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L’UTILIZZO DEI MEDICINALI PLASMADERIVATI IN ITALIA
Istituto Superiore di Sanità 12 maggio 2016, Roma
GLOBAL TRENDS IN PLASMA-DERIVED MEDICINAL PRODUCTS SUPPLY AND
DEMAND
Patrick Robert The Marketing Research Bureau, Inc.
The data used to develop the charts and tables shown in this presentation have been compiled from the Marketing Research Bureau’s database, scientific articles, congress proceedings, companies’ annual reports, publications and statistics published by national and international organizations, as well as by various plasma industry stakeholders, such as patients’ advocacy groups.
SOURCE OF THE DATA
GENERAL INFORMATION
All the data and information come from sources generally available to the public. Their accuracy is not guaranteed, and the Marketing Research Bureau assumes no liability for their use.
The data used to describe the Italian market in this presentation are estimates based on information obtained from various private and public sources, which do not include the Italian Centro Nazionale Sangue and Istituto Superiore di Sanità. Therefore, some of the figures may differ markedly from any report published by these bodies. The data describing the Italian market will be revised by the Marketing Research Bureau if and when new, more accurate data become available from these or other sources.
IMPORTANT NOTE ABOUT THE ITALIAN MARKET DATA
Global Plasma Proteins Market 2014 Sales history & Forecast by Product
Table of Contents
• By Product • By Region and Country • Average Consumption by Country
• IVIG and SCIG (IgG) • Albumin • Factor VIII
Global Plasma Proteins Market 2014 Sales history & Forecast by Product
Table of Contents
• By Product • By Region and Country • Average Consumption by Country
• IVIG and SCIG (IgG) • Albumin • Factor VIII
IVIG + SCIG = 47% of total market, albumin 15%, factor VIII, 9%
THE WORLDWIDE PLASMA PROTEINS MARKET BY PRODUCT - 2014
Hyperimmunes (IM & IV)
5.8%
All Others19.5%
Factor VIII (Plasma Derived)
8.9%
Factor IX & PCC (Plasma Derived)
4.4%
Polyvalent IVIG/SCIG46.9%
Albumin14.5%
Without Recombinant Factors
Total Market $18,514.0 Million
THE WORLDWIDE PLASMA FRACTIONS MARKET BY PRODUCT - 2000
Factor IX (Plasma Derived)
4.4%
Fraction V28.9%
Polyvalent IGIV27.6%
Factor VIII (Plasma Derived)15.4%
All Others (Fibrin glue, ATIII, A1-PI,
etc)14.4%
Hyperimmunes (IM & IV)
9.3%
WITHOUT rFVIIITotal Market $5,100.6 (MM)
IVIG = 28% of total market, albumin 29%, factor VIII 15%
THE WORLDWIDE PLASMA FRACTIONS MARKETBY PRODUCT - 1986
(Without recombinant Factors)
IVIG = 21% of total market, albumin 45%, factor VIII 17%
All Others1.4%
Polyvalent IVIG21.2%
Albumin45.0%
Hyperimmunes (IM & IV)
13.7%
Factor IX (Plasma Derived)
1.9%
Factor VIII (Plasma Derived)16.8%
Total Market $1,853.7 (MM)
9
THE PLASMA PROTEINS MARKET IN EUROPE - 2014MARKET SHARES BY PRODUCTWithout Recombinant Factors
IVIG38%
IMIG/SCIG5%
Albumin9%
Fibrin Glue2%
Factor VIII16%
Hyperimmunes (IM)5%AT III
1%aPCC5%
All Others4%
vW Factor3%
AAT4%
PCC5%
Factor IX3%
Total Market: $5.49 Billion
IVIG + SCIG = 38% of total market, albumin 9%, factor VIII, 16%
10
aPCC5%
Fibrin Sealant4%
Albumin19%
Factor VIII12%
AT III8%
IMIG5%
Hyper IgG5%
All others3%
PCC2%
Factor IX1%
vW Factor2%
IGIV+SCIG34%
Total Market: $644.6 Million
THE PLASMA PROTEINS MARKET IN ITALY - 2014MARKET SHARES BY PRODUCTWithout Recombinant Factors
IVIG + SCIG = 34% of total market, albumin 19%, factor VIII, 12%
Consumption Trends by Product
• Over time, the consumption of polyvalent immune globulins and of several specialty products (C-1 esterase inhibitor, alpha-1 antitrypsin, fibrinogen, prothrombin complex) will increase,
• The use of plasma-derived coagulation factors will continue to shift to low income countries,
• Albumin consumption will grow in Asia, decline in southern Europe, and remain stable or grow moderately in northern Europe.
• These trends will apply to Italy, except for antithrombin III, the use of which may continue to increase.
12
ANTITHROMBIN III AND TETANUS IMMUNOGLOBULININ SELECTED COUNTRIES 2012-2014
Million MillionAT III IUs Population IU/Capita
Japan 204 127 1.6 Italy 145 61.2 2.4 Germany 65.7 82.5 0.8 Sweden 2 9.6 0.2
(000) MillionAnti Tet Vials Population Vials/Capita
Japan 56 127 0.4 Italy 440 61.2 7.2 Germany 335 82.5 4.1 Argentina 332 41.5 8.0
Global Plasma Proteins Market 2014 Sales history & Forecast by Product
Table of Contents
• By Product • By Region and Country • Average Consumption by Country
• IVIG and SCIG (IgG) • Albumin • Factor VIII
World Population by Region - 2013
Europe10.7%
Asia & Pacific57.8%
North America4.8%South America
8.8%
Middle East/Africa17.9%
North America holds 44% of the global market but has only 5% of the world population while Africa and the Middle East together hold 5% of the market with 18% of the world population
THE WORLDWIDE PLASMA PROTEINS MARKET BY REGION - 2014
South America 5.6%
North America 44.3%
Africa 1.2%
Asia & Pacific/Oceania
19.1%
Middle-East3.4%
Europe 26.4%
WITHOUT RECOMBINANT FACTORS
Total Market $18,514.0 Million
15
THE PLASMA PROTEINS MARKET IN EUROPE - 2014TOTAL MARKET BY COUNTRYWithout Recombinant Factors
Spain7.5% Italy
11.7%
Germany28.5%
France15.0%
United Kingdom7.8%
Other Western Europe17.3%
Eastern Europe12.3%
Total Market $5.49 billion
16
THE PLASMA PROTEINS MARKET IN EUROPE - 2014TOTAL MARKET BY COUNTRY
With Recombinant Factors
Spain6.8% Italy
13.4%
Germany25.7%
France16.1%
United Kingdom8.6%
Other Western Europe18.6%
Eastern Europe10.8%
Total Market $8.24 billion
Global Plasma Proteins Market 2014 Sales history & Forecast by Product
Table of Contents
• By Product • By Region and Country • Average Consumption by Country
• IVIG and SCIG (IgG) • Albumin • Factor VIII
1.44.5
7.09.4
5.711.1
8.514.0
27.434.0
50.366.0
52.569.6
51.985.0
28.392.7
62.8127.7
91.6174.0
99.4179.5
99.6200.1
Russia
Brazil
China
Turkey
Japan
Italy
Spain
UK
Germany
France
Australia
Canada
USA
2005 2014
INTRAVENOUS/SUB-CUTANEOUS (IVIG/SCIG) CONSUMPTION BY COUNTRY(Kilograms per Million People)
The IVIG consumption per capita has virtually doubled in many countries between 2005 and 2014
International differences in per capita consumption of IVIG/SCIG can be explained by:
• Number of patients diagnosed and treated, physicians’ awareness and training,
• Use for chronic diseases treatment vs. acute conditions
• Competition from alternative therapies and pharmaceutical drugs
• off-label use and reimbursement of
• Product promotion, brand competition
• Influence of patients advocacy groups
• Most important, funding.
Southern European countries generally use more albumin than northern European countries
118.7147.7
187.5168.0
119.2181.1
117.5189.9
146.1190.0
115.4193.2
172.9197.1
205.6199.1
189.3
216.8223.0
227.7180.0
249.4174.1
258.7247.5
280.3278.9281.5
405.5336.3
299.6337.8
304.9339.6
255.7361.3
273.2522.6
611.5677.9
19.4680.9
Finland
Switzerland
Norway
United Kingdom
Montenegro
Poland
Croatia
Slovakia
Average
Portugal
Germany
Serbia
Denmark
France
Belgium
Spain
Slovenia
Sweden
Austria
Greece
Italy
AVERAGE ALBUMIN USAGE IN EUROPE 2011 - 2014(Kg. per Million Population)
2011 2014
International differences in per capita consumption of albumin can be explained by:
• Medical practice and specific countries’ regulations,
• Epidemiology,
• Limited competition from non plasma-based plasma volume replacement solutions,
• Availability of supply,
• Funding.
22
5.65.7
5.05.8
4.75.8
5.36.1
5.96.4
5.46.6
4.76.8
6.36.9
7.67.5
6.1 7.7
7.27.9
6.68.3
7.38.6
7.38.8
7.99.1
8.19.2
8.39.6
Austria
Slovakia
Switzerland
Average
Denmark
Norway
Poland
France
Belgium
Finland
United Kingdom
Slovenia
Hungary
Italy
Germany
Ireland
Sweden
FACTOR VIII CONSUMPTION PER CAPITA IN EUROPE 2011 & 2014
2014
2011
Plasma-derived & recombinant(International Units/Inhabitant)
In 2014, Italy had the fourth factor VIII per capita consumption ratio in Europe
International differences in factor VIII consumption per capita can be explained by:
• Diagnosis, prophylactic treatment, immune tolerance • Availability of funding • Product promotion, brand competition • Influence of hemophilia patients organizations The new recombinant extended half-life factor products, as well as of monoclonal antibodies and subsequently of gene therapy, will cause a sea-change in hemophilia care in the coming years. Patients in low income countries are likely to benefit from the availability of numerous plasma-derived and recombinant factor products at reduced cost.
Global Plasma Proteins Market 2014 Sales history & Forecast by Product
Table of Contents
• By Product • By Region and Country • Average Consumption by Country
• IVIG and SCIG (IgG) • Albumin • Factor VIII
Compounded Average Growth Rate (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 9.7 15.7 19.727.7
35.5 36.647.4 54.8
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 IVIG/SCIG FROM 1984 TO 2014Metric Tons
2008 2010 20122014
20162018
2020
81.9
102.6115.4
130.5
153.3167.0
180.2
-
20.0
40.0
60.0
80.0
100.0
120.0
140.0
160.0
180.0
200.0
GLOBAL DEMAND FOR POLYVALENT INTRAVENOUS/SUBCUTANEOUS IMMUNE GLOBULIN (IVIG/SCIG)
(Metric Tons) 2008 - 2020
• IVIG & SCIG usage will continue to grow as more patients are diagnosed, new indications are approved and funding becomes available.
• In the low income countries, IVIG is primarily prescribed for acute situations. Patients with chronic conditions need to resort to other treatment modalities.
• By 2020, some 180 tons of IgG is forecasted
FACTORS INFLUENCING THE FUTURE IGG DEMAND
Global Plasma Proteins Market 2014 Sales history & Forecast by Product
Table of Contents
• By Product • By Region and Country • Average Consumption by Country
• IVIG and SCIG (IgG) • Albumin • Factor VIII
CAGR +3.6% per year since 1984 +4.8% per year since 2000
1974
1976
1978
1980
1982
1984
1986
1988
1990
1992
1994
1996
1998
2000
2002
2004
2006
2008
2010
2012
2014
2016
130.0160.0180.0210.0235.0267.1275.7302.6
365.6414.4
1,014.3
845.3
716.3
608.0549.2521.8
450.5433.8405.8427.0455.7439.6
-
200.0
400.0
600.0
800.0
1,000.0
1,200.0
WORLDWIDE ALBUMIN DEMAND 1974 - 2016Metric Tons
2008 2010 2012 2014 2016 2018 2020
549,152608,000
716,300
845,300
1,014,3001,115,730
1,227,303
-
200,000
400,000
600,000
800,000
1,000,000
1,200,000
1,400,000
THE GLOBAL ALBUMIN MARKETFROM 1986 TO 2020
(Kilograms)
• Albumin usage will continue to grow as health care services improve in a growing number of countries, new indications are approved and plasma volume replacement solutions are less popular.
• By 2020, a global consumption of about 1,200 tons of albumin is forecasted.
FACTORS INFLUENCING THE FUTURE ALBUMIN DEMAND
Global Plasma Proteins Market 2014 Sales history & Forecast by Product
Table of Contents
• By Product • By Region and Country • Average Consumption by Country
• IVIG and SCIG (IgG) • Albumin • Factor VIII
5/55
1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014
1,308 1,438 1,481 1,6121,837
2,129
1,878
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
1,308 1,4381,481 1,612 1,8372,129
2,6643,038
3,705 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
6,246
6,905
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%
• The global factor VIII usage will grow at a more modest rate than in the past, particularly in the high income countries, due to the market penetration of extended half-life (EHL) recombinant factor products.
• More patients will have access to plasma-derived clotting factors in low income countries
• By 2020, a global consumption of about 10.5 billion factor
VIII units is forecasted, including 6.2 billion units of recombinant products (standard and EHL).
FACTORS INFLUENCING THE FUTURE FACTOR VIII DEMAND