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Bleeding Disorders World Pharmaceutical Industry 2014-2024

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For an Executive Summary of this report please contact ediz.ibrahim@visiongain.com (+44 (0)20 7549 9976) or refer to our website …

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

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  • 1. Bleeding Disorders: World Pharmaceutical Industry and Market 2014-2024 ©notice This material is copyright by visiongain. It is against the law to reproduce any of this material without the prior written agreement of visiongain. You cannot photocopy, fax, download to database or duplicate in any other way any of the material contained in this report. Each purchase and single copy is for personal use only.
  • 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 www.visiongain.com
  • 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? www.visiongain.com
  • 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 www.visiongain.com
  • 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? www.visiongain.com
  • 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 www.visiongain.com
  • 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? www.visiongain.com
  • 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 www.visiongain.com
  • 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 ($m), 2013-2024 www.visiongain.com
  • 10. Contents Table 5.4 The US Bleeding Disorders Market: Revenue ($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 ($m) and Market Share (%) Forecast, 2013-2024 Table 6.1 Bleeding Disorders: Candidates in Pre-Registration, 2013 Table 6.2 Bleeding Disorders: Candidates in Phase III Development, 2013 Table 6.3 Bleeding Disorders: Candidates in Phase II/III Development, 2013 Table 6.4 Bleeding Disorders: Candidates in Phase I/II Development, 2013 Table 6.5 Bleeding Disorders: Candidates in Phase I Development, 2013 www.visiongain.com
  • 11. Contents Table 7.1 The Leading Companies of the Bleeding Disorders Market: Revenues ($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 www.visiongain.com
  • 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 ($m), 2013-2024 www.visiongain.com
  • 13. Contents Figure 4.14 Rixubis: Revenue Forecast ($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 www.visiongain.com
  • 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) www.visiongain.com
  • 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 www.visiongain.com
  • 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 $368m. The product has seen strong annual growth in recent years. Driving this strong revenue generation is the chronic nature of the disease, which requires long term treatment, generating repeat sales. Additionally, Amgen is licensed to market Nplate in the US, all of Europe, Canada, Australia, New Zealand, Mexico, all Central and South American countries and certain countries in Africa, Asia and the Middle East meaning the drug is available to a large patient population. After approval, Nplate was subject to restricted distribution as a result of safety concerns arising from the limited experience with the drug. However, these Risk Evaluation and Modification Strategies (REMS) were modified in December 2011; prescribers, healthcare institutions, pharmacies and patients no longer have to enroll in REMS programmes in order to prescribe, dispense or take these drugs. This modification has resulted in an expanding market for Nplate. Amgen is conducting clinical trials with Nplate in the treatment of thrombocytopenia caused by hepatitis C, multiple myeloma and other cancers (chemotherapy-induced). Indication expansions www.visiongain.com Page 58
  • 17. Bleeding Disorders: World Pharmaceutical Industry and Market 2014-2024 will also result in an expanding market for Nplate. As a result of these factors, revenue generated by Nplate will see strong growth until 2016. Between 2012 and 2018, revenue generated by Nplate will expand at a CAGR of 7.65%. However, Nplate competes directly with GlaxoSmithKline’s Promacta and from 2016 onwards, the annual rate of growth in revenue will begin to decline as a result of market saturation. Table 4.19 Nplate: Revenue ($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. www.visiongain.com Page 59