Stakeholder Insight: Insulin Use in Type 2 Diabetes

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1 A Datamonitor Report Stakeholder Insight: Insulin Use in Type 2 Diabetes From Last Resort to Early Intervention Published: May-04 Product Code: DMHC1989 Providing you with: Analysis of Datamonitor s Diabetes Insight survey: 388 physicians in the 7 major markets, validated via in-depth interviews with international experts Determination of the prevalence of type 1 and type 2 diabetes, with forecasts to 2012 Use this Report to... Understand the factors limiting the use of insulin in type 2 diabetes, based on both physician and patient perception Analysis of the use of insulin therapy in the treatment of type 2 diabetes by line of therapy and evaluation of early vs. late initiation of insulin Assessment of the potential patient population for non-injected insulin: evaluation of switch from injected insulin and add-on to OAD therapy

2 Stakeholder Insight: Insulin Use in Type 2 Diabetes - From Last Resort to Early Intervention DMHC1989 Introduction Only 13-28% of drug-treated type 2 diabetes patients receive insulin therapy. The late initiation of insulin reflects the general trend that it is a last resort therapy in the treatment of type 2 diabetes. Datamonitor believes that there will be a shift towards earlier initiation of insulin in the future, along with increased uptake, following the introduction of non-injected insulin. Although attitudes towards the use of insulin in the treatment of type 2 diabetes have improved over recent years, there is still a degree of reluctance among both physicians and patients to initiate this form of therapy due to concerns over the risk of hypoglycemia, compliance with subcutaneous injections and possible weight gain. Key findings and highlights Datamonitor believes that for insulin therapy to be initiated earlier, additional clinical trials are required to support this strategy and this will help to convince physicians of the role of insulin therapy in the treatment of type 2 diabetes. Reasons to buy Due to rising rates of obesity and the aging population, type 2 diabetes is an emerging epidemic: Datamonitor estimates there will be 50.1m diabetics in the seven major markets in Despite the large patient population, Datamonitor s physician research reveals that only 50% of type 2 diabetics across the seven major markets are diagnosed. The late initiation of insulin reflects the trend that insulin is a therapy of last resort in the treatment of type 2 diabetes. Although some experts believe that the earlier initiation of insulin is emerging, additional clinical trials are required to support this strategy. Non-injected insulins are expected to overcome the key unmet need in the insulin market by providing a more convenient mode of administration, and they are also expected to increase the overall use of insulin in type 2 diabetes patients and shorten the time to initiation. Understand the factors limiting the use of insulin in type 2 diabetes, based on both physician and patient perception Validate product forecasting based on diagnosis and treatment rates, and the estimated future use of insulin in the treatment of type 2 diabetes Recognize lucrative target populations, in terms of unmet need and patient potential, in order to successfully position developmental products For more information... Contact John Savopoulos, Lead Analyst, Infectious Diseases tel: fax:

3 Sample pages from the analysis...despite the large patient population, Datamonitor's physician research reveals that only 50% of type 2 diabetics across the seven major markets are diagnosed. Additionally, only 13-28% of drug-treated type 2 diabetes patients receive insulin therapy... Katy Wynn, Datamonitor Cardiovascular Analyst

