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Stakeholder Insight: Insulin Use in Type 2 Diabetes - From Last Resort to Early Intervention

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.

Scope

Analysis of interviews with 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

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

Report Highlights
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 2012. 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.

Reasons to Purchase

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

Table of Contents

• CHAPTER 1 EXECUTIVE SUMMARY - page 4
  • Scope of the analysis - page 4
  • Datamonitor insight into the type 2 diabetes insulin market - page 5
    • Summary - page 12
  • Key metrics - page 13
• TABLE OF CONTENTS - page 15
• CHAPTER 2 INTRODUCTION AND SCOPE - page 23
  • Coverage of the Stakeholder Insight Survey - page 23
• CHAPTER 3 COUNTRY TREATMENT TREES - page 26
  • Introduction to the treatment trees - page 26
  • US - page 27
  • Japan - page 29
  • France - page 31
  • Germany - page 33
  • Italy - page 35
  • Spain - page 37
  • UK - page 39
• CHAPTER 4 DISEASE DEFINITION AND EPIDEMIOLOGY - page 41
  • Definition of type 2 diabetes - page 41
    • Etiology of type 2 diabetes - page 41
    • Complications of type 2 diabetes - page 42
  • Epidemiology of type 1 and type 2 diabetes - page 44
    • Current prevalence of type 1 and type 2 diabetes - page 44
    • Future prevalence of type 2 diabetes - page 46
• CHAPTER 5 DIAGNOSIS AND TREATMENT RATES - page 49
  • Diagnosis - page 49
    • Symptoms and diagnosis - page 49
    • Diagnosis rates - page 51
  • Who manages patients with type 2 diabetes? - page 53
  • Treatment options - page 55
    • Existing therapy for type 2 diabetes - page 55
    • Treatment rates - page 57
  • Treatment guidelines for type 2 diabetes - page 60
    • Clinical practice guidelines from the ADA - page 60
    • The AACE system of Intensive Diabetes Self-Management - page 62
    • Physician and patient understanding of treatment guidelines - page 62
• CHAPTER 6 INSULIN PRESCRIBING TRENDS - page 64
  • Indications for insulin use in type 2 diabetes - page 64
  • Overall use of insulin in type 2 diabetes - page 66
    • Current prescribing of insulin in type 2 diabetes - page 67
    • Change in insulin prescribing over the last three years - page 70
    • Change in the prescribing of insulin over the next three years - page 74
  • Reasons for and against insulin use in type 2 diabetes - page 80
    • Factors driving the use of insulin in type 2 diabetes - page 80
    • Factors limiting the use of insulin in type 2 diabetes - page 82
• CHAPTER 7 BREAKDOWN OF INSULIN THERAPY - page 111
  • Overview of line of therapy in type 2 diabetes - page 112
    • Breakdown by line of therapy - page 112
    • Monotherapy versus combination therapy - page 113
  • Breakdown of insulin use by line of therapy - page 115
    • Overview of insulin use by line of therapy - page 115
    • Breakdown of insulin prescribing at first line by physician type - page 117
    • Breakdown of insulin prescribing at second line by physician type - page 119
    • Breakdown of insulin prescribing at third line and beyond by physician type - page 125
  • Analysis of early versus late initiation of insulin - page 128
    • When is insulin therapy currently initiated in type 2 diabetics? - page 128
    • Clinical evidence supporting early initiation of insulin - page 129
  • Breakdown of insulin use by type and brand - page 131
    • Breakdown of insulin use by insulin type - page 134
    • Breakdown of insulin use by brand - page 148
• CHAPTER 8 POTENTIAL FOR NON-INJECTED INSULINS - page 155
  • Overview of the non-injected insulin pipeline - page 155
  • Inhaled insulin - page 156
    • Exubera - the most advanced non-injected insulin - page 158
    • AERx iDMS - improving patient compliance - page 160
    • Technosphere Insulin - marketing partner required - page 162
    • AIR insulin - lack of financial support from Eli Lilly - page 163
    • Phase I inhaled insulin projects - page 164
  • Oral insulin - page 165
    • Oralin - termination of agreement with Eli Lilly - page 166
    • Emisphere oral insulin - seeking a partner to further development - page 167
    • HIM2 - further investigation in type 2 diabetes patients required - page 168
    • Macrulin - continued development uncertain - page 169
  • Barriers for non-injected insulin - page 169
    • Comparable efficacy and safety - page 170
    • Improved patient compliance - page 171
    • Reproducibility and accuracy of dosing - page 172
    • Switching patients from injected to non-injected insulin - page 173
    • Competitive pricing - page 174
  • Patient potential for non-injected insulin - page 175
    • Switch from injected insulin or OAD therapy - page 176
    • Add-on to existing OAD therapy - page 177
  • Will non-injected insulin result in the earlier initiation of insulin? - page 179
• CHAPTER 9 OPINION LEADER AND STAKEHOLDER TRANSCRIPTS - page 181
  • Prof Burden - page 182
    • Treatment guidelines - page 182
    • Initiation of insulin in type 2 diabetes - page 184
    • Self-monitoring blood glucose (SMBG) - page 188
    • Choice of insulin therapy - page 190
    • The advent of non-injected insulins - page 191
  • Prof Fonseca - page 193
    • Treatment guidelines - page 193
    • Initiation of insulin in type 2 diabetes - page 193
    • Self-monitoring blood glucose (SMBG) - page 195
    • Choice of insulin therapy - page 196
    • The advent of non-injected insulins - page 198
  • David McAughey - page 199
    • Treatment guidelines and patient awareness - page 199
    • Initiation of insulin in type 2 diabetes - page 202
    • Self-monitoring blood glucose (SMBG) - page 207
    • The advent of non-injected insulins - page 209
  • Emma Bunn - page 211
    • Treatment guidelines and patient awareness - page 211
    • Initiation of insulin in type 2 diabetes - page 214
    • Self-monitoring blood glucose (SMBG) - page 217
    • The advent of non-injected insulins - page 219
    • Epidemiology - page 221
    • General bibliography - page 222
  • Physician research methodology - page 226
    • Physician sample breakdown - page 226
  • Type 2 diabetes Insight survey questionnaire - page 231
    • Section 1: Physician perceptions of patient segmentation - page 231
    • Section 2: Treatment patterns in first-, second- and third-line therapy - page 232
    • Section 3: Key branded products - page 234
    • Section 5: Prescribing trends - page 234
    • Section 7: Insulin therapy in type 2 patients - page 235
    • Disclaimer - page 238


