Dallas, TX: ReportsandReports announce it will carry Italy Pharmaceutical Market Overview Generic penetration set to rise Market Research Report in its Store. Browse complete Italy Pharmaceutical Market Overview Generic penetration set to rise Report The prescription pharmaceutical market in Italy was valued at $24.9 billion in 2009. Key growth drivers for branded pharma include the growing use of chronic high-value innovative treatments driven by a growing elderly population, the high proportion of the healthcare budget spent on pharmaceuticals, and a high level of brand loyalty among Italian patients. Scope Highlights Due to high pharmaceutical spend driven by limited generic usage, Italy employs a range of pricing and reimbursement tools to control costs. As a result, drug prices in Italy are among the lowest in Europe, a factor which is largely behind the country’s high parallel export activity. As a result of reforms introduced in April 2009, branded pharma companies are now forced to maintain brand prices at a higher price than the first generic product to market. This is likely to increase the level of brand erosion post patent expiry. A number of pharma players in Italy are closing or downsizing their manufacturing and/or R&D operations in an effort to reduce costs. However, the Agenzia Italiana del Farmaco is taking steps to tackle a number of issues affecting the Italian pharma industry in order to attract investment into the country, and to ensure drugs’ quality and safety. Reasons to Purchase Table of Content ABOUT DATAMONITOR HEALTHCARE 2 About the Healthcare Strategic Analysis Team 2 Country specific reports: 2 Global issue reports: 2 1. Executive Summary 3 Strategic scoping and focus 3 Key findings – healthcare drivers and resistors in Italy 4 Socio-demographic and economic analysis in Italy 7 Socio-demographic trends 7 Socio-economic trends 8 Healthcare system and drug regulatory analysis in Italy 9 Healthcare expenditure 9 Healthcare system overview 10 Regulatory issues 10 Pricing and reimbursement issues 10 Prescription pharmaceutical sales analysis in Italy 12 Pharmaceutical market size 12 Leading therapy areas 12 Leading prescription pharmaceutical brands 12 Leading pharmaceutical companies 12 Drug expiry analysis in Italy 14 Generics market 14 Brand erosion post patent expiry 14 Biosimilars market 14 Pharmaceutical industry infrastructure analysis in Italy 16 Pharmaceutical industry infrastructure overview 16 R&D infrastructure trends 16 Manufacturing infrastructure trends 17 Related reports 19 Upcoming related reports 19 Table of Contents 20 2. Socio-demographic and economic analysis in Italy 21 Key findings 21 Socio-demographic trends 21 Socio-economic trends 21 Demographic trends in Italy 22 Population in Italy expected to drop 23 Population growth rate in Italy remains low due to low birth rates 24 Proportion of elderly people in Italy expected to rise and then level off 26 Life expectancy will continue to increase in Italy 27 Disease burden in Italy – leading cause of death is heart disease 28 Neuropsychiatric conditions account for the highest disease burden in Italy 29 Political climate in Italy 31 Italy has a multi-party political landscape 31 Italian economic growth impacted by regional disparities and corruption 32 The worst part of the recession may be over, but the economy is still vulnerable 33 Italy imposes measures to reign in pharmaceutical expenditure 35 Business environment in Italy 35 Investors are somewhat deterred from investing in Italy 35 The recession has impacted export activity and unemployment levels 36 Income and corporation tax in Italy are moderate 36 3. Healthcare system and drug regulatory analysis in Italy 37 Key findings 37 Healthcare expenditure 37 Healthcare system overview 37 Regulatory issues 37 Pricing and reimbursement issues 38 Healthcare expenditure in Italy is below OECD average 39 Healthcare system in Italy 41 SSN is the main healthcare provider in Italy 41 SSN is funded through taxation 43 Healthcare policy is determined by regional governments 43 ASLs are financed by the regional governments 44 Italy’s healthcare system aims to prioritize patient rights but patient satisfaction remains below EU average 45 Italy has good health outcomes in life-threatening diseases 45 Most Italians use the SSN, but many now also have private health insurance 45 In Lombardy both public and private hospitals are equally eligible for public funds 46 Primary care in Italy is provided mainly via independent general practitioners 46 Regulatory issues in Italy 48 Drug approval and regulatory processes in Italy 48 AIFA is responsible for regulating medicines 49 The EU centralized procedure is convenient but expensive 50 Decentralized procedure introduced to address disputes in mutual recognition procedure 50 The regulatory process in Italy is slow 51 Regional requirements present additional obstacles 51 Brands tend to be launched later in Italy 51 Intellectual property environment in Italy 52 Intellectual property protection lags behind other EU countries and recent court decisions reinforced its pro-generic legislation 52 Complementary Certificate of Protection extends patent life in Italy 53 Italy has used compulsory licensing to promote competition 53 Data exclusivity issues in Italy 53 Italy follows the 8+2+1 rule 53 Pediatric SPC extension provides additional market exclusivity period 54 Drug counterfeiting – Italy is one of the worst hit markets in Europe 54 Parallel trade – Italy is a major exporter 55 Pricing and reimbursement in Italy 56 Pharma companies face strict pricing pressures in Italy 56 AIFA regulates pricing and reimbursement of medicines 57 Pricing and reimbursement are interlinked in Italy – Average European Price system has been replaced by a negotiation system for determining pricing and reimbursement at drug launch Reimbursement in Italy 60 Drugs are grouped