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Table of Contents
Executive Summary Market Overview Regulatory Environment Clinical Trials in Singapore Clinical Trial Types Clinical Trials by Therapeutic Areas Market Engineering Measurements Market Engineering Measurements Market Analysis Market Drivers Market Restraints Revenue Forecasts Clinical Trial Revenue Contribution by Phase Private Sector Sponsors of Clinical Trials Research and Development Trends in Singapore Competitive Analysis Competitive Structure Decision Support Databases About Frost and Sullivan 7 10 11 12 13 14 15 16 17 18 21 23 25 26 27 28 29 30 37
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List of Figures
CRO Market: Number of Clinical Trial Certificates Issued by the HSA (Singapore), 2000-2009 CRO Market: Market Drivers Ranked in Order of Impact (Singapore), 2010-2015 CRO Market: Market Restraints Ranked in Order of Impact (Singapore), 2010-2015 CRO Market: Revenue Forecasts (Singapore), 2009-2015 CRO Market: Competitive Structure (Singapore), 2009 Decision Support Database: Government Healthcare Expenditure (World), 2002-2012 Decision Support Database: Population Aged 65 and Above (World), 2002-2012 12 18 21 23 29 31 34
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List of Charts
CRO Market: Overview of Regulatory Agencies for Clinical Trials (Singapore), 2009 CRO Market: Types of Clinical Trials Conducted (Singapore), 2008 and 2009 CRO Market: Types of Clinical Trials Conducted by Therapeutic Areas (Singapore), 2007-2009 CRO Market: Market Engineering Measurements (Singapore), 2009 CRO Market: Revenue Forecasts (Singapore), 2009-2015 CRO Market: Clinical Trial Revenue Contribution by Phase (Singapore), 2009-2015 CRO Market: Private Sector Clinical Trial Sponsors by Type (Singapore), 2009, 2012, and 2015 CRO Market: Total R&D Expenditure on Biomedical and Related Sciences (Singapore), 2009-2015 11 13 14 16 24 25 26 27
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Executive Summary
Executive Summary
Market Trends The number of clinical trials conducted in Singapore has increased from 157 in 2000 to 262 in 2009, registering a compound annual growth rate (CAGR) of 5.9 percent. International trials comprise more than 80.0 percent of trials and are likely to continue to make up the majority in the future. There is a growing trend towards regional trials as Japanese regulations allow data from other countries to be accepted for drug launches in Japan. Currently, local trials comprise less than 10.0 percent of the total trials and offer limited growth potential as local pharmaceutical companies face challenges in raising funds. Oncology holds the highest interest for multinational pharmaceutical companies, with clinical pharmacology as the next highest; ophthalmology is also of growing interest. The size of the Singapore clinical trials market (phase I to phase IV) is estimated at US$128.4 million in 2009 and is forecasted to reach US$ 166.5 million in 2015, growing at a CAGR of 4.4% Currently, phases II, III, and IV contribute maximum revenues to the market, but by 2015, phases III and IV are expected to shrink. However, government initiatives for early phase trials are expected to increase the revenues of phase I, along with that of phase II. There is a fairly strong interest in biomarkers research, and Singapore will continue to see strong activity in this area due to companies making significant investments in the same. As a result, there is likely to be an increase in the number of clinical trials that incorporate biomarkers research.
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Singapores advanced infrastructure and investment from multinational pharmaceutical companies have made it conducive for trials, including early stage trials. From the regulatory perspective, there is likely to be an increased number of applications for trials that use flexible study designs to reduce time and costs of conducting clinical research.
Growth Opportunities
With Pfizer expanding its phase I unit in Singapore, there is an opportunity for the country to attract to similar studies in the country. In tandem with this, abbreviated non-clinical packages (for example, fewer animal studies and shorter duration pre-clinical studies) will become more visible. A growing emphasis on translational research within pharmaceutical R&D will help Singapore due to the Governments $1.10 billion investments in building the countrys translational and clinical research capabilities.
