For an Executive Summary of this report please contact ediz.ibrahim@visiongain.com (+44 (0)20 7549 9976) or refer to our website http://www.visiongain.com/Report/1167/Bleeding-Disorders-World-Pharmaceutical-Industry-and-Market-2014-2024

1. Bleeding Disorders: World
Pharmaceutical Industry and Market
2014-2024
©notice
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2. Contents
1. Executive Summary
1.1
What This Report Covers
1.2
Bleeding Disorders: World Pharma Industry and Market Overview 2013-2024
1.3
Chapter Outlines
1.4
Research and Analysis Methods
2. Introduction to Bleeding Disorders
2.1
Understanding Haemostasis and Coagulation
2.1.1 Vascular Spasm
2.1.2 Platelet Activation and Aggregation
2.1.3 Coagulation
2.2
An Introduction to the Bleeding Disorders and Their Treatment
2.2.1 Haemophilia A, B and C
2.2.2 Von Willebrand Disease
2.2.3 Thrombocytopenia
3. The World Pharmaceutical Market for Bleeding Disorders 2014-2024
3.1
The World Pharmaceutical Market for Bleeding Disorders in 2012
3.2
The Bleeding Disorders Pharmaceutical Market: An Overarching Revenue Forecast
2014-2024
3.3
The Pharmaceutical Market by Bleeding Disorder: Comparison of Revenue and Market
Share, 2018 and 2024
3.4
The World Pharmaceutical Market for Bleeding Disorders by Therapeutic Subclass:
Grouped Revenue Forecasts 2014-2024
3.5
Haemophilia A Accounted for Almost 70% of the Market in 2012
3.6
Haemophilia B Will See Increasing Prominence in the Bleeding Disorders Market
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3. Contents
3.7
Thrombocytopenia
3.8
Other Coagulation Factor Deficiencies
3.9
Summary of the Research and Analyses
4. Leading Drugs of the Market for Treating Bleeding Disorders, 20142024
4.1
The Leading Drugs for the Treatment of Bleeding Disorders in 2012
4.2
Leading Bleeding Disorder Drugs: Comparison of Revenue and Market Share, 2018
and 2024
4.3
Leading Bleeding Disorder Drugs: A Grouped Revenue Forecast, 2014-2024
4.4
Advate Will Continue to Dominate the Market
4.5
NovoSeven: Patent Protection Has Expired, But Revenue Generation Remains Strong
4.6
Kogenate: Needle-Free Delivery Makes it an Attractive Option for Patients
4.7
BeneFIX Faces Competition in 2013 – How Will This Affect Revenue?
4.8
FEIBA: The Original Treatment for Disease with Inhibitors
4.9
ReFacto/ Xyntha: Produced Using an Entirely Synthetic Purification Process
4.10
Helixate: Marketing Agreement With Bayer Extends Until 2017
4.11
Nplate: The Leading Product for Thrombocytopenia in 2012
4.12
Alphanate: A Staple Treatment for Bleeding Disorders Since 1978
4.13
Promacta Competes With Nplate, But Which Will Prove Most Successful?
4.14
Promising Compounds in the Developmental Pipeline
4.14.1
Rixubis: The First Recombinant FIX Treatment Factor for Routine Prophylaxis in
Haemophilia B
4.14.2
Eloctate: The First Long-Acting Clotting Factor Therapy for Haemophilia A?
4.14.3
Alprolix: The First Long-Acting Clotting Factor Treatment for Haemophilia B?
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4. Contents
4.14.4
N8-GP: Novo Nordisk’s Long Acting Compound for the Treatment of Haemophilia
A
4.14.5
N9-GP: Novo Nordisk’s Long-Acting Treatment for Haemophilia B
5. The Leading National Pharmaceutical Markets for Bleeding
Disorders, 2014-2024
5.1
The Leading National Markets for Bleeding Disorders: The US Dominates in 2012
5.2
The Leading National Markets: Comparison of Revenue and Market Share, 2018 and
2024
5.3
Leading National Pharmaceutical Markets for Bleeding Disorders: Grouped Revenue
Forecasts, 2014-2024
5.4
The US Will Continue to Dominate the Bleeding Disorders Market Throughout the
Forecast Period
5.5
The EU5: What Prospects There?
