Intravenous Immunoglobulin (IVIg) - Global Strategic Business Report

This report analyzes the worldwide markets for Intravenous Immunoglobulin (IVIg) in US$ Million. The report provides separate comprehensive analytics for the US, Canada, Europe, Asia-Pacific, 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.

The report profiles 27 companies including many key and niche players such as:

- Baxter International Inc.
- Beijing Tiantan Biological Products Co. Ltd.
- Bharat Serums and Vaccines Ltd.
- Biotest AG
- China Biologic Products Inc.
- Guizhou Taibang Biological Products Co. Ltd.
- CSL Limited
- CSL Behring
- Grifols S.A
- Huanlan Biological Engineering Inc.
- Kedrion S.p.A.
- LFB Group
- Octapharma AG
- OMRIX Biopharmaceuticals Ltd.
- Shanghai RAAS Blood Products Co. Ltd.
- Sichuan Yuanda Shuyang Pharmaceutical Co. Ltd.

Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs.

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

II. Executive Summary

1. INDUSTRY OVERVIEW
Intravenous Immunoglobulin - A Proliferating Biologic
Outlook
Table 1: Global IVIg Sales by Geographic Region (2012): Percentage Breakdown of Volume Sales by Region for North America, Europe, Asia-Pacific, Latin America, and Rest of World (includes corresponding Graph/Chart)
Growth Drivers and Challenges
All Hopes on IVIg Approval for Alzheimer's of IVIg - Analyzing Pros and Cons
Increasing Awareness of Primary Immunodeficiency Disease to Drive IVIg Market
Subcutaneous IVIg Formulations Gain Therapeutic Foothold
Competitive Scenario
Table 2: Global Market for IVIg (2012): Percentage Share Breakdown of Value Sales by Plasma Fractionators for CSL, Baxter, Grifols, Octapharma, LFB Group, Kedrion, Biotest and Others (includes corresponding Graph/Chart)
Table 3: Global Market for IVIg (2012): Percentage Share Breakdown of Volume Sales by Plasma Fractionators for Grifols, Baxter, CSL, Octapharma, Kedrion, Biotest and Others (includes corresponding Graph/Chart)
Indications Addressed by Major Global IVIg Manufacturers
IVIg Products Offered by Global Leading Players (2012)
Octagam Returns to Market with Full Force
IVIg Prices to Remain Strong both in the US and Outside the US
Table 4: Average IVIg Product Price in the US during the Years 2008-2011 (US$/gram) (includes corresponding Graph/Chart)
Table 5: Average IVIg Product Price Outside the US during the Years 2008-2011 (US$/gram) (includes corresponding Graph/Chart)

2. PLASMA PROTEINS - AN OVERVIEW
Plasma Market Witnesses Surging Demand
Table 6: Global Market for Plasma Proteins (2012): Percentage Breakdown of Value Sales by Product for Polyvalent IVIg & SCIg, Albumin, Factor VIII (Plasma Derived), Hyperimmunes (IM&IV), Factor IX (Plasma Derived) and Others (includes corresponding Graph/Chart)
Table 7: Global Market for Plasma Proteins (2012): Percentage Breakdown of Value Sales by Geographic Region for North America, Europe, Asia-Pacific, Latin America, and Rest of World (includes corresponding Graph/Chart)
Table 8: Global Plasma Market (2012): Percentage Breakdown of Market Share by Company for Baxter, Grifols, CSL Ltd, and Others (includes corresponding Graph/Chart)
Regulations Exercise a Tight Rein over Plasma Therapy & Immunoglobulins

3. IMMUNOGLOBULINS - AN OVERVIEW
Overview
Per Capita Consumption Rate Varies Across Countries
Table 9: Global Immunoglobulin (IVIg and SCIg) Market (2012): Per Capita Consumption for Select Countries (in grams per 1000 Inhabitants) (includes corresponding Graph/Chart)
Baxter's Gammagard, the Leading Immunoglobulin Product in the US
Strong Demand from Major Indications and Pipeline SCIg Products to Fuel Growth
Table 10: Global Immunoglobulin Usage by Indication (2012): Percentage Share Breakdown of Volume Usage for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Primary Immunodeficiency Disorders (PID), Other Neuroimmunologic Disorders, Immune Thrombocytopenic Purpura (ITP) and Others (includes corresponding Graph/Chart)
Table 11: Global Immunoglobulin (IVIg & SCIg) Market (21012): Percentage Breakdown of Volume Share by Medical Specialty (includes corresponding Graph/Chart)
Favorable Reimbursement and High Usage make US the Largest Consumer of Immunoglobulins Worldwide
Growing Adoption of Screening Programs to Reduce Usage of Immunoglobulins in the Treatment of SCID
IVIg and SCIg: A Face-off!
Cost of Product and Treatment
Side-Effects
Frequency of Treatment
Safety Considerations
Patient Response to Treatment Varies
Site of Care

