Commercial Insight: Cancer Targeted Therapies and Immunotherapies -Top monoclonal antibody brands will resist competitive pressures through to 2019

Introduction

The oncology market has witnessed a sizeable shift of focus away from cytotoxic therapies and antihormonal therapies towards the more lucrative targeted therapies and immunotherapies class in the last decade. This class boasts several of the top-selling anticancer brands overall, and has fueled most of the recent rapid growth of the oncology market as a whole.

Scope

*Forecast sales of every marketed cancer targeted therapy and immunotherapy in each of the seven major markets over the period 2009 to 2019

*Analysis and segmentation of the market at various levels including drug class, country, brand and company

*Comprehensive brand profiles and analysis for the key brands, including approval dates, patent expiries and all key events likely to impact sales

*Snapshot of the cancer targeted therapies and immunotherapies market in the rest of the world

Highlights

Between 2010 and 2019, conditions in the oncology market will support relatively high growth rates for the targeted therapies and immunotherapies currently on the market. Combined sales in this class will grow at a CAGR of 6.6 % from $19.5 billion in 2009 to reach $36.8 billion in 2019.

Avastin (bevacizumab; Roche/Chugai) was the leading oncology brand in 2009. Despite a number of setbacks (including failures in Phase III trials in certain new indications) and potential threats, sales of Avastin will continue to grow, driven by further indication expansions and increasing uptake in existing indications and new territories.

With a dominant presence in three of the four highest incidence solid tumors and the highest incidence hematological malignancy, Roche dominates the cancer targeted therapies and immunotherapies market. This will continue through to 2019, driven by the strong performance of the company’s monoclonal antibody franchise.

Reasons to Purchase

*Quantify the performance of each of the marketed cancer targeted therapies and immunotherapies in the seven major markets over the period 2009 to 2019

*Assess the changing key opportunities and threats both for currently marketed and pipeline targeted therapy and immunotherapy brands

*Identify the leading brands in this market over the next 10 years and understand the key factors driving their success

