ハーセプチンの市場規模、シェア、動向分析レポート：製品別、用途別、支払者別、流通チャネル別、地域別、セグメント予測、2025年～2030年

ハーセプチン市場の成長と動向

Grand View Research, Inc.の最新レポートによると、世界のハーセプチン市場規模は2030年までに41億米ドルに達すると予測され、2025年から2030年までのCAGRは5.5%で成長すると予測されています。

ハーセプチン市場の主な促進要因は、HER2陽性がん、特に乳がんや胃がんの治療においてその有効性が確立されていることです。ハーセプチンは、HER2受容体を直接阻害し、腫瘍の増殖を抑制し、免疫介在性細胞毒性を活性化することにより、治療パラダイムに革命をもたらしました。ハーセプチンは、早期および転移性がんにおける標準治療薬として位置づけられており、その世界の需要を支えています。ハーセプチンは併用療法、特に化学療法やペルツズマブのような新しいHER2標的薬との併用療法においてその役割を果たし、治療上の関連性をさらに高めています。ネオアジュバントおよびアジュバントでの承認により、ハーセプチンの患者ベースは拡大し、実臨床でのエビデンスがハーセプチンの長期生存効果を支持し続けています。

しかしながら、ハーセプチンの市場は、米国（2019年）と欧州（2014年）における主要特許の失効により大きく変化しており、バイオシミラー競合の波が押し寄せています。この変化は、特に価格に敏感な市場において、先発品に対する厳しい価格圧力と独占権の低下につながりました。これに対しロシュは、皮下（SC）製剤や、ペルツズマブ＋トラスツズマブの合剤であるPhesgo（SC）の開発など、ライフサイクル・マネジメント戦略を実施し、利便性の向上、投与時間の短縮、患者ロイヤルティの維持を目指してきました。これらのイノベーションは、ヘルスケアの効率を高めるだけでなく、臨床現場においてバイオシミラーに対する競争力を提供します。

トラスツズマブのバイオシミラーの状況は強固で急速に拡大しており、ファイザー、アムジェン、バイオコン・バイオロジクス、サムスン・バイオエピス、セルトリオンなど複数の企業が世界市場で承認を取得しています。高所得地域でも新興地域でもトラスツズマブ・バイオシミラーの採用が拡大しており、HER2標的治療へのアクセスが民主化され、治療コストが大幅に低下しています。これはヘルスケアシステムと患者に恩恵をもたらす一方で、ロシュのブランドであるハーセプチンにとっては市場シェア侵食のリスクとなります。世界の規制当局は、明確な互換性ガイドラインやインセンティブを与える調達モデルを通じてバイオシミラーの採用を支援しており、その普及はさらに加速しています。インド、中国、ラテンアメリカなどの地域では、各国固有のバイオシミラーの数が増加しており、特にコスト抑制が優先される地域では競争が激化しています。

このような逆風にもかかわらず、適応拡大、戦略的提携、地域の成長を通じて、ハーセプチン市場には大きな機会が残されています。特に、ヘルスケアシステムがより効率的な投与方法を模索していることから、外来や地域でのSCハーセプチンやPhesgoの使用は拡大する見込みです。さらに、HER2陽性胃がんにおけるペムブロリズマブのような免疫チェックポイント阻害剤との併用レジメンへのトラスツズマブの組み入れは、その使用に新たなフロンティアを開きつつあります。これらの新しい併用療法は臨床試験で評価されており、ハーセプチンの役割は従来のHER2陽性の適応症以外にも拡大する可能性があります。さらに、認知度の向上、検診率の上昇、低・中所得国における診断へのアクセスの改善は、バイオシミラー競合により単価が下落したとしても、販売量の伸びを促進すると予想されます。

今後、ハーセプチン市場は、オリジネーターとバイオシミラーの共存が標準となる新たな均衡で安定する可能性が高いです。ロシュの戦略的軸足を付加価値製品と実臨床成績データに移すことは、市場での存在感を維持する上で極めて重要であろう。一方、バイオシミラーメーカーは、スケールメリット、コストリーダーシップ、地域的パートナーシップを活用し、十分なサービスを受けていない市場への浸透を図る構えです。また、新たなデリバリー・イノベーションとデジタル治療モニタリング・ツールは、進化する治療モデルにおけるトラスツズマブの有用性を高める可能性があります。全体として、ハーセプチンは、独占権や価格決定力という点ではもはや優位に立つことはできないかもしれないが、HER2を標的としたがん治療において、特に広範な併用戦略や統合ケアソリューションの一環として、極めて重要な役割を果たし続けるであろう。

