Global Intravenous Immunoglobulin (IVIg) Industry

  • July 2013
  • -
  • Global Industry Analysts
  • -
  • 135 pages

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., and 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.

Table Of Contents




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. INDUSTRY OVERVIEW II-1
Intravenous Immunoglobulin - A Proliferating Biologic II-1
Outlook II-1
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) II-2
Growth Drivers and Challenges II-2
All Hopes on IVIg Approval for Alzheimer’s of IVIg - Analyzing
Pros and Cons II-3
Increasing Awareness of Primary Immunodeficiency Disease to
Drive IVIg Market II-4
Subcutaneous IVIg Formulations Gain Therapeutic Foothold II-4
Competitive Scenario II-4
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) II-5

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) II-5
Indications Addressed by Major Global IVIg Manufacturers II-5
IVIg Products Offered by Global Leading Players (2012) II-6
Octagam Returns to Market with Full Force II-6
IVIg Prices to Remain Strong both in the US and Outside the US II-6
Table 4: Average IVIg Product Price in the US during the
Years 2008-2011 (US$/gram) (includes corresponding
Graph/Chart) II-6

Table 5: Average IVIg Product Price Outside the US during the
Years 2008-2011 (US$/gram) (includes corresponding
Graph/Chart) II-7

2. PLASMA PROTEINS - AN OVERVIEW II-8
Plasma Market Witnesses Surging Demand II-8
Table 6: Global Market for Plasma Proteins (2012): Percentage
Breakdown of Value Sales by Product for Polyvalent IVIg and
SCIg, Albumin, Factor VIII (Plasma Derived), Hyperimmunes
(IMandIV), Factor IX (Plasma Derived) and Others (includes
corresponding Graph/Chart) II-8

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) II-9

Table 8: Global Plasma Market (2012): Percentage Breakdown of
Market Share by Company for Baxter, Grifols, CSL Ltd, and
Others (includes corresponding Graph/Chart) II-9
Regulations Exercise a Tight Rein over Plasma Therapy and
Immunoglobulins II-9

3. IMMUNOGLOBULINS - AN OVERVIEW II-10
Overview II-10
Per Capita Consumption Rate Varies Across Countries II-10
Table 9: Global Immunoglobulin (IVIg and SCIg) Market (2012):
Per Capita Consumption for Select Countries (in grams per
1000 Inhabitants) (includes corresponding Graph/Chart) II-11
Baxter’s Gammagard, the Leading Immunoglobulin Product in the US II-11
Strong Demand from Major Indications and Pipeline SCIg
Products to Fuel Growth II-11
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) II-13

Table 11: Global Immunoglobulin (IVIg and SCIg) Market (21012):
Percentage Breakdown of Volume Share by Medical Specialty
(includes corresponding Graph/Chart) II-13
Favorable Reimbursement and High Usage make US the Largest
Consumer of Immunoglobulins Worldwide II-14
Growing Adoption of Screening Programs to Reduce Usage of
Immunoglobulins in the Treatment of SCID II-14
IVIg and SCIg: A Face-off! II-14
Cost of Product and Treatment II-14
Side-Effects II-15
Frequency of Treatment II-15
Safety Considerations II-15
Patient Response to Treatment Varies II-15
Site of Care II-15

4. THERAPY OVERVIEW II-16
Introduction II-16
Intravenous Immunoglobulin II-16
Mechanism of IVIg Action II-16
IVIg Dosage and Treatment Response Time II-17
Complications and Side Effects of Using IVIg II-17
Precautions to be Undertaken II-18
Intravenous Immunoglobulin - Indications II-18
FDA Approved Indications for IVIg II-18
Common IVIg Intravenous Dosing Recommendations by Indication II-19
Off-Label Usage of IVIg II-19
Select Off-Label Indications for IVIg II-19
Applications by Medical Specialty II-20
Neurology II-20
Hematology II-21
Immunology II-21
Dermatology II-21
Nephrology, Rheumatology, Ophthalmology, and Other Diseases II-21

