REFERENCE CODE GDHCER052 PUBLICAT ION DATE NOVEMBER 2013 DIABETIC NEPHROPATHY - EPIDEMIOLOGY FORECAST TO 2022

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1 REFERENCE CODE GDHCER052 PUBLICAT ION DATE NOVEMBER 2013 DIABETIC NEPHROPATHY -

2 Executive Summary Diabetic nephropathy is one of the microvascular complications of diabetes, along with diabetic neuropathy and diabetic retinopathy. With the increasing prevalence of diabetes around the world, diabetic nephropathy is the most common type of chronic kidney disease (KDOQI, 2007; Zimmet et al., 2001). When diabetes is not properly controlled, the high concentration of glucose in the blood overloads the kidneys, causing the kidneys to filter too much blood. When uncontrolled diabetes persists for 15 to 25 years, the blood vessels in the kidneys become damaged, resulting in abnormal amounts of albumin in the urine and a reduced glomerular filtration rate (GFR). Diabetic nephropathy eventually progresses to end-stage renal disease (ESRD), or kidney failure, which requires dialysis or kidney transplantation (ADA, 2013; CDA, 2012; NHS, 2011; NKUDIC, 2013). In this report, GlobalData epidemiologists utilized nationally-representative data from peer-reviewed journals to provide the total prevalent cases of diabetic nephropathy in the diagnosed diabetic population in the seven major markets (7MM) (US, France, Germany, Italy, Spain, UK, and Japan). Moreover, the forecast methodology was consistent across all of the 7MM in order to allow for a meaningful comparison of the total prevalent cases of diabetic nephropathy in these markets. In 2012, as shown in below mentioned figure there were million total prevalent cases of diabetic nephropathy in the diagnosed diabetic population in the 7MM, with approximately 44% of the total prevalent cases (6.1 million total prevalent cases) being in the US alone. GlobalData epidemiologists forecast that there will be million total prevalent cases of diabetic nephropathy in the diagnosed diabetic population in the 7MM by 2022, with an annual growth rate (AGR) of 4.16% during the forecast period. GlobalData epidemiologists forecast an increase in the total prevalent cases of diabetic nephropathy in the diagnosed diabetic population in each of the 7MM due to an increase in the prevalence of diagnosed diabetics in the 7MM. 7MM, Total Prevalent Cases of Diabetic Nephropathy in the Diagnosed Diabetic Population, Both Sexes, N, 2012 and MM US 5EU Japan Spain Germany France Italy UK 1,698,672 1,241,262 1,168,782 1,043,172 1,423, ,143 1,087, , , ,452 6,281,690 4,581,289 3,911,371 3,292,411 9,677,470 6,159,771 14,033,471 19,870, ,000,000 10,000,000 15,000,000 20,000,000 25,000,000 Total Prevalent Cases of Diabetic Nephropathy in the Diagnosed Diabetic Population (N) Source: GlobalData; Koopman et al., 2006; Pedro et al., 2010; Ohta et al., 2010; USCB, 2012 Note: 5EU = France, Germany, Italy, Spain, and UK; 7MM = US, 5EU and Japan 2

3 Table of Contents 1 Table of Contents 1 Table of Contents List of Tables List of Figures Introduction Catalyst Related Reports Upcoming Reports Epidemiology Disease Background Risk Factors and Comorbidities Poor glycemic control elevates the risk of diabetic nephropathy Global Trends US EU Japan Epidemiological Forecast for Diabetic Nephropathy ( ) Forecast Methodology Sources Used Sources Not Used Epidemiological Forecast for Diabetic Nephropathy ( ) Forecast Assumptions and Methods, Diagnosed Prevalent Cases of Diabetes Forecast Assumptions and Methods Diabetic Nephropathy

4 Table of Contents 3.6 Epidemiology Forecast for Diabetic Nephropathy ( ) Total Prevalent Cases of Diabetic Nephropathy Total Prevalent Cases of Diabetic Nephropathy by Age Total Prevalent Cases of Diabetic Nephropathy by Sex Total Prevalent Cases of Comorbid Hypertension in Total Diabetic Nephropathy Discussion Epidemiological Forecast Insight Limitations of the Analysis Strengths of the Analysis Appendix Bibliography About the Authors Epidemiologists Reviewers Global Director of Epidemiology and Health Policy Global Head of Healthcare About GlobalData About EpiCast Disclaimer