ハーセプチン市場レポートハイライト

• 製品別では、米国と欧州におけるハーセプチンの主な特許満了後、先進国市場と新興国市場の両方で広く採用されたバイオシミラーが2024年のハーセプチン市場を席巻し、50.93%の最大シェアを占めました。費用対効果の高いトラスツズマブ・バイオシミラーが複数のメーカーから発売されたことで、特にがん罹患率が高く、コストに敏感なヘルスケアシステムを有する地域において、HER2標的治療へのアクセスが大幅に改善しました。競合価格、現地製造、支持的な規制の枠組みが、バイオシミラーの普及にさらに拍車をかけています。対照的に、生物学的製剤／オリジネーター（ロシュのハーセプチン）セグメントは第2位のシェアを占めているが、バイオシミラーに市場独占権と販売量を奪われ続けているため、減少傾向にあります。
• 用途別では、乳がんが2024年のハーセプチン市場を57.68%のシェアで支配しており、これはHER2陽性乳がんの第一選択薬および術後補助療法としての使用が確立されていることが背景にあります。早期および転移性乳がんにおける同剤の長年にわたる役割は、強力な臨床エビデンスとガイドラインの支持と相まって、継続的な需要を確実なものにしています。胃がん/胃食道がんは、HER2陽性胃がんおよび胃食道がんに対する承認拡大と、ペムブロリズマブのようなチェックポイント阻害薬との併用による使用拡大により、予測期間中最も速いCAGRで成長すると予測されます。
• 支払者に基づくと、新興国市場全体でブランドおよびバイオシミラーのトラスツズマブが幅広く償還されていることから、2024年には民間/民間保険セグメントが91.03%と最大のシェアを占めました。HER2標的治療へのアクセスは、通常、包括的な腫瘍学給付制度でカバーされています。公的保険部門は、特に新興経済圏で成長が加速すると予想され、そこでは国の医療プログラムが、オリジネーター生物製剤の費用対効果の高い代替品としてバイオシミラーへのアクセスを拡大しています。
• 販売チャネル別では、病院薬局が2024年の市場シェア51.77%で引き続きトップであり、がんセンターにおける輸液ベースの投与とモニタリングの必要性を反映しています。ハーセプチンは点滴製剤であり、がん治療レジメンが複雑であることから、病院を拠点とするシステムでの投与が強化されています。ハーセプチンの皮下注製剤や配合剤であるフェスゴ（トラスツズマブ＋ペルツズマブ）が外来や在宅医療の現場で広く採用されるようになり、より柔軟で患者の利便性が向上するため、専門薬局のCAGRが最も速いと予測されます。
• 2024年4月、FDAはEnhertu（fam-trastuzumab deruxtecan-nxki）を、切除不能または転移性で前治療の全身療法後に進行したHER2陽性固形がんの治療薬として早期承認しました。これは、HER2標的治療薬としては初の腫瘍診断薬としての承認であり、乳がんや胃がんなどの従来の適応症以外にも使用が拡大されることになります。今回の承認は、DESTINY-PanTumor02試験の結果に基づいており、エンヘルツは胆道がん、膀胱がん、子宮内膜がんなど複数のがん種で意義のある奏効率を示しました。この開発により、HER2標的治療の臨床的有用性が大幅に拡大し、エンヘルツは進化するプレシジョン・オンコロジーの展望における主要なプレーヤーとして位置づけられます。

目次

第1章 調査手法と範囲

第2章 エグゼクティブサマリー

第3章 ハーセプチン市場の変数、動向、範囲

• 市場系統の見通し
• 市場力学
  • 市場成長要因分析
  • 市場抑制要因分析
• ビジネス環境分析
  • 業界分析- ポーターのファイブフォース分析
  • PESTLE分析
  • 特許満了分析
  • 価格設定と償還シナリオ
  • M&Aと取引
  • ジェネリック医薬品/バイオシミラーの影響

