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World Intravenous (IV) Iron Drugs Industry

  • January 2015
  • -
  • Global Industry Analysts
  • -
  • 135 pages

This report analyzes the worldwide markets for Intravenous (IV) Iron Drugs in US$ Million. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2013 through 2020. Also, a seven-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 17 companies including many key and niche players such as -

Actavis, Inc.
AMAG Pharmaceuticals, Inc.
Fresenius Medical Care AG & Co. KGaA
Galenica Ltd.
Luitpold Pharmaceuticals, Inc.

Table Of Contents

World Intravenous (IV) Iron Drugs Industry



I. INTRODUCTION, METHODOLOGY and PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation and Reporting Level I-2
Quantitative Techniques and Analytics I-3
Product Definitions and Scope of Study I-3


II. EXECUTIVE SUMMARY

1. OUTLOOK II-1
IV Iron Drugs Market - A Quick Primer II-1
US and Europe Dominate IV Iron Market II-2
Asia-Pacific - The Fastest Growing Market II-2
Recession Fails to Affect Market Growth II-2
Positive Outlook for the Healthcare Industry Signals Prospects II-3
Table 1: Healthcare Spending as a Percentage of GDP in Select
Countries (includes corresponding Graph/Chart) II-4

2. INDUSTRY OVERVIEW and TRENDS II-5
IDA and Treatment - An Overview II-5
Dialysis Clinics - Major Market for IV Iron Supplements II-6
Table 2: World Distribution of Dialysis Patients by Country
(2013): Number of Patients in Thousands for Brazil, China,
Japan, Mexico, US and Others (includes corresponding
Graph/Chart) II-6

Table 3: World Dialysis Prevalence by Country (2013):
Prevalence in Patients per Million Population for Brazil,
China, Japan, Mexico, US and Others (includes corresponding
Graph/Chart) II-6

Table 4: Global Iron Deficiency Anemia Prevalence by Risk
Groups - Preschool Children, School-age Children, Pregnant
Women, Non-Pregnant Women, Men and Elderly Analyzed by
Prevalence Percentage (includes corresponding Graph/Chart) II-7

Table 5: Iron Deficiency Prevalence by Disease: Analyzed by
Percentage Number of Patients with ID and IDA in CKD (with
dialysis), Non-Dialysis-CKD, Congestive Heart Failure,
Chemotherapy Induced Anemia, Irritable Bowel Disease, Patient
Blood Management (Surgery), Heavy Uterine Bleeding and
Postpartum (OB-GYN) (includes corresponding Graph/Chart) II-7
IV Iron Drugs - An Overview II-8
Select IV Iron Drugs Prescribed for Iron Deficiency II-8
Table 6: Global Sales of Select IV Iron Drugs in US$ Million:
2013 (includes corresponding Graph/Chart) II-9
Galenica - The Global Leader in IV Iron II-10
Venofer® - Galenica's Wonder Drug II-10
Venofer Continues to Lose Ground II-11
Ferinject/Injectafer - A Promising Revenue Spinner for Galenica II-11
Feraheme Surges Ahead; Manufacturer Eyes Expansion of
Indications II-12
The Vulnerable Ageing Population Supports Demand II-12
Table 7: Global Population Statistics for the 65+ Age Group
(Male and Female) for Major Countries/Regions: 2013E (includes
corresponding Graph/Chart) II-13
Changing Preferences Favor IV Iron Drugs II-14
Comparison of Ferrous Salts with IV Iron Therapy II-14
Chronic Kidney Disease - The Predominant Growth Factor II-15
Other Chronic Diseases with IDA Offer Prospects for IV Iron Drugs II-15
Anemia in Heart Failure - A Market with Huge Potential II-16
Chemotherapy Induced Anemia to Promote IV Iron Supplements II-16
Table 8: Global Cancer Incidence by Region (2012): Number of
New Cancer Cases for Asia-Pacific, Europe, North and South
America, and Africa (includes corresponding Graph/Chart) II-17
Correction of IDA in Pregnancy Signals Opportunities II-17
Women's Health - Key Growth Opportunity II-18
Perioperative and Postoperative Anemia - A Niche Market Beckons II-18
Adverse Reactions of IV Iron Preparations Raise Concerns II-19
Peginesatide - A Possible Threat to IV Iron II-19
Dosing Limitations Plague IV Iron Market II-20
Select Therapeutic Areas and the Required Iron Doses II-20

