Global Hemophilia Market Report : 2012 Edition

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Global Hemophilia Market Report--------------------------------------------------

2012

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Executive Summary

With an ever changing technological environment and an unstable economic scenario, many scientific studies are being conductedwhich are leading to the discovery of new coagulation factors, proteins and plasma concentrates used for treating chronic diseases andmedical conditions. The market for hemophilia products has shown continuous growth in the past years growing at a CAGR of around

8.96% during 2006-11 and is projected to expand steadily in the years to come. The occurrence rate of bleeding disorders such ashemophilia is increasing, calling for an increased usage of blood plasma products. The male population of the world is rising and malesare the ones who are worst affected by hemophilia as they carry only one X chromosome. Females are only the carriers of this disease.Furthermore, the increasing expenditure is also responsible for higher utilization of recombinant and plasma derived coagulationfactors. The existing treatments for hemophilia treatment comprise of blood plasma derivatives and recombinant factors.

The leading players in the hemophilia treatment market include: Baxter, Grifols, Pfizer and Novo Nordisk, among others, competingmainly on the basis of product pricing and performance, supply of the products, and continuous offering of new and innovative proteinand blood plasma derivatives. Apart from this, the presence of several players operating at domestic level, emergence of new players,and agreements with government agencies, academic and research institutions make the therapeutic landscape of hemophilia market

fiercely competitive.The key trends in the hemophilia treatment market are the increasing inclination towards prophylaxis, limiting the use of central venousaccess device for prophylactic treatment, development of long-acting Factor VIII and IX, deep penetration of rFVIII products within theemerging markets. The recent developments in the respective field include gene therapy for treating hemophilia B, half life extension of the recombinant coagulation factors, development of 4-factor PCC for reversal of vitamin K antagonist anticoagulant therapy along withrecent approval of ADVATE in China apart from other clinical trials on run. The major factors driving the growth of the industry are theincreasing number of new patients registering themselves for treatment at the hospitals and other healthcare institutions, growing malepopulation, rising expenditure on healthcare globally, and the increased life expectancy for hemophilia patients.

Although this industry has been witnessing an aggressive growth with latest technological advancements, still there are factors like

antibody neutralization and lack of diagnostic facilities leading to improper or late detection of the disease, which are posing acutechallenges in front of every other person falling within the realm of this therapeutic field. The report provides an analysis of the globalhemophilia treatment market. It also discusses the major trends, growth drivers and potential markets. The report presents thecompetitive structure of the industry and profiles major players in the market with a discussion of their key business strategies.

By combining SPSS Inc.’s data integration and analysis capabilities with our relevant findings, we have predicted the future growth of the industry. We employed various significant variables that have an impact on this industry and created regression models with SPSSBase to determine the future direction of the industry. Before deploying the regression model, the relationship between severalindependent or predictor variables and the dependent variable was analyzed using standard SPSS output, including charts, tables andtests.

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Growth of Hemophilia market over last five years

Depending upon the coagulation factor deficiency, thereare different types of hemophilia:

- Type …..: Dominant genus all over the world, which

occurs due to the inability to produce clotting factor …………..occurring in one in …………………..births.…………………………………..

- Type ………: Caused by the lack of clotting factor ……… and is known to affect a large ……………….……………………………………………………………

…………………..

- Hemophilia with ……..: Certain patients developinhibitors against coagulation factor ……………...

………………………………………coagulation factor ……….., a drug manufactured by …………..

Existing Treatments for hemophilia are:

- Blood Plasma derivatives:………………..

- Recombinant factors: ……………………..

The global hemophilia treatment market revenues havebeen moving on an aggressive growth path,………………..………………….

The global hemophilia market growth of about …………%was observed in 2011 over …………………………………..………………………………………

2006 2007 2008 2009 2010 2011

U S $

B i l l i o n

Number of Patients by Hemophilia Type (2011)

Global Hemophilia Treatment Market Revenues (2006-2011)



Latest technological advancements driving Market growth

The recombinant FVIII market showed a rising trend due to itswide acceptance over ………………………………………………...………………………….………………growth of roughly…………

………..%over a period…………………US$..... ……………billion………………….. to US$....... …..billion in 2011.

