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  1. 1. 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.
  2. 2. 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
  3. 3. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND 1. Factor VIII Usage in the past Twenty Five Years
  4. 4. 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
  5. 5. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  6. 6. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  7. 7. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  8. 8. 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
  9. 9. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  10. 10. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  11. 11. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  12. 12. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND The gap between the industrialized and the emerging countries, while remaining significant, somewhat narrowed.
  13. 13. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  14. 14. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  15. 15. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  16. 16. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  17. 17. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND Factor VIII per Capita in Selected Countries 1995 2000 2005 United Kingdom 2.2 4.2 5.2 United States 2.3 3.6 5.2 Italy 1.9 3.2 5.0 Hungary 1.3 3.2 4.4 Japan 0.9 1.9 2.8 Greece 0.7 1.5 1.8 Brazil 0.5 0.8 1.2 Venezuela 0.1 0.5 1.1 Turkey 0.1 0.8 1.1 Mexico 0.0 0.3 0.4 Peru 0.1 0.2 0.2 Egypt 0.0 0.0 0.1 China 0.0 0.0 0.0
  18. 18. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  19. 19. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  20. 20. 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
  21. 21. 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)
  22. 22. Global Factor VIII Market Forecast Average Annual Growth Rate Plasma-derived and Recombinant South America 4.2% North America 2.5% Europe 2.5% Asia & Pacific * 3.9% Middle East & Africa 7.8% World 3.1% Recombinant Factor VIII South 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 VIII South America 4.3% North America 2.5% Europe 1.0% Asia & Pacific * 6.0% Middle East & Africa 7.9% World 3.6%
  23. 23. 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 2015 South America 526.9 579.6 637.5 701.3 North America 1,959.1 2,076.6 2,201.2 2,333.3 Europe 2,680.3 2,841.1 3,011.6 3,192.3 Asia & Pacific 683.0 746.8 816.6 893.2 Middle East & Africa 372.6 439.7 518.8 612.2 World 6,221.9 6,683.8 7,185.8 7,732.3
  24. 24. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  25. 25. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  26. 26. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND Global Factor VIII Market Forecast (Conservative Scenario) (Million International Units) Plasma-derived Factor VIII 2007 2010 2012 2015 South America 486.2 536.4 591.8 652.8 North America 335.5 355.6 377.0 399.6 Europe 997.6 1,023.8 1,048.9 1,072.6 Asia & Pacific 267.0 305.8 349.2 397.8 Middle East & Africa 363.6 429.8 507.9 600.2 World 2,449.9 2,651.5 2,874.8 3,122.9
  27. 27. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  28. 28. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  29. 29. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND Global Factor VIII Market Forecast (Conservative Scenario) (Million International Units) Recombinant Factor VIII 2007 2010 2012 2015 South America 40.7 43.1 45.7 48.5 North America 1,623.6 1,721.0 1,824.3 1,933.7 Europe 1,682.7 1,817.3 1,962.7 2,119.7 Asia & Pacific 416.0 441.0 467.4 495.5 Middle East & Africa 9.0 9.9 10.9 12.0 World 3,772.0 4,032.3 4,311.0 4,609.4
  30. 30. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  31. 31. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  32. 32. 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
  33. 33. 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
  34. 34. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND Worldwide IVIG Requirements (metric tons) 2008 2012 2015 IVIG not approved 82.3 107.9 132.2 IVIG approved 82.3 107.9 151.6 Worldwide Plasma Fractionation Throughput (million liters) 2000 2007 2012 2015 IVIG not approved 22.3 26.5 31.7 33.8 IVIG approved 22.3 26.5 31.7 38.8
  35. 35. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  36. 36. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  37. 37. 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
  38. 38. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND Global Plasma-derived Factor VIII Production (million International Units) 2000 2007 2012 2015 IVIG not approved 2,683 3,185 3,804 4,060 IVIG approved 2,683 3,185 3,804 4,662
  39. 39. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  40. 40. 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 2015 South America 526.9 685.0 890.5 1,157.6 North America 1,959.1 2,115.8 2,285.1 2,467.9 Europe 2,680.3 2,894.7 3,126.3 3,376.4 Asia & Pacific 683.0 887.9 1,154.3 1,500.6 Middle East & Africa 372.6 484.4 629.7 818.6 World 6,221.9 7,067.8 8,085.8 9,321.1
  41. 41. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  42. 42. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND Global Factor VIII Market Forecast (Conservative Scenario) (Million International Units) Plasma-derived Factor VIII 2007 2010 2012 2015 South America 486.2 638.2 836.6 1,095.7 North America 335.5 297.4 248.5 186.9 Europe 997.6 1,010.1 1,015.5 1,012.3 Asia & Pacific 267.0 422.0 632.4 916.1 Middle East & Africa 363.6 474.0 617.8 804.9 World 2,449.9 2,841.7 3,350.8 4,015.9
  43. 43. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  44. 44. 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 61.9 North America 1,623.6 1,818.4 2,036.6 2,281.0 Europe 1,682.7 1,884.6 2,110.8 2,364.1 Asia & Pacific 416.0 465.9 521.8 584.5 Middle East & Africa 9.0 10.4 11.9 13.7 World 3,772.0 4,226.1 4,735.0 5,305.2
  45. 45. TRENDS IN COAGULATION FACTORS SUPPLY AND DEMAND
  46. 46. Global Factor VIII Market Forecast Average Annual Growth Rate Plasma-derived and Recombinant South America 13.8% North America 3.3% Europe 3.3% Asia & Pacific * 13.8% Middle East & Africa 13.8% World 6.4% Recombinant Factor VIII South 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 VIII South America 14.3% North America -7.4% Europe 0.0% Asia & Pacific * 23.4% Middle East & Africa 14.0% World 8.3%
  47. 47. 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.
  48. 48. 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
  49. 49. 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.
  50. 50. 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
  51. 51. 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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