5.5.1 Germany Will Remain the Largest of the EU5 Markets
5.5.2 France: Increasing Uptake of Prophylactic Therapy Will Drive Growth
5.5.3 Italy: The 3rd Largest Market of the EU5
5.5.4 The UK: Well Developed Infrastructure for the Treatment of Bleeding Disorders
5.5.5 Spain: Use of Recombinant Coagulation Factors is Relatively Low At Present
5.6
Japan: Use of Prophylactic Treatment is Lower Than That of the Western World
5.7
China: A Growing Domestic Bleeding Disorders Pharmaceutical Market
5.8
Brazil: Baxter Will Be the Exclusive Provider of Recombinant Therapy for the Next 10
Years
5.9
India: 90% of Patients Are Unable to Afford Treatment Costs
5.10
Russia: Treatment Levels Per Capita Are High
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5. Contents
6. Bleeding Disorders: R&D Pipelines, 2013
6.1
The R&D Pipeline for Bleeding Disorders: An Overview
6.2
Four Candidates Are In Pre-Registration
6.2.1 Novo Nordisk’s NovoEight
6.2.2 Novo Nordisk’s NovoThirteen: Denied Approval by the FDA For the Second Time;
Will It Be Third Time Lucky?
6.2.3 Biogen Idec’s Eloctate: The First Long-Acting Treatment for Haemophilia A?
6.2.4 Biogen Idec’s Alprolix: The First Long-Acting Treatment for Haemophilia B?
6.3
The Phase III Development Pipeline: Novo Nordisk Has a Strong Presence
6.3.1 Novo Nordisk’s N8-GP and N9-GP: Second in Class Treatments?
6.3.2 Baxter’s rFVIIa BI
6.3.3 Octapharma’s Human-cl rhFVIII
6.4
The Phase II/III Development Pipeline: An Abundance of Haemophilia A Treatments
6.4.1 Baxter’s BAX855: Another Long-Acting Haemophilia A Treatment
6.4.2 Baxter has Purchased OBI-1 from Inspiration Biopharmaceuticals
6.5
The Phase I/II Development Pipeline: Gene Therapy for Haemophilia B
6.6
The Phase I Development Pipeline: Offerings From Novo Nordisk and Pfizer
6.6.1 Novo Nordisk’s mAb2021
6.6.2 Pfizer’s PF-05280602
7. Leading Companies of the Bleeding Disorders Pharmaceutical
Market
7.1
The Leading Companies of the Bleeding Disorders Pharmaceutical Market
7.2
Baxter Accounted for Over 30% of the Bleeding Disorders Market in 2012, But Will It
Remain Market Leader?
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6. Contents
7.3
Novo Nordisk: Demonstrating Commitment to Treating Bleeding Disorders
7.4
Bayer: A Limited Product Portfolio?
7.5
Pfizer: Declining Market Share During the Forecast Period?
7.6
CSL Behring Has the largest Portfolio of Bleeding Disorder Drugs
7.7
Grifols Will Have a Declining Market Share
7.8
Amgen: Single Stake in the Bleeding Disorders Market
7.9
Octapharma: Branching Into Recombinant Coagulation Factors
7.10
GSK: Bleeding Disorders Are Not a Main Therapeutic Focus
7.11
Biogen Idec: Market Entry Anticipated in 2014
8. Qualitative Analysis of the Bleeding Disorders Pharmaceutical
Market, 2013-2024
8.1
Strengths and Weaknesses of the Bleeding Disorders Pharmaceutical Market, 2013
8.1.1 Treatment of Bleeding is Essential
8.1.2 The Threat of Generic/Biosimilar Competition is Low
8.1.3 Advances in Technology Have Improved Treatment Options
8.1.4 A Small Patient Population Ultimately Restricts the Market
8.1.5 Emerging National Markets: Patients Often Having Little Access to Treatments
8.1.6 High Barriers to Market Entry
8.1.7 The Burden of Prophylactic Therapy
8.2
The Opportunities and Threats Facing the Market, 2014-2024
8.2.1 Low Switch Rate Among Patients Receiving Treatment for Bleeding Disorders: An
Opportunity and a Threat
8.2.2 Demand for Treatment in the Emerging Markets is Increases, But Are Recombinant
Therapies Too Expensive?