4 Stakeholder Insight: Insulin Use in Type 2 Diabetes - From Last Resort to Early Intervention DMHC1989 Table of contents EXECUTIVE SUMMARY Scope of the analysis Datamonitor insight into the type 2 diabetes insulin market - Summary Key metrics INTRODUCTION AND SCOPE Coverage of the Stakeholder Insight Survey COUNTRY TREATMENT TREES Introduction to the treatment trees US Japan France Germany Italy Spain UK DISEASE DEFINITION AND EPIDEMIOLOGY Definition of type 2 diabetes - Etiology of type 2 diabetes - Complications of type 2 diabetes Epidemiology of type 1 and type 2 diabetes - Current prevalence of type 1 and type 2 diabetes - Future prevalence of type 2 diabetes DIAGNOSIS AND TREATMENT RATES Diagnosis - Symptoms and diagnosis - Diagnosis rates Who manages patients with type 2 diabetes? Treatment options - Existing therapy for type 2 diabetes - Treatment rates Treatment guidelines for type 2 diabetes - Clinical practice guidelines from the ADA - The AACE system of Intensive Diabetes Self-Management - Physician and patient understanding of treatment guidelines INSULIN PRESCRIBING TRENDS Indications for insulin use in type 2 diabetes Overall use of insulin in type 2 diabetes - Current prescribing of insulin in type 2 diabetes - Change in insulin prescribing over the last three years - Change in the prescribing of insulin over the next three years Reasons for and against insulin use in type 2 diabetes - Factors driving the use of insulin in type 2 diabetes - Factors limiting the use of insulin in type 2 diabetes BREAKDOWN OF INSULIN THERAPY Overview of line of therapy in type 2 diabetes - Breakdown by line of therapy - Monotherapy versus combination therapy Breakdown of insulin use by line of therapy - Overview of insulin use by line of therapy - Breakdown of insulin prescribing at first line by physician type - Breakdown of insulin prescribing at second line by physician type - Breakdown of insulin prescribing at third line and beyond by physician type Analysis of early versus late initiation of insulin - When is insulin therapy currently initiated in type 2 diabetics? - Clinical evidence supporting early initiation of insulin Breakdown of insulin use by type and brand - Breakdown of insulin use by insulin type - Breakdown of insulin use by brand POTENTIAL FOR NON-INJECTED INSULINS Overview of the non-injected insulin pipeline Inhaled insulin - Exubera - the most advanced non-injected insulin - AERx idms - improving patient compliance - Technosphere Insulin - marketing partner required - AIR Insulin - lack of financial support from Eli Lilly - Phase I inhaled insulin projects Oral insulin - Oralin - termination of agreement with Eli Lilly - Emisphere oral insulin - seeking a partner to further development - HIM2 - further investigation in type 2 diabetes patients required - Macrulin - continued development uncertain Barriers for non-injected insulin - Comparable efficacy and safety - Improved patient compliance - Reproducibility and accuracy of dosing - Switching patients from injected to non-injected insulin - Competitive pricing Patient potential for non-injected insulin - Switch from injected insulin or OAD therapy - Add-on to existing OAD therapy Will non-injected insulin result in the earlier initiation of insulin? OPINION LEADER AND STAKEHOLDER TRANSCRIPTS Prof Burden - Treatment guidelines - Initiation of insulin in type 2 diabetes - Self-monitoring blood glucose (SMBG) - Choice of insulin therapy - The advent of non-injected insulins Prof Fonseca - Treatment guidelines - Initiation of insulin in type 2 diabetes - Self-monitoring blood glucose (SMBG) For more information... Contact John Savopoulos, Lead Analyst, Infectious Diseases tel: fax:

5 - Choice of insulin therapy - The advent of non-injected insulins David McAughey - Treatment guidelines and patient awareness - Initiation of insulin in type 2 diabetes - Self-monitoring blood glucose (SMBG) - The advent of non-injected insulins Emma Bunn - Treatment guidelines and patient awareness - Initiation of insulin in type 2 diabetes - Self-monitoring blood glucose (SMBG) - The advent of non-injected insulins - Epidemiology - General bibliography Physician research methodology - Physician sample breakdown Type 2 diabetes Insight survey questionnaire - Section 1: Physician perceptions of patient segmentation - Section 2: Treatment patterns in first-, second- and third-line therapy - Section 3: Key branded products - Section 5: Prescribing trends - Section 7: Insulin therapy in type 2 patients - Disclaimer TABLES Table 1: Table 2: Table 3: Table 4: Table 5: Table 6: Table 7: Table 8: Table 9: Table 10: Table 11: Table 12: Current prevalence of type 2 diabetes across the seven major markets, Future prevalence of type 2 diabetes in the seven major markets, Prevalence of type 1 and type 2 diabetes across the seven major markets, Future prevalence of type 1 and type 2 diabetes in the seven major markets, ADA evidence grading system for clinical practice guidelines Changes in insulin prescribing over the last three years by physician type across the seven major markets, Estimated changes in insulin prescribing over the next three years by physician type across the seven major markets, Incidence of hypoglycemia with insulin glargine versus NPH insulin from a meta-analysis of 2,304 type 2 diabetes patients, Three clinical trials showing insulin detemir to induce weight loss Breakdown of line of therapy by monotherapy versus combination therapy in the seven major markets, Overall breakdown of insulin use by line of therapy in the seven major markets, Proportion of patients on second-line combination therapy prescribed insulin, by physician type, Table 13: Proportion of patients on third-line combination therapy prescribed insulin, by physician type, Table 14: Characteristics of the key types of insulin Table 15: Overview of the non-injected insulin pipeline, 2004 Table 16: Physicians' reaction to inhaled insulin: sub-analysis of a Phase II proof-of-concept trial, Table 17: Indications for insulin therapy in type 2 diabetes Table 18: Factors positively influencing the use of insulin in type 2 diabetes Table 19: Factors positively influencing the use of insulin in type 2 diabetes Table 20: Factors positively influencing the use of insulin in type 2 diabetes Table 21: US physician sample breakdown, Table 22: Japan physician sample breakdown, Table 23: France physician sample breakdown, Table 24: Germany physician sample breakdown, Table 25: Italy physician sample breakdown, Table 26: Spain physician sample breakdown, Table 27: UK physician sample breakdown, Table 28: Specialist services provided by PCPs Table 29: Breakdown of the management of type 2 diabetes by physician type Table 30: Breakdown of treatment by lifestyle advice versus drug therapy Table 31: Breakdown of treatment by line of therapy Table 32: Breakdown of treatment by monotherapy versus combination therapy Table 33: Insulin combination therapy at second line Table 34: Insulin combination therapy at third line or beyond Table 35: Insulin breakdown by brand Table 36: Past and future insulin prescribing trends Table 37: Factors limiting the decision to use insulin in the treatment of type 2 diabetes Table 38: Factor driving the decision to use insulin in the treatment of type 2 diabetes Table 39: Insulin breakdown by type Table 40: Past and future insulin prescribing trends FIGURES Figure 1: Key drivers of the type 2 diabetes insulin market to 2012 Figure 2: Overview of diagnosis rates, treatment rates and insulin prescribing trends in the seven major markets, Figure 3: Overall breakdown of insulin prescribing trends in the US, Figure 4: Breakdown of insulin prescribing by line of therapy in the US, Figure 5: Overall breakdown of insulin prescribing trends in Japan, Figure 6: Breakdown of insulin prescribing by line of therapy in Japan,...One of the most important concerns that physicians have about the introduction of non-injected insulin is the fact that they are unlikely to be priced competitively with injected insulin, as five to ten times more insulin is required... Katy Wynn, Datamonitor Cardiovascular Analyst

