2010-6

摘要

Introduction

The UK prescription pharmaceutical market was valued at $28.4 billion in 2009. Key growth drivers include growing use of chronic high-value innovative treatments driven by a rising elderly population, high public healthcare expenditure as proportion of total healthcare expenditure, relatively light pricing controls through the PPRS, and speedy domestic drug approvals.

Scope

*Overview of the UK's socioeconomic and demographic trends, healthcare system, regulation, pricing and reimbursement and intellectual property position

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

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

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

Highlights

The UK pharmaceutical industry has to some extent been cushioned from the effects of the recession. However, the NHS now faces cuts  and with price cuts to be implemented in Southern Europe further stimulating the parallel exportation of drugs out of these markets, branded drug sales in the UK market will certainly be impacted.

The UK's Department of Health is considering imposing mandatory generic substitution at the pharmacist level, as part of the renegotiated PPRS which came into effect in 2009. Mandatory substitution should boost generics volume uptake in the UK, but the extent of the increase is likely to be limited, given the widespread use of generics in the UK.

The UK has a strong track record for drug development. However, Roche and Novartis have threatened to pull out of the UK due to ongoing debates over drug pricing, expensive and bureaucratic clinical trials, and recent non-approval decisions by NICE. Also, a number of key players are downsizing their UK operations in an effort to reduce costs.

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 the UK, analyzing key therapy areas, brands and companies.

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

目录及图表

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 - UK healthcare drivers and resistors 4
Socio-demographic and economic analysis 8
UK socio-demographic trends 8
UK socio-economic trends 8
Healthcare system and drug regulatory analysis 10
UK healthcare expenditure 10
UK healthcare system overview 11
UK regulatory issues 11
UK pricing and reimbursement issues 11
Prescription pharmaceutical sales analysis 13
UK pharmaceutical market size 13
UK leading therapy areas 13
UK leading prescription pharmaceutical brands 13
UK pharmaceutical companies 13
Drug expiry analysis 15
UK generics market 15
UK brand erosion post patent expiry 15
UK biosimilars market 15
Pharmaceutical industry infrastructure analysis 17
UK pharmaceutical industry infrastructure overview 17
UK R&D infrastructure trends 17
UK manufacturing infrastructure trends 18
Related reports 20
Upcoming related reports 20
Table of Contents 21
2. Socio-demographic and economic analysis 22
Key findings 22
UK socio-demographic trends 22
UK socio-economic trends 22
Demographic trends in the UK 23
UK population growth rate expected to slow 24
Birth rate in UK is declining 26
Proportion of elderly people in the UK expected to rise and then level off 27
Life expectancy will continue to increase in the UK and across other markets 28
Disease burden in the UK 29
Ischemic heart disease is the leading cause of death in the UK 29
Non-communicable diseases are the main cause of overall disease burden in the UK 31
Communicable diseases are a relatively uncommon cause of death in the UK, but healthcare-associated infections are on the rise 32
Political climate in the UK 33
The recent general election has resulted in a change of ruling political party and the formation of a coalition government 33
UK economy still vulnerable after recession 34
Pharma has historically been relatively well insulated from the recession, but the NHS could face cuts 36
The UK has high standards of living, but there are income inequalities 37
Business environment in the UK 37
UK corporate tax rate one of the lowest in the EU 37
Unemployment rate is high 38
3. Healthcare system and drug regulatory analysis 39
Key findings 39
UK healthcare expenditure 39
UK healthcare system 39
UK regulatory issues 39
UK pricing and reimbursement issues 40
Healthcare expenditure - UK lags behind most developed nations 41
Healthcare system in the UK 43
NHS is the main healthcare provider in the UK 43
A number of stakeholders exist within the NHS 44
Investment in the NHS has risen substantially over the last decade, but cuts loom 46
UK is lagging behind other countries in health outcomes 46
Private healthcare provision is supplementary to the NHS 47
Primary versus hospital care - the number of hospital beds is falling in the UK as community care becomes more prominent 48
Healthcare system reform in the UK 48
Regulatory issues in the UK 50
Drug approval and regulatory processes 50
MHRA is the national body in charge of regulating medicines 50
Cost of regulatory filings varies according to type of authorization procedure used 51
UK's MHRA boasts short approval times 52
The application process in the UK is straightforward 53
UK license holders must report adverse drug reactions to EudraVigilance 54
New initiatives aim to reduce regulatory burdens on Pharma 54
The EU centralized procedure is convenient but expensive 54
Decentralized procedure introduced to address disputes in mutual recognition procedure 55
Country order of launch - brands tend to launch early in the UK 55
Intellectual property environment − UK court determines validity of patents in the UK 56
High number of patent litigations and expensive fees but litigation times are short 56
Supplementary protection certificates give extra protection 57
Data exclusivity issues in the UK - the 8+2+1 rule 57
Pediatric SPC extension provides additional market exclusivity period 58
Drug counterfeiting - UK is becoming an easy target for counterfeiters 58
Drug importation in the UK − companies wishing to import or export medicines must have licenses 59
Although the UK is generally a target country for parallel trade a recent surge in parallel exports has led to shortages of medicines 60
Pricing and reimbursement in the UK 62
Pricing issues in the UK 64
PPRS is a light form of pricing regulation 64
2009 PPRS introduced flexible pricing to reward innovation 66
Value-based pricing in the future? 66
UK drug prices among lowest in Western markets as a result of weak pound 67
Discounts obtained by hospitals, PCTs and pharmacies add further complexity to determining UK drug prices 68
Reimbursement issues in the UK 68
NICE is the key reimbursement body in the UK 68
SMC is NICE's equivalent in Scotland 69
Cost-effectiveness analysis forms the basis of NICE's appraisal 69
NICE appraises only a subset of drugs 71
NICE's review process - thorough but lengthy 72
Patient empowerment can have an impact on NICE reviews 73
Time delays caused by NICE are a significant issue 74
NICE has issued a number of controversial decisions and negative guidance over the past few years 74
Lack of transparency and over-reliance on QALY draws criticism from pharma industry 75
NICE's appraisal process prompted parliamentary review 76
Risk-sharing schemes are becoming the norm for expensive drugs 77
End-of-life guidance does not guarantee NICE approval 79
Better access to drugs on the horizon in the UK? 80
Will the new cancer drug fund improve access to cancer treatments in the UK? 81
Other pricing and reimbursement issues in the UK 81
Prescription charges do not have a significant impact on which drug is dispensed 81
Top-up payments have been introduced recently but used mostly for drugs not approved by NICE 81
4. Prescription pharmaceutical sales analysis 82
Key findings 82
Pharmaceutical market size in the UK 83
Leading therapy areas in the UK 85
Central nervous system drugs hold the largest share of the UK market value 87
Oncology drugs exhibited the strongest sales during 2005-09 88
Immunology and inflammation drugs showed the fastest sales growth between 2008 and 2009 88
Gastroenterology and cardiovascular drugs saw declining sales 88
Leading prescription pharmaceutical brands in the UK 90
Leading brand Seretide may face competition from faster-growing Symbicort 91
Lipitor has begun to suffer from sales erosion from other generic statins 91
Enbrel's solid growth is attributed to its superior efficacy and having secured approval for multiple indications 91
Leading pharmaceutical companies in the UK prescription pharmaceutical market 94
The leading international companies struggle to maintain growth momentum 95
The leading domestic companies experience impressive growth 98
GlaxoSmithKline 99
AstraZeneca 100
Shire 100
5. Drug expiry analysis 101
Key findings 101
UK generics market 101
UK brand erosion post patent expiry 101
UK biosimilars market 101
UK generics market dynamics 103
UK generics volume uptake 104
UK generics value uptake 105
UK generics market size 106
Drivers and resistors in the UK generics market 107
The proportion of prescribed and dispensed generic drugs has been steadily rising in the UK 108
The government is looking to impose mandatory generic substitution to further drive generic uptake 109
Improved efficiency in generic pricing across PCTs could significantly cut drug costs 110
Savings achievable through increased generic statin use have made them a target for cost-cutting initiatives 110
Large price differential between brands and generics is indicative of a commodity generics market in the UK 111
Key generics players in the UK market 113
Opportunities for the generics industry 114
Small molecule brand erosion in the UK 116
Overview of drugs analyzed 116
Mean level of brand erosion in the UK 117
Brand erosion in the UK retail and hospital setting 118
Brand erosion by therapy area in the UK 120
Brand erosion by drug formulation in the UK 122
UK biosimilars market dynamics 124
Drivers and resistors to biosimilar uptake in the UK - hospital purchasing decisions pivotal to driving biosimilar uptake 124
Key players in the UK biosimilars market 125
Biosimilar epoetin 125
Epoetin volume and value market share 126
Branded epoetin prices in the UK market post biosimilar entry 128
Biosimilar epoetin market share 129
Biosimilar filgrastim 130
Filgrastim volume and value market share 130
Branded filgrastim prices in the UK market post biosimilar entry 132
Biosimilar filgrastim market share 134
Biosimilar somatropin 135
Somatropin volume and value market share 136
New and future biosimilar launches 138
Opportunities for the biosimilars industry 139
Branded monoclonal antibody therapies could soon face biosimilar incursion 142
Biosimilars in development internationally 143
6. Pharmaceutical industry infrastructure analysis 145
Key findings 145
UK pharmaceutical industry infrastructure overview 145
UK R&D infrastructure trends 145
UK manufacturing infrastructure trends 145
UK pharmaceutical industry infrastructure overview 147
R&D and manufacturing strategies in the UK 147
R&D operations downsized to produce more focused pipeline offering higher returns 148
Manufacturers reduce investment in UK facilities and look to outsourcing 149
Key company infrastructure in the UK 149
Pfizer 150
Pfizer's acquisition and integration of Wyeth has resulted in the closure of two R&D sites 153
Pfizer phases out manufacturing in the UK 153
Pfizer enhances its biotech capabilities through M&A activity 155
GlaxoSmithKline 156
GlaxoSmithKline restructures to focus on rare diseases, downsizing R&D in the UK 158
Two manufacturing plants to shut due to lower demand as a result of generic competition 159
Berkshire Hathaway buys a small stake in GlaxoSmithKline 161
Sanofi-Aventis 162
Sanofi-Aventis restructures, cutting R&D spend in favor of R&D partnership agreements 164
Lower demand for maturing drugs leads to closure of a UK manufacturing plant 164
Sanofi-Aventis's acquisition of Acambis expands its vaccines offering 166
AstraZeneca 167
AstraZeneca to implement heavy cuts in R&D workforce 169
Manufacturing capabilities replaced by outsourcing 169
Merck & Co. 171
Roche 175
Roche's strengthens its pipeline with promising early-stage compounds 179
Johnson & Johnson 180
DePuy strengthens its hip implants offering through the acquisition of Finsbury Orthopaedics 182
Eli Lilly 184
Novartis 188
UK manufacturing site helped Novartis reach record sales in 2009 190
Latest restructuring plan has created a leaner operating environment 191