Global Markets for Asthma and COPD Drugs

Published by: BCC Research

Published: Aug. 1, 2012 - 159 Pages

Table of Contents

CHAPTER 1 INTRODUCTION

STUDY GOALS AND OBJECTIVES

REASONS FOR DOING THE STUDY

SCOPE OF REPORT

METHODOLOGY

INTENDED AUDIENCE

INFORMATION SOURCES

ANALYST CREDENTIALS

RELATED BCC REPORTS

BCC ONLINE SERVICES

DISCLAIMER

CHAPTER 2 SUMMARY

SUMMARY TABLE GLOBAL MARKET FOR ASTHMA AND COPD PRESCRIPTION DRUGS BY DISEASE, THROUGH 2017 ($ MILLIONS)

SUMMARY FIGURE GLOBAL MARKET FOR ASTHMA AND COPD PRESCRIPTION DRUGS BY REGION, 2012 AND 2017 (%)

CHAPTER 3 OVERVIEW

PULMONARY DRUG DELIVERY

PULMONARY CONDITIONS AND THERAPIES

RESPIRATORY SYSTEM

LUNG

Particle Size, Toxicity and Drug Deposition

Systemic and Local Therapy

Pulmonary Drug Delivery-Devices

Device Characteristics

Manufacturing Techniques

ASTHMA

Symptoms of Asthma

Global Prevalence

CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Symptoms of COPD

Medication Treatment

Types of Medication Treatments

Classification of Asthma and COPD Medications

Bronchodilators

Quick-acting Bronchodilators

Two Classes of Long-Term Bronchodilators

Anti-inflammatory Drugs

Combination Inhaled Corticosteroids and Long-acting Beta-2 Agonists (ICS/LABA)

Advantages of ICS/LABA

TABLE 1 MARKETED ASTHMA AND COPD DRUG CLASSES

Drug Delivery Methods

Inhaled Drugs

Metered-dose Inhaler

Pressurized MDI Devices

Types of Metered-dose Inhalers

Breath-activated Inhalers

Types of Breath-activated Inhalers

Dry Powder Inhalers

Disadvantages of DPI

Types of DPI Inhalers

Nebulizers

Usage

Types of Nebulized Drugs

Oral and Injectable Drugs

Oral Drug Types

Injectable Drug Types

ADVANTAGES/DISADVANTAGES OF DRUG DELIVERY METHODS

DRUG DEVELOPMENT PROCESS

DEVELOPMENT OF DISEASE-MODIFYING DRUGS

New Drug Targets

TECHNICAL ASPECTS IN THE DEVELOPMENT OF INHALED DRUGS

INTELLECTUAL PROPERTY RIGHTS

DRUG DEVELOPMENT

COMPLEX REGULATORY DRUG APPROVAL PROCESS

Approval Times

REGULATORY ISSUES

REMOVAL OF CFC-PROPELLED INHALERS

FDA DRUG SAFETY WARNINGS

INDUSTRY PLAYERS

TIERS OF COMPETITION

MAJOR DRUG MANUFACTURERS

GlaxoSmithKline

Merck

Boehringer Ingelheim

TABLE 2 NET REVENUES FOR TOP SIX ASTHMA/COPD PRODUCT MANUFACTURERS, WITH PRODUCT(S), 2010 AND 2011 ($ MILLIONS)

SPECIALTY PHARMACEUTICAL COMPANIES

Teva Pharmaceutical

Chiesi Farmaceutici

Sunovion/Sepracor

TABLE 3 NET REVENUES FOR TOP SPECIALTY ASTHMA/COPD MANUFACTURERS WITH PRODUCT(S), 2010 AND 2011 ($ MILLIONS)

SMALLER COMPANIES

TABLE 4 NET REVENUES FOR SMALLER ASTHMA/COPD PRODUCT MANUFACTURER, WITH PRODUCT, 2010 AND 2011 ($ MILLIONS)

ACQUISITIONS AND MERGERS

TABLE 5 ACQUISITIONS AND MERGERS IN THE ASTHMA AND COPD MARKET, JANUARY 2008 TO JUNE 2012 ($ MILLIONS)