5. REGULATORY APPROVALS II-22
CSL Behring Obtains EC Marketing Approval for Privigen® for
CIDP Patients II-22
CSL Behring Obtains FDA Approval for Privigen® to Treat PID
and ITP II-22
Biotest Pharmaceuticals Obtains FDA Approval for BIVGAMâ„¢ IVIg II-22
Baxter Obtains EC Marketing Approval for HyQvia II-22
Green Cross Receives Approval to Commence Phase III Clinical
Trials II-23
Baxter Bags FDA Approval for GAMMAGARD LIQUID to Treat MMN II-23
Baxter Receives EU Approval for Using KIOVIG to Treat MMN II-23
Benesis Bags Regulatory Approval for Extra Indication of
Venoglobulin IH II-24
CSL Behring Obtains EC Marketing Approval for Hizentra® II-24
CSL Behring Secures FDA Approval to Increase Shelf Life of
Hizentra II-24
Talecris Biotherapeutics Holdings Obtains FDA Approval for
Gamunex-C II-25
CSL Behring Secures FDA Approval to Increase Shelf Life of
Privigen® II-25
China includes IVIg on Rural Reimbursement List II-25

6. PRODUCT INNOVATIONS/INTRODUCTIONS II-26
Octapharma Canada Introduces Octagam®10% in Canada II-26
Biotest Introduces BIVIgAMâ„¢ in the US II-26
Octapharma USA Re-launches Octagam® 5% Liquid II-26
Baxter Unveils GAMMAGARD Liquid 10% Solution in 30g Dosage II-26
LFB Biomedicaments Unveils CLAIRYG® Liquid Intravenous
Immunoglobulin II-27
Grifols Introduces Flebogamma® 10%DIF Intravenous Immunoglobulin II-27
Grifols Introduces Niuliva® II-28

7. RECENT INDUSTRY ACTIVITY II-29
Octapharma Completes Phase II Clinical Trial of Octagam 10%
for Alzheimer’s II-29
Grifols International Establishes New IVIg Purification
Facility in Los Angeles II-29
Sorrento Therapeutics Secures Global Rights for Using G-MAB®
Antibody Library Technology to Produce rIVIg II-29
Momenta Pharmaceuticals Acquires Sialic Switch Assets of
Virdante Pharmaceuticals II-30
Grifols’ AMBAR Study Integrates Therapeutic Plasmapheresis
with Alternating Infusion of IVIg and Albumin for Treatment
of Alzheimer’s Disease II-30
Biotest Publishes Clinical Trial Data Related to New
Investigational IVIg Product II-30
Baxter and Halozyme Therapeutics Publish Results of HyQ Phase
III Trials II-30
Octagam® Returns to the US Market Following FDA Approval II-31
EC Withdraws Suspension of Marketing Authorization for
Octagam® and Octagam® 10% II-31
Octapharma Obtains Approval for Octagam® Re-supply in Australia II-31
Wuhan Institute of Biologic Products and China National
Biotech Group Expand Partnership with ProMetic Life Sciences II-32
Sao Paulo State Establishes Plasma Fractionation Plant II-32
GE Healthcare and Neste Jacobs Forge Partnership to Promote
Self-Reliance in Plasma Fractionation Globally II-32
ProMetic Life Sciences and Novozymes Enter into Strategic
Alliance II-33
Abraxis BioScience and ProMetic Life Sciences Ink
Collaboration Agreement II-33
Grifols Takes Over Talecris II-34

8. FOCUS ON SELECT PLAYERS II-35
Baxter International Inc. (US) II-35
Beijing Tiantan Biological Products Co., Ltd (China) II-35
Bharat Serums and Vaccines Limited (India) II-35
Biotest AG (Germany) II-36
China Biologic Products, Inc (China) II-36
Guizhou Taibang Biological Products Co., Ltd (China) II-37
CSL Limited (Australia) II-37
CSL Behring LLC (US) II-37
Grifols, S.A (Spain) II-38
Hualan Biological Engineering Inc. (China) II-38
Kedrion S.p.A. (Italy) II-38
LFB Group (France) II-39
Octapharma AG (Switzerland) II-39
OMRIX Biopharmaceuticals Ltd (Israel) II-39
Shanghai RAAS Blood Products Co., Ltd. (China) II-40
Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd (China) II-40

9. GLOBAL MARKET PERSPECTIVE II-41
Table 12: World Recent Past, Current and 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) II-41

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) II-42

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 and 2018 (includes corresponding Graph/Chart) II-43


III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Outlook III-1
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) III-1

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) III-1

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) III-2
Favorable Reimbursement and High Usage make US the Largest
Consumer of Immunoglobulins Worldwide III-2
IVIg Reimbursement Scenario III-2
Growing Adoption of Screening Programs to Reduce Usage of
Immunoglobulins in the Treatment of SCID III-2
IDF Reveals Acceptance of the Medicare IVIg Access Act by
Congress III-3
US Blood Supply System - A Schematic III-4
Regulatory Approvals III-4
Product Launch III-6
Strategic Corporate Developments III-6
Select Players III-8
B.Market Analytics III-10
Table 18: US Recent Past, Current and Future Analysis for
Intravenous Immunoglobulin with Annual Revenue Figures in
US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-10

Table 19: US Historic Review for Intravenous Immunoglobulin
with Annual Revenue Figures in US$ Million for Years 2004
through 2009 (includes corresponding Graph/Chart) III-10

2. CANADA III-11
A.Market Analysis III-11
Outlook III-11
Highest Per Capita Consumption of IVIg III-11
Canadian Blood Services - at the Forefront of Blood
Collection in Canada III-11
Product Launches III-11
Strategic Corporate Development III-12
B.Market Analytics III-13
Table 20: Canadian Recent Past, Current and Future Analysis
for Intravenous Immunoglobulin with Annual Revenue Figures
in US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-13

Table 21: Canadian Historic Review for Intravenous
Immunoglobulin with Annual Revenue Figures in US$ Million
for Years 2004 through 2009 (includes corresponding
Graph/Chart) III-13

3. JAPAN III-14
A.Market Analysis III-14
Outlook III-14
Regulatory Approval III-14
B.Market Analytics III-14
Table 22: Japanese Recent Past, Current and Future Analysis
for Intravenous Immunoglobulin with Annual Revenue Figures
in US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-14

Table 23: Japanese Historic Review for Intravenous
Immunoglobulin with Annual Revenue Figures in US$ Million
for Years 2004 through 2009 (includes corresponding
Graph/Chart) III-15

4. EUROPE III-16
A.Market Analysis III-16
Outlook III-16
Key Statistics III-16
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) III-16

Table 25: European Immunoglobulin (IVIg and SCIg) Per
Capita Consumption in Grams per Thousand Inhabitants (2008 and
2012) (includes corresponding Graph/Chart) III-17
European Sub-Q IVIg Product Approvals III-17
Regulatory Approvals III-17
Strategic Corporate Developments III-18
B.Market Analytics III-20
Table 26: European Recent Past, Current and 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) III-20

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) III-21

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) III-22

4a. FRANCE III-23
A.Market Analysis III-23
Outlook III-23
Research Initiative in France III-23
High-dose Intravenous Immunoglobulin to Offer Respite for
Primary Sjögren’s Syndrome Patients III-23
LFB Group - A Key Player III-23
B.Market Analytics III-24
Table 29: French Recent Past, Current and Future Analysis for
Intravenous Immunoglobulin with Annual Revenue Figures in
US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-24

Table 30: French Historic Review for Intravenous
Immunoglobulin with Annual Revenue Figures in US$ Million
for Years 2004 through 2009 (includes corresponding
Graph/Chart) III-24

4b. GERMANY III-25
A.Market Analysis III-25
Outlook III-25
Biotest AG - A Key Player III-25
B.Market Analytics III-26
Table 31: German Recent Past, Current and Future Analysis for
Intravenous Immunoglobulin with Annual Revenue Figures in
US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-26

Table 32: German Historic Review for Intravenous
Immunoglobulin with Annual Revenue Figures in US$ Million
for Years 2004 through 2009 (includes corresponding
Graph/Chart) III-26

4c. ITALY III-27
A.Market Analysis III-27
Outlook III-27
Kedrion S.p.A. - A Key Player III-27
B.Market Analytics III-28
Table 33: Italian Recent Past, Current and Future Analysis for
Intravenous Immunoglobulin with Annual Revenue Figures in
US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-28

Table 34: Italian Historic Review for Intravenous
Immunoglobulin with Annual Revenue Figures in US$ Million
for Years 2004 through 2009 (includes corresponding
Graph/Chart) III-28

