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転移性HER2陽性乳がん：市場考察、疫学、市場予測 (2034年)

Metastatic HER2 positive Breast Cancer - Market Insight, Epidemiology And Market Forecast - 2034

出版日
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DelveInsight
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英文 276 Pages
納期
2～10営業日
カスタマイズ可能
適宜更新あり
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転移性HER2陽性乳がん：市場考察、疫学、市場予測 (2034年)
出版日: 2024年01月01日
発行: DelveInsight
ページ情報: 英文 276 Pages
納期: 2～10営業日
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概要

転移性HER2陽性乳がん市場

HER2治療における最近の進歩により、HER2陽性乳がんの管理は強化されましたが、疾患の不均一性と薬剤耐性メカニズムにより、再発は依然として重要な課題です。

HERCEPTINの承認は、HER2陽性乳がん治療の転換点となりました。HERCEPTINは、固形がんに対する最初の標的治療薬であり、コンパニオン診断薬と併用された最初の薬剤でした。

化学療法との併用によるトラスツズマブの有効性にもかかわらず、治療歴のないHER2陽性転移性乳がん患者のかなりの部分 (30～50%) は、初期に良好な反応を示さず、トラスツズマブに対する耐性を示しています。このことは、トラスツズマブの限界と、新規治療による耐性の問題に取り組む継続的研究の必要性を強調しています。

PERJETAはトラスツズマブおよび化学療法と並行して使用されることが多く、ペルツズマブの承認は重要なマイルストーンとなりました。トラスツズマブとペルツズマブの併用療法は、ネオアジュバントおよび転移性前治療の標準治療となっています。

ADCの開発は、転移性乳がん、特にHER2陽性乳がんの治療におけるブレークスルーを意味します。なかでもKADCYLAは、乳がん治療薬として初めてFDAの承認を得た。

HERCEPTIN、PERJETA、KADCYLA、ENHERTUなどの抗HER2療法は、HER2陽性がんの治療パラダイムを変えました。

Seagenの包括的なTUKYSA開発計画には、HER2陽性乳がんの2次治療としてTUKYSAとENHERTUを併用する第II相試験 (HER2CLIMB-04)、および1次治療維持療法としてTUKYSAとHERCEPTINおよびロシュのPERJETAを評価する第III相試験 (HER2CLIMB-05) が含まれます。

TUKYSAとKADCYLAはともにHER2標的薬であり、AstraZenecaとDaiichi SankyoのADCであるENHERTUのプレッシャーにさらされています。

Byondis、Hoffmann-La Roche、Ambrx、Zymeworks/Jazz Pharmaceuticalsなどの企業は、HER2陽性乳がんの中後期研究開発に積極的に取り組んでいます。HER2陽性乳がんのパイプラインには潜在的な薬剤はまだ少ないです。

ARX788は、そのユニークなADC構造により、ENHERTU投与後の患者に選択されるADCとなる可能性があります。

有望な新規抗HER2治療薬が出現するにつれて、この領域は革命を続け、三次治療以降のガイドラインに新規治療オプションが含まれ始めると思われます。

2023年には、米国が主要7ヶ国のHER2陽性乳がん市場全体の最大シェア約60%を占めています。

当レポートでは、世界のHER2陽性乳がん市場の過去・将来の疫学的動向を分析すると共に、世界の主要7ヶ国 - 米国、欧州主要4ヶ国 (EU4：ドイツ、スペイン、イタリア、フランス)・英国、日本 - のHER2陽性乳がん市場の詳細動向を調査しております。

当レポートでは、HER2陽性乳がんの現在の治療手段や新たな治療薬、個々の治療薬の市場シェア、市場規模の実績値・予測値 (2020～2034年) を、主要7ヶ国ごとに掲載しています。また、現在のHER2陽性乳がんの治療法/アルゴリズム、アンメットメディカルニーズも網羅し、最良の機会を発掘し、市場の潜在力を評価します。

分析対象地域

  • 米国
  • EU4 (ドイツ、フランス、イタリア、スペイン)・英国
  • 日本
  • 分析期間：2020年～2034年

転移性HER2陽性乳がんの疾患理解と治療アルゴリズム

HER2陽性乳がんの概要

乳がんは、乳房内の異常ながん細胞が増殖し、腫瘍を形成することで発症します。通常、乳管または乳腺小葉から発生します。

一部の乳がんは、ヒト上皮成長因子受容体2 (HER2) 遺伝子に依存して増殖します。このようながんはHER2+と呼ばれ、HER2遺伝子のコピーが多いか、HER2タンパク質の量が多いです。これらのタンパク質は"受容体"とも呼ばれます。HER2遺伝子はがん細胞で見られるHER2タンパク質を作り、腫瘍細胞の増殖に重要です。ヒト上皮成長因子受容体-2陽性 (HER2+) は、HER2タンパク質が陽性である乳がんです。HER2+乳がんは、ヒト上皮成長因子受容体-2陰性 (HER2-) 乳がんに比べて増殖が速く、転移や再発の可能性が高いです。患者さんのHER2ステータスは、乳がん検査でHER2タンパク質が陽性か陰性かによって決定されます。

転移性HER2陽性乳がんの診断

腫瘍変異検査などの各種検査：MSI-H/dMMR変異、PD-1、PD-L1検査、FISH (蛍光in situハイブリダイゼーション)、免疫組織化学 (IHC)、次世代シークエンシング、ポリメラーゼ連鎖反応、遺伝リスク検査など：BRCA検査は、HER2陽性乳がんの有無を判定するために採用されます。報告書に記載される結果は、実施された特定の検査によって異なります。IHC検査 (免疫組織化学) とFISH検査 (蛍光in situハイブリダイゼーション) の2つが広く用いられています。

