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Italy Pharmaceutical Market Overview Generic penetration set to rise Product Image

Italy Pharmaceutical Market Overview Generic penetration set to rise

  • ID: 1289486
  • July 2010
  • Region: Italy
  • 195 pages
  • Datamonitor

Introduction

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

-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 READ MORE >

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1. Executive Summary
Strategic scoping and focus
Key findings - healthcare drivers and resistors in Italy
Socio-demographic and economic analysis in Italy
Socio-demographic trends
Socio-economic trends
Healthcare system and drug regulatory analysis in Italy
Healthcare expenditure
Healthcare system overview
Regulatory issues
Pricing and reimbursement issues
Prescription pharmaceutical sales analysis in Italy
Pharmaceutical market size
Leading therapy areas
Leading prescription pharmaceutical brands
Leading pharmaceutical companies
Drug expiry analysis in Italy
Generics market
Brand erosion post patent expiry
Biosimilars market
Pharmaceutical industry infrastructure analysis in Italy
Pharmaceutical industry infrastructure overview
R&D infrastructure trends
Manufacturing infrastructure trends
Related reports
Upcoming related reports

2. Socio-demographic and economic analysis in Italy
Key findings
Socio-demographic trends
Socio-economic trends
Demographic trends in Italy
Population in Italy expected to drop
Population growth rate in Italy remains low due to low birth rates
Proportion of elderly people in Italy expected to rise and then level off
Life expectancy will continue to increase in Italy
Disease burden in Italy - leading cause of death is heart disease
Neuropsychiatric conditions account for the highest disease burden in Italy
Political climate in Italy
Italy has a multi-party political landscape
Italian economic growth impacted by regional disparities and corruption
The worst part of the recession may be over, but the economy is still vulnerable
Italy imposes measures to reign in pharmaceutical expenditure
Business environment in Italy
Investors are somewhat deterred from investing in Italy
The recession has impacted export activity and unemployment levels
Income and corporation tax in Italy are moderate
3. Healthcare system and drug regulatory analysis in Italy
Key findings
Healthcare expenditure
Healthcare system overview
Regulatory issues
Pricing and reimbursement issues
Healthcare expenditure in Italy is below OECD average
Healthcare system in Italy
SSN is the main healthcare provider in Italy
SSN is funded through taxation
Healthcare policy is determined by regional governments
ASLs are financed by the regional governments
Italy's healthcare system aims to prioritize patient rights but patient satisfaction remains below EU average
Italy has good health outcomes in life-threatening diseases
Most Italians use the SSN, but many now also have private health insurance
In Lombardy both public and private hospitals are equally eligible for public funds
Primary care in Italy is provided mainly via independent general practitioners
Regulatory issues in Italy
Drug approval and regulatory processes in Italy
AIFA is responsible for regulating medicines
The EU centralized procedure is convenient but expensive
Decentralized procedure introduced to address disputes in mutual recognition procedure
The regulatory process in Italy is slow
Regional requirements present additional obstacles
Brands tend to be launched later in Italy
Intellectual property environment in Italy
Intellectual property protection lags behind other EU countries and recent court decisions reinforced its pro-generic legislation
Complementary Certificate of Protection extends patent life in Italy
Italy has used compulsory licensing to promote competition
Data exclusivity issues in Italy
Italy follows the 8+2+1 rule
Pediatric SPC extension provides additional market exclusivity period
Drug counterfeiting - Italy is one of the worst hit markets in Europe
Parallel trade - Italy is a major exporter