8.2.3 High Barriers to Market Entry Will Limit Competition, But Also Limit Development
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7. Contents
8.3
Social, Technological, Economic and Political Forces Influencing the Bleeding Disorders
Pharmaceutical Market, 2014-2024
8.3.1 Social Factors
8.3.2 Technological Factors
8.3.3 Economic Factors
8.3.4 Political Factors
9. Research Interview
9.1
Interview With Dr Kamran Kamyar, M.D., Medical Manager, AryoGen Biopharma
9.1.1 On the State of the Current Market
9.1.2 On AryoGen’s Presence in the Market
9.1.3 On Important Developments in the Industry
10. Conclusions from Our Study
10.1
The World Pharmaceutical Market for Bleeding Disorders, 2014-2024
10.2
Bleeding Disorders: Leading Products on the Market, 2014-2024
10.3
Leading National Markets for the Bleeding Disorder Pharmaceutical Industry, 2014-
2024
10.4
Trends in that Industry and Market
10.4.1
Bleeding Disorders Are Serious Conditions Requiring Frequent Drug Treatment
10.4.2
The Demand for Drug Treatment Is Increasing
10.4.3
The R&D Pipeline is Well Stocked, But What Does This Mean for the Industry?
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8. Contents
List of Tables
Table 1.1 Currency Exchange Rates
Table 2.1 The Coagulation Factors: Compound Name, Associated Bleeding Disorder and
Bleeding Severity
Table 2.2 Treatment for VWD: Drug, Mechanism of Action and Disease Type
Table 3.1 The World Pharmaceutical Market for Bleeding Disorders by Disorder: Revenues ($m)
and Market Shares (%), 2012
Table 3.2 The Pharmaceutical Market for Bleeding Disorders: Overarching Revenue Forecast
($m), 2013-2024
Table 3.3 The World Market by Bleeding Disorder: Comparison of Revenues ($m) and Market
Shares (%), 2018 and 2024
Table 3.4 The World Market for Bleeding Disorders by Disorder: Grouped Revenue ($m) and
Market Share (%) Forecasts, 2013-2024
Table 3.5 Haemophilia A: Revenue ($m) and Market Share (%) Forecast, 2013-2024
Table 3.6 Haemophilia B: Revenue ($m) and Market Share (%) Forecast, 2013-2024
Table 3.7 Thrombocytopenia: Revenue ($m) and Market Share (%) Forecast, 2013-2024
Table 3.8 Other Coagulation Factor Deficiencies: Revenue ($m) and Market Share (%) Forecast,
2013-2024
Table 4.1 The Leading Drugs of the Bleeding Disorders Pharmaceutical Market: Revenues ($m)
and Market Shares (%), 2012
Table 4.2 The Leading Drugs for the Bleeding Disorders: Comparison of Revenues ($m) and
Market Shares (%), 2018 and 2024
Table 4.3 Leading Drugs: Grouped Revenue Forecasts ($m), 2013-2024
Table 4.4 Advate: Key Facts
Table 4.5 Advate: Revenue ($m) and Market Share (%) Forecast, 2013-2024
Table 4.6 NovoSeven: Key Facts
Table 4.7 NovoSeven: Revenue ($m) and Market Share (%) Forecast, 2013-2024
Table 4.8 Kogenate: Key Facts
Table 4.9 Kogenate: Revenue ($m) and Market Share (%) Forecast, 2013-2024
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9. Contents
Table 4.10 BeneFIX: Key Facts
Table 4.11 BeneFIX: Revenue ($m) and Market Share (%) Forecast, 2013-2024
Table 4.12 FEIBA: Key Facts