患者さんがどのHER2検査を受けたかを知ることは重要です。一般に、HER2陽性乳がんを標的とする薬剤に反応するのは、IHC 3+またはFISH陽性のがんのみです。IHC 2+の検査結果は境界型と呼ばれます。IHC 2+の場合は、その組織をFISH検査で再検査します。

転移性HER2陽性乳がんの治療

転移性乳がんは、主に標的療法とホルモン療法で治療されます。第一選択治療は、エストロゲン受容体、プロゲステロン受容体、HER2受容体などの受容体の状態によって異なります。HER2受容体とエストロゲン受容体の両方が陽性の場合、初回治療ではホルモン療法、HER2標的療法、または両者の併用療法が行われます。

抗HER2療法 (HER2阻害薬またはHER2標的療法とも呼ばれる) は、早期から転移性までのHER2陽性乳がんの全ステージの治療に使用される一群の医薬品です。HERCEPTIN (トラスツズマブ) は、早期および進行期のHER2陽性乳がんを治療し、化学療法や、場合によってはPERJETA (ペルツズマブ) と呼ばれる別の標的療法と併用することができます。ENHERTU、KADCYLA、PHESGOなどの抗体薬物複合体は、切除不能または転移性のHER2陽性乳がんを治療することができます。別の治療法であるNERLYNXは、進行期および転移性のHER2陽性乳がんを治療するために化学療法を併用します。これとは別に、TUKYSA (ツカチニブ) は、少なくとも1種類の抗HER2薬で治療した後、手術で完全に切除できない転移性または局所進行HER2陽性乳がんを治療します。

転移性HER2陽性乳がんの疫学

  • 当レポートでは、世界の主要7ヶ国 - 米国、EU4 (ドイツ、フランス、イタリア、スペイン)・英国、日本 - における乳がんの総発生件数や、HER2陽性乳がんの総発生症件数、HER2陽性乳がんのホルモン状態、HER2陽性乳がんの年齢別発症件数、HER2陽性乳がんの病期別発症件数、HER2陽性乳がんの治療可能な発症件数などの疫学的動向の実績値・予測値 (2020～2034年) を分析しています。
  • この推計によると、主要7市場におけるHER2陽性乳がんの罹患者総数は、2023年には約10万2,000人となります。主要7ヶ国の症例は予測期間中、すなわち2024～2034年に増加すると予想されます。
  • HR+/HER2+乳がん症例は米国で最も多く、～32,000例を占めました。
  • 推計によると、HER2陽性乳がんの症例の多くは米国の40～60歳代で発生し、2023年には全症例の約52%を占めています。
  • EU4・英国では、ドイツが2023年のHER2陽性乳がん罹患者数で最大 (約11,000人) となる一方、スペインは罹患者数が最小でした。
  • 日本では、HER2陽性乳がんのステージ別罹患数はステージIIで最も多く、2023年には約6,000例でした。
  • 米国における転移性HER2陽性乳がんの年齢別発送 (2023年)

目次

第1章 主な考察

第2章 分析概要

第3章 転移性HER2陽性乳がん：市場概要

  • HER2陽性乳がんの市場シェア：クラス別 (%、2023年)
  • HER2陽性乳がんの市場シェア：クラス別 (%、2034年)

第4章 HER2陽性乳がん：エグゼクティブサマリー

第5章 主な出来事

第6章 疫学と市場分析の調査手法

第7章 疾患の背景と概要

  • イントロダクション
  • 乳がんの種類
    • 乳がんのサブタイプ
    • 乳がん分子のサブタイプ
  • HER2タンパク質
  • HER2陽性乳がん
  • HER2陽性乳がんの症状
  • HER2陽性乳がんのリスク要因
  • シグナル経路
  • HER2の状況の診断と検査
    • バイオマーカー検査
  • 診断ガイドライン
    • ASCOのガイドライン
  • HER2およびHR標的療法に対する反応と耐性に影響を与える要因
    • HER2自体
    • ホルモン受容体
    • PI3K/AKT/mTOR経路
    • 免疫関連
  • 治療と管理
  • HER2陽性乳がんの治療アルゴリズム
  • 治療ガイドライン
  • 主要7ヶ国における乳がんスクリーニングの推奨事項

第8章 疫学と患者人口

  • 主な分析結果
  • 仮定と根拠
  • 主要7ヶ国における乳がんの総発症件数
  • 主要7ヶ国におけるHER2陽性乳がんの総発症例数
  • 米国
    • 米国における乳がんの総発生件数
    • 米国におけるHER2陽性乳がんの発生件数
    • 米国におけるHER2陽性乳がんの発生件数：ホルモンの状態別
    • 米国におけるHER2陽性乳がんの発生件数：病期別
    • 米国におけるHER2陽性乳がんの発生件数：年齢別
    • 米国におけるHER2陽性乳がんの治療対象者プール
  • EU4・英国
    • EU4・英国における乳がんの総発生件数
    • EU4・英国におけるHER2陽性乳がんの発生件数
    • EU4・英国におけるHER2陽性乳がんの発生件数：ホルモンの状態別
    • EU4・英国におけるHER2陽性乳がんの発生件数：病期別
    • EU4・英国におけるHER2陽性乳がんの発生件数：年齢別
    • EU4・英国におけるHER2陽性乳がんの治療対象者プール
  • 日本
    • 日本における乳がんの総罹患率
    • 日本におけるHER2陽性乳がんの発生率
    • 日本におけるホルモン状態別HER2陽性乳がん症例の発生率
    • 日本におけるHER2陽性乳がんのステージ別発生率
    • 日本におけるHER2陽性乳がんの年齢別発生率
    • 日本におけるHER2陽性乳がんの治療対象者プール

