Cystic Fibrosis: Market Research Report

Date: June 22, 2010
Pages: 402
Price:
US$ 3,950.00
Publisher: Global Industry Analysts, Inc
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: C1D1590E5CFEN
Leaflet:

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Cystic Fibrosis: Market Research Report
This report analyzes the US market for Cystic Fibrosis in Millions of US$.

Annual estimates and forecasts are provided for the period of 2007 through 2015.

Also, a six-year historic analysis is provided for this market.

The report profiles 56 companies including many key and niche players such as Abbott Laboratories, Axcan Pharma, Inc., Digestive Care, Inc., Gilead Sciences, Inc., Eurand N.V., Inspire Pharmaceuticals, Inc., KaloBios Pharmaceuticals, Inc., Nektar Therapeutics, PTC Therapeutics, Inc., Transave, Inc., Vertex Pharmaceuticals, Inc., Actelion Ltd., F. Hoffmann–La Roche Ltd., Novartis AG, and Pharmaxis Ltd.

Market data and analytics are derived from primary and secondary research.

Company profiles are mostly extracted from URL research and reported select online sources.
I.INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations
Disclaimers
Data Interpretation & Reporting Level
Quantitative Techniques & Analytics
Product Definitions and Scope of Study

II. A US MARKET REPORT

1.MARKET OVERIVEW

A Global Fact Sheet on Cystic Fibrosis
Current and Future Analysis
Cystic Fibrosis: A Life-Limiting Genetic Disease
Cystic Fibrosis Scenario in the US
Narrowing Mortality in the US
Median Survival Age (MSA) of Patients with CF in United States
Caucasians at Greater Risk
A Market with Huge Unmet Medical Needs
Pulmozyme and TOBI Dominate CF Market

Table 1. US Market for Cystic Fibrosis by Leading Drugs (2008): Annual Sales in US$ Million for Pulmozyme and TOBI

Genentech/Roche and Novartis Lead the Pack
Other Potential Market Contenders
Mega Deals for Niche Local Players

2.CYSTIC FIBROSIS TREATMENT: AN OVERVIEW

Existing Treatment Options for Cystic Fibrosis
A Quick Glance at Common Drugs for Cystic Fibrosis Management
Analysis of Drugs Indicated for Management of Cystic Fibrosis
Antibiotic Therapy for Lung Infections
Select Antibiotics Approved for CF Treatment
TOBI (Tobramycin inhalation solution)
Other Common Cystic Fibrosis Infections and Recommended Antibiotics
Cayston (Aztreonam for inhalation solution)
Combination Antibiotic Therapy
Pulmozyme – The Effective Mucolytic Agent
Pancreatic Enzyme Replacement Therapy (PERT) for EPI
FDA Approval Made Mandate for PI Products
Most Commonly Prescribed Pes
Leading PE Drugs Worldwide for Treating Pancreatic Insufficiency Associated with Cystic Fibrosis
ULTRASE (Axcan Pharma)
VIOKASE (Axcan Pharma)
CREON® (Solvay Pharmaceuticals)
PANZYTRAT (Axcan Pharma)
ZENPEP TM (Eurand N.V.)
Additional Treatment for Patients with CF
Surgical and Other Techniques
Lung Transplantation – Recommended for Rare Cases of CF
Feeding Tube – For Extra Nutrition
Bowel Surgery – To Remove any Blockage in Bowel

3.RESEARCH IN CYSTIC FIBROSIS SPACE

Pitfalls in Current Cystic Fibrosis Treatment
Areas of Research & Development
Major Companies Active in Cystic Fibrosis Research
Companies and Area of Research
Gene Therapy- A Step Towards Cure
PLASmin™ - The Only Investigational Drug Based on Gene Therapy
Rising Concerns over Animal-Derived Drugs

4.PIPELINE ANALYSIS

Active Cystic Fibrosis Pipeline – A Ray of Hope
Cystic Fibrosis Pipeline (As of January 2010)
Gene Therapy
Protein Assist/Repair Therapy:
Restoration of Salt Transport Therapy:
Anti-Inflammatory Agents:
Anti-infective Agents:
Other Developmental Drugs:

5.DISEASE OVERVIEW

Cystic Fibrosis - A Hereditary Disease
Mutation in CFTR Gene – A Major Cause of CF
DF508 – The Most Common Mutation that Affects CFTR Protein

Table 2. Most Common Mutations and Worldwide Frequency (includes corresponding Graph/Chart)

Hereditary Risk of the Disease
Pathophysiology of the Disease
Symptoms of Cystic Fibrosis
Common Symptoms in Early Childhood
Common Symptoms in Grownups or Adults:
Complications Associated with Cystic Fibrosis
Sinus and Lung Illness
Pancreatic, Gastrointestinal, and Liver Disease
Endocrine Disorders
Infertility
Diagnosis of Cystic Fibrosis
Newborn Test
Sweat Test
The IRT Test
Carrier Test
Antenatal Test
Other Common Tests
Prenatal Diagnosis of Cystic Fibrosis
Tests to Diagnose CF-Related Complications
Cystic Fibrosis in Kids

