SINEMET (PARKINSON’S DISEASE) - FORECAST AND MARKET .
REF ER EN CE CO DE GDH C390DFR PU BLIC AT IO N D AT E M AR CH 2014SINEMET (PARKINSON’S DISEASE) FORECAST AND MARKET ANALYSIS TO 2022
SINEMET (PARKINSON’S DISEASE) FORECAST AND MARKET ANALYSIS TO 2022Executive SummaryThe tables below provides a summary of the keymetrics for Sinemet and Sinemet CR in the 8MMParkinson’s Disease (PD) markets during theforecast period from 2012–2022.2012 Market SalesUS 3.4m5EU 6.4mJapanSinemet: Key Metrics in the 8MM Parkinson’sDisease Markets, 2012–20222012 Market SalesUS 167.2m5EU 43.8mJapan 20.8mBrazil 45.0mTotal 276.7mKey Events (2012–2022)Sinemet CR: Key Metrics in the 8MM Parkinson’sDisease Markets, 2012–2022Level of ImpactLaunch of Impax’s Rytary in 2015 inEurope N/ABrazil 0.7mTotal 10.4mKey Events (2012–2022)Level of ImpactLaunch of Impax’s Rytary in 2015 inEurope 2022 Market SalesUS 4.7m5EU 37.4mJapanN/ABrazil 1.5m2022 Market SalesGlobal*US 165.2m8MM US, France, Germany, Italy, Spain, UK, Japan, and Brazil 12.7m5EU 37.4mJapan 27.0m5EU France, Germany, Italy, Spain, and UKBrazilGlobal*N/A Not AvailableSource: GlobalData 57.1m 286.7m8MM US, France, Germany, Italy, Spain, UK, Japan, and Brazil5EU France, Germany, Italy, Spain, and UKSales for Sinemet in the Parkinson’s DiseaseMarketN/A Not AvailableSource: GlobalDataSinemet sales are expected to increase from 276.7 million in 2012 to 286.7 million in 2022with a Compound Annual Growth Rate (CAGR) of0.4%.Sales of Sinemet CR in 2012 were 10.4 million,expected to increase to 12.7 million by 2022, witha CAGR of 2.0%.Sinemet (Parkinson’s Disease) - Forecast and Market Analysis to 2022 GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.2
SINEMET (PARKINSON’S DISEASE) FORECAST AND MARKET ANALYSIS TO 2022Executive SummaryMajor growth drivers for Sinemet in Parkinson’sThe figure below illustrates the global Sinemetdisease market over the forecast period include:sales by region during the forecast period. Considered gold standard in symptomaticSales of Sinemet by Region, 2012-2022control; decades of use with proven safety and2012Total: 276.7mefficacy. Strong US presence, where Roche’s Madopar16.3%is not sold Active ingredient (levodopa) is the most7.5%effective drug at controlling motor symptomsConversely, major barriers to the growth of60.4%15.8%Sinemet in Parkinson’s disease market include: US5EUHigh pill burden, especially in advancedJapanpatientsBrazil2022Total: 286.7mSustained-release formulation never provensuperior to immediate release. Therefore it is19.9%not commonly used Patients develop motor fluctuations, includingON-OFF time and dyskinesia, due to pulsatileactivation of dopamine receptors9.4%13.0%57.6%Source: GlobalDataSinemet (Parkinson’s Disease) - Forecast and Market Analysis to 2022 GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.3
SINEMET (PARKINSON’S DISEASE) FORECAST AND MARKET ANALYSIS TO 2022Executive SummaryThe figure below illustrates the global Sinemet CRsales by region during the forecast period.Sales of Sinemet CR by Region, 2012-2022What Do the Physicians Think?Physicians state that dyskinesia remains a majorunmet need and stress the impact that an antidyskinetic medication would have on the treatment2012Total: 10.4mof Parkinson’s disease.6.6%“Let’s say if we do not consider what is untreatabletoday [balance, falls, dementia], then the main32.2%challenge is probably treating dyskinesia.”[EU] KOL, November 201361.2%US“Wearing-off wouldn’t be a problem, if the patients5EUdo not develop severe dyskinesia. Because if youJapancan control dyskinesia, then you can use the drugBrazil[at a] high enough [dose] to control any motorfluctuation. So wearing-off itself, it’s easier to treat.2022Total: 12.7mThe problem is most patients with wearing-off, they11.8%do have dyskinesia too, and when you try to adjust37.1%the dose in order to control wearing-off, then thepatient may develop dyskinesia, or a worseningform of dyskinesia.”[EU] KOL, November 201351.0%Source: GlobalDataSinemet (Parkinson’s Disease) - Forecast and Market Analysis to 2022 GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.4