COMPETITIVE FACTORS

SIX COMPETITIVE FACTORS

Delivery Mode and Convenience

Product Efficacy and Dosage Frequency

Safety

Combination Drugs

Drug Pricing

Sales and Marketing

SIGNIFICANT TRENDS

GLOBAL AGING POPULATION LEADS TO INCREASING ASTHMA AND COPD

PREVALENCE

NEW DRUG LAUNCHES OFFER ENHANCED TREATMENT OPTIONS

PATENT EXPIRATIONS OF MAJOR DRUGS AND GENERIC DRUG LAUNCHES WILL

CHANGE THE MARKET

TABLE 6 MAJOR ASTHMA/COPD DRUGS THAT LOSE PATENT PROTECTION BETWEEN 2008 AND 2024

MARKET CHALLENGES

TECHNICAL- AND MARKET-SPECIFIC EXPERTISE REQUIRED TO COMPETE IN THIS THERAPEUTIC AREA

FILLING UNMET NEEDS

DISEASE-MODIFYING DRUGS

SUPERIOR EFFICACY DRUGS

IMPROVED SAFETY PROFILE DRUGS

IMPROVED DRUG DELIVERY MODALITIES

IMPROVED QUALITY OF LIFE FOR PATIENTS

REGIONAL ANALYSIS

THE AMERICAS

Demographic Findings

Asthma and Children in the Americas

Loss of Patent Protection

Product Usage

EMRA

Demographic Findings

Asthma and Children

Product Usage

ASIA

Demographic Findings

Asthma and Children in Asia

Product Usage

CHAPTER 4 DISEASE OVERVIEW

SYMPTOM COMPARISONS

TABLE 7 ASTHMA AND COPD SYMPTOM COMPARISONS

ASTHMA OVERVIEW

ASTHMA IN CHILDREN

ASTHMA IN ADULTS

GLOBAL ECONOMIC BURDEN OF ASTHMA

CLASSIFICATION OF ASTHMA

TABLE 8 CLASSIFICATION OF ASTHMA, BY SYMPTOMS

CAUSES AND RISK FACTORS

DIAGNOSIS

Diagnostic Tests

Spirometry

Peak Flow Test

Methacholine Bronchial Challenge Test

Nitric Oxide Test

Skin or Blood Test

DRUG CLASSES APPROVED IN THE TREATMENT OF ASTHMA AND COPD

TABLE 9 ASTHMA AND COPD DRUG CLASSES

Bronchodilators

Anti-inflammatory drugs

Combination Therapies of Bronchodilators and Anti-inflammatory Drugs

MEDICATION TREATMENT ALGORITHMS

First Line Therapy

Second Line Therapy

CHRONIC OBSTRUCTIVE PULMONARY DISEASE

CLASSIFICATION OF COPD

TABLE 10 CLASSIFICATION OF COPD AND ASTHMA

CAUSES AND RISK FACTORS

DIAGNOSIS

COPD TREATMENT METHODS

Vaccine

Rehabilitation

Oxygen Therapy

Surgery

Medication Treatments

Drug Selection

REGIONAL STATISTICS

ACCESS TO CARE

AVAILABILITY OF TREATMENTS

NORTH AMERICA

Asthma in the U.S.

Adults and Asthma in the U.S.

Asthma in Canada

Asthma in Central America

Asthma in the Caribbean

ASTHMA IN SOUTH AMERICA

TABLE 11 PERCENT OF SELECTED POPULATIONS WITH DIAGNOSED ASTHMA IN THE AMERICAS (%)

COPD IN THE U.S.