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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 cancer targeted therapies and immunotherapies market 3
Related reports 4
Upcoming related reports 5
Table of Contents 6
Market Definition 7
Definition of the cancer market 7
Cancer targeted therapies and immunotherapies by ATC class 7
L1D0: Antineoplastic antibiotics 7
L1X3: Antineoplastic monoclonal antibodies 8
L1X4: Antineoplastic protein kinase inhibitors 8
L1X9: All other antineoplastics 8
L4A0: Immunosuppressive agents 8
Market Overview 9
Seven major markets 9
Current and future market overview 9
Targeted therapies and immunotherapies will continue to be the leading class of anticancer therapy in terms of value and growth through to 2019 9
Indication expansions will offset patent expiries in the cancer targeted therapies and immunotherapies market 10
The five major European markets and Japan will grow at a higher rate, reducing the US market's dominance 13
Monoclonal antibodies will lead the cancer targeted therapies and immunotherapies market out to 2019 14
The dominance of Roche's monoclonal antibody franchise will continue through to 2019 16
Opportunities and threats 19
Opportunity 1: aging population will result in increasing cancer incidence 20
Opportunity 2: oncology therapy sales continue to experience strong growth 20
Opportunity 3: high levels of unmet need 21
Opportunity 4: potential for chronic treatment 21
Threat 1: the transition toward specialist secondary care indications may lead to intensified competition 22
Threat 2: the cost of drug development continues to rise 22
Threat 3: ongoing cost-containment measures 22
Threat 4: possible market entry of biosimilar monoclonal antibodies 23
US 24
Current and future market assessment 24
Sales growth in the US will become considerably slower in comparison to Japan and the five major European markets 24
Most cancer targeted therapy and immunotherapy sales in the US will continue to come from the monoclonal antibodies 24
Avastin will continue its US market dominance through to 2019, with forecast peak sales of $4.8 billion 26
Opportunities and threats 28
Opportunity 1: the US's large population and high healthcare expenditure offer commercial opportunities 29
Opportunity 2: healthcare reform will boost the number of insured in the US 29
Opportunity 3: closure of the Medicare Part D coverage gap is good news for branded pharma 29
Threat 1: growing regulatory pressures increase costs and decrease market penetration for pharma 29
Threat 2: patent expiries and the resulting generic competition will erode branded sales revenues 30
Threat 3: the US health reform law will intensify cost-containment pressures 30
Japan 31
Current and future market assessment 31
Japan is set to become the second largest market for cancer targeted therapies and immunotherapies by 2019 31
The pattern of sales by drug class in Japan will resemble the other major markets more closely by 2019 32
Avastin will become the leading targeted cancer therapy brand in Japan by 2019 33
Opportunities and threats 35
Opportunity 1: the aging population represents a large and growing patient base 35
Opportunity 2: generic sales erosion remains low in Japan 35
Opportunity 3: decrease in lag times for launch of new drugs could accelerate new launches 36
Threat 1: government-enforced biennial cuts continue to have a negative effect on market growth 36
Threat 2: proposal to change current pricing system will be of limited benefit to Japanese Pharma 37
Threat 3: encouraging decrease in lag times for launch of new drugs 37
Five major European markets (5EU) 38
Current and future market assessment 38
Sales of targeted therapies and immunotherapies will grow more rapidly in the 5EU than in the US through to 2019 38
Monoclonal antibodies will remain the leading class of targeted therapy and immunotherapy in the 5EU 39
Avastin is close to becoming the leading targeted therapy and immunotherapy brand in the 5EU 40
Opportunities and threats 41
Opportunity 1: EU Cancer Task Force will improve availability of information while generating R&D funds 42
Opportunity 2: streamlined regulatory process through reorganization of European Medicines Agency 42
Threat 1: new European drug price reductions are likely to affect pharma industry growth 43
Threat 2: higher generic uptake in less mature EU markets will impact branded sales revenues 43
Threat 3: EC inquiry into delays in generics market entry will have myriad ramifications for the industry 44
Threat 4: Spain's price cuts and reference groups are driving drug prices down 45
Threat 5: France's new low reimbursement rate 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 46
Threat 7: Germany's new cost-effectiveness analysis system may add to downward pressure on prices 48
Threat 8: impending cuts to oncology drug prices in Italy under its pay-for-performance scheme 48
France 49
Current and future market assessment 49
France will remain the largest market in the 5EU for cancer targeted therapies and immunotherapies through to 2019 49
Germany 53
Current and future market assessment 53
While price cuts will restrict near-term growth, Germany will remain the second largest of the 5EU markets through to 2019 53
Italy 57
Current and future market assessment 57
