Commercial Insight: Cytotoxic Therapies Market Growth Will Slow Due To Increasing Genericization

Transcription

1 Commercial Insight: Cytotoxic Therapies Market Growth Will Slow Due To Increasing Genericization Report summary In-depth analysis of the current and future cytotoxic therapies market across the US, 5EU and Japan, plus a rest of world snapshot Quantify the performance of each of the marketed cytotoxic therapy cancer brands in the seven major markets over the period 2008 to Cytotoxic therapy sales forecasts for brands and generics from 2008 to Assessment of the leading cancer brands and drug classes to identify key success factors within this sector Assess the strategies of several leading players in the cytotoxics market

2 About this report Introduction The cytotoxics market is mature and characterized by an increasing level of genericization. Several blockbuster products will undergo patent expiry during the forecast period, however, by virtue of these drugs success, generic entry will ensure continued growth. Coupled with the launch of several new brands, steady growth of the cytotoxics market will occur to, at a CAGR of 3.1 per cent. The first cytotoxic was approved in 1949; since then, the market has grown exponentially, with a plethora of commercially available products and seven major market sales of $13.8 billion in Despite the increasing incorporation of the molecular targeted therapies into standard regimens, cytotoxics will remain the cornerstone of treatment for years to come. Several products have achieved blockbuster status, and high levels of competition exist. This has raised barriers to entry significantly, with any new product required to show great superiority over the competition. Key findings and highlights The cytotoxics market was worth $13.8 billion in 2008 across the seven major pharmaceutical markets, and is forecast to grow to $18.7 billion by, achieving a CAGR of 3.1 per cent. The launch of Dacogen (decitabine; Eisai/Johnson & Johnson) and Vidaza (azacitidine; Celgene) in the 5EU and Japanese markets will contribute significantly to this growth. In 2008, Taxotere (docetaxel; Sanofi-Aventis), Eloxatin (oxaliplatin; Sanofi-Aventis) and Gemzar (gemcitabine; Eli Lilly) were the top three cytotoxics, with sales over $1 billion. Despite facing patent expiry during the forecast period and guaranteed generic entry, Taxotere and Eloxatin will remain in the top three in, along with Dacogen. The key events to impact the cytotoxics market during the forecast period are the launch of new drugs, expansion into new indications and patent expiries. Several blockbuster products with annual sales of over $1 billion are due to undergo patent expiry during the forecast period, however, generic entry will ensure continued market growth. Reasons to buy Quantify the performance of each of the marketed cytotoxic therapy cancer brands in the seven major markets over the period 2008 to 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 The US is forecast to lose nearly half its market share by due to high levels of generic erosion of key branded products Oncology Analyst, Datamonitor