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Market Overview
10
Regulatory Environment
Clinical trial regulation is regulated by: The Medicines Act 1975 Medicines (Clinical Trials) (Amendment) Regulations 1998. Singapore Guideline for Good Clinical Practice (SGGCP) require to be observed.
CRO Market: Overview of Regulatory Agencies for Clinical Trials (Singapore), 2009
Health Sciences Authority
Protects and advances national health and safety National regulator for health products Administers clinical trials for new drugs; issues clinical trial certificates and pre-marketing product approvals
Guidelines fall within the broad framework of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). For technical guidelines not covered by the ICH, reference is taken from the Food & Drug Administration (FDA) and European Agency for the Evaluation of Medicinal Products (EMEA). Regulatory approval is issued by the Health Products regulation Group (HPRG) and Health Sciences Authority (HSA) in the form of Clinical Trial Certificates (CTC). Pre-clinical studies do not require to be registered with the HSA. However, they are reviewed for adherence to ICH safety requirements prior to approval of a clinical trial.
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95
98
87
104
Note: All figures are rounded; the base year is 2009. Source: www.hsa.gov.sg; Frost & Sullivan
These numbers show the total number of trials started each year. About 80.0 percent of the trials are initiated by industry, while 20.0 percent are initiated by investigators this is a trend consistent over the decade. There is a variance in the number of trials recorded in clinicaltrials.gov and HSA. The latter provides a more complete picture since obtaining a CTC is mandatory, while listing on clinicaltrials.gov is voluntary.
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International trials are likely to remain the majority of clinical trials in Singapore during the next 2-3 years, from 2011 to 2013.
84.0 82.0
70.0 60.0 50.0 40.0 30.0 20.0 10.0 0.0 Local Trials International Trials 8.0 8.0 2008 10.0 8.0 2009 Regional Trials
There is a growing trend toward regional trials, and this is likely to continue in the future as Japans regulations now allow trial data from other countries to be accepted in Japan. There is an increasing interest in conducting trials in the region from companies based in South Korea, Taiwan, and China that would also increase the demand for clinical research outsourcing in the country.
Note: All figures are rounded; the base year is 2009. Source: Frost & Sullivan
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Note: All figures are rounded; the base year is 2009. Source: Frost & Sullivan
Note: the category of Others includes respiratory, central nervous system, and nephrology. Oncology remains a therapeutic area of the highest interest for multinational pharmaceuticals investing in Singapore, followed by clinical pharmacology. There has been growing interest in ophthalmology from 2007, with trials being conducted for conditions such as glaucoma and myopia. Cardiology and neurology have declined in percentage, with neurology decreasing to zero trials in 2009.
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Trend Increasing
Revenues (2009)
$128.4 million
Increasing
Potential Revenues (maximum future market size) Base year market growth rate Compound annual growth rate Degree of competition
Note: All figures are rounded; the base year is 2009. Source: Frost & Sullivan
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Market Analysis
17
Market Drivers
CRO Market: Market Drivers Ranked in Order of Impact (Singapore), 2010-2015
Rank 1 Driver
Strong environment in terms of infrastructure, medical talent, regulatory approvals, and IP protection will attract increasing numbers of international trials Strong government commitment and investment in the biomedical sciences sector, with a focus on clinical research, will lead to the market expansion Singapores focus on globally relevant disease areas will increase the countrys attractiveness as a favored trials market Strong interest in translational medicine will lead to an increase in the number of clinical trials that incorporate biomarker research, an area of high interests for pharmaceutical MNCs
1-2 Years
3-4 Years
5-6 Years
High
High
High
Medium/High
High
Very High
Medium/High
High
High
Medium
Medium
Medium/High
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2. Strong Government Commitment and Investment in the Biomedical Sciences Sector, with a Focus on Clinical Research, will Lead to the Market Expansion Total R&D expenditure comprised 3.0 percent of GDP in 2010. Biomedical Sciences Initiative was being built up as fourth pillar of economy. 2006-2010: $1.10 billion committed to translational and clinical research.