Pricing and reimbursement in Italy
Pharma companies face strict pricing pressures in Italy
AIFA regulates pricing and reimbursement of medicines
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
Drugs are grouped into reimbursement categories
Regions can develop their own formularies and drug prescribing groups
Expenditure ceilings have been imposed on pharmaceuticals to control healthcare spending
Drug monitoring and risk-sharing agreements have been introduced in Italy
Pharma must grant rebates to hospitals in Italy
Patient co-payment help reduce SSN expenditure
Pharmacist substitution incentivized since 2009
Pricing in Italy
A system for evaluating and setting prices of innovative drugs was introduced in 2008
Reference pricing is a key cost-containment tool in Italy for off-patent drugs
Price cuts are a major cost containment tool in Italy
Pricing and reimbursement negotiations contribute to delays in drug launches in Italy
4. Prescription pharmaceutical sales analysis in Italy
Key findings
Pharmaceutical market size
Leading therapy areas
Leading prescription pharmaceutical brands
Leading pharmaceutical companies
Pharmaceutical market size in Italy
Leading therapy areas in Italy
Cardiovascular drugs collectively hold the largest market share but have exhibited flat sales growth
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
Leading pharmaceutical brands in Italy
Lipitor is the top selling brand and is set to maintain its position in Italy due to strong brand loyalty
Herceptin's strong sales growth is attributed to superior efficacy and unbeatable gold standard status
Eprex has exhibited solid growth although its future position remains uncertain due to fierce competition
Leading pharmaceutical companies in Italy
The leading international companies hold the lion's share of the Italian pharmaceutical market
The leading domestic companies are exhibiting faster growth rates
Menarini
5. Drug expiry analysis in Italy
Key findings
Generics market
Brand erosion post patent expiry
Biosimilars market
Italy generics market dynamics
Italian generics volume uptake
Italian generics value uptake
Italian generics market size
Drivers and resistors in the Italian generics market
The Italian generics market is experiencing strong growth that is set to continue
Variation in regional generic prescribing rates driven by access to funding
Incentives for pharmacists drive up generic dispensing but hit generics company margins
12% price cut further impacts generic company margins
Maintaining price differential between branded and generics drugs will drive growth
Italian cultural factors predispose brand loyalty
Key players in the Italian generics market
Opportunities for the generics industry
Small molecule brand erosion in Italy
Overview of drugs analyzed
Mean level of brand erosion in Italy
Brand erosion in the Italian retail and hospital setting
Brand erosion by therapy area in Italy
Brand erosion by drug formulation in Italy
Biosimilars market dynamics in Italy
Drivers of biosimilar uptake
Resistors to biosimilar uptake in Italy
Key players in the Italian biosimilars market
Biosimilar epoetin
Epoetin volume and value market share
Biosimilar epoetin market share
Biosimilar filgrastim
Filgrastim volume and value market share
Biosimilar somatropin
Somatropin volume and value market share
New and future biosimilar launches
Opportunities for the biosimilars industry
Branded monoclonal antibody therapies could soon face biosimilar incursion
Biosimilars in development internationally
6. Pharmaceutical Industry Infrastructure analysis in Italy
Key findings
Pharmaceutical industry infrastructure overview
R&D infrastructure trends
Manufacturing infrastructure trends
Overview of pharma infrastructure in Italy
R&D and manufacturing strategies in Italy
Big Pharma cut domestic R&D workforce, but drug discovery set to benefit from public-private collaborations
Pharma divests manufacturing sites, favoring a more outsourced model
Key company infrastructure in Italy
Pfizer
Pfizer divests manufacturing sites in order to shift production to outsourcing