第9章 患者動向

第10章 HER2陽性乳がんの主な評価項目

第11章 上市済み製品

  • 主な競合企業
  • HERCEPTIN (トラスツズマブ)：Roche
    • 製品説明
    • 規制のマイルストーン
    • その他の開発活動
    • 安全性と効能
    • 製品プロファイル
  • HERCEPTIN HYLECTA (トラスツズマブ、ヒアルロニダーゼ-oysk)：Roche
  • ENHERTU (fam-トラスツズマブ デルクステカン-nxk): Daiichi Sankyo/AstraZeneca
    • 現在のパイプライン活動
  • PHESGO (ペルツズマブ、トラスツズマブ、ヒアルロニダーゼ-zzxf)：Roche/Chugai
  • KADCYLA (アドトラスツズマブエムタンシン)：Roche/Chuga
  • MARGENZA (マルゲツキシマブ-cmkb ：MacroGenics
  • TUKYSA (ツカチニブ)：Seagen
  • NERLYNX (ネラチニブ)：Puma Biotechnology
  • PERJETA (ペルツズマブ)：Roche
  • TYKERB/TYVERB (ラパチニブ)：Novartis

第12章 新たな治療法

  • 主な競合企業
  • SYD985 (トラスツズマブデュオカルマジン)：Byondis
    • 製品説明
    • その他の開発活動
    • 臨床開発
    • 安全性と効能
  • ジレデストラント：Roche
  • ARX788：Ambrx
  • ザニダタマブ：Zymeworks/Jazz Pharmaceuticals
  • IBRANCE (パルボシクリブ)：Pfizer

第13章 HER2陽性乳がん：主要7ヶ国の市場分析

  • 主な分析結果
  • 市場見通し
  • HER2陽性乳がん治療薬の承認スケジュール
  • コンジョイント分析
  • 主要な市場予測の前提条件
  • 主要7ヶ国のHER2陽性乳がんの総市場規模
  • 米国の市場規模
    • 米国におけるHER2陽性乳がんの総市場規模
    • 米国におけるHER2陽性乳がんの市場規模：治療薬別
  • EU4・英国の市場規模
    • EU4・英国におけるHER2陽性乳がんの総市場規模
    • EU4・英国におけるHER2陽性乳がんの市場規模：治療薬別
  • 日本市場規模
    • 日本におけるHER2陽性乳がんの総市場規模
    • 日本におけるHER2陽性乳がんの市場規模：治療薬別

第14章 HER2陽性乳がんの市場アクセスと償還

  • HERCEPTIN (トラスツズマブ)：Genentech
  • MARGENZA (マルゲツキシマブ)：MacroGenics
  • PHESGO (ペルツズマブ/トラスツズマブ/ヒアルロニダーゼ)：Genentech
  • TUKYSA (ツカチニブ)：Seagen
  • NERLYNX (ネラチニブ)：Puma biotech
  • タイケルブ (ラパチニブ)：Novartis
  • PERJETA (ペルツズマブ)：Roche
  • KADCYLA (トラスツズマブエムタンシン)：Roche/Chugai
  • ENHERTU (トラスツズマブデルクステカン)：Daiichi/AstraZeneca
  • 支払者の範囲