The global treatment market for hemophilia B was worthUS$......... bil lion in 2010. As a whole, ………………….……..%…………………………………………………………………………..………………………………………………… ..

Out of the total hemophilia treatment market size, somewherearound US$....billion of sales …………..……………………………

…witnessed an increase of ……% from US$.... billion in…………………………………………………………………………

…………….

Annual Global Sales of NovoSeven (2007-2011)Global Recombinant FIX Market Size (2006-2011)

)

Global Recombinant FVIII Market Revenues (2005-2011)

)

2006 2007 2008 2009 2010 2011

U S $ B i l l i o n

2005 2006 2007 2008 2009 2010 2011

U S $ B i l l i o n

2007 2008 2009 2010 2011

U S $ B i l l i o n



competitive………….

• Males predominantly suffer with hemophilia as they have only single X chromosome in the pair of somatic chromosomes. Theglobal male population ……………………………………………………………………………………………………………………..

• The ongoing trends in the hemophilia market are …………………………………………………………………………………………….

• Industry developments include gene therapy development for treating hemophilia B, development of ……….PCC for reversal of

vitamin K ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………..

• The major factors driving the industrial growth are rising male population, ………, increasing ………………………………………

………………………………………………………………………………………………………..

• The key players of the industry are …………………………………………………………………………………………………..

• The global hemophil ia market is forecasted to be US$........bil lion for the year 2012 as compared to US$........bil lion in 2011,registering a minute increase of roughly….%. ………………………………………………………………………………………………….……………………………………………………………………………… .

Note: Market attractiveness is inverse of penetration. Low penetration means high attractiveness and vice-versa

12 years &under

13-17years

18-21years

Over 22years

%

2 0 0 5

2 0 0 6

2 0 0 7

2 0 0 8

2 0 0 9

2 0 1 0

2 0 1 1

2 0 1 2 F

2 0 1 3 F

2 0 1 4 F

B i l l i o n

Use of Prophylaxis in Different Age Brackets (2011) Global Male Population (2005-2014F)



Table of Contents

1. Hemophilia: An Overview

2. Market Overview2.1 Global Hemophilia Market

Market ValueNo. of Patients

2.2 Global Hemophilia Market by Type2.2.1 Hemophilia AMarket CharacteristicsMarket SizeKey Products2.2.2 Hemophilia BMarket Characteristics

Market SizeKey Products2.2.3 Hemophilia with Inhibitor

2.3 Global Hemophilia Therapeutics Market by Region2.3.1 AustraliaMarket OverviewVolume of PatientsDemand of Plasma Derived Factor IXDemand of Recombinant Factor IX

2.3.2 The USMarket OverviewPlasma Derived rFVIII Market ShareDistribution Growth of FVIII productsNew Patient Registrations

3. Hemophilia Market Dynamics3.1 Key Trends3.1.1 Inclination towards Prophylaxis3.1.2 Abated Use of Central Venous Access Device for

Prophylactic

List of Graphs & Tables

List of Graphs

Number of Patients by Hemophilia Type (2010)Global Hemophilia Treatment Market Revenues (2006-2011)

Global Hemophilia A Market Size (2010-2016F)Global Recombinant FVIII Market Revenues (2005-2011)Global Hemophilia B Market Size (2010-2016F)Global Recombinant FIX Market Size (2006-2011) Annual Global Sales of NovoSeven (2007-2011)Quarterly Sales of Novoseven (Q109-Q112)Major Clotting Disorders, by Volume of Patients Requiring Treatment(2010)Demand of Plasma Derived Factor IX in Australia (2007-2010)Demand of Recombinant Factor IX in Australia (2007-2010)The US Plasma Derived FVIII Market Share by Companies (2010)Distribution Growth of rFVIII products in the US (Nov 2010-Nov 2011)Use of Prophylaxis in Different Age Brackets (2011)Global Male Population (2005-2014F)Novo Nordisk Revenue Share by Business Segments (2011)Novo Nordisk Revenues & Net Income (2008-2011)Baxter’s Revenue by Business Segments (2011)