into reimbursement categories 60 Regions can develop their own formularies and drug prescribing groups 61 Expenditure ceilings have been imposed on pharmaceuticals to control healthcare spending 61 Drug monitoring and risk-sharing agreements have been introduced in Italy 61 Pharma must grant rebates to hospitals in Italy 63 Patient co-payment help reduce SSN expenditure 63 Pharmacist substitution incentivized since 2009 64 Pricing in Italy 64 A system for evaluating and setting prices of innovative drugs was introduced in 2008 64 Reference pricing is a key cost-containment tool in Italy for off-patent drugs 66 Price cuts are a major cost containment tool in Italy 66 Pricing and reimbursement negotiations contribute to delays in drug launches in Italy 67 4. Prescription pharmaceutical sales analysis in Italy 69 Key findings 69 Pharmaceutical market size 69 Leading therapy areas 69 Leading prescription pharmaceutical brands 69 Leading pharmaceutical companies 69 Pharmaceutical market size in Italy 70 Leading therapy areas in Italy 73 Cardiovascular drugs collectively hold the largest market share but have exhibited flat sales growth 75 Musculoskeletal drugs exhibited the fastest sales and volume growth due to rapid uptake of a new first-in-class drug Gastroenterology market is contracting due to intensifying generic competition 76 Leading pharmaceutical brands in Italy 77 Lipitor is the top selling brand and is set to maintain its position in Italy due to strong brand loyalty 80 Herceptin’s strong sales growth is attributed to superior efficacy and unbeatable gold standard status 80 Eprex has exhibited solid growth although its future position remains uncertain due to fierce competition 80 Leading pharmaceutical companies in Italy 82 The leading international companies hold the lion’s share of the Italian pharmaceutical market 83 The leading domestic companies are exhibiting faster growth rates 86 Menarini 87 5. Drug expiry analysis in Italy 88 Key findings 88 Generics market 88 Brand erosion post patent expiry 88 Biosimilars market 88 Italy generics market dynamics 91 Italian generics volume uptake 92 Italian generics value uptake 93 Italian generics market size 94 Drivers and resistors in the Italian generics market 95 The Italian generics market is experiencing strong growth that is set to continue 97 Variation in regional generic prescribing rates driven by access to funding 98 Incentives for pharmacists drive up generic dispensing but hit generics company margins 99 12% price cut further impacts generic company margins 99 Maintaining price differential between branded and generics drugs will drive growth 99 Italian cultural factors predispose brand loyalty 100 Key players in the Italian generics market 102 Opportunities for the generics industry 103 Small molecule brand erosion in Italy 105 Overview of drugs analyzed 105 Mean level of brand erosion in Italy 106 Brand erosion in the Italian retail and hospital setting 108 Brand erosion by therapy area in Italy 109 Brand erosion by drug formulation in Italy 112 Biosimilars market dynamics in Italy 115 Drivers of biosimilar uptake 115 Resistors to biosimilar uptake in Italy 115 Key players in the Italian biosimilars market 116 Biosimilar epoetin 117 Epoetin volume and value market share 117 Biosimilar epoetin market share 117 Biosimilar filgrastim 119 Filgrastim volume and value market share 119 Biosimilar somatropin 119 Somatropin volume and value market share 120 New and future biosimilar launches 122 Opportunities for the biosimilars industry 123 Branded monoclonal antibody therapies could soon face biosimilar incursion 125 Biosimilars in development internationally 126 6. Pharmaceutical Industry Infrastructure analysis in Italy 128 Key findings 128 Pharmaceutical industry infrastructure overview 128 R&D infrastructure trends 128 Manufacturing infrastructure trends 128 Overview of pharma infrastructure in Italy 129 R&D and manufacturing strategies in Italy 129 Big Pharma cut domestic R&D workforce, but drug discovery set to benefit from public-private collaborations 130 Pharma divests manufacturing sites, favoring a more outsourced model 131 Key company infrastructure in Italy 131 Pfizer 132 Pfizer divests manufacturing sites in order to shift production to outsourcing 136 Sanofi-Aventis 137 Roche 141 GlaxoSmithKline 145 Menarini 149 Merck & Co. 153 Novartis 157 Novartis acquires Mipharm’s commercial and marketing operations 161 AstraZeneca 162 AstraZeneca sold its manufacturing plant although it will continue to operate as a supplier for the company 166 Bayer Schering 167 Johnson & Johnson 171 Bibliography 174 Socio-demographic and Economic analysis 174 Publications and online articles 174 Datamonitor reports and products 176 Healthcare system & drug regulation 176 Publications and online articles 176 Datamonitor reports and products 180 Prescription pharmaceutical sales analysis 181 Publications and online articles 181 Datamonitor reports and products 181 Drug expiry analysis 181 Publications and online articles 181 Datamonitor reports and products 183 Industry infrastructure analysis 184 Publications and online articles 184 Appendix 186 Exchange rates 186 Brand erosion – additional data and analysis 187 Brand erosion – methodology 189 Datamonitor prescription pharmaceutical definition and therapy area classification 192 About Datamonitor 193 About Datamonitor Healthcare 193 Datamonitor consulting 193 Disclaimer 195 Browse complete Italy Pharmaceutical Market Overview Generic penetration set to rise Report Browse all Healthcare Market Research Reports Browse all Datamonitor Market Research Reports RSS Browse all Latest Report Related Reports: Biofuels for Commercial Aviation: A New Market Set To Rise The rise and rise of exchange traded funds Italy Orthopedic Devices Market Outlook to 2016 About Us: Contact:
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