3. Singapores Focus on Globally Relevant Disease Areas will Increase the Countrys Attractiveness as a Favored Trials Market Singapores research initiatives and expertise are focused in cancer, eye diseases, neuroscience, metabolic diseases, and infectious diseases. These are in line with disease areas of global concern and major pharmaceutical companies product portfolios. This strategic alignment will attract companies to Singapore for clinical trials.
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Market Restraints
CRO Market: Market Restraints Ranked in Order of Impact (Singapore), 2010-2015
Rank 1 2 Restraint
Limited population size will restrain the expansion of late stage trials Limited talent pool results in the need to import specialized talent
1-2 Years
Medium
3-4 Years
Medium
5-6 Years
Medium
Low/Medium
Low
Low
Source: Frost & Sullivan
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2. Limited Talent Pool Results in the Need to Import Specialized Talent Sources of new highly specialized talent are limited as the current workforce, while qualified, is young and has limited experience in this field. Currently, several of the countrys key scientific leaders are foreigners, while there is still a relatively small number of medical specialists, resulting in a need to bring in specialists from the United States and Europe for clinical trials.
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Revenue Forecasts
CRO Market: Revenue Forecasts (Singapore), 2009-2015 Year 2009 2010 2011 2012 2013 2014 2015 CAGR (2009-2015) Revenues ($ Million) 128.4 132.6 138.0 143.8 151.3 158.6 166.5 Revenue Growth Rate (%) 4.4 3.3 4.1 4.2 5.2 4.8 5.0 4.4
Note: All figures are rounded; the base year is 2009. Source: Frost & Sullivan
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Revenues ($ Million)
128.4
132.6
138.0
143.8
2009
2010
2011
2012 Year
2013
2014
2015
Revenues ($ Million)
Note: All figures are rounded; the base year is 2009. Source: Frost & Sullivan
The clinical trials market in Singapore (phase I through phase IV) is estimated to generate $166.5 million by 2015, driven strongly by expansion in the number of early stage trials (phases I and II). The current interest in translational medicine will intensify and will contribute to the expansion of the market in terms of an increase of trials involving biomarker research.
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151.3
158.6
166.5
6.0
Revenues ($ Million)
21.0 52.8
19.7 54.2
18.5 55.5
55.5 37 2015
Phase I
Phase II
Phase III
Phase IV
Note: All figures are rounded; the base year is 2009. Source: Frost & Sullivan
Corporate and government investment in translational and clinical research, along with early phase trials, will be the key reasons for the growth of the phase I and phase II segments. The share of contribution from later stage trials is estimated to decline as Singapores relatively small population and patient pool will restrain the growth of the phase III and phase IV segments.
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2015
47.0
14.0
12.0
12.0
15.0
2012
60.0
12.0
7.0
12.0
9.0
12.0 90.0
1.0 100.0
Clinical Trials (%) MNC Pharmaceutical Biotech Company Specialty Pharmaceutical Emerging Biotech Company
Note: All figures are rounded; the base year is 2009. Source: Frost & Sullivan
Emerging Pharmaceutical
Multinational pharmaceutical companies contribute to nearly 80.0 percent of clinical trial revenues. In the next few years, there will be an increase in revenue share from specialty pharmaceutical companies as well as emerging biotech/biologics companies as pharmaceutical industrys focus on these areas increases.