6.RESEARCH AND DEVELOPMENT INITIATIVES OF COMPANIES

Vertex Announces Phase IIa Results of VX-809
Actelion’s Miglustat Proves Effective for Treating Cystic Fibrosis
Transave Announces Phase II Clinical Trial Results of Arikace™
Alnara Announces Positive Phase III Results of Liprotamase
Novartis Announces Phase III Results of Tobramycin Inhalation Powder
KaloBios Announces Encouraging Phase I/II Results of KB001
PTC Therapeutics Initiates Ataluren’s Phase III Trial
Mpex Posts Positive Results of Phase 2b Study of Aeroquin
Pharmaxis Announces Positive Results for Bronchitol
Inspire Pharmaceuticals Provides Update on Denufosol Tetrasodium’s Phase III Clinical Trial Program
Vertex Announces Promising Phase 2a Clinical Trial Results of VX-770
RegeneRx Biopharmaceuticals to Develop Cystic Fibrosis Drug
Venus Remedies Introduces Tobracef for CF Induced Lung Infection
Axentis Pharma Commences Phase IIa Trial with Fluidosome®
Kamada Announces Positive Phase 2 Results of Alpha-1 Antitrypsin
Actelion Initiates Phase 2a Proof-of-Concept Clinical Trial with Miglustat in Cystic Fibrosis Patients
Forest Labs Commences Phase III Trials of New Dry Powder Formulation for Lung Infection Associated with CF

7.RECENT INDUSTRY ACTIVITY

Abbott Acquires Solvay Pharmaceuticals
KaloBios Signs Deal with Sanofi Pasteur for KB001
Roche Acquires Genentech
Altus Pharmaceuticals Announces Strategic Realignment, Withdraws Product Development Activities of Trizytek
Gilead Sciences Receives License for P-680 from Parion Sciences
NIH Awards Additional Grant to DiscoveryBioMed for CF Product Development
Lonza Group and Alnara Pharmaceuticals Sign Agreement
Alnara Pharmaceuticals Acquires Rights to Liprotamase
Protea Biosciences Sign Agreement with Mayoly Spindler
Axentis Pharma Obtains Orphan Drug Status for Liposomal Formulation of Tobramycin
Novartis Completes Acquisition of Nektar’s Pulmonary Business
Gilead Sciences Submits MAA to EMEA for Aztreonam Lysine
VGX Pharmaceuticals and CFT Sign Agreement
Parion Sciences Receives Funds to Develop GSP9411
Genzyme to Acquire Marketing Rights Over PTC124
EPIX Pharmaceuticals Expands Partnership Deal with CFFTI

8.PRODUCT APPROVALS

Gilead Receives US FDA Approval for Marketing Cayston® in the US
McNeil Pediatrics Obtains Approval for Pancreaze
FDA Approves CREON® for Treating EPI in Patients with CF
Gilead Wins Conditional Marketing Authorization for Cayston® from EC
Eurand Launches ZENPEP for Pacreatic Insufficiency Associated with CF
Pharmaxis Submits Application to TGA for Approval of Brochitol in Australia
Aradigm Receives Orphan Drug Status for Inhaled Liposomal Ciprofloxacin
Eurand Obtains Complete Response Letter from US FDA for Zentase, a Pancreatic Enzyme Product
Pharmaxis Files Application with EMA for Bronchitol

9.FOCUS ON SELECT GLOBAL PLAYERS

Abbott Laboratories (USA)
Axcan Pharma Inc. (Canada)
Digestive Care, Inc. (USA)
Gilead Sciences, Inc. (USA)
Eurand N.V. (The Netherlands)
Inspire Pharmaceuticals, Inc. (USA)
KaloBios Pharmaceuticals, Inc. (USA)
Nektar Therapeutics (USA)
PTC Therapeutics, Inc. (USA)
Transave, Inc. (USA)
Vertex Pharmaceuticals, Inc. (USA)
Actelion Ltd. (Switzerland)
F. Hoffmann–La Roche Ltd. (Switzerland)
Novartis AG (Switzerland)
Pharmaxis Ltd. (Australia)

10.US MARKET PERSPECTIVE

Table 3. US Recent Past, Current & Future Analysis for Cystic Fibrosis Therapeutics Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)
Table 4. US Historic Review for Cystic Fibrosis Therapeutics Independently Analyzed with Annual Sales Figures in US$ Million for Years 2001 through 2006 (includes corresponding Graph/Chart)

III. COMPETITIVE LANDSCAPE

Total Companies Profiled: 56 (including Divisions/Subsidiaries - 59)
Region/CountryPlayers
The United States
Canada
Japan
Europe
France
Germany
The United Kingdom
Italy
Rest of Europe
Asia-Pacific (Excluding Japan)
Middle East
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