CHAPTER 1 EXECUTIVE SUMMARY

3

Scope of the analysis

3

Datamonitor insight into the cancer market

4

CHAPTER 2 MARKET DEFINITION AND OVERVIEW

15

Market definition for this report

15

Cytotoxics

15

L1A - Alkylating agents

15

L1B - Antimetabolites

16

L1C - Vinca alkaloids and other plant-derived products

16

L1D - Antineoplastic antibiotics

16

L1X2 - Platinum compounds

17

Antihormonal therapies

17

L2A3 - Luteinizing hormone-releasing hormone analogs

17

L2B1 - Anti-estrogens

17

L2B2 - Anti-androgens

17

L2B3 - Aromatase inhibitors

18

Targeted therapies

18

L1X3 - Antineoplastic monoclonal antibodies

18

L1X9 - All other antineoplastics

18

The Top 20 cancer therapeutics

19

Current market situation

22

CHAPTER 3 COUNTRY MARKET ASSESSMENTS

26

Current and future opportunities and threats in the cancer market

26

Global opportunities and threats

26

Opportunities

26

Threats

31

US: opportunities and threats

36

Opportunities

36

Threats

38

Japan: opportunities and threats

40

Opportunities

40

Threats

41

EU5: opportunities and threats

43

Opportunities

43

Threats

45

France: opportunities and threats

47

Opportunities

47

Threats

48

Germany: opportunities and threats

49

Opportunities

49

Threats

50

Italy: opportunities and threats

51

Opportunities

51

Threats

52

Spain: opportunities and threats

54

Opportunities

54

Threats

55

UK: opportunities and threats

56

Opportunities

56

Threats

56

Summary of environmental issues affecting the cancer market size

59

CHAPTER 4 FORECAST ANALYSIS

61

Country-specific assumptions and events

61

Effect of Medicare Modernization Act in the US

61

Biennial price cuts in Japan

61

Generic erosion assumptions

61

Product-specific assumptions and events

62

Cytotoxics

62

Schering-Plough's Temodar/Temodal (temozolomide)

62

Eli Lilly's Alimta (pemetrexed)

63

Eli Lilly's Gemzar (gemcitabine)

64

Taiho Pharmaceuticals' TS-1 (tegafur, gimeracil & oteracil)

66

Taiho Pharmaceuticals' UFT (tegafur & uracil)

67

Pharmion Corp's Vidaza (5-azacitidine)

68

Roche's Xeloda (capecitabine)

69

Pfizer/Yakult/Daiichi's Camptosar/Campto (irinotecan)

70

Pierre Fabre/GlaxoSmithKline's Navelbine (vinorelbine)

71

Bristol-Myers Squibb's Taxol (paclitaxel)

72

Sanofi-Aventis's Taxotere (docetaxel)

74

Johnson & Johnson/Schering-Plough's Doxil/Caelyx (pegylated liposomal doxorubicin)

77

Pfizer's Ellence/Farmorubicin (epirubicin)

78

Sanofi-Aventis's Eloxatin (oxaliplatin)

79

Bristol-Myers Squibb's Paraplatin (carboplatin)

82

Antihormonal therapies

83

Debiopharm's Decapeptyl (triptorelin)

83

Takeda/TAP/Abbott/Wyeth's Lupron (leuprorelin)

84

Sanofi-Aventis's Suprefact (buserelin)

84

AstraZeneca's Zoladex (goserelin)

85

AstraZeneca's Nolvadex (tamoxifen)

86

AstraZeneca's Casodex (bicalutamide)

88

AstraZeneca's Arimidex (anastrozole)

89

Pfizer's Aromasin (exemestane)

91

Novartis's Femara (letrozole)

92

Targeted therapies

94

Genentech/Roche's Avastin (bevacizumab)

94

ImClone/Bristol-Myers Squibb/Merck KGaA's Erbitux (cetuximab)

96

Genentech/Roche's Herceptin (trastuzumab)

99

Genentech/Roche's Rituxan/MabThera (rituximab)

101

Novartis's Gleevec/Glivec (imatinib)

103

AstraZeneca's Iressa (gefitinib)

105

OSI Pharmaceuticals/Genentech/Roche's Tarceva (erlotinib)

107

Ortho Biotech/Millennium Pharmaceuticals' Velcade (bortezomib)

