糖尿病治療薬市場動向

Abstract

Overview

Introduction

Type 2 diabetes is an emerging epidemic driven by the escalating prevalence of obesity and by an ageing population. Diagnosis rates will continue to increase as improved awareness raises the public profile of the disease. Despite several established classes of oral anti-diabetic agents an unmet need for a safe, efficacious agent which can halt or reverse long-term disease progression remains.

Scope

• Survey of 180 PCPs, medical diabetologists and endocrinologists conducted in the seven major markets
• Comparison of physician survey with recent clinical developments, clinical trial results and current clinical guidelines
• Investigation of clinical unmet needs

Report Highlights

Type 2 diabetes is an emerging epidemic with an estimated 55 million people affected by the condition in the seven major markets. Despite the raise profile of the disease physician research reveals that only approximately 50% of patients are diagnosed and of those around 80% receive treatment

Novel classes of incretin mimetics, GLP-1 agonist and DDP-IV inhibitors, have the potential to improve time to secondary failure and are likely to be adopted by international guidelines in the near future. Despite the launch of these new products significant unmet needs remain in drug efficacy, safety and disease progression.

Long-term safety data is expected to become increasingly important following safety issues raised by recent meta-analyses of rosiglitazone over ischemic events. This will raise the safety bar for new products and is likely to lead to new classes requiring a long safety record before they are recommended as 1st- or 2nd- line therapies

Reasons to Purchase

• Assess how changes in diagnosis rates will influence the type 2 diabetes market
• Identify the changes in physician prescription habits and the changes in complication rates and analyze the impact of changes in treatment decisions
• Benchmark brand awareness and perceptions surrounding product positioning in order to formulate competitive lifecycle management strategies

Table of Contents

• ABOUT DATAMONITOR HEALTHCARE
  • About the Cardiovascular pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Key Findings
• CHAPTER 2 INTRODUCTION AND SCOPE
  • Scope of the analysis
  • Related reports
  • Common abbreviations used throughout this report:
• CHAPTER 3 COUNTRY TREATMENT ALGORITHMS
  • Introduction
    • US
    • Japan
    • France
    • Germany
    • Italy
    • Spain
    • UK
    • 5 European Markets Summary Algorithms
• CHAPTER 4 DISEASE DEFINITION AND OVERVIEW
  • Definition of diabetes
  • Segmentation of diabetes
    • Type 1 diabetes
    • Type 1.5 diabetes
    • Type 2 diabetes
  • Etiology and Risk factors
    • Mechanisms of development of diabetes
    • Genetic or acquired causes
  • Risk factors
    • Obesity
      • T2 diabetes epidemic hand-in-hand with obesity epidemic
    • Race
      • T2 diabetes more prevalent in Hispanics and African Americans than in Caucasians
    • Family history
      • T2 diabetes in first-degree relatives is a strong prognostic indicator
    • Advanced age
    • Gender and other factors
    • Gestational diabetes mellitus
• CHAPTER 5 EPIDEMIOLOGY OF DIABETES
  • Epidemiology of diabetes
    • Diabetes presents a worldwide public health problem
    • Current prevalence of type 1 and type 2 diabetes
    • Increasing prevalence of type 2 diabetes
    • Increase in prevalence to epidemic proportion
    • Datamonitor epidemiology forecast
      • Methodology
    • Epidemic rise in incidence of T2 diabetes
• CHAPTER 6 DIAGNOSIS AND PATIENT MANAGEMENT
  • Patient management
    • The majority of diabetics are diagnosed and managed by primary care practitioners
    • Referral to a specialist
  • Diagnosis rates in type 2 diabetes
  • Reasons for the poor diagnosis rate
    • Insidious nature of the disease
    • Lack of screening
    • Awareness of guidelines
    • Validity of diagnostic tests
    • Misdiagnosis of T2 and T1 diabetes
  • Strategies to increase diagnosis rates
    • The need for a targeted screening program
  • Late stage of diagnosis
  • Disease indicators at presentation
• CHAPTER 7 DIABETIC COMPLICATIONS
  • Complications of type 2 diabetes
    • Microvascular complications
      • Nephropathy
      • Retinopathy
      • Neuropathy
    • Macrovascular complications
      • Effect of macrovascular complications on type 2 diabetes treatment
    • End-stage disease considerations
  • Co-morbidities
    • Obesity
      • Effect of obesity on type 2 diabetes treatment
    • Hypertension
    • Dyslipidemia
• CHAPTER 8 TREATMENT OPTIONS FOR TYPE 2 DIABETES
  • Treatment guidelines for type 2 diabetes
    • Clinical practice guidelines from the ADA/EASD
    • The AACE clinical practice guidelines
  • Lifestyle management for type 2 diabetes
  • Pharmacological treatment for type 2 diabetes
  • Oral antidiabetic (OAD) agents
    • Biguanides (metformin)
    • Sulfonylureas
    • Prandial glucose regulators (PGRs)
    • Thiazolidinediones
    • Alpha-glucosidase inhibitors (AGIs)
    • Incretin Mimetics
    • Glucagon-like peptide-1 agonists (GLP-1s)
    • Dipeptidyl peptidase-4 inhibitors (DPP-4s)
  • Insulins
    • Lantus
    • Levemir
    • Humalog
    • Novolog
    • NovoLin
    • Humulin
    • Apidra
• CHAPTER 9 FIRST-LINE PHARMACOTHERAPY
  • Overview
    • First-line monotherapy
    • First-line combination therapy
• CHAPTER 10 SECOND-LINE PHARMACOTHERAPY
  • Overview
    • Second-line monotherapy
    • Second-line combination therapy
• CHAPTER 11 THIRD-LINE PHARMACOTHERAPY
  • Overview
    • Third-line monotherapy
    • Third-line combination therapy
• CHAPTER 12 TRANSITION TO INSULIN THERAPY
  • History of insulin therapy
  • Indications for insulin use in type 2 diabetes
  • Time of initiation of insulin therapy
  • Drivers for insulin uptake
    • Improved of glycemic control
    • Earlier initiation of insulin therapy
  • Restraints for uptake of insulin
    • Weight gain
    • Risk of hypoglycemia
    • Patient education and compliance with subcutaneous injections
    • Cost and reimbursement issues
  • Use of insulin
    • Overall usage of insulin
    • Changes to insulin prescribing habits
    • Past, present and future use
    • Usage of different types of insulin
  • Physician perception of different types of insulin
  • Brand map overview
    • Interpreting a brand map
      • Long-acting insulins: Lantus (Glargine) and Levemir (Detemir)
      • Short-acting insulins: Humalog (Lispro) and Apidra (Glulisine)
      • Failure of inhaled insulin
• CHAPTER 13 PRESCRIBING TRENDS IN THE TREATMENT OF TYPE 2 DIABETES
  • The evolution of the treatment regimen
    • Factors determining the alteration to a treatment regimen
    • Patient empowerment
    • Uptake of single-pill combination (SPC) therapies
  • The evolution of the treatment algorithm
    • Sulfonylureas and Metformin
    • Loss of confidence in TZDS
    • PGRs and AGIs
    • Insulin shifted down treatment algorithm by new classes of incretin mimetic
• CHAPTER 14 PRESCRIBING INFLUENCES IN THE TREATMENT OF TYPE 2 DIABETES
  • Factors influencing prescribing decisions in T2 diabetes
    • Efficacy is the major prescribing influence in type 2 diabetes
    • Safety is also an important prescribing influence
    • Cost issues possibly not as important as for other indications
    • Beta cell salvage and time to secondary failure
    • Mode of administration
    • Dosing frequency
  • Physician perception of existing therapies in type 2 diabetes
  • Brand map overview
    • Interpreting a brand map
    • Physician perception of established classes of antidiabetic drugs
    • Physician perception of novel classes of antidiabetic drugs
• CHAPTER 15 UNMET NEEDS IN TYPE 2 DIABETES
  • Overview
    • Each unmet need is ordered by relative importance, and discussed in more detail below:
    • Insulin response variability
    • Poor diagnosis
      • Routine screening programs to improve poor diagnosis rate
    • Guideline awareness
    • Non-invasive blood glucose measurement (BMG)
    • Tolerability
      • Incidence of hypoglycemic events
      • Delivery-related complications
      • Weight gain
    • Mode of administration (MoA)
      • Reluctance to self-inject
    • Patient compliance
    • Insulin secretion patterns
    • Patient awareness
    • Efficacy
• APPENDIX A
  • Bibliography
• APPENDIX B
  • Physician research methodology
    • Physician sample breakdown
      • US
      • Japan
      • France
      • Germany
      • Italy
      • Spain
      • UK
• APPENDIX C
  • The survey questionnaire
  • List of Tables
    • Table 1: Prevalence of diabetes mellitus is forecast to increase by the International Diabetes Foundation (IDF), 2003-2025
    • Table 2: Prevalence rate of type 1 and type 2 diabetes in the seven major markets (%), 2006-2015
    • Table 3: Estimated absolute prevalence of diabetes in the seven major markets (millions), 2007-2017
    • Table 4: Framingham Heart Study data on lipid levels in men and women with and without diabetes
    • Table 5: ADA evidence grading system for clinical practice guidelines
    • Table 6: Comparator Insulins by onset of action, 2006
    • Table 7: US physician sample breakdown, 2007
    • Table 8: Japan physician sample breakdown, 2007
    • Table 9: France physician sample breakdown, 2007
    • Table 10: Germany physician sample breakdown, 2007
    • Table 11: Italy physician sample breakdown, 2007
    • Table 12: Spain physician sample breakdown, 2007
    • Table 13: UK physician sample breakdown, 2007
  • List of Figures
    • Figure 1: Population demographic for diagnosed type 2 diabetic patients in the US, 2007
    • Figure 2: Population, treatment and treatment outcome data for type 2 diabetic patients in US, 2007
    • Figure 3: TypeFigTitleHere
    • Figure 4: Population, treatment and treatment outcome data for type 2 diabetic patients in Japan, 2007
    • Figure 5: Population demographic for diagnosed type 2 diabetic patients in France, 2007
    • Figure 6: Population, treatment and treatment outcome data for type 2 diabetic patients in France, 2007
    • Figure 7: Population demographic for diagnosed type 2 diabetic patients in Germany, 2007
    • Figure 8: Population, treatment and treatment outcome data for type 2 diabetic patients in Germany, 2007
    • Figure 9: Population demographic for diagnosed type 2 diabetic patients in Italy, 2007
    • Figure 10: Population, treatment and treatment outcome data for type 2 diabetic patients in Germany, 2007
    • Figure 11: Population demographic for diagnosed type 2 diabetic patients in Spain, 2007
    • Figure 12: Population, treatment and treatment outcome data for type 2 diabetic patients in Italy, 2007
    • Figure 13: Population demographic for diagnosed type 2 diabetic patients in the UK, 2007
    • Figure 14: Population, treatment and treatment outcome data for type 2 diabetic patients in the UK, 2007
    • Figure 15: Population, treatment and treatment outcome data for RCC in the 5EU, 2007 (continued)
    • Figure 16: Population, treatment and treatment outcome data for type 2 diabetic patients in the 5EU, 2007
    • Figure 17: Specialty of physician diagnosing and managing diabetic patients.
    • Figure 18: Estimated percentage of diagnosed type 2 diabetics in the seven major markets
    • Figure 19: Estimated percentage of diagnosed type 2 diabetics who are classified as either overweight or obese.
    • Figure 20: Estimated percentage of diagnosed type 2 diabetics who are classified as prehypertensive or hypertensive.
    • Figure 21: Estimated percentage of diagnosed type 2 diabetics with each degree of plasma cholesterol elevation
    • Figure 22: Proportion of type 2 diabetics in the seven major markets with complications
    • Figure 23: Proportion of type 2 diabetics with complications that suffer from microvascular and/or macrovascular complications in the seven major markets
    • Figure 24: Proportion of type 2 diabetics with different stages of nephropathy in the seven major markets
    • Figure 25: Average time from the diagnosis of diabetes required for the development of different stages of diabetic nephropathy in the seven major markets, 2007.
    • Figure 26: Proportion of type 2 diabetics with retinopathy in the seven major markets
    • Figure 27: Average time required for the development of diabetic retinopathy in the seven major markets
    • Figure 28: Proportion of type 2 diabetics with neuropathy in the seven major markets
    • Figure 29: Average time required for the development of diabetic neuropathy in the seven major markets
    • Figure 30: Proportion of type 2 diabetics with macrovascular complications in the seven major markets
    • Figure 31: Average time for the development of macrovascular complications in the seven major markets
    • Figure 32: Proportion of type 2 diabetics with serious complications (e.g. ESRD, acute MI, amputation)
    • Figure 33: Treatment algorithm for type 2 diabetes, recommended by the 2006 ADA/EASD clinical practice guidelines.
    • Figure 34: Percentage of diagnosed type 2 patients receiving drug therapy and/or lifestyle management in the seven major markets
    • Figure 35: Breakdown of patients by line of treatment in the seven major markets
    • Figure 36: Mechanism of action of sulfonylureas and prandial glucose regulators
    • Figure 37: Percentage of patients on monotherapy versus. combination therapy at first-line therapy, 2007.
    • Figure 38: Breakdown of overall drug class usage in patients on first-line therapy in the seven major markets
    • Figure 39: Breakdown of combination therapy at first-line in the seven major markets
    • Figure 40: Percentage of patients in monotherapy vs. combination therapy in second-line therapy
    • Figure 41: Breakdown of drug class use in patients on second-line monotherapy in the seven major markets
    • Figure 42: Breakdown of drug class use in patients on second-line monotherapy in the seven major markets
    • Figure 43: Percentage of patients on monotherapy versus combination therapy in third-line therapy, 2007.
    • Figure 44: Breakdown of drug class use in patients on third-line monotherapy in the seven major markets, 2007.
    • Figure 45: Breakdown of drug regimen use in patients on third-line combination therapy in the seven major markets
    • Figure 46: Common insulin regimens
    • Figure 47: When to start insulin therapy in type 2 diabetes?
    • Figure 48: Time to the inititation of insulin therapy
    • Figure 49: Specialists' rankings of the factors influencing insulin prescribing in the seven major markets (1 = most influencing, 5 = least influencing)
    • Figure 50: Uptake of insulin across the seven major markets, 2007.
    • Figure 51: Proportion of drug-treated type 2 diabetes patients prescribed insulin either alone or in combination therapy, by line of therapy, across the seven major markets, 2007
    • Figure 52: Comparison of current (2007) insulin prescription pattern with that in 2004, and 2010.
    • Figure 53: Brand map for the different types of insulin
    • Figure 54: Factors influencing therapy changes, 2007
    • Figure 55: Therapy changes across the seven major markets, 2007
    • Figure 56: Factors influencing the uptake of SPCs across the seven major markets, 2007
    • Figure 57: Uptake of SPCs across the seven major markets, 2007
    • Figure 58: Physicians' changing prescribing trends 2004-2010
    • Figure 59: Evolution of the treatment algorithm
    • Figure 60: Evolution of the treatment algorithm
    • Figure 61: Evolution of the treatment algorithm
    • Figure 62: Relative weighting given to each prescribing influence for type 2 diabetes drug therapy across the seven major markets, 2007
    • Figure 63: Brand map of established antidiabetic drugs in 7MM, 2007
    • Figure 64: Brand map of novel classes of antidiabetic drugs in 7MM, 2007
    • Figure 65: Unmet need for antidiabetic drugs in 7MM, 2007
    • Figure 66: Unmet need in blood glucose measurement (BMG)