SINEMET (PARKINSON’S DISEASE) FORECAST AND MARKET ANALYSIS TO 2022Executive Summary“I think sometimes we’re a bit dismissive in saying“Extended-release levodopa will take the place ofwe don’t see the motor complications that we usedregular drugs [immediate-release levodopa]. Evento see, and I think that’s true, because we’ve got ain the early phase of the disease, they are betterrange of different drugs. But, some people arefor patients and will reduce the amount ofreally still struggling. Twenty percent of the dayfluctuations in later disease, as they progress. Ifthey’re OFF, [while] twenty percent of the daytheythey’re dyskinetic. That’s forty percent of the dayavailable,that’s bad for them, and we say, ‘well, it’s not asimmediate-release formulations [in early stage.]”[slow-releaselevodopatherapies]wereI would prescribe them over thebad as the bad ol’ days,’ but it’s still pretty bad for[OUS] KOL, November 2013them We still don’t really have an oral drug that“If extended release of levodopa are available weis anti-dyskinetic.”may choose such agents as initial therapies, not[EU] KOL, October 2013only in advanced cases but as initial therapy.”“The most challenging [unmet need] Every day I[OUS] KOL, November 2013see a few patients for whom treatment is verychallenging to me, particularly patients with markedwearing-off, with dyskinesia during ON, it’s verydifficult to treat with the current medication. If aredonotlimitedtreattotheunderlying disease. Although there are no late-are eligible for deep brain stimulation, it’s okay, butstage therapies that will be launched to meet thispatients over [age] 75, with marked wearing-off,need during the forecast period, physicians believedyskinesia, falling down, and freezing, it’s verythat early pipeline agents hold the promise ofdifficult to treat. And it’s very ncements for PD in recent history.[OUS] KOL, November 2013Physicians believe that the introduction of slowrelease levodopa will have a significant impact onthe market and be preferred over immediaterelease formulations.Sinemet (Parkinson’s Disease) - Forecast and Market Analysis to 2022 GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.5
SINEMET (PARKINSON’S DISEASE) FORECAST AND MARKET ANALYSIS TO 2022Executive Summary“At this point, it’s not [enough] to show that you can“Current treatment options are all symptomatichave an improvement of one hour of time. It’streatments,interesting, and it should be the first step. But wediscover[are] wait[ing] for the next step; we [are] wait[ing]Parkinson’sfor drugs that have disease-modifying properties.successful yet.”Meaning that if we take [these drugs], we can ewanttotreatmentsnonehaveforbeen[OUS] KOL, November 2013a better fate than not having these drugs for sixmonth[s] or one year I’m afraid that if a drugcould arrive on the market, it will not have a hugeimpactifitjust [demonstrates] symptomaticimprovement of one hour of time.”[EU] KOL, November 2013Sinemet (Parkinson’s Disease) - Forecast and Market Analysis to 2022 GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.6