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Note: All figures are rounded; the base year is 2009. Source: Frost & Sullivan
Private sector R&D expenditure on biomedical and related sciences constitutes over two-fifths of the sectors R&D expenditure, reaffirming Singapores attractiveness as a hub for biomedical sciences. The government has committed $1.10 billion to drive translational and clinical research (TCR). The initiative includes increasing the base of clinician scientists and clinical research publications. A total of $90.0 million has also been committed to TCR programs, which focus on key disease areas such as cancer, eye diseases, and metabolic diseases. Recent investments in Singapore include Roches announcement in 2010 to invest $134.0 million to build a Translational Medical Research Hub, Eli Lilly, Merck & Co, and Pfizers 2010 announcement to combine resources to form the Asian Cancer Research Group (ACRG), and Abbott Nutritions investment of $75.0 million to set up a global R&D center in 2009.
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Competitive Analysis
28
Competitive Structure
CRO Market: Competitive Structure (Singapore), 2009
Number of CROs in Singapore Types of Competitors ~15 Type 1 : Full service multinational CROs headquartered outside Singapore Type 2 : Full service CROs headquartered in Singapore with multi-Asian operations Type 3 : Specialized services provider, e.g., preclinical only Tiers of Competition Tier 1 : Market share more than 30.0% each Quintiles Tier 2 : Market share 10.0%-20.0% each PPD, Covance, Parexel Tier 3 : Market share up to 10.0% each Maccine, Kendle, ICON, i3 Global, others Key End-user Groups MNC pharmaceutical companies Specialty pharmaceutical companies Biotechnology/biologics companies
Source: Frost & Sullivan
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30
2003
61.6 765.7 827.3
2004
70.7 824.2 895.0
2005
81.4 891.3 972.7
2006
89.8 999.5 1,089.3
2007
95.7 1,077.2 1,172.9
2008
101.5 1,158.4 1,259.9
2009
107.0 1,243.4 1,350.3
2010
112.1 1,332.9 1,445.0
2011
116.7 1,426.8 1,543.5
2012
120.7 1,531.8 1,652.5
27.1 24.2 5.4 5.9 2.3 257.7 1.9 4.0 0.9 1.2 13.4 11.0 2.6 357.5
34.7 27.7 5.6 7.6 2.9 278.5 2.2 5.3 0.9 1.2 16.0 11.5 3.0 396.9
42.5 32.3 5.9 8.7 3.2 306.1 2.5 6.7 1.0 1.3 18.2 12.4 3.4 444.1
47.4 37.7 6.5 10.0 3.5 305.5 2.8 7.5 1.1 1.4 21.4 14.1 3.8 462.4
50.4 43.0 7.1 11.1 4.0 315.6 3.2 8.3 1.2 1.5 24.0 15.2 4.3 488.8
