胰島素在二型糖尿病上的應用

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.

Scope of this report

• 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

Research and analysis 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.

Key reasons to read this report

• 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

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the type 2 diabetes insulin market

Summary

Key metrics

CHAPTER 2 INTRODUCTION AND SCOPE

Coverage of the Stakeholder Insight Survey

CHAPTER 3 COUNTRY TREATMENT TREES

Introduction to the treatment trees

US

Japan

France

Germany

Italy

Spain

UK

CHAPTER 4 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

CHAPTER 5 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

CHAPTER 6 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

CHAPTER 7 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

CHAPTER 8 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?

CHAPTER 9 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)

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

List of Tables

Table 1: Current prevalence of type 2 diabetes across the seven major markets, 2003

Table 2: Future prevalence of type 2 diabetes in the seven major markets, 2004-12

Table 3: Prevalence of type 1 and type 2 diabetes across the seven major markets, 2003

Table 4: Future prevalence of type 1 and type 2 diabetes in the seven major markets, 2004-12

Table 5: ADA evidence grading system for clinical practice guidelines

Table 6: Changes in insulin prescribing over the last three years by physician type across the seven major markets, 2003

Table 7: Estimated changes in insulin prescribing over the next three years by physician type across the seven major markets, 2003

Table 8: Incidence of hypoglycemia with insulin glargine versus NPH insulin from a meta-analysis of 2,304 type 2 diabetes patients, 2003

Table 9: Three clinical trials showing insulin detemir to induce weight loss

Table 10: Breakdown of line of therapy by monotherapy versus combination therapy in the seven major markets, 2003

Table 11: Overall breakdown of insulin use by line of therapy and by monotherapy versus combination therapy in the seven major markets, 2003

Table 12: Proportion of patients on second-line combination therapy prescribed insulin, by physician type, 2003

Table 13: Proportion of patients on third-line combination therapy prescribed insulin, by physician type, 2003

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, 2003

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, 2003

Table 22: Japan physician sample breakdown, 2003

Table 23: France physician sample breakdown, 2003

Table 24: Germany physician sample breakdown, 2003

Table 25: Italy physician sample breakdown, 2003

Table 26: Spain physician sample breakdown, 2003

Table 27: UK physician sample breakdown, 2003

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

List of 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, 2003

Figure 3: Overall breakdown of insulin prescribing trends in the US, 2003

Figure 4: Breakdown of insulin prescribing by line of therapy and by monotherapy versus combination therapy in the US, 2003

Figure 5: Overall breakdown of insulin prescribing trends in Japan, 2003

Figure 6: Breakdown of insulin prescribing by line of therapy and by monotherapy versus combination therapy in Japan, 2003

Figure 7: Overall breakdown of insulin prescribing trends in France, 2003

Figure 8: Breakdown of insulin prescribing by line of therapy and by monotherapy versus combination therapy in France, 2003

Figure 9: Overall breakdown of insulin prescribing trends in Germany, 2003

Figure 10: Breakdown of insulin prescribing by line of therapy and by monotherapy versus combination therapy in Germany, 2003

Figure 11: Overall breakdown of insulin prescribing trends in Italy, 2003

Figure 12: Breakdown of insulin prescribing by line of therapy and by monotherapy versus combination therapy in Italy, 2003

Figure 13: Overall breakdown of insulin prescribing trends in Spain, 2003

Figure 14: Breakdown of insulin prescribing by line of therapy and by monotherapy versus combination therapy in Spain, 2003

Figure 15: Overall breakdown of insulin prescribing trends in the UK, 2003

Figure 16: Breakdown of insulin prescribing by line of therapy and by monotherapy versus combination therapy in the UK, 2003

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, 2003

Figure 19: Estimated breakdown of the management of type 2 diabetes in the general population by physician type, 2003

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, 2003

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, 2003

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

Figure 26: Estimated change in the prescribing of insulin in type 2 diabetes across the seven major markets over the next three years, 2003

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

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

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

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

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

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, 2003

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, 2003

Figure 36: Proportion of patients on second-line therapy prescribed insulin as monotherapy, by physician type, 2003

Figure 37: Proportion of patients on third-line and beyond monotherapy prescribed insulin, by physician type, 2003

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, 2003

Figure 40: Past and future changes in the use of rapid-acting insulin across the seven major markets, 2003

Figure 41: Past and future changes in the use of short-acting insulin across the seven major markets, 2003

Figure 42: Past and future changes in the use of intermediate-acting insulin across the seven major markets, 2003

Figure 43: Past and future changes in the use of long-acting insulin across the seven major markets, 2003

Figure 44: Future changes in the use of long-acting peakless insulin across the seven major markets, 2003

Figure 45: Past and future changes in the use of premixed insulin across the seven major markets, 2003

Figure 46: Proportion of type 2 diabetes patients on insulin therapy receiving each brand of insulin in the seven major markets, 2003

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, 2003

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