3. REGULATORY OVERVIEW II-21
Increasing Trend towards Bundled Reimbursements II-21
A Glimpse of Regulations in the US and Europe II-21
Comparison of Approved Indications and Safety Warnings for
Select FDA Approved IV Iron Drugs II-22
Coverage of IV Iron and ESA in the Reimbursement Packages of
Dialysis Services across Belgium, Germany, Netherlands, the
UK, France, the US and Ontario, Canada II-22

4. OVERVIEW OF INTRAVENOUS (IV) IRON DRUGS II-23
Iron - A Vital Element II-23
Iron-Deficiency Anemia II-23
Intravenous Therapy II-23
Patients of Chronic Illnesses, the Elderly and Women - The
High Risk Population II-23
Treatment for Iron Deficiency Anemia II-24
Iron Requirement in Chronic Kidney Disease II-25
Classification of Iron Deficiency in CKD II-25
Treating Iron Deficiency in CKD Patients II-25
Side Effects of Iron Supplementation in CKD II-25
Methods of Restoring Iron II-26
Oral Iron Therapy II-26
IV Iron-Infusion Therapy II-27
Intravenous (IV) Iron II-27
Conditions for Receiving Iron Injections II-28
Injection Procedure II-28
Categories of Iron Injections II-29
Suitability of IV Iron Preparation II-30
Suitability of Regimen II-30
Management of Iron Doses II-31
Effectiveness of Iron Injection II-31
Requirement of Test Dose II-31
Adverse Effects of Iron Injections II-31
Iron Therapy: Caution II-32
Duration of Iron Infusion II-32
Iron Overdose II-32
Iron-Out-of-Balance Therapies II-32
Blood Donation II-32
Therapeutic Phlebotomy II-33
Red Cell Apheresis II-33
Iron Chelation Therapy II-33
Iron-Chelating Drugs II-33
Desferrioxamine or Desferal II-33
Deferiprone or Ferriprox II-34
Conditions for Undergoing Iron Chelation Therapy II-34
Kinds of Chelation Therapy II-34
Side Effects Caused by IV Iron Chelation II-35

5. PRODUCT LAUNCHES/APPROVALS II-36
FDA approves Injectafer® for the Treatment of IDA II-36
Takeda Pharmaceutical Company Introduces Rienso® in Europe II-36
Pharmacosmos Launches Monofer® Intravenous Iron Drug II-36

6. RECENT INDUSTRY ACTIVITY II-37
American Regent Steps Up Injectafer® Promotions II-37
AMAG Files for Rienso Label Expansion in Europe II-37
AMAG Receives FDA Complete Response Letter for Feraheme® II-37
Vifor Pharma and Zeria Pharmaceutical Co., Ltd. Sign Exclusive
Licensing Agreement for Ferinject® in Japan II-37
Watson Pharmaceuticals Changes Name to Actavis II-37
Luitpold Pharmaceuticals Obtains FDA Acceptance for Review of
Injectafer® NDA II-37
AMAG Pharmaceuticals Receives FDA Acceptance for Feraheme®
sNDA Review II-37
Takeda Issues Rienso Recall in Switzerland II-38
EC Approves Takeda's Rienso® to Treat Anemia II-38
BioLink Life Sciences to Commence Phase I Trial of FCP II-38

7. FOCUS ON SELECT PLAYERS II-39
Actavis, Inc. (US) II-39
AMAG Pharmaceuticals, Inc. (US) II-39
Fresenius Medical Care AG and Co. KGaA (Germany) II-39
Galenica Ltd. (Switzerland) II-40
Vifor Pharma Ltd. (Switzerland) II-40
Luitpold Pharmaceuticals, Inc. (US) II-41
American Regent, Inc. (US) II-41
Pharmacosmos A/S (Denmark) II-41
Sanofi US (US) II-42
Takeda Pharmaceutical Company Limited (Japan) II-42

8. GLOBAL MARKET PERSPECTIVE II-43
Table 9: World Recent Past, Current and Future Analysis for
Intravenous (IV) Iron Drugs by Geographic Region - US, Canada,
Japan, Europe, Asia-Pacific, Latin America and Rest of World
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) II-43

Table 10: World Historic Review for Intravenous (IV) Iron
Drugs by Geographic Region - US, Canada, Japan, Europe,
Asia-Pacific, Latin America and Rest of World Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) II-44

Table 11: World 15-Year Perspective for Intravenous (IV) Iron
Drugs by Geographic Region - Percentage Breakdown of Dollar
Sales for US, Canada, Japan, Europe, Asia-Pacific, Latin
America and Rest of World Markets for Years 2006, 2014 and 2020
(includes corresponding Graph/Chart) II-45


III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Current and Future Analysis III-1
CKD Fuels the US Market for IV Iron III-1
Addressing Broader IDA Indicates Opportunities III-1
CMS Reimbursement Shifts to Bundled Payment for Dialysis III-2
Comparison of the Old (Fixed Payment) and Bundled Payment
Reimbursement Models III-2
The Anticipated Effect of Bundling Reimbursement on Clinical
Practice III-2
ESRD QIP Related Measures for the Years 2012, 2013 and 2014 III-3
Concerns over Allergic Reactions Prompts FDA to Issue Warning III-3
Potential Short-Term and Long-Term Safety Concerns of IV
Iron Preparations III-3
Competitive Scenario III-4
Table 12: Leading IV Iron Drugs in the US Market (2013):
Percentage Breakdown of Value Sales for Feraheme,
Ferrlecit, Venofer and Others (includes corresponding
Graph/Chart) III-4

Table 13: Leading Drugs in the US Non-Dialysis IV Iron
Market (2011 and 2013): Percentage Breakdown of Volume Sales
for Feraheme, Ferrlecit + Generic Ferric Gluconate, Venofer
and Others (includes corresponding Graph/Chart) III-4

Table 14: Iron Deficiency Prevalence by Disease: Analyzed
by Percentage Share of Patients with ID and IDA for Select
Diseases (includes corresponding Graph/Chart) III-5

Table 15: Preferred Therapy for New ESRD Patients in the
US: Percentage Breakdown by Number of Patients Opting for
Hemodialysis, Transplant and Peritoneal Dialysis (includes
corresponding Graph/Chart) III-6
Does Dose Limitation Affect Venofer's Sales? III-6
Product Approval III-6
Strategic Corporate Developments III-6
Key Players III-7
B.Market Analytics III-10
Table 16: US Recent Past, Current and Future Analysis for
Intravenous (IV) Iron Drugs Market Analyzed with Annual
Sales Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) III-10

Table 17: US Historic Review for Intravenous (IV) Iron Drugs
Market Analyzed with Annual Sales Figures in US$ Million for
Years 2006 through 2012 (includes corresponding Graph/Chart) III-11

2. CANADA III-12
Market Analysis III-12
Table 18: Canadian Recent Past, Current and Future Analysis
for Intravenous (IV) Iron Drugs Market Analyzed with Annual
Sales Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) III-12

Table 19: Canadian Historic Review for Intravenous (IV) Iron
Drugs Market Analyzed with Annual Sales Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-13

3. JAPAN III-14
A.Market Analysis III-14
Current and Future Analysis III-14
Market Overview III-14
Bundled Payment Policy Encourages IV Iron Use III-14
Strategic Corporate Development III-14
Takeda Pharmaceutical Company Limited - A Key Player III-15
B.Market Analytics III-15
Table 20: Japanese Recent Past, Current and Future Analysis
for Intravenous (IV) Iron Drugs Market Analyzed with Annual
Sales Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) III-15

Table 21: Japanese Historic Review for Intravenous (IV) Iron
Drugs Market Analyzed with Annual Sales Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-16

