Commercial Insight: Cytotoxic Therapies - Drug launches in rare indications to offset the decline in cytotoxic sales

Introduction

Growth of cytotoxics will remain static over the forecast period with a CAGR of -0.1%. Several blockbuster products are due to undergo patent expiry over the forecast period and the loss of their branded sales will negatively impact on the growth of this market. But the launch of a number of drugs in rare indications will stabilize growth in this market and offset its decline from generic entry.

Scope

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

*Cytotoxic 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

*Assess the strategies of the leading companies in the cytotoxics market

Highlights

Sales of cytotoxic drugs are forecast to decline in the seven major markets from $14 billion in 2009 to $13.9 billion by 2019, at a CAGR of -0.1%. The launch of Dacogen (decitabine; Eisai/Johnson & Johnson) and Vidaza (azacitidine; Celgene) in the 5EU and Japanese markets will slow down the decline in cytotoxic sales over the forecast period.

In 2009, Taxotere (docetaxel; Sanofi-Aventis), Eloxatin (oxaliplatin; Sanofi-Aventis) and Alimta (pemetrexed; Eli Lilly) were the top three cytotoxics, with sales over $1 billion. Alimta will remain among the top three brands in 2019, along with Dacogen and Vidaza.

The keys events to impact the cytotoxics market in the forecast period involve new drug launches, approvals into new indications and patent expiries. Several products with annual sales of over $1 billion are due to undergo patent expiry over the forecast period, however, new drug launches in rarer indications will compensate for this loss of sales.

