Innovations and Pipelines for Respiratory Disorders: Niche markets, New Products and Future Developments

Published by: Business Insights

Published: Aug. 1, 2008 - 145 Pages

Table of Contents

Innovations and pipelines for respiratory disorders

Executive Summary

Market introduction and outlook

Asthma

COPD

Cystic fibrosis

Pulmonary hypertension

Respiratory allergies

Respiratory tract infections

Key companies and pipelines

Chapter 1 Market introduction and outlook

Summary

Market introduction

Respiratory disease classification

Region-specific product sales revenues

Existing product pipeline

Leading marketed innovatives

Innovatives classification

Nasal preparations

Nasonex

Anti-asthma and COPD preparations

Seretide

Singulair

Spiriva

Cough and cold preparations

Pulmozyme

Systemic antihistamines

Xyzal

Key events to impact the respiratory market

Decreasing numbers of new product approvals

Regulatory affairs update

Emergence of molecular testing

Discontinued gene therapy research for cystic fibrosis

Patent challenge: Ivax vs Advair

Positive result for Seretide in COPD

Emergence of innovative drug classes

Chapter 2 Asthma

Summary

Market introduction

Etiology

Epidemiology

Unmet needs

Future drivers of growth and innovation

Combination therapies

Non-steroidal anti-inflammatories

PG-D2 agonists

CCR3 antagonists

Targeting the mast cells directly

Monoclonal antibodies

Novel Anti-TNF targets

Inhaled immunostimulatory DNA

Novel therapies for severe neutrophilic asthma

Gene Therapy

Chapter 3 COPD

Summary

Market introduction

Etiology

Epidemiology

Unmet needs

Future drivers of growth and innovation

Novel long-acting combination therapies

Triple combinations

Oral anti inflammatories

Phosphodiesterase inhibitors

CXCR2 Agonists

Proteinase targets

Other novel first in class mechanisms

Chapter 4 Cystic fibrosis

Summary

Market introduction

Etiology

Epidemiology

Unmet needs

Future drivers of growth and innovation

Gene therapy

Cystic fibrosis transmembrane regulator (CFTR) Protein Modulators

Targeting ion channel deficit

Anti-inflammatories

Anti-infectives

Active vaccines

Chapter 5 Pulmonary hypertension

Summary

Etiology

Epidemiology

Unmet needs

Future drivers of growth and innovation

Peptide hormones

Long-acting therapy

5 HT-2B Antagonists

Monoclonal Antibody therapy

Chapter 6 Respiratory allergies

Summary

Market introduction

Etiology

Epidemiology

Unmet needs

Future drivers of growth and innovation

Corticosteroids

Antihistamines

Anti-inflammatories

Nasal decongestants

Novel “immunodrug” approach

Chapter 7 Respiratory tract infections

Summary

Market introduction

Etiology

Epidemiology

Unmet needs

Future drivers of growth and innovation

Antibiotics

Anti-virals

Vaccine development

Monoclonal antibodies

Chapter 8 Key companies and pipelines

Summary

Introduction

GlaxoSmithKline

Leading market revenue drivers

Upcoming milestones

Leading Innovatives pipeline

Preclinical

Phase II

Boehringer Ingelheim

Leading market revenue drivers

Leading innovatives pipeline

Preclinical

Phase II

Merck & Co.

Upcoming milestones

Leading Innovatives pipeline

AstraZeneca

Leading market revenue drivers

Upcoming milestones

Leading Innovatives pipeline

Preclinical

Phase I

Phase II

Chapter 9 Appendix

Index

List of Figures

Figure 1.1: Growth in global respiratory product sales revenues, 2003-2007 ($m)

Figure 1.2: Share of respiratory product global sales revenues by ATC2 classification, 2007 ($m)

Figure 1.3: Global respiratory and pulmonary product pipeline, May 2008

Figure 1.4: Total respiratory market, growth metrics and sales revenues by therapy area, global,

2003-2007

Figure 1.5: Global sales by drug class, 2007 ($m)

Figure 1.6: Global revenues for asthma and COPD related drug classes, 2007 ($m)

Figure 1.7: NDAs for novel respiratory drugs, FDA, 2003-2008

Figure 1.8: Key disease pathways, emerging drug targets and company-specific areas of interest

for respiratory disorders

Figure 1.9: Lung alveolar epithelial cell - Key biochemical pathways and respiratory drug targets

Figure 2.10: Comparative etiology of an asthmatic bronchiole

Figure 2.11: The Asthma Innovatives R&D Pipeline

Figure 3.12: The COPD Innovatives R&D pipeline

Figure 4.13: The cystic fibrosis innovatives R&D pipeline

Figure 5.14: The PAH Innovatives R&D Pipeline

Figure 6.15: The respiratory allergies innovatives pipeline

Figure 7.16: Etiology of common respiratory tract infections

Figure 8.17: Top 10 companies by sales revenue, total respiratory product sales growth metrics

2003-2007, global

Figure 8.18: GlaxoSmithKline respiratory and pulmonary product pipeline, July 2008

Figure 8.19: Boehringer Ingelheim respiratory and pulmonary product pipeline, July 2008

Figure 8.20: Merck & Co respiratory and pulmonary product pipeline, July 2008

Figure 8.21: AstraZeneca respiratory and pulmonary product pipeline, July 2008

List of Tables

Table 1.1: Estimated Annual Incidence for selected respiratory diseases by WHO sub region, 2002, ‘000’s

Table 1.2: Estimated annual incidence for selected respiratory diseases by sex, 2002, ‘000s

Table 1.3: Global sales of innovatives by drug class, 2007 ($m)

Table 1.4: Top five diagnoses - share of total nasal preparations Rx market (EU5, US and Japan), 2007

Table 1.5: Key anti-asthma and COPD growth drivers, global, 2007 ($m)

Table 1.6: Global sales of Leading anti-asthma and COPD brands, 2003-2007 ($m)

Table 1.7: Singulair; major product milestones

Table 1.8: Leading branded systemic antihistamines, global, 2007 ($m)

Table 2.9: Asthma prevalence and diagnosed populations, EU5, US and Japan, 2007

Table 2.10: Anti-asthma Monoclonal Antibodies, June 2008

Table 3.11: Estimated prevalence of COPD, EU5, US and Japan, 2006 (‘000s)

Table 4.12: Annual incidence estimates of Cystic fibrosis in the 7MM, 2008

Table 4.13: P aeruginosa pipeline vaccine candidates

Table 5.14: Estimated prevalence of PAH by region, 2005 (millions)

Table 5.15: Current breakdown of presenting PAH patients by severity

Table 5.16: Strengths and weaknesses, currently marketed pulmonary hypertension therapies

Table 6.17: Total diagnosed AR population aged over 20 years according to severity (%) and allergen (millions) in the 7 MM, 2006

Table 7.18: Incidence of RTI diagnoses, US, 2006, millions

Table 8.19: GlaxoSmithKline; Leading drug class sales for respiratory disorders, global, 2003- 2007 ($m)

Table 8.20: Boehringer Ingelheim; Leading drug class sales for respiratory disorders, global, 2003- 2007 ($m)

Table 8.21: AstraZeneca; Leading drug class sales for respiratory disorders, global, 2003-2007 ($m)

Table 9.22: Measurement of severity amongst COPD sufferers

Abstract

• The respiratory and pulmonary product market expanded at a CAGR of 9.3% over the period 2003-07. Growth has been most prominent in the sale of anti-asthma and COPD products, which accounted for 55% of global respiratory revenues in 2007.
• Anti-asthma and COPD treatments are predominantly comprised of innovative products, which accounted for 64.9% of total product revenues in 2007. Revenue growth in this category is being driven by the sale of both plain, inhaled anticholinergics and inhaled combination products (B2 stimulants and corticosteroids).
• GlaxoSmithKline is the global market leader for respiratory product sales. GSK’s dominance will be reinforced by a strong R&D portfolio that includes a number of phase II combination candidates.
• Research into treatments for cystic fibrosis are currently concentrated on methods of non-viral gene transfer. The successful launch of gene therapy innovatives is not expected until 2030.
• Real-time PCR is a significant development in the treatment of respiratory tract infections, allowing rapid/accurate pathogen identification through genotyping. This will create market potential for targeted, pathogen-specific first line anti-infective treatments.

• Assess patient potential, treatment trends and sales patterns across the global respiratory market with this report’s analysis of countries including Japan, France, Germany, Italy, Spain, the UK and the US.
• Discover which respiratory indications have the greatest potential to provide franchise growth and profile the key drivers of growth and innovation across Asthma, COPD, Cystic Fybrosis, Pulmonary Hypertension, Respiratory Allergies and Respiratory tract infections.
• Compare the product pipelines, therapy area investments and growth metrics of key players in the respiratory disorders market with this report’s assessment of major companies including GSK, Merck & Co., Boehringer Ingelheim, and AstraZeneca.
• Examine the major unmet needs within the global respiratory disorders market, identify the latest key events and understand the most important issues affecting major companies within this sector.
• Evaluate leading mechanisms of action under development and discover which have the potential to fill current market niches, with this report’s analysis of clinical/preclinical results, potential market positioning, sales performance and investment activity.

• Shifting R&D focus. The majority of currently marketed therapies are aimed at treating presenting symptomology, however new disease models have identified biomarkers involved in pathological disease progression which may act as targets for pipeline drug candidates.
• Increased regulatory scrutiny. Stringent analysis of datasets and increased requirements for dataset submission has put pressure on drug developers to focus their pipelines around leading candidates.
• Drive for innovation. The success of leading companies is heavily reliant upon a small number of branded products (eg. Singulair accounts for 99.86% of Merck & Co's respiratory portfolio revenues). Many leading players are now aiming to expand their portfolios by developing new drug candidates with novel mechanisms.
• COPD/Asthma development potential. The most significant opportunities for drug developers remain within the COPD and asthma patient populations, where present treatment regimens are largely inadequate and convenient dosing regimens are required.

• What are the leading existing marketed innovatives and how has their success been achieved?
• What are the most exciting compounds currently in development for the different respiratory disease indications?
• What is the forecast sales potential of these products?
• How will novel products be positioned to maximize their potential?
• How do the product pipelines of leading respiratory companies compare and what are their investment and growth strategies?
• What are the differences between the treatment models of leading companies in terms of clinical development?
• Which companies are best positioned to succeed over 2008-12 based on their pipeline clinical candidates?

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