携帯型吸入器市場の動向‐ブランドの差別化とジェネリックへの対抗策

Abstract

Overview

Introduction

An overview ofthe market for portable inhalers, looking at market shares,usefulness as tools for franchise protection and -expansion. Patient- and physician preferences are being analyzed as well as suitablility of molecules and inhaler types.,

Scope

• Summary of the advantages and disadvantages of the main types of portable inhaler devices
• Market overview highlighting CFC-free and CFC-containing devices and devices delivering branded and generic molecules, based on 2007 IMS Sales Data
• Overview of portable inhaler devices in non-pulmonary diseases, including inhaled insulin for the treatment of diabetes
• Assessment of opportunities to use portable inhaler devices as key factors in a product' s commercial success throughout its lifecycle

Report Highlights

Although a direct link between the type of device and level of disease control has never been proven, the latter is possibly indirectly influenced by the respective device' s ease of use, its airflow resistance and the patient' s device preferences.

There are still opportunities in the asthma/COPD market to gain market share by differentiating with an improved inhaler device. One of such strategies would be to introduce a product line of different molecules in the same device model in order to give physicians the opportunity to minimize the scope for error on the patient side.

Inhaled drugs are increasingly being developed for systemic use in non-pulmonary diseases. Reasons for this include improved patient acceptance and compliance and a faster onset of action. However, the commercial failure of Pfizer' s inhaled insulin illustrates the difficulties in striking the right balance.

Reasons to Purchase

• Understand key advantages and disadvantages of different types of portable inhaler devices
• Identify future challenges for portable inhaler devices and best method of meeting these
• Assess the respiratory market' s segmentation and dynamics by device type and brand/generic split

