Sixth WFH Global Forum on the Safety and Supply of Treatment products for bleeding disorders Montréal, Canada, September 24-25, 2009 PROJECTED TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND Patrick Robert The Marketing Research Bureau, Inc.
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Sixth WFH Global Forum on the Safety and
Supply of Treatment products for bleeding
disorders
Montréal, Canada, September 24-25, 2009
PROJECTED TRENDS IN
COAGULATION FACTORS SUPPLY AND DEMAND
Patrick RobertThe Marketing Research Bureau, Inc.
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
1. Factor VIII Usage in the past Twenty Five Years
2. Conservative Forecast of the Global Factor VIII Demand to 2015
3. Forecast of the Global Factor VIII Supply to 2015
4. Aggressive Forecast of the Global Factor VIII Demand to 2015
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
1. Factor VIII Usage in the past Twenty Five Years
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
• In the early 1980’s, hemophilia patients were treated mainly on demand
• The introduction of recombinant factor VIII (rFVIII) in 1993 opened a new era in hemophilia treatment. Many patients switched to rFVIII. Prophylaxis and Immune Tolerance began to be accepted
• The market growth occurred primarily in the industrialized countries, although purchases by governments in emerging markets also contributed to the higher demand
• The global volume of factor VIII concentrate used increased from 1.3 billion units in 1984 to 3.7 billion units in 2000 and 6.2 billion units in 2007
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
1,322
1,455 1,503
1,636
1,867 1,869 1,878
1,689
2,1242,068
2,190
2,450
-
500
1,000
1,500
2,000
2,500
1984 1986 1988 1990 1992 1994 1996 1998 2000 2003 2005 2007
THE WORLDWIDE FACTOR VIII MARKET - PLASMA-DERIVEDFROM 1984 TO 2007 (International Units x MM)
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
-
260
786
1,349
1,581
2,158
3,135
3,772
-
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
1992 1994 1996 1998 2000 2003 2005 2007
THE WORLDWIDE FACTOR VIII MARKET - RECOMBINANTFROM 1992 TO 2007 (International Units x MM)
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
1,322
-
1,455
-
1,503
-
1,636
-
1,8672,129
2,664
3,038
3,705
4,226
5,325
6,222
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
1984 1986 1988 1990 1992 1994 1996 1998 2000 2003 2005 2007
THE WORLDWIDE FACTOR VIII MARKET - PLASMA-DERIVED AND RECOMBINANT FROM 1984 TO 2007 (International Units x MM)
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
• The most populous regions, which were underserved in the 1980’s, gradually enjoyed a better access to clotting factors.
• Recombinant factor VIII usage grew faster in Europe and North America, while the other regions used almost exclusively plasma-derived factor VIII
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
GLOBAL FACTOR VIII CONSUMPTION BY REGION FROM 1984 TO 2007PLASMA-DERIVED AND RECOMBINANT
(International Units x 1,000)
-
500
1,000
1,500
2,000
2,500
3,000
1984 1986 1988 1990 1992 1994 1996 1998 2000 2003 2005 2007
South America
North America
Europe
Asia & Pacific
Middle East &Africa
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
GLOBAL FACTOR VIII CONSUMPTION BY REGION FROM 1984 TO 2007RECOMBINANT
(International Units x 1,000)
-
200
400
600
800
1,000
1,200
1,400
1,600
1,800
1994 1996 1998 2000 2003 2005 2007
RoW
North America
Europe
Asia & Pacific
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
GLOBAL FACTOR VIII CONSUMPTION BY REGION FROM 1984 TO 2007PLASMA-DERIVED
(International Units x 1,000)
-
200
400
600
800
1,000
1,200
1984 1986 1988 1990 1992 1994 1996 1998 2000 2003 2005 2007
South America
North America
Europe
Asia & Pacific
Middle East &Africa
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
The gap between the industrialized and the emerging countries, while remaining significant, somewhat narrowed.