4. EUROPE III-17
A.Market Analysis III-17
Current and Future Analysis III-17
Research Thrusts IV Iron Therapies into Limelight III-17
List of Available IV Iron Drugs in Europe III-17
An Overview of the Competitive Landscape III-18
Table 22: Leading IV Iron Drugs in Europe (2013):
Percentage Share Breakdown of Value Sales for Cosmofer,
Ferinject, Ferrlecit/Gluconate, Generics, Iron Sucrose
Similars (ISS), Venofer, and Others (includes corresponding
Graph/Chart) III-18
EMA Issues New Precautionary Guidelines for IV Iron Supplements III-18
Product Launch III-19
Strategic Corporate Developments III-19
B.Market Analytics III-20
Table 23: European Recent Past, Current and Future Analysis
for Intravenous (IV) Iron Drugs by Geographic Region/Country -
France, Germany, Italy, UK, Spain, Russia and Rest of
Europe Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-20

Table 24: European Historic Review for Intravenous (IV) Iron
Drugs by Geographic Region/Country - France, Germany, Italy,
UK, Spain, Russia and Rest of Europe Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2006 through 2012 (includes corresponding Graph/Chart) III-21

Table 25: European 15-Year Perspective for Intravenous (IV)
Iron Drugs by Geographic Region/Country - Percentage
Breakdown of Dollar Sales for France, Germany, Italy, UK,
Spain, Russia and Rest of Europe Markets for Years 2006,
2014 and 2020 (includes corresponding Graph/Chart) III-22

4a. FRANCE III-23
Market Analysis III-23
Table 26: French Recent Past, Current and Future Analysis
for Intravenous (IV) Iron Drugs Market Analyzed with Annual
Sales Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) III-23

Table 27: French Historic Review for Intravenous (IV) Iron
Drugs Market Analyzed with Annual Sales Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-24

4b. GERMANY III-25
A.Market Analysis III-25
Current and Future Analysis III-25
Fresenius Medical Care Ag and Co. Kgaa - A Key Player III-25
B.Market Analytics III-26
Table 28: German Recent Past, Current and Future Analysis
for Intravenous (IV) Iron Drugs Market Analyzed with Annual
Sales Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) III-26

Table 29: German Historic Review for Intravenous (IV) Iron
Drugs Market Analyzed with Annual Sales Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-27

4c. ITALY III-28
Market Analysis III-28
Table 30: Italian Recent Past, Current and Future Analysis
for Intravenous (IV) Iron Drugs Market Analyzed with Annual
Sales Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) III-28

Table 31: Italian Historic Review for Intravenous (IV) Iron
Drugs Market Analyzed with Annual Sales Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-29

4d. THE UNITED KINGDOM III-30
Market Analysis III-30
Table 32: UK Recent Past, Current and Future Analysis for
Intravenous (IV) Iron Drugs Market Analyzed with Annual
Sales Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) III-30

Table 33: UK Historic Review for Intravenous (IV) Iron Drugs
Market Analyzed with Annual Sales Figures in US$ Million for
Years 2006 through 2012 (includes corresponding Graph/Chart) III-31

4e. SPAIN III-32
Market Analysis III-32
Table 34: Spanish Recent Past, Current and Future Analysis
for Intravenous (IV) Iron Drugs Market Analyzed with Annual
Sales Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) III-32

Table 35: Spanish Historic Review for Intravenous (IV) Iron
Drugs Market Analyzed with Annual Sales Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-33

4f. RUSSIA III-34
Market Analysis III-34
Table 36: Russian Recent Past, Current and Future Analysis
for Intravenous (IV) Iron Drugs Market Analyzed with Annual
Sales Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) III-34

Table 37: Russian Historic Review for Intravenous (IV) Iron
Drugs Market Analyzed with Annual Sales Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-35

4g. REST OF EUROPE III-36
A.Market Analysis III-36
Current and Future Analysis III-36
IV Iron Market in Switzerland III-36
Table 38: Swiss IV Iron Market by Therapeutic Area:
Percentage Breakdown of Value Sales for Cardiology,
Gastroenterology, Geriatry, Gynaecology, Internal Medicine,
Nephrology, Oncology, and Others (includes corresponding
Graph/Chart) III-36
Product Launch III-37
Strategic Corporate Development III-37
Key Players III-37
B.Market Analytics III-39
Table 39: Rest of European Recent Past, Current and Future
Analysis for Intravenous (IV) Iron Drugs Market Analyzed
with Annual Sales Figures in US$ Million for Years 2013
through 2020 (includes corresponding Graph/Chart) III-39