第15章 アンメットニーズ

第16章 SWOT分析

第17章 KOLの見解

第18章 付録

第19章 DelveInsightのサービス内容

第20章 免責事項

第21章 DelveInsightについて

図表

List of Tables

  • Table 1: Summary of HER2-Positive Breast Cancer and Epidemiology (2020-2034)
  • Table 2: Intrinsic Subtype of Breast Cancer
  • Table 3: Recommendation for HR-positive or -negative and HER2-positive Breast Cancer
  • Table 4: NCCN Recommendation for Adjuvant HER2-targeted Therapy Options: HER2+
  • Table 5: Breast Cancer Screening Recommendations for Women at Average Risk
  • Table 6: The US Preventive Services Task Force Recommendation
  • Table 7: Total Incident Cases of Breast Cancer in the 7MM (2020-2034)
  • Table 8: Total Incident Cases of HER2-positive Breast Cancer in the 7MM (2020-2034)
  • Table 9: Total Incidence of Breast Cancer in the United States (2020-2034)
  • Table 10: Incidence of HER2-positive Breast Cancer in the United States (2020-2034)
  • Table 11: Incidence of HER2-positive Breast Cancer Cases by Hormonal Status in the United States (2020-2034)
  • Table 12: Stage-specific Incidence of HER2-positive Breast Cancer in the United States (2020-2034)
  • Table 13: Age-specific Incidence of HER2-positive Breast Cancer in the United States (2020-2034)
  • Table 14: Treatment-eligible Cases of HER2-positive Breast Cancer in the United States (2020-2034)
  • Table 15: Total Incidence of Breast Cancer in EU4 and the UK (2020-2034)
  • Table 16: Total Incidence of Breast Cancer in Japan (2020-2034)
  • Table 17: Incidence of HER2-positive Breast Cancer in Japan (2020-2034)
  • Table 18: Incidence of HER2-positive Breast Cancer Cases by Hormonal Status in Japan (2020-2034)
  • Table 19: Stage-specific Incidence of HER2-positive Breast Cancer in Japan (2020-2034)
  • Table 20: Age-specific Incidence of HER2-positive Breast Cancer in Japan (2020-2034)
  • Table 21: Treatment-eligible cases of HER2-positive Breast Cancer in Japan (2020-2034)
  • Table 22: Marketed Drug Key Cross
  • Table 23: ENHERTU, Clinical Trial Description, 2024
  • Table 24: KADCYLA, Clinical Trial Description, 2024
  • Table 25: MARGENZA, Clinical Trial Description, 2024
  • Table 26: TUKYSA, Clinical Trial Description, 2024
  • Table 27: NERLYNX, Clinical Trial Description, 2024
  • Table 28: TYKERB, Clinical Trial Description, 2024
  • Table 29: Comparison of Emerging Drugs
  • Table 30: SYD985, Clinical Trial Description, 2024
  • Table 31: Giredestrant, Clinical Trial Description, 2024
  • Table 32: ARX788, Clinical Trial Description, 2024
  • Table 33: Zanidatamab Clinical Trial Description, 2024
  • Table 34: IBRANCE, Clinical Trial Description, 2024
  • Table 35: Key Market Forecast Assumption of HER2-positive Breast Cancer in the US
  • Table 36: Key Market Forecast Assumption of HER2-positive Breast Cancer in EU4 and the UK
  • Table 37: Key Market Forecast Assumption of HER2-positive Breast Cancer in Japan
  • Table 38: Market Size of HER2-positive Breast Cancer in the 7MM, in USD million (2020-2034)
  • Table 39: Market Size of HER2-positive Breast Cancer in the US, in USD million (2020-2034)
  • Table 40: Market Size of HER2-positive Breast Cancer by Therapies in the US, in USD million (2020-2034)
  • Table 41: Market Size of HER2-positive Breast Cancer in EU4 and the UK, in USD million (2020-2034)
  • Table 42: Market Size of HER2-positive Breast Cancer by Therapies in EU4 and the UK, in USD million (2020-2034)
  • Table 43: Market Size of HER2-positive Breast Cancer in Japan, in USD million (2020-2034)
  • Table 44: Market Size of HER2-positive Breast Cancer by Therapies in Japan, in USD million (2020-2034)

List of Figures

  • Figure 1: Molecular Subtypes of Breast Cancer
  • Figure 2: Overview of Estrogen Receptor (ER) and HER2 Signaling Crosstalk
  • Figure 3: Algorithm for Evaluation of HER2 Protein Expression by Immunohistochemistry (IHC) Assay of the Invasive Component of a Breast Cancer Specimen
  • Figure 4: Algorithm for Evaluation of HER2 Gene Amplification by in situ Hybridization (ISH) Assay of the Invasive Component of a Breast Cancer Specimen

Using a Single-signal (HER2 gene) Assay (single-probe ISH)

  • Figure 5: Algorithm for Evaluation of HER2 Gene Amplification by In Situ Hybridization (ISH) Assay of the Invasive Component of a Breast Cancer

Specimen Using A Dual-signal (HER2 gene) Assay (dual-probe ISH)

  • Figure 6: Management of Early HER2-positive breast cancer in Italy
  • Figure 7: Treatment Algorithm for the Treatment of HER2-positive mBC
  • Figure 8: Current Treatment for HER2-positive Breast Cancer
  • Figure 9: ESMO Recommendation for First-line Treatment of HER2-positive MBC
  • Figure 10: ESMO Recommendation for Second-line Treatment of HER2-positive MBC
  • Figure 11: ESMO Recommendation for Third-line and Beyond Treatment of HER2-positive MBC
  • Figure 12: Systemic Treatment of Recurrent Unresectable (Local or Regional) or Stage IV (M1) Disease: ER- and/or PR-Positive; HER2-Positive
  • Figure 13: Systemic Treatment of Recurrent Unresectable (Local or Regional) or Stage IV (M1) Disease: ER- and/or PR-positive; HER2-positive
  • Figure 14: Systemic Treatment of Recurrent Unresectable (Local or Regional) or Stage IV (M1) Disease: ER- and/or PR-negative; HER2-positive
  • Figure 15: Total Incident Cases of Breast Cancer in the 7MM (2020-2034)
  • Figure 16: Total Incident Cases of HER2-positive Breast Cancer in the 7MM (2020-2034)
  • Figure 17: Total Incidence of Breast Cancer in the United States (2020-2034)
  • Figure 18: Incidence of HER2-positive Breast Cancer in the United States (2020-2034)
  • Figure 19: Incidence of HER2-positive Breast Cancer Cases by Hormonal Status in the United States (2020-2034)
  • Figure 20: Stage-specific Incidence of HER2-positive Breast Cancer in the United States (2020-2034)
  • Figure 21: Age-specific Incidence of HER2-positive Breast Cancer in the United States (2020-2034)
  • Figure 22: Treatment-eligible Pool for HER2-positive Breast Cancer in the United States (2020-2034)
  • Figure 23: Total Incidence of Breast Cancer in EU4 and the UK (2020-2034)
  • Figure 24: Incidence of HER2-positive Breast Cancer in EU4 and the UK (2020-2034)
  • Figure 25: Incidence of HER2-positive Breast Cancer Cases by Hormonal Status in EU4 and the UK (2020-2034)
  • Figure 26: Stage-specific Incidence of HER2-positive Breast Cancer in EU4 and the UK (2020-2034)
  • Figure 27: Age-specific Incidence of HER2-positive Breast Cancer in EU4 and the UK (2020-2034)
  • Figure 28: Treatment-eligible Pool for HER2-positive Breast Cancer in EU4 and the UK (2020-2034)
  • Figure 29: Total Incidence of Breast Cancer in Japan (2020-2034)
  • Figure 30: Incidence of HER2-positive Breast Cancer in Japan (2020-2034)
  • Figure 31: Incidence of HER2-positive Breast Cancer Cases by Hormonal Status in Japan (2020-2034)
  • Figure 32: Stage-specific Incidence of HER2-positive Breast Cancer in Japan (2020-2034)
  • Figure 33: Age-specific Incidence of HER2-positive Breast Cancer in Japan (2020-2034)
  • Figure 34: Treatment-eligible Pool for HER2-positive Breast Cancer in Japan (2020-2034)
  • Figure 35: Market Size of HER2-positive Breast Cancer in the 7MM, in USD million (2020-2034)
  • Figure 36: Market Size of HER2-positive Breast Cancer in the US, in USD million (2020-2034)
  • Figure 37: Market Size of HER2-positive Breast Cancer by Therapies in the US, in USD million (2020-2034)
  • Figure 38: Market Size of HER2-positive Breast Cancer in EU4 and the UK, in USD million (2020-2034)
  • Figure 39: Market Size of HER2-positive Breast Cancer by Therapies in EU4 and the UK, in USD million (2020-2034)
  • Figure 40: Market Size of HER2-positive Breast Cancer in Japan, in USD million (2020-2034)
  • Figure 41: Market Size of HER2-positive Breast Cancer by Therapies in Japan, in USD million (2020-2034)
  • Figure 42: Unmet Needs
目次