Table of Contents

• ABOUT DATAMONITOR HEALTHCARE
  • About the Infectious disease and Respiratory (ID&R) pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Market definition for this report
  • Objective of the analysis
  • Strategic scoping and focus
  • Data definitions, limitations and assumptions
    • Standard units
    • Derivation of Pricing Trends
  • Datamonitor insight into the portable inhaler devices market
  • Contributing experts
  • Related reports
  • Upcoming related reports
• CHAPTER 2 PORTABLE INHALER DEVICES OVERVIEW
  • Metered dose inhalers
    • Pressurized metered dose inhalers
      • Advantages
      • Disadvantages
    • Breath-activated metered dose inhalers
      • Advantages
      • Disadvantages
  • Dry powder inhalers
    • Single-unit dose DPIs
    • Multi-dose reservoir DPIs
    • Multi-unit dose DPIs
    • Advantages
      • DPIs do not require actuation-inhalation co-ordination like pMDIs
    • Disadvantages
      • The wide variety of DPI types requires thorough patient-training
      • DPI performance relies on the strength of inhalation
      • Environmental factors have an impact on DPI performance
  • Soft mist inhaler (the Respimat)
• CHAPTER 3 CURRENT MARKET SITUATION
  • Value and volume of the different inhaler devices
    • Sales of pMDIs versus DPIs versus BAIs
      • The pressurized metered dose inhalers
      • The dry powder inhalers
      • The breath-activated metered dose inhalers
    • Sales of branded versus generic products
    • Sales of CFC-containing versus CFC-free devices
    • Value and volume per country
  • Pricing of the different inhaler devices
    • Pricing of pMDIs versus DPIs versus BAIs
    • Pricing of branded versus generic products
    • Pricing of CFC-containing versus CFC-free devices
  • The availability of devices per molecule
    • Inhaled corticosteroids/long-acting beta2-agonist combinations
    • Inhaled corticosteroids
    • Long-acting beta2-agonists
    • Long-acting anticholinergics
    • Short-acting beta2-agonists
• CHAPTER 4 THE LINK BETWEEN INHALER DEVICES AND DISEASE CONTROL
  • The importance of disease control
  • The relation between inhaler devices and disease control
    • Poor inhaler technique
  • The relation between inhaler devices and molecules
  • Does the ideal inhaler device exist?
• CHAPTER 5 GAINING MARKET SHARE THROUGH INHALER DEVICES
  • Spiriva (tiotropium bromide)
    • Spiriva differentiated with the help of the Respimat
  • The CFC-HFA switch in the US
    • HFA as an alternative to CFC
    • 3M' s patents will prevent entry of other HFA SABAs
    • Impact on individual brands
  • Generic ICS/LABA combination products
• CHAPTER 6 PORTABLE INHALER DEVICES IN NON-PULMONARY DISEASES
  • Inhaled insulin for the treatment of diabetes
    • Where does Exubera' s failure leave the other inhaled insulins in development?
  • Inhaled drugs for the treatment of migraine
  • Inhaled apomorphine for the treatment of Parkinson' s disease and erectile dysfunction
  • Inhaled fentanyl for the treatment of breakthrough pain
  • Inhaled drugs for the treatment of other non-pulmonary diseases
• CHAPTER 7 THE FUTURE OF PORTABLE INHALER DEVICES
  • A differentiating device has biggest impact in medium-mature markets
  • The availability of a high number of molecules in the same device may lead to product uptake
  • The role of cost-effectiveness studies will become more important
  • The interaction among Big Pharma, generics companies and drug delivery companies will continue to develop
    • The growing importance of generics companies and drug delivery companies
• BIBLIOGRAPHY
  • Papers
  • Websites
  • Press releases
  • Datamonitor reports
• APPENDIX A INDEXED HISTORICAL SALES
  • Six major markets
  • United States
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom
• APPENDIX B INDEXED HISTORICAL VOLUME
  • Six major markets
  • United States
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom
• APPENDIX C PRICING
  • Six major markets
  • United States
  • France
  • Germany
  • Italy
  • Spain
  • UK
• APPENDIX D OVERVIEW OF DEVICES AVAILABLE PER MOLECULE AND COUNTRY
  • Inhaled corticosteroid/long-acting beta2-agonist combinations
  • Inhaled corticosteroids
  • Long-acting beta2-agonists
  • Long-acting anticholinergics
  • Short-acting beta2-agonists
  • Short-acting anticholinergics
  • Short-acting anticholinergic/beta2-agonist combinations
• APPENDIX E
  • Contributing experts
  • Report methodology
  • About Datamonitor
    • About Datamonitor Healthcare
    • About the Infectious Disease & Respiratory analysis team
    • Disclaimer
  • List of Tables
    • Table 1: Overview of New Form Codes included in this report
    • Table 2: Inhaler assessment grades
    • Table 3: Mean scores for pMDI + Volumatic, Turbuhaler and Easi-Breathe groups for each aspect of technique
    • Table 4: Patient inhaler preference
    • Table 5: Indexed total value sales by device type, molecule status and the presence of CFC, in the six major markets, 2003-07
    • Table 6: Indexed total volume (standard units) by device type, molecule status and the presence of CFC, in the six major markets, 2003-07
    • Table 7: Indexed total value sales by device type, in the six major markets, 2003-07
    • Table 8: Indexed total value sales of pMDIs by molecule status and the presence of CFC, in the six major markets, 2003-07
    • Table 9: Indexed total value sales of DPIs by molecule status and the presence of CFC, in the six major markets, 2003-07
    • Table 10: Indexed total value sales of BAIs by molecule status and the presence of CFC, in the six major markets, 2003-07
    • Table 11: Indexed total value sales of devices delivering branded versus generic molecules, across all device types, in the six major markets, 2003-07
    • Table 12: Indexed total value sales of CFC-containing and CFC-free devices, irrespective of the molecules status, in the six major markets, 2003-07
    • Table 13: Pricing of portable inhaler devices per standard unit in the six major markets, 2003-07
    • Table 14: Prices of HFA (levo)salbutamol products in 2007
    • Table 15: Inhaled insulin products
    • Table 16: Number of asthma patients using single or multiple inhaler devices and proportion of those patients with inadequate technique, over two time periods
    • Table 17: Indexed total sales by device type, molecule status and the presence of CFC, in the six major markets, 2003-07
