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Intravenous (IV) Iron Drugs - Global Strategic Business Report

Global Industry Analysts, Inc, August 2010, Pages: 165

This report analyzes the worldwide markets for Intravenous (IV) Iron Drugs in US$ Million. 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 18 companies including many key and niche players such as AMAG Pharmaceuticals, Inc., Fresenius Medical Care AG & Co. KGaA, Galenica Ltd., Vifor Pharma Ltd., Luitpold Pharmaceuticals, Inc., American Regent, Inc., Pharmacosmos A/S, Rockwell Medical Technologies, Inc., Sanofi-Aventis U.S. LLC, Syner-Med (Pharmaceutical Products) Ltd., and Watson Pharmaceuticals, Inc.

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

II. Executive Summary

1. INDUSTRY OVERVIEW II-1
A Quick Primer II-1
Current and Future Analysis II-1
United States - The Largest Market for IV Iron Drugs II-1
Europe and Rest of World - High Potential Markets II-2
Noteworthy Trends in the IV Iron Drug Market II-2
No Impact of Recession on Intravenous Iron Market II-2
Dialysis Clinics are Major Clients for IV Iron Supplements II-2
Global Iron Supplement Market II-2
Table 1: Global Intravenous (IV) Iron Market (2006):
Percentage Breakdown of Value Sales for Intravenous Iron Drug
Type - Non Generics and Generics II-3

Table 2: Leading Players in the Global Intravenous (IV) Iron
Market (2006): Percentage Breakdown of Value Sales for Vifor,
Sanofi-Aventis, Pharmacosmos, and Others (including Generics)
(includes corresponding Graph/Chart) II-3
Vifor Pharma - Dominates IV Iron Drugs Market II-3

2. OVERVIEW OF INTRAVENOUS (IV) IRON DRUGS II-4
Significance of Iron in Human Body II-4
Intravenous Therapy II-4
Iron-Deficiency Anemia II-4
People with High Susceptibility to Anemia II-4
Older Adults & the Elderly II-5
Cancer Patients II-5
Women of Child-bearing Age II-5
Chronic Kidney Disease Patients II-5
HIV/AIDS Patients II-5
People with Inflammatory Bowel Disease II-5
Diabetics II-6
People with Heart Disease II-6
Critically Ill Patients II-6
Infants II-6
People with Other Diseases II-6
Table 3: Intravenous (IV) Iron Drugs Market (2009):
Prevalence of Iron Deficiency Disease (IDA) by Risk Groups-
Pregnant Women, Children (1-2 years), Women (12-49
years), Women (50+ years), and Men (12+ years) (includes
corresponding Graph/Chart) II-6
Treatment for Iron Deficiency Anemia II-7
Iron Requirement in Chronic Kidney Disease II-7
Classification of Iron Deficiency in CKD II-7
Treating Iron Deficiency in CKD Patients II-7
Side Effects of Iron Supplementation in CKD II-8
Methods of Restoring Iron II-8
Oral Iron Therapy II-9
IV Iron-Infusion Therapy II-9
Intravenous (IV) Iron II-9
Conditions for Receiving Iron Injections II-10
Injection Procedure II-11
Categories of Iron Injections II-11
Ferumoxytol II-11
Iron Dextran II-12
Carbohydrate Iron II-12
Suitability of IV Iron Preparation II-12
Suitability of Regimen II-13
Management of Iron Doses II-13
Effectiveness of Iron Injection II-14
Requirement of Test Dose II-14
Side Effects of Iron Injections II-15
Iron Therapy: Caution II-15
Relevance of Iron Infusion Time II-15
Iron Overdose II-15
Iron-Out-of-Balance Therapies II-16
Blood Donation II-16
Therapeutic Phlebotomy II-16
Red Cell Apheresis II-16
Iron Chelation Therapy II-16
Iron-Chelating Drugs II-17
Desferrioxamine or Desferal II-17
Deferiprone or Ferriprox II-17
Conditions for Undergoing Iron Chelation Therapy II-17
Kinds of Chelation Therapy II-18
Side Effects Caused by IV Iron Chelation II-18
Conclusion II-19

3. SELECT IV IRON DRUGS PRESCRIBED FOR IRON DEFICIENCY II-20
Iron Sucrose (Venofer®) II-20
Iron dextran (InFed®, Dexferrum®) II-20
Sodium Ferric Gluconate (Ferrlecit®) II-21
Ferumoxytol (FerahemeTM) II-21
Ferric Carboxymaltose (Ferinject®, Injectafer®) II-22

4. SOLUBLE FERRIC PYROPHOSPHATE (SFP): A PIPELINE DRUG II-23

5. CLINICAL TRIALS II-24
Rockwell Medical Technologies Presents Positive Clinical Data
on Phase IIb Study of SFP II-24
FAIR-HF Study Meets Primary Endpoints in Treating Iron
Deficiency and Chronic Heart Failure II-25

6. PRODUCT LAUNCHES/APPROVALS II-26
AMAG Pharmaceuticals Launches Feraheme™ in the US II-26
Feraheme™ Receives FDA Approval for Intravenous Iron Therapy
in Adult CKD Patients II-26
Syner-Med Unveils Ferinject® in the UK II-27
Galencia Receives Approval in EU for Ferinject II-27

