Orphan Drugs for CNS Diseases 2014-2024
 

Orphan Drugs for CNS Diseases 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/1178/Orphan-Drugs-for-CNS-Diseases-R-D-and-Market-2014-2024

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    Orphan Drugs for CNS Diseases 2014-2024 Orphan Drugs for CNS Diseases 2014-2024 Document Transcript

    • Orphan Drugs for CNS Diseases: R&D 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.
    • Contents 1. Executive Summary 1.1 Orphan Drugs for CNS Diseases: Market Overview 1.2 Report Contents – Chapter Overviews 1.3 Research and Analysis Methods 2. Introduction to Orphan Drugs for CNS Disorders 2.1 Defining Orphan Diseases 2.2 What are the Major Orphan CNS Indications? 2.2.1 Huntington’s Disease 2.2.2 Amyotrophic Lateral Sclerosis (ALS) 2.2.3 Myasthenia Gravis 2.2.4 Other Orphan CNS Indications 2.3 Orphan Drug Designation: Providing Incentives to Companies 2.3.1 What Benefits Come with Orphan Drug Designation? 2.4 Demand for Orphan Drugs Gathers Momentum 2.4.1 Development of Orphan Drugs 3. The World Orphan CNS Drugs Market, 2014-2024 3.1 How Large Was the Orphan Drugs Market in 2013? 3.1.1 Huntington’s Disease: The Largest Orphan CNS Disease Sector in 2012 3.2 The Orphan CNS Drug Market: Revenue Forecast, 2013-2024 3.2.1 What Will Drive Growth in the Market to 2024? www.visiongain.com
    • Contents 3.2.2 What Will Restrain the Market From 2014-2024? 3.3 Orphan Drugs in Huntington’s Disease 3.3.1 Huntington’s Disease: Submarket Forecast, 2013-2024 3.3.1.1 Huge Unmet Need to Drive HD Treatment Market 3.3.1.2 Enactment of New Law in US May Add Growth Impetus 3.4 Orphan Drugs in Amyotrophic Lateral Sclerosis 3.4.1 Amyotrophic Lateral Sclerosis: Submarket Forecast, 2013-2024 3.4.1.1 New Drug Launches Will Provide Market Recovery Following Patent Expiry of Rilutek 3.5 Orphan Drugs in Myasthenic Gravis 3.5.1 Myasthenia Gravis: Submarket Forecast, 2013-2024 3.5.1.1 Clinical R&D into New Treatments Keep Patients Hopeful 4. Leading National Markets for Rare CNS Indications 2014-2024 4.1 Regional Breakdown of The Orphan CNS Drug Market 4.2 Leading National Markets: Revenue Forecasts, 2013-2024 4.3 The US: The Leading Market for Orphan CNS Drugs in 2012 4.3.1 Orphan Drug Regulations in the US 4.3.2 Benefits for Orphan Drug Developers 4.3.3 The US Orphan CNS Drug Market: Revenue Forecast, 2013-2024 4.4 Orphan Drugs in Leading EU Markets 4.4.1 The EU5 Orphan CNS Drug Market: Revenue Forecasting, 2013-2024 4.4.1.1 The Incentives for Orphan Drug Development in the EU 4.4.2 Orphan CNS Drugs in the EU5: Submarket Revenue Forecasts, 2013-2024 www.visiongain.com
    • Contents 4.4.2.1 The German Orphan CNS Drug Market: Revenue Forecast, 2013-2024 4.4.2.2 The French Orphan CNS Drug Market: Revenue Forecast, 2013-2024 4.4.2.3 The UK Orphan CNS Drug Market: Revenue Forecast, 2013-2024 4.4.2.4 The Spanish Orphan CNS Drug Market: Revenue Forecast, 2013-2024 4.4.2.5 The Italian Orphan CNS Drug Market: Revenue Forecast, 2013-2024 4.5 The Japanese Orphan CNS Drug Market: Revenue Forecast, 2013-2024 4.5.1 Orphan Drug Regulations and Benefits in Japan 4.6 Potential for Orphan CNS Drugs in Emerging National Markets, 2013-2024 4.6.1 The Chinese Orphan CNS Drug Market: Revenue Forecast, 2013-2024 4.6.2 The Indian Orphan CNS Drug Market: Revenue Forecast, 2013-2024 4.6.2.1 Large Patient Population to Draw Drug Developers to India 4.6.3 The Russian Orphan CNS Drug Market: Revenue Forecast, 2013-2024 4.6.3.1 Attempts to Introduce Orphan Designation and Incentives 2010-2013 4.6.4 The Brazilian Orphan CNS Drug Market: Revenue Forecast, 2013-2024 5. Outlooks for Leading Orphan CNS Drugs 2014-2024 5.1 Huntington’s Disease Treatments 5.1.1 Xenazine (Tetrabenazine; Lundbeck/Valeant Pharmaceuticals) 5.1.1.1 Omerus Pipeline HD Treatment Receives Orphan Designation 5.1.1.2 Xenazine: Revenue Forecast, 2013-2024 5.2 Amyotrophic Lateral Sclerosis Treatments 5.2.1 Rilutek (Riluzole; Covis Pharmaceuticals) 5.2.1.1 Patent Expiry to Cause Influx of Generic Treatments 5.2.1.2 Rilutek: Revenue Forecast, 2013-2024 www.visiongain.com
    • Contents 5.3 Myasthenia Gravis Treatments 5.3.1 Mestinon (Pyridostigmine bromide; Valeant Pharmaceuticals) 5.3.1.1 Lack of Novel Treatments to Compete With Branded Drug 5.3.1.2 Mestinon: Revenue Forecast, 2013-2024 5.3.2 Imuran (Azathioprine; Prometheus Laboratories/Aspen Pharmacare) 5.3.2.1 Serious Adverse Events May Further Reduce Use of Imuran 5.3.2.2 Imuran: Revenue Forecast, 2013-2024 6. Orphan CNS Drugs: R&D Pipelines 6.1 Drugs in the Huntington’s Disease Pipeline 6.1.1 ALN-HTT (Alnylam Pharmaceuticals/Medtronic Inc.): Drug-Device Combination Therapy 6.1.2 HD-02 (Avicena Group Inc.): Correcting the Body’s Cellular Energy 6.1.3 CERE-120 (Ceregene Inc.): Delivering Neurotrophic Factors to Reverse Disease Process 6.1.4 Lead Compounds (Chaperone Therapeutics): Targeting Protein Misfolding 6.1.5 CX929 (Cortex Pharmaceuticals): Ampakine Treatment to Encourage Neuronal Growth 6.1.6 EPI-743 (Edison Pharmaceuticals): Redox Therapy in Preclinical Testing 6.1.7 GSK356278 (GSK): Respiration Treatment in Line for Additional HD Indication 6.1.8 Modified Antisense Oligo-Nucleotides (Isis Pharmaceuticals): Partnering with Roche to Aid Drug Discovery 6.1.9 NsG33 (Meteorin; NsGene A/S): Neurotrophic Protein Shown to Stimulate Neurite Growth in Preclinical Studies 6.1.10 LSD-1/MAO-B Inhibitor (Oryzon Genomics): Reducing Enzyme Activity May Provide Therapeutic Benefit www.visiongain.com
    • Contents 6.1.11 PBT2 (Prana Biotechnology): Targeting Metal-Protein Interactions to Reduce Protein Aggregation 6.1.12 PRO289 (Prosensa): Lowering Levels of Mutant Gene Proteins 6.1.13 RP103 (Raptor Pharmaceutical Corporation): Cysteamine Treatment Receives Orphan Designation 6.1.14 Zinc DNA Transcription Factors (Sangamo Biosciences/Shire AG): Switching Genes On and Off 6.1.15 Selisistat (SEN196; Siena Biotechnology): Orphan Drug Targeting Sirtuin Protein Inhibition in Phase II Development 6.1.16 Huntexil (Teva Pharmaceuticals): Neutralizing Dopaminergic Activity 6.2 Drugs in the Amyotrophic Lateral Sclerosis Pipeline, 2013 6.2.1 ALS-02, ALS-05 and ALS-08 (The Avicena Group): Designated Orphan Drug in Advanced Clinical Testing 6.2.2 NurOwn™ (BrainStorm Cell Therapeutics): Stem Cell Treatment to Replace Damaged Cells 6.2.3 Tirasemtiv (CK-2017357; Cytokinetics): Skeletal Muscle Activator Advances to Phase II Trials 6.2.4 E0302 (Mecobalamin; Eisai): Vitamin B12 Therapy Shown to Improve Muscle Wasting 6.2.5 Ozanezumab (GSK1223249; GSK): Monoclonal Antibody Treatment Recruiting Patients for Phase II Trial 6.2.6 Radicut (Edaravone; Mitsubishi Tanabe): Free Radical Scavenger in Advanced Trials 6.2.7 Region Specific Stem Cells (Neuralstem): Neuronal Stem Cell Therapy in Preclinical Testing 6.2.8 NP001 (Neuraltus Pharmaceuticals): Altering Macrophage Activity 6.2.9 sNN0029 (NeuroNova): Growth Factor Treatment Shown to Improve Muscle Strength www.visiongain.com
