ISR Reports - COPD Market, Treatment, and Pipeline Development Overview

COPD: Market, Treatment and Development Overview 1

COPD: Market, Treatment and Development
In this summary…
Introduction 2
Overview
Major Sections 2
Companies/Therapies/
Pipelines 3
Table of Contents 4
List of Tables 6
List of Figures 7
Samples Pages 8
Ordering 11
Q2, 2012
Length: 146 Pages, including 68
Charts and Graphs
Publisher: Industry Standard
Research (ISR)
Valuable for:
Pharma / Biotech
Marketing
Sales
Sales Training
R&D
Contract Sales Organizations
Contract Research Organizations

This report offers a unique therapeutic assessment and in-depth market and pipeline analysis, providing a
combined view of the COPD pipeline not available elsewhere. The purpose of this report is to give an extensive
overview of the current and future COPD market and discuss the activities of the key players and some of the
issues surrounding COPD drug development.

Scope of the Research Decision-making Focused
- COPD Disease Overview - Opportunity assessment, COPD market size
- Epidemiology of COPD - Market dynamics, how products currently in the pipeline
could unseat current therapies and shake-up the market
- Current COPD Therapies
- Identify strategic development opportunities
- COPD Market Size
- Enhance commercialization strategic planning
- Leading COPD Companies and Products
- Competitive assessment, provides a full analysis and
- Clinical Development Analysis and
Pipeline for COPD Drug Therapies summary of major COPD companies, including: Current
products, financial summary, and R&D efforts

info@ISRreports.com © 2012 Industry Standard Research www.ISRreports.com


Introduction
It is widely recognized that the global social and economic burden of COPD is high; affecting an
estimated 64 million people worldwide. However, the availability of accurate data for COPD prevalence
is hampered by variability in study methodology and both under-diagnosis and misdiagnosis of the
disease. While 12 million Americans are diagnosed with COPD, it is estimated that an additional 12
million remain undiagnosed. The economic burden of COPD is tremendous. This creates a tremendous
opportunity for substantial economic gains by pharmaceutical companies that can bring novel products
to market. In Europe the annual economic burden of respiratory diseases is estimated to be
approximately €102 billion, with COPD responsible for over half of the burden.

The COPD market is currently dominated by a few therapies in a very limited number of classes which
are used to manage the symptoms of COPD, but have little effect on the underlying, poorly understood
disease process. The substantial unmet need associated with the disease creates significant market
potential for players in the field. Indeed the COPD market is set to undergo significant change, with the
recent launch of a new product class and new highly anticipated combination therapies with block-
buster potential set to reach market in the near and mid-term. The patent expiration and arrival of
generics of some of the fields’ key drugs will also herald change in the market.

Major Report Sections
1. Chronic Obstructive Lung Disease (COPD)
2. Epidemiology of COPD
a) COPD prevalence
b) Future prevalence
3. Current COPD Therapies
a) Current treatment options
b) Unmet patient needs
4. COPD Market Size
5. Leading COPD Companies and Products
a) Key players in the respiratory and COPD market
6. Clinical Development Issues for COPD Drug Therapies
a) Clinical trial design requirements and selection of endpoints
b) COPD development plans
c) Competition in COPD arena
7. Clinical Development Pipeline
a) R&D trends in the treatment of COPD
b) Upcoming companies in COPD Research

A full table of contents is available on page 4



Companies, Treatment Therapies, and Pipelines
Leading COPD Companies
The leading COPD companies were included in this analysis. Depending on information available, ISR’s
report provides financial summaries, key COPD products, and COPD R&D activities for:
- GlaxoSmithKline
- Merck & Co
- Boehringer Ingelheim
- AstraZeneca
- Novartis
- Sunovion
- Almirall
- Nycomed
- Forest Labs

Currently Available Treatment Options

Bronchodilators Therapies Non-bronchodilator Therapies
- Beta2-Adrenergic Agonists - Antibiotics
- Short-Acting Beta2-Adrenergic Agonists - Oral Mucolytic Therapy
(SABA) - Alpha-1 Antitrypsin Augmentation
- Long-Acting Beta2-Adrenergic Agonists Therapy (AAAT)
(LABA) - Oxygen Therapy
- Ultra-LABAs - Surgical Treatments
- Antimuscarinics
- Inhaled Corticosteroids (ICS)
- Oral Corticosteroids
- LABA and ICS Combinations
- SABA and SAMA Combinations
- Xanthine Derivatives
- Selective Phosphodiesterase Type 4 (PDE-4)
Inhibitors

Upcoming Companies in COPD Treatment
- Vectura
- Theravance
- Pearl Therapeutics
- Elevation Pharmaceuitcals
- Rottapharm Madaus
- Sandoz



