Global Intravenous (IV) Iron Drugs Industry

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Global Intravenous (IV) Iron Drugs Industry

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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 2010 through 2018. Also, a six-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 20 companies including many key and niche players such as -
Actavis, Inc.
AMAG Pharmaceuticals, Inc.
Fresenius Medical Care AG & Co. KGaA
Galenica Ltd.
Vifor Pharma Ltd.
Luitpold Pharmaceuticals, Inc.
American Regent, Inc.

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

II. EXECUTIVE SUMMARY

1. OUTLOOK II-1
A Quick Primer II-1
Current and Future Analysis II-2
Asia-Pacific to Lead Growth Market Growth II-2
Recession - A Period of Sustained Growth II-2

2. INDUSTRY OVERVIEW & TRENDS II-3
Dialysis Clinics - Major Market for IV Iron Supplements II-3
Table 1: Number of Patients on Dialysis in Select Markets
Worldwide: 2012 (includes corresponding Graph/Chart) II-3

Table 2: 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-4

Table 3: 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-4
IV Iron Drugs - An Overview II-5
Select IV Iron Drugs Prescribed for Iron Deficiency II-5
Table 4: Global Sales of Leading IV Iron Drugs in US$
Million: 2009- 2011 (includes corresponding Graph/Chart) II-7
Venofer® - Galenica's Wonder Drug for the IV Iron Market II-7
The Vulnerable Ageing Population Supports Demand II-8
Table 5: Global Population Statistics for the 65+ Age Group:
2012 (in Millions) (includes corresponding Graph/Chart) II-8
Changing Preference Favors IV Iron Drugs Market II-9
Comparison of Ferrous Salts with IV Iron Therapy II-9
Chronic Kidney Disease - The Predominant Growth Factor II-10
Other Chronic Diseases with IDA Create Growing Demand for IV
Iron Drugs II-10
Anemia in Heart Failure - A Market with Huge Potential II-11
Cancer Patients with IDA Promote Demand for External Iron
Supplements II-11
Table 6: 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-12
Correction of IDA in Pregnancy Signals Opportunities II-12
Women's Health - A Key Growth Factor II-13
Perioperative and Postoperative Anemia - A Niche Market Beckons II-13
Adverse Reactions of IV Iron Preparations Raise Concerns II-14
Peginesatide - A Possible Threat to IV Iron II-14

3. REGULATORY OVERVIEW II-15
Increasing Trend towards Bundled Reimbursements II-15
A Glimpse of Regulations in the US and Europe II-15
Comparison of Approved Indications and Safety Warnings for
Select FDA Approved IV Iron Drugs II-16
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-16

4. OVERVIEW OF INTRAVENOUS (IV) IRON DRUGS II-17
Iron - A Vital Element II-17
Iron-Deficiency Anemia II-17
Intravenous Therapy II-17
Patients of Chronic Illnesses, the Elderly and Women - The
High Risk Population II-17
Treatment for Iron Deficiency Anemia II-18
Iron Requirement in Chronic Kidney Disease II-18
Classification of Iron Deficiency in CKD II-19
Treating Iron Deficiency in CKD Patients II-19
Side Effects of Iron Supplementation in CKD II-19
Methods of Restoring Iron II-20
Oral Iron Therapy II-20
IV Iron-Infusion Therapy II-21
Intravenous (IV) Iron II-21
Conditions for Receiving Iron Injections II-22
Injection Procedure II-22
Categories of Iron Injections II-23
Suitability of IV Iron Preparation II-24
Suitability of Regimen II-24
Management of Iron Doses II-25
Effectiveness of Iron Injection II-25
Requirement of Test Dose II-25
Adverse Effects of Iron Injections II-25
Iron Therapy: Caution II-26
Duration of Iron Infusion II-26
Iron Overdose II-26
Iron-Out-of-Balance Therapies II-26
Blood Donation II-26
Therapeutic Phlebotomy II-27
Red Cell Apheresis II-27
Iron Chelation Therapy II-27
Iron-Chelating Drugs II-27
Desferrioxamine or Desferal II-27
Deferiprone or Ferriprox II-28
Conditions for Undergoing Iron Chelation Therapy II-28
Kinds of Chelation Therapy II-28
Side Effects Caused by IV Iron Chelation II-29

5. PRODUCT LAUNCHES/APPROVALS II-30
FDA approves Injectafer® for the treatment of IDA II-30
Takeda Pharmaceutical Company Introduces Rienso® in Europe II-30
Pharmacosmos Launches Monofer® Intravenous Iron Drug II-30

6. RECENT INDUSTRY ACTIVITY II-31
Vifor Pharma and Zeria Pharmaceutical Co., Ltd. Sign Exclusive
Licensing Agreement for Ferinject® in Japan II-31
Rockwell Medical Technologies Completes Phase III Trials for
Triferic II-31
Watson Pharmaceuticals Changes Name to Actavis II-31
Luitpold Pharmaceuticals Obtains FDA Acceptance for Review of
Injectafer® NDA II-32
AMAG Pharmaceuticals Receives FDA Acceptance for Feraheme®
sNDA Review II-32
EC Approves Takeda's Rienso® to Treat Anemia II-32
BioLink Life Sciences to Commence Phase I Trial of FCP II-32
Pharmacosmos Signs License Agreement with Eddingpharm for
Monofer® and CosmoFer® for China II-33
Galenica Acquires Vifor Uriach Pharma SL and Primary Care
Division of Uriach II-33
Galenica and Fresenius Enter into Joint Venture in Human
Health Sector II-33
AMAG Pharmaceuticals Inks Agreement with Takeda Pharmaceutical
Company for Feraheme® II-33
Pharmacosmos Bags Marketing Authorizations for Monofer® II-34
Pharmacosmos Launches New Subsidiary II-34

7. FOCUS ON SELECT PLAYERS II-35
Actavis, Inc. (US) II-35
AMAG Pharmaceuticals, Inc. (US) II-35
Fresenius Medical Care AG & Co. KGaA (Germany) II-35
Galenica Ltd. (Switzerland) II-36
Vifor Pharma Ltd. (Switzerland) II-36
Luitpold Pharmaceuticals, Inc. (US) II-36
American Regent, Inc. (US) II-37
Pharmacosmos A/S (Denmark) II-37
Rockwell Medical Technologies, Inc. (US) II-37
Sanofi US (US) II-38

8. GLOBAL MARKET PERSPECTIVE II-39
Table 7: 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 2010 through 2018 (includes
corresponding Graph/Chart) II-39

Table 8: 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 2004 through 2009 (includes corresponding
Graph/Chart) II-40

Table 9: 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 2004, 2013 and
2018 (includes corresponding Graph/Chart) II-41

III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Current & 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-4
Competitive Scenario III-4
Table 10: US Market for IV Iron Drugs by Product (2012):
Percentage Breakdown of Value Sales for Venofer, Feraheme,
Ferrlecit, INFeD, Dexferrum and Others (includes
corresponding Graph/Chart) III-4

Table 11: US Non-Dialysis IV Iron Therapy Market by
Products (2012): Percentage Breakdown by Volume of IV
Administered for Venofer, INFeD, Feraheme, Ferrlecit,
Dexferrum and Generic Sodium Ferric Gluconate (includes
corresponding Graph/Chart) III-5

Table 12: 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-5
Product Approval III-6
Strategic Corporate Developments III-6
Key Players III-8
B.Market Analytics III-11
Table 13: US Recent Past, Current and Future Analysis for
Intravenous (IV) Iron Drugs Analyzed with Annual Sales
Figures in US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-11

Table 14: US Historic Review for Intravenous (IV) Iron Drugs
Analyzed with Annual Sales Figures in US$ Million for Years
2004 through 2009 (includes corresponding Graph/Chart) III-11

2. CANADA III-12
A.Market Analysis III-12
Current & Future Analysis III-12
B.Market Analytics III-12
Table 15: Canadian Recent Past, Current and Future Analysis
for Intravenous (IV) Iron Drugs Analyzed with Annual Sales
Figures in US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-12

Table 16: Canadian Historic Review for Intravenous (IV) Iron
Drugs Analyzed with Annual Sales Figures in US$ Million for
Years 2004 through 2009 (includes corresponding Graph/Chart) III-13

3. JAPAN III-14
A.Market Analysis III-14
Current & Future Analysis III-14
Strategic Corporate Development III-14
B.Market Analytics III-15
Table 17: Japanese Recent Past, Current and Future Analysis
for Intravenous (IV) Iron Drugs Analyzed with Annual Sales
Figures in US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-15