Metastatic HER2 positive Breast Cancer Market

Recent advancements in HER2 treatments have enhanced HER2-positive breast cancer management, yet relapse remains a primary challenge due to disease heterogeneity and drug resistance mechanisms.

The approval of HERCEPTIN marked a turning point in HER2-positive breast cancer treatment. HERCEPTIN was the first targeted treatment for a solid tumor and the first drug to be paired with a companion diagnostic.

Despite the effectiveness of trastuzumab in combination with chemotherapy, a substantial portion (30-50%) of treatment-naive HER2-positive metastatic breast cancer patients do not respond well initially, indicating resistance to trastuzumab. This underscores its limitations and the need for ongoing research to tackle resistance issues with novel therapies.

PERJETA is often used alongside trastuzumab and chemotherapy; pertuzumab's approval marked a significant milestone. The combination of trastuzumab and pertuzumab has become a standard of care for neoadjuvant and metastatic front-line settings.

The development of ADCs represents a breakthrough in treating metastatic breast cancer, particularly in HER2-positive breast cancer. Among these, KADCYLA was the first to gain FDA approval for breast cancer treatment.

Anti-HER2 therapies, such as HERCEPTIN, PERJETA, KADCYLA, ENHERTU, and others, have changed the treatment paradigm of HER2-positive cancers, which were previously associated with more aggressive disease and poorer outcomes.

Seagen's comprehensive TUKYSA development plan includes a Phase II trial (HER2CLIMB-04) combining TUKYSA with ENHERTU for second-line HER2-positive breast cancer and a Phase III trial (HER2CLIMB-05) evaluating TUKYSA with HERCEPTIN and Roche's PERJETA as a first-line maintenance regimen.

Both TUKYSA and KADCYLA are HER2-targeted agents, and both are under pressure from AstraZeneca and Daiichi Sankyo's ADC ENHERTU, which has handily beaten KADCYLA in a head-to-head trial.

Companies like Byondis, Hoffmann-La Roche, Ambrx, and Zymeworks/Jazz Pharmaceuticals actively engage in mid and late-stage research and development efforts for HER2-positive breast cancer. The pipeline of HER2-positive breast cancer possesses few potential drugs.

ARX788 may potentially become the ADC of choice for post-ENHERTU patients with its unique ADC structure.

As promising novel anti-HER2 treatments emerge, the field will continue to revolutionize, with guidelines beginning to include novel treatment options in the third-line setting and thereafter.

In 2023, the United States accounted for the maximum share of the total market of HER2-positive breast cancer in the 7MM was around 60%.

DelveInsight's "Metastatic HER2-positive Breast Cancer Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of the HER2-positive breast cancer, historical and forecasted epidemiology as well as the HER2-positive breast cancer market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The Metastatic HER2-positive breast cancer market report provides current treatment practices, emerging drugs, HER2-positive breast cancer market share of the individual therapies, and current and forecasted HER2-positive breast cancer market size from 2020 to 2034, segmented by seven major markets. The report also covers current HER2-positive breast cancer treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered:

  • The United States
  • EU4 (Germany, France, Italy, and Spain) and the United Kingdom
  • Japan
  • Study Period: 2020-2034

Metastatic HER2-positive Breast Cancer Disease Understanding and Treatment Algorithm

HER2-positive Breast Cancer Overview

Breast cancer initiates when abnormal cancerous cells in the breast grow and proliferate, creating a tumor. It usually starts in the ducts or lobules of the breast.

Some breast cancers depend on the human epidermal growth factor receptor 2 (HER2) gene to grow. These cancers are called HER2+ and have many copies of the HER2 gene or high levels of the HER2 protein. These proteins are also called "receptors." The HER2 gene makes the HER2 protein found in cancer cells and is important for tumor cell growth. Human epidermal growth factor receptor-2 positive (HER2+) is breast cancer that tests positive for the HER2 protein. HER2+ breast cancer grows faster and is more likely to spread and return than human epidermal growth factor receptor-2 negative (HER2-) breast cancer. Patients' HER2 status is determined by whether breast cancer tests are positive or negative for the HER2 protein.