7. RECENT INDUSTRY ACTIVITY II-28
AMAG Pharmaceuticals Inks Agreement with Takeda Pharmaceutical
Company for Feraheme® II-28
Pharmacosmos Bags Marketing Authorizations for Monofer® II-28
Pharmacosmos Launches New Subsidiary II-28
Watson Pharmaceuticals Inks License Agreement with GeneraMedix II-29
Dabur Pharma Gets A New Name II-29
AMAG Pharmaceuticals Inks Agreement with 3SBio II-29
Fresenius Kabi Acquires Dabur Pharma II-30
Fresenius Medical Care Inks License Agreement with Luitpold
Pharmaceuticals and American Regent II-30
Fresenius Medical Care Inks Licensing Agreements for IV Iron
Products II-31

8. FOCUS ON SELECT GLOBAL PLAYERS II-32
AMAG Pharmaceuticals, Inc. (US) II-32
Fresenius Medical Care AG & Co. KGaA (Germany) II-32
Galenica Ltd. (Switzerland) II-32
Vifor Pharma Ltd. (Switzerland) II-32
Luitpold Pharmaceuticals, Inc. (US) II-33
American Regent, Inc. (US) II-33
Pharmacosmos A/S (Denmark) II-34
Rockwell Medical Technologies, Inc. (US) II-34
Sanofi-Aventis U.S. LLC (US) II-34
Syner-Med (Pharmaceutical Products) Ltd. (UK) II-34
Watson Pharmaceuticals, Inc. (US) II-35

9. GLOBAL MARKET PERSPECTIVE II-36
Table 4: World Recent Past, Current and Future Analysis for
Intravenous (IV) Iron 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-36

Table 5: World Historic Review for Intravenous (IV) Iron 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-37

Table 6: World 13-Year Perspective for Intravenous (IV) Iron
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-38

III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Outlook III-1
CKD Revs up Growth in the US Market for IV Iron III-1
Regulatory Environment to Affect IV Iron Market in Future III-1
Noteworthy Trend in IV Iron Utilization in the US III-1
Competitive Scenario III-2
Table 7: US IV Iron Therapy Replacement Market (2009):
Percentage Breakdown of Volume Sales by Products for
Venofer, Ferrlecit, INFeD, Dexferrum and Feraheme (includes
corresponding Graph/Chart) III-2

Table 8: US IV Iron Therapy Replacement Market (2008):
Percentage Breakdown of Value Sales by Products for
Venofer, Ferrlecit, INFeD, and Dexferrum (includes
corresponding Graph/Chart) III-2
Product Launches/Approvals III-3
Strategic Corporate Developments III-4
Select Players III-5
B.Market Analytics III-7
Table 9: US Recent Past, Current and Future Analysis for
Intravenous (IV) Iron Drugs with Annual Sales Figures in US$
Million for Years 2007 through 2015 (includes corresponding
Graph/Chart) III-7

Table 10: US Historic Review for Intravenous (IV) Iron Drugs
with Annual Sales Figures in US$ Million for Years 2001
through 2006 (includes corresponding Graph/Chart) III-8

2. EUROPE III-9
A.Market Analysis III-9
Outlook III-9
Product Launches/ Approvals III-9
Strategic Corporate Developments III-9
Select Players III-11
B.Market Analytics III-13
Table 11: European Recent Past, Current and Future Analysis
for Intravenous (IV) Iron Drugs with Annual Sales Figures in
US$ Million for Years 2007 through 2015 (includes
corresponding Graph/Chart) III-13

Table 12: European Historic Review for Intravenous (IV) Iron
Drugs with Annual Sales Figures in US$ Million for Years
2001 through 2006 (includes corresponding Graph/Chart) III-13

3. REST OF WORLD III-14
A.Market Analysis III-14
Outlook III-14
Strategic Corporate Developments III-14
B.Market Analytics III-15
Table 13: Rest of World Recent Past, Current and Future
Analysis for Intravenous (IV) Iron Drugs with Annual Sales
Figures in US$ Million for Years 2007 through 2015 (includes
corresponding Graph/Chart) III-15

Table 14: Rest of World Historic Review for Intravenous (IV)
Iron Drugs with Annual Sales Figures in US$ Million for
Years 2001 through 2006 (includes corresponding Graph/Chart) III-15

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 18 (including Divisions/Subsidiaries - 24)

---------
Region/Country Players
---------
The United States 9
Japan 1
Europe 8
France 1
Germany 2
The United Kingdom 2
Rest of Europe 3
Asia-Pacific (Excluding Japan) 6
---------

- AMAG Pharmaceuticals, Inc. (US)
- Fresenius Medical Care AG & Co. KGaA (Germany)
- Galenica Ltd. (Switzerland)
- Vifor Pharma Ltd. (Switzerland)
- Luitpold Pharmaceuticals, Inc. (US)
- American Regent, Inc. (US)
- Pharmacosmos A/S (Denmark)
- Rockwell Medical Technologies, Inc. (US)
- Sanofi-Aventis U.S. LLC (US)
- Syner-Med (Pharmaceutical Products) Ltd. (UK)
- Watson Pharmaceuticals, Inc. (US)

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