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Oct 1, 2012

Brazil Pharmaceutical Market Overview – Strong market growth continues, but regulatory risks increase

Key growth drivers in Brazil include the expanding population, improved access to healthcare, and the burgeoning middle class which is increasingly opting for branded drugs. Consequently, Big Pharma is targeting Brazil to offset slowing sales growth in more developed markets.

Features and benefits

Analysis of population demographics, economic wealth, disease burden, level of industrialization, and political structure in Brazil.
Insight into the healthcare system, drug regulation, drug pricing, drug reimbursement, and intellectual property position in Brazil.
Assesses the generics and biosimilars landscape in terms of regulatory issues, level of penetration, and key players in Brazil.
Overview of key market segment sales and top companies, and R&D and manufacturing infrastructure for the leading pharmaceutical companies in Brazil.

Buy a copy of this report @ http://www.reportsnreports.com/reports/194883-brazil-pharmaceutical-market-overview-strong-market-growth-continues-but-regulatory-risks-increase.html

Report Details:
Published: September 2012
No. of Pages: 139
Price:Single User License:US$5700 Corporate User License:US$14250

Highlights

Overall, health expenditure as a percentage of GDP is increasing which reflects the fact that healthcare and access to treatment (and thus pharmaceutical spending) is an increasing priority for the government.

Intellectual property protection remains problematic for branded pharma, with issues associated with patent linkage, drawn-out patent reviews, conflict between the two agencies involved in assessing patent applications, and the fact that there is no set period of data exclusivity.

Strong market growth in conjunction with improving regulatory standards has led to Brazil becoming a hotbed of investment from both multinational and domestic companies. Big Pharma players are gaining a stronger presence through M&A, benefiting from strong brand image of the local manufacturers.

Your key questions answered

How is the regulatory landscape in Brazil changing and what is is the impact of pricing and reimbursement controls on market access in Brazil?
What are the drivers and resistors of generic and biosimilars uptake in the Brazilian pharmaceutical market?
Which pharmaceutical market segments in Brazil have the fastest growth rates?

Mar 5, 2012

The Outlook for Pharmaceuticals Worldwide

Espicom’s Pharmaceutical Market Outlook reports have been used by senior management in commerce and industry for 30 years. Why? Because our experienced team of researchers and analysts combine economic, scientific, demographic and language skills to produce an unmatched and critical evaluation of the operating environment for pharmaceutical companies.

An unmatched level of intelligence sourcing

Our full time team of experts regularly access over 1,200 primary source information points in regulatory authorities, health organisations, statistics offices and industry. Much of the information in the Pharmaceutical Market Outlook reports is not readily available in English elsewhere. Espicom partners with the widely regarded Economist Intelligence Unit (EIU) to provide up-to-date economic data – a constant requirement in these rapidly changing times.

Detailed analysis & novel forecasts

Assembling comprehensive data is one thing, but our strength lies in its interpretation. What does it mean and what are the implications for operations and business development? Our analysis is second to none and the economic and market forecasts are built on solid research principles and continually assessed to reflect current and anticipated market conditions.

Worldwide Pharmaceuticals Outlook Market

Published: March 2012
Price: US$ 17490

Global industry...

By 2016, the global pharmaceutical market, including pharmacy and hospital sales, is forecast to be worth around US$1.6 trillion at retail prices. High growth in emerging markets will leverage slow growth in developed markets. Cost-containment policies will be offset against market demands for more effective products. Health access will expand, due to increasing generic penetration.

Localisation
The local market is the operating environment in which companies have to work. Domestic priorities set the agenda that affects a company’s operations, therefore the prevailing macroenvironment needs to be both understood and planned for. In this way, pharmaceutical companies have strengthened their capabilities to increase sales in local and international markets.

Beyond BRIC markets

The USA will continue to be the first worldwide economy, but other emerging markets will perform well, led by China, India, Russia and Brazil. However, a second wave of emerging markets will arise, namely South Korea, Mexico, Turkey, Indonesia and Poland. In an environment that is becoming more regulated, pharmaceutical producers are re-aligning their global strategies.

Quality information = business confidence

Any investment in market information must make a real return in terms of market knowledge and business efficiency. That demands the data is of the highest quality, thoroughly researched with primary sources and with insightful analysis and forecasts. Our team of analysts – with science, language and analysis skills – work full time to produce pharmaceutical market information that is second to none. With Pharmaceutical Market Outlook you get comprehensive market evaluation on which you can rely.
Guaranteed.

Feb 19, 2012

Emerging Pharmaceutical Market - Czech Republic – Planned Healthcare Reform Plans Forecast to Slow Growth Rates

GBI Research’s new report, Emerging Pharmaceutical Market - Czech Republic – Planned Healthcare Reform Plans Forecast to Slow Growth Rates provides in-depth analysis of trends, issues and challenges in the pharmaceutical market in the Czech Republic. The report analyzes overall pharmaceutical and outsourcing market structure in the Czech Republic. The report provides competitive benchmarking for the leading companies and analyzes the M&A and strategic partnerships that shape the Czech pharmaceutical market. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts. The Czech Republic pharmaceutical market is one of the most attractive markets in Central and Eastern Europe. The availability of cost effective skilled labour, high quality infrastructure and EU harmonious regulations are the main reasons for the fast growth of the Czech pharmaceutical industry. Most local drug manufacturers and distributors are owned by big international pharmaceutical firms. GBI Research valued the Czech pharmaceutical market at $3.1 billion in 2010, which grew with a compound annual growth rate (CAGR) of 11.7% from 2004 to 2010. The Czech healthcare sector will witness many new healthcare reforms in the coming years, with the primary objective of reducing growing drug expenditure. In response to these healthcare policies, the Czech pharmaceutical market is expected to witness a lower growth rate in forecast period.

Czech Republic Emerging Pharmaceutical Market

Published: February 2012
No. of Pages:
Price : Single User License - US$3500

GBI Research has analyzed that in 2011, generics had a share of over 50% of the Czech pharmaceutical market. Czech government reforms encourage the manufacture and use of generic drugs, in an attempt to limit drug expenditure and provide low cost-effective public healthcare. Government healthcare policies, coupled with numerous active generic manufacturing companies in the country, will increase the share of generics in the market during the forecast period. The Czech Republic is showing a moderate recovery from the economic downturn in 2009; increased industrial outputs and government structural reforms in various sectors including healthcare have contributed to the growth. GBI Research analyzed that the new healthcare reform policy which is expect to be implemented from 2012, with elements of “standard” and “above standard” care, in which patients pay more for above standard (expensive drugs and services) care and an increase in co-payments from the patients, reduces healthcare affordability for individual patients and will pose a major challenge to the Czech pharmaceutical market.

Scope

Overall pharma, biotech and outsourcing market structure in Czech Republic
Czech Republic pharmaceutical market characterization, including market size, major regulatory bodies, pricing and reimbursement issues, major distribution channel and intellectual property rights.
Czech Republic CRO market growth.
Analysis of the leading segments within the Czech Republic pharmaceutical industry.
Key market drivers and restraints that have a significant impact on the Czech Republic pharmaceutical market.
Competitive benchmarking of leading companies in pharmaceutical and CRO markets.
Key M&A activities and strategic partnership deals that have taken place between 2009 and mid 2011.

Jan 18, 2012

Solid Organ Transplant Immunosupressants Market to 2018 - Limited Availability of Donors Drives Improvements in Organ Procurement and Preservation Methods

GBI Research, the leading business intelligence provider, has released its latest research, Solid Organ Transplant Immunosuppressant Market to 2018 – Limited Availability of Donors Drives Improvements in Organ Procurement and Preservation Methods, which provides insight into the global solid organ transplant immunosuppressant drug market until 2018. The report provides an in-depth analysis of the following five transplant areas: heart, lung, pancreas, liver and kidney. It also details immunosuppressant drug markets in the following key regions: the US, the top five countries of Europe and Japan. The report also includes details about immunosuppressant drug R&D pipelines.

Solid Organ Transplant Immunosupressants Market

Published:January 2012
No. of Pages: 87

The report is built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis by GBI Research’s team of industry experts. GBI Research analysis shows that the global market for immunosuppressant drugs used in transplants is projected to increase at a compound annual growth rate (CAGR) of 6.7% from 2004–2010. The market is forecast to grow at a CAGR of 6.1% from 2010–2018, to reach a value of $5.6 billion in 2018. GBI Research analysis found the R&D pipeline for the immunosuppressant drug market to be moderate. The leading companies in this market, F. Hoffman La Roche, Novartis AG, Genzyme Corporation and Astellas Pharma Inc., are also analyzed in this report.

Scope

Analysis of the five major solid organ immunosuppressant drugs market which include heart transplant, pancreas transplant, lung transplant, kidney transplant and liver transplant immunosuppressant drug market
Data and analysis of the immunosuppressant drug market in the leading regions of the world: the US, the top five countries of Europe and Japan.
Annualized market data for the immunosuppressant drug market from 2004–2010, with forecasts to 2018.
Market data on the geographical landscape and therapeutic landscape, including market sizes, market shares, annual costs of therapy and target populations.
Key drivers and restraints that have had a significant impact on the market.
Pipeline analysis of the immunosuppressant drug market for the five types of transplant.
Competitive landscape of the global immunosuppressant drug market including benchmarking of top companies. The key companies studied in this report are: F. Hoffman La Roche, Novartis AG, Genzyme Corporation and Astellas Pharma Inc.

Reasons to Buy

The report will aid business development and help marketing executives strategize product launches, and:
Build effective strategies to launch pipeline products by identifying potential geographies.
Develop key strategic initiatives by studying the key strategies of top competitors.
Develop market entry and market expansion strategies by identifying geographic markets poised for strong growth.
Reinforce R&D pipelines by identifying new target mechanisms which can produce first in class molecules with better efficacy and safety.

Oct 4, 2010

Brazil Pharmaceutical Market Overview – Expanding healthcare access drives double-digit sales growth now available at ReportsandReports

Dallas, TX: ReportsandReports announce it will carry Brazil Pharmaceutical Market Overview – Expanding healthcare access drives double-digit sales growth Market Research Report in its Store.

Brazil’s retail pharmaceutical market was valued at $12.6 billion in 2009, having grown by 14.3% between 2008 and 2009. Key growth drivers include the expanding population, improved access to healthcare, and the burgeoning middle class which is increasingly opting for branded drugs. Consequently, Big Pharma is targeting Brazil to off-set slowing sales growth in more developed markets.

Scope

Overview of socioeconomic and demographic trends, healthcare system, regulation, pricing, reimbursement and intellectual property position in Brazil

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

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

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

Highlights

Brazil spent 10.8% of its GDP on both retail and hospital prescribed pharmaceuticals in 2009, reflecting the government’s changing priorities, prioritizing healthcare including initiatives to expand access to medicines.

Intellectual property protection remains problematic for branded pharma, with issues associated with patent linkage, drawn out patent reviews, conflict between the two agencies involved in assessing patent applications, and the fact that there is no set period of data exclusivity.

Strong market growth in conjunction with improving regulatory standards has led to Brazil becoming a hotbed for investment from both multinational and domestic companies. Big Pharma players are gaining a stronger presence through M&A, expanding operations, and new product launches.

Reasons to Purchase

Evaluate the evolving regulatory landscape and the impact of pricing and reimbursement controls on market access in Brazil.
Quantify the size and growth of the prescription pharmaceutical market in Brazil, analyzing key therapy areas, brands and companies.
Assess drivers and resistors of generic and biosimilars uptake in Brazil.

Original Source : Brazil Pharmaceutical Market

Buy Now : Market Research

Table Of Contents

ABOUT DATAMONITOR HEALTHCARE 2

About the Healthcare Strategic Analysis Team 2

Geographic specific reports: 2

Global issue reports: 2

1. Brazil – Executive Summary 3

Strategic scoping and focus 3

Key findings – healthcare drivers and resistors in Brazil 4

Brazil – Socio-demographic and economic analysis 7

Socio-demographic trends 7

Socioeconomic trends 8

Brazil – Healthcare system and drug regulatory analysis 11

Brazil healthcare expenditure 11

Brazil healthcare system overview 12

Brazil regulatory issues 13

Brazil pricing and reimbursement issues 13

Brazil – Prescription pharmaceutical sales analysis 15

Pharmaceutical market size 15

Leading therapy areas 15

Leading pharmaceutical brands 15

Leading pharmaceutical companies 15

Brazil – Drug expiry analysis 17

Brazil retail generics market 17

Brazil brand erosion post patent expiry 17

Brazil biosimilars market 17

Brazil – Pharmaceutical Industry Infrastructure analysis 19

Pharmaceutical industry infrastructure overview 19

Related reports 21

Upcoming related reports 21

2. Brazil – Socio-demographic and economic analysis 23

Key findings 23

Socio-demographic trends 23

Socioeconomic trends 23

Demographic trends in Brazil 25

Brazil’s population expected to expand rapidly, peaking in 2040 26

Declining number of births with improving infant mortality rates 28

The Brazilian population is slowly aging 29

The Brazilian population is living longer 30

Disease burden in Brazil 31

Heart disease a leading cause of death in Brazil as in more developed markets 32

Violence and social deprivation still significant despite progress 33

An unexpectedly high rate of prostate cancer deaths representative of gaps in healthcare provision 34

Political climate 35

The end of the Lula government but his legacy will live on 35

The effect of the global economic crisis has been felt less in Brazil 36

PAC gives Brazil much needed infrastructure development 36

Is the Brazilian economy in danger of overheating? 37

Debt reduction a fundamental feature of Lula’s economic policy 38

Increased prosperity has brought income disparities 41

Business environment 41

Setting up business in Brazil can be complex and difficult 41

The Brazilian tax system is complicated and confusing 42

Workforce is extensive but poorly educated 42

3. Brazil – Healthcare system and drug regulatory analysis 44

Key findings 44

Brazil healthcare expenditure 44

Brazil healthcare system overview 44

Brazil regulatory issues 45

Brazil pricing and reimbursement issues 45

Healthcare system 47

Healthcare expenditure in Brazil is rising 47

Growing cost pressures may lead to a cut in the medication budget 49

Healthcare is delivered through two systems 50

The SUS provides universal healthcare coverage in Brazil 51

SUS management has become less centralized 52

Private health insurance system – most Brazilians use the SUS, but the private health segment is expanding 53

Brazil has sought to expand healthcare coverage to reduce inequalities 54

The Family Health Program reduces burden on hospitals and specialist care 54

The Popular Pharmacy program was set up to increase the supply of medicines to the poor 55

Regulatory issues in Brazil 56

Drug approval and regulatory processes – pharma companies regard Brazil’s regulatory environment as unpredictable 56

ANVISA is the national body in charge of regulating medicines in Brazil 56

Similares are being phased out – bioequivalence studies are required for generic drugs in Brazil since 2003 57

Plant inspections are causing lengthy approval times in Brazil 57

ANVISA introduces a new decree on pharmacovigilance 58

Intellectual property protection in Brazil 58

The speed of patent review is slow and backlogs exist 58

There is conflict between the two agencies involved in assessing patent applications 59

There is no set period of data exclusivity in Brazil 59

Compulsory licenses on HIV/AIDS drugs were used only as a threat until May 2007 60

Pipeline patents have awarded several HIV/AIDS drugs extra protections but could be overruled in the future 61

Drug counterfeiting is on the rise in Brazil 61

Drug importation – imported pharmaceuticals have to be registered with ANVISA 62

Pricing and reimbursement in Brazil 63

Pricing issues in Brazil 63

Pricing of new drugs is controlled by the CMED 63

Prices of marketed pharmaceuticals are controlled through price freezes and increases 64

Antiretroviral therapies are priced low in Brazil 65

Reimbursement issues in Brazil – Reimbursable pharmaceuticals are included on the National list of Essential Medicines 66

The Pharmaceutical Care in Primary Healthcare program provides access to essential drugs 67

Strategic program for pharmaceutical assistance includes medicines for neglected diseases 67

The Specialist Pharmaceutical Assistance Component provides specialist and high-cost medicines 68

Despite the SUS reimbursement programs, many patients still do not have access to medicines 68

4. Brazil – Prescription pharmaceutical sales analysis 70

Key findings 70

Pharmaceutical market size 70

Leading therapy areas 70

Leading pharmaceutical brands 70

Leading pharmaceutical companies 70

Pharmaceutical market size in Brazil 72

Leading therapy areas in Brazil 74

Central nervous system was the largest therapy area in terms of sales 76

Musculoskeletal drugs have shown the fastest growth rates 76

Urology and metabolic have shown the slowest growth rates 77

Leading pharmaceutical brands in Brazil 78

Top-selling drug Dorflex sees its franchise extended with follow-up product 81

Cialis to maintain momentum thanks to lifecycle management strategy 81

Lipitor is expected to continue reaching high sales even after patent expiration 81

Leading pharmaceutical companies in Brazil 82

Sanofi-Aventis is now the leading pharma company in Brazil following its acquisition of Medley

Novartis’s Brazilian retail sales growth driven by its Diovan franchise 84

The leading domestic companies are exhibiting double-digit growth rates 86

EMS 87

Eurofarma 87

Neo Quimica 88

5. Brazil – Drug expiry analysis 89

Key findings 89

Brazil retail generics market 89

Brazil brand erosion post patent expiry 89

Brazil biosimilars market 89

Brazilian generics market dynamics 91

Similares versus true generics 92

Brazilian generics volume uptake 94

Brazilian generics value uptake 95

Brazilian generics market size 96

Drivers and resistors in the Brazilian generics market 97

Several legislative measures have driven generic uptake 98

Loose patent regulations lead to increased market potential for generic players 99

Market pressures drive down generics prices below the mandatory 35% discount 99

International pressures could hamper generics importers 100

Similares provide affordable healthcare, but bioequivalence legislation has fueled the uptake of true generics 100

Key generics players in the Brazilian market 101

Acquiring local generics players is key strategy for foreign players to penetrate the Brazilian market 102

Sanofi-Aventis extends its dominance in Brazil 103

Pfizer seeks to extend its presence in Brazil 104

Valeant acquires two Brazilian generic drug companies 105

Lupin committed to gaining ground in Brazil 105

Opportunities for the generics industry 106

Small molecule brand erosion in the Brazilian market 107

Number of generic entrants by therapy area 107

Brazil biosimilars market dynamics 108

Drivers and resistors of biosimilar growth in Brazil 108

Rising healthcare costs 108

Biosimilars approval process enacted in 2005 109

Indian-based companies dominate the market 109

New and future biosimilar launches 111

Opportunities for the biosimilar industry 112

Monoclonal antibody therapies could soon face biosimilar incursion in Brazil 113

Biosimilars in development internationally 115

6. Brazil – Pharmaceutical Industry Infrastructure analysis 116

Key findings 116

Pharmaceutical industry infrastructure overview 116

Key company infrastructure in Brazil 117

EMS 118

Novartis 121

Ache Labs 125

Medley 128

Sanofi-Aventis 128

Eurofarma 131

Pfizer 134

Bayer Schering 138

Castro Marques 141

Merck & Co. 143

7. Bibliography 147

Brazil – Executive summary 147

Publications and online articles 147

Brazil – Socio-demographic and economic analysis 148

Publications and online articles 148

Datamonitor reports and products 151

Brazil – Healthcare systems and regulations 151

Publications and online articles 151

Datamonitor reports and products 155

Brazil – Prescription pharmaceutical sales 155

Publications and online articles 155

Brazil – Drug expiry analysis 156

Publications and online articles 156

Datamonitor reports and products 159

Brazil – Pharmaceutical industry infrastructure analysis 160

Publications and online articles 160

Datamonitor reports and products 161

APPENDIX 162

Exchange rates used in this report 162

Datamonitor prescription pharmaceutical definition and therapy area classification 163

About Datamonitor 164

About Datamonitor Healthcare 164

Datamonitor consulting 164

Disclaimer 165

Disclaimer 166

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Aug 16, 2010

Australia Pharmaceutical Market Overview - Reforms and continued price cuts will change the healthcare landscape now available at ReportsandReports

Dallas, TX: ReportsandReports announce it will carry Australia Pharmaceutical Market Overview – Reforms and continued price cuts will change the healthcare landscape Market Research Report in its Store.

Browse complete Pharmaceutical Market Report

Introduction

The prescription pharmaceutical market in Australia was valued at $9.1 billion in 2009. Key growth drivers include the growing use of chronic high-value innovative treatments driven by a rising elderly population and high public spending as a proportion of total healthcare expenditure.

Scope

* Overview of Australia’s socioeconomics and demographics, healthcare system, regulation, pricing and reimbursement and intellectual property position.

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

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

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

Highlights

Australia’s health expenditure totaled $81.8 billion, representing 9.1% of gross domestic product (GDP) in the financial year of 200708, which is the same percentage of GDP as the previous year. Australia’s health expenditure as a proportion of GDP has been comparable to that seen in Europe, with most of its spending coming from the government.

Lipitor (atorvastatin, Pfizer) generated significantly higher sales than any other brand on the Australian pharmaceutical market in 2009 ($550m). The second and third highest-selling brands, Crestor (rosuvastatin; AstraZeneca) and Nexium (esomeprazole; AstraZeneca), lag far behind Lipitor and did not even reach half of its sales.

Compared with Europe, where 17 biosimilars of five different molecules have been approved since 2006, Australia’s biosimilar market is small, particularly in terms of sales at $45,000. Somatropin is the only biologic that has biosimilar versions available, although the market is still very much dominated by the original branded product.

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 Australia, analyzing key therapy areas, brands and companies.

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

Table Of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Healthcare Strategic Analysis Team

Geographic-specific reports:

Global issue reports:

About the Healthcare Asia-Pacific Team

1. Australia – Executive Summary

Strategic scoping and focus

Key findings – healthcare drivers and resistors in Australia

Australia – Socio-demographic and economic analysis

Socio-demographic trends

Socio-economic trends

Australia – Healthcare system and drug regulatory analysis

Healthcare expenditure

Healthcare system overview

Regulatory issues

Pricing and reimbursement issues

Australia – Prescription pharmaceutical sales analysis

Pharmaceutical market size

Leading therapy areas

Leading prescription pharmaceutical brands

Leading pharmaceutical companies

Australia – Drug expiry analysis

Generics market

Brand erosion post patent expiry

Biosimilars market

Australia – Pharmaceutical industry infrastructure analysis

Pharmaceutical industry infrastructure overview

R&D infrastructure trends

Manufacturing infrastructure trends

Related reports

Upcoming related reports

Table of Contents

2. Australia – Socio-demographic and economic Analysis

Key findings

Socio-demographic trends

Socio-economic trends

Demographic trends in Australia

High population growth is a hot topic in Australia

Australia’s birth rate is expected to stabilize

Proportion of elderly individuals is set to rise

Australia’s life expectancy is one of the highest compared with other markets

Australia is a culturally and ethnically diverse country

Ischemic heart disease tops disease burden in Australia

Political climate in Australia

Federal elections are set for August 21, 2010

The 2010-11 Budget shows that the government’s priorities include reforms in health and hospitals

Memorandum of Understanding (MoU) is good for innovators, but not so good for generics companies

Fifth Community Pharmacy Agreement was received positively all around

Australia’s economy performs relatively well despite global downturn

Australia is doing comparatively well in the face of the global financial crisis

Unemployment rate experienced a small setback

Business environment in Australia

Corporate tax rate is high compared with other medium-sized OECD countries, but likely to be lowered

Unexpected price cuts led to uncertainty in Australia’s pharmaceutical business environment

Historically strong Australian biotechnology industry took a big hit from global downturn

3. Australia – Healthcare system and drug regulatory analysis

Key findings

Healthcare expenditure

Healthcare system overview

Regulatory issues

Pricing and reimbursement issues

Healthcare expenditure – Australia’s growth in pharmaceutical spending is under debate

Australia’s healthcare system

The structure of the Australian healthcare system is complex

Reforms aim to decrease complexity and inequalities by changing the funding and governance of health and hospitals

Government focuses on early intervention and the integration of care in the community

Medicare provides Australians with a range of free services

Medicare Australia funds and provides public healthcare services

Pharmaceutical Benefits Scheme (PBS) funds the use of prescription drugs

The Australian government promotes the uptake of private health insurance

GP Super Clinics will be established in order to improve access to primary care

Australia’s hospital system is split between a public and private market

Rural and Indigenous health are key focal points

National Medicines Policy aims to improve health outcomes through appropriate access to medicines

The Pharmaceutical Health and Rational Use of Medicines Committee and National Prescribing Service focus on quality use of medicines

Regulatory issues in Australia

Therapeutic Goods Administration (TGA) largely adopts EU standards

The Advisory Committee on Prescription Medicines (ACPM) has taken over from the Australian Drug Evaluation Committee (ADEC)

New organizational structure was put in place in mid-2010

New fees for the evaluation of prescription medicines

Therapeutic Goods Administration (TGA) reforms aim to reduce regulatory burden

Accelerated application entry and improved application coordination (streamlined submission process)

Increased transparency of prescription medicine regulatory process (the AusPAR project)

Improved access to prescription medicine information (the PI/CMI project)

The ‘biologicals framework’ refreshes regulations for biologicals

Intellectual property environment

Standard 20-year patent can be extended by up to 5 years

Data exclusivity is 5 years, during which ‘springboarding’ is allowed

Pricing reforms may encourage ‘evergreening’

Drug counterfeiting is less of a problem in Australia than in other developed markets

Drug importation is controlled by the government and patent holders

Drug reimbursement in Australia

Reimbursement is decided by the Pharmaceutical Benefits Advisory Committee (PBAC)

High level of evidence is needed for a drug to be added to reimbursement list

Transparency in PBAC decisions has improved

Probability of a positive PBAC outcome was 75% in 2009, but lower for major applications

Parallel applications to the TGA and PBAC will become possible from 2011

AUD10m ($7.9m) threshold for cabinet approval remains

Section 100 programs provide drugs under special arrangements

Drug pricing in Australia

Prices are negotiated by the Pharmaceutical Benefits Pricing Authority (PBPA)

Latest Pharmaceutical Benefits Scheme (PBS) reforms led to considerable drug price reductions

The price disclosure program singles out generics for further price cuts

Criticized ‘therapeutic groups’ have been put to a halt by the Memorandum of Understanding (MoU)

The PBPA uses different types of pricing models

Reference pricing method is mainly used for products in Formulary 1

Cost Plus method is mainly used for products in Formulary 2

Weighted Average Monthly Treatment Cost (WAMTC) is a key feature in therapeutic groups