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
World Population by Region - 1984
Europe14.8%
Asia & Pacific57.9%
North America5.5%
South America8.3%
Middle East & Africa13.5%
Factor VIII Consumption (International Units) - 1984
Europe44.1%
Asia & Pacific10.5%
South America1.4%
North America43.0%
Middle East & Africa1.1%
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
World Population by Region - 1990
Europe13.7%
Asia & Pacific58.2%
Middle East & Africa14.4%South America
8.4%
North America5.3%
Factor VIII Consumption (International Units) - 1990
North America36.6%
South America2.9% Asia & Pacific
12.2%
Europe45.8%
Middle East & Africa2.5%
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
World Population by Region - 2002
Europe11.7%
Asia & Pacific58.2%
Middle East & Africa16.3%South America
8.6%
North America5.1%
Factor VIII Consumption (International Units) - 2003
North America33.9%
South America5.9% Asia & Pacific
12.5%
Europe41.7%
Middle East & Africa6.0%
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
World Population by Region - 2007
Europe10.8%
Asia & Pacific58.1%
North America5.0%
South America8.7%
Middle East & Africa17.4%
Factor VIII Consumption (International Units) - 2007
Middle East & Africa6.0%
Europe43.1%
Asia & Pacific11.0%
South America8.5%
North America31.5%
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
Factor VIII per Capita in Selected Countries
1995 2000 2005United Kingdom 2.2 4.2 5.2United States 2.3 3.6 5.2Italy 1.9 3.2 5.0Hungary 1.3 3.2 4.4Japan 0.9 1.9 2.8Greece 0.7 1.5 1.8Brazil 0.5 0.8 1.2Venezuela 0.1 0.5 1.1Turkey 0.1 0.8 1.1Mexico 0.0 0.3 0.4Peru 0.1 0.2 0.2Egypt 0.0 0.0 0.1China 0.0 0.0 0.0
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
-
1.0
2.0
3.0
4.0
5.0
6.0
UnitedKingdom
UnitedStates
Italy Hungary Japan Greece Brazil Venezuela Turkey Mexico Peru Egypt China
1995
2000
2005
FACTOR VIII CONSUMPTION PER CAPITA IN SELECTED COUNTRIES1995 - 2000 - 2005
1995 2000 2005
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
FACTOR VIII CONSUMPTION IN SELECTED COUNTRIES(International Units from 1995 to 2005)
- 100 200 300 400 500 600
Pakistan
Indonesia
Costa Rica
Thailand
Egypt
Peru
India
Greece
Venezuela
Hungary
Mexico
China
Turkey
Spain
Brazil
Italy
United Kingdom
Japan
Germany
1995 2000 2005
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
1. Factor VIII Usage in the past Twenty Five Years
2. Conservative Forecast of the Global Factor VIII Demand to 2015
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
This Forecast extrapolates the usage trends observed in each region in the past eight years.