Table 4.13 FEIBA: Revenue ($m) and Market Share (%) Forecast, 2013-2024
Table 4.14 ReFacto/ Xyntha: Key Facts
Table 4.15 ReFacto/ Xyntha: Revenue ($m) and Market Share (%) Forecast, 2013-2024
Table 4.16 Helixate: Key Facts
Table 4.17 Helixate: Revenue ($m) and Market Share (%) Forecast, 2013-2024
Table 4.18 Nplate: Key Facts
Table 4.19 Nplate: Revenue ($m) and Market Share (%) Forecast, 2013-2024
Table 4.20 Alphanate: Key Facts
Table 4.21 Alphanate: Revenue ($m) and Market Share (%) Forecast, 2013-2024
Table 4.22 Promacta: Key Facts
Table 4.23 Promacta: Revenue ($m) and Market Share (%) Forecast, 2013-2024
Table 4.24 Rixubis: Key Facts
Table 4.25 Rixubis: Revenue ($m) and Market Share (%) Forecast, 2013-2024
Table 4.26 Eloctate: Key Facts
Table 4.27 Eloctate: Revenue ($m) and Market Share (%) Forecast, 2013-2024
Table 4.28 Alprolix: Key Facts
Table 4.29 Alprolix: Revenue ($m) and Market Share (%) Forecast, 2013-2024
Table 4.30 N8-GP: Key Facts
Table 4.31 N8-GP: Revenue ($m) and Market Share (%) Forecast, 2013-2024
Table 4.32 N9-GP: Key Facts
Table 4.33 N9-GP: Revenue ($m) and Market Share (%) Forecast, 2013-2024
Table 5.1 Leading National Markets for Bleeding Disorders: Revenues ($m) and Market Shares
(%), 2012
Table 5.2 The Leading National Markets: Comparison of Revenues ($m) and Market Shares (%),
2018 and 2024
Table 5.3 The Leading National Markets for Bleeding Disorders: Grouped Revenue Forecasts
($m), 2013-2024
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10. Contents
Table 5.4 The US Bleeding Disorders Market: Revenue ($m) and Market Share (%) Forecast,
2013-2024
Table 5.5 The EU5 Bleeding Disorders Market by Country: Revenue ($m) and Market Share (%)
Forecasts, 2013-2024
Table 5.6 The German Bleeding Disorder Market: Revenue ($m) and Market Share (%) Forecast,
2013-2024
Table 5.7 The French Bleeding Disorders Market: Revenue ($m) and Market Share (%) Forecast,
2013-2024
Table 5.8 The Italian Bleeding Disorders Market: Revenue ($m) and Market Share (%) Forecast,
2013-2024
Table 5.9 The UK Bleeding Disorders Market: Revenue ($m) and Market Share (%) Forecast,
2013-2024
Table 5.10 The Spanish Bleeding Disorders Market: Revenue ($m) and Market Share (%)
Forecast, 2013-2024
Table 5.11 The Japanese Bleeding Disorders Market: Revenue ($m) and Market Share (%)
Forecast, 2013-2024
Table 5.12 The Chinese Bleeding Disorders Market: Revenue ($m) and Market Share (%)
Forecast, 2013-2024
Table 5.13 The Brazilian Bleeding Disorders Market: Revenue ($m) and Market Share (%)
Forecast, 2013-2024
Table 5.14 The Indian Bleeding Disorders Market: Revenue ($m) and Market Share (%) Forecast,
2013-2024
Table 5.15 The Russian Bleeding Disorders Market: Revenue ($m) and Market Share (%)
Forecast, 2013-2024
Table 6.1 Bleeding Disorders: Candidates in Pre-Registration, 2013
Table 6.2 Bleeding Disorders: Candidates in Phase III Development, 2013
Table 6.3 Bleeding Disorders: Candidates in Phase II/III Development, 2013
Table 6.4 Bleeding Disorders: Candidates in Phase I/II Development, 2013
Table 6.5 Bleeding Disorders: Candidates in Phase I Development, 2013
