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Anemia Drugs - Global Strategic Business Report Product Image

Anemia Drugs - Global Strategic Business Report

  • Published: April 2010
  • Region: Global
  • 490 Pages
  • Global Industry Analysts, Inc

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.

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I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-3
Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3
Short Acting ESAs I-3
Long Acting ESAs I-4

II. Executive Summary

1. INDUSTRY OVERVIEW II-1
Current and Future Market Analysis II-1
Analysis by Geographic Region II-1
Analysis by Formulation II-1
Key Market Drivers II-1
Market Inhibitors II-1
Market Characterized by Large Untreated Patient Pool II-2
Market Competition II-2
Number of Anemia Drugs by Development Phase II-2
Table 1: Number of Anemia Drugs under Different Development
Phases, Including Marketed Drugs (2009) (includes
corresponding Graph/Chart) II-2
Major Companies in Early-Stage Anemia Drugs II-3
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) II-3
Existing Drugs for Treatment of Anemia II-3
List of Existing Anemia Drugs Available in the Market, along
with Indication (2009) II-3
Pipeline Drugs II-4
List of Select Pipeline Drugs for Treatment of Anemia (2009) II-4
Patent Expiry for Major Anemia Drugs II-4
Major Anemia Drugs Available in the US Market Along with
their Patent Expiry Year II-4

2. ERYTHROPOIESIS-STIMULATING AGENTS (ESAs) - A REVIEW II-5
Introduction to ESAs II-5
Short-acting ESAs II-5
Long-acting ESAs II-5
Global Market Overview II-5
Market Restraints II-6
Dosage Frequency II-6
Risk of Cardiovascular Events and PRCA II-6
Lack of Effectiveness II-6
Lack of Product Differentiation II-6
Lack of Cost-Effectiveness for Health Insurance Providers II-7
Changing Dynamics of Use of ESAs Worldwide II-7
Latent Decline in Use of ESAs to Spur IV Iron Market II-7

3. MAJOR ANEMIA DRUGS WORLDWIDE AND PIPELINE CANDIDATES II-8
Aranesp® (Darbepoetin alfa) II-8
Contraindications of Aranesp® II-8
Side Effects Profile II-8
EPOGEN® (Epoetin alfa) II-9
Contraindications of Epogen II-9
Side Effects Profile II-9
PROCRIT (Epoetin alfa) II-9
Contraindications of PROCRIT II-10
Side Effects Profile II-10
MIRCERA II-10
Contraindications of MIRCERA II-10
Side Effects Profile II-11
A Quick Insight into Select Promising Pipeline Candidates II-11
FG-2216 (FibroGen and Astellas) II-11
PBI-1402 (ProMetic) II-11
Hematide (Affymax and Takeda) II-12
AKB-6548 (Akebia) II-12
ACE-536 (Acceleron) II-12
ACE-011 (Acceleron) II-12

4. ANEMIA - AN INSIGHT II-13
What is Anemia? II-13
The Role Of RBCs in Anemia II-13
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) II-14
Classification Approaches II-14
Kinetic Approach II-14
Morphological Approach II-15
Risk Factors for Anemia II-15
Symptoms of Anemia II-15
Possible Complications II-15
Diagnoses of Anemia II-16
Laboratory Tests for Anemia Diagnoses II-16
Types of Anemia II-17
Iron Deficiency Anemia II-17
Macrocytic Anemia II-18
Normocytic Anemia II-18
Dimorphic Anemia II-18
Heinz Body Anemia II-18
Folic Acid Deficiency Anemia II-18
Vitamin B12 Deficiency Anemia II-19
Vitamin C Deficiency Anemia II-19
Hemolytic Anemia II-19
Autoimmune Hemolytic Anemia II-19
Sickle Cell Anemia II-20
Aplastic Anemia II-20
Fanconi Anemia II-20
Pregnancy Anemia II-20
Anemia of Chronic Disease II-21
Disease-induced/ Treatment-induced Anemia II-21
Anemia Associated with CKD II-21
Anemia Associated with ESRD II-21
Anemia Associated with Cancer II-22
Chemotherapy-induced Anemia II-22
Anemia Associated with Other Conditions II-22
Treatment of Anemia II-22
Erythropoiesis-Stimulating Agents (ESAs) II-23
Blood Transfusion II-24
Hyperbaric Oxygen Treatment II-24
Supplements Treatment II-24
Iron Supplements/Therapy II-25
Folic Acid Supplements II-25
Vitamin B12 Supplements II-25
Nutritional Treatment II-25
Herbal Treatment II-26
Homeopathy Treatment II-26
Alternative Treatment II-26

5. PRODUCT APPROVALS AND CLINICAL TRIALS II-27
Affymax Concludes Patient Treatment in Phase III Program for
Hematide™ II-27
Akebia Announces Results from Phase 1a Clinical Trial on AKB-6548 II-27
Acceleron Releases Data from Animal Studies on ACE-536 II-28
Genzyme Corp. Releases Phase III Clinical Trial Data of FluCAM II-28
Palkion Initiates Preclinical Study for Oral Anemia Drug II-28
AMAG Pharmaceuticals Introduces Feraheme™ Injection II-29
Acceleron Pharma and Celgene Commence Phase II Clinical Trial
of ACE-011 II-29
FibroGen Enters into Phase-II Clinical Trials for FG-4592/ASP1517 II-29
FibroGen Resumes Patient Enrollment Process for Phase II Trial
of FG-4592/ASP1517 II-30
HemaQuest Pharmaceuticals Completes Phase I Clinical Trial of
HQK-1001 II-30
Astellas Obtains Clearance to Resume Clinical Trials of YM 311 II-30
Takeda and Affymax Suspends Clinical Trials of Hematide™ in
Chemotherapy-Induced Anemia II-31
St. John Hospital and Medical Center Completes Phase-III
Clinical Trials for Ferumoxytol II-31
ProMetic Life Sciences Releases Phase II Clinical Trial Data
of Oral PBI-1402 II-31
Health Canada Issues Notice of Compliance to Roche for MIRCERA II-31
Sandoz Obtains EC Approval for Biosimilar Epoetin Alfa II-32
Hospira Obtains EC Clearance for Retacrit™ II-32
Roche Obtains EC Approval for Mircera in Anemia Treatment II-32
Roche Launches Mircera in Germany and UK II-33
Roche Secures European Approval for NeoRecormon II-33
Neose Obtains FDA Clearance for Clinical Trials on NE-180 II-33

6. RECENT INDUSTRY ACTIVITY II-34
Affymax Receives Milestone Payment from Takeda for Hematide II-34
AMAG and Takeda Ink Licensing Deal II-34
District Court Prevents Launch of Roche’s Mircera in US II-34
Chugai Files for Approval of Epogin® for Additional Indication
in Japan II-34
Watson Pharmaceuticals and GeneraMedix Ink Licensing Agreement II-35
Chugai Files for Approval of R744 for Renal Anemia in Japan II-35
OPK Biotech Expands Production and Research Activities II-35
GSK and Entelos Team Up for Silico Research in Developing
Novel Anti-Anemia Drugs II-35
Clinical Data Acquires Adenosine Therapeutics II-36
StemCyte Inks JV Agreement with Cadila and Apollo Hospitals II-36
Prolong Pharmaceuticals and Zydus Cadila Enters into
Collaboration II-36
ProQuest Investments Enters into Joint Venture with
CrystalGenomics II-37
FDA Accepts IND for Icagen’s Senicapoc II-37

7. FOCUS ON SELECT GLOBAL PLAYERS II-38
Acceleron Pharma, Inc. (US) II-38
Akebia Therapeutics, Inc. (US) II-38
Amgen, Inc. (US) II-38
Bristol-Myers Squibb Company (US) II-39
Centocor Ortho Biotech Products, L.P. (US) II-40
F. Hoffmann-La Roche Ltd. (Switzerland) II-40
Chugai Pharmaceutical Co. Ltd. (Japan) II-40
Fibrogen, Inc. (US) II-41
GlaxoSmithKline PLC (UK) II-41
Hospira, Inc. (US) II-41
Novartis International AG (Switzerland) II-42
Pfizer, Inc. (US) II-42
ProMetic Life Sciences, Inc. (Canada) II-43
Takeda Pharmaceutical Company Limited (Japan) II-43

8. GLOBAL MARKET PERSPECTIVE II-44
Analytics By Geographic Region II-44
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) II-44

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) II-45

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) II-46
Analytics By Drug Formulation II-47

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) II-47

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) II-48

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 II-48

III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Outlook III-1
FDA Amendments Prune Anemia Market for ESA Therapies III-1
High Unmet Healthcare Needs and Challenges Abound in CKD
Non-Dialysis Sector III-2
Growing Need for Iron Replacement Anemia Drugs III-2
Vifors Venofer - The Leading Iron-Replacement Drug III-3
Product Approvals and Clinical Trials III-3
Strategic Corporate Developments III-8
Select Players III-9
B.Market Analytics III-13
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) III-13

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) III-14

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 III-14

2. EUROPE III-15
A.Market Analysis III-15
Current & Future Analysis III-15
European Approval of Biosimilars of Anemia Drugs III-15
European Approved Anemia Drugs III-15
Product Approvals and Clinical Trials III-16
Select Players III-17
B.Market Analytics III-19
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) III-19

Table 14: European Historic Review for Anemia Drugs with
Annual Sales Figures in US$ Million for Years 2001 through
2006 (includes corresponding Graph/Chart) III-19

3. REST OF WORLD III-20
A.Market Analysis III-20
Outlook III-20
Product Approvals and Clinical Trials III-20
Strategic Corporate Developments III-21
Select Players III-23
B.Market Analytics III-24
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) III-24

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) III-25

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 51 (including Divisions/Subsidiaries - 54)

---------
Region/Country Players
---------
The United States 28
Canada 2
Japan 6
Europe 10
France 1
Germany 2
The United Kingdom 2
Italy 1
Rest of Europe 4
Asia-Pacific (Excluding Japan) 8

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