Metastatic HER2-positive Breast Cancer Diagnosis

Various tests such as tumor mutation testing: MSI-H/dMMR mutation, PD-1, and PD-L1 testing, FISH (Fluorescence in Situ Hybridization), Immunohistochemistry (IHC), Next-generation sequencing, Polymerase chain reaction, and genetic risk testing: BRCA tests are employed to determine the presence of HER2-positive breast cancer. The appearance of results in the report will vary based on the specific test conducted. Two widely used tests are the IHC test (Immunohistochemistry) and the FISH test (Fluorescence in Situ Hybridization).

It is important to know which HER2 test the patient had. Generally, only cancers that test IHC 3+ or FISH positive respond to the medicines that target HER2-positive breast cancers. An IHC 2+ test result is called borderline. If the patient has an IHC 2+ result, ask to retest the tissue with the FISH test.

Metastatic HER2-positive Breast Cancer Treatment

Metastatic breast cancer is primarily treated with targeted therapy and hormonal therapy. First-line treatment choice depends on receptor status, including estrogen, progesterone, and HER2 receptors. In cases where both HER2 and estrogen receptors are positive, initial treatment may involve hormonal therapy, HER2-targeted therapy, or a combination of both.

Anti-HER2 therapies (also called HER2 inhibitors or HER2-targeted therapies) are a class of medicines used to treat all stages of HER2-positive breast cancer, from early-stage to metastatic. HERCEPTIN (trastuzumab) treats early-stage and advanced HER2-positive breast cancer and can be given with chemotherapy and sometimes another targeted therapy called PERJETA (pertuzumab). Antibody-drug conjugates such as ENHERTU, KADCYLA, and PHESGO can treat unresectable or metastatic HER2-positive breast cancer. Another therapy, NERLYNX, combines chemotherapy to treat advanced-stage and metastatic HER2-positive breast cancer. Apart from this, TUKYSA (tucatinib) treats metastatic or locally advanced HER2-positive breast cancer that cannot be completely removed with surgery after the cancer has been treated with at least one anti-HER2 medicine.

Metastatic HER2-positive Breast Cancer Epidemiology

  • The HER2-positive breast cancer epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incidence of breast cancer, total incident cases of HER2-positive breast cancer, hormonal status of HER2-positive breast cancer, age-specific cases of HER2-positive breast cancer, stage-specific cases of HER2-positive breast cancer, and Treatment-eligible Cases of HER2-positive Breast Cancer in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.
  • According to the estimates, the total incident population of HER2-positive breast cancer in the seven major markets was nearly 102,000 cases in 2023. The cases in the 7MM are expected to increase during the forecast period, i.e., 2024-2034.
  • The HR+/HER2+ breast cases were highest in the United States, accounting for ~32,000 cases.
  • According to the estimates, most cases of HER2-positive breast cancer occur in people between 40 and 60 in the United States, accounting for ~52% of total cases in 2023.
  • Among EU4 and the UK, Germany had the maximum total incident cases of HER2-positive breast cancer, with ~11,000 cases in 2023, while Spain accounted for the least number of cases.
  • In Japan, stage-specific cases of HER2-positive breast cancer were highest in Stage II, accounting for ~6,000 cases in 2023.
  • Metastatic HER2-positive Breast Cancer Cases by Age in the United States in 2023

Table of Contents

1 Key Insights

2 Report Introduction

3 Metastatic HER2-positive Breast Cancer Market Overview at a Glance

  • 3.1 Market Share by Class (%) Distribution of HER2-positive Breast Cancer in 2023
  • 3.2 Market Share by Class (%) Distribution of HER2-positive Breast Cancer in 2034

4 Executive Summary of HER2-positive Breast Cancer

5 Key Events

6 Epidemiology and Market Methodology

7 Disease Background and Overview

  • 7.1 Introduction
  • 7.2 Types of Breast Cancer
    • 7.2.1 Subtypes of Breast Cancer
    • 7.2.2 Molecular Subtypes of Breast Cancer
  • 7.3 HER2 Protein
  • 7.4 HER2-positive Breast Cancer
  • 7.5 Symptoms of HER2-positive Breast Cancer
  • 7.6 Risk Factors of HER2-positive Breast Cancer
  • 7.7 Signaling Pathway
  • 7.8 Diagnosis and Testing for HER2 Status
    • 7.8.1 Biomarker Testing
      • 7.8.1.1 Tumor Markers
  • 7.9 Diagnosis Guidelines
    • 7.9.1 ASCO Guidelines
  • 7.1 Factors Affecting the Response and Resistance to HER2- and HR-Targeted Therapies
    • 7.10.1 HER2 Itself
    • 7.10.2 Hormone Receptors
    • 7.10.3 PI3K/AKT/mTOR Pathway
    • 7.10.4 Immune-related
  • 7.11 Treatment and Management
    • 7.11.1 Targeted Therapy for HER2-positive Breast Cancer
      • 7.11.1.1 Monoclonal Antibodies
      • 7.11.1.2 Antibody-drug Conjugates
      • 7.11.1.3 Tyrosine Kinase Inhibitors
    • 7.11.2 Management of HER2-positive Early Breast Cancer in Italy
      • 7.11.2.1 Neoadjuvant Therapy of HER2+ Breast Cancer
      • 7.11.2.2 Adjuvant Therapy of HER2+ Breast Cancer
  • 7.12 Treatment Algorithm for HER2-positive Breast Cancer
  • 7.13 Treatment Guidelines
    • 7.13.1 ASCO Guideline for Patients with HER2-positive Breast Cancer
    • 7.13.2 ESMO Guideline (2022)
    • 7.13.3 G-BA Updates on Disease Management Programs (DMP) for Women with Breast Cancer
    • 7.13.4 NCCN Guidelines for Breast Cancer (2023)
      • 7.13.4.1 Systemic Treatment of Recurrent Unresectable (Local or Regional) or Stage IV (M1) Disease: ER- and/or PR-positive; HER2-positive
      • 7.13.4.2 Systemic Treatment of Recurrent Unresectable (Local or Regional) or Stage IV (M1) Disease: ER- and/or PR-negative; HER2-positive
      • 7.13.4.3 Systemic Therapy Regimens For Recurrent Unresectable (Local or Regional) or Stage IV (M1) Disease
      • 7.13.4.4 NCCN-recommended HER-targeted Therapy
  • 7.14 Screening Recommendations for Breast Cancer in the 7MM
    • 7.14.1 Summary of Breast Cancer Screening Recommendations for Women at Average Risk in the United States
    • 7.14.2 American Cancer Society (ACS) Recommendations for the Early Detection of Breast Cancer
    • 7.14.3 Recommendations Made by the USPSTF (US Preventive Service Task Force): 2016
    • 7.14.4 Breast Cancer Screening in Germany
      • 7.14.4.1 IQWiG Recommendation: Mammography Screening Program
    • 7.14.5 European Commission Initiative on Breast Cancer (ECIBC) Guidelines for Screening Ages (2022)
    • 7.14.6 The Italian Group Recommendation for Mammography
    • 7.14.7 Screening Recommendation in France
    • 7.14.8 Breast Cancer Screening in Spain
    • 7.14.9 NHS Breast Screening Program
    • 7.14.10 Screening Recommendation in Japan
      • 7.14.10.1 The Japanese Society of Gynecologic Oncology (JSGO)