6 Stakeholder Insight: Insulin Use in Type 2 Diabetes - From Last Resort to Early Intervention DMHC1989 Figure 7: Overall breakdown of insulin prescribing trends in France, Figure 8: Breakdown of insulin prescribing by line of therapy in France, Figure 9: Overall breakdown of insulin prescribing trends in Germany, Figure 10: Breakdown of insulin prescribing by line of therapy in Germany, Figure 11: Overall breakdown of insulin prescribing trends in Italy, Figure 12: Breakdown of insulin prescribing by line of therapy in Italy, Figure 13: Overall breakdown of insulin prescribing trends in Spain, Figure 14: Breakdown of insulin prescribing by line of therapy in Spain, Figure 15: Overall breakdown of insulin prescribing trends in the UK, Figure 16: Breakdown of insulin prescribing by line of therapy in the UK, Figure 17: ADA diagnostic criteria for pre-diabetes and diabetes Figure 18: Proportion of type 2 diabetics diagnosed in the general population in the seven major markets, Figure 19: Estimated breakdown of the management of type 2 diabetes in the general population by physician type, Figure 20: Development timeline for antidiabetic drug classes Figure 21: The history of insulin Figure 22: Breakdown of type 2 diabetes management by lifestyle therapy alone versus drug therapy in the seven major markets, Figure 23: When to start insulin therapy in type 2 diabetes? Figure 24: Proportion of drug-treated type 2 diabetes patients prescribed insulin either alone or in combination therapy, by physician type, across the seven major markets, Figure 25: Comparison of current prescribing of insulin in type 2 diabetes with level of prescribing three years ago across the seven major markets, Figure 26: Estimated change in the prescribing of insulin in type 2 diabetes across the seven major markets over the next three years, Figure 27: Specialists' rating of the importance of the improvement in glycemic control in influencing the decision to use insulin in the treatment of type 2 diabetes, Figure 28: Specialists' rating of the importance of the risk of hypoglycemia in limiting the decision to use insulin in the treatment of type 2 diabetes, Figure 29: Specialists' rating of the importance of patient compliance with sc injections in limiting the decision to use insulin in the treatment of type 2 diabetes, Figure 30: Specialists' rating of the importance of cost and reimbursement issues in limiting the decision to use insulin in the treatment of type 2 diabetes, Figure 31: Specialists' rating of the importance of possible weight gain in limiting the decision to use insulin in the treatment of type 2 diabetes, Figure 32: Factors driving versus limiting the use of SMBG in patients with type 2 diabetes, 2004 Figure 33: Proportion of drug-treated type 2 diabetes patients receiving each line of therapy in the seven major markets, Figure 34: Approved insulin combinations, 2004 Figure 35: Proportion of patients on first-line therapy prescribed insulin either alone or in combination, by physician type, Figure 36: Proportion of patients on second-line therapy prescribed insulin as monotherapy, by physician type, Figure 37: Proportion of patients on third-line and beyond monotherapy prescribed insulin, by physician type, Figure 38: Common insulin regimens Figure 39: Breakdown of insulin use by type among type 2 diabetes patients currently using insulin in the seven major markets, Figure 40: Past and future changes in the use of rapid-acting insulin across the seven major markets, Figure 41: Past and future changes in the use of short-acting insulin across the seven major markets, Figure 42: Past and future changes in the use of intermediate-acting insulin across the seven major markets, Figure 43: Past and future changes in the use of long-acting insulin across the seven major markets, Figure 44: Future changes in the use of long-acting peakless insulin across the seven major markets, Figure 45: Past and future changes in the use of premixed insulin across the seven major markets, Figure 46: Proportion of type 2 diabetes patients on insulin therapy receiving each brand of insulin in the seven major markets, Figure 47: Overview of the inhaled insulin pipeline, 2004 Figure 48: Overview of the oral insulin pipeline, 2004 Figure 49: Barriers that non-injected insulins need to overcome, 2004 Figure 50: Proportion of type 2 diabetes patients estimated to be switched to non-injected insulin across the seven major markets, Figure 51: Proportion of type 2 diabetes patients not previously prescribed insulin expected to receive non-injected insulin as an add-on to existing OAD therapy, For more information... Contact John Savopoulos, Lead Analyst, Infectious Diseases tel: fax:

7 Datamonitor: Your total information solution Datamonitor is a premium business information company helping 5,000 of the world's leading companies across the Automotive, Consumer Markets, Energy, Financial Services, Healthcare and Technology sectors. Our products and services are specifically designed to support our clients key business processes - from corporate strategy to competitive intelligence. We provide an independent and trustworthy source of data, analysis and forecasts to improve these processes and ultimately, to help grow your business. Corporate Strategy & Business Planning Product Development & Commercialization Targeting & Influencing the Market Market & Competitive Intelligence Quality Data Expert Analysis Future Forecasts Make more effective strategic and business decisions Accelerate delivery of commercial success Assess and influence your commercial and market environment Maintain or obtain critical competitive advantage HELPING TO GROW YOUR BUSINESS Nobody speaks louder than our clients 3M Abbott Accenture Alcon Labs Allergan Almirall-Prodesfarma Alpha-Beta Technologies Altana Pharma AG Amersham Amgen Amrad Angelini Acraf AstraZeneca AT Kearney Aventis Baxter Bayer Beaufour Ipsen Biochemie Boehringer Ingelheim Boots Bristol-Myers Squibb British Biotech Cantab Caremark International Chiesi Chiron Chugai CMC Co Daiichi Deutsche Morgan Grenfell Elan Eli Lilly Esteve Flamel Fournier Fujisawa Gehe Gist Brocades GlaxoSmithKline IBM Immuno AG Johnson & Johnson Jouveinal LEK Lipha Lundbeck Merck KGaA Merck & Co Novartis Novo Nordisk Pfizer Pharmachemie Pierre Fabre Pliva Procter & Gamble Ranbaxy Recordati Sankyo Sanofi-Synthélabo Schering AG Schering-Plough Schwarz Serono Shire Pharmaceuticals Solvay Takeda TAP Pharmaceutical Teva UCB Uriach Viatris Wyeth 89% of our clients use Datamonitor research to develop competitive intelligence Source: Datamonitor Customer Research

8 Stakeholder Insight: Insulin Use in Type 2 Diabetes - From Last Resort to Early Intervention DMHC1989 Interested in this topic? Datamonitor Healthcare's Cardiovascular Strategic Planning Program (SPP) is a tailored, continuous advisory service combining In-Depth Analyses and Market Briefs from the Cardiovascular portfolio with Analyst Support, Data and Slide Packs, and an Executive Presentation. With a strong focus on flexibility and edelivery, we offer a customized service that enables you to meet challenges head-on and identify new opportunities. Related products available Stakeholder Insight: Metabolic Syndrome Analysis of changes in perception and awareness of metabolic syndrome, using data from 380 physician interviews. Published: May-04 Product code: DMHC1988 Commercial Perspectives: Diabetes - Type 2 Epidemic Driving Aggressive Therapy Detailed product profiles for the leading insulin and oral antidiabetic brands and the impact of key events on current and future market dynamics. Published: Oct-03 Product code: DMHC1944 Diabetic Nephropathy: Prevalence, Progression, Prevention and Potential An evaluation of the current and future potential for the diabetic nephropathy market based on epidemiology data of renal disease progression in type 2 diabetes, treatment guidelines and ongoing clinical trials. Published: Oct-03 Product code: BFHC0625 Pipeline Insight: Diabetes Drug Delivery and Diagnostics - Towards the Non-invasive Revolution Insightful analysis into the insulin delivery and diagnostic devices currently in development for diabetes. Published: Jun-03 Product code: DMHC1866 * Please refer to our website for up-to-date prices. You can search for a product by Title or Product Code. For more information on these and other related analyses, go to: Subscribe to Healthcare Monitor A monthly update of the latest Healthcare products, events, news and special offers from Datamonitor, delivered to you by . To subscribe your contact details to with Subscribe in the subject line.

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