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Italy Pharmaceutical Market Overview Generic penetration set to rise now available at ReportsandReports

The prescription pharmaceutical market in Italy was valued at .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

*Overview of Italy’s socioeconomic and demographic trends, healthcare system, regulation, pricing and reimbursement and intellectual property position

*Assesses the size of Italy’s pharmaceutical market by prescribing setting, therapy area, leading brands and by leading companies

*Examines Italy’s generics and biosimilars landscape in terms of regulatory issues, level of penetration, key players and degree of brand erosion

*Quantifies Italy’s R&D and manufacturing infrastructure for the leading pharmaceutical companies, including key metrics and domestic M&A analysis

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

*Evaluate the evolving regulatory landscape and the impact of pricing and reimbursement controls on market access.

*Quantify the size and growth of the prescription pharmaceutical market in Italy, analyzing key therapy areas, brands and companies.

*Assess drivers and resistors of generic and biosimilars uptake in Italy as well as the level of erosion brands can expect to face post patent expiry.

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 57

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 75

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