4. THERAPY OVERVIEW
Introduction
Intravenous Immunoglobulin
Mechanism of IVIg Action
IVIg Dosage and Treatment Response Time
Complications and Side Effects of Using IVIg
Precautions to be Undertaken
Intravenous Immunoglobulin - Indications
FDA Approved Indications for IVIg
Common IVIg Intravenous Dosing Recommendations by Indication
Off-Label Usage of IVIg
Select Off-Label Indications for IVIg
Applications by Medical Specialty
Neurology
Hematology
Immunology
Dermatology
Nephrology, Rheumatology, Ophthalmology, and Other Diseases

5. REGULATORY APPROVALS
CSL Behring Obtains EC Marketing Approval for Privigen® for CIDP Patients
CSL Behring Obtains FDA Approval for Privigen® to Treat PID and ITP
Biotest Pharmaceuticals Obtains FDA Approval for BIVGAM™ IVIg
Baxter Obtains EC Marketing Approval for HyQvia
Green Cross Receives Approval to Commence Phase III Clinical Trials
Baxter Bags FDA Approval for GAMMAGARD LIQUID to Treat MMN
Baxter Receives EU Approval for Using KIOVIG to Treat MMN
Benesis Bags Regulatory Approval for Extra Indication of Venoglobulin IH
CSL Behring Obtains EC Marketing Approval for Hizentra®
CSL Behring Secures FDA Approval to Increase Shelf Life of Hizentra
Talecris Biotherapeutics Holdings Obtains FDA Approval for Gamunex-C
CSL Behring Secures FDA Approval to Increase Shelf Life of Privigen®
China includes IVIg on Rural Reimbursement List

6. PRODUCT INNOVATIONS/INTRODUCTIONS
Octapharma Canada Introduces Octagam®10% in Canada
Biotest Introduces BIVIgAM™ in the US
Octapharma USA Re-launches Octagam® 5% Liquid
Baxter Unveils GAMMAGARD Liquid 10% Solution in 30g Dosage
LFB Biomédicaments Unveils CLAIRYG® Liquid Intravenous Immunoglobulin
Grifols Introduces Flebogamma® 10%DIF Intravenous Immunoglobulin
Grifols Introduces Niuliva®

7. RECENT INDUSTRY ACTIVITY
Octapharma Completes Phase II Clinical Trial of Octagam 10% for Alzheimer's
Grifols International Establishes New IVIg Purification Facility in Los Angeles
Sorrento Therapeutics Secures Global Rights for Using G-MAB® Antibody Library Technology to Produce rIVIg
Momenta Pharmaceuticals Acquires Sialic Switch Assets of Virdante Pharmaceuticals
Grifols' AMBAR Study Integrates Therapeutic Plasmapheresis with Alternating Infusion of IVIg and Albumin for Treatment of Alzheimer's Disease
Biotest Publishes Clinical Trial Data Related to New Investigational IVIg Product
Baxter and Halozyme Therapeutics Publish Results of HyQ Phase III Trials
Octagam® Returns to the US Market Following FDA Approval
EC Withdraws Suspension of Marketing Authorization for Octagam® and Octagam® 10%
Octapharma Obtains Approval for Octagam® Re-supply in Australia
Wuhan Institute of Biologic Products and China National Biotech Group Expand Partnership with ProMetic Life Sciences
Sao Paulo State Establishes Plasma Fractionation Plant
GE Healthcare and Neste Jacobs Forge Partnership to Promote Self-Reliance in Plasma Fractionation Globally
ProMetic Life Sciences and Novozymes Enter into Strategic Alliance
Abraxis BioScience and ProMetic Life Sciences Ink Collaboration Agreement
Grifols Takes Over Talecris