SINEMET (PARKINSON’S DISEASE) FORECAST AND MARKET ANALYSIS TO 2022Table of Contents1123Table of ContentsTable of Contents . 71.1List of Tables . 101.2List of Figures . 10Introduction . 112.1Catalyst. 112.2Related Reports . 11Disease Overview . 143.13.1.1Etiology . 143.1.2Pathophysiology . 173.1.3Prognosis . 193.1.4Quality of Life . 203.24Etiology and Pathophysiology . 14Symptoms . 20Disease Management . 224.1Overview . 224.1.1Diagnosis – The UK Brain Bank Criteria . 224.1.2Treatment Guidelines and Leading Prescribed Drugs . 234.2Treatment Synopsis . 264.2.1Dopaminergic Therapy Classes. 264.2.2Treatment of Parkinson’s Disease by Stage . 284.2.3Other Treatment Options . 31Sinemet (Parkinson’s Disease) - Forecast and Market Analysis to 2022 GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.7
SINEMET (PARKINSON’S DISEASE) FORECAST AND MARKET ANALYSIS TO 2022Table of Contents4.3567Parkinson’s Disease Assessment Scales . 314.3.1Unified Parkinson’s Disease Rating Scale (UPDRS) . 324.3.2Hoehn and Yahr Clinical Staging . 344.3.3Other Clinical Assessments. 35Competitive Assessment . 365.1Overview . 365.2Strategic Competitor Assessment . 385.3Product Profiles – Levodopa Combination Therapy . 39Sinemet (carbidopa/levodopa) . 406.1Overview . 406.2Efficacy . 426.3Safety . 426.4SWOT Analysis . 436.5Forecast . 43Appendix. 467.1Bibliography . 467.2Abbreviations . 507.3Methodology . 537.4Forecasting Methodology . 537.4.1Diagnosed Parkinson’s Disease Patients . 537.4.2Percent Drug-Treated Patients . 547.4.3General Pricing Assumptions . 547.4.4Compliance Assumptions . 55Sinemet (Parkinson’s Disease) - Forecast and Market Analysis to 2022 GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.8
SINEMET (PARKINSON’S DISEASE) FORECAST AND MARKET ANALYSIS TO 2022Table of Contents7.4.5Individual Drug Assumptions . 567.4.6Generic Erosion . 577.5Physicians and Specialists Included in this Study . 587.6About the Authors . 607.6.1Author . 607.6.2Global Head of Healthcare . 617.7About GlobalData. 627.8Disclaimer . 62Sinemet (Parkinson’s Disease) - Forecast and Market Analysis to 2022 GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.9
SINEMET (PARKINSON’S DISEASE) FORECAST AND MARKET ANALYSIS TO 2022Table of Contents1.1List of TablesTable 1: Symptoms of Parkinson’s Disease . 21Table 2: UK Brain Bank Diagnostic Criteria . 23Table 3: Diagnosis and Treatment Guidelines for Parkinson’s Disease . 24Table 4: Most Prescribed Drugs for Parkinson’s Disease by Class in the Global Markets, 2014. 25Table 5: Dopaminergic Therapy in Parkinson’s Disease . 28Table 6: UPDRS Clinical Assessment of Disease Severity . 33Table 7: Parkinson’s Disease Assessment Scales Used in Clinical Trials . 35Table 8: Treatment of Motor Symptoms in Parkinson’s Disease . 37Table 9: Leading Treatments for Parkinson’s Disease, 2014 . 38Table 10: Product Profile – Sinemet . 41Table 11: Sinemet SWOT Analysis, 2014 . 43Table 12: Global Sales Forecasts ( m) for Sinemet, 2012–2022 . 44Table 13: Global Sales Forecasts ( m) for Sinemet CR, 2012–2022 . 451.2List of FiguresFigure 1: Overview – L-dopa Metabolism and Inhibitor Classes. 27Figure 2: Overview – Treatment of Motor Symptoms of Parkinson’s Disease . 29Sinemet (Parkinson’s Disease) - Forecast and Market Analysis to 2022 GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.10
SINEMET (PARKINSON’S DISEASE) FORECAST AND MARKET ANALYSIS TO 2022Introduction2Introduction2.1CatalystThe Parkinson’s disease market is expected to grow from 3.6 billion to 5.3 billion over the 10year forecast period. A major driving force behind this is the increase in the global population andadvancements in healthcare that contribute to an aging population at increased risk for Parkinson’sdisease. The population of Parkinson’s disease patients is expected to increase from 3.2 millionpeople in 2012 to 4.3 million in 2022 in the eight major markets covered. The market forParkinson’s disease is expected to grow as it is the second most common neurological disorder,with an increased prevalence in the elderly.Parkinson’s disease has had a history of successful drugs that are highly effective; however, unmetneeds remain. Advancements in technology and drug delivery systems have driven growth in thismarket during the forecast period and made it a less risky market than other neurologicalconditions, while still holding potential for a big payout. While all products to this point have treatedthe signs and symptoms of Parkinson’s disease rather than the underlying condition, the growingunderstanding of the nervous system holds promise for a breakthrough in the development ofdisease-modifying agents. Ample opportunity in the Parkinson’s disease market remains. As mostproducts have been launched by collaborative efforts of at least two companies, we expect suchstrategic partnerships to continue during the coming decade in the market for Parkinson’s disease.2.2 Related ReportsGlobalData (2013) EpiCast: Parkinson’s Disease – Epidemiology Forecast to 2022, November2013, GDHCER043 GlobalData (2012) PharmaPoint: Alzheimer’s Disease – Global Drug Forecast and MarketAnalysis to 2022, July 2013 GDHC016PIDR. GlobalData (2014). PharmaPoint: Parkinson’s Disease – Global Drug Forecast and MarketAnalysis to 2022, March 2014, GDHC82PIDR GlobalData (2014). Parkinson’s Disease – US Drug Forecast and Market Analysis to 2022,March 2014, GDHC235CFRSinemet (Parkinson’s Disease) - Forecast and Market Analysis to 2022 GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.11
SINEMET (PARKINSON’S DISEASE) FORECAST AND MARKET ANALYSIS TO 2022Introduction GlobalData (2014). Parkinson’s Disease – 5EU Drug Forecast and Market Analysis to 2022,March 2014, GDHC236CFR GlobalData (2014). Parkinson’s Disease – Japan Drug Forecast and Market Analysis to 2022,March 2014, GDHC237CFR GlobalData (2014). Parkinson’s Disease – Brazil Drug Forecast and Market Analysis to 2022,March 2014, GDHC238CFR GlobalData (2014). Madopar (Parkinson’s Disease) – Forecast and Market Analysis to 2022,March 2014, GDHC389DFR GlobalData (2014). Duodopa (Parkinson’s Disease) – Forecast and Market Analysis to 2022,March 2014, GDHC391DFR GlobalData (2014). Stalevo/Comtan (Parkinson’s Disease) – Forecast and Market Analysis to2022, March 2014, GDHC392DFR GlobalData (2014). Neupro (Parkinson’s Disease) – Forecast and Market Analysis to 2022,March 2014, GDHC393DFR GlobalData (2014). Requip/Requip XL (Parkinson’s Disease) – Forecast and Market Analysisto 2022, March 2014, GDHC394DFR GlobalData (2014). Apokyn (Parkinson’s Disease) – Forecast and Market Analysis to 2022,March 2014, GDHC395DFR GlobalData (2014). Azilect (Parkinson’s Disease) – Forecast and Market Analysis to 2022,March 2014, GDHC396DFR GlobalData (2014). Nouriast (Parkinson’s Disease) – Forecast and Market Analysis to 2022,March 2014, GDHC397DFR GlobalData (2014). Safinamide (Parkinson’s Disease) – Forecast and Market Analysis to 2022,March 2014, GDHC398DFR GlobalData (2014). Tozadenant (Parkinson’s Disease) – Forecast and Market Analysis to2022, March 2014, GDHC399DFRSinemet (Parkinson’s Disease) - Forecast and Market Analysis to 2022 GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.12
SINEMET (PARKINSON’S DISEASE) FORECAST AND MARKET ANALYSIS TO 2022Introduction GlobalData (2014). CVT-301 (Parkinson’s Disease) – Forecast and Market Analysis to 2022,March 2014, GDHC400DFR GlobalData (2014). Rytary/IPX066 (Parkinson’s Disease) – Forecast and Market Analysis to2022, March 2014, GDHC401DFR GlobalData (2014). Opicapone (Parkinson’s Disease) – Forecast and Market Analysis to 2022,March 2014, GDHC402DFR GlobalData (2014). Mavoglurant/AFQ056 (Parkinson’s Disease) – Forecast and MarketAnalysis to 2022, March 2014, GDHC403DFR GlobalData (2014). CD/LD-GR (Parkinson’s Disease) – Forecast and Market Analysis to 2022,March 2014, GDHC404DFR GlobalData (2014). Parkinson’s Disease – Current and Future Players, March 2014,GDHC1033FPRSinemet (Parkinson’s Disease) - Forecast and Market Analysis to 2022 GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.13