Italy will see the highest growth of cancer targeted therapies and immunotherapies in the 5EU in the next ten years 57
Spain 61
Current and future market assessment 61
Price cuts will restrict near-term growth of cancer targeted therapies and immunotherapies sales in Spain 61
UK 65
Current and future market assessment 65
Cost-effectiveness restrictions will continue to hamper growth of cancer targeted therapies and immunotherapies in the UK through to 2019 65
Rest of the world snapshot 69
Current market assessment 69
Rest of the world sales represent 20% of the global cancer targeted therapies and immunotherapies market 69
Opportunities and threats 70
Opportunity 1: incidence of cancer is forecast to increase in the BRIC countries 70
Opportunity 2: emerging markets continue to attract pharma companies despite challenges 71
Threat 1: cost of new therapies is a barrier to market penetration 71
Threat 2: weak intellectual property rights significantly restrict the value of branded product sales 71
Brand Dynamics 72
Overview of competitive landscape 72
Avastin, Rituxan and Herceptin will maintain their 2009 position as the top three brands in 2019 72
Drivers of brand choice 73
Efficacy and toxicity of a drug are the most important drivers of cancer therapy brand choice 73
Trends in marketing strategies 74
Marketing strategy for leading brands 74
Avastin (bevacizumab; Roche/Chugai) 76
Drug profile 76
Product positioning 77
SWOT analysis 78
Brand forecast to 2019 79
Despite uncertainties over its future in breast cancer and Phase III developmental setbacks, Avastin will remain the leading cancer brand through to 2019 79
Rituxan/MabThera (rituximab; Biogen Idec/Roche/Chugai/Zenyaku Kogyo) 82
Drug profile 82
Product positioning 83
SWOT analysis 84
Brand forecast to 2019 85
Rituxan appears to likely to resist the competitive threat from Arzerra, although biosimilars will have a negative impact on revenue before the end of the forecast period 85
Herceptin (trastuzumab; Roche/Chugai) 87
Drug profile 87
Product positioning 88
SWOT analysis 89
Brand forecast to 2019 90
Biosimilars are likely to provide the greatest threat to Herceptin's market share over the forecast period 90
Gleevec/Glivec (imatinib; Novartis) 93
Drug profile 93
Product positioning 94
SWOT analysis 95
Brand forecast to 2019 95
Expiry of Gleevec's patent in all of the seven major markets will have the most significant negative impact on sales, reducing seven major market sales to below $1 billion by 2019 95
Revlimid (lenalidomide; Celgene) 98
Drug profile 98
Product positioning 99
SWOT analysis 99
Brand forecast to 2019 100
Revlimid's potential across a broad range of indications could allow it to become the 'Avastin' of the hematological malignancies market, achieving rapid sales growth over the forecast period 100
Key Developers 103
Strategic overview 103
Trends in corporate strategy 104
The high-risk nature of indication expansion in broad patient populations has prompted a switch in strategy for developers of targeted therapies and immunotherapies 104
Partnerships in the targeted therapies and immunotherapies market offer considerable benefits for smaller players and Big Pharma alike 105
Roche 106
Corporate strategy 106
Roche's monoclonal antibodies franchise will allow it to maintain its leading position in the targeted therapies and immunotherapies market to 2019 106
Cancer targeted therapies and immunotherapies portfolio assessment 106
Roche's diverse pipeline will further help to consolidate its hold of the market 106
Novartis 108
Corporate strategy 108
Novartis's success in the cancer targeted therapies and immunotherapies market stems from the pursuit of a niche indication 108
Cancer targeted therapies and immunotherapies portfolio assessment 109
Novartis's portfolio shows both a continuing commitment to niche indications and an increasing focus on higher incidence tumor types 109
Portfolio assessment of other leading companies 111
Strategy overview 111
Big Pharma is turning to biologics in order to maintain presence in the oncology market 111
Bibliography 116
Journal papers 116
Websites 117
Datamonitor reports 122
Other 123
APPENDIX A - Market Assumptions 124
Forecasting assumptions 124
Patent expiries 125
Data definitions, limitations and assumptions 126
Standard units 126
Country group definitions 126
Rest of the world 126
The 'all other EU countries' group 126
The 'Other non-EU countries' group 126
Forecast methodology 126
Derivation of sales forecasts and pricing trends 127
Exchange rates 127
Report methodology 127
APPENDIX B 128
About Datamonitor 128
About Datamonitor Healthcare 128
About the Oncology analysis team 129
Disclaimer 131
List of Tables
Table 1: Definition of cancer targeted therapies and immunotherapies market, 2010 7
Table 2: Sales and growth of cancer targeted therapies and immunotherapies in the seven major pharmaceutical markets, by class, 2009-2019 9
Table 3: Key events impacting the cancer targeted therapies and immunotherapies market in the seven major markets, 2010-19 11
Table 4: Cancer targeted therapies and immunotherapies sales forecasts in the seven major markets ($m), 2009-2019 18
Table 5: Summary of opportunities and threats to impact the cancer targeted therapies and immunotherapies across the seven major markets, 2010-19 19