Risk sharing agreements lack transparency

Special patient contributions apply in some cases

The Access to Medicines Working Group (AMWG) facilitates discussion between the government and pharmaceutical industry on PBS reforms

PBAC evaluates bDMARDs in cost-effectiveness review

Australian Government Productivity Commission highlights specific concerns about the regulation of medicines in Australia

Requirement for multiple ethics approvals

Timeliness and cost of manufacturing audits/GMP assessments

TGA transparency and communication

Concerns about PBS listing and pricing processes

Delays in achieving PBS listing due to overlapping processes

Concerns about marketing and advertising rules

Australia’s healthcare reforms

4. Australia – Prescription pharmaceutical sales analysis

Key findings

Pharmaceutical market size

Leading therapy areas

Leading prescription pharmaceutical brands

Leading pharmaceutical companies

Pharmaceutical market size in Australia

Leading therapy areas in Australia

Cardiovascular drugs hold the largest share of the Australian market value

Central nervous system products hold the second-largest share of the Australian market value

Musculoskeletal drugs exhibited the strongest growth in sales in 2005-09 and 2008-09

The hematology class experienced the most rapid decline in growth

Leading pharmaceutical brands in Australia

Lipitor achieved by far the highest sales in Australia in 2009, but generics are expected in 2012

Crestor experiences a huge uptake in sales but may face price cuts and uncertain patent protection

Nexium’s sales are going strong despite its price being linked to generic omeprazole

Leading companies in the Australian pharmaceutical market

Leading international companies active in Australia account for 63% of the pharmaceutical market

Leading Australian companies only make up 7% of the Australian pharmaceutical market

Sigma Pharmaceuticals

CSL

iNova Pharmaceuticals

5. Australia – Drug expiry analysis

Key findings

Generics market

Brand erosion post patent expiry

Biosimilars market

Australia generics market dynamics

Australia generics volume uptake

Australia generics value uptake

Drivers and resistors in the Australian generics market

Brand substitution is allowed if equivalence has been shown

Prevention of brand substitution by physicians is possible, but uncommon

Competing on price is difficult for generics manufacturers in Australia

High generics prices are targeted in continued price cuts

Pharmacists receive AUD1.50 for each script of a premium-free PBS drug they dispense

The Generic Medicines Industry Association (GMiA) unites key generics players

The National Prescribing Service (NPS) promotes generics education

Key generics players in Australia

Generic simvastatin is main single source of income for key generics players in Australia

Opportunities for the generics industry

Small molecule brand erosion in Australia

Overview of drugs analyzed

Mean level of brand erosion in Australia

Brand erosion in the Australian retail and hospital setting

Brand erosion by therapy area in Australia

Brand erosion by drug formulation in Australia

Biosimilars market dynamics in Australia

Drivers of biosimilar uptake – Australia bases its biosimilar approval pathway on that of the EU

Resistors of biosimilar uptake – limitations around reimbursement may cast a shadow over the commercial attractiveness of biosimilars in Australia

Somatropin is the only biosimilar available in Australia

Key players in the Australian biosimilars market

Monoclonal antibodies represent a major opportunity for the biosimilars industry

Over $400m in monoclonal antibody sales to go off-patent before 2015

However, branded monoclonal antibody uptake is currently hampered by reimbursement issues

International drivers and resistors to biosimilar monoclonal antibody uptake

Monoclonal antibody biosimilars in development internationally

6. Australia – Pharmaceutical industry infrastructure analysis

Key findings

Pharmaceutical industry infrastructure overview

R&D infrastructure trends

Manufacturing infrastructure trends

Overview of the pharmaceutical infrastructure in Australia

R&D and manufacturing strategies in Australia

Australia misses out as clinical trials are moved to Asia

Key company infrastructure in Australia

Pfizer

AstraZeneca

Sanofi-Aventis

GlaxoSmithKline

Novartis

Merck & Co.

Johnson & Johnson

Sigma Pharmaceuticals

Roche

Mylan

7. Bibliography

Australia – Executive Summary