Table 40: Rest of European Historic Review for Intravenous
(IV) Iron Drugs Market Analyzed with Annual Sales Figures in
US$ Million for Years 2006 through 2012 (includes
corresponding Graph/Chart) III-40

5. ASIA-PACIFIC III-41
Market Analysis III-41
Table 41: Asia-Pacific Recent Past, Current and Future
Analysis for Intravenous (IV) Iron Drugs by Geographic
Region/Country - China, India and Rest of Asia-Pacific
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-41

Table 42: Asia-Pacific Historic Review for Intravenous (IV)
Iron Drugs by Geographic Region/Country - China, India and
Rest of Asia-Pacific Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2006 through
2012 (includes corresponding Graph/Chart) III-42

Table 43: Asia-Pacific 15-Year Perspective for Intravenous
(IV) Iron Drugs by Geographic Region/Country - Percentage
Breakdown of Dollar Sales for China, India and Rest of
Asia-Pacific Markets for Years 2006, 2014 and 2020 (includes
corresponding Graph/Chart) III-43

5a. CHINA III-44
Market Analysis III-44
Table 44: Chinese Recent Past, Current and Future Analysis
for Intravenous (IV) Iron Drugs Market Analyzed with Annual
Sales Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) III-44

Table 45: Chinese Historic Review for Intravenous (IV) Iron
Drugs Market Analyzed with Annual Sales Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-45

5b. INDIA III-46
Market Analysis III-46
Table 46: Indian Recent Past, Current and Future Analysis
for Intravenous (IV) Iron Drugs Market Analyzed with Annual
Sales Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) III-46

Table 47: Indian Historic Review for Intravenous (IV) Iron
Drugs Market Analyzed with Annual Sales Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-47

5c. REST OF ASIA-PACIFIC III-48
Market Analysis III-48
Table 48: Rest of Asia-Pacific Recent Past, Current and
Future Analysis for Intravenous (IV) Iron Drugs Market
Analyzed with Annual Sales Figures in US$ Million for Years
2013 through 2020 (includes corresponding Graph/Chart) III-48

Table 49: Rest of Asia-Pacific Historic Review for
Intravenous (IV) Iron Drugs Market Analyzed with Annual
Sales Figures in US$ Million for Years 2006 through 2012
(includes corresponding Graph/Chart) III-49

6. LATIN AMERICA III-50
Market Analysis III-50
Table 50: Latin American Recent Past, Current and Future
Analysis for Intravenous (IV) Iron Drugs by Geographic
Region - Brazil and Rest of Latin American Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2013 through 2020 (includes corresponding
Graph/Chart) III-50

Table 51: Latin American Historic Review for Intravenous
(IV) Iron Drugs by Geographic Region - Brazil and Rest of
Latin American Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2006 through 2012
(includes corresponding Graph/Chart) III-51

Table 52: Latin American 15-Year Perspective for Intravenous
(IV) Iron Drugs by Geographic Region - Percentage Breakdown
of Dollar Sales for Brazil and Rest of Latin American
Markets for Years 2006, 2014 and 2020 (includes corresponding
Graph/Chart) III-52

7. REST OF WORLD III-53
Market Analysis III-53
Table 53: Rest of World Recent Past, Current and Future
Analysis for Intravenous (IV) Iron Drugs Market Analyzed
with Annual Sales Figures in US$ Million for Years 2013
through 2020 (includes corresponding Graph/Chart) III-53

Table 54: Rest of World Historic Review for Intravenous (IV)
Iron Drugs Market Analyzed with Annual Sales Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-54


IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 17 (including Divisions/Subsidiaries - 20)

The United States (6)
Japan (2)
Europe (5)
- Germany (1)
- Rest of Europe (4)
Asia-Pacific (Excluding Japan) (7)

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