EMRA

Asthma in EMRA

Scandinavian/Baltic countries

Asthma in the UK and Ireland

Asthma in Western Europe

Asthma in Eastern Europe

Asthma in Russia

Asthma in the Middle East

TABLE 12 PERCENT OF SELECTED POPULATIONS WITH DIAGNOSED ASTHMA IN THE EMRA (%)

COPD in EMRA

COPD in Russia

ASIA

Asthma in Asia

Asthma in Central Asia

Asthma in Southern Asia

Asthma in China/Taiwan/Mongolia

Asthma in Northeast Asia

Asthma in Southeast Asia

Asthma in Oceania

TABLE 13 PERCENT OF SELECTED POPULATIONS WITH DIAGNOSED ASTHMA IN ASIA

COPD in Asia

CHAPTER 5 MARKETS BY DRUG CLASS

TABLE 14 PROJECTED GLOBAL MARKET FOR ASTHMA AND COPD DRUG, BY DRUG CLASS, THROUGH 2017 ($ MILLIONS)

BRONCHODILATORS

MARKET REVENUES AND FORECAST

FIGURE 1 GLOBAL BRONCHODILATOR MARKET, BY TYPE, 2012 AND 2017 (%)

TABLE 15 PROJECTED GLOBAL MARKET FOR BRONCHODILATORS, THROUGH 2017 ($ MILLIONS)

MANUFACTURERS' MARKET SHARE FOR BRONCHODILATORS

FIGURE 2 GLOBAL MARKET SHARE FOR BRONCHODILATORS BY COMPANY, 2011 (%)

SHORT-ACTING BETA-2 AGONISTS

TABLE 16 SHORT-ACTING BETA-2 AGONISTS, WITH APPROVAL AND PATENT EXPIRY DATES, 2011

Market Revenues and Forecast

Advantages/Disadvantages

TABLE 17 PROJECTED MARKET FOR SHORT-ACTING BETA-2 AGONIST BRONCHODILATORS, THROUGH 2017 ($ MILLIONS)

LONG-ACTING BETA-2 AGONISTS

TABLE 18 LONG-ACTING BETA-2 AGONISTS, 2011

Market Revenues and Forecast

TABLE 19 PROJECTED GLOBAL MARKET FOR LABA PRODUCTS, THROUGH 2017 ($ MILLIONS)

FIGURE 3 MARKET SHARE FOR LABA BRONCHODILATORS BY COMPANY, 2011 (%)

ANTICHOLINERGICS AND COMBINATION ANTICHOLINERGICS/SABA

TABLE 20 ANTICHOLINERGICS AND COMBINATION ANTICHOLINERGICS/SABA BY MANUFACTURER, 2011

Market Revenues and Forecast

TABLE 21 PROJECTED GLOBAL MARKET FOR ANTICHOLINERGICS, THROUGH 2017 ($ MILLIONS)

ANTI-INFLAMMATORY DRUGS

Market Revenues and Forecast

FIGURE 4 MARKET SHARE OF ANTI-INFLAMMATORY DRUGS BY TYPE, 2012 AND 2017 (%)

TABLE 22 PROJECTED GLOBAL MARKET FOR ANTI-INFLAMMATORY DRUGS BY TYPE, THROUGH 2017 ($ MILLIONS)

Inhaled Corticosteroids

TABLE 23 INHALED CORTICOSTERIODS, 2011

FIGURE 5 MARKET SHARE OF LEADING MANUFACTURERS OF INHALED CORTICOSTERIODS, 2011 (%)

Competition in the ICS market

TABLE 24 PROJECTED GLOBAL MARKET FOR INHALED CORTICOSTEROIDS, THROUGH 2017 ($ MILLIONS)

LEUKOTRIENE MODIFIERS

TABLE 25 LEUKOTRIENE MODIFIERS, 2011

Market Revenues and Forecast

TABLE 26 PROJECTED GLOBAL MARKET FOR LEUKOTRIENE MODIFIERS, THROUGH 2017 ($ MILLIONS)

FIGURE 6 GLOBAL MARKET FOR LEUKOTRIENE MODIFIERS, BY MANUFACTURER, 2012 AND 2017 (%)

PDE-4 INHIBITORS

TABLE 27 PROJECTED GLOBAL MARKET FOR PDE-4 DRUGS, THROUGH 2017 ($ MILLIONS)

BIOLOGICAL DRUGS

MARKET REVENUES AND FORECAST

Increasing Market for Biological Drugs to Treat Asthma

TABLE 28 PROJECTED GLOBAL MARKET FOR ASTHMA BIOLOGICAL DRUGS, THROUGH 2017 ($ MILLIONS)