• List of Tables
• Table 1: Current prevalence of type 2 diabetes across the seven major markets, 2003 - page 13
• Table 2: Future prevalence of type 2 diabetes in the seven major markets, 2004-12 - page 13
• Table 3: Prevalence of type 1 and type 2 diabetes across the seven major markets, 2003 - page 45
• Table 4: Future prevalence of type 1 and type 2 diabetes in the seven major markets, 2004-12 - page 47
• Table 5: ADA evidence grading system for clinical practice guidelines - page 61
• Table 6: Changes in insulin prescribing over the last three years by physician type across the seven major markets, 2003 - page 73
• Table 7: Estimated changes in insulin prescribing over the next three years by physician type across the seven major markets, 2003 - page 77
• Table 8: Incidence of hypoglycemia with insulin glargine versus NPH insulin from a meta-analysis of 2,304 type 2 diabetes patients, 2003 - page 87
• Table 9: Three clinical trials showing insulin detemir to induce weight loss - page 99
• Table 10: Breakdown of line of therapy by monotherapy versus combination therapy in the seven major markets, 2003 - page 114
• Table 11: Overall breakdown of insulin use by line of therapy and by monotherapy versus combination therapy in the seven major markets, 2003 - page 115
• Table 12: Proportion of patients on second-line combination therapy prescribed insulin, by physician type, 2003 - page 121
• Table 13: Proportion of patients on third-line combination therapy prescribed insulin, by physician type, 2003 - page 127
• Table 14: Characteristics of the key types of insulin - page 132
• Table 15: Overview of the non-injected insulin pipeline, 2004 - page 156
• Table 16: Physicians' reaction to inhaled insulin: sub-analysis of a Phase II proof-of-concept trial, 2003 - page 162
• Table 17: Indications for insulin therapy in type 2 diabetes - page 186
• Table 18: Factors positively influencing the use of insulin in type 2 diabetes - page 187
• Table 19: Factors positively influencing the use of insulin in type 2 diabetes - page 194
• Table 20: Factors positively influencing the use of insulin in type 2 diabetes - page 204
• Table 21: US physician sample breakdown, 2003 - page 226
• Table 22: Japan physician sample breakdown, 2003 - page 227
• Table 23: France physician sample breakdown, 2003 - page 227
• Table 24: Germany physician sample breakdown, 2003 - page 228
• Table 25: Italy physician sample breakdown, 2003 - page 228
• Table 26: Spain physician sample breakdown, 2003 - page 229
• Table 27: UK physician sample breakdown, 2003 - page 229
• Table 28: Specialist services provided by PCPs - page 230
• Table 29: Breakdown of the management of type 2 diabetes by physician type - page 231
• Table 30: Breakdown of treatment by lifestyle advice versus drug therapy - page 231
• Table 31: Breakdown of treatment by line of therapy - page 232
• Table 32: Breakdown of treatment by monotherapy versus combination therapy - page 232
• Table 33: Insulin combination therapy at second line - page 233
• Table 34: Insulin combination therapy at third line or beyond - page 233
• Table 35: Insulin breakdown by brand - page 234
• Table 36: Past and future insulin prescribing trends - page 234
• Table 37: Factors limiting the decision to use insulin in the treatment of type 2 diabetes - page 235
• Table 38: Factor driving the decision to use insulin in the treatment of type 2 diabetes - page 235
• Table 39: Insulin breakdown by type - page 236
• Table 40: Past and future insulin prescribing trends - page 236


