GLOBAL PLASMA SUPPLY AND PRODUCT DEMAND

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!


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%


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%


Total Market $15,222 Million


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)


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


Table of Contents!


2.   Albumin!

3.   Factor VIII!


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


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)


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)


Table of Contents!


2.   Albumin!

3.   Factor VIII!


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


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


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



Table of Contents!


2.   Albumin!

3.   Factor VIII!


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


-

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


-

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


-

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!


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


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


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!

Documents

GLOBAL PLASMA SUPPLY AND PRODUCT DEMAND