8 Epidemiology and Patient Population

  • 8.1 Key Findings
  • 8.2 Assumptions and Rationale
  • 8.3 Total Incident Cases of Breast Cancer in the 7MM
  • 8.4 Total Incident Cases of HER2-positive Breast Cancer in the 7MM
  • 8.5 The United States
    • 8.5.1 Total Incidence of Breast Cancer in the United States
    • 8.5.2 Incidence of HER2-positive Breast Cancer in the United States
    • 8.5.3 Incidence of HER2-positive Breast Cancer Cases by Hormonal Status in the United States
    • 8.5.4 Stage-specific Incidence of HER2-positive Breast Cancer in the United States
    • 8.5.5 Age-specific Incidence of HER2-positive Breast Cancer in the United States
    • 8.5.6 Treatment-eligible Pool for HER2-positive Breast Cancer in the United States
  • 8.6 EU4 and the UK
    • 8.6.1 Total Incidence of Breast Cancer in EU4 and the UK
    • 8.6.2 Incidence of HER2-positive Breast Cancer in EU4 and the UK
    • 8.6.3 Incidence of HER2-positive Breast Cancer Cases by Hormonal Status in EU4 and the UK
    • 8.6.4 Stage-specific Incidence of HER2-positive Breast Cancer in EU4 and the UK
    • 8.6.5 Age-specific Incidence of HER2-positive Breast Cancer in EU4 and the UK
    • 8.6.6 Treatment-eligible Pool for HER2-positive Breast Cancer in EU4 and the UK
  • 8.7 Japan
    • 8.7.1 Total Incidence of Breast Cancer in Japan
    • 8.7.2 Incidence of HER2-positive Breast Cancer in Japan
    • 8.7.3 Incidence of HER2-positive Breast Cancer Cases by Hormonal Status in Japan
    • 8.7.4 Stage-specific Incidence of HER2-positive Breast Cancer in Japan
    • 8.7.5 Age-specific Incidence of HER2-positive Breast Cancer in Japan
    • 8.7.6 Treatment-eligible Pool for HER2-positive Breast Cancer in Japan