Reasons to Purchase

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

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

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

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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 cytotoxic therapies market 3
Related reports 4
Upcoming related reports 5
Table of Contents 6
1. MARKET DEFINITION 7
Market definition for this report 7
Cytotoxic therapies by ATC class 7
L1A -Alkylating agents 7
L1B -Antimetabolites 7
L1C -Vinca alkaloids and other plant-derived products 8
L1D -Antineoplastic antibiotics 8
L1X2 -Platinum compounds 8
L1X9 -All other antineoplastics 8
2. MARKET OVERVIEW 9
Seven major markets 9
Current and future market overview 9
The cytotoxics therapies market is set to experience negative growth to 2019 with a large number of products losing their patents over the next 5 years 9
Patent expiries on the leading cytotoxic brands are set to occur within the next 5 years 10
The US is due to lose nearly half its value by 2019 due to generic erosion of key branded products 12
The antimetabolites are forecast to account for the largest proportion of market share through to 2019 13
The current leading cytotoxic brands are forecast to lose significant market share by 2019 due to patent expiry 15
The cytotoxics market will experience contract from $14 billion in 2009 to $13.9 billion in 2019 across the seven major pharmaceutical markets 16
Opportunities and threats 18
Opportunity 1: aging population will result in increasing cancer incidence 18
Opportunity 2: oncology therapy sales continue to experience strong growth 19
Opportunity 3: high levels of unmet need 20
Threat 1: Pharma's transition towards specialist secondary care indications may further increase competition in the oncology market 21
Threat 2: the cost of drug development continues to rise 21
Threat 3: ongoing cost-containment measures 21
US 22
Current and future market assessment 22
The large impact that generic erosion has on sales of branded drugs will cause a decrease in the US cytotoxics market 22
The cytotoxics market will shrink from $7 billion in 2009 to $4.4 billion in 2019 in the US 24
Opportunities and threats 26
Opportunity 1: with a large population and high healthcare expenditure, the US will continue to offer commercial opportunities for drug developers 26
Opportunity 2: healthcare reform will lead to an increase in the number of insured in the US 27
Opportunity 3: closure of the Medicare Part D coverage gap is good news for branded Pharma 27
Threat 1: growing regulatory pressures increase costs and decrease market penetration for Pharma 27
Threat 2: patent expiries and the resulting generic competition will erode branded sales revenues 28
Threat 3: in the long run, US health reform law will intensify cost-containment pressures 28
Japan 29
Current and future market assessment 29
The cytotoxics market in Japan will experience growth of nearly 2% from 2009 to 2019 29
The cytotoxics market will grow from $2.4 billion in 2009 to $2.8 billion in 2019 in Japan 31
Opportunities and threats 33
Opportunity 1: the aging population represents a large and growing patient base 33
Opportunity 2: generic sales erosion remains low in Japan 33
Opportunity 3: decrease in lag times for launch of new drugs could accelerate new launches 34
Threat 1: government-enforced biennial cuts continue to have a negative effect on market growth 34
Threat 2: healthcare proposal to change current pricing system will be of limited benefit to Japanese Pharma 35
Threat 3: changes to reference pricing will bring down launch prices 36
Five major European markets (5EU) 36
Current and future market assessment 36
The cytotoxics therapies market in the five major EU markets will grow through to 2019 as a result of several key product launches 36
The cytotoxics market will grow from $4.6 billion in 2009 to $6.5 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 the EU regulatory process 42
Threat 1: new European drug price reductions are likely to impact the growth of the pharma industry 42
Threat 2: higher generic uptake in less mature EU markets will impact on branded sales revenues 43
Threat 3: the European Commission 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 45
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 48
Threat 8: additional cuts to the price of oncology drugs are forthcoming in Italy under its pay-for-performance scheme 48
France 49
Current and future market assessment 49
The cytotoxics market will grow from $1.5 billion in 2009 to $1.8 billion in 2019 in France 49
Germany 52
Current and future market assessment 52
The cytotoxics market will grow from $1.1 billion in 2009 to $1.6 billion in 2019 in Germany 52
Italy 56
Current and future market assessment 56
The cytotoxics market will grow from $0.8 billion in 2009 to $1.2 billion in 2019 in Italy 56
Spain 60
Current and future market assessment 60
The cytotoxics market will grow from $0.7 billion in 2009 to $1.1 billion in 2019 in Spain 60
UK 63
Current and future market assessment 63
The cytotoxics market will grow from $5m in 2009 to $1 billion in 2019 in the UK 63
Rest of the world snapshot 66
Current market assessment 66
Rest of the World sales represent 22% of the global cytotoxics market 66
Opportunities and threats 69
Opportunity 1: incidence of cancer is forecast to increase in the BRIC countries 69
Opportunity 2: emerging markets continue to attract despite challenges 69
Threat: cost of new therapies is a barrier to market penetration 70
3. BRAND DYNAMICS 71
Overview of competitive landscape 71
Alimta and Taxotere will remain among the top 4 leading cytotoxic brands in both 2009 and 2019 71
Efficacy and toxicity of a drug are the most important drivers of cytotoxic brand choice 73
Trends in marketing strategies 74