8. FOCUS ON SELECT PLAYERS
Baxter International Inc. (US)
Beijing Tiantan Biological Products Co., Ltd (China)
Bharat Serums and Vaccines Limited (India)
Biotest AG (Germany)
China Biologic Products, Inc (China)
Guizhou Taibang Biological Products Co., Ltd (China)
CSL Limited (Australia)
CSL Behring LLC (US)
Grifols, S.A (Spain)
Hualan Biological Engineering Inc. (China)
Kedrion S.p.A. (Italy)
LFB Group (France)
Octapharma AG (Switzerland)
OMRIX Biopharmaceuticals Ltd (Israel)
Shanghai RAAS Blood Products Co., Ltd. (China)
Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd (China)

9. GLOBAL MARKET PERSPECTIVE
Table 12: World Recent Past, Current & Future Analysis for Intravenous Immunoglobulin by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart)
Table 13: World Historic Review for Intravenous Immunoglobulin by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart)
Table 14: World 15-Year Perspective for Intravenous Immunoglobulin by Geographic Region - Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), and Rest of World Markets for Years 2004, 2013 & 2018 (includes corresponding Graph/Chart)

III. MARKET

1. THE UNITED STATES
A.Market Analysis
Outlook
Table 15: North American Market for IVIg (2012): Percentage Share Breakdown of Volume Sales by Plasma Fractionators for Grifols, Baxter, CSL Behring and Others (includes corresponding Graph/Chart)
Table 16: US Market for Immunoglobulins (2011): Percentage Share Breakdown of Value Sales by Product for Gammagard Liquid/Kiovig, Flebogamma/Gamunex, Privigen/Carimune NF, Octagam and Others (includes corresponding Graph/Chart)
Table 17: US Market for IVIg Products (2012): Percentage Breakdown of Volume Sales by Indication for CIDP, PID, Other Neurological Diseases, ITP and Others (includes corresponding Graph/Chart)
Favorable Reimbursement and High Usage make US the Largest Consumer of Immunoglobulins Worldwide
IVIg Reimbursement Scenario
Growing Adoption of Screening Programs to Reduce Usage of Immunoglobulins in the Treatment of SCID
IDF Reveals Acceptance of the Medicare IVIg Access Act by Congress
US Blood Supply System - A Schematic
Regulatory Approvals
Product Launch
Strategic Corporate Developments
Select Players
B.Market Analytics
Table 18: US Recent Past, Current & Future Analysis for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart)
Table 19: US Historic Review for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart)

2. CANADA
A.Market Analysis
Outlook
Highest Per Capita Consumption of IVIg
Canadian Blood Services - at the Forefront of Blood Collection in Canada
Product Launches
Strategic Corporate Development
B.Market Analytics
Table 20: Canadian Recent Past, Current & Future Analysis for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart)
Table 21: Canadian Historic Review for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart)

3. JAPAN
A.Market Analysis
Outlook
Regulatory Approval
B.Market Analytics
Table 22: Japanese Recent Past, Current & Future Analysis for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart)
Table 23: Japanese Historic Review for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart)

4. EUROPE
A.Market Analysis
Outlook
Key Statistics
Table 24: European Market for IVIg (2012): Percentage Share Breakdown of Volume Sales by Plasma Fractionators for Grifols, CSL Behring, Baxter Healthcare, Kedrion, Octapharma, Biotest and Others (includes corresponding Graph/Chart)
Table 25: European Immunoglobulin (IVIg and SCIg) Per Capita Consumption in Grams per Thousand Inhabitants (2008 & 2012) (includes corresponding Graph/Chart)
European Sub-Q IVIg Product Approvals
Regulatory Approvals
Strategic Corporate Developments
B.Market Analytics
Table 26: European Recent Past, Current & Future Analysis for Intravenous Immunoglobulin by Geographic Region
France, Germany, Italy, UK, Spain and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart)
Table 27: European Historic Review for Intravenous Immunoglobulin by Geographic Region - France, Germany, Italy, UK, Spain and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart)
Table 28: European 15-Year Perspective for Intravenous Immunoglobulin by Geographic Region - Percentage Breakdown of Revenues for France, Germany, Italy, UK, Spain and Rest of Europe Markets for Years 2004, 2013 and 2018 (includes corresponding Graph/Chart)
4a. FRANCE
A.Market Analysis
Outlook
Research Initiative in France
High-dose Intravenous Immunoglobulin to Offer Respite for Primary Sjögren's Syndrome Patients
LFB Group - A Key Player
B.Market Analytics
Table 29: French Recent Past, Current & Future Analysis for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart)
Table 30: French Historic Review for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart)
4b. GERMANY
A.Market Analysis
Outlook
Biotest AG - A Key Player
B.Market Analytics
Table 31: German Recent Past, Current & Future Analysis for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart)
Table 32: German Historic Review for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart)
4c. ITALY
A.Market Analysis
Outlook
Kedrion S.p.A. - A Key Player
B.Market Analytics
Table 33: Italian Recent Past, Current & Future Analysis for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart)
Table 34: Italian Historic Review for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart)
4d. THE UNITED KINGDOM
A.Market Analysis
Outlook
New Concept to Stimulate Plasma Market: Welsh Blood Service Proposes Sale of Blood Plasma
Regulatory Approval
B.Market Analytics
Table 35: The UK Recent Past, Current & Future Analysis for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart)
Table 36: The UK Historic Review for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart)
4e. SPAIN
A.Market Analysis
Outlook
Product Launches
Strategic Corporate Development
Grifols, S.A - A Key Player
B.Market Analytics
Table 37: Spanish Recent Past, Current & Future Analysis for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart)
Table 38: Spanish Historic Review for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart)
4f. REST OF EUROPE
A.Market Analysis
Outlook
Strategic Corporate Development
Octapharma Ag (Switzerland) - A Key Player
B.Market Analytics
Table 39: Rest of Europe Recent Past, Current & Future Analysis for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart)
Table 40: Rest of Europe Historic Review for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart)