    • Contents 6.2.10 TDI-132 (Gilenya™; Novartis & The ALS Therapy Development Institute): Therapy to Counteract Aggressive Immune Cells 6.3 Drugs in the Myasthenia Gravis Pipeline, 2013 6.3.1 Soliris® (Eculizumab; Alexion Pharmaceuticals): Blood Disorder Treatment Investigated as Potential MG Therapy 6.3.2 BHT-3034 (Bayhill Therapeutics): Vaccine Therapy to Reverse Harmful Immune Responses 6.3.3 BKT130 (Biokine Therapeutics): Chemokine Inhibitor 6.3.4 CK-2017357 (Tirasemtiv; Cytokinetics): Designated Orphan Drug Tested in Multiple Indications 7. Orphan Drugs in CNS: Industry Trends, 2014-2024 7.1 Orphan Drugs in CNS: Strengths and Weaknesses, 2013-2024 7.2 Orphan Drugs in CNS: Opportunities and Threats, 2013-2024 7.3 Orphan Drugs in CNS: STEP Analysis, 2013-2024 7.3.1 Social Factors 7.3.1.1 Ethical Considerations in Funding Orphan Drug Development 7.3.2 Technological Developments 7.3.2.1 Increased Understanding of Disease Will Drive Innovation 7.3.3 Economic Pressures 7.3.3.1 Discounts in Drug Prices Will Increase Accessibility 7.3.4 Political Issues 7.3.4.1 Harmonising Global Regulatory Pathways 7.4 Trends in Orphan CNS Drug Development 7.4.1 Clinical Trials for Orphan Drugs www.visiongain.com
    • Contents 7.4.1.1 Are Adverse Events More Acceptable for Orphan Drugs? 7.4.1.2 Challenges and Opportunities in Patient Recruitment 7.4.2 Biomarkers for Orphan CNS Indications 7.4.2.1 Companion Diagnostics: Driving Personalised Medicine 7.4.3 The Role of Public Funding in Orphan Drug Development 7.5 Commercialising Orphan Drugs in CNS 7.5.1 Pricing of Orphan Drugs May Become Crucial to Success 7.5.2 Market and Patient Access Are Crucial for Orphan Drug Success 7.5.3 Repositioning Drugs for Orphan CNS Indications 7.5.3.1 Expanding Beyond Orphan Indications 7.5.4 Big Pharma and Orphan Drugs 7.5.4.1 Orphan Drugs Fit the Personalised Medicine Model 7.5.5 Common Market Entry Strategies 7.5.6 Orphan Indications as an Opportunity for Generic Drug Manufacturers 8. Research Interviews 8.1 Dr Tsao-Nivaggioli, CEO and Board Member, Avicena Group 8.1.1 Avicena Group 8.1.2 Rare Diseases and Applying for Orphan Drug Status 8.1.3 HD-02: Targeting the Body’s Cellular Energy Systems 8.1.4 Challenges in Developing Orphan Drugs 8.1.5 Future Growth Opportunities and Perspective for the Market 8.2 Respondent from Edison Pharmaceuticals 8.2.1 Edison Pharmaceuticals www.visiongain.com
    • Contents 8.2.2 Defining Orphan Disease and Drug Submissions in Target Markets 8.2.3 The Market Potential (and Risk) of Pursuing Treatments for Mitochondrial Diseases 8.2.4 Company Alliances and Future Prospects for the Market 9. Conclusions from Our Study 9.1 The State of the Orphan CNS Drugs Market 9.2 Renewed Interest in Rare CNS Diseases will Stimulate that Market 9.3 The US will Maintain its Market Dominance from 2014-2024 9.4 High Price of Treatments May Limit Market Potential www.visiongain.com
    • Contents List of Tables Table 1.1 Currency Exchange Rates Table 1.2 Common Abbreviations Used in this Report Table 2.1 EU Prevalence Statistics for Selected Rare CNS Indications, 2013 Table 3.1 Global Orphan CNS Drug Market: Revenue ($m) and Market Share (%) by Sector, 2012 Table 3.2 Global Orphan CNS Drug Market: Overall Market and Revenue Forecasts by Sector ($m, AGR %, CAGR %), 2013-2024 Table 3.3 Global Orphan CNS Drug Market: Submarket Shares (%), 2012-2024 Table 3.4 Huntington’s Disease Submarket: Revenue Forecast ($m, AGR %, CAGR %), 2013-2024 Table 3.5 Amyotrophic Lateral Sclerosis Submarket: Revenue Forecast ($m, AGR %, CAGR %), 20132024 Table 3.6 Myasthenia Gravis Submarket: Revenue Forecast ($m, AGR %, CAGR %), 2013-2024 Table 4.1 Global Orphan CNS Drug Market: Revenue ($m) and Market Share (%) by Region, 2012 Table 4.2 Global Orphan CNS Drug Market: Revenue Forecasts ($m, AGR %, CAGR %) by Region, 20132024 Table 4.3 Global Orphan CNS Drug Market: Regional Submarket Shares (%),2012-2024 Table 4.4 US Orphan CNS Drug Market: Revenue Forecast ($m, AGR %, CAGR %), 2013-2024 Table 4.5 EU5 Orphan CNS Drug Market: Revenue ($m) and Market Share (%) by Country, 2012 Table 4.6 EU5 Orphan CNS Drug Market: Revenue Forecast ($m, AGR %, CAGR %) by Country, 20132024 Table 4.7 Fee Reductions (%) Available for SMEs Developing Orphan Drugs in the EU, 2013 Table 4.8 German Orphan CNS Drug Market: Revenue Forecast ($m, AGR %, CAGR %), 2013-2024 Table 4.9 French Orphan CNS Drug Market: Revenue Forecast ($m, AGR %, CAGR %), 2013-2024 Table 4.10 UK Orphan CNS Drug Market: Revenue Forecast ($m, AGR %, CAGR %), 2013-2024 Table 4.11 Spanish Orphan CNS Drug Market: Revenue Forecast ($m, AGR %, CAGR %), 2013-2024 Table 4.12 Italian Orphan CNS Drug Market: Revenue Forecast ($m, AGR %, CAGR %), 2013-2024 Table 4.13 Japanese Orphan CNS Drug Market: Revenue Forecast ($m, AGR %, CAGR %), 2013-2024 Table 4.14 Chinese Orphan CNS Drug Market: Revenue Forecast ($m, AGR %, CAGR %), 2013-2024 Table 4.15 Indian Orphan CNS Drug Market: Revenue Forecast ($m, AGR %, CAGR %), 2013-2024 Table 4.16 Russian Orphan CNS Drug Market: Revenue Forecast ($m, AGR %, CAGR %), 2013-2024 Table 4.17 Brazilian Orphan CNS Drug Market: Revenue Forecast ($m, AGR %, CAGR %), 2013-2024 www.visiongain.com
    • Contents Table 5.1 Top Orphan CNS Drugs: Revenues ($m) and Leading Revenue Shares (%), 2012 Table 5.2 Xenazine: Revenue ($m), 2009-2012 Table 5.3 Xenazine: Revenue Forecast ($m, AGR %, CAGR %), 2013-2024 Table 5.4 Rilutek: Revenue ($m), 2010-2012 Table 5.5 Rilutek: Revenue Forecast ($m, AGR %, CAGR %), 2013-2024 Table 5.6 Mestinon: Revenue ($m), 2010-2012 Table 5.7 Mestinon: Revenue Forecast ($m, AGR %, CAGR %), 2013-2024 Table 5.8 Imuran: Revenue ($m), 2008-2012 Table 5.9 Imuran: Revenue Forecast ($m, AGR %, CAGR %), 2013-2024 Table 6.1 Selected Pipeline Candidates in Development for Huntington’s Disease, 2012 Table 6.2 Selected Pipeline Candidates in Development for ALS, 2013 Table 6.3 Selected Pipeline Candidates in Development for Myasthenia Gravis, 2013 Table 7.1 Global Orphan CNS Drug Market: Strengths and Weaknesses, 2013-2024 Table 7.2 Global Orphan CNS Drug Market: Opportunities and Threats, 2013-2024 Table 9.1 Global Orphan CNS Drug Market: Revenue ($m, CAGR %), and Market Share (%) by Sector, 2012, 2018 & 2024 Table 9.2 Global Orphan CNS Drug Market: Revenue ($m, CAGR %) and Market Share (%) by Region, 2012, 2018 & 2024 www.visiongain.com