3 Sample pages Market Overview Key Developers Table 3: Key events impacting the cytotoxic therapies market, 2008 US 5EU Japan Ixempra (ixabepilone), which is set to achieve seven major market sales of $847m by, while Johnson & Johnson with Eisai is responsible for co-marketing Dacogen (decitabine), which is forecast to achieve sales of $1.1 billion by. In, Johnson & Johnson will be the second leading company in terms of cytotoxic sales, while Bristol-Myers Squibb will be the fourth leading company. Trends in corporate strategy 2009 Clolar (NI) Camptosar (PE) Calsed (NI) Doxil (PE) Gemzar (PE) Eloxatin (NI) Vidaza (FL) Gemzar (PE) Yondelis (FL) Temodar (PE) TS-1 (PE) 2010 Dacogen (NI) Clolar (NI) Alimta (PE) Eloxatin (EE) Dacogen (FL) Doxil (PE) Gemzar (NI) Doxil (PE) Treanda (FL) Hycamtin (PE) Taxotere (PE) Treanda (NI) 2011 Alimta (PE) Gemzar (NI) Clolar (PE) Dacogen (FL) Ixempra (NI) Hycamtin (PE) Doxil (NI) Vidaza (EE) Ixempra (FL) Eloxatin (NI) Ixempra (FL) Treanda (NI) 2012 Calsed (FL) Calsed (FL) Doxil (NI) Clolar (PE) Ixempra (NI) Eloxatin (NI) Vidaza (NI) Hycamtin (PE) Ixempra (NI) Taxotere (PE) TS-1 (NI) Vidaza (FL) Yondelis (FL) 2013 Arranon (PE) Xeloda (PE) Dacogen (PE) Eloxatin (PE) Gemzar (PE) Gemzar (NI) Taxotere (PE) Xeloda (PE) 2014 Temodar (PE) 2015 Treanda (PE) Alimta (PE) 2016 UFT (PE) 2017 NB: this is not an exhaustive representation of all the events forecast to impact the cytotoxics market 5EU = five major EU markets (France, Germany, Italy, Spain, and the UK) EE = exclusivity expiration; FL = first regional launch; NI = approval in new indication; PE = patent expiry Source: Datamonitor; Thomson Pharma, May 2009, Copyright D A T A M O N I T O R Commercial Insight: Cytotoxic Therapies DMHC2523 Datamonitor (Published 06/2009) Page 19 This report is a licensed product and is not to be photocopied Approval in multiple tumor types is most likely to result in significant sales The leading players in the cytotoxic market employ similar corporate strategies, by launching drugs applicable for use in multiple tumor types. Even if approval is in relatively low incidence tumor types, the collective use of a drug in numerous cancers has the potential to result in significant sales. Alternatively, if a drug is approved for only one tumor type, seeking approval across multiple lines of treatment can also result in significant sales. For example, Sanofi-Aventis has achieved, and will maintain, its position as the top company in the cytotoxics market with its blockbuster products Eloxatin and Taxotere. Eloxatin is used across all lines of treatment in colorectal cancer, one of the big four tumor types (Eloxatin Prescribing Information; products.sanofi-aventis.us). Taxotere is approved for use in eight tumor types, including three of the big four tumor types (breast cancer, prostate cancer, lung cancer and colorectal cancer) (Taxotere Prescribing Information; products.sanofi-aventis.us). A mature and heavily genericized market means that the experience of large pharmaceutical companies is crucial However, the cytotoxics market has become relatively mature, with high levels of competition between products. Increasing levels of genericization mean it is difficult for new players and/or new products to enter the market and gain significant market share. To overcome this, some smaller companies have taken to partnering with large pharmaceutical companies which have greater experience in the cytotoxics market, in order to increase potential success of their products. For example, Dacogen was originally developed by SuperGen, which then signed an agreement with MGI Pharma in September 2004, granting MGI Pharma exclusive worldwide rights to its development, manufacture, commercialization and distribution. In July 2006, Johnson & Johnson licensed exclusive development and Commercial Insight: Cytotoxic Therapies DMHC2523 Datamonitor (Published 06/2009) Page 104 This report is a licensed product and is not to be photocopied Contact our customer service team for more sample pages... Europe tel: fax: reports@datamonitor.com Americas tel: fax: reports@datamonitor.com Middle East tel: fax: reports@datamonitor.com Asia Pacific tel: fax: reports@datamonitor.com

4 Table of contents ABOUT DATAMONITOR HEALTHCARE About the Oncology pharmaceutical analysis team EXECUTIVE SUMMARY Strategic scoping and focus Datamonitor insight into the cytotoxic therapies market Related reports Upcoming related reports MARKET DEFINITION Market definition for this report - Cytotoxic therapies by ATC class MARKET OVERVIEW Seven major markets - Current and future market overview US Japan Five major European markets (5EU) France Germany Italy Spain UK Rest of the world snapshot - Current market assessment BRAND DYNAMICS Overview of competitive landscape - Taxotere and Eloxatin will be in the top 3 cytotoxic brands in 2008 and Drivers of brand choice - Efficacy and toxicity of a drug are the most important drivers of cytotoxic brand choice Trends in marketing strategies - Marketing strategy for leading brands Leading cytotoxic brands - Taxotere (docetaxel; Sanofi-Aventis) - Eloxatin (oxaliplatin; Sanofi-Aventis) - Gemzar (gemcitabine; Eli Lilly) - Dacogen (decitabine; Eisai/Johnson & Johnson) KEY DEVELOPERS Strategic overview Trends in corporate strategy - Approval in multiple tumor types is most likely to result in significant sales - A mature and heavily genericized market means that the experience of large pharmaceutical companies is crucial - The current pipeline is relatively small and contains several reformulations of leading cytotoxic brands Sanofi-Aventis - Corporate strategy - Oncology cytotoxics portfolio assessment Eli Lilly - Corporate strategy - Oncology cytotoxics portfolio assessment Portfolio assessment of other leading companies CASE STUDIES Introduction Case study - Supergeneric cytotoxics...not so super? BIBLIOGRAPHY Journal papers Websites Datamonitor reports Other APPENDIX A - MARKET ASSUMPTIONS New product launches Patent expiries