5. ASIA-PACIFIC
A.Market Analysis
Outlook
Table 41: Asia-Pacific Market for Immunoglobulin (IVIg and SCIg) (2005 & 2010): Per Capita Consumption (Grams per Thousand Inhabitants) (includes corresponding Graph/Chart)
B.Market Analytics
Table 42: Asia-Pacific Recent Past, Current & Future Analysis for Intravenous Immunoglobulin by Geographic Region
Australia, China and Rest of Asia-Pacific Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart)
Table 43: Asia-Pacific Historic Review for Intravenous Immunoglobulin by Geographic Region - Australia, China and Rest of Asia-Pacific Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart)
Table 44: Asia-Pacific 15-Year Perspective for Intravenous Immunoglobulin by Geographic Region - Percentage Breakdown of Revenues for Australia, China and Rest of Asia-Pacific Markets for Years 2004, 2013 and 2018 (includes corresponding Graph/Chart)
5a. AUSTRALIA
A.Market Analysis
Outlook
Overview
Table 45: Australia IVIg Usage by Main Indications (% of grams used annually) (includes corresponding Graph/Chart)
Revised Criteria for Clinical Use of IVIg in Australia
Australian Blood Product Market - An Overview
Australian Red Cross Blood Service
Strategic Corporate Development
Csl Limited - A Key Player
B.Market Analytics
Table 46: Australian Recent Past, Current & Future Analysis for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart)
Table 47: Australian Historic Review for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart)
5b. CHINA
A.Market Analysis
Outlook
Overview
Strategic Corporate Development
Select Players
B.Market Analytics
Table 48: Chinese Recent Past, Current & Future Analysis for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart)
Table 49: Chinese Historic Review for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart)
5c. REST OF ASIA-PACIFIC
A.Market Analysis
Outlook
Indonesia - An Overview
Bharat Serums and Vaccines Ltd (India) - A Key Player
B.Market Analytics
Table 50: Rest of Asia-Pacific Recent Past, Current & Future Analysis for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart)
Table 51: Rest of Asia-Pacific Historic Review for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart)

6. REST OF WORLD
A.Market Analysis
Outlook
Overview of the Middle East
Iran Attains Self-Sufficiency in Plasma Production
Strategic Corporate Development
Omrix Biopharmaceuticals Ltd (Israel) - A Key Player
B.Market Analytics
Table 52: Rest of World Recent Past, Current & Future Analysis for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart)
Table 53: Rest of World Historic Review for Intravenous Immunoglobulin with Annual Revenue Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart)

IV. COMPETITIVE LANDSCAPE
Total Companies Profiled: 27 (including Divisions/Subsidiaries - 34)
The United States (9)
Canada (2)
Japan (2)
Europe (9)
- France (2)
- Germany (1)
- The United Kingdom (1)
- Italy (1)
- Spain (1)
- Rest of Europe (3)
Asia-Pacific (Excluding Japan) (11)
Middle-East (1)