4d. THE UNITED KINGDOM III-29
A.Market Analysis III-29
Outlook III-29
New Concept to Stimulate Plasma Market: Welsh Blood Service
Proposes Sale of Blood Plasma III-29
Regulatory Approval III-29
B.Market Analytics III-30
Table 35: The UK Recent Past, Current and Future Analysis for
Intravenous Immunoglobulin with Annual Revenue Figures in
US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-30

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) III-30

4e. SPAIN III-31
A.Market Analysis III-31
Outlook III-31
Product Launches III-31
Strategic Corporate Development III-31
Grifols, S.A - A Key Player III-32
B.Market Analytics III-33
Table 37: Spanish Recent Past, Current and Future Analysis for
Intravenous Immunoglobulin with Annual Revenue Figures in
US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-33

Table 38: Spanish Historic Review for Intravenous
Immunoglobulin with Annual Revenue Figures in US$ Million
for Years 2004 through 2009 (includes corresponding
Graph/Chart) III-33

4f. REST OF EUROPE III-34
A.Market Analysis III-34
Outlook III-34
Strategic Corporate Development III-34
Octapharma Ag (Switzerland) - A Key Player III-34
B.Market Analytics III-35
Table 39: Rest of Europe Recent Past, Current and Future
Analysis for Intravenous Immunoglobulin with Annual Revenue
Figures in US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-35

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) III-36

5. ASIA-PACIFIC III-37
A.Market Analysis III-37
Outlook III-37
Table 41: Asia-Pacific Market for Immunoglobulin (IVIg and
SCIg) (2005 and 2010): Per Capita Consumption (Grams per
Thousand Inhabitants) (includes corresponding Graph/Chart) III-37
B.Market Analytics III-38
Table 42: Asia-Pacific Recent Past, Current and 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) III-38

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) III-39

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) III-40

5a. AUSTRALIA III-41
A.Market Analysis III-41
Outlook III-41
Overview III-41
Table 45: Australia IVIg Usage by Main Indications (% of
grams used annually) (includes corresponding Graph/Chart) III-41
Revised Criteria for Clinical Use of IVIg in Australia III-42
Australian Blood Product Market - An Overview III-42
Australian Red Cross Blood Service III-42
Strategic Corporate Development III-43
Csl Limited - A Key Player III-43
B.Market Analytics III-44
Table 46: Australian Recent Past, Current and Future Analysis
for Intravenous Immunoglobulin with Annual Revenue Figures
in US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-44

Table 47: Australian Historic Review for Intravenous
Immunoglobulin with Annual Revenue Figures in US$ Million
for Years 2004 through 2009 (includes corresponding
Graph/Chart) III-45

5b. CHINA III-46
A.Market Analysis III-46
Outlook III-46
Overview III-46
Strategic Corporate Development III-46
Select Players III-47
B.Market Analytics III-49
Table 48: Chinese Recent Past, Current and Future Analysis for
Intravenous Immunoglobulin with Annual Revenue Figures in
US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-49

Table 49: Chinese Historic Review for Intravenous
Immunoglobulin with Annual Revenue Figures in US$ Million
for Years 2004 through 2009 (includes corresponding
Graph/Chart) III-50

5c. REST OF ASIA-PACIFIC III-51
A.Market Analysis III-51
Outlook III-51
Indonesia - An Overview III-51
Bharat Serums and Vaccines Ltd (India) - A Key Player III-51
B.Market Analytics III-52
Table 50: Rest of Asia-Pacific Recent Past, Current and Future
Analysis for Intravenous Immunoglobulin with Annual Revenue
Figures in US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-52

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) III-53

6. REST OF WORLD III-54
A.Market Analysis III-54
Outlook III-54
Overview of the Middle East III-54
Iran Attains Self-Sufficiency in Plasma Production III-54
Strategic Corporate Development III-54
Omrix Biopharmaceuticals Ltd (Israel) - A Key Player III-54
B.Market Analytics III-55
Table 52: Rest of World Recent Past, Current and Future
Analysis for Intravenous Immunoglobulin with Annual Revenue
Figures in US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-55

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) III-56


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)

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