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11. Contents
Table 7.1 The Leading Companies of the Bleeding Disorders Market: Revenues ($m) and Market
Shares (%), 2012
Table 7.2 Baxter: Product Portfolio for Bleeding Disorders, 2013
Table 7.3 Novo Nordisk: Bleeding Disorders Product Portfolio, 2013
Table 7.4 Bayer: Bleeding Disorders Product Portfolio, 2013
Table 7.5 Pfizer: Bleeding Disorders Product Portfolio, 2013
Table 7.6 CSL Behring: Bleeding Disorders Product Portfolio, 2013
Table 7.7 Grifols: Bleeding Disorders Product Portfolio, 2013
Table 7.8 Amgen: Bleeding Disorders Product Portfolio, 2013
Table 7.9 Octapharma: Bleeding Disorders Product Portfolio, 2013
Table 7.10 GlaxoSmithKline: Bleeding Disorders Product Portfolio, 2013
Table 7.11 Biogen Idec: Bleeding Disorders Product Portfolio, 2013
Table 8.1 Strengths and Weaknesses of the Bleeding Disorders Pharmaceutical Market, 2013
Table 8.2 Opportunities and Threats Facing the Bleeding Disorders Pharmaceutical Market,
2013-2024
Table 8.3 Social, Technological, Economic and Political Factors Influencing the Bleeding
Disorders Market (STEP Analysis), 2013-2024
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12. Contents
List of Figures
Figure 2.1 Diagram of the Coagulation Cascade
Figure 3.1 The World Pharmaceutical Market for Bleeding Disorders by Disorder: Market Shares
(%), 2012
Figure 3.2 The Pharmaceutical Market for Bleeding Disorders: Overarching Revenue Forecast
($m), 2013-2024
Figure 3.3 The World Market by Bleeding Disorder: Market Shares (%), 2018
Figure 3.4 The World Market by Bleeding Disorder: Market Shares (%), 2024
Figure 3.5 Haemophilia A: Revenue Forecast ($m), 2013-2024
Figure 3.6 The Haemophilia A Submarket: Driving and Restraining Factors, 2013
Figure 3.7 Haemophilia B: Revenue Forecast ($m), 2013-2024
Figure 3.8 The Haemophilia B Submarket: Driving and Restraining Factors, 2013
Figure 3.9 Thrombocytopenia: Revenue Forecast ($m), 2013-2024
Figure 3.10 The Thrombocytopenia Submarket: Driving and Restraining Factors, 2013
Figure 3.11 Other Coagulation Factor Deficiencies: Revenue Forecast ($m), 2013-2024
Figure 4.1 Leading Drugs of the Bleeding Disorders Pharmaceutical Market: Market Shares (%),
2012
Figure 4.2 Leading Drugs for Bleeding Disorders: Market Shares (%), 2018
Figure 4.3 Leading Drugs for Bleeding Disorders: Market Shares (%), 2024
Figure 4.4 Advate: Revenue Forecast ($m), 2013-2024
Figure 4.5 NovoSeven: Revenue Forecast ($m), 2013-2024
Figure 4.6 Kogenate: Revenue Forecast ($m), 2013-2024
Figure 4.7 BeneFIX: Revenue Forecast ($m), 2013-2024
Figure 4.8 FEIBA: Revenue Forecast ($m), 2013-2024
Figure 4.9 ReFacto/ Xyntha: Revenue Forecast ($m), 2013-2024
Figure 4.10 Helixate: Revenue Forecast ($m), 2013-2024
Figure 4.11 Nplate: Revenue Forecast ($m), 2013-2024
Figure 4.12 Alphanate: Revenue Forecast ($m), 2013-2024
Figure 4.13 Promacta: Revenue Forecast ($m), 2013-2024
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13. Contents
Figure 4.14 Rixubis: Revenue Forecast ($m), 2013-2024
Figure 4.15 Eloctate: Revenue Forecast ($m), 2013-2024
Figure 4.16 Alprolix: Revenue Forecast ($m), 2013-2024
Figure 4.17 N8-GP: Revenue Forecast ($m), 2013-2024
Figure 4.18 N9-GP: Revenue Forecast ($m), 2013-2024
Figure 5.1 Leading National Markets for Bleeding Disorders: Market Share (%), 2012
Figure 5.2 Leading National Markets for Bleeding Disorders: Market Shares (%), 2018
Figure 5.3 Leading National Markets for Bleeding Disorders: Market Share (%), 2024
Figure 5.4 The US Bleeding Disorders Market: Revenue Forecast ($m), 2013-2024
Figure 5.5 The EU5 Bleeding Disorders Market: Revenue Forecast ($m), 2013-2024
Figure 5.6 The German Bleeding Disorders Market: Revenue Forecast ($m), 2013-2024
Figure 5.7 The French Bleeding Disorders Market: Revenue Forecast ($m), 2013-2024
Figure 5.8 The Italian Bleeding Disorders Market: Revenue Forecast ($m), 2013-2024
Figure 5.9 The UK Bleeding Disorders Market: Revenue Forecast ($m), 2013-2024
Figure 5.10 The Spanish Bleeding Disorders Market: Revenue Forecast ($m), 2013-2024
Figure 5.11 The Japanese Bleeding Disorders Market: Revenue Forecast ($m) 2013-2024
Figure 5.12 The Chinese Bleeding Disorders Market: Revenue Forecast ($m), 2013-2024
Figure 5.13 The Brazilian Bleeding Disorders Market: Revenue Forecast ($m), 2013-2024
Figure 5.14 The Indian Bleeding Disorders Market: Revenue Forecast ($m), 2013-2024
Figure 5.15 The Russian Bleeding Disorders Market: Revenue Forecast ($m), 2013-2024
Figure 6.1 Overview of R&D Pipeline for Bleeding Disorders: Candidates Filed for Approval or in
Phase III Trials, 2013
Figure 7.1 Leading Companies of the Bleeding Disorders Market: Market Share (%), 2012
Figure 10.1 The World Market for Bleeding Disorders by Disorder: Comparison of Revenues
($m), 2012-2024
Figure 10.2 Leading Drugs of the Bleeding Disorders Market: Comparison of Revenues ($m),
2012, 2018 and 2024
Figure 10.3 Leading National Markets for Bleeding Disorders: Comparison of Revenues ($m),
2012, 2018 and 2024
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14. Contents
Organisations Mentioned in the Report
Amgen
AryoGen Biopharma
Asklepios Biopharmaceuticals
Baxter
Bayer
Beijing Northland Biotech
Biogen Idec
Brazilian Ministry of Health
Canadian Haemophilia Society
Cangene Corporation
Catalyst Biosciences
Chatham Therapeutics
CSL Behring
Eisai
Empresa Brasileira de Hemoderivadose Biotechnologia
European Medicines Agency (EMA)
Food and Drug Administration (US FDA)
Genetics Institute
GlaxoSmithKline (GSK)
Green Cross Corporation
Grifols Biologicals
Haemophilia Centres of England, Scotland, Northern Ireland or Wales
Haemophilia Treatment Centre Collaborative Network of China (HTCCNC)
Haemophilialife
Hemobrás
Inspiration Biopharmaceuticals
Ipsen Pharma
Italian Association of Haemophilia Centres (AICE)
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15. Contents
Johns Hopkins Medicine
Ligand Pharmaceuticals
National Health Service (NHS)
National Heart, Lung and Blood Institute
Nektar Therapeutics
Novo Nordisk
Octapharma
Pfizer
Shenyang Sunshine Pharmaceutical Co.