Table 6: Sales and growth of cancer targeted therapies and immunotherapies in the US, by class, 2009-2019 24
Table 7: Top five branded cancer targeted therapies and immunotherapies in the US in 2009 and 2019 26
Table 8: Cancer targeted therapies and immunotherapies sales forecasts in the US ($m), 2009-2019 27
Table 9: Summary of opportunities and threats to impact the cancer targeted therapies and immunotherapies market in the US, 2010-19 28
Table 10: Sales and growth of cancer targeted therapies and immunotherapies in Japan, by class, 2009-2019 31
Table 11: Top five branded cancer targeted therapies and immunotherapies in Japan in 2009 and 2019 33
Table 12: Cancer targeted therapies and immunotherapies sales forecasts in Japan ($m), 2009-2019 33
Table 13: Summary of opportunities and threats to impact the cancer targeted therapies and immunotherapies market in Japan, 2010-19 35
Table 14: Sales and growth of cancer targeted therapies and immunotherapies in the five major European markets, by class, 2009-2019 38
Table 15: Top five branded cancer targeted therapies and immunotherapies in the five major European markets in 2009 and 2019 40
Table 16: Cancer targeted therapies and immunotherapies sales forecasts in the five major European markets ($m), 2009-2019 40
Table 17: Summary of opportunities and threats to impact the cancer targeted therapies and immunotherapies across the five major European markets, 2010-19 42
Table 18: Risk-sharing agreements between NICE and selected pharma companies in the UK, 2009-2010 47
Table 19: Sales and growth of cancer targeted therapies and immunotherapies in France, by class, 2009-2019 49
Table 20: Top five branded cancer targeted therapies and immunotherapies in France in 2009 and 2019 51
Table 21: Cancer targeted therapies and immunotherapies sales forecasts in France ($m), 2009-2019 51
Table 22: Sales and growth of cancer targeted therapies and immunotherapies in Germany, by class, 2009-2019 53
Table 23: Top five branded cancer targeted therapies and immunotherapies in Germany in 2009 and 2019 55
Table 24: Cancer targeted therapies and immunotherapies sales forecasts in Germany ($m), 2009-2019 55
Table 25: Sales and growth of cancer targeted therapies and immunotherapies in Italy by class, 2009-2019 57
Table 26: Top five branded cancer targeted therapies and immunotherapies in Italy in 2009 and 2019 59
Table 27: Cancer targeted therapies and immunotherapies sales forecasts in Italy ($m), 2009-2019 59
Table 28: Sales and growth of cancer targeted therapies and immunotherapies in Spain, by class, 2009-2019 61
Table 29: Top five branded cancer targeted therapies and immunotherapies in Spain in 2009 and 2019 63
Table 30: Cancer targeted therapies and immunotherapies sales forecasts in Spain ($m), 2009-2019 63
Table 31: Sales and growth of cancer targeted therapies and immunotherapies in the UK, by class, 2009-2019 65
Table 32: Top five branded cancer targeted therapies and immunotherapies in the UK in 2009 and 2019 67
Table 33: Cancer targeted therapies and immunotherapies sales forecasts in the UK ($m), 2009-2019 67
Table 34: Comparison of cancer targeted therapy and immunotherapy sales, by class, in the US, Japan, five major EU markets and rest of the world markets, 2009 70
Table 35: Branded cancer targeted therapy and immunotherapy drug sales in the seven major markets, 2009-2019 72
Table 36: Marketing strategies employed by the companies behind the top four targeted cancer therapy and immunotherapy brands, 2009 75
Table 37: Avastin (bevacizumab; Roche/Chugai) - drug profile, 2010 77
Table 38: Factors impacting revenues of Avastin, 2010-19 80
Table 39: Rituxan/MabThera (rituximab; Biogen Idec/Roche/Chugai/Zenyaku Kogyo) - drug profile, 2010 83
Table 40: Factors impacting revenues of Rituxan/MabThera, 2010-19 86
Table 41: Herceptin (trastuzumab; Roche/Chugai) - drug profile, 2010 88
Table 42: Factors impacting revenues of Herceptin, 2010-19 91
Table 43: Gleevec/Glivec (imatinib; Novartis) - drug profile, 2010 93
Table 44: Factors impacting revenues of Gleevec/Glivec, 2010-19 97
Table 45: Revlimid (lenalidomide; Celgene) - drug profile, 2010 98
Table 46: Factors impacting revenues of Revlimid, 2010-19 101
Table 47: Leading companies in the cancer targeted therapies and immunotherapies market, by sales, in the seven major markets, 2009-2019 103
Table 48: Assessment of Roche's cancer targeted therapies and immunotherapies portfolio, 2010 107
Table 49: Assessment of Novartis's cancer targeted therapies and immunotherapies portfolio, 2010 110
Table 50: Assessment of Bristol-Myers Squibb's cancer targeted therapies and immunotherapies portfolio, 2010 112
Table 51: Assessment of Celgene's cancer targeted therapies and immunotherapies portfolio, 2010 113
Table 52: Assessment of Pfizer's cancer targeted therapies and immunotherapies portfolio, 2009 114
Table 53: Regional launch dates for targeted therapies and immunotherapies in the seven major markets, 2010-19 124
Table 54: Patent expiry dates for the approved targeted therapies and immunotherapies in the seven major pharmaceutical markets, 2010-19 125
List of Figures
Figure 26: Methodology for forecasting price to remove impact of currency fluctuations on future trend 127

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