SINEMET (PARKINSON’S DISEASE) FORECAST AND MARKET ANALYSIS TO 2022Appendix7.7About GlobalDataGlobalData is a leading global provider of business intelligence in the Healthcare industry.GlobalData provides its clients with up-to-date information and analysis on the latest developmentsin drug research, disease analysis, and clinical research and development. Our integrated businessintelligence solutions include a range of interactive online databases, analytical tools, reports andforecasts. Our analysis is supported by a 24/7 client support and analyst team.GlobalData has offices in New York, Boston, London, India and Singapore.7.8DisclaimerAll Rights Reserved.No part of this publication may be reproduced, stored in a retrieval system or transmitted in anyform by any means, electronic, mechanical, photocopying, recording or otherwise, without the priorpermission of the publisher, GlobalData.Sinemet (Parkinson’s Disease) - Forecast and Market Analysis to 2022 GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.62
Brazil 45.0m Total 276.7m Key Events (2012–2022) Level of Impact . Table 11: Sinemet SWOT Analysis, 2014 .43. Sinemet (Parkinson’s Disease) - Forecast and Market Analysis to 2022 SINEMET (PARKINSON’S DISEASE) - FORECAST AND MARKET ANALYSIS TO 2022 . Sinemet (Parkinson’s Disease) - Forecast and Market Analysis to 2022 .
Diet and Parkinson's Disease Information on Parkinson's Disease INDEX National Headquarters Parkinson Plaza 135 Parkinson Avenue Staten Island, N.Y. 10305 1-800-223-2732 www.apdaparkinson.org apda@apdaparkinson.org National Young Onset Center Glenbrook Hospital 2100 Pfingsten Rd. Glenview, Ill. 60026 1-877-223-3801 www.youngparkinsons.org
SINEMET MR PPI-SEM-T-08-2007 carbidopa y levodopa SEM-CEN-20072380 1 INFORMACIÓN PARA EL PACIENTE SOBRE SINEMET Por favor lea cuidadosamente este panfle
›ICD-9 codes 332.0 idiopathic Parkinson’s disease, primary 332.1 Parkinson’s disease, secondary ›ICD-10 codes G20 Parkinson's disease (including hemiparkinsonism, paralysis agitans, and parkinsonism or Parkinson's disease) –NOS –Idiopathic –Primary G21 sec
San Francisco VA Medical Center Parkinson’s Disease Research Education Clinical Center November 15, 2007 History of Parkinson’s Disease First described in 1817 by James Parkinson, En
True/ False Every hour, two people in the UK are told they have Parkinson's. True/ False People with Parkinson's may experience difficulty swallowing food or drink. True/ False . t ,I Parkinson's only affects the over 50s. 5 True/ False The main symptoms of Parkinson's are tremor, rigidity and slowness of movement. True/ False 6 7
behavior. One scale that FDA suggests is the Columbia Suicide Severity Rating Scale (C-SSRS) (available at Columbia Suicide Severity Rating Scale Website). Subgroup Recommendations Parkinson’s disease These instruments and elements are recommended for use in all Parkinson’s disease studies: Core instruments:
Eye movements typically follow very distinct patterns. In Parkinson's disease, the loss of cells that use dopamine (a brain chemical) to coordinate movement can cause alterations in these patterns. While these changes may be unnoticeable to a casual observer, they could be detected wih more sensitive eye testing, such as that used by VCU .
AngularJS is an extensible and exciting new JavaScript MVC framework developed by Google for building well-designed, structured and interactive single-page applications (SPA). It lays strong emphasis on Testing and Development best practices such as templating and declarative bi-directional data binding. This cheat sheet co-authored by Ravi Kiran and Suprotim Agarwal, aims at providing a quick .