Spanish Haemophilia Society
Swedish Orphan Biovitrum
United Kingdom Haemophilia Centre Doctors’ Organisation (UKHCDO)
US Food and Drug Administration (FDA)
World Federation of Haemophilia
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16. Bleeding Disorders: World Pharmaceutical
Industry and Market 2014-2024
Between 2012 and 2018, revenue generated by sales of Helixate will increase at a CAGR of
0.16%. Between 2018 and 2024, revenue will decrease at a CAGR of -1.5%. In 2024, sales of the
drug will generate $463m, accounting for 2.67% of the total market.
4.11 Nplate: The Leading Product for Thrombocytopenia in 2012
Table 4.18 Nplate: Key Facts
Drug
Company
Approval Date
US
EU
Indication
Route of Administration
2012
Revenue ($m)
2011
2010
US
Patent Expiry
EU
Nplate (romiplostim)
Amgen
Aug-08
Feb-09
Thrombocytopenia
Injection
368
297
229
Jan-22
Oct-19
Source: visiongain 2013
Nplate is marketed by Amgen. It was approved by the FDA in August 2008 and by the EMA in
February 2009 for the treatment of thrombocytopenia in adults with idiopathic thrombocytopenic
purpura, an autoimmune disease. It is a fusion protein analogue of thrombopoietin, a naturally
occurring hormone which regulates platelet count. Nplate works by raising and sustaining the blood
platelet count using the same mechanism of action as this hormone. Upon its launch, it
represented a novel therapeutic approach to thrombocytopenia in this patient population.
In 2012, sales of Nplate generated $368m. The product has seen strong annual growth in recent
years. Driving this strong revenue generation is the chronic nature of the disease, which requires
long term treatment, generating repeat sales. Additionally, Amgen is licensed to market Nplate in
the US, all of Europe, Canada, Australia, New Zealand, Mexico, all Central and South American
countries and certain countries in Africa, Asia and the Middle East meaning the drug is available to
a large patient population. After approval, Nplate was subject to restricted distribution as a result of
safety concerns arising from the limited experience with the drug. However, these Risk Evaluation
and Modification Strategies (REMS) were modified in December 2011; prescribers, healthcare
institutions, pharmacies and patients no longer have to enroll in REMS programmes in order to
prescribe, dispense or take these drugs. This modification has resulted in an expanding market for
Nplate.
Amgen is conducting clinical trials with Nplate in the treatment of thrombocytopenia caused by
hepatitis C, multiple myeloma and other cancers (chemotherapy-induced). Indication expansions
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17. Bleeding Disorders: World Pharmaceutical
Industry and Market 2014-2024
will also result in an expanding market for Nplate. As a result of these factors, revenue generated
by Nplate will see strong growth until 2016. Between 2012 and 2018, revenue generated by Nplate
will expand at a CAGR of 7.65%. However, Nplate competes directly with GlaxoSmithKline’s
Promacta and from 2016 onwards, the annual rate of growth in revenue will begin to decline as a
result of market saturation.
Table 4.19 Nplate: Revenue ($m) and Market Share (%) Forecast, 2013-2024
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
Market Share (%) 3.61 3.74 3.90 3.97 4.06 4.04 4.03 3.91 3.76 3.62 3.46 3.30 3.05
Revenue ($m)
368 405 445 481 519 545 573 584 590 584 566 555
527
AGR (%)
10
10
8
8
5
5
2
1
-1
-3
-2
-5
CAGR (%)
7.65
-1.36
Source: visiongain 2013
Figure 4.11 Nplate: Revenue Forecast ($m), 2013-2024
700
600
Revenue ($m)
500
400
300
200
100
0
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Year
Source: visiongain 2013
Revenue generated by Nplate will peak in 2020 at $590m, accounting for 3.76% of the total
bleeding disorders market. From 2021 onwards competition in the market will result in negative
annual growth. Between 2018 and 2024, revenue will decrease at a CAGR of -1.36%. In 2024,
sales of Nplate will generate $527m, accounting for 3.05% of the total market.
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