109

Pipeline and newly marketed products

111

Amgen's ABX-EGF (panitumumab)

111

Onyx Pharmaceuticals/Bayer's Nexavar (sorafenib)

114

Bristol-Myers Squibb's Sprycel (dasatinib)

117

Pfizer's Sutent (sunitinib)

119

GlaxoSmithKline's Tykerb (lapatinib)

121

Data definitions, limitations and assumptions

124

Standard units

124

Japanese market data

124

Derivation of sales forecasts and pricing trends

124

Forecasts

124

Forecast methodology

125

CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES

126

Introduction

126

Case study 1

126

Changes to the Top 20 cancer therapeutics between 2005 and 2015

126

The Top 20 cancer therapeutics in 2005 - cytotoxics have the largest share

126

The Top 20 cancer therapeutics in 2015 - targeted therapies are key

129

Product sales growth between 2005 and 2015

131

Individual country Top 20 cancer therapeutics

134

Case study 2

139

Genentech/Roche's Avastin: increasing market penetration and line extensions expected to break all boundaries

139

The first commercialized angiogenesis inhibitor

139

The Genentech/Roche partnership: a key to success

140

Expanding range of indications

141

Despite formulation issues, the monoclonal antibodies generally confer greater clinical benefit than the small molecules

143

Competitor threats to be heeded

144

Biosimilars: should Genentech and Roche take note?

145

A prime example of becoming the leader in a new drug class

146

Case study 3

146

The impact of targeted therapies in redefining cancer

146

Greater understanding & new technologies have enabled the development of molecular targeted therapies

146

Redefining classification of tumor types

147

Genentech/Roche's Herceptin: using patient population subtypes to expedite regulatory approval

147

Commercial potential for diagnostics and biomarkers

148

APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS

150

Cytotoxics market data

150

Antihormonal therapies market data

158

Targeted therapies market data

163

APPENDIX B - MARKET FORECAST DATA

168

US forecasts

168

Japan forecasts

170

France forecasts

172

Germany forecasts

174

Italy forecasts

176

Spain forecasts

178

UK forecasts

180

EU5 forecasts

182

Seven major market forecasts

184

APPENDIX C

186

Bibliography

186

Report methodology

194

About Datamonitor

195

About Datamonitor Healthcare

195

About the Oncology analysis team

196

Disclaimer

197

List of Tables

Table 1: Definition of the cancer market, 2006

15

Table 2: Top 20 cancer therapeutics in the US, Japan, France and Germany, 2005

20

Table 3: Top 20 cancer therapeutics in Italy, Spain, the UK and collective seven major markets, 2005

21

Table 4: Key pipeline/newly marketed drugs included in the Top 20 cancer therapeutics

22

Table 5: Seven major market sales of Top 20 cancer therapeutics by drug class, 2005

22

Table 6: Key targeted therapies included in the Top 20 cancer therapeutics

23

Table 7: Key cytotoxics included in the Top 20 cancer therapeutics

24

Table 8: Key antihormonal therapies included in the Top 20 cancer therapeutics

25

Table 9: Market share of Taxotere, 2005

75

Table 10: Market share of Eloxatin

80

Table 11: Approved indications for Rituxan in the US and EU, 2006

102

Table 12: Clinical pipeline for ABX-EGF, 2006

111

Table 13: Clinical pipeline for Nexavar, 2006

115

Table 14: Clinical pipeline for Sprycel, 2006

117

Table 15: Summary of Phase II Sprycel clinical trial results

118

Table 16: Clinical pipeline for Sutent, 2006

120

Table 17: Clinical pipeline for Tykerb, 2006

122

Table 18: Seven market forecast sales of the Top 20 cancer therapeutics, 2005

127

Table 19: Seven market forecast sales of the Top 20 cancer therapeutics, 2015

129

Table 20: Top 20 cancer therapeutics in the US, 2005-15

135

Table 21: Top 20 cancer therapeutics in Japan, 2005-15

136

Table 22: Top 20 cancer therapeutics in the five EU markets, 2005-15

138

Table 23: Key events in Avastin's lifecycle

139

Table 24: Seven market forecast sales of Avastin, 2005-15

141

Table 25: Global forecast sales of Avastin based on company-reported data, 2005-15