5 Table of Contents 1.1 List of Tables Table 1: Classification of Patients Based on the Levels of Albuminuria for the Three Standard Tests... 8 Table 2: 7MM, Sources of the Total Prevalence Data Used in the Analysis of Diabetic Nephropathy Table 3: 7MM, Sources Excluded from the Analysis of Diabetic Nephropathy Table 4: Table 5: Table 6: 7MM, Total Prevalent Cases of Diabetic Nephropathy in the Diagnosed Diabetic Population, Both Sexes, Ages 40 Years, N, MM, Total Prevalent Cases of Diabetic Nephropathy in the Diagnosed Diabetic Population, Both Sexes, by Age, N, Row (%), MM, Total Prevalent Cases of Diabetic Nephropathy in the Diagnosed Diabetic Population, by Sex, Ages 40, N, Row (%), List of Figures Figure 1: Figure 2: Figure 3: Figure 4: 7MM, Total Prevalent Cases of Diabetic Nephropathy in the Diagnosed Diabetic Population, Both Sexes, Ages 40 Years, N, MM, Total Prevalent Cases of Diabetic Nephropathy in the Diagnosed Diabetic Population, Both Sexes, by Age, N, MM, Total Prevalent Cases of Diabetic Nephropathy in the Diagnosed Diabetic Population, by Sex, Ages 40 Years, N, MM, Total Prevalent Cases of Comorbid Hypertension in Total Prevalent Cases of Diabetic Nephropathy, Both Sexes, Ages 40 Years, N,

6 Introduction 2 Introduction 2.1 Catalyst Diabetic nephropathy is one of the microvascular complications of diabetes, along with diabetic neuropathy and diabetic retinopathy. With the increasing prevalence of diabetes around the world, diabetic nephropathy is the most common type of chronic kidney disease (KDOQI, 2007; Zimmet et al., 2001). This report provides an overview of the risk factors, comorbidities, and the global and historical trends for diabetic nephropathy in the diagnosed diabetic population in the seven major markets (7MM) (US, France, Germany, Italy, Spain, UK, and Japan). The report also includes a 10-year epidemiological forecast for the total prevalent cases of diabetic nephropathy in the diagnosed diabetic population in the 7MM, segmented by age (40 to 85 years) and sex. To forecast the total prevalent cases of diabetic nephropathy, GlobalData epidemiologists utilized nationally-representative data from peer-reviewed journals to provide the age- and sexspecific total prevalent cases of diabetic nephropathy in the diagnosed diabetic population in the 7MM. Moreover, the forecast methodology was consistent across all the 7MM in order to allow for a meaningful comparison of the total prevalent cases of diabetic nephropathy in these markets. According to GlobalData s forecast, the total prevalent cases of diabetic nephropathy in the diagnosed diabetic population in the 7MM will grow at a rate of 41.6% over the next decade, from million prevalent cases in 2012 to million prevalent cases in In 2012, the US had 6,159,771 total prevalent cases of diabetic nephropathy, comprising nearly 44% of the total prevalent cases of diabetic nephropathy in the diagnosed diabetic population in the 7MM. 6

7 Appendix 4.3 About GlobalData GlobalData is a leading global provider of business intelligence in the Healthcare industry. GlobalData provides its clients with up-to-date information and analysis on the latest developments in drug research, disease analysis, and clinical research and development. Our integrated business intelligence solutions include a range of interactive online databases, analytical tools, reports and forecasts. Our analysis is supported by a 24/7 client support and analyst team. GlobalData has offices in New York, Boston, London, India and Singapore. 4.4 About EpiCast EpiCast is a series of premier epidemiology reports written and developed by Masters and PhD level epidemiologists. EpiCast Reports are in-depth, high quality, transparent and market-driven, providing expert analysis of epidemiological trends and forecasting of patient populations for major markets. Specifically, the reports identify disease trends over a 10-year forecast period in six to seven major markets (US, France, Germany, Italy, Spain, UK, Japan). Additional countries, such as Canada, Brazil, India and China, are covered in these reports if their markets are highly relevant. 38

8 Appendix 4.5 Disclaimer All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GlobalData. 39