53.4 48.4 7.8 12.0 4.6 327.0 3.7 9.2 1.4 1.6 27.0 16.1 4.8 516.7
56.3 54.0 8.6 13.1 5.2 336.8 4.2 9.9 1.5 1.7 30.2 17.2 5.4 543.9
59.0 59.9 9.6 14.3 6.0 348.5 4.8 10.5 1.6 1.8 33.6 18.7 6.0 574.3
61.8 66.3 10.6 15.6 6.9 361.9 5.4 11.1 1.8 1.9 37.3 19.9 6.9 607.3
64.4 73.2 11.7 16.8 7.9 376.0 6.0 11.7 2.0 1.9 41.4 21.1 8.1 642.0
66.9 81.3 12.9 18.1 9.1 390.9 6.7 12.1 2.2 2.0 45.8 22.1 9.3 679.4
5.05 11.62 10.34 8.82 14.83 3.59 13.13 7.11 10.70 5.45 11.52 6.61 13.80 5.65
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2003
13.5 20.9 2.1 9.0 134.6 203.3 9.1 0.9 9.6 92.4 1.6 31.3 18.9 10.1 46.4 24.2 21.5 118.3 767.6
2004
15.5 24.3 2.5 10.3 156.6 231.6 10.4 1.1 11.6 105.6 1.9 35.7 21.6 11.6 55.0 28.6 24.2 142.6 890.9
2005
16.2 25.7 2.6 10.9 166.3 240.6 11.9 1.4 12.2 108.5 2.1 36.2 25.1 12.3 63.2 29.1 25.2 152.3 941.8
2006
16.9 26.8 2.7 11.6 174.8 247.9 12.8 1.5 13.4 112.9 2.3 39.8 26.8 12.9 67.6 30.4 26.9 162.6 990.3
2007
17.5 28.0 2.9 12.2 182.9 255.1 13.7 1.7 14.5 116.7 2.4 40.7 28.5 13.6 71.8 31.7 28.7 173.0 1,035.3
2008
18.1 29.1 3.0 12.9 191.3 262.2 14.5 1.8 15.5 120.5 2.4 41.8 30.3 14.3 76.1 33.5 30.5 183.5 1,081.3
2009
18.7 30.1 3.2 13.6 199.0 269.1 15.4 1.9 16.6 124.3 2.5 42.9 32.2 14.9 80.5 35.5 32.3 194.7 1,127.3
2010
19.2 31.1 3.3 14.2 206.4 276.3 16.3 2.1 17.7 127.6 2.6 44.4 33.8 15.6 84.5 37.6 34.2 206.0 1,172.8
2011
19.7 32.1 3.5 14.9 213.9 283.6 17.2 2.2 18.8 130.7 2.7 45.9 35.4 16.3 88.6 39.9 36.1 217.1 1,218.6
2012
20.2 33.1 3.6 15.5 221.0 290.7 18.2 2.3 19.9 133.3 2.7 47.3 37.0 17.0 92.3 42.6 38.1 229.0 1,263.7
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2003
1.2 6.2 6.8 4.7 18.8 2,116.2
2004
1.1 6.3 7.4 6.8 21.6 2,375.2
2005
1.3 6.4 8.0 6.5 22.3 2,549.6
2006
1.5 6.7 8.7 6.8 23.7 2,756.9
2007
1.7 7.1 9.1 7.2 25.1 2,929.0
2008
1.9 7.4 9.6 7.6 26.5 3,105.3
2009
2.2 7.9 10.0 8.0 28.1 3,288.9
2010
2.4 8.5 10.5 8.3 29.7 3,479.5
2011
2.7 9.1 11.0 8.7 31.5 3,676.2
2012
3.0 9.7 11.4 9.2 33.3 3,885.5
Note: All figures are rounded; the base year is 2005. Source: Frost & Sullivan Definition The above figures indicate health care expenditure by government
Note
1. Figures for 2005 are Frost & Sullivan estimates
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2003
4.2 35.9 40.1
2004
4.2 36.3 40.5
2005
4.3 36.7 41.0
2006
4.4 37.2 41.6
2007
4.5 37.9 42.4
2008
4.6 38.7 43.3
2009
4.7 39.5 44.2
2010
4.9 40.2 45.1
2011
5.0 41.1 46.1
2012
5.2 42.6 47.7
2.5 92.6 0.8 48.7 11.1 23.1 1.0 0.5 3.2 0.3 3.7 2.0 4.4 193.8
2.5 95.0 0.8 49.9 11.6 23.7 1.0 0.5 3.3 0.3 3.9 2.1 4.6 199.2
2.6 97.1 0.9 51.1 12.2 24.2 1.1 0.5 3.4 0.3 4.1 2.2 4.8 204.3
2.6 99.3 0.9 52.5 12.7 24.8 1.1 0.5 3.5 0.4 4.3 2.2 5.0 209.6
2.7 101.7 0.9 54.0 13.2 25.5 1.2 0.5 3.6 0.4 4.5 2.3 5.2 215.4
2.7 104.0 0.9 55.6 13.6 26.3 1.2 0.5 3.8 0.4 4.7 2.3 5.4 221.4
2.8 106.1 0.9 57.4 14.1 27.0 1.2 0.5 3.9 0.4 4.9 2.4 5.5 227.1
2.8 108.5 0.9 59.2 14.6 27.7 1.3 0.5 4.0 0.4 5.0 2.4 5.7 233.2
2.9 111.3 1.0 61.2 15.0 28.1 1.3 0.5 4.2 0.4 5.2 2.5 5.9 239.4
3.0 114.4 1.0 63.3 15.5 28.3 1.4 0.5 4.3 0.4 5.3 2.5 6.1 246.0
3.1 118.2 1.0 65.5 15.8 29.1 1.5 0.6 4.5 0.5 5.6 2.6 6.3 254.0
2.59 2.54 1.96 3.29 3.13 2.18 3.91 2.29 3.61 4.07 3.56 2.24 3.26 2.79
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Population aged 65 and above (Mn) 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 CAGR % (2005 - 2012)
1.3 1.8 0.8 0.8 9.7 14.2 1.9 0.0 0.4 10.7 0.1 2.2 0.7 1.7 7.0 1.5 1.1 9.4 65.4
1.3 1.8 0.8 0.8 9.8 14.6 2.0 0.0 0.5 10.9 0.1 2.2 0.7 1.8 7.1 1.6 1.1 9.4 66.4
1.3 1.8 0.8 0.8 9.9 15.1 2.0 0.0 0.5 11.1 0.1 2.3 0.7 1.8 7.1 1.6 1.1 9.5 67.4
1.4 1.8 0.8 0.8 10.0 15.6 2.0 0.0 0.5 11.3 0.1 2.3 0.7 1.8 7.1 1.6 1.2 9.5 68.4
1.4 1.8 0.8 0.9 10.0 16.0 2.0 0.0 0.5 11.5 0.1 2.4 0.7 1.8 7.2 1.6 1.2 9.6 69.3
1.4 1.8 0.8 0.9 10.0 16.3 2.0 0.0 0.5 11.6 0.1 2.4 0.7 1.8 7.2 1.6 1.2 9.6 70.0
1.5 1.8 0.9 0.9 10.1 16.5 2.1 0.0 0.5 11.7 0.1 2.4 0.7 1.9 7.3 1.7 1.2 9.7 70.8
1.5 1.8 0.9 0.9 10.2 16.7 2.1 0.0 0.5 11.7 0.1 2.5 0.7 1.9 7.4 1.7 1.2 9.9 71.7
1.5 1.9 0.9 0.9 10.3 16.8 2.1 0.0 0.5 11.8 0.1 2.5 0.7 1.9 7.5 1.8 1.3 10.0 72.4
1.5 1.9 1.0 0.9 10.5 16.7 2.1 0.0 0.5 11.9 0.1 2.6 0.8 1.9 7.5 1.8 1.3 10.2 73.3
1.5 1.9 1.0 1.0 10.8 16.8 2.1 0.0 0.6 12.1 0.1 2.7 0.8 2.0 7.6 1.8 1.3 10.5 74.6
1.38 0.99 2.81 2.23 1.26 0.80 0.88 0.00 2.65 0.95 2.25 2.53 2.09 1.24 1.00 2.37 2.03 1.58 1.24
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2003
3.2 0.6 0.6 2.2 6.6 367.4
2004
3.3 0.6 0.6 2.2 6.7 375.7
2005
3.4 0.6 0.6 2.3 6.9 384.3
2006
3.5 0.6 0.6 2.3 7.1 393.1
2007
3.7 0.6 0.7 2.4 7.4 402.0
2008
3.8 0.6 0.7 2.4 7.6 410.3
2009
4.0 0.7 0.7 2.5 7.8 418.9
2010
4.1 0.7 0.7 2.5 8.0 427.6
2011
4.3 0.7 0.7 2.6 8.3 437.4
2012
4.5 0.7 0.8 2.6 8.6 450.1
Note: All figures are rounded; the base year is 2005. Source: Frost & Sullivan Definition The above figures represent total midyear population aged 65 years and above
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