    • Contents List of Figures Figure 2.1 Orphan Disease Prevalence by Country/Region, 2013 Figure 2.2 Orphan Drugs Clinical Pipeline by Therapeutic Category, 2012 Figure 2.3 Orphan Drug Designation Benefits in Major Markets, 2013 Figure 3.1 Orphan Drug Approvals in the US, 2000-2013 Figure 3.2 Global Orphan CNS Drug Market: Share (%) by Sector, 2012 Figure 3.3 Global Orphan CNS Drug Market: Revenue Forecast ($m), 2013-2024 Figure 3.4 Global Orphan CNS Drug Market: Submarket Shares (%), 2018 Figure 3.5 Global Orphan CNS Drug Market: Submarket Shares (%), 2024 Figure 3.6 Global Orphan CNS Drug Market: Drivers and Restraints, 2014-2024 Figure 3.7 Huntington’s Disease Market: Revenue Forecast ($m), 2013-2024 Figure 3.8 Amyotrophic Lateral Sclerosis Market: Revenue Forecast ($m), 2013-2024 Figure 3.9 Myasthenia Gravis Market: Revenue Forecast ($m), 2013-2024 Figure 4.1 Global Orphan CNS Drug Market: Share (%) by Region, 2012 Figure 4.2 Global Orphan CNS Drug Market: Share (%) by Region, 2018 Figure 4.3 Global Orphan CNS Drug Market: Share (%) by Region, 2024 Figure 4.4 US Orphan CNS Drug Market: Revenue Forecast ($m), 2013-2024 Figure 4.5 EU5 Orphan CNS Drug Market: Share (%) by Country, 2012 Figure 4.6 EU5 Orphan CNS Drug Market: Revenue Forecast ($m), 2013-2024 Figure 4.7 German Orphan CNS Drug Market: Revenue Forecast ($m), 2013-2024 Figure 4.8 French Orphan CNS Drug Market: Revenue Forecast ($m), 2013-2024 Figure 4.9 UK Orphan CNS Drug Market: Revenue Forecast ($m), 2013-2024 Figure 4.10 Spanish Orphan CNS Drug Market: Revenue Forecast ($m), 2013-2024 Figure 4.11 Italian Orphan CNS Drug Market: Revenue Forecast ($m), 2013-2024 Figure 4.12 Japanese Orphan CNS Drug Market: Revenue Forecast ($m), 2013-2024 Figure 4.13 Chinese Orphan CNS Drug Market: Revenue Forecast ($m), 2013-2024 Figure 4.14 Indian Orphan CNS Drug Market: Revenue Forecast ($m), 2013-2024 Figure 4.15 Russian Orphan CNS Drug Market: Revenue Forecast ($m), 2013-2024 www.visiongain.com
    • Contents Figure 4.16 Brazilian Orphan CNS Drug Market: Revenue Forecast ($m), 2013-2024 Figure 5.1 Top Orphan CNS Drug: Revenue Shares (%), 2012 Figure 5.2 Xenazine: Revenue ($m), 2009-2012 Figure 5.3 Xenazine: Revenue Share (%) by Region, 2012 Figure 5.4 Xenazine: Revenue Forecast ($m), 2013-2024 Figure 5.5 Rilutek: Revenue ($m), 2010-2012 Figure 5.6 Rilutek: Revenue Forecast ($m), 2013-2024 Figure 5.7 Mestinon: Revenue ($m), 2010-2012 Figure 5.8 Mestinon: Revenue Forecast ($m), 2013-2024 Figure 5.9 Imuran: Revenue ($m), 2008-2012 Figure 5.10 Imuran: Revenue Forecast ($m), 2013-2024 Figure 9.1 Global Orphan CNS Drug Market: Revenue ($m) by Sector, 2012, 2018 & 2024 Figure 9.2 Global Orphan CNS Drug Market: Revenue ($m) by Region, 2012, 2018 & 2024 www.visiongain.com
    • Contents Companies and Other Organisations Mentioned in This Report Alexion Pharmaceuticals Agência Nacional de Vigilância Sanitária (ANVISA, Brazil) Alnylam Pharmaceuticals Apotex Aspen Pharmacare Avicena Group Bayhill Therapeutics BHR Pharma Biogen Idec Biokine Therapeutics Biovail BrainStorm Cell Therapeutics California's Stem Cell Agency Cambridge Laboratories Ceregene Chaperone Therapeutics Committee for Orphan Medicinal Products (COMP) Core Pharmaceuticals Cortex Pharmaceuticals Covis Pharmaceuticals Cytokinetics Edison Pharmaceuticals Eisai European Commission European Medicines Agency (EMA) European Union Food and Drug Administration (FDA, US) www.visiongain.com
    • Contents Glenmark Generics Global Pharmaceuticals (generics division of Impax Laboratories GlaxoSmithKline (GSK) Huntington's Disease Society of America (HDSA) Isis Pharmaceuticals Lundbeck Massachusetts General Hospital Medtronic Ministry of Health, Labor and Welfare (MHLW, Japan) Mitsubishi Tanabe National Institute for Health and Care Excellence (NICE) National Institute for Neurological Disorders and Stroke (NINDS) Neuralstem Neuraltus Pharmaceuticals NeuroNova NeuroSearch Novartis NsGene Omerus Corporation Oryzon Genomics Pfizer Prana Biotechnology Prestwick Pharmaceuticals Prometheus Laboratories Prosensa Raptor Pharmaceuticals Rare Disease UK Roche Roxane Pharmaceuticals Russian Ministry of Health and Social Development (MOHSD) www.visiongain.com
