High national debt and a falling birth rate create a poor economic outlook and challenging market environment for pharma companies in Italy. Generic penetration is among the lowest in the world. However, as payers seek to control healthcare spending, generic uptake will increase.Analysis of population demographics, economic indicators, and political developments in Italy.Insight into the healthcare system, drug regulation, drug pricing, drug reimbursement, and disease burden.Evaluation of the generics and biosimilars landscape in terms of regulatory issues, cultural factors, and level of penetration.Analysis of the key drivers and resistors of generics and biosimilars markets.Italy's birth rate is lower than most other developed European markets. Combined with high national debt, this will result in challenging economic conditions. The greatest impact will be on the market for branded pharma, while generics companies will benefit.Italy's healthcare spending is comparable with other OECD countries, but lower than the average for France, Germany, Spain, and the UK. Public healthcare accounts for the vast majority of spend, which is delivered through 20 regional health agencies.Italy has among the lowest levels of generic usage (by both volume and value). Healthcare policy is devolved to regional agencies, which has led to large variation in generic uptake across the country. However, cost-cutting reforms including price cuts have been introduced to increase generic usage nationally.How is the regulatory landscape in Italy changing and what is the impact of pricing and reimbursement controls on market access'What are the drivers and resistors of generic and biosimilars uptake in Italy's pharmaceutical market'How have leading pharma companies in Italy been impacted by industry challenges'

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Italy Pharmaceutical Market Overview ' Challenging outlook due to
austerity and falling birth rate
Published on December 2012
Report Summary
High national debt and a falling birth rate create a poor economic outlook and challenging market environment for pharma companies
in Italy. Generic penetration is among the lowest in the world. However, as payers seek to control healthcare spending, generic
uptake will increase.
Analysis of population demographics, economic indicators, and political developments in Italy.
Insight into the healthcare system, drug regulation, drug pricing, drug reimbursement, and disease burden.
Evaluation of the generics and biosimilars landscape in terms of regulatory issues, cultural factors, and level of penetration.
Analysis of the key drivers and resistors of generics and biosimilars markets.
Italy's birth rate is lower than most other developed European markets. Combined with high national debt, this will result in
challenging economic conditions. The greatest impact will be on the market for branded pharma, while generics companies will
benefit.
Italy's healthcare spending is comparable with other OECD countries, but lower than the average for France, Germany, Spain, and
the UK. Public healthcare accounts for the vast majority of spend, which is delivered through 20 regional health agencies.
Italy has among the lowest levels of generic usage (by both volume and value). Healthcare policy is devolved to regional agencies,
which has led to large variation in generic uptake across the country. However, cost-cutting reforms including price cuts have been
introduced to increase generic usage nationally.
How is the regulatory landscape in Italy changing and what is the impact of pricing and reimbursement controls on market access'
What are the drivers and resistors of generic and biosimilars uptake in Italy's pharmaceutical market'
How have leading pharma companies in Italy been impacted by industry challenges'
Table of Content
Table of Contents
Executive Summary 2
Healthcare drivers and resistors in Italy 2
Sociodemographic and Economic Analysis 7
Key findings 7
Demographic trends 8
Disease burden 14
Political and economic climate 17
Healthcare System and Drug Regulatory Analysis 21
Key findings 21
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Healthcare expenditure 23
Insurance and healthcare system 25
Regulatory issues 32
Pricing and reimbursement 39
Generics and Biosimilars 55
Key findings 55
Generics market dynamics 56
Drivers and resistors in the generics market 60
Biosimilars market dynamics 65
Bibliography 66
Sociodemographic and economic analysis 66
Healthcare system and drug regulatory analysis 67
Generics and biosimilars 73
Appendix 77
Contributors 77
Exchange rates used in this report 77
About Datamonitor 77
Disclaimer 78
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