Global Intravenous Immunoglobulin (IVIg) Industry

NEW YORK, Sept. 5, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Global Intravenous Immunoglobulin (IVIg) Industry

http://www.reportlinker.com/p01010170/Global-Intravenous-Immunoglobulin-IVIg-Industry.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Blood_Supply,_Tissue_Banking_and_Transplantation

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.

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. 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 &

SCIg, Albumin, Factor VIII (Plasma Derived), Hyperimmunes

(IM&IV), 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 &

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 & 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 BIVGAM™ 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 BIVIgAM™ 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 Biomédicaments 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 & 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 & 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 & 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 & 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 & 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 &

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 & 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 & 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 & 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 & 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 & 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 & 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 & 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 & 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 & 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 & 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 & 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 & 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 & 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)

To order this report: Global Intravenous Immunoglobulin (IVIg) Industry

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