Anemia Drugs: Market Research Report

April 2010 | 490 pages | ID: A4D7E3337D0EN
Global Industry Analysts, Inc

Abstracts

This report analyzes the worldwide markets for Anemia Drugs in US$ Million by the following segments: Short Acting ESAs (Erythropoiesis Stimulating Agents), and Long Acting ESAs (Erythropoiesis Stimulating Agents).

The report provides separate comprehensive analytics for the US, Europe, and Rest of World.

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

Also, a six-year historic analysis is provided for these markets.

The report profiles 51 companies including many key and niche players such as Acceleron Pharma, Inc., Akebia Therapeutics, Inc., Amgen, Inc., Bristol-Myers Squibb Company, Centocor Ortho Biotech Products, L.P., F. Hoffmann-La Roche Ltd., Chugai Pharmaceutical Co.Ltd., Fibrogen, Inc., GlaxoSmithKline PLC, Hospira, Inc., Novartis International AG, Pfizer, Inc., ProMetic Life Sciences, Inc., and Takeda Pharmaceutical Company Limited.

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

Company profiles are mostly extracted from URL research and reported select online sources.

Contents

I.INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

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

II. EXECUTIVE SUMMARY

1.INDUSTRY OVERVIEW

Current and Future Market Analysis
Analysis by Geographic Region
Analysis by Formulation
Key Market Drivers
Market Inhibitors
Market Characterized by Large Untreated Patient Pool
Market Competition
Number of Anemia Drugs by Development Phase

Table 1. Number of Anemia Drugs under Different Development Phases, Including Marketed Drugs (2009) (includes corresponding Graph/Chart)

Major Companies in Early-Stage Anemia Drugs

Table 2. List of Major 5 Early-Stage Companies (Preclinical or Phase I) Along with the Number of Anemia Products Offered (2009) (includes corresponding Graph/Chart)

Existing Drugs for Treatment of Anemia
List of Existing Anemia Drugs Available in the Market, along with Indication (2009)
Pipeline Drugs
List of Select Pipeline Drugs for Treatment of Anemia (2009)
Patent Expiry for Major Anemia Drugs
Major Anemia Drugs Available in the US Market Along with their Patent Expiry Year

2.ERYTHROPOIESIS-STIMULATING AGENTS (ESAS) – A REVIEW

Introduction to ESAs
Short-acting ESAs
Long-acting ESAs
Global Market Overview
Market Restraints
Dosage Frequency
Risk of Cardiovascular Events and PRCA
Lack of Effectiveness
Lack of Product Differentiation
Lack of Cost-Effectiveness for Health Insurance Providers
Changing Dynamics of Use of ESAs Worldwide
Latent Decline in Use of ESAs to Spur IV Iron Market

3.MAJOR ANEMIA DRUGS WORLDWIDE AND PIPELINE CANDIDATES

Aranesp® (Darbepoetin alfa)
Contraindications of Aranesp®
Side Effects Profile
EPOGEN® (Epoetin alfa)
Contraindications of Epogen
Side Effects Profile
PROCRIT (Epoetin alfa)
Contraindications of PROCRIT
Side Effects Profile
MIRCERA
Contraindications of MIRCERA
Side Effects Profile
A Quick Insight into Select Promising Pipeline Candidates
FG-2216 (FibroGen and Astellas)
PBI-1402 (ProMetic)
Hematide (Affymax and Takeda)
AKB-6548 (Akebia)
ACE-536 (Acceleron)
ACE-011 (Acceleron)

4.ANEMIA – AN INSIGHT

What is Anemia?
The Role Of RBCs in Anemia

Table 3. World Health Organization Recommended Hemoglobin (Hb) Threshold Limit for Anemia in g/dl and mmol/l by Age Group for Children, Women and Men (includes corresponding Graph/Chart)