第4章 ハーセプチン市場：製品別ビジネス分析

• 製品市場シェア、2024年と2030年
• 製品セグメントダッシュボード
• 市場規模、予測、動向分析（製品別、2018～2030年）
• 生物学的製剤
• バイオシミラー

第5章 ハーセプチン市場：用途別ビジネス分析

• 用途市場シェア、2024年および2030年
• 用途セグメントダッシュボード
• 市場規模、予測、動向分析（用途別、2018～2030年）
• 乳がん
• 胃がん

第6章 ハーセプチン市場：支払者別ビジネス分析

• 支払者市場シェア、2024年および2030年
• 支払者セグメントダッシュボード
• 市場規模、予測、動向分析（支払者別、2018～2030年）
• 商業/個人
• 公共

第7章 ハーセプチン市場：流通チャネル別ビジネス分析

• 流通チャネル市場シェア、2024年および2030年
• 流通チャネルセグメントダッシュボード
• 市場規模、予測、動向分析（流通チャネル別、2018～2030年）
• 病院薬局
• 専門薬局

第8章 ハーセプチン市場：地域別推定・動向分析

• 地域別市場シェア分析、2024年および2030年
• 地域市場ダッシュボード
• 市場規模と予測動向分析、2018年から2030年まで：
• 北米
  • 国別、2018年～2030年
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • 英国
  • ドイツ
  • フランス
  • イタリア
  • スペイン
  • デンマーク
  • スウェーデン
  • ノルウェー
• アジア太平洋
  • 日本
  • 中国
  • インド
  • オーストラリア
  • 韓国
  • タイ
• ラテンアメリカ
  • ブラジル
  • アルゼンチン
• 中東およびアフリカ
  • 南アフリカ
  • サウジアラビア
  • アラブ首長国連邦
  • クウェート

第9章 競合情勢

• 参入企業概要
• 企業の市況分析
• 企業分類
• 戦略マッピング
• 企業プロファイル/リスト
  • Roche Holding AG（Genentech）
  • Pfizer Inc.
  • Samsung Bioepis Co., Ltd.
  • Amgen Inc.
  • Celltrion Healthcare Co., Ltd.
  • Biocon Limited
  • Mylan NV（Viatris）
  • Prestige Biopharma
  • Shanghai Henlius Biotech, Inc.
  • AryoGen Pharmed
  • Dr. Reddy's Laboratories

