Commercial Insight: Cytotoxic Therapies - Drug Launches In Rare Indications To Offset The Decline In

Introduction

Introduction

Antihormonal cancer therapies are a class of drugs used predominantly in the treatment of breast cancer and prostate cancer. The high incidence of these tumor types translates into a significant commercial potential for drug developers. Collectively, the antihormonal therapy cancer brands generated sales of about $7.0 billion in the seven major pharmaceutical markets in 2009.

Scope

*In-depth analysis of the current and future antihormonal therapies market across the US, 5EU and Japan, plus a rest of world snapshot

*Antihormonal therapy sales forecasts for brands and generics from 2009 to 2019

*Assessment of the leading cancer brands and drug classes to identify key success factors within this sector

*Evaluation of the strategies of leading players in the antihormonals market

Highlights

The antihormonals market was worth $7.0 billion in 2009 across the seven major pharmaceutical markets. Datamonitor forecasts the antihormonals market will shrink marginally in the forecast period 20092019, at a CAGR of negative 0.7%.

In 2019 the top three brands in terms of forecast sales will be Arimidex, Lupron (leuprolide; Takeda/Abbott) and Casodex (bicalutamide; AstraZeneca). Despite losing around 54% of its current sales value to generic competitors, Arimidex will retain its market leading position.

In a mature market, the importance of product lifecycle management is high. AstraZeneca was the key player in the market in 2009, with an antihormonals portfolio valued at over $3.2 billion. With successful lifecycle management and a considerable investment in marketing activities, AstraZeneca has built a strong brand presence for its products.

Reasons to Purchase

*Quantify the performance of each of the marketed antihormonal therapy cancer brands in the seven major markets over the period 2009 to 2019

*Acquire a detailed account of antihormonal therapy cancer brand dynamics and the events that drive and limit their market growth

*Benchmark antihormonal therapy cancer brands against their generics and rest of class and align their 7MM performance with a rest of world snapshot

Table of Contents :

OVERVIEW 1

Catalyst 1

Summary 1

About Datamonitor healthcare 2

About the Oncology pharmaceutical analysis team 2

EXECUTIVE SUMMARY 3

Strategic scoping and focus 3

Datamonitor insight into the antihormonal cancer therapies market 3

Related reports 4

Upcoming related reports 4

Table of Contents 5

MARKET DEFINITION 6

Definition of the cancer market 6

Antihormonal therapies by ATC class 6

L2A3 - Luteinizing hormone-releasing hormone agonists 6

L2B1 - Anti-estrogens 7

L2B2 - Anti-androgens 7

L2B3 - Aromatase inhibitors 7

L2B9 - Other hormone antagonists 7

MARKET OVERVIEW 9

Seven major markets 10

Current and future market overview 10

The antihormonals market will shrink marginally in the forecast period 10

Patent expiries of leading antihormonal brands are set to occur within the next 5 years 10

The US will suffer the greatest impact of generic erosion, losing around 25% of its value over the forecast period 12

The aromatase inhibitors will continue to be the leading drug class in 2019 13

The current leading antihormonal brands will suffer generic sales erosion but will maintain a high level of sales 14

The antihormonal therapies market will shrink from $7.0 billion in 2009 to $6.5 billion in 2019 across the seven major pharmaceutical markets 15

Opportunities and threats 17

Opportunity 1: aging population will result in increasing cancer incidence 17

Opportunity 2: oncology therapy sales continue to experience strong growth 18

Opportunity 3: high levels of unmet need 19

Threat 1: Pharma's transition towards specialist secondary care indications may further competition in the oncology market 20

Threat 2: the cost of drug development continues to rise 20

Threat 3: ongoing cost-containment measures 20

US 21

Current and future market assessment 21

The US antihormonals market will suffer the greatest impact of generic sales erosion 21

Opportunities and threats 25

Opportunity 1: the US's large population and high healthcare expenditure will continue to offer commercial opportunities for drug developers 25

Opportunity 2: healthcare reform will boost the number of insured in the US 25

Opportunity 3: closure of the Medicare Part D coverage gap is good news for branded Pharma 26

Threat 1: growing regulatory pressures increase costs and decrease market penetration for Pharma 26

Threat 2: patent expiries and the resulting generic competition will erode branded sales revenues 27

Threat 3: the US health reform law will intensify cost-containment pressures 27

Japan 28

Current and future market assessment 28

The antihormonals market in Japan is forecast to grow over the forecast period 28

Opportunities and threats 32

Opportunity 1: the aging population represents a large and growing patient base 32

Opportunity 2: generic sales erosion remains low in Japan 32

Opportunity 3: decrease in lag times for launch of new drugs could accelerate new launches 33

Threat 1: government-enforced biennial cuts continue to have a negative effect on market growth 33

