT with 366 services21.
QLD 30% NSW 30% VIC 16% WA 9% SA 8% TAS 6% NT 1% ACT .22% Figure 3: Telehealth services by year and quarter20
1,809 5,220 6,096 12,937 16,524 19,111 15,398 20,300 22,610 24,108 25,489 0 5,000 10,000 15,000 20,000 25,000 30,000
Number of telehealth services
Quarter
Figure 4: Telehealth services provided by State and Territories20
Health expenditure in
Australia
In 2011-12 spending on health in Australia totaled over $140 billion or 9.5% of GDP (approximately $5,881 in recurrent expenditure per person). The majority (70%) of health spending in Australia is funded by the federal, state and territory governments with the largest component ($42 billion) for the provision of public hospital services (an annual spending growth rate of approximately 6%)22.
Cardiovascular disease (CVD) has the highest level of healthcare expenditure of any disease group in Australia ranking it ahead of oral health, mental disorders and musculoskeletal conditions. In 2008-09 estimated expenditure for CVD was $7,605 million or 12% of all allocated health care expenditure in Australia. CHD expenditure accounted for over one quarter of CVD
expenditure in 2008-09 (27%)23. Individuals contributed around $24.8 billion out-of-pocket on purchasing health services (approximately AU$1,101 per capita).
The funding of aids and appliances is heavily reliant on individuals, who make up 68% of the total aids and appliances expenditure of $3.7 billion in 2011-12. 0 4,000 8,000 12,000 16,000 20,000 24,000 28,000 32,000 36,000 40,000 44,000 !"#$%%$&'" Area of expenditure
Australian Government State/territory
$ millio
n
Non-government
Figure 5: Recurrent health expenditure, by area of expenditure and source of funds in 2011–1222
0 10 20 30 40 50
Percentage of total health expenditure
Year Australian Government State/territory Individals Health insurance funds Other non-government Figure 6: Total health expenditure, by source of funds as a
proportion of total health expenditure, 2001-02 to 2011-1222
Individuals 68% Government 17% Health insurance funds 13% Other 2%
Figure 7: Expenditure on aids and appliances in 2011-12 by source of funds in Australia22
16 Medical Technology in Australia: Key facts and figures 2014
International health
expenditure and trends
Australia’s population size is small in comparison to other countries with only 0.33% of the world’s total population. The total Australian population in 2011 was approximately 22.3 million. In comparison to other advanced nations: Canada 34.5 million, the United Kingdom 61.8 million, France 65.1 million, the US 311.6 million and China 1.53 billion. Public and private health expenditure per capita for major economies is shown below. The United States continues to outspend all other OECD countries at two and a half times the average. In 2011 Australia spent US$3,800 per capita, 13% above the OECD average24.
In 2014 global healthcare spending as a percentage of GDP will average 10.5%, with regional percentages of 17.4% in North America, 10.7% in Western Europe, 8% in Latin America, 6.6% in Asia/ Australasia and 6.4% in the Middle East/ Africa.
In 2012 total global healthcare spending rose by an estimated 1.9%. It continued to rise in 2013 with total spending of 2.6% and is expected to continue that trend by an annual average of 5.3% until 201725.
European economic conditions appear to be stabilizing, but some southern European nations face further need for continuing debt reductions including reducing public spending. Most affected may be Portugal, where health spending is unlikely to start recovering until 2017. Greece and Spain may also take until at least 201625 to recover.
Health expenditure in North America is set to rise by an annual average of 4.4% from 2013-17. Growth will be driven partly by the expanded access to health insurance coverage through the Affordable Care Act and Medicaid25.
The Asia-Pacific region’s healthcare spending is expected to grow at a rate of 7.1% from 2013-2017. India has expanded its primary care policy priority and is expected to increase spending at an average rate of 17% a year, followed by China at over 14% a year. Indonesia, Thailand, the Philippines, and Malaysia are also likely to see an increase in growth as they expand their health insurance systems, while healthcare spending in Japan is expected to further increase due to its rapidly aging population25.
0 1000 2000 3000 4000 5000 6000 7000 8000 9000 United States Canada
Germany France Australia
United Kingdom
OECD Japan New Zealand
RussianFederation China India
US$ PPP
Country
Private Public Figure 8: Health expenditure per capita for OECD and emerging
Relative costs of medical
technology
Medical technology is often blamed for the high cost of healthcare. Data from both local and international sources show that this assumption is incorrect. Data from the World Medical Markets Fact Book 2012 (Espicom) which covers expenditure on medical devices in 66 countries shows that expenditure on devices is relatively low compared to other health costs.
Of the 66 countries from which data is available, Australia ranked 13th for total health spending per capita and 15th for medical device spending per capita. Australia was ranked 54th when measuring medical device spending as a percentage of total health spending, indicating that spending on medical devices is a small percentage of total health expenditure.
There was a decline in spending on medical devices from 3.8% of total health spending in Australia in 2006 to 3.3% in 2011 (a decline of 12%). Australia ranked as low as 41st for medical device spending as a percentage of GDP per capita and device spending per capita accounted for only 0.29% of GDP per capita on average. The data suggests that in comparison to other countries, spending on medical devices is relatively low in Australia and has only minor impact on overall costs26. KPMG performs an annual survey of manufacturing costs internationally, including manufacturing costs for medical devices. In the most recent survey, Canada ranks first among the nine countries with the lowest manufacturing costs having re-established a competitive advantage since 2012. France and Italy rank fourth and fifth respectively in the standings and continue to represent mid-cost countries amongst the mature market nations. The final four countries are tightly grouped with a significant convergence of business
costs in recent years (within one percent of the US baseline). Japan and Australia have moved ahead of the US since 2012, leaving Germany as the only country with business costs higher than the US. The most dramatic change in the international cost competitiveness rankings is Japan,
which now ranks in sixth place among the nine nations. Years of low inflation allowed Japan to gradually improve its competitive position during the 2000s and now with the drop in value of the Yen over the last two years, Japan is significantly more competitive27.
0 1 2 3 4 5 6 2006 2007 2008 2009 2010 2011
% Medtech expenditure of total
health expenditure Year Japan USA France UK Australia Canada Figure 9: Medical technology expenditure as a percentage of total
health expenditure 2006-2011 (per capita, current US$), for select high GDP OECD countries26
85 90 95 100 105 110 115
Manufacturing index (US=100)
Country
2012 2014 Figure 10: Medical device manufacturing costs in 201427
18 Medical Technology in Australia: Key facts and figures 2014
6. The medical technology
industry in Australia
Start-up companies 54%
Established as a subsidiary of a multinational company 35% Formed as derivative companies from other companies 2% Universities 1%
As a result of mergers 2%
The medical technology industry has grown substantially since 1990 with the majority of companies (62%) established during the 1990-2012 period. Only 10% of medical technology companies operating in Australia were established prior to 1970. Throughout the 1950s and 60s the industry experienced sustained growth, but it was not until post-1970 that more rapid expansion occurred. Almost 40% of companies in Australia today were established post-2000.
Size of industry
The Australian Register of
Therapeutic Goods (ARTG), the most comprehensive listing of medical technologies available in Australia, has approximately 44,000 medical device entries, supplied by over 2,400 sponsors, of which over 500 are medical technology companies29.
Employment
28The medical technology industry in Australia employs more than 19,000 people30. The ABS estimates that in 2009-10 there were 12,545 people employed in the medical technology manufacturing sector, including those in the medical and surgical equipment (n=11,199) and photographic, optical and ophthalmic equipment (n=1,346) manufacturing sectors31.
55%
24%
12%
Products supplied
by the industry
Medical technology companies develop, manufacture and supply a wide variety of devices. Principal products supplied or manufactured in Australia include single use technologies (11%), implantable devices (9%), anaesthetic/respiratory devices (8%) and orthopaedic devices (7%). The data was obtained through the MTAA industry wide survey
.
1950-60 1970 1980 1990 2000 2010
Historical timeline of entrants to the Medical Technology sector
22%10% 40%
The main areas of therapeutic
focus for Australian companies
Cardiovascular (13%)Anaesthesia (11%) Musculoskeletal (10%) Skin (8%)
Industry structure growth
28Geographical locations
of medical technology
20 Medical Technology in Australia: Key facts and figures 2014
Imports and exports
Nearly all medical technology products manufactured in Australia are also exported, while the majority of medical technology products used in Australia are imported. In 2013-14 the value of medical technology imports was $5.59 billion and the value of medical technology exports was $2.23 billion32.
Australia imports significantly more medical devices than it exports (a net deficit in trade in medical technology). There are several steps that can be taken to increase the sustainability of the medical technology sector, which could contribute to a stronger healthcare system and support the robustness of Australian manufacturing. These include the capability to identify, design, develop, make and sell products that are in demand; maximise leverage from strong and sustainable partnerships through local and global supply chains; and seek markets in emerging growth economies33.
Table 3: Top ten medical technology import and export products (2013-14) (according to value)
Top import
items Top export items
Other Respiratory instruments
Artificial Artificial body parts body parts Imaging Other instruments Spectacle Hearing aids components Needles/ Spectacle syringes components Cardiac Other* Woundcare Imaging Orthopaedic Dental equipment Dental Optical/ equipment ophthalmic Other* Needles/syringes *Other includes surgical gloves, glass ampoules, first aid boxes and kits, and laboratory, hygienic or pharmaceutical glassware.
Industry value in Australia
There is no official data collected on sales of medical technology in Australia. MTAA calculates the size of the industry based on extrapolation of data from its database, and from statistics collected by its third party service provider via an industry wide survey and the quarterly Market Barometer Online Survey (MBOS)34. This information is augmented by data obtained from the Manta Media website.
Total revenue for the Australian medical technology industry for 2012-13 was over $10.2 billion. And with the inclusion of IVD sales ($800 million)35 and dental products ($765 million)36, the total revenue for the medical technology industry was approximately $11.8 billion.
Australia has 35 medical device companies listed on the Australian Securities Exchange (ASX), comprising 22% of total value (MCap=$11,406 million)37.
MBOS constitutes data from 20 of the largest MTAA member companies reporting their Australian quarterly revenue in medical devices. Data from the first quarter 2014 survey shows the following increases and decreases38: Sales revenue increases:
• Long-term moving annual total (MAT) sales across all areas have grown by 8% (year on year)
• Service repair grew by 75% between Q4 2013 and Q1 2014. The largest segment is consumables with 8% growth.
Sales revenue decreases:
• Sales for Q1 2014 were 10% lower than sales in Q4 2013 (this is a seasonal decline across all states)
• Public and private hospital sales declined with the greatest decline for public hospitals (16% down from Q4 2013).
Growth of 5.4% per annum over the next five years for medical and surgical equipment manufacturing has been forecast39. Key external drivers include demand from hospitals and wholesalers, an increase in medical and surgical products as a result of visits to doctors, increased capital expenditure on machinery and an increase in product demand as a result of improved health funding. While private hospitals/clinics represent about 10% of the market for industry products, this group is characterised by high-technology sales. A key driver of consumption in Australia is an ageing population.
Industry value globally
The worldwide medical technology market is expected to achieve global sales of US$455 billion by 2018 and to grow at 4.5% per annum from 2012-18. The analysis by EvaluateMedTech, based on in-depth forecasting models for the top 180 global medical technology companies, reported that medical technology is set to outperform the prescription drug market (3.8% growth per annum).
In 2018 in vitro diagnostics is expected to be the world’s largest medical technology segment with sales of US$58.9 billion. Neurology is the fastest growing segment with 6.9% growth per annum while diabetic care and orthopaedics are forecast to be the slowest segments with 3.4% growth per annum1.
Device area Worldwide sales (2012) (US$bn) Worldwide sales (2018) (US$bn) CAGR* % growth 1 In vitro diagnostics 43.6 58.9 +5.1 2 Cardiology 38.1 48.7 +4.2 3 Diagnostic imaging 36.1 45.1 +3.8 4 Orthopaedics 32.7 40.0 +3.4 5 Ophthalmics 23.6 32.9 +5.7 6 Endoscopy 17.7 24.2 +5.3 7 Drug delivery 17.7 22.0 +3.7
8 General & Plastic surgery 13.4 18.4 +5.4
9 Dental 12.6 16.5 +4.6
10 Wound management 11.9 14.7 +3.5
11 Diabetic care 11.8 14.4 +3.4
12 Nephrology 10.9 13.9 +4.1
13 Ear, Nose & Throat (ENT) 6.6 9.5 +6.2 14 Anaesthesia & Respiratory 6.1 8.5 +5.6
15 Neurology 5.3 8.0 +6.9
*Compound Annual Growth Rate
Johnson & Johnson is forecast to remain the number one medical technology company in terms of global sales, with US$33.4 billion in sales projected in 2018. Nonetheless, its share of the medtech market is expected to fall, from 7.9% in 2012
to 7.3% by 2018. The fastest growing of the top 20 companies are lens maker Essilor International and Baxter International, which is active in a variety of areas including dialysis and drug delivery1. 27.4 17.7 16.6 11 9.8 9.6 9.6 9.6 8.7 7.2 6.7 6.7 6.6 6.5 5.7 5.5 5.1 5 4.8 3.7 0 5 10 15 20 25 30 Worl
d wide medtech sales (
US$billion) +3% +4% +5% +4% +4% +5% +3% +3% +9% +2% +5% +5% +4% +5% +5% +9% +4% +2% +8% +8% CAGR 2012-2018 (%) Figure 11: Medical technology sales for the top 20 international companies in 20121
22 Medical Technology in Australia: Key facts and figures 2014
7. Medical technology regulation and
reimbursement in Australia
Medical device inclusions
in the Australian Register of
Therapeutic Goods
In Australia, medical devices must be included in the TGA Australian Register of Therapeutic Goods (ARTG) before they can be supplied. New medical technologies are added to the ARTG daily.
In June 2014 there were 43,952 entries for medical devices in the ARTG, estimated to represent between 500,000 and 1,000,000 different devices.
Class Risk Level Examples of technology
Class I Low Non-sterile dressings, wheelchairs, re-usable surgical instruments, devices for export only Class I(m) Low to Medium Class I devices with a measuring function, such as thermometers and patient scales Class I(s) Low to Medium Class I devices supplied sterile, such as sterile adhesive bandages
Class IIa Low to Medium Electrocardiographs, hearing aids, X-ray films, dental fillings, TENS muscle stimulators Class IIb Medium to
High
PCA pumps, blood bags, orthopaedic plates and screws, device disinfectants, condoms Class III High Heart valves, breast implants, drug-eluting coronary stents, hip and knee replacements AIMD* High Pacemakers, implantable defibrillators, cochlear implants, ventricular assist devices
*Active implantable medical devices
There was a large increase in Class III devices entered in the ARTG during 2013 (up 133% from the previous year), due to the reclassification of hip, knee and shoulder joint replacements in 2012 from Class IIb to Class III. Approximately 500 of the 853 Class III devices entered in the ARTG in 2013 (and which remained in the ARTG in June 2014) were related to one of these joint implants.
Medical technology listed
on the Prostheses List
Under the Private Health Insurance Act 2007, private health insurers are required to pay mandatory benefits for a range of prostheses that are provided as part of an episode of hospital (substitute) treatment where a Medicare benefit is payable for the associated professional service (surgery) and the product is included on the ARTG. The DoH lists prostheses benefits biannually on the Prostheses List (PL).
Table 5: Classification system used for medical devices listed in the Australian Register of Therapeutic Goods40
Figure 12: Australian Register of Therapeutic Goods medical device entries at June 2014 by device class41
All medical devices supplied domestically or exported from Australia are regulated by the Therapeutic Goods Administration (TGA), which uses a risk-based classification system.
The reimbursement of medical technology in Australia is more complicated and occurs in many forms. Some processes are interrelated, while others are stand alone schemes. For medical devices that are implantable (prostheses), eligibility for reimbursement within the Australian private health insurance system is assessed by the Prostheses List Advisory Committee (PLAC) in the Department of Health (DoH).
Class I 48%
Class IIa 24% Class IIb 13%
Class III 9%
24 Medical Technology in Australia: Key facts and figures 2014
Prostheses list category Number of products Part A - Prostheses Specialist Orthopaedic 2,863 Spinal 1,422 Hip 1,104 Knee 1,034 General Miscellaneous 851 Plastic and Reconstructive 711
Vascular 504
Neurosurgical 454
Cardiac 378
Urogenital 228
Ophthalmic 220
Ear, Nose & Throat 181
Cardiothoracic 74
Orthopaedic 14
Plastic and Reconstructive* 3
Total 10,041
Part B - Human tissue products
Orthopaedic 244
Cardiothoracic 20
Ophthalmic 15
Dermatologic 8
Total 287
Part C - Other devices
General Miscellaneous 7
Cardiac 6
Total 13
Source: MTAA analysis
*Bone Matrix Implants (artificial)
The February 2014 PL listed 10,341 items on Parts A, B and C. Of these items, 68% are supplied by MTAA member companies. The list includes 539 changed billing codes; 388 for new products, 45 resulting from expansions, 61 resulting from transfers, 10 from compressions and 35 from duplications42.
Based on the 2011 Health Technology Assessment (HTA) Review
reforms, benefit negotiations (gap payments) were abolished, and a single benchmark benefit point was determined for each clinical subgroup and assigned a suffix. In the February 2013 PL, 119 items were still gap listed, and this was reduced to 9 gap-permitted prostheses in the orthopaedic and specialist orthopaedic categories in the February 2014 PL42.
There were 2,834 items on the February 2014 PL that were also listed on the 2005 list (product category changes not analysed). There were 7,207 items that could not be matched because of billing code changes. The matched items show that the average minimum benefits have decreased by $35.76 since 2005. If increases in the CPI were taken into account, benefits would have increased by 26%. If health CPI was taken into account, the increase would have been 46%.
In the year to March 2014, benefits of approximately $1.7 billion were paid by registered private health insurers. Annual expenditure grew by 10%, while utilisation grew by 11%43.
Table 6: Number of products listed on the February 2014 Prostheses List by product category
2, 427 59 216 1, 135 693 312 53 2, 726 52 190 1, 073 617 366 60 2, 715 50 284 1, 311 562 853 71 500 1,000 1,500 2,000 2,500 3,000
Class I Class I(m) Class I(s) Class II(a) Class II(b) Class III AIMD
Number of devices included
ARTG class
2011 2012 2013 Figure 13: Australian Register of Therapeutic Goods license starting dates by device class41
100,000 200,000 300,000 400,000 500,000 600,000 100,000,000 200,000,000 300,000,000 400,000,000 500,000,000 Number of prosth eses Benefits (A UD$)
Prostheses Total Benefits Prostheses Total Number
0% 5% 10% 15% 20%
Plastic and Reconstructive Cardiothoracic
Ear, Nose & Throat Urogenital Neurosurgical Vascular Ophthalmic Spinal General Miscellaneous Other Specialist Orthopaedic Hip Knee Cardiac
Figure 14: Private Health Insurance Administration Council prostheses expenditure by quarter43
The clinical category with the greatest amount of benefits paid was cardiac, comprising 20% of all prostheses benefits, with an annual expenditure totaling $334 million to March 2014.
Figure 15: Private Health Insurance Administration Council proportion of prostheses benefits paid by product category43
26 Medical Technology in Australia: Key facts and figures 2014
8. Clinical research and
innovation in Australia
Medical technology and
clinical research in Australia
Australia continues to be recognised internationally for the conduct of high quality clinical trials. Clinical trials represent a major investment in Australia - with an estimated worth of $1 billion per annum to the Australian economy including more than $450 million of foreign investment44. The number of clinical trials conducted in Australia continues to grow steadily. In 2013 there were 570 medical technology clinical trials registered in Australia - a growth of 19% from 201245.
Research and Development
The annual spend for research and development (R&D) in 2011-12 for medical and surgical equipment manufacturing was $237 million47. This is an increase of approximately $20 million (or 9%) from the previous year.
There is a range of funding/
government assistance available for medical technology companies in Australia48. The R&D Tax Incentive was introduced in 2011, replacing the R&D Tax Concession, R&D Tax Offset, and the associated Incremental Premium and International Premium Concession systems49. It provides a tax offset to encourage companies to engage in R&D and product development. The R&D Tax Incentive provides a 43.5% refundable tax offset to eligible entities with an aggregated turnover of less than $20 million per annum and a non-refundable 38.5% tax offset to all other eligible entities. The incentive helps businesses offset some of their R&D costs. It is a broad-based entitlement program open to companies of all sizes in all sectors that are conducting eligible R&D.
The MTAA is part of a group of organisations, including Cook Medical Australia, AusBiotech, and the Export Council of Australia, that has proposed an Australian Innovation and Manufacturing (AIM) Incentive, or ‘Patent Box’ scheme focused on supporting local innovators and manufacturers50. Specifically, the scheme would offer a reduction in tax payable from profits derived from the commercialisation of qualifying intellectual property (IP), addressing the losses that result when Australian IP is sold or manufactured overseas. Once an innovative idea reaches the commercialisation phase, companies would be incentivised to keep Australian IP and manufacturing in Australia (the scheme would reward companies who succeed in exporting products). 7658 5971 1243 490 80 125 171 931 1215 570 262 229
28 Medical Technology in Australia: Key facts and figures 2014 0 50 100 150 200 250 300 350 400 450 500 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Number of patent grants
Year
2000 2001 2002 2003 2004
2005
2006
2007
2008
2009 2010 2011
2012
Patent grants 117
135
171
187
176
190
209
225
250
252
369
469
484
Australian medical technogy patent grants (2000 - 2011)
Figure 17: Number of Australian medical technology patent grants from 2000-1253
Patent applications
The World Health Organization (WHO) and the World Intellectual Property Organization (WIPO) collaborate to respond to increasing demand for innovative medical technologies, and to ensure access to these technologies51.
Patent applications by medical technology companies provide a good indicator of innovation. In Australia, medical technology patent applications made up 7.8% of the total number of applications between 1999-2013
(comparable to pharmaceuticals 6.5% and civil engineering 7.7%)52. The number of Australian medical technology patent grants has shown a steady increase since 2009.
30 Medical Technology in Australia: Key facts and figures 2014
Timeline of key Australian medical technology inventions
1926 The world’s first electronic heart pacemaker is developed at Sydney’s Crown Street Women’s Hospital by Dr Mark Lidwell and Edgar Booth
1930s The humidicrib is developed in Tasmania in response to the polio epidemic and is a portable alternative to the ‘iron lung’ made from plywood. The technology is used to save premature babies
1961 Drs George Kossoff and David Robinson build the first ultrasound scanner and pioneer the field of fetal ultrasound obstetrics
1970s Professor Earl Owen and microscope manufacturers Zeiss pioneer microsurgery, which uses specialised microinstruments and equipment for precision surgery
1978 The first person is implanted with a cochlear implant (bionic ear) developed by Professor Graeme Clark at the University of Melbourne
1980s Dr Victor Chang pioneers modern heart transplantation in Australia. His work in conjunction with St Vincent’s Hospital leads to the development of the artificial heart valve
1981 Professor Colin Sullivan and co-workers at Sydney University invent the continuous positive airway pressure
(CPAP) machine, which supplies pressure to keep the airways of sleep apnoea patients open during sleep 1990 Professor Fred Hollows is named Australian of the Year for his work in eye health, including the
development of low cost manufacturing of intraocular lenses
1991 Drs Michael Ryan and Stephen Ruff from Sydney perfect plastic rod bone repair, using plastic rods rather than metal pins and tubes, which interfere with scans (e.g. MRI)
1992 Optical research scientist Stephen Newman develops the world’s first multi-focal contact lens in Queensland, giving clear vision at all distances to individuals with presbyopia
1998 The Solarscan™ device is developed, which scans the skin and compares the image to a database to determine whether sunspots are melanomas
1999 Long-wearing night and day contact lenses that transmit an increased volume of oxygen and can
remain in place for 30 days are developed by the Cooperative Research Centre for Eye Research and Technology in NSW
2005 Dr Fiona Wood is named Australian of the Year for her work in burns treatment, including the develoment of
spray-on skin for burns victims
2010 An Australian hospital performs the Southern Hemisphere’s first total artificial heart implant. The artificial mechanical device mimics the function of both heart ventricles, which are responsible for pumping blood
2011 Melbourne-based company Phosphagenics aims to offer patients with diabetes the world’s first
transdermally delivered insulin
2013 A partnership between scientists at the University of Wollongong and St Vincent’s Hospital in Melbourne leads to a breakthrough in tissue engineering, with researchers growing cartilage from stem cells in 3D
printed scaffolds to treat cancers, osteoarthritis and traumatic injury
2014 A handheld bio-pen is developed by the University of Wollongong, which will allow surgeons to design customised implants on-site and at the time of surgery. The BioPen prototype was designed and built using 3D printing equipment and will be suitable for repairing damaged bone and cartilage
32 Medical Technology in Australia: Key facts and figures 2014
Medical technology can deliver significant savings to the health system over time, and enable individuals who are kept well to remain productive and contribute in the workplace and community. Unfortunately, the benefits of medical technology are often poorly understood, insufficiently articulated and developed, and may be perceived as being a cost burden on the healthcare system.
MTAA developed the Value of Technology (VOT) research project to contribute to an improved understanding of the impact of advances in medical technology on healthcare expenditure in Australia, and the associated costs and benefits for the Australian healthcare system and community54. The outcome of the VOT research provides evidence-based support for a range of technologies that might not have strong Australian evidence to date and/or lack funding.
Previous MTAA VOT research areas include insulin pump therapy for diabetes, modern wound care devices, and remote monitoring for chronic heart failure patients with implantable cardiac devices.
Home dialysis
55Chronic kidney disease (CKD) is a long-term health condition of the kidney that lasts for at least three months with evidence of kidney damage and/or reduced kidney function56. Individuals with CKD (including early stages) have increased mortality, primarily from cardiovascular complications57. End stage kidney disease (ESKD) is the most severe form of CKD characterised by total or almost total impairment of renal function (i.e. below 10% of normal kidney function). The majority of individuals with ESKD need dialysis or a transplant for survival.
The common causes of ESKD are58:
• diabetes
• glomerulonephritis
• hypertension polycystic kidney disease
• reflux nephropathy.
Burden of disease
Around one in three adult Australians is at increased risk of developing CKD59.
There are more than 1.7 million Australians with CKD60. The prevalence of CKD and ESKD is projected to rise by up to 80% by 2020 due to an ageing population and the rising prevalence of diabetes in Australia.
CKD (and ESKD) disproportionately affects individuals in low
socioeconomic circumstances, particularly Indigenous Australians61. Indigenous Australians, particularly those living in remote areas, have a higher incidence of ESKD - around 20–30 times greater than the national average62.
The treatment options for ESKD, known as renal replacement therapies (RRT), include renal dialysis and kidney transplantation. However, there is a shortage of kidneys available for transplant in Australia63.
Economic burden
The direct healthcare cost of CKD in 2004-05 was estimated at $900 million. The cost of treating ESKD from 2009-2020 is estimated to be $12 billion to the Australian Government. Incidences of CKD are projected to increase by more than 54% by 202064.
Cost burden of ESKD includes:
• cost of hospitalisations - over $1.1 billion annually65
• loss in productivity64
• transport costs (70% of dialysing is performed in hospitals and satellite facilities - up to $50 per week per patient66).
Treatment options
Dialysis is a treatment that uses diffusion and a filter to clean wastes out of the blood. There are two main forms of dialysis: haemodialysis (HD) and peritoneal dialysis (PD).
Dialysis can be conducted at various locations:
• hospital or ‘in-centre’ units - dialysis units located in tertiary hospitals with fully staffed renal services
• satellite centres - regional/ remote community dialysis facilities linked with a tertiary centre renal unit but without onsite trained nephrology assistance
• in the home - patients dialyse at home and have the option to dialyse more frequently and/or have longer treatments. Only around 30% of all dialysis is performed in the home67.
34 Medical Technology in Australia: Key facts and figures 2014 0 5,000 10,000 15,000 20,000 25,000 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 Number of patients Year Transplantation Dialysis Total ESKD Modality 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 Transplantation 5309 5524 5800 6026 6316 6567 6880 7128 7526 7916 8377 8781 9320 Dialysis 6409 6851 7263 7719 8004 8641 9262 9730 10166 10451 10677 10998 11446 Total ESKD 11718 12375 13063 13745 14320 15208 16142 16858 17692 18367 19054 19779 20766 Figure 20: Prevalence of ESKD, dialysis and transplantation
Figure 19: Number of patients with end-stage kidney disease undergoing dialysis and transplantation in Australia68
Figure 18: Number of patients treated for end-stage kidney disease in Australia projected to rise60
0 5,000 10,000 15,000 20,000 25,000 2000 2002 2004 2006 2008 2010 2012 2014 2017 2019 Number of patients Year Female Male Projected Female Projected Male
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
% of all
dialysis
Facility Dialysis
HomeDialysis
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 Home Dialysis 2480 2580 2569 2624 2596 2679 2941 3086 3193 3177 3056 3041 3275 Facility Dialysis 3929 4271 4694 5095 5408 5962 6321 6644 6973 7274 7621 7957 8171Figure 21: Proportion of dialysis individuals on each treatment modality in Australia
36 Medical Technology in Australia: Key facts and figures 2014
1 EvaluateMedTech World Preview 2013, Outlook to 2018 – The Future of Medtech
2 In accordance with section 41BD of the Therapeutic Goods Act 1989, and definition of an IVD medical device in the Therapeutic Goods (Medical Devices) Regulations 2002
3 Modified from www.eucomed.org/medical-technology/value-benefits
4 Australian Government Department of Social Services, 2014. Discussion paper on ‘Key directions for the Commonwealth Home Support Programme – Basic support for older people living at home’
5 ARC Centre of Excellence in Population Ageing Research, 2014. Research brief on ‘Aged care in Australia: Part 1 – Policy, demand and funding’
6 OECD 2014. OECD Factbook 2014: Economic, Environmental and Social Statistics. OECD Publishing
7 AIHW 2014. Trends in coronary heart disease mortality: age groups and populations. Cardiovascular disease series no. 38. Cat. no. CVD 67. Canberra: AIHW
8 ABS 2014. Catalogue 3303.0 – Causes of death, Australia, 2012
9 Australian Government Department of Treasury, 2010. Australia to 2050: future challenges – the 2010 Intergenerational Report
10 Parliament of Australia, 2013. Health in Australia: A quick guide. Available at: http://www.aph.gov.au/About_Parliament/ Parliamentary_Departments/Parliamentary_Library/pubs/rp/rp1314/QG/HealthAust
11 PHIAC 2014. Annual report 2012-13
12 AIHW 2014. Australian hospital statistics 2012-13. Health services series no. 54. Cat. no. HSE 145. Canberra: AIHW 13 AIHW 2013. Australian hospital statistics 2012-13: Elective surgery waiting times. Health services series no. 51 Cat. no.
HSE 140. Canberra: AIHW
14 IHPA 2014. National Hospital Cost Data Collection. Australian Public Hospitals Cost Report 2011-12, Round 16 15 Australian Government Department of Health. Health portfolio changes. Updated 13 May 2014. Available at: http://www.health.gov.au/internet/budget/publishing.nsf/Content/budget2014-Health-Portfolio-Changes 16 Queensland Competition Authority, 2014. Final report on ‘Price disparities for disability aids and equipment’ 17 AIHW 2014. Health expenditure Australia 2011-12: analysis by sector. Health and welfare expenditure series no. 51.
Cat. no. HWE 60. Canberra: AIHW.
18 AIHW 2013. Australia’s welfare 2013. Australia’s welfare series no.11. Cat. no. AUS 174. Canberra: AIHW 19 ABS 2013. Catalogue 4430.0 – Disability, Ageing and Carers, Australia: Summary of findings, 2012 20 Graph based on data sourced by MBS, 2014. Available at:
http://www.mbsonline.gov.au/internet/mbsonline/publishing.nsf/Content/connectinghealthservices-factsheet-stats 21 Medicare Australia 2014. Medicare Australia Statistics on Telehealth services. Accessed in June 2014
22 AIHW 2013. Health expenditure Australia 2011-12. Health and welfare expenditure series no. 50. Cat. no. HWE 59. Canberra: AIHW
23 AIHW 2014. Health-care expenditure on cardiovascular diseases 2008-09. Cat. no. CVD 65. Canberra: AIHW 24 OECD 2014. Society at a glance 2014: OECD social indicators. OECD Publishing
25 Deloitte 2014. 2014 Global health care outlook – Shared challenges, shared opportunities 26 World Medical Markets Fact Book 2012. Espicom Business Intelligence
27 KPMG 2014. Competitive Alternatives: KPMG’s Guide to International Business Location Costs. 2014 Edition 28 MTAA Industry wide survey 2012
29 Data obtained from the TGA. ARTG as at 13 June 2014
30 Estimate from MTAA database and MTAA industry wide survey 2012
31 ABS 2011. Catalogue 8159.0 – Experimental Estimates for the Manufacturing Industry, 2009-10
32 MTAA analysis. Data source: ABS, International Trade: Customised Report for Department of Industry, 2014
33 Future Manufacturing Industry Innovation Council, 2011. Trends in manufacturing to 2020 – A foresighting discussion paper
34 This information is augmented by data obtained from Manta Media: www.manta.com/world/Oceania/Australia/ 35 IVD Australia 2011. Annual report 2011
36 Australian Dental Industry Association, 2014. Dental industry business conditions survey. FY2013-14 Third Quarter 37 PriceWaterhouseCoopers 2014. Walking the tightrope: Policy and the life science sector. BioForum, Edition 47, Quarter 3
FY14, April 2014
38 See http://mtaaweb01/about-the-industry/industry-statistics/surveys (link accessible for members)
39 IBISWorld 2010. IBISWorld Industry Report C2832. Medical and Surgical Equipment Manufacturing in Australia 40 TGA 2011. Australian regulatory guidelines for medical devices (ARGMD). Part 1 – Introduction. Version 1.1 May 2011 41 Data obtained from the TGA. ARTG as at 13 June 2014
42 Prostheses List February 2014. Available at: http://www.health.gov.au/internet/main/publishing.nsf/Content/prostheses-list-pdf.htm
43 http://phiac.gov.au/industry/industry-statistics/prostheses/
44 Australian Government 2011. Clinically competitive: Boosting the business of clinical trials in Australia. Clinical Trials Action Group Report
45 Australian New Zealand Clinical Trials Registry (ANZCTR). Available at: http://www.anzctr.org.au/Support/Statistics.aspx. Accessed 2 July 2014
46 ClinicalTrials.gov. Available at: https://clinicaltrials.gov/. Accessed 2 July 2014
47 ABS 2013. Catalogue 8104.0 – Research and Experimental Development, Businesses, Australia, 2011-12
48 MTAA. See http://mtaa.org.au/about-the-industry/commercial/government-programs (link accessible for members) 49 Australian Taxation Office, 2012. R&D Tax Incentive. Available at:
https://www.ato.gov.au/Business/Research-and-development-tax-incentive/
50 MTAA. AIM Incentive. Available at: http://mtaa.org.au/docs/position-papers/aim-incentive-august-2014.pdf?sfvrsn=0 51 World Health Organization, World Intellectual Property Organization and World Trade Organization, 2012. Promoting access
to medical technologies and innovation – intersections between public health, intellectual property and trade
52 World Intellectual Property Organization. Statistical country profiles. Available at: http://www.wipo.int/ipstats/en/statistics/ country_profile/profile.jsp?code=AU
53 World Intellectual Property Organization. Statistics Data Center. Available at: http://ipstats.wipo.int/ipstatv2/ 54 MTAA. Value of Technology Project. Available at: http://www.mtaa.org.au/about-the-industry/value-of-technology 55 MTAA. Value of Technology report on Home Dialysis. Available at:
http://www.mtaa.org.au/about-the-industry/value-of-technology/home-dialysis
56 National Kidney Foundation, 2002. Kidney disease outcomes quality initiative (K/DOQI) clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. American Journal of Kidney Diseases. 2002. 39(2 Suppl 1): S1-266
57 Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalisation. New England Journal of Medicine. 2004. 351(13): 1296-305
58 AIHW 2009. An overview of chronic kidney disease in Australia, 2009. Cat. no. PHE 111. Canberra: AIHW
59 Chadban SJ, Briganti EM, Kerr PG, Dunstan DW, Welborn TA, Zimmet PZ, Atkins RC. Prevalence of kidney da
