The prescription pharmaceutical market in Australia was valued at $9.1

Рубрика: Articles. Автор: admin. Понедельник 28 Ноя 2011 в 1:49 дп

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 Publications and online articles Datamonitor reports and products Australia – Socio-demographic and economic analysis Publications and online articles Australia – Healthcare system and drug regulatory analysis Publications and online articles Datamonitor reports and products Australia – Prescription pharmaceutical sales analysis Publications and online articles Australia – Drug expiry analysis Publications and online articles Datamonitor reports and products Australia – Pharmaceutical industry infrastructure analysis Publications and online articles APPENDIX Exchange rate used in this report Australia brand erosion – additional data Australia brand erosion – methodology Datamonitor prescription pharmaceutical definition and therapy area classification About Datamonitor About Datamonitor Healthcare Datamonitor consulting Disclaimer Disclaimer


Отзывов нет »

Отзывов нет.

RSS-лента комментариев. Адрес для трекбека

Ваш отзыв







Copyright © 2010 Кабельное ТВ от «Бриз ТВ».

Powered by WordPress