Sanofi-Aventis
Roche
GlaxoSmithKline
Menarini
Merck & Co.
Novartis
Novartis acquires Mipharm's commercial and marketing operations
AstraZeneca
AstraZeneca sold its manufacturing plant although it will continue to operate as a supplier for the company
Bayer Schering
Johnson & Johnson
Bibliography
Socio-demographic and Economic analysis
Publications and online articles
Datamonitor reports and products
Healthcare system & drug regulation
Publications and online articles
Datamonitor reports and products
Prescription pharmaceutical sales analysis
Publications and online articles
Datamonitor reports and products
Drug expiry analysis
Publications and online articles
Datamonitor reports and products
Industry infrastructure analysis
Publications and online articles
Appendix
Exchange rates
Brand erosion - additional data and analysis
Brand erosion - methodology
Datamonitor prescription pharmaceutical definition and therapy area classification
About Datamonitor
About Datamonitor Healthcare
Datamonitor consulting
Disclaimer
List of Tables
Table 1: Italy - changes in the key value drivers of the Italian pharmaceutical market, 2005-09
Table 2: Italy - demographic indicators, 2005 and 2010
Table 3: Italy - key economic indicators, 2005-2012
Table 4: Italy - healthcare expenditure indicators, 2006-09
Table 5: Italy - a range of pricing and reimbursement tools are used
Table 6: Italy - sales and volume of the prescription pharmaceutical market ($ and IMS Standard Units), 2009
Table 7: Italy - key metrics for the generics and biosimilars markets, 2008-09
Table 8: Italy - pharmaceutical industry metrics
Table 9: Italy - R&D and manufacturing infrastructure data, 2010
Table 10: Italy - demographic indicators, 2005 and 2010
Table 11: Italy - top 10 causes of mortality, 2004
Table 12: Italy - disability-adjusted life years (DALY) rates compared to Australia, Japan, the BRIC nations, North America and other key European markets, 2004
Table 13: Italy - key economic indicators, 2005-2012
Table 14: Italy - healthcare expenditure indicators, 2006-09
Table 15: Italy - numbers of hospitals beds, physicians and nurses per 1,000 individuals, 2002 and 2007
Table 16: Order of launch for new molecules in the US, France, Germany, Italy, Spain and the UK, 2005-09
Table 17: Italy - a range of pricing and reimbursement tools are used
Table 18: Italy - reimbursement of pharmaceuticals
Table 19: Italy - across-the-board price cuts of reimbursable drugs, 2002-07
Table 20: Average number of days required to complete negotiation procedure in Italy, 2006
Table 21: Italy - sales and volume of the prescription pharmaceutical market ($ and IMS Standard Units), 2009
Table 22: Italy - pharmaceutical sales by therapy area ($m and %), 2005-09
Table 23: Italy - pharmaceutical volume by therapy area (SUm and %), 2005-09
Table 24: Italy - sales growth for top 20 pharmaceutical brands ($m and %), 2009
Table 25: Italy - volume growth for top 20 pharmaceutical brands (SUm and %), 2009
Table 26: Italy - sales growth for the leading international pharmaceutical companies ($ and %), 2009
Table 27: Italy - volume growth for the leading international pharmaceutical companies ($ and %), 2009
Table 28: Italy - sales growth for the leading Italian-based pharmaceutical companies ($ and %), 2009
Table 29: Italy - volume growth for the leading Italian-based pharmaceutical companies ($ and %), 2009
Table 30: Italy - key metrics for the generics and biosimilars markets, 2008-09
Table 31: Italy - comparison of generic penetration versus other major pharmaceutical markets ($ billion and %), 2007-08
Table 32: Italy - leading generics companies, 2009
Table 33: Italy - brands exposed to generic competition, 2010-12
Table 34: Italy - key metrics for the biosimilars market, 2009
Table 35: Italy - leading biosimilar companies, 2009
Table 36: Biosimilars approved and rejected in Europe by the European Medicines Agency (EMA) to June 2010
Table 37: Italy - 2009 sales of biologics both expired and expected to come off-patent in 2010-15