List of Tables

• Table 1 List of secondary sources
• Table 2 List of abbreviations
• Table 3 Global Herceptin market, by region, 2018 - 2030 (USD Million)
• Table 4 Global Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 5 Global Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 6 Global Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 7 Global Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 8 North America Herceptin market, by country, 2018 - 2030 (USD Million)
• Table 9 North America Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 10 North America Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 11 North America Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 12 North America Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 13 U.S. Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 14 U.S. Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 15 U.S. Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 16 U.S. Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 17 Canada Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 18 Canada Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 19 Canada Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 20 Canada Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 21 Mexico Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 22 Mexico Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 23 Mexico Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 24 Mexico Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 25 Europe Herceptin market, by country, 2018 - 2030 (USD Million)
• Table 26 Europe Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 27 Europe Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 28 Europe Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 29 Europe Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 30 UK Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 31 UK Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 32 UK Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 33 UK Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 34 Germany Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 35 Germany Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 36 Germany Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 37 Germany Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 38 France Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 39 France Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 40 France Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 41 France Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 42 Italy Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 43 Italy Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 44 Italy Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 45 Italy Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 46 Spain Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 47 Spain Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 48 Spain Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 49 Spain Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 50 Norway Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 51 Norway Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 52 Norway Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 53 Norway Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 54 Denmark Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 55 Denmark Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 56 Denmark Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 57 Denmark Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 58 Sweden Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 59 Sweden Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 60 Sweden Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 61 Sweden Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 62 Asia Pacific Herceptin market, by country, 2018 - 2030 (USD Million)
• Table 63 Asia Pacific Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 64 Asia Pacific Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 65 Asia Pacific Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 66 Asia Pacific Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 67 Japan Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 68 Japan Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 69 Japan Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 70 Japan Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 71 China Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 72 China Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 73 China Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 74 China Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 75 India Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 76 India Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 77 India Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 78 India Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 79 Australia Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 80 Australia Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 81 Australia Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 82 Australia Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 83 South Korea Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 84 South Korea Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 85 South Korea Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 86 South Korea Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 87 Thailand Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 88 Thailand Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 89 Thailand Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 90 Thailand Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 91 Latin America Herceptin market, by country, 2018 - 2030 (USD Million)
• Table 92 Latin America Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 93 Latin America Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 94 Latin America Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 95 Latin America Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 96 Brazil Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 97 Brazil Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 98 Brazil Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 99 Brazil Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 100 Argentina Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 101 Argentina Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 102 Argentina Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 103 Argentina Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 104 Middle East & Africa Herceptin market, by country, 2018 - 2030 (USD Million)
• Table 105 Middle East & Africa Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 106 Middle East & Africa Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 107 Middle East & Africa Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 108 Middle East & Africa Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 109 South Africa Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 110 South Africa Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 111 South Africa Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 112 South Africa Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 113 Saudi Arabia Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 114 Saudi Arabia Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 115 Saudi Arabia Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 116 Saudi Arabia Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 117 UAE Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 118 UAE Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 119 UAE Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 120 UAE Herceptin market, by distribution channel, 2018 - 2030 (USD Million)
• Table 121 Kuwait Herceptin market, by product, 2018 - 2030 (USD Million)
• Table 122 Kuwait Herceptin market, by application, 2018 - 2030 (USD Million)
• Table 123 Kuwait Herceptin market, by dosage form, 2018 - 2030 (USD Million)
• Table 124 Kuwait Herceptin market, by distribution channel, 2018 - 2030 (USD Million)

List of Figures

• Fig. 1 Herceptin market segmentation
• Fig. 2 Market research process
• Fig. 3 Data triangulation techniques
• Fig. 4 Primary research pattern
• Fig. 5 Market research approaches
• Fig. 6 Value-chain-based sizing & forecasting
• Fig. 7 Market formulation & validation
• Fig. 8 Market snapshot
• Fig. 9 Application outlook (USD Million)
• Fig. 10 Competitive landscape
• Fig. 11 Herceptin market dynamics
• Fig. 12 Herceptin market: Porter's five forces analysis
• Fig. 13 Herceptin market: PESTLE analysis
• Fig. 14 Herceptin market by product product (USD Million)
• Fig. 15 Biologic product revenue trend in Herceptin market (USD Million)
• Fig. 16 Biosimilar product market share analysis (USD Million)
• Fig. 17 Herceptin market application segmentation (USD Million)
• Fig. 18 Breast cancer treatment revenue share in Herceptin market (USD Million)
• Fig. 19 Gastric cancer Herceptin usage trend and forecast (USD Million)
• Fig. 20 Herceptin market by payer product (USD Million)
• Fig. 21 Commercial/private insurance coverage and adoption trend (USD Million)
• Fig. 22 Public insurance reimbursement growth in Herceptin market (USD Million)
• Fig. 23 Herceptin distribution channel market share (USD Million)
• Fig. 24 Hospital pharmacy distribution analysis for Herceptin (USD Million)
• Fig. 25 Specialty pharmacy Herceptin delivery growth trend (USD Million)
• Fig. 26 Herceptin market revenue, by region
• Fig. 27 Regional marketplace: Key takeaways
• Fig. 28 North America Herceptin market, 2018 - 2030 (USD Million)
• Fig. 29 U.S. country dynamics
• Fig. 30 U.S. Herceptin market, 2018 - 2030 (USD Million)
• Fig. 31 Canada country dynamics
• Fig. 32 Canada Herceptin market, 2018 - 2030 (USD Million)
• Fig. 33 Mexico country dynamics
• Fig. 34 Mexico Herceptin market, 2018 - 2030 (USD Million)
• Fig. 35 Europe Herceptin market, 2018 - 2030 (USD Million)
• Fig. 36 UK country dynamics
• Fig. 37 UK Herceptin market, 2018 - 2030 (USD Million)
• Fig. 38 Germany country dynamics
• Fig. 39 Germany Herceptin market, 2018 - 2030 (USD Million)
• Fig. 40 France country dynamics
• Fig. