GLOBAL TRENDS IN PLASMA-DERIVED MEDICINAL PRODUCTS … · 2018-06-28 · 12 maggio 2016, Roma...

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

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%


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%


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


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


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


Table of Contents



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


Table of Contents



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.


Table of Contents



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


Table of Contents



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


Table of Contents



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


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


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

Thank you

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GLOBAL TRENDS IN PLASMA-DERIVED MEDICINAL PRODUCTS … · 2018-06-28 · 12 maggio 2016, Roma...

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