5 Table of contents (continued) Rest of class definition Data definitions, limitations and assumptions - Standard units - Japanese market data - Rest of the World - Derivation of sales forecasts and pricing trends Forecast methodology Report methodology APPENDIX B About Datamonitor - About Datamonitor Healthcare - About the Oncology analysis team - Disclaimer LIST OF TABLES Table 1: Definition of the cytotoxic therapies market, 2009 Table 2: Sales and growth of cytotoxic therapy drug classes in the seven major markets, Table 3: Key events impacting the cytotoxic therapies market, Table 4: Cytotoxic therapy sales forecasts in the seven major markets ($m), Table 5: Summary of opportunities and threats to impact the cytotoxics market across the seven major markets, Table 6: Sales and growth of cytotoxic therapy drug classes in the US, Table 7: Top 5 branded cytotoxics in the US in 2008 and Table 8: Cytotoxic therapy sales forecasts in the US ($m), Table 9: Summary of opportunities and threats to impact the cytotoxics market in the US, Table 10: Sales and growth of cytotoxic therapy drug classes in Japan, Table 11: Top 5 branded cytotoxics in Japan in 2008 and Table 12: Cytotoxic therapy sales forecasts in Japan ($m), Table 13: Summary of opportunities and threats to impact the cytotoxics market in Japan, 2009 Table 14: Sales and growth of cytotoxic therapy drug classes in the five major European markets, Table 15: Top 5 branded cytotoxics in the five major European markets in 2008 and Table 16: Cytotoxic therapy sales forecasts in the five major European markets ($m), Table 17: Summary of opportunities and threats to impact the cytotoxics market in the five major European markets, 2009 Table 18: Top 5 branded cytotoxics in France in 2008 and Table 19: Cytotoxic therapy sales forecasts in France ($m), Table 20: Top 5 branded cytotoxics in Germany in 2008 and Table 21: Cytotoxic therapy sales forecasts in Germany ($m), Table 22: Top 5 branded cytotoxics in Italy in 2008 and Table 23: Cytotoxic therapy sales forecasts in Italy ($m), Table 24: Top 5 branded cytotoxics in Spain in 2008 and Table 25: Cytotoxic therapy sales forecasts in Spain ($m), Table 26: Top 5 branded cytotoxics in the UK in 2008 and Table 27: Cytotoxic therapy sales forecasts in the UK ($m), Table 28: Comparison of cytotoxic drug class sales ($m) in the seven major markets and Rest of the World, 2008 Table 29: Comparison of cytotoxic drug class sales ($m) in the BRIC countries, Australia and Canada, 2008 Table 30: Leading branded cytotoxic drug sales in the seven major markets ($m), Table 31: Marketing strategies employed by the companies behind the top three cytotoxic brands, 2009 Table 32: Taxotere - drug profile, 2009 Table 33: Impacting factors on the revenues of Taxotere, Table 34: Eloxatin - drug profile, 2009 Table 35: Impacting factors on the revenues of Eloxatin, Table 36: Gemzar - drug profile, 2009 Table 37: Impacting factors on the revenues of Gemzar, Table 38: Dacogen - drug profile, 2009 Table 39: Ongoing Phase III trial investigating Dacogen in acute myeloid leukemia Table 40: Impacting factors on the revenues of Dacogen, Table 41: Leading companies in the seven major market cytotoxic therapies market, Table 42: Late-phase cytotoxics pipeline, 2009 Table 43: Assessment of Sanofi-Aventis's cytotoxics portfolio, 2009 Table 44: Assessment of Eli Lilly's cytotoxics portfolio, 2009 Table 45: Assessment of Pfizer's cytotoxics portfolio, 2009 Table 46: Assessment of Bristol-Myer Squibb's cytotoxics portfolio, 2009 Table 47: Assessment of Roche's cytotoxics portfolio, 2009 Table 48: FDA approvals for Taxol, Table 49: Historical global sales of Taxol ($m), Table 50: Approved and investigational paclitaxel reformulations, 2009 Table 51: Historical global sales of Abraxane ($m), Table 52: Regional launch dates for new cytotoxics in the seven major markets, Table 53: Patent expiry dates for the approved cytotoxics in the seven major pharmaceutical markets, LIST OF FIGURES Figure 1: Cytotoxic therapy sales ($m) by country in the seven major markets, Figure 2: Cytotoxic therapy sales ($m) by drug class in the seven major markets, Figure 3: Performance of leading cytotoxic therapy brands in the seven major markets, 2008 versus Figure 4: Seven major market population aged 60 and over, Figure 5: Global therapy sales ($m), For a full list of tables and figures please refer to

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