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GLOBAL PLASMA SUPPLY AND!PRODUCT DEMAND!
IPFA/BCA Global Symposium on !The Future for Blood and Plasma Donations!
Sacramento, CA!23-24 September 2014!
Patrick Robert!The Marketing Research Bureau, Inc.!
The data used to develop the charts and tables shown in this presentation have been compiled from surveys conducted by the Marketing Research Bureau in some fifty countries, and published in various syndicated reports.!
All the data and information originate from sources generally available to the public. Their accuracy is not guaranteed, and the Marketing Research Bureau assumes no liability for their use. © 2014!
METHODOLOGY!
• Market Overview!• Plasma Products Demand!• Plasma Fractionation Projection!• Plasma Supply!
Table of Contents!
• Market Overview!• Plasma Products Demand!• Plasma Fractionation Projection!• Plasma Supply!
Table of Contents!
THE WORLDWIDE PLASMA PROTEINS MARKET BY PRODUCT - 2012
Hyperimmunes (IM & IV)
3.8%
All Others22.2%
Factor VIII (Plasma Derived)10.6%
Factor IX (Plasma Derived)
2.5%
Polyvalent IVIG/SCIG47.6%
Albumin13.3%
WITHOUT RECOMBINANT FACTORS
Total Market $15,222 Million
THE WORLDWIDE PLASMA PROTEINS MARKET BY COMPANY - 2012
All Others 9.2%
Baxter22.3%
CSL Behring22.6%
Mitsubishi/Benesis1.4%
Kedrion3.8%
Non-Profit Organizations 11.0%
Octapharma7.1%
Biotest3.0%
Grifols19.6%
WITHOUT RECOMBINANT FACTORS
Total Market 15,222.4 Million
THE WORLDWIDE PLASMA PROTEINS MARKET BY REGION - 2012
South America 5.5%
North America 43.2%
Africa 1.1%
Asia & Pacific14.2%
Middle-East3.3%
Europe 30.8%
Oceania 1.9%
WITHOUT RECOMBINANT FACTORS
Total Market $15,222 Million
• Market Overview!• Plasma Products Demand!• Plasma Fractionation Projection!• Plasma Supply!
Table of Contents!
• Market Overview!• Plasma Products Demand!
Table of Contents!
1. IV/Subcutaneous Immune Globulin (IVIG/SCIG)!
2. Albumin!
3. Factor VIII!
4. Market Drivers!
CAGR!+10.2% per year since 1984!+7.9% per year since 2000!
1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014
7.4 8.9 9.715.7 19.7
27.735.5 36.6
47.454.8
63.473.2
83.2
106.9
123.9
143.6
0.0
20.0
40.0
60.0
80.0
100.0
120.0
140.0
160.0
WORLDWIDE DEMAND FOR INTRAVENOUS & SUBCUTANEOUS IMMUNE GLOBULIN (IVIG/SCIG) 1984 - 2014
Metric Tons
2008 2010 2012 2014 2016 2018 2020
81.9102.6 115.4
133.7155.0
179.8
208.7
-
50.0
100.0
150.0
200.0
250.0
GLOBAL DEMAND FOR POLYVALENT INTRAVENOUS/SUBCUTANEOUS IMMUNE GLOBULIN (IVIG/SCIG)
(Metric Tons) 2008 - 2020
Global annual growth 2012-‐20: 7.7%
-
20,000
40,000
60,000
80,000
100,000
120,000
1986 1988 1990 1992 1994 1996 1998 2000 2003 2005 2008 2010 2012 2014 2016 2018 2020
South America North America Europe Asia & Pacific Middle East & Africa Oceania
THE POLYVALENT IVIG MARKET BY REGIONFROM 1986 TO 2020 (Est.)
(Kilograms)
Global annual growth 2012-‐20: 7.7%
THE IV/SCIG MARKET BY MEDICAL SPECIALTY IN THE UNITED STATES
2012 AND 2017 (Percentages)
41% 41%
28% 29%
16% 13%
5%8%
3%3%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2012 2017
Pulmonology/Cardiology
Ophthalmology
Obstetrics/Neonatology
Infectious Diseases
Rheumatology/Nephrology
Dermatology
Transplant
Hematology/Oncology
Allergy/Immunology
Neurology
• Market Overview!• Plasma Products Demand!
Table of Contents!
1. IV/Subcutaneous Immune Globulin (IVIG/SCIG)!
2. Albumin!
3. Factor VIII!
4. Market Drivers!
1984
1986
1988
1990
1992
1994
1996
1998
2000
2002
2004
2006
2008
2010
2012
2014
267.1275.7302.6365.6
414.4439.6455.7427.0
405.8433.8450.5521.8549.2
608.0
716.3780.1
0.0
100.0
200.0
300.0
400.0
500.0
600.0
700.0
800.0
WORLDWIDE ALBUMIN DEMAND 1984 - 2014Metric Tons
CAGR!+3.6% per year since 1984!+4.8% per year since 2000!
