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Pharmaceutical Outlook 2007
Informa Healthcare, January 2006, Pages: 58
This report takes a look at what we think will happen in 2007, eg who will be the companies to watch, where the key new drugs will come from, the new regulations that are going to come into force next year and their impact, etc. It will give companies an overview of the year to come and help them plan their business strategy for 2007.
Pharma companies, consultants and financiers want to know what is in store for the year to come. This report, compiled by Peter Rixon, but with contributions from the editors of all the major titles reveals what we think will happen in the year to come. With chapters on the pharma market, generics, patent expiries and legal action, and regulation, it looks at each aspect in the market in detail and explores the potential developments in each area. All chapters are backed up by charts, tables and other key statistics, making it an essential companion for the industry in the year to come.
Across the world, governments are becoming more aware not only of the prevalence of lifestyle diseases, such as heart disease and diabetes, but the need to treat these diseases early to avoid paying for more complicated, hospital-based procedures.
Healthcare spending has grown faster than GDP in every OECD country except Finland over the past 15 years. In most of these countries, the bulk of healthcare costs are financed through taxes, with an average of 73% of health spending publicly funded.
Meeting the health needs of a more enlightened population means finding extra money from already overstretched governmental budgets. According to the Organisation for Economic Co-operation and Development (OECD), the only ways to do this will be for governments to raise taxes, cut spending in other areas, or make people pay out of their own pocket. And, even then, this may simply maintain their existing healthcare systems.
Health spending as a percentage of GDP across the OECD was an average of 8.9% in 2004. This is projected to increase rapidly as countries begin to pay for new medical technologies and to tackle the consequences of an ageing population.
In the coming year, the pharmaceutical industry will have to do much to help governments to face these challenges, providing new drugs for that ageing population. However, the government drive to cut costs will also bring with it challenges for the industry.
Outlook 2007 from Scrip Reports looks at the immediate hurdles facing industry. In Chapter 1, we look at the industry’s prospects for growth, while Chapter 2 examines the most promising emerging markets in more detail.
The development of the generics industry and government programmes to promote the use of generics as a way to cut costs is outlined in Chapter 3.
There are a number of regulatory challenges and opportunities currently on the horizon - most significantly, the European Paediatric Regulation to encourage trials of drugs in children; the renegotiation of the Prescription Drug User Fee and Congressional discussions to introduce safety legislation. These are examined in Chapter 4.
Chapter 5 looks at the legal threats facing industry, from patent expiry, to the ongoing product liability litigation against Merck & Co over Vioxx. It also examines the legal impact of governments’ increasing reliance on cost effectiveness analysis as a basis for reimbursement status.
The drug development strategies being adopted by the major players are examined in Chapter 6, while clinical trials strategies in the wake of TeGenero’s disasterous trial for TGN1412 are examined in Chapter 7.
CHAPTER 1 THE PHARMA MARKET 7
1.1 Overview 7
1.2 Products 8
1.3 Companies to watch 10
1.4 Conclusion 12
1.5 References 12
CHAPTER 2 EMERGING MARKETS 13
2.1 China 13
2.2 India 15
2.3 Russia 15
2.4 Latin America 16
2.5 Central and Eastern Europe 17
2.6 References 17
CHAPTER 3 NEW HORIZONS FOR GENERICS 19
3.1 Growth 19
3.2 Biogenerics 20
3.3 Emerging markets 20
3.4 Compulsory licencing 21
CHAPTER 4 REGULATORY DEVELOPMENTS 23
4.1 The Innovative Medicines Initiative 23
4.2 Advanced therapies 24
4.3 Medicines for children 24
4.4 Drug safety in the US 30
4.5 Risk evaluation 30
4.6 PDUFA 31
4.7 References 39
CHAPTER 5 LEGAL ACTION 41
5.1 Patent losses for big pharma 41
5.2 Drive for cost effectiveness proves costly 43
5.3 Ongoing woes for Merck & Co 44
CHAPTER 6 DRUG DEVELOPMENT 45
6.1 Failure to translate successes 45
6.2 Company pipelines 46
6.3 References 48
CHAPTER 7 CLINICAL TRIALS OUTLOOK 49
7.1 Global picture 49
7.2 Outsourcing 49
7.3 Paediatric legislation 50
7.4 Attitudes towards clinical trials 50
7.5 Phase IV trials 51
7.6 Critical Path Initiative (CPI) 52
7.7 References 52
LIST OF TABLES
Table E.1.1 Top 15 countries by share of GDP spent on healthcare
Table 1.1 Global pharmaceutical sales up to 2007
Table 1.2 Global pharma sales by region, 2005
Table 1.3 Areas of expected product growth, therapeutic and regional
Table 4.1 The EMEA’s list of cardiology products for which paediatric indications and formulations are required
Table 4.2 The FDA’s Critical Path Initiative opportunities list
Table 5.1 US patent expiries in 2007
LIST OF FIGURES
Figure 6.1 Development pipelines of the top 5 pharmaceutical companies