Table 38: Italy - pharmaceutical industry metrics
Table 39: Italy - prescription sales growth for the top 10 pharmaceutical companies ($m and %), 2009
Table 40: Italy - Pfizer's R&D and manufacturing infrastructure (post-merger with Wyeth), 2010
Table 41: Italy - Pfizer's R&D and manufacturing infrastructure data, 2010
Table 42: Italy - Pfizer's Italy-based M&A activity, Q1 2008-Q1 2010
Table 43: Italy - Sanofi-Aventis's R&D and manufacturing infrastructure, 2010
Table 44: Italy - Sanofi-Aventis's R&D and manufacturing infrastructure data, 2010
Table 45: Italy - Roche's R&D and manufacturing infrastructure, 2010
Table 46: Italy - Roche's R&D and manufacturing infrastructure data, 2010
Table 47: Italy - GlaxoSmithKline's R&D and manufacturing infrastructure, 2010
Table 48: Italy - GlaxoSmithKline's R&D and manufacturing infrastructure data, 2010
Table 49: Italy - Menarini's R&D and manufacturing infrastructure, 2010
Table 50: Italy - Menarini's R&D and manufacturing infrastructure data, 2010
Table 51: Italy - Merck & Co.'s R&D and manufacturing infrastructure, 2010
Table 52: Italy - Merck & Co.'s R&D and manufacturing infrastructure data, 2010
Table 53: Italy - Novartis's R&D and manufacturing infrastructure, 2010
Table 54: Italy - Novartis's R&D and manufacturing infrastructure data, 2010
Table 55: Italy - Novartis's Italy-based M&A activity, Q1 2008-Q1 2010
Table 56: Italy - AstraZeneca's R&D and manufacturing infrastructure, 2010
Table 57: Italy - AstraZeneca's R&D and manufacturing infrastructure data, 2010
Table 58: Italy - AstraZeneca's Italy-based M&A activity, Q1 2008-Q1 2010
Table 59: Italy - Bayer Schering's R&D and manufacturing infrastructure, 2010
Table 60: Italy - Bayer Schering's R&D and manufacturing infrastructure data, 2010
Table 61: Italy - Johnson & Johnson's R&D and manufacturing infrastructure, 2010
Table 62: Italy - Johnson & Johnson's R&D and manufacturing infrastructure data, 2010
Table 63: Currency exchange rates, 2010
Table 64: ATC (anatomical therapeutic chemical) classification codes assigned to a given therapy area within the prescription pharmaceutical market
List of Figures
Figure 1: Italy - key value drivers of Italy's pharmaceutical market, 2009
Figure 2: Italy - drivers and resistors facing branded pharmaceutical companies
Figure 3: Italy - population and population growth rate, 1950-2050
Figure 4: Italy - population growth compared to the other seven major markets, Australia, Japan, the BRIC nations, North America and other key European markets, 1950-2050
Figure 5: Italy - birth rates per 1,000 individuals compared to Australia, Japan, the BRIC nations, North America and other key European markets, 1950-2050
Figure 6: Italy - proportion of population over 65 years compared to Australia, Japan, the BRIC nations, North America and other key European markets, 1950-2050
Figure 7: Italy - life expectancy compared to Australia, Japan, the BRIC nations, North America and other key European markets,1950-2050
Figure 8: Italy - GDP per capita growth rate compared to Australia, Japan, the BRIC nations, North America and other key European markets, 2005-09
Figure 9: Debt trap rankings for Italy, France, Germany, Spain, UK, US, Canada, Australia and Japan, 2010
Figure 10: Unemployment rates in Italy, France, Germany, Italy, Spain, UK, US, Canada, Australia, Japan, Brazil, India, Russia and China, 1990-2008
Figure 11: Italy - the proportion of GDP expenditure on healthcare is lower than that of most other developed nations, 2007
Figure 12: Italy - structure of the healthcare system, 2009
Figure 13: Italy: Routes to obtaining marketing authorization
Figure 14: Italy - the structure of the Italian Medicines Agency (AIFA)
Figure 15: EU: the 8+2+1 market exclusivity rule
Figure 16: Italy - pricing and reimbursement negotiation procedure
Figure 17: RFOM's web-based approach for the management of oncology patients
Figure 18: Italy - categories for evaluating prices of new drugs set out by AIFA
Figure 19: Italy - relative sales and volume of the Italian prescription pharmaceutical market (indexed against volume or value in 2005), 2005-09