Leading cytotoxic brands 75
Taxotere (docetaxel; Sanofi-Aventis) 75
Drug profile 75
Product positioning 76
SWOT analysis 76
Brand forecast to 2019 77
Taxotere sales are forecast to fall after 2010 to $723m in 2019 77
Eloxatin (oxaliplatin; Sanofi-Aventis) 79
Drug profile 79
Product positioning 80
SWOT analysis 81
Brand forecast to 2019 81
Eloxatin sales will continue to fall through to 2019 in response to genericization 81
Alimta (pemetrexed; Eli Lilly) 83
Drug profile 84
Product positioning 84
SWOT analysis 85
Brand forecast to 2019 85
Alimta's sales are forecast to exceed $2 billion in 2016 before dropping to $0.7 billion in 2019 85
Gemzar (gemcitabine; Eli Lilly) 87
Drug profile 87
Product positioning 88
SWOT analysis 89
Brand forecast to 2019 89
Gemzar sales are forecast to decrease after 2012, losing more than 50% of sales after 2013 89
4. KEY DEVELOPERS 92
Strategic overview 92
Trends in corporate strategy 93
Approval in multiple tumor types is most likely to result in significant sales 93
A mature and heavily genericized market means Big Pharma's experience is crucial 93
Currently there are relatively few novel cytotoxics in development 93
Sanofi-Aventis 94
Corporate strategy 94
Oncology cytotoxics portfolio assessment 94
Eli Lilly 96
Corporate strategy 96
Oncology cytotoxics portfolio assessment 96
Portfolio assessment of other leading companies 97
BIBLIOGRAPHY 99
Journal papers 99
Websites 99
Other 104
Datamonitor reports 104
Appendix A - Market Assumptions 106
Forecasting assumptions 106
New product launches 106
Patent expiries 106
Rest of class definition 107
Data definitions, limitations and assumptions 108
Standard units 108
Country group definitions 108
Rest of the World 108
The 'all other EU countries' group 108
The 'Other non-EU countries' group 108
Forecast methodology 109
Derivation of sales forecasts and pricing trends 109
Exchange rates 109
Report methodology 109
Appendix B 110
About Datamonitor 110
About Datamonitor Healthcare 110
About the Oncology analysis team 111
Disclaimer 112
List of Tables
Table 1: Definition of the cytotoxic therapies market, 2010 7
Table 2: Sales and growth of cytotoxic therapy drug classes in the seven major markets ($m), 2009-2019 9
Table 3: Key events impacting cytotoxic therapies in the seven major markets, 2009-2019 11
Table 4: Cytotoxic therapy sales forecasts in the seven major markets ($m), 2009-2019 16
Table 5: Summary of opportunities and threats too impact the cytotoxics market across the seven major markets, 2010-19 18
Table 6: Sales and growth of cytotoxic therapy drug classes in the US ($m), 2009-2019 22
Table 7: Top 5 branded cytotoxics in the US in 2009 and 2019 24
Table 9: Summary of opportunities and threats to impact the cytotoxics market in the US, 2010-19 26
Table 10: Sales and growth of cytotoxic therapy drug classes in Japan ($m), 2009-2019 29
Table 11: Top 5 branded cytotoxic therapies in Japan in 2009 and 2019 31
Table 12: Cytotoxic therapy sales forecasts in Japan ($m), 2009-2019 31
Table 13: Summary of opportunities and threats to impact the cytotoxics market in Japan, 2010-19 33
Table 14: Sales and growth of cytotoxic therapy drug classes in the five major EU markets ($m), 2009-2019 36
Table 15: Top 5 branded cytotoxics in the five major European markets in 2009 and 2019 38
Table 16: Cytotoxic therapy sales forecasts in the five major European markets ($m), 2009-2019 38
Table 17: Summary of opportunities and threats to impact the cytotoxics market in the five major EU markets, 2010-19 41
Table 18: Risk-sharing agreements entered into with NICE in the UK, 2009-2010 47
Table 19: Top 5 branded cytotoxics in France in 2009 and 2019 50
Table 20: Cytotoxic therapy sales forecasts in France ($m), 2009-2019 51
Table 21: Top 5 branded cytotoxics in Germany in 2009 and 2019 54
Table 22: Cytotoxic therapy sales forecasts in Germany ($m), 2009-2019 55
Table 23: Top 5 branded cytotoxics in Italy in 2009 and 2019 58
Table 24: Cytotoxic therapy sales forecasts in Italy ($m), 2009-2019 58
Table 25: Top 5 branded cytotoxics in Spain in 2009 and 2019 61
Table 26: Cytotoxic therapy sales forecasts in Spain ($m), 2009-2019 61
Table 27: Top 5 branded cytotoxics in the UK in 2009 and 2019 64
Table 28: Cytotoxic therapy sales forecasts in the UK ($m), 2009-2019 64
Table 29: Comparison of cytotoxic drug class sales in the seven major markets and Rest of the World ($m), 2009 68
Table 30: Comparison of cytotoxic drug class sales in the BRIC countries, other EU countries and all other non-EU countries ($m), 2009 69
Table 31: Leading branded cytotoxic drug sales in the seven major markets ($m), 2009-2019 71
Table 32: Marketing strategies employed by the companies behind the top three cytotoxic brands, 2010 74
Table 33: Taxotere (docetaxel)-drug profile, 2010 75
Table 34: Impacting factors on the revenues of Taxotere, 2009-2019 79
Table 35: Eloxatin (oxaliplatin)-drug profile, 2010 80
Table 36: Impacting factors on the revenues of Eloxatin, 2009-2019 83
Table 37: Alimta (pemetrexed)-drug profile, 2010 84
Table 38: Impacting factors on the revenues of Alimta, 2009-2019 87
Table 39: Gemzar (gemcitabine)-drug profile, 2010 88
Table 40: Impacting factors on the revenues of Gemzar, 2009-2019 91
Table 41: Leading companies in the cytotoxic therapies market in the seven major markets ($m), 2009-2019 92
Table 42: Assessment of Sanofi-Aventis's cytotoxics portfolio, 2010 95
Table 43: Assessment of Eli Lilly's cytotoxics portfolio, 2010 96
Table 44: Assessment of Merck/Schering Plough's cytotoxics portfolio, 2010 97
Table 45: Assessment of Roche's cytotoxics portfolio, 2010 98
Table 46: Regional launch dates for new cytotoxics in the seven major markets, 2009-2019 106
Table 47: Patent expiry dates for the approved cytotoxics in the seven major pharmaceutical markets, 2009-2019 107

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