Table 18: Japanese Historic Review for Intravenous (IV) Iron
Drugs Analyzed with Annual Sales Figures in US$ Million for
Years 2004 through 2009 (includes corresponding Graph/Chart) III-15

4. EUROPE III-16
A.Market Analysis III-16
Current & Future Analysis III-16
Research Thrusts IV Iron Therapies into Limelight in Europe III-16
List of Available IV Iron Drugs in Europe III-16
EMA Issues New Precautionary Guidelines for IV Iron Supplements III-16
Product Launch III-17
Strategic Corporate Developments III-17
B.Market Analytics III-18
Table 19: 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 2010 through 2018 (includes
corresponding Graph/Chart) III-18

Table 20: 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
2004 through 2009 (includes corresponding Graph/Chart) III-19

Table 21: European15-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 2004,
2013 and 2018 (includes corresponding Graph/Chart) III-20

4a. FRANCE III-21
A.Market Analysis III-21
Current & Future Analysis III-21
B.Market Analytics III-21
Table 22: French Recent Past, Current and Future Analysis
for Intravenous (IV) Iron Drugs Analyzed with Annual Sales
Figures in US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-21

Table 23: French Historic Review for Intravenous (IV) Iron
Drugs Analyzed with Annual Sales Figures in US$ Million for
Years 2004 through 2009 (includes corresponding Graph/Chart) III-22

4b. GERMANY III-23
A.Market Analysis III-23
Current & Future Analysis III-23
Fresenius Medical Care Ag & Co. KGaA - A Key Player III-23
B.Market Analytics III-23
Table 24: German Recent Past, Current and Future Analysis
for Intravenous (IV) Iron Drugs Analyzed with Annual Sales
Figures in US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-23

Table 25: German Historic Review for Intravenous (IV) Iron
Drugs Analyzed with Annual Sales Figures in US$ Million for
Years 2004 through 2009 (includes corresponding Graph/Chart) III-24

4c. ITALY III-25
A.Market Analysis III-25
Current & Future Analysis III-25
B.Market Analytics III-25
Table 26: Italian Recent Past, Current and Future Analysis
for Intravenous (IV) Iron Drugs Analyzed with Annual Sales
Figures in US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-25

Table 27: Italian Historic Review for Intravenous (IV) Iron
Drugs Analyzed with Annual Sales Figures in US$ Million for
Years 2004 through 2009 (includes corresponding Graph/Chart) III-26

4d. THE UNITED KINGDOM III-27
A.Market Analysis III-27
Current & Future Analysis III-27
Strategic Corporate Development III-27
B.Market Analytics III-27
Table 28: UK Recent Past, Current and Future Analysis for
Intravenous (IV) Iron Drugs Analyzed with Annual Sales
Figures in US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-27

Table 29: UK Historic Review for Intravenous (IV) Iron Drugs
Analyzed with Annual Sales Figures in US$ Million for Years
2004 through 2009 (includes corresponding Graph/Chart) III-28

4e. SPAIN III-29
A.Market Analysis III-29
Current & Future Analysis III-29
Strategic Corporate Development III-29
B.Market Analytics III-29
Table 30: Spanish Recent Past, Current and Future Analysis
for Intravenous (IV) Iron Drugs Analyzed with Annual Sales
Figures in US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-29

Table 31: Spanish Historic Review for Intravenous (IV) Iron
Drugs Analyzed with Annual Sales Figures in US$ Million for
Years 2004 through 2009 (includes corresponding Graph/Chart) III-30

4f. RUSSIA III-31
A.Market Analysis III-31
Current & Future Analysis III-31
B.Market Analytics III-31
Table 32: Russian Recent Past, Current and Future Analysis
for Intravenous (IV) Iron Drugs Analyzed with Annual Sales
Figures in US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-31

Table 33: Russian Historic Review for Intravenous (IV) Iron
Drugs Analyzed with Annual Sales Figures in US$ Million for
Years 2004 through 2009 (includes corresponding Graph/Chart) III-32

4g. REST OF EUROPE III-33
A.Market Analysis III-33
Current & Future Analysis III-33
Switzerland Offers Scope for IV Iron in Nephrology III-33
Table 34: Swiss IV Iron Market by Therapeutic Area
(2006-2010): Annual Revenues in US$ Million for Dialysis,
Pre-Dialysis and Other Therapies (includes corresponding
Graph/Chart) III-33
Product Launch III-34
Strategic Corporate Development III-34
Key Players III-34
B.Market Analytics III-36
Table 35: Rest of European Recent Past, Current and Future
Analysis for Intravenous (IV) Iron Drugs Analyzed with
Annual Sales Figures in US$ Million for Years 2010 through
2018 (includes corresponding Graph/Chart) III-36

Table 36: Rest of European Historic Review for Intravenous
(IV) Iron Drugs Analyzed with Annual Sales Figures in US$
Million for Years 2004 through 2009 (includes corresponding
Graph/Chart) III-37

5. ASIA-PACIFIC III-38
A.Market Analysis III-38
Current & Future Analysis III-38
B.Market Analytics III-38
Table 37: 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 2010 through 2018 (includes
corresponding Graph/Chart) III-38

Table 38: 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 2004 through
2009 (includes corresponding Graph/Chart) III-39

Table 39: 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 2004, 2013 and 2018 (includes
corresponding Graph/Chart) III-40

5a. CHINA III-41
A.Market Analysis III-41
Current & Future Analysis III-41
Strategic Corporate Development III-41
B.Market Analytics III-41
Table 40: Chinese Recent Past, Current and Future Analysis
for Intravenous (IV) Iron Drugs Analyzed with Annual Sales
Figures in US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-41

Table 41: Chinese Historic Review for Intravenous (IV) Iron
Drugs Analyzed with Annual Sales Figures in US$ Million for
Years 2004 through 2009 (includes corresponding Graph/Chart) III-42

5b. INDIA III-43
A.Market Analysis III-43
Current & Future Analysis III-43
B.Market Analytics III-43
Table 42: Indian Recent Past, Current and Future Analysis
for Intravenous (IV) Iron Drugs Analyzed with Annual Sales
Figures in US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-43

Table 43: Indian Historic Review for Intravenous (IV) Iron
Drugs Analyzed with Annual Sales Figures in US$ Million for
Years 2004 through 2009 (includes corresponding Graph/Chart) III-44

5c. REST OF ASIA-PACIFIC III-45
A.Market Analysis III-45
Current & Future Analysis III-45
B.Market Analytics III-45
Table 44: Rest of Asia-Pacific Recent Past, Current and
Future Analysis for Intravenous (IV) Iron Drugs Analyzed
with Annual Sales Figures in US$ Million for Years 2010
through 2018 (includes corresponding Graph/Chart) III-45

Table 45: Rest of Asia-Pacific Historic Review for
Intravenous (IV) Iron Drugs Analyzed with Annual Sales
Figures in US$ Million for Years 2004 through 2009 (includes
corresponding Graph/Chart) III-46

6. LATIN AMERICA III-47
A.Market Analysis III-47
Current & Future Analysis III-47
B.Market Analytics III-47
Table 46: Latin American Recent Past, Current and Future
Analysis for Intravenous (IV) Iron Drugs by Geographic
Region/Country - Brazil and Rest of Latin American Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2010 through 2018 (includes corresponding
Graph/Chart) III-47

Table 47: Latin American Historic Review for Intravenous
(IV) Iron Drugs by Geographic Region/Country - Brazil and
Rest of Latin American Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2004 through
2009 (includes corresponding Graph/Chart) III-48

Table 48: Latin American 15-Year Perspective for Intravenous
(IV) Iron Drugs by Geographic Region/Country - Percentage
Breakdown of Dollar Sales for Brazil and Rest of Latin
American Markets for Years 2004, 2013 and 2018 (includes
corresponding Graph/Chart) III-49

7. REST OF WORLD III-50
A.Market Analysis III-50
Current & Future Analysis III-50
B.Market Analytics III-50
Table 49: Rest of World Recent Past, Current and Future
Analysis for Intravenous (IV) Iron Drugs Analyzed with
Annual Sales Figures in US$ Million for Years 2010 through
2018 (includes corresponding Graph/Chart) III-50

Table 50: Rest of World Historic Review for Intravenous (IV)
Iron Drugs Analyzed with Annual Sales Figures in US$ Million
for Years 2004 through 2009 (includes corresponding
Graph/Chart) III-51

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 20 (including Divisions/Subsidiaries - 22)

The United States (8)
Japan (2)
Europe (4)
- Germany (1)
- Rest of Europe (3)
Asia-Pacific (Excluding Japan) (8)

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