9 Patient Journey

10 Key Endpoints in HER2-positive Breast Cancer

11 Marketed Drugs

  • 11.1 Key Competitors
  • 11.2 HERCEPTIN (trastuzumab): Roche
    • 11.2.1 Product Description
    • 11.2.2 Regulatory Milestones
    • 11.2.3 Other Developmental Activities
    • 11.2.4 Safety and Efficacy
    • 11.2.5 Product Profile
  • 11.3 HERCEPTIN HYLECTA (trastuzumab and hyaluronidase-oysk): Roche
    • 11.3.1 Product Profile
    • 11.3.2 Regulatory Milestones
    • 11.3.3 Safety and Efficacy
    • 11.3.4 Product Profile
  • 11.4 ENHERTU (fam-trastuzumab deruxtecan-nxk): Daiichi Sankyo/AstraZeneca
    • 11.4.1 Product Description
    • 11.4.2 Regulatory Milestones
    • 11.4.3 Other Developmental Activities
    • 11.4.4 Current Pipeline Activity
      • 11.4.4.1 Clinical Trials Information
    • 11.4.5 Safety and Efficacy
    • 11.4.6 Product Profile
  • 11.5 PHESGO (pertuzumab, trastuzumab, and hyaluronidase-zzxf): Roche/Chugai
    • 11.5.1 Product Description
    • 11.5.2 Regulatory Milestones
    • 11.5.3 Other Developmental Activities
    • 11.5.4 Safety and Efficacy
    • 11.5.5 Product Profile
  • 11.6 KADCYLA (ado-trastuzumab emtansine): Roche/Chugai
    • 11.6.1 Product Description
    • 11.6.2 Regulatory Milestones
    • 11.6.3 Other Developmental Activities
    • 11.6.4 Current Pipeline Activity
      • 11.6.4.1 Clinical Trials Information
    • 11.6.5 Safety and Efficacy
    • 11.6.6 Product Profile
  • 11.7 MARGENZA (margetuximab-cmkb): MacroGenics
    • 11.7.1 Product Description
    • 11.7.2 Regulatory Milestones
    • 11.7.3 Other Developmental Activities
    • 11.7.4 Current Pipeline Activity
      • 11.7.4.1 Clinical Trials Information
    • 11.7.5 Safety and Efficacy
    • 11.7.6 Product Profile
  • 11.8 TUKYSA (tucatinib): Seagen
    • 11.8.1 Product Description
    • 11.8.2 Regulatory Milestones
    • 11.8.3 Other Developmental Activities
    • 11.8.4 Current Pipeline Activity
      • 11.8.4.1 Clinical Trials Information
    • 11.8.5 Safety and Efficacy
    • 11.8.6 Product Profile
  • 11.9 NERLYNX (neratinib): Puma Biotechnology
    • 11.9.1 Product Description
    • 11.9.2 Regulatory Milestones
    • 11.9.3 Other Developmental Activities
    • 11.9.4 Current Pipeline Activity
      • 11.9.4.1 Clinical Trials Information
    • 11.9.5 Safety and Efficacy
    • 11.9.6 Product Profile
  • 11.10 PERJETA (pertuzumab): Roche
    • 11.10.1 Product Description
    • 11.10.2 Regulatory Milestones
    • 11.10.3 Other Developmental Activities
    • 11.10.4 Safety and Efficacy
    • 11.10.5 Product Profile
  • 11.11 TYKERB/TYVERB (lapatinib): Novartis
    • 11.11.1 Product Description
    • 11.11.2 Regulatory Milestones
    • 11.11.3 Other Developmental Activities
    • 11.11.4 Current Pipeline Activity
      • 11.11.4.1 Clinical Trials Information
    • 11.11.5 Safety and Efficacy
    • 11.11.6 Product Profile

12 Emerging Drugs

  • 12.1 Key Competition
  • 12.2 SYD985 (trastuzumab duocarmazine): Byondis
    • 12.2.1 Product Description
    • 12.2.2 Other Developmental Activities
    • 12.2.3 Clinical Development
      • 12.2.3.1 Clinical Trial Information
    • 12.2.4 Safety and Efficacy
  • 12.3 Giredestrant: Roche
    • 12.3.1 Product Description
    • 12.3.2 Clinical Development
      • 12.3.2.1 Clinical Trial Information
  • 12.4 ARX788: Ambrx
    • 12.4.1 Product Description
    • 12.4.2 Other Developmental Activities
    • 12.4.3 Clinical Development
      • 12.4.3.1 Clinical Trial Information
    • 12.4.4 Safety and Efficacy
  • 12.5 Zanidatamab: Zymeworks/Jazz Pharmaceuticals
    • 12.5.1 Product Description
    • 12.5.2 Other Developmental Activities
    • 12.5.3 Clinical Development
      • 12.5.3.1 Clinical Trials Information
    • 12.5.4 Safety and Efficacy
  • 12.6 IBRANCE (palbociclib): Pfizer
    • 12.6.1 Product Description
    • 12.6.2 Other Developmental Activities
    • 12.6.3 Clinical Development
      • 12.6.3.1 Clinical Trial Information

13 HER2-positive Breast Cancer: 7MM Market Analysis

  • 13.1 Key Findings
  • 13.2 Market Outlook
  • 13.3 Approval Timeline of HER2-positive Breast Cancer Drugs
    • 13.3.1 United States
    • 13.3.2 EU4 and the UK
    • 13.3.3 Japan
  • 13.4 Conjoint Analysis
  • 13.5 Key Market Forecast Assumptions
  • 13.6 Total Market Size of HER2-positive Breast Cancer in the 7MM
  • 13.7 United States Market Size
    • 13.7.1 Total Market Size of HER2-positive Breast Cancer in the United States
    • 13.7.2 Market Size of HER2-positive Breast Cancer by Therapies in the United States
  • 13.8 EU4 and the UK Market Size
    • 13.8.1 Total Market Size of HER2-positive Breast Cancer in EU4 and the UK
    • 13.8.2 Market Size of HER2-positive Breast Cancer by Therapies in EU4 and the UK
  • 13.9 Japan Market Size
    • 13.9.1 Total Market Size of HER2-positive Breast Cancer in Japan
    • 13.9.2 Market Size of HER2-positive Breast Cancer by Therapies in Japan

14 HER2-positive Breast Cancer Market Access and Reimbursement

  • 14.1 HERCEPTIN (trastuzumab): Genentech
  • 14.2 MARGENZA (margetuximab): MacroGenics
  • 14.3 PHESGO (pertuzumab/trastuzumab/hyaluronidase): Genentech
  • 14.4 TUKYSA (tucatinib): Seagen
  • 14.5 NERLYNX (neratinib): Puma biotech
  • 14.6 TYKERB (lapatinib): Novartis
  • 14.7 PERJETA (pertuzumab): Roche
  • 14.8 KADCYLA (trastuzumab emtansine): Roche/Chugai
  • 14.9 ENHERTU (trastuzumab deruxtecan): Daiichi/AstraZeneca
  • 14.1 Payer Coverage

15 Unmet Needs

16 SWOT Analysis

17 KOL Views

18 Appendix

  • 18.1 Bibliography
  • 18.2 Report Methodology

19 DelveInsight Capabilities

20 Disclaimer

21 About DelveInsight