Table of Contents
To obtain the full table of contents for this report, please download our free full
report preview from our website:

http://www.isrreports.com/industry-reports/preview/copd-market-treatment-and-
development-overview

List of Tables
To obtain the full list of tables included in this report, please download our free full


List of Figures
To obtain the full list of figures included in this report, please download our free full




Sample Pages
From the section entitled “COPD Prevalence: Europe”
Europe with highest rates found in Italy and Germany. This does not entirely reflect data from WHO Europe on
the prevalence of smoking in Europe (see Figure 2). Germany has one of the highest rates of smoking
prevalence, estimated at approximately 34% which correlates with the countries high COPD prevalence,
however by comparison Italy reports a smoking prevalence of only 24% but an estimated COPD prevalence as
high as that of Germany. Sweden reports a high COPD prevalence but at 16% one of the lowest smoking
prevalence rates in Europe (33).

Figure 1: COPD Prevalence in Europe

Source: European White Lung Book

Figure 2. Smoking Prevalence Rates in Selected European Countries

Source: WHO



Sample Pages
From the section entitled “R&D Trends in Treatment of COPD”

Chapter 7: Clinical Development Pipeline

R&D Trends in the Treatment of COPD
Fixed Dose Combination Therapies

The development pipeline is dominated by fixed dose combination products. These include both LABA/ICS
combinations and LABA/LAMA combinations. Those in the LABA/ICS category are predominantly aimed at
combining the “ultra-LABAs” with ICS in order to provide once-daily dosing. The most advanced is GSK’s
Relovair, which ultimately hopes to replace the twice-daily Advair which will face generic competition in the
short to mid-term.

The development of once daily LABAs has brought the possibility of combination with LAMAs in one product.
Several of these combinations are now in late-stage development. Both muscarinic antagonists and beta2
agonists cause bronchodilation, but by different mechanisms of action. They also have non-bronchodilator
effects that can be complementary and beneficial in patients with COPD. The combination integrates two
medications which are often prescribed individually to optimize disease control, into one inhaler, thus cutting
the medication burden. This concept is being taken one step further by small biotech company Pearl
Therapeutics who are currently investigating a triple combination LABA/LAMA/ICS.

In an advance to the direct combination of two agents in one dosage form, GSK is developing a bifunctional long
acting bronchodilator, GSK961081, which combines both muscarinic antagonist and beta2 agonist activities in a
single molecule. The company’s aim is to combine bifunctional activity and high lung selectivity to develop a
product with greater efficacy than single mechanism bronchodilators and with equal or better tolerability. The
molecule could then be combined with ICS in a single dose inhaler.

Novel Anti-inflammatory Therapies

As the understanding of the inflammatory process which underlies COPD grows and develops it raises the
possibility of targeting appropriate inflammatory mediators in order to relieve symptoms and affect the
underlying disease process. By directly influencing the cellular components of inflammation or interfering with
mediators which regulate the migration and activation of inflammatory cells, the inflammatory cascade can be
interrupted or inactivated. New entities directed at some of these potential targets are beginning to make their
way through the clinical trial process.



Sample Pages
From the section entitled “Respiratory Market Size”

Table 10: Drivers and Constraints on the COPD Market

Market Drivers Market Constraints

 Large and expanding patient population  Patent expiration on key therapies
 Increased diagnosis and drug treatment  Threat of generic entry in near term
 Changing views of respiratory disorders  Restrictions on healthcare budgets favour
 XXXXXXXXX XXXXXXXXXXX XXXXXXXXXX generics use
 XXXXX XXXXXXXXXX  XXXX XXXXXXXXX XXXX XX X XXXXXXXXX
 Market with blockbuster potential  XXXX XXXXXXXX XXX X XXXXXXX XXXXX XXX
 XXXXXXXX XXXXXXXXXX XXX XXX XXXX X X XXX XX XXXX XXXXXXXXXXXXXX XXXX
XXXXX XX XXXX X XXXX XXXXXX XXXXXX XXXXXXXX XXXXXXX
 Underserved disease with considerable XXXXXX XX XXXX XXXXXXX X XXXXXXX
unmet needs  Increased bargaining power of purchasers
 A number of recently approved therapies  Relatively poor understanding of the disease
with growth potential process making it difficult to target new
 Potential for new therapy classes in the treatments
short to mid term
 New drugs with new mechanisms of action
in the longer term
 XXXXX XXXX XXXX XXXXXX XX X XXXX XXXX
XXXXX XXXXX
 XXXXXXXX XXX XXXXXXXXXXX
XXXXXXXXXXXXX



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