Figure 20: Italy - pharmaceutical sales by therapy area (%), 2005-09
Figure 21: Italy - sales growth for the leading pharmaceutical brands ($m and %), 2009
Figure 22: Italy - sales growth for leading pharmaceutical companies (%), 2005-09
Figure 23: Italy - comparison of generic volume uptake versus other major pharmaceutical markets (%), 2007-08
Figure 24: Italy - comparison of generic value uptake versus other major pharmaceutical markets (%), 2007-08
Figure 25: Italy - comparison of generics market size versus other major pharmaceutical markets ($ billion), 2007-08
Figure 26: Italy - drivers and resistors to generic uptake before and after 2009 reforms
Figure 27: Italy - historical and forecast growth in the Italian generics market, 2001-2011
Figure 28: Italy - number of physicians prescribing generics (000s) against total number of physicians (000s) in Italy, 2003-07
Figure 29: Italy - generics and off-patent drugs as volume (%) and value (%) of the Italian pharmaceutical market, 2008
Figure 30: Italy - branded sales at risk of generic erosion ($m), 2010-2012
Figure 31: Italy - mean erosion (by value and volume) of branded small molecules during the first 2 years of generic competition (%)
Figure 32: Italy - mean erosion (by value and volume) of branded small molecules by prescribing setting in Italy market during the first 2 years of generic competition
Figure 33: Italy - mean erosion (by value and volume) of branded small molecules by therapy area during the first 2 years of generic competition
Figure 34: Italy - mean erosion (by value and volume) of branded small molecules by formulation during the first 2 years of generic competition
Figure 35: Italy - biosimilar epoetin market share by value and volume (%), 2008-09
Figure 36: Italy - biosimilar somatropin value and volume uptake, 2006-09
Figure 37: Italy - 2009 sales ($m) by product class of biologics expected to come off-patent in 2010-15
Figure 38: Drivers and resistors to biosimilar monoclonal antibody entry, 2010
Figure 39: Key biosimilars in development internationally by product class, 2010
Figure 40: Pharma's strategic responses to slowing sales and operating profit growth
Figure 41: Italy - Pfizer's manufacturing presence (post-merger with Wyeth) , 2010
Figure 42: Italy - Pfizer's pharmaceutical operations (post-merger with Wyeth), 2010
Figure 43: Italy - Sanofi-Aventis's R&D presence, 2010
Figure 44: Italy - Sanofi-Aventis's pharmaceutical operations, 2010
Figure 45: Italy - Roche's manufacturing presence, 2010
Figure 46: Italy - Roche's pharmaceutical operations, 2010
Figure 47: Italy - GlaxoSmithKline's R&D and manufacturing presence, 2010
Figure 48: Italy - GlaxoSmithKline's pharmaceutical operations, 2010
Figure 49: Italy - Menarini's R&D and manufacturing presence, 2010
Figure 50: Italy - Menarini's pharmaceutical operations, 2010
Figure 51: Italy - Merck & Co.'s R&D and manufacturing presence, 2010
Figure 52: Italy - Merck & Co.'s and Schering-Plough's pharmaceutical operations, 2010
Figure 53: Italy - Novartis's R&D presence, 2010
Figure 54: Italy - Novartis's pharmaceutical operations, 2010
Figure 55: Italy - AstraZeneca's R&D and manufacturing presence, 2010
Figure 56: Italy - AstraZeneca's pharmaceutical operations, 2010
Figure 57: Italy - Bayer Schering's manufacturing presence, 2010
Figure 58: Italy - Bayer Schering's pharmaceutical operations, 2010
Figure 59: Italy - Johnson & Johnson's pharmaceutical operations, 2010
Figure 60: Italy - sales erosion of branded small molecules during the first 2 years of generic competition
Figure 61: Italy - volume erosion of branded small molecules during the first 2 years of generic competition
Figure 62: Drugs experiencing generic erosion between Q1 2006 and Q2 2007
Figure 63: Erosion curves for each drug experiencing generic entry
Figure 64: Mean erosion curve for drugs A, B, and C experiencing generic entry

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Note: Product cover images may vary from those shown

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