Threat 2: healthcare proposal to change current pricing system will be of limited benefit to Japanese Pharma 34

Threat 3: encouraging decrease in lag times for launch of new drugs 34

Five major European markets (5EU) 36

Current and future market assessment 36

The antihormonals therapies market in the five European countries will show marginal growth 36

The antihormonal therapies market will grow from $2.6 billion in 2009 to $2.7 billion in 2019 in the five major European markets 38

Opportunities and threats 40

Opportunity 1: EU Cancer Task Force will improve the availability of information while generating funds for research 41

Opportunity 2: reorganization of the European Medicines Agency (EMA) expected to streamline EU regulatory process 41

Threat 1: new European drug price reductions are likely to affect pharma industry growth 41

Threat 2: higher generic uptake in less mature EU markets will impact branded sales revenues 42

Threat 3: EC inquiry into delays in generics market entry will have wide-ranging ramifications for the branded and generics industry 43

Threat 4: Spain's price cuts and reference groups are driving drug prices down 44

Threat 5: new low reimbursement rate created in France signals the growing pressure for cost-containment 44

Threat 6: NICE will remain a significant hurdle to commercialization of cancer drugs in the UK, despite relaxation of its cost-effectiveness criteria 45

Threat 7: Germany's new cost-effectiveness analysis system could add to the downward pressure on drug prices 46

Threat 8: additional cuts to the price of oncology drugs in Italy are impending under its pay-for-performance scheme 47

France 48

Current and future market assessment 48

The antihormonal therapies market in France will peak at around $654m in 2010. 48

Germany 51

Current and future market assessment 51

The antihormonals therapies market will grow from $727m in 2009 to $835m in 2019 in Germany 51

Italy 55

Current and future market assessment 55

The antihormonal therapies market will grow from $484m in 2009 to $512m in 2019 in Italy 55

Spain 58

Current and future market assessment 58

The antihormonals market in Spain will marginally shrink from $418m in 2009 to $396m in 2019 in Spain 58

UK 61

Current and future market assessment 61

The antihormonal therapies market will grow from $333m in 2009 to $348m in 2019 in the UK 61

Rest of the world snapshot 65

Current market assessment 65

Rest of the world sales represent 18% of the global antihormonals market 65

Opportunities and threats 66

Opportunity 1: incidence of cancer is forecast to increase in the BRIC countries 66

Opportunity 2: emerging markets continue to attract pharma companies despite challenges 67

Threat 1: cost of new therapies is a barrier to market penetration 67

BRAND DYNAMICS 68

Overview of competitive landscape 68

Arimidex, Lupron and Casodex will be the top three antihormonal brands in 10 years time 68

Drivers of brand choice 69

Efficacy and toxicity are the most important drivers of brand choice 69

Trends in marketing strategies 70

Marketing strategy for leading brands 70

Patient information and support programs 71

Direct-to-consumer advertising 73

Arimidex (anastrozole; AstraZeneca) 74

Drug profile 75

Product positioning 75

SWOT analysis 76

Brand forecast to 2019 77

Arimidex set to lose 54% of its current sales value to generic competitors 77

Lupron (leuprolide; Takeda/Abbott) 81

Drug profile 81

Product positioning 81

SWOT analysis 83

Brand forecast to 2019 83

Lupron will be the top selling antihormonal therapy in 2019, with sales in excess of $1 billion 83

Casodex (bicalutamide; AstraZeneca) 85

Drug profile 86

Product positioning 86

SWOT analysis 87

Brand forecast to 2019 88

Patent expiries set to hamper sales of this class-leading brand 88

KEY DEVELOPERS 90

Strategic overview 90

Trends in corporate strategy 91

Strategic lifecycle management is essential in the antihormonals market 91

Commercialization partnerships are common for smaller players 91

AstraZeneca 91

Corporate strategy 91

Oncology antihormonals portfolio assessment 92

Takeda 93

Corporate strategy 93

Oncology antihormonals portfolio assessment 93

Portfolio assessment of other leading companies 94

BIBLIOGRAPHY 96

Journal papers 96

Websites 96

Datamonitor reports 101

Other 102

APPENDIX A - MARKET ASSUMPTIONS 103

Forecasting assumptions 103

New product launches 103

Patent expiries 103

Data definitions, limitations and assumptions 104

Standard units 104

Country group definitions 104

Rest of the World 104

The 'all other EU countries' group 104

The 'Other non-EU countries' group 104

Forecast methodology 105

Derivation of sales forecasts and pricing trends 105

Exchange rates 105

Report methodology 106

APPENDIX B 107

About Datamonitor 107

About Datamonitor Healthcare 107

About the Oncology analysis team 108

Disclaimer 110

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by: Aarkstore Enterprise

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