• List of Figures
• Figure 1: Key drivers of the type 2 diabetes insulin market to 2012 - page 12
• Figure 2: Overview of diagnosis rates, treatment rates and insulin prescribing trends in the seven major markets, 2003 - page 14
• Figure 3: Overall breakdown of insulin prescribing trends in the US, 2003 - page 27
• Figure 4: Breakdown of insulin prescribing by line of therapy and by monotherapy versus combination therapy in the US, 2003 - page 28
• Figure 5: Overall breakdown of insulin prescribing trends in Japan, 2003 - page 29
• Figure 6: Breakdown of insulin prescribing by line of therapy and by monotherapy versus combination therapy in Japan, 2003 - page 30
• Figure 7: Overall breakdown of insulin prescribing trends in France, 2003 - page 31
• Figure 8: Breakdown of insulin prescribing by line of therapy and by monotherapy versus combination therapy in France, 2003 - page 32
• Figure 9: Overall breakdown of insulin prescribing trends in Germany, 2003 - page 33
• Figure 10: Breakdown of insulin prescribing by line of therapy and by monotherapy versus combination therapy in Germany, 2003 - page 34
• Figure 11: Overall breakdown of insulin prescribing trends in Italy, 2003 - page 35
• Figure 12: Breakdown of insulin prescribing by line of therapy and by monotherapy versus combination therapy in Italy, 2003 - page 36
• Figure 13: Overall breakdown of insulin prescribing trends in Spain, 2003 - page 37
• Figure 14: Breakdown of insulin prescribing by line of therapy and by monotherapy versus combination therapy in Spain, 2003 - page 38
• Figure 15: Overall breakdown of insulin prescribing trends in the UK, 2003 - page 39
• Figure 16: Breakdown of insulin prescribing by line of therapy and by monotherapy versus combination therapy in the UK, 2003 - page 40
• Figure 17: ADA diagnostic criteria for pre-diabetes and diabetes - page 50
• Figure 18: Proportion of type 2 diabetics diagnosed in the general population in the seven major markets, 2003 - page 51
• Figure 19: Estimated breakdown of the management of type 2 diabetes in the general population by physician type, 2003 - page 53
• Figure 20: Development timeline for antidiabetic drug classes - page 55
• Figure 21: The history of insulin - page 56
• Figure 22: Breakdown of type 2 diabetes management by lifestyle therapy alone versus drug therapy in the seven major markets, 2003 - page 58
• Figure 23: When to start insulin therapy in type 2 diabetes? - page 65
• 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, 2003 - page 67
• Figure 25: Comparison of current prescribing of insulin in type 2 diabetes with level of prescribing three years ago across the seven major markets, 2003 - page 70
• Figure 26: Estimated change in the prescribing of insulin in type 2 diabetes across the seven major markets over the next three years, 2003 - page 75
• 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, 2003 - page 81
• 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, 2003 - page 84
• 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, 2003 - page 90
• 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, 2003 - page 93
• 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, 2003 - page 96
• Figure 32: Factors driving versus limiting the use of SMBG in patients with type 2 diabetes, 2004 - page 103
• Figure 33: Proportion of drug-treated type 2 diabetes patients receiving each line of therapy in the seven major markets, 2003 - page 112
• Figure 34: Approved insulin combinations, 2004 - page 117
• Figure 35: Proportion of patients on first-line therapy prescribed insulin either alone or in combination, by physician type, 2003 - page 118
• Figure 36: Proportion of patients on second-line therapy prescribed insulin as monotherapy, by physician type, 2003 - page 120
• Figure 37: Proportion of patients on third-line and beyond monotherapy prescribed insulin, by physician type, 2003 - page 126
• Figure 38: Common insulin regimens - page 133
• Figure 39: Breakdown of insulin use by type among type 2 diabetes patients currently using insulin in the seven major markets, 2003 - page 135
• Figure 40: Past and future changes in the use of rapid-acting insulin across the seven major markets, 2003 - page 138
• Figure 41: Past and future changes in the use of short-acting insulin across the seven major markets, 2003 - page 140
• Figure 42: Past and future changes in the use of intermediate-acting insulin across the seven major markets, 2003 - page 142
• Figure 43: Past and future changes in the use of long-acting insulin across the seven major markets, 2003 - page 144
• Figure 44: Future changes in the use of long-acting peakless insulin across the seven major markets, 2003 - page 145
• Figure 45: Past and future changes in the use of premixed insulin across the seven major markets, 2003 - page 147
• Figure 46: Proportion of type 2 diabetes patients on insulin therapy receiving each brand of insulin in the seven major markets, 2003 - page 149
• Figure 47: Overview of the inhaled insulin pipeline, 2004 - page 157
• Figure 48: Overview of the oral insulin pipeline, 2004 - page 165
• Figure 49: Barriers that non-injected insulins need to overcome, 2004 - page 170
• Figure 50: Proportion of type 2 diabetes patients estimated to be switched to non-injected insulin across the seven major markets, 2003 - page 176
• 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, 2003 - page 178

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