2008 2010 2012 2014 2016 2018 2020
549.2611.9 665.3
736.7816.6
906.0
1006.2
0.0
200.0
400.0
600.0
800.0
1000.0
1200.0
THE GLOBAL ALBUMIN MARKETFROM 1986 TO 2020
(Metric Tons)
Global annual growth 2012-‐20: 5.3%
Annual Growth Rates Assumptions!• Asia & Pacific + 7%!• South America + 6%!• North America + 4%!• Europe 3%!• Middle East & North Africa 5%!• Oceania 4%!
0
50,000
100,000
150,000
200,000
250,000
300,000
350,000
400,000
450,000
500,000
1986 1988 1990 1992 1994 1996 1998 2000 2003 2005 2008 2010 2012 2014 2016 2018 2020
South America North America Europe Asia & Pacific ME & Africa Oceania
THE ALBUMIN MARKET BY REGIONFROM 1986 TO 2020
(Kilograms)
• Market Overview!• Plasma Products Demand!
Table of Contents!
1. IV/Subcutaneous Immune Globulin (IVIG/SCIG)!
2. Albumin!
3. Factor VIII!
4. Market Drivers!
5/55!
1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014
1,3081,4381,481 1,6121,837
2,1291,878
1,663
2,124 2,1152,375 2,496
2,881
3,319
3,617
3,942
0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
WORLDWIDE DEMAND FOR FACTOR VIII 1984 - 2014Plasma-derived, Million International Units
CAGR!+3.7% per year since 1984!+4.5% per year since 2000!
5/55!
1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014
1,3081,4381,4811,6121,8372,129
2,6643,0383,705 3,963
4,943
6,020
6,908
8,000
8,956
9,760
0
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
10,000
WORLDWIDE DEMAND FOR FACTOR VIII 1984 - 2014Plasma-derived & Recombinant - Million International Units
Total Market Plasma-Derived
CAGR!+6.9% per year since 1984!+7.2% per year since 2000!
THE WORLDWIDE FACTOR VIII MARKETFROM 2008 TO 2020 Est.
(International Units x Million)
2,8813,421
3,759 3,718 3,902 4,102 4,3204,024
4,6935,192 5,241
5,5535,888
6,2466,905
8,114
8,952 8,9599,455
9,99010,566
0
2,000
4,000
6,000
8,000
10,000
12,000
2008 2010 2012 2014 2016 2018 2020
Plasma-derived Recombinant Total Market
Global annual growth 2012-‐20: 2.1%
• Market Overview!• Plasma Products Demand!
Table of Contents!
1. IV/Subcutaneous Immune Globulin (IVIG/SCIG)!
2. Albumin!
3. Factor VIII!
4. Market Drivers!
PLASMA REQUIREMENTS FOR ALBUMIN, FACTOR & IVIG1974 - 2014 - Million Liters
-
5.0
10.0
15.0
20.0
25.0
30.0
1974
1976
1978
1980
1982
1984
1986
1988
1990
1992
1994
1996
1998
2000
2002
2004
2006
2008
2010
2012
2014
Plasma for Albumin
1974
1976
1978
1980
1982
1984
1986
1988
1990
1992
1994
1996
1998
2000
2002
2004
2006
2008
2010
2012
2014
130.0160.0180.0
210.0235.0
267.1275.7302.6
365.6414.4
780.1
716.3
608.0
549.2521.8
450.5433.8405.8
427.0455.7439.6
-
100.0
200.0
300.0
400.0
500.0
600.0
700.0
800.0
WORLDWIDE ALBUMIN DEMAND 1974 - 2014Metric Tons
1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014
1,3081,4381,481 1,6121,837
2,1291,878
1,663
2,124 2,1152,375 2,496
2,881
3,319
3,617
3,942
0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
WORLDWIDE DEMAND FOR FACTOR VIII 1984 - 2014Plasma-derived, Million International Units
PLASMA REQUIREMENTS FOR ALBUMIN, FACTOR & IVIG1974 - 2014 - Million Liters
-
5.0
10.0
15.0
20.0
25.0
30.0
1974
1976
1978
1980
1982
1984
1986
1988
1990
1992
1994
1996
1998
2000
2002
2004
2006
2008
2010
2012
2014
Plasma for Factor VIII
1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014
7.4 8.9 9.715.7 19.7
27.735.5 36.6
47.454.8
63.473.2
83.2
106.9
123.9
143.6
0.0
20.0
40.0
60.0
80.0
100.0
120.0
140.0
160.0
WORLDWIDE DEMAND FOR INTRAVENOUS & SUBCUTANEOUS IMMUNE GLOBULIN (IVIG/SCIG) 1984 - 2014Metric Tons
PLASMA REQUIREMENTS FOR ALBUMIN, FACTOR & IVIG1974 - 2014 - Million Liters
-
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
1974
1976
1978
1980
1982
1984
1986
1988
1990
1992
1994
1996
1998
2000
2002
2004
2006
2008
2010
2012
2014
Plasma for IVIG
PLASMA REQUIREMENTS FOR ALBUMIN, FACTOR & IVIG1974 - 2014 - Million Liters
-
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
1974
1976
1978
1980
1982
1984
1986
1988
1990
1992
1994
1996
1998
2000
2002
2004
2006
2008
2010
2012
2014
Plasma for Albumin Plasma for Factor VIII Plasma for IVIG
• From 1974 to 1980, albumin drove the plasma market because neither factor VIII nor IVIG were available in large quantities. One liter of plasma generated 28 grams of albumin.!
• In 1980, plasma-derived factor VIII became the market driver: its global needs determined the quantity of plasma to fractionate. Its production yield was 150-180 international units per liter of plasma.!
• IVIG took over as the market driver in 2000, and will keep this role in the foreseeable future. Its production yield is about 4.5 grams per liter of plasma.!
Market Drivers!
• Market Overview!• Plasma Products Demand!• Plasma Fractionation Projection!• Plasma Supply!
Table of Contents!
32,590
45,500
55,200
30,332
36,564
46,633
0
10,000
20,000
30,000
40,000
50,000
60,000
2013 2016 2020
Capacity Throughput
CAPACITY AND THROUGHPUT OF THE LARGEST FRACTIONATORS 2013 - 2020
(Thousand Liters)
PLASMA FRACTIONATION CAPACITY BY REGION FROM 2002 TO 2012
(THOUSAND LITERS)
12,95210,887 11,042
12,444
8,140
14,330
2,004 2,376 2,122 2,010 2,160 2,195
20,46218,874
16,489
13,99214,890
11,544
9,44210,292
15,785
8,7507,3246,894
0
5,000
10,000
15,000
20,000
25,000
1999 2002 2004 2007 2010 2012
Europe North America Asia & Pacific All Others
PLASMA FRACTIONATION THROUGHPUT BY REGION FROM 2002 TO 2012
(THOUSAND LITERS)
12,201
8,781
6,898
4,550
1,644 1,338 1,520 1,586 1,634
18,420
16,660
11,63711,03511,700
9,671
7,115
5,0385,726
5,0285,226
02,0004,0006,0008,000
10,00012,00014,00016,00018,00020,000
2002 2004 2007 2010 2012
Europe North America Asia & Pacific All Others
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
2013 2016 2020
CAPACITY OF THE LARGEST FRACTIONATORS 2013 - 2020
GrifolsCLS BehringBaxterOctapharmaKedrionBiotestOthers *
"Others" are LFB and BPL
• Plasma Proteins Market Overview!• Plasma Products Demand!• Plasma Products Supply!• Plasma Supply!
Table of Contents!
TYPE OF PLASMA PROCESSED WORLDWIDE - 1996 TO 2012COMMERCIAL COMPANIES & NON-PROFIT ORGANIZATIONS
(Thousand Liters)
Total in 2012: 36,792,000 Liters
14,925
17,64818,633
16,32818,157
25,583
27,855
7,3988,471 8,060 8,937
7,7688,1698,542
-
5,000
10,000
15,000
20,000
25,000
30,000
1996 1999 2002 2004 2007 2010 2012
Source Plasma Recovered Plasma
Apheresis plasma is increasingly fractionated in all regions!
TYPE OF PLASMA PROCESSED IN EUROPE - 1996 TO 2012NON-PROFIT ORGANIZATIONS
(Thousand Liters)
282
648934
588808
1,069
1,639
3,5503,772
1,1921,499
1,2291,110
1,772
-
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
1996 1999 2002 2004 2007 2010 2012
Source Plasma Recovered Plasma
TYPE OF PLASMA PROCESSED IN ASIA FROM 1996 TO 2012NON-PROFIT ORGANIZATIONS
(Thousand Liters)
755
1,739
1,310 1,375
2,903
1,276
863853613
469738
502398400
-
500
1,000
1,500
2,000
2,500
3,000
3,500
1996 1999 2002 2004 2007 2010 2012
Source Plasma Recovered Plasma *
TYPE OF PLASMA FRACTIONATED IN NORTH AMERICA FROM 1996 TO 2012COMMERCIAL COMPANIES & NON-PROFIT ORGANIZATIONS
(Thousand Liters)
8,097
7,2737,731
5,925
8,396
10,050
1,650
5,308
1,0501,590 1,190670
1,120 1,275
-
2,000
4,000
6,000
8,000
10,000
12,000
1996 1999 2002 2004 2007 2010 2012
Source Plasma Recovered Plasma
Chart 14
• In 2012, a total of about 36.8 million liters of source and recovered plasma were fractionated worldwide - 27.9 million liters of source and 8.9 million liters of recovered.!
• Between 1996 and 2012, on an annual basis (CAGR), the global plasma supply for fractionation has increased by:!
• Approximately 40% to 50% more plasma will be needed in 2020 than in 2013 (50 million liters vs. 36 million)!
Plasma Supply - Conclusion!
Source plasma: 4% per year!Recovered plasma:1.2%!Overall plasma for fractionation: 3.2% !
Thank you!