The specific conditions of each geographical area are taken into account (access to care, availability of funding, preference for plasma-derived or recombinant product, etc)
Global Factor VIII Market Forecast Average Annual Growth Rate
Plasma-derived and RecombinantSouth America 4.2%North America 2.5%Europe 2.5%Asia & Pacific * 3.9%Middle East & Africa 7.8%World 3.1%
Recombinant Factor VIIISouth America 2.5%North America 2.5%Europe 3.3%Asia & Pacific * 2.5%Middle East & Africa 4.2%World 2.9%
Plasma-derived Factor VIIISouth America 4.3%North America 2.5%Europe 1.0%Asia & Pacific * 6.0%Middle East & Africa 7.9%World 3.6%
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
Global Factor VIII Market Forecast (Conservative Scenario)(Million International Units)
Plasma-derived and Recombinant Factor VIII
2007 2010 2012 2015South America 526.9 579.6 637.5 701.3North America 1,959.1 2,076.6 2,201.2 2,333.3Europe 2,680.3 2,841.1 3,011.6 3,192.3Asia & Pacific 683.0 746.8 816.6 893.2Middle East & Africa 372.6 439.7 518.8 612.2World 6,221.9 6,683.8 7,185.8 7,732.3
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
1,322
-
1,455
-
1,503
-
1,636
-
1,8672,129
2,664
3,038
3,705
4,226
5,325
6,222
6,684
7,186
7,732
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
1984 1986 1988 1990 1992 1994 1996 1998 2000 2003 2005 2007 2010 2012 2015
THE WORLDWIDE FACTOR VIII MARKET - PLASMA-DERIVED AND RECOMBINANT FROM 1984 TO 2015 (International Units x MM)
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
GLOBAL FACTOR VIII CONSUMPTION BY REGION FROM 1984 TO 2015PLASMA-DERIVED AND RECOMBINANT
(International Units x 1,000)
-
500
1,000
1,500
2,000
2,500
3,000
3,500
1984 1986 1988 1990 1992 1994 1996 1998 2000 2003 2005 2007 2010 2012 2015
South America
North America
Europe
Asia & Pacific
Middle East &Africa
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
Global Factor VIII Market Forecast (Conservative Scenario)(Million International Units)
Plasma-derived Factor VIII
2007 2010 2012 2015South America 486.2 536.4 591.8 652.8North America 335.5 355.6 377.0 399.6Europe 997.6 1,023.8 1,048.9 1,072.6Asia & Pacific 267.0 305.8 349.2 397.8Middle East & Africa 363.6 429.8 507.9 600.2World 2,449.9 2,651.5 2,874.8 3,122.9
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
1,322
1,455 1,5031,636
1,867 1,869 1,8781,689
2,124 2,0682,190
2,4502,651
2,875
3,123
-
500
1,000
1,500
2,000
2,500
3,000
3,500
1984 1986 1988 1990 1992 1994 1996 1998 2000 2003 2005 2007 2010 2012 2015
THE WORLDWIDE FACTOR VIII MARKET - PLASMA-DERIVED FROM 1984 TO 2015 (International Units x MM)
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
GLOBAL FACTOR VIII CONSUMPTION BY REGION FROM 1984 TO 2015PLASMA-DERIVED
(International Units x 1,000)
-
200
400
600
800
1,000
1,200
1984 1986 1988 1990 1992 1994 1996 1998 2000 2003 2005 2007 2010 2012 2015
South America
North America
Europe
Asia & Pacific
Middle East &Africa
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
Global Factor VIII Market Forecast (Conservative Scenario)(Million International Units)
Recombinant Factor VIII
2007 2010 2012 2015South America 40.7 43.1 45.7 48.5North America 1,623.6 1,721.0 1,824.3 1,933.7Europe 1,682.7 1,817.3 1,962.7 2,119.7Asia & Pacific 416.0 441.0 467.4 495.5Middle East & Africa 9.0 9.9 10.9 12.0World 3,772.0 4,032.3 4,311.0 4,609.4
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
-
260
786
1,349
1,581
2,158
3,135
3,772
4,032
4,311
4,609
-
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
4,500
5,000
1992 1994 1996 1998 2000 2003 2005 2007 2010 2012 2015
THE WORLDWIDE FACTOR VIII MARKET - RECOMBINANTFROM 1992 TO 2015 (International Units x MM)
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
GLOBAL FACTOR VIII CONSUMPTION BY REGION FROM 1984 TO 2015RECOMBINANT
(International Units x 1,000)
-
500
1,000
1,500
2,000
2,500
1994 1996 1998 2000 2003 2005 2007 2010 2012 2015
RoW
North America
Europe
Asia & Pacific
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
1. Factor VIII Usage in the past Twenty Five Years
2. Conservative Forecast of the Global Factor VIII Demand to 2015
3. Forecast of the Global Factor VIII Supply to 2015
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
• The expected approval of IVIG for the treatment for Alzheimer’s disease is likely to cause a demand surge
• Additional quantities of plasma will need to be processed.
• Larger quantities of factor VIII will be generated from the fractionation process
• By 2015, the full impact of this new situation will be felt
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
Worldwide IVIG Requirements (metric tons)
2008 2012 2015IVIG not approved 82.3 107.9 132.2IVIG approved 82.3 107.9 151.6
Worldwide Plasma Fractionation Throughput (million liters)
2000 2007 2012 2015IVIG not approved 22.3 26.5 31.7 33.8IVIG approved 22.3 26.5 31.7 38.8
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
100.8 107.9120.8
135.3
151.6
68.0 75.282.3
88.1 94.2100.8
107.9115.4
123.5132.2
0.0
20.0
40.0
60.0
80.0
100.0
120.0
140.0
160.0
GLOBAL DEMAND FOR POLYVALENT INTRAVENOUS IMMUNEGLOBULIN (IVIG) WITH/WITHOUT ALZHEIMER TREATMENT APPROVAL
FROM 2006 TO 2016 (Metric Tons)
Alzheimer not Approved Alzheimer Approved
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
PLASMA FRACTIONATED WORLDWIDE FROM 1984 TO 2015 (Thousand Liters, source & recovered)
-
5,000
10,000
15,000
20,000
25,000
30,000
35,000
40,000
45,000
1984 1986 1988 1990 1992 1994 1996 1998 2000 2003 2005 2007 2010 2012 2015
IVIG not approved IVIG approved
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
1. Factor VIII Usage in the past Twenty Five Years
2. Conservative Forecast of the Global Factor VIII Demand to 2015
3. Forecast of the Global Factor VIII Supply to 2015
4. Aggressive Forecast of the Global Factor VIII Demand to 201
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
Global Plasma-derived Factor VIII Production(million International Units)
2000 2007 2012 2015IVIG not approved 2,683 3,185 3,804 4,060IVIG approved 2,683 3,185 3,804 4,662
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
GLOBAL FACTOR VIII PRODUCTION FROM 1984 TO 2015 (Million International Units)
-
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
4,500
5,000
1984 1986 1988 1990 1992 1994 1996 1998 2000 2003 2005 2007 2010 2012 2015
IVIG not approved IVIG approved
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
Global Factor VIII Market Forecast (Conservative Scenario)(Million International Units)
Plasma-derived and Recombinant Factor VIII
2007 2010 2012 2015South America 526.9 685.0 890.5 1,157.6North America 1,959.1 2,115.8 2,285.1 2,467.9Europe 2,680.3 2,894.7 3,126.3 3,376.4Asia & Pacific 683.0 887.9 1,154.3 1,500.6Middle East & Africa 372.6 484.4 629.7 818.6World 6,221.9 7,067.8 8,085.8 9,321.1
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
1,321.8
-
1,455.0
-
1,502.7
-
1,636.1
-
1,867.3
2,129
2,664
3,038
3,705
4,226
5,325
6,222
7,068
8,086
9,321
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
10,000
1984 1986 1988 1990 1992 1994 1996 1998 2000 2003 2005 2007 2010 2012 2015
THE WORLDWIDE FACTOR VIII MARKET - PLASMA-DERIVED AND RECOMBINANT FROM 1984 TO 2015 - AGGRESSIVE SCENARIO (International
Units x MM)
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
Global Factor VIII Market Forecast (Conservative Scenario)(Million International Units)
Plasma-derived Factor VIII
2007 2010 2012 2015South America 486.2 638.2 836.6 1,095.7North America 335.5 297.4 248.5 186.9Europe 997.6 1,010.1 1,015.5 1,012.3Asia & Pacific 267.0 422.0 632.4 916.1Middle East & Africa 363.6 474.0 617.8 804.9World 2,449.9 2,841.7 3,350.8 4,015.9
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
1,3221,455 1,503
1,636
1,867 1,869 1,8781,689
2,124 2,0682,190
2,450
2,842
3,351
4,016
-
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
4,500
1984 1986 1988 1990 1992 1994 1996 1998 2000 2003 2005 2007 2010 2012 2015
THE WORLDWIDE FACTOR VIII MARKET - PLASMA-DERIVED FROM 1984 TO 2015 - AGGRESSIVE SCENARIO (International Units x MM)
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
Global Factor VIII Market Forecast (Conservative Scenario)(Million International Units)
Recombinant Factor VIII (Best Guess)
2007 2010 2012 2015
South America 40.7 46.8 53.8 61.9North America 1,623.6 1,818.4 2,036.6 2,281.0Europe 1,682.7 1,884.6 2,110.8 2,364.1Asia & Pacific 416.0 465.9 521.8 584.5Middle East & Africa 9.0 10.4 11.9 13.7World 3,772.0 4,226.1 4,735.0 5,305.2
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
-
260
786
1,3491,581
2,158
3,135
3,772
4,226
4,735
5,305
-
1,000
2,000
3,000
4,000
5,000
6,000
1992 1994 1996 1998 2000 2003 2005 2007 2010 2012 2015
THE WORLDWIDE FACTOR VIII MARKET - RECOMBINANTFROM 1992 TO 2015 AGGRESSIVE SCENARIO (International Units x MM)
Global Factor VIII Market Forecast Average Annual Growth Rate
Plasma-derived and RecombinantSouth America 13.8%North America 3.3%Europe 3.3%Asia & Pacific * 13.8%Middle East & Africa 13.8%World 6.4%
Recombinant Factor VIIISouth America 6.5%North America 5.1%Europe 5.1%Asia & Pacific * 5.1%Middle East & Africa 6.4%World 5.1%
Plasma-derived Factor VIIISouth America 14.3%North America -7.4%Europe 0.0%Asia & Pacific * 23.4%Middle East & Africa 14.0%World 8.3%
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
CONCLUSIONS
• By 2015, the global supply of factor VIII (plasma derived and recombinant) is expected to be significantly larger than it is today.
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
CONCLUSIONS
• By 2015, the global supply of factor VIII (plasma derived and recombinant) is expected to be significantly larger than it is today.
• This will facilitate access to care to many hemophilia patients, as well as von Willebrand disease patients, in countries with limited access to clotting factor products so far
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
CONCLUSIONS
• By 2015, the global supply of factor VIII (plasma derived and recombinant) is expected to be significantly larger than it is today.
• This will facilitate access to care to many hemophilia patients, as well as von Willebrand disease patients, in countries with limited access to clotting factor products so far
• More patients will be able to treat prophylactically and immune tolerance induction will be also be facilitated.
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
CONCLUSIONS
• By 2015, the global supply of factor VIII (plasma derived and recombinant) is expected to be significantly larger than it is today.
• This will facilitate access to care to many hemophilia patients, as well as von Willebrand disease patients, in countries with limited access to clotting factor products so far
• More patients will be able to treat prophylactically and immune tolerance induction will be also be facilitated.
• This increase will result from the expected approval of IVIG for Alzheimer’s disease treatment because the surge in IVIG demand will require additional volumes of plasma to be fractionated
TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
CONCLUSIONS
• By 2015, the global supply of factor VIII (plasma derived and recombinant) is expected to be significantly larger than it is today.
• This will facilitate access to care to many hemophilia patients, as well as von Willebrand disease patients, in countries with limited access to clotting factor products so far
• More patients will be able to treat prophylactically and immune tolerance induction will be also be facilitated.
• This increase will result from the expected approval of IVIG for Alzheimer’s disease treatment because the surge in IVIG demand will require additional volumes of plasma to be fractionated
• It will also result from the launch of several new recombinant factor VIII products, although their quantities cannot be predicted. New forms of factor VIII products (longer half-life) will be offered to hemophilia patients
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