CONTENTS

8 OVERVIEW

8 Latest key takeaways

10 DISEASE BACKGROUND

10 Definition

10 Risk factors

12 Symptoms

12 Diagnosis

12 Determination of HER2 status

13 Patient segmentation

14 TREATMENT

14 Referral patterns

14 Operable Stage I-III HER2+ breast cancer

14 Inoperable Stage III HER2+ breast cancer

14 Neoadjuvant/adjuvant therapy regimens

15 Treatment guidelines for Stage IV or recurrent HER2+ breast cancer

18 EPIDEMIOLOGY

21 Breast cancer subtypes

23 MARKETED DRUGS

30 PIPELINE DRUGS

43 KEY REGULATORY EVENTS

43 England's NICE Says Yes To Kadcyla In Early Breast Cancer

43 Seattle Genetics Wins Early US FDA Approval For Tukysa, Plans Rapid Launch

43 Japan Enhertu Nod Another Boost For Daiichi's Oncology Hopes

43 Ide-Cel and Enhertu Sponsors Keep Fingers Crossed For EMA Fast-Track

44 India's SPARC Keeps Paclitaxel Ambition Burning For Now

44 Assessment Aid Speeds FDA Review Of Nerlynx In Third-Line Breast Cancer

44 Seattle Genetics' Tucatinib Moves Quickly From BTD To NDA

44 Enhertu Earns Second-Fastest Review Time Of 2019

45 First Filing, In Japan, For Daiichi's Lead ADC As Others Progress

45 FDA Approves Amgen And Allergan's Kanjinti Trastuzumab Biosimilar

46 PROBABILITY OF SUCCESS

47 CLINICAL TRIAL LANDSCAPE

48 Sponsors by status

49 Sponsors by phase

50 Recent events

52 DRUG ASSESSMENT MODEL

54 MARKET DYNAMICS

55 FUTURE TRENDS

55 Launches of new targeted therapies and label expansions will drive growth in the HER2+ breast cancer market over the
forecast period