Classification Approaches
Kinetic Approach
Morphological Approach
Risk Factors for Anemia
Symptoms of Anemia
Possible Complications
Diagnoses of Anemia
Laboratory Tests for Anemia Diagnoses
Types of Anemia
Iron Deficiency Anemia
Macrocytic Anemia
Normocytic Anemia
Dimorphic Anemia
Heinz Body Anemia
Folic Acid Deficiency Anemia
Vitamin B12 Deficiency Anemia
Vitamin C Deficiency Anemia
Hemolytic Anemia
Autoimmune Hemolytic Anemia
Sickle Cell Anemia
Aplastic Anemia
Fanconi Anemia
Pregnancy Anemia
Anemia of Chronic Disease
Disease-induced/ Treatment-induced Anemia
Anemia Associated with CKD
Anemia Associated with ESRD
Anemia Associated with Cancer
Chemotherapy-induced Anemia
Anemia Associated with Other Conditions
Treatment of Anemia
Erythropoiesis-Stimulating Agents (ESAs)
Blood Transfusion
Hyperbaric Oxygen Treatment
Supplements Treatment
Iron Supplements/Therapy
Folic Acid Supplements
Vitamin B12 Supplements
Nutritional Treatment
Herbal Treatment
Homeopathy Treatment
Alternative Treatment

5.PRODUCT APPROVALS AND CLINICAL TRIALS

Affymax Concludes Patient Treatment in Phase III Program for Hematide™
Akebia Announces Results from Phase 1a Clinical Trial on AKB-6548
Acceleron Releases Data from Animal Studies on ACE-536
Genzyme Corp. Releases Phase III Clinical Trial Data of FluCAM
Palkion Initiates Preclinical Study for Oral Anemia Drug
AMAG Pharmaceuticals Introduces Feraheme™ Injection
Acceleron Pharma and Celgene Commence Phase II Clinical Trial of ACE-011
FibroGen Enters into Phase-II Clinical Trials for FG-4592/ASP1517
FibroGen Resumes Patient Enrollment Process for Phase II Trial of FG-4592/ASP1517
HemaQuest Pharmaceuticals Completes Phase I Clinical Trial of HQK-1001
Astellas Obtains Clearance to Resume Clinical Trials of YM 311
Takeda and Affymax Suspends Clinical Trials of Hematide™ in Chemotherapy-Induced Anemia
St. John Hospital and Medical Center Completes Phase-III Clinical Trials for Ferumoxytol
ProMetic Life Sciences Releases Phase II Clinical Trial Data of Oral PBI-1402
Health Canada Issues Notice of Compliance to Roche for MIRCERA
Sandoz Obtains EC Approval for Biosimilar Epoetin Alfa
Hospira Obtains EC Clearance for Retacrit™
Roche Obtains EC Approval for Mircera in Anemia Treatment
Roche Launches Mircera in Germany and UK
Roche Secures European Approval for NeoRecormon
Neose Obtains FDA Clearance for Clinical Trials on NE-180

6.RECENT INDUSTRY ACTIVITY

Affymax Receives Milestone Payment from Takeda for Hematide
AMAG and Takeda Ink Licensing Deal
District Court Prevents Launch of Roche’s Mircera in US
Chugai Files for Approval of Epogin® for Additional Indication in Japan
Watson Pharmaceuticals and GeneraMedix Ink Licensing Agreement
Chugai Files for Approval of R744 for Renal Anemia in Japan
OPK Biotech Expands Production and Research Activities
GSK and Entelos Team Up for Silico Research in Developing Novel Anti-Anemia Drugs
Clinical Data Acquires Adenosine Therapeutics
StemCyte Inks JV Agreement with Cadila and Apollo Hospitals
Prolong Pharmaceuticals and Zydus Cadila Enters into Collaboration
ProQuest Investments Enters into Joint Venture with CrystalGenomics
FDA Accepts IND for Icagen’s Senicapoc

7.FOCUS ON SELECT GLOBAL PLAYERS

Acceleron Pharma, Inc. (US)
Akebia Therapeutics, Inc. (US)
Amgen, Inc. (US)
Bristol-Myers Squibb Company (US)
Centocor Ortho Biotech Products, L.P. (US)
F. Hoffmann-La Roche Ltd. (Switzerland)
Chugai Pharmaceutical Co. Ltd. (Japan)
Fibrogen, Inc. (US)
GlaxoSmithKline PLC (UK)
Hospira, Inc. (US)
Novartis International AG (Switzerland)
Pfizer, Inc. (US)
ProMetic Life Sciences, Inc. (Canada)
Takeda Pharmaceutical Company Limited (Japan)

8.GLOBAL MARKET PERSPECTIVE

Analytics By Geographic Region

Table 4. World Recent Past, Current and Future Analysis for Anemia Drugs by Geographic Region – US, Europe and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)

Table 5. World Historic Review for Anemia Drugs by Geographic Region – US, Europe and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2001 through 2006 (includes corresponding Graph/Chart)

Table 6. World 13-Year Perspective for Anemia Drugs by Geographic Region – Percentage Breakdown of Dollar Sales for US, Europe and Rest of World Markets for Years 2003, 2009 and 2015 (includes corresponding Graph/Chart)

Analytics By Drug Formulation

Table 7. World Recent Past, Current & Future Market Analysis for Anemia Drugs by Formulation – Short Acting ESAs and Long Acting ESAs Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)

Table 8. World Historic Review Markets for Anemia Drugs by Formulation – Short Acting ESAs and Long Acting ESAs Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2001 through 2006 (includes corresponding Graph/Chart)

Table 9. World 13-Year Perspective for Anemia Drugs by Formulation – Percentage Breakdown of Dollar Sales for Short Acting ESAs and Long Acting ESAs for Years 2003, 2009 & 2015

III. MARKET

1.THE UNITED STATES

A. MARKET ANALYSIS

Outlook
FDA Amendments Prune Anemia Market for ESA Therapies
High Unmet Healthcare Needs and Challenges Abound in CKD Non-Dialysis Sector
Growing Need for Iron Replacement Anemia Drugs
Vifor's Venofer – The Leading Iron-Replacement Drug
Product Approvals and Clinical Trials
Strategic Corporate Developments
Select Players

B. MARKET ANALYTICS

Table 10. US Recent Past, Current and Future Analysis for Anemia Drugs by Formulation – Short Acting ESAs and Long Acting ESAs Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)

Table 11. US Historic Review for Anemia Drugs by Formulation – Short Acting ESAs and Long Acting ESAs Independently Analyzed with Annual Sales Figures in US$ Million for Years 2001 through 2006 (includes corresponding Graph/Chart)

Table 12. US 13-Year Perspective for Anemia Drugs by Formulation – Percentage Share Breakdown of Dollar Sales for Short Acting ESAs and Long Acting ESAs for Years 2003, 2009 and 2015

2.EUROPE

A. MARKET ANALYSIS

Current & Future Analysis
European Approval of Biosimilars of Anemia Drugs
European Approved Anemia Drugs
Product Approvals and Clinical Trials
Select Players

B. MARKET ANALYTICS

Table 13. European Recent Past, Current and Future Analysis for Anemia Drugs with Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)

Table 14. European Historic Review for Anemia Drugs with Annual Sales Figures in US$ Million for Years 2001 through 2006 (includes corresponding Graph/Chart)

3.REST OF WORLD

A. MARKET ANALYSIS

Outlook
Product Approvals and Clinical Trials
Strategic Corporate Developments
Select Players

B. MARKET ANALYTICS

Table 15. Rest of World Recent Past, Current and Future Analysis for Anemia Drugs with Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)

Table 16. Rest of World Historic Review for Anemia Drugs with Annual Sales Figures in US$ Million for Years 2001 through 2006 (includes corresponding Graph/Chart)

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 51 (including Divisions/Subsidiaries - 54)
Region/CountryPlayers
The United States
Canada
Japan
Europe
France
Germany
The United Kingdom
Italy
Rest of Europe
Asia-Pacific (Excluding Japan)