Baxter’s Revenues and Net Income (2008-2011)Grifols Revenue Share by Business Segments (2011)Grifols Revenues & Profits (2008-2011)Pfizer’s Revenue Share by Business Segments (2011)

Pfizer’s Revenues & Net Income (2008-2011)Global Hemophilia Treatment Market Forecast (2010-2014F)

List of Tables

Market Characteristics for Hemophilia A Treatments (2010)Revenues of Key Products in Hemophilia A Treatment Market (2010 &2016F)Products for Hemophilia A Treatment

Market Characteristics for Hemophilia B Treatments (2010)

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3.1.3 Long-Acting Factor VIII and IX Development3.1.4 Growing Penetration of rFVIII Products in Emerging Markets –Opportunity for Manufacturers

3.2 Industry Developments3.2.1 Innovative Gene Therapy for Treating Heamophilia B

3.2.2 Extended Half Life of the Recombinant Coagulation Factors3.2.3 Development of 4-factor PCC for Reversal of Vitamin K Antagonist Anticoagulant Therapy3.2.4 Approval of ADVATE in China3.2.5 Baxter’s Phase I Clinical Trial of Treatment for Hemophilia A

3.3 Growth Drivers3.3.1 Increasing New Patient Registration3.3.2 Rising Male Population3.3.3 Increasing Expenditure on Healthcare

3.3.4 Increasing Life Expectancy for Hemophilia Patients

3.4 Challenges3.4.1 Risk of Antibody Neutralization3.4.2 Misdiagnosis of the Disease

4. Hemophilia Market - Competitive ScenarioCompetition in Hemophilia A MarketCompetition in Hemophilia B Market

5. Company Profiles5.1 Novo NordiskBusiness DescriptionKey FinancialsBusiness StrategiesFocus on Hormone TherapyEstablish Leadership Position

5.2 Baxter InternationalBusiness Description

Key Financials

Revenues of Key products in Hemophilia B Treatment Market (2010 &2016F)Products for Treatment of Hemophilia BNew Patient Registrations in the US Bleeding Disorders Market (1998-2013E)Growth in the New Patient Registrations in the US (2009-2013E)

Treatment of Hemophilia B Patients registered at CDC, the US (December 2011)Long Acting FIX & FVIII under Late-Stage Development% Conversion to Recombinant Factor VIII Products in Selected Countries(2010)Reduction in the Number of Injections required by using Half-LifeExtensionExtended Half Life rFVIII AgentsExtended Half Life rFIX AgentsNew Patient Registrations in Worldwide Bleeding Disorders Market (2008-

2013E)Viral Infection Rates among Hemophiliacs (by Disease Type)Competition in Hemophilia A Market – Emerging ProductsCompetition in Hemophilia B Market – Emerging ProductsDependent & Independent Variables (2006-2011)Correlation MatrixModel Summary – Coefficient of DeterminationRegression Coefficients Output

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Business StrategiesFocus on Investment in Research & Development Achieving Growth through Sustainable Development

5.3 GrifolsBusiness DescriptionKey FinancialsBusiness StrategiesExpansion in Other Geographic RegionsGrowth through Mergers & Acquisitions

5.4 Pfizer, Inc.Business DescriptionKey FinancialsBusiness StrategiesFocus on GrowthStrategic Acquisitions

6. Market Outlook6.1 Market Forecast

6.2 Forecast Methodology

6.2.1 Dependent and Independent Variables6.2.2 Correlation Analysis6.2.3 Regression Analysis

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Global Hemophilia Market Report : 2012 Edition