55 Uptake of combination regimens will drive high revenues

55 Pipeline drugs will face strong competition in a saturated market

56 Trastuzumab biosimilars will have a minor impact on the overall market

57 CONSENSUS FORECASTS

62 RECENT EVENTS AND ANALYST OPINION

62 Tukysa for Breast Cancer (May 29, 2020)

63 Kadcyla for Breast Cancer (May 13, 2020)

65 Onzeald for Breast Cancer (February 27, 2020)

66 Leronlimab for Breast Cancer (January 31, 2020)

67 Oral Paclitaxel for Breast Cancer (December 13, 2019)

68 Perjeta/Herceptin SQ FDC for Breast Cancer (December 12, 2019)

68 Enhertu for Breast Cancer (December 11, 2019)

70 Tukysa for Breast Cancer (December 11, 2019)

71 MCLA-128 for Breast Cancer (October 23, 2019)

72 Margetuximab for Breast Cancer (October 22, 2019)

74 Tukysa for Breast Cancer (October 21, 2019)

75 Verzenio for Breast Cancer (September 28, 2019)

77 Oral Paclitaxel for Breast Cancer (August 7, 2019)

78 Multiple Drugs for Breast Cancer (June 25, 2019)

79 Margetuximab for Breast Cancer (June 4, 2019)

80 Nerlynx for Breast Cancer (June 4, 2019)

82 Perjeta for Breast Cancer (June 2, 2019)

84 KEY UPCOMING EVENTS

86 KEY OPINION LEADER INSIGHTS

87 UNMET NEEDS

88 BIBLIOGRAPHY

89 Prescription information

91 APPENDIX

LIST OF FIGURES

13 Figure 1: Staging of HER2+ breast cancer

20 Figure 2: Trends in incident cases of breast cancer, 2018-27

30 Figure 3: Overview of pipeline drugs for breast cancer in the US

30 Figure 4: Pipeline drugs for breast cancer, by company

31 Figure 5: Pipeline drugs for breast cancer, by drug type

31 Figure 6: Pipeline drugs for breast cancer, by classification

46 Figure 7: Probability of success in the breast cancer pipeline

47 Figure 8: Clinical trials in breast cancer

47 Figure 9: Top 10 drugs for clinical trials in breast cancer

48 Figure 10: Top 10 companies for clinical trials in breast cancer

48 Figure 11: Trial locations in breast cancer

49 Figure 12: Breast cancer trials status

50 Figure 13: Breast cancer trials sponsors, by phase

52 Figure 14: Datamonitor Healthcare's drug assessment summary for HER2+ breast cancer

54 Figure 15: Market dynamics for HER2+ breast cancer

55 Figure 16: Future trends in HER2+ breast cancer

63 Figure 17: Tukysa for Breast Cancer (May 29, 2020): Phase II - HER2CLIMB

65 Figure 18: Kadcyla for Breast Cancer (May 13, 2020): Phase III - KAITLIN (w/Perjeta, HER2+)

70 Figure 19: Enhertu for Breast Cancer (December 11, 2019): Phase II - DESTINY-Breast01 (HER2+)

74 Figure 20: Margetuximab for Breast Cancer (October 22, 2019): Phase III - SOPHIA (HER2+)

75 Figure 21: Tukysa for Breast Cancer (October 21, 2019): Phase II - HER2CLIMB

77 Figure 22: Verzenio for Breast Cancer (September 28, 2019): Phase II - monarcHER

78 Figure 23: Oral Paclitaxel for Breast Cancer (August 7, 2019): Phase III - KX-ORAX-001 (S. America)

80 Figure 24: Margetuximab for Breast Cancer (June 4, 2019): Phase III - SOPHIA (HER2+)

82 Figure 25: Nerlynx for Breast Cancer (June 4, 2019): Phase III - NALA - w/Xeloda vs. Tykerb/Xeloda (HER2+)

83 Figure 26: Perjeta for Breast Cancer (June 2, 2019): Phase III - CLEOPATRA

84 Figure 27: Key upcoming events in breast cancer (one of two)

85 Figure 28: Key upcoming events in breast cancer (two of two)

87 Figure 29: Unmet needs in HER2+ breast cancer

LIST OF TABLES

17 Table 1: Preferred branded treatments for HER2+ breast cancer

19 Table 2: Incident cases of breast cancer, 2018-27

21 Table 3: Five-year prevalent cases of breast cancer, 2018-27

22 Table 4: Breast cancer subtypes

24 Table 5: Marketed drugs for HER2+ breast cancer

32 Table 6: Pipeline drugs for HER2+ breast cancer in the US

58 Table 7: Historical global sales, by drug ($m), 2015-19

60 Table 8: Forecasted global sales, by drug ($m), 2020-24

62 Table 9: Tukysa for Breast Cancer (May 29, 2020)

64 Table 10: Kadcyla for Breast Cancer (May 13, 2020)

65 Table 11: Onzeald for Breast Cancer (February 27, 2020)

66 Table 12: Leronlimab for Breast Cancer (January 31, 2020)

67 Table 13: Oral Paclitaxel for Breast Cancer (December 13, 2019)

68 Table 14: Perjeta/Herceptin SQ FDC for Breast Cancer (December 12, 2019)

69 Table 15: Enhertu for Breast Cancer (December 11, 2019)

71 Table 16: Tukysa for Breast Cancer (December 11, 2019)

72 Table 17: MCLA-128 for Breast Cancer (October 23, 2019)

73 Table 18: Margetuximab for Breast Cancer (October 22, 2019)

74 Table 19: Tukysa for Breast Cancer (October 21, 2019)

76 Table 20: Verzenio for Breast Cancer (September 28, 2019)

77 Table 21: Oral Paclitaxel for Breast Cancer (August 7, 2019)

78 Table 22: Multiple Drugs for Breast Cancer (June 25, 2019)

79 Table 23: Margetuximab for Breast Cancer (June 4, 2019)

81 Table 24: Nerlynx for Breast Cancer (June 4, 2019)
83 Table 25: Perjeta for Breast Cancer (June 2, 2019)