    • Contents Sangamo Biosciences Sanofi Shire Siena Biotechnology State Food and Drug Administration (SFDA, China) Sun Pharmaceutical Industries Teva Pharmaceuticals The ALS Therapy Development Institute University Hospital Tübingen University of Kyoto Valeant Pharmaceuticals World Health Organisation (WHO) Zydus Pharmaceuticals www.visiongain.com
    • Orphan Drugs for CNS Diseases: R&D and Market 2014-2024 Figure 5.5 Rilutek: Revenue ($m), 2010-2012 70.0 60.0 Revenue ($m) 50.0 40.0 30.0 20.0 10.0 0.0 2010 2011 2012 Year Source: Company reports 2013, visiongain 2014 5.2.1.1 Patent Expiry to Cause Influx of Generic Treatments The patent for Rilutek - which gave it marketing exclusivity in the US - expired in June 2013 (EU patent expired in October 2012). On the same day of the US patent expiration, the FDA granted approval to two companies to market generic versions of riluzole including, Apotex Corporation and Glenmark Generics. As a result, Rilutek can expect strong competition from generics in the US in the coming 10 years. A US-based company, Actavis, was the first company to launch a generic version of Rilutek in October 2012, following patent expiry of the drug in major European markets. The product was launched by Actavis in the UK, Germany, France, Italy, the Netherlands, Spain, Sweden, Denmark, Norway, and Hungary. At launch, the generic drug price was apparently set at just over $120 for a pack of 56 tablets. Considering the branded Rilutek drug may reportedly cost upwards of $2,000, the generic treatment represents an attractive and likely preferred option for patients. The generic versions of riluzole from both Apotex and Glenmark Generics were launched on the same day following US patent expiry (June 2013). With a number of low-cost generic alternatives available on the market, this will likely cause sales of the Rilutek to fall over the forecast period of this report. www.visiongain.com Page 81
    • Orphan Drugs for CNS Diseases: R&D and Market 2014-2024 5.2.1.2 Rilutek: Revenue Forecast, 2013-2024 Visiongain forecasts that revenue for Rilutek will fall sharply during the early forecast period of this report, on account of the loss of patent exclusivity of the drug in June 2013, prompting the launch of generic alternatives on to the market. From 2012 onwards, revenue for Rilutek is predicted to reach $41.8m in 2018 (down from $64.0m in 2012) and $25.3m in 2024 (Table 5.5 and Figure 5.6). As well as competition from generics, revenue for Rilutek will also be affected by increased use of new treatments launched. Figure 5.6 Rilutek: Revenue Forecast ($m), 2013-2024 80.0 70.0 Revenue ($m) 60.0 50.0 40.0 30.0 20.0 10.0 0.0 Year Source: visiongain 2014 Table 5.5 Rilutek: Revenue Forecast ($m, AGR %, CAGR %), 20132024 Revenue ($m) Annual Growth (%) CAGR (%, 2012-2018) Revenue ($m) Annual Growth (%) CAGR (%, 2018-2024) CAGR (%, 2012-2024) 2012 64.0 2013 67.2 5 2014 63.8 -5 2015 59.4 -7 2016 53.4 -10 2017 47.6 -11 2019 36.4 -13 2020 32.8 -10 2021 29.8 -9 2022 27.7 -7 2023 26.1 -6 2018 41.8 -12 -6.8 2024 25.3 -3 -8.1 -7.4 Source: visiongain 2014 www.visiongain.com Page 82