142

Table 26: Alimta: key facts

150

Table 27: Camptosar: key facts

151

Table 28: Doxil: key facts

151

Table 29: Ellence: key facts

152

Table 30: Eloxatin: key facts

152

Table 31: Gemzar: key facts

153

Table 32: Navelbine: key facts

153

Table 33: Paraplatin: key facts

154

Table 34: Taxol: key facts

154

Table 35: Taxotere: key facts

155

Table 36: Temodar: key facts

155

Table 37: TS-1: key facts

156

Table 38: UFT: key facts

156

Table 39: Vidaza: key facts

157

Table 40: Xeloda: key facts

157

Table 41: Arimidex: key facts

158

Table 42: Aromasin: key facts

158

Table 43: Casodex: key facts

159

Table 44: Decapeptyl: key facts

159

Table 45: Femara: key facts

160

Table 46: Lupron: key facts

160

Table 47: Nolvadex: key facts

161

Table 48: Suprefact: key facts

161

Table 49: Zoladex: key facts

162

Table 50: Avastin: key facts

163

Table 51: Erbitux: key facts

163

Table 52: Gleevec: key facts

164

Table 53: Herceptin: key facts

164

Table 54: Iressa: key facts

165

Table 55: Nexavar: key facts

165

Table 56: Rituxan: key facts

166

Table 57: Sutent: key facts

166

Table 58: Tarceva: key facts

167

Table 59: Velcade: key facts

167

Table 60: Top 20 cancer therapeutics forecasts in the US, 2005-15 (1 of 2)

168

Table 61: Top 20 cancer therapeutics forecasts in the US, 2005-15 (2 of 2)

169

Table 62: Top 20 cancer therapeutics forecasts in Japan, 2005-15 (1 of 2)

170

Table 63: Top 20 cancer therapeutics forecasts in Japan, 2005-15 (2 of 2)

171

Table 64: Top 20 cancer therapeutics forecasts in France, 2005-15 (1 of 2)

172

Table 65: Top 20 cancer therapeutics forecasts in France, 2005-15 (2 of 2)

173

Table 66: Top 20 cancer therapeutics forecasts in Germany, 2005-15 (1 of 2)

174

Table 67: Top 20 cancer therapeutics forecasts in Germany, 2005-15 (2 of 2)

175

Table 68: Top 20 cancer therapeutics forecasts in Italy, 2005-15 (1 of 2)

176

Table 69: Top 20 cancer therapeutics forecasts in Italy, 2005-15 (2 of 2)

177

Table 70: Top 20 cancer therapeutics forecasts in Spain, 2005-15 (1 of 2)

178

Table 71: Top 20 cancer therapeutics forecasts in Spain, 2005-15 (2 of 2)

179

Table 72: Top 20 cancer therapeutics forecasts in the UK, 2005-15 (1 of 2)

180

Table 73: Top 20 cancer therapeutics forecasts in the UK, 2005-15 (2 of 2)

181

Table 74: Top 20 cancer therapeutics forecasts in the EU5, 2005-15 (1 of 2)

182

Table 75: Top 20 cancer therapeutics forecasts in the EU5, 2005-15 (2 of 2)

183

Table 76: Top 20 cancer therapeutics forecasts in the seven major markets, 2005-15 (1 of 2)

184

Table 77: Top 20 cancer therapeutics forecasts in the seven major markets, 2005-15 (2 of 2)

185

List of Figures

Figure 1: Seven market population aged 60 and over, 2000-50

26

Figure 2: Increasing incidence of cancer with increasing age

27

Figure 3: Seven major pharmaceutical market oncology sales, 2004-14

28

Figure 4: Summary of global opportunities and threats affecting the cancer market, 2006

59

Figure 5: Summary of regional opportunities and threats affecting the cancer market, 2006

60

Figure 6: Seven market sales of the Top 20 cancer therapeutics by drug class, 2005

128

Figure 7: Seven market sales of the Top 20 cancer therapeutics by drug class, 2015

130

Figure 8: Seven market cytotoxics sales growth, 2005-15

131

Figure 9: Seven market antihormonal therapies sales growth, 2005-15

132

Figure 10: Seven market targeted therapies sales growth, 2005-15

133

Figure 11: Forecast sales of Avastin, 2005-15

142