    • Table 18: Indexed total sales by device type, molecule status and the presence of CFC, in the US, 2003-07
    • Table 19: Indexed total sales by device type, molecule status and the presence of CFC, in France, 2003-07
    • Table 20: Indexed total sales by device type, molecule status and the presence of CFC, in Germany, 2003-07
    • Table 21: Indexed total sales by device type, molecule status and the presence of CFC, in Italy, 2003-07
    • Table 22: Indexed total sales by device type, molecule status and the presence of CFC, in Spain, 2003-07
    • Table 23: Indexed total sales by device type, molecule status and the presence of CFC, in the UK, 2003-07
    • Table 24: Indexed total volume by device type, molecule status and the presence of CFC, in the six major markets, 2003-07
    • Table 25: Indexed total volume by device type, molecule status and the presence of CFC, in the US, 2003-07
    • Table 26: Indexed total volume by device type, molecule status and the presence of CFC, in France, 2003-07
    • Table 27: Indexed total volume by device type, molecule status and the presence of CFC, in Germany, 2003-07
    • Table 28: Indexed total volume by device type, molecule status and the presence of CFC, in Italy, 2003-07
    • Table 29: Indexed total volume by device type, molecule status and the presence of CFC, in Spain, 2003-07
    • Table 30: Indexed total volume by device type, molecule status and the presence of CFC, in the UK, 2003-07
    • Table 31: Pricing of portable inhaler devices per standard unit in the six major markets, 2003-07
    • Table 32: Pricing of portable inhaler devices per standard unit in the US, 2003-07
    • Table 33: Pricing of portable inhaler devices per standard unit in France, 2003-07
    • Table 34: Pricing of portable inhaler devices per standard unit in Germany, 2003-07
    • Table 35: Pricing of portable inhaler devices per standard unit in Italy, 2003-07
    • Table 36: Pricing of portable inhaler devices per standard unit in Spain, 2003-07
    • Table 37: Pricing of portable inhaler devices per standard unit in the UK, 2003-07
    • Table 38: Overview of devices per country delivering inhaled corticosteroid/long-acting beta2-agonist combinations, 2007
    • Table 39: Overview of devices per country delivering inhaled corticosteroids, 2007
    • Table 40: Overview of devices per country delivering long-acting beta2-agonists, 2007
    • Table 41: Overview of devices per country delivering long-acting anticholinergics, 2007
    • Table 42: Overview of devices per country delivering short-acting beta2-agonists, 2007
    • Table 43: Overview of devices per country delivering short-acting anticholinergics, 2007
    • Table 44: Overview of devices per country delivering short-acting anticholinergic/beta2-agonist combinations, 2007
  • List of Figures
    • Figure 1: Timeline of the development of inhaler devices for pulmonary diseases
    • Figure 2: Advantages and disadvantages of the main three types of portable inhaler devices
    • Figure 3: A pressurized metered dose inhaler
    • Figure 4: Market share of pMDIs in the total portable inhaler market in Europe, 2007
    • Figure 5: pMDI-dependent errors made by patients when using their usual inhaler
    • Figure 6: A breath-activated metered dose inhaler
    • Figure 7: Patients' perception of the ease of use of a pMDI and a BAI
    • Figure 8: Distribution of NHS costs for BAI and standard pMDI patients
    • Figure 9: Several types of dry powder inhalers
    • Figure 10: Instructions for DPI use from patient information leaflets
    • Figure 11: The Respimat Soft Mist Inhaler (SMI)
    • Figure 12: Sales of inhaled drugs in the six major markets, 2006-16
    • Figure 13: The asthma/COPD market by method of drug delivery, 2007
    • Figure 14: Indexed total value sales by device type, molecule status and the presence of CFC, in the six major markets, 2003-07
    • Figure 15: Indexed total volume (standard units) by device type, molecule status and the presence of CFC, in the six major markets, 2003-07
    • Figure 16: Indexed total value sales by device type, in the six major markets, 2003-07
    • Figure 17: Indexed total value sales of pMDIs by molecule status and the presence of CFC, in the six major markets, 2003-07
    • Figure 18: Indexed total value sales of DPIs by molecule status and the presence of CFC, in the six major markets, 2003-07
    • Figure 19: Indexed total value sales of BAIs by molecule status and the presence of CFC, in the six major markets, 2003-07
    • Figure 20: Indexed total value sales of devices delivering branded versus generic molecules, across all device types, in the six major markets, 2003-07
    • Figure 21: Indexed total value sales of CFC-containing and CFC-free devices, irrespective of the molecules status, in the six major markets, 2003-07
    • Figure 22: Value and volume shares of the different types of devices in the US, 2007
    • Figure 23: Value and volume shares of the different types of devices in France, 2007
    • Figure 24: Value and volume shares of the different types of devices in Germany, 2007
    • Figure 25: Value and volume shares of the different types of devices in Italy, 2007
    • Figure 26: Value and volume shares of the different types of devices in Spain, 2007
    • Figure 27: Value and volume shares of the different types of devices in the UK, 2007
    • Figure 28: The average price per SU for the four main device types in the six major markets, 2003-07
    • Figure 29: The average price per SU for branded and generic molecules across all device types in the six major markets, 2003-07
    • Figure 30: The average price per SU for CFC and CFC-free devices across all types in the six major markets, 2003-07
    • Figure 31: Overview of the links between the device and disease control
    • Figure 32: Levels of asthma control according to the GINA guidelines
    • Figure 33: Characteristics of an ideal inhaler device
    • Figure 34: Factors influencing inhaler choice
    • Figure 35: Key drivers and resistors for the success of inhaled drug delivery in non-pulmonary diseases
    • Figure 36: Reasons why Exubera (inhaled insulin) failed
    • Figure 37: Overview of the characteristics of three types of asthma/COPD markets per drug class, 2007
    • Figure 38: Overview of the inhaled drug delivery sector