COMBINATION ICS/LABA DRUGS

TABLE 29 COMBINATION ICS/LABA DRUGS, 2011

MARKET REVENUES AND FORECAST

TABLE 30 PROJECTED GLOBAL MARKET FOR COMBINATION ICS/LABA DRUGS, THROUGH 2017 ($ MILLIONS)

FIGURE 7 MARKET SHARE OF MANUFACTURERS OF ICS/LABA, 2011 (%)

Market Dynamics

Flutiform

Dulera

Relovair

REGIONAL ANALYSIS

TABLE 31 PROJECTED REVENUES FROM ASTHMA/COPD DRUGS BY REGION, THROUGH 2017 ($ MILLIONS)

The Americas

TABLE 32 PROJECTED REVENUES FROM ASTHMA/COPD DRUGS IN THE AMERICAS REGION, THROUGH 2017 ($ MILLIONS)

Projected Use of Asthma/COPD Drugs, by Americas’ Regions

TABLE 33 PROJECTED USE OF ASTHMA/COPD DRUGS IN THE AMERICAS' REGION, THROUGH 2017 ($ MILLIONS)

FIGURE 8 MARKET PERCENT OF ASTHMA/COPD DRUGS IN THE AMERICAS REGION, 2012 AND 2017 (%)

EMRA

TABLE 34 PROJECTED REVENUES FROM ASTHMA/COPD DRUGS IN THE EMRA, THROUGH 2017 ($ MILLIONS)

TABLE 35 PROJECTED USE OF ASTHMA/COPD DRUGS IN THE EMRA REGION, THROUGH 2017 ($ MILLIONS)

FIGURE 9 MARKET PERCENT OF ASTHMA/COPD DRUGS IN THE EMRA, 2012 AND 2017 (%)

Asia

TABLE 36 PROJECTED REVENUES FROM ASTHMA/COPD DRUGS IN THE ASIAN REGION, THROUGH 2017 ($ MILLIONS)

TABLE 37 PROJECTED USE OF ASTHMA/COPD DRUGS, BY REGION IN ASIA, THROUGH 2017 ($ MILLIONS)

FIGURE 10 MARKET PERCENTAGE OF ASTHMA/COPD DRUGS, BY REGION IN ASIA, 2012 AND 2017 (%)

CHAPTER 6 MARKETS BY DISEASE

FIGURE 11 GLOBAL MARKET FOR ASTHMA AND COPD PRESCRIPTION DRUGS BY DISEASE, 2011 (%)

ASTHMA DRUGS

MARKET REVENUES FOR ASTHMA DRUGS

MARKET SHARES, BY COMPANY

FIGURE 12 MARKET SHARES OF LEADING MANUFACTURERS OF ASTHMA DRUGS, 2011 (%)

NEW BRANDED ASTHMA DRUGS LAUNCHES

GENERIC DRUG LAUNCHES

TABLE 38 PROJECTED GLOBAL MARKET FOR ASTHMA PRESCRIPTION DRUGS, THROUGH 2017 ($ MILLIONS)

CHRONIC OBSTRUCTIVE PULMONARY DISEASE

FIGURE 13 MARKET SHARES OF LEADING MANUFACTURERS OF COPD DRUGS, 2011 (%)

TABLE 39 PROJECTED GLOBAL MARKET FOR COPD PRESCRIPTION DRUGS, THROUGH 2017 ($ MILLIONS)

BRANDED COPD PRODUCT LAUNCHES

COMBINATION ASTHMA/COPD DRUGS

TABLE 40 PROJECTED GLOBAL MARKET FOR COMBINATION ASTHMA/COPD DRUGS, THROUGH 2017 ($ MILLIONS)

FIGURE 14 MARKET SHARES OF LEADING MANUFACTURERS OF COMBINATION ASTHMA/COPD DRUGS, 2011 (%)

TABLE 41 PROJECTED GLOBAL MARKET FOR COMBINATION ASTHMA/COPD PRESCRIPTION DRUGS, THROUGH 2017 ($ MILLIONS)

CHAPTER 7 EMERGING TRENDS AND PRODUCT PIPELINE REVIEW

THE "ASTHMA GENE"

ORAL DRUGS FOR ASTHMA

LEUKOTRIENE ORAL DRUGS

Masitinib

Oral Antifungal Treatment for Severe Asthma

DISEASE MODIFYING DRUGS

ASTHMA FORMULATIONS

COPD FORMULATIONS

BOEHRINGER INGELHEIM

FOREST LABORATORIES/AMIRALL SA

ELEVATION PHARMACEUTICALS

PEARL THERAPEUTICS

NOVEL BIOLOGICS

AMG 157

AMG 176

MEPOLIZUMAB

ULTRA LONG-ACTING MUSCARINIC ANTAGONISTS

ULTRA LONG-ACTING B2 AGONISTS (ULTRA-LABA)

LAMA AND LABA COMBINATION DRUGS

ANTI-INFLAMMATORY DRUGS

ANTI-PROTEASE

CHEMOKINE ANTAGONISTS

PPAR AGONISTS

ASTHMA/COPD DRUG DEVELOPMENT, BY COMPANY

TABLE 42 ASTHMA/COPD PRODUCTS UNDER DEVELOPMENT, BY COMPANY, 2012

ASTHMA DEVICES

CHAPTER 8 APPROVED DRUGS AND PATENT REVIEW

TABLE 43 APPROVED DRUGS TO TREAT ASTHMA AND COPD, 1996 THROUGH 2011

TABLE 44 DRUGS SEEKING APPROVAL TO TREAT ASTHMA AND COPD 2012 THROUGH 2013

PATENT REVIEW

TABLE 45 ASTHMA/COPD TREATMENT PATENTS, BY COMPANY, DISEASE, PATENT NUMBER, YEAR FILED, 2011 THROUGH 2012

FIGURE 15 PERCENT OF REVIEWED PATENTS FOR ASTHMA, COPD, AND COMBINATION USE, JANUARY 2011 TO MAY 2012 (%)

TABLE 46 ASTHMA/COPD TREATMENT PATENTS, BY NUMBER, COMPANY, DESCRIPTION, AND DATE ISSUED, 2011 THROUGH 2012

TABLE 47 ASTHMA/COPD DRUG TREATMENT PATENTS ISSUED BETWEEN JANUARY 2011 AND MAY 2012, BY COMPANY

FIGURE 16 ASTHMA/COPD PATENTS, BY COUNTRY, 2011 THROUGH 2012 (%)

CHAPTER 9 COMPANY PROFILES

ACTIENT PHARMACEUTICALS

AEROVANCE, INC.

ALMIRALL, S.A.

AMGEN INC.

APTAR PHARMA

ARGENTA DISCOVERY, LTD.

ASTRAZENECA

ASTRAZENECA PHARMACEUTICALS, LP

BOEHRINGER INGELHEIM GMBH

CHIESI FARMACEUTICI SPA

CORNERSTONE THERAPEUTICS

CYTOS BIOTECHNOLOGY AG

DEY PHARMA (MYLAN SPECIALTY L.P.)

FOREST LABORATORIES, INC.

GENENTECH, INC. (ROCHE)

GLAXO WELLCOME U.K., LTD.

GLAXOSMITHKLINE U.S.

MEDICINOVA

MEDICIS PHARMACEUTICAL

MEDIMMUNE

MERCK & CO., INC.

NOVARTIS PHARMA

NOVARTIS CORPORATION

NOVARTIS PHARMACEUTICALS CORPORATION

NYCOMED INTERNATIONAL (TAKEDA INTERNATIONAL)

OSIRIS THERAPEUTICS, INC.

PFIZER, INC.

SEPRACOR, INC. (SUNOVION)

SKYEPHARMA PLC

TEVA PHARMACEUTICAL INDUSTRIES, LTD.

TEVA PHARMACEUTICALS USA

THERAVANCE

RELOVAIR

LAMA/LABA (GSK573719/VILANTROL)

BIFUNCTIONAL MUSCARINIC ANTAGONIST-BETA2 AGONIST PROGRAM

INHALED LONG-ACTING MUSCARINIC ANTAGONIST (LAMA)

TOPIGEN PHARMACEUTICALS, INC. (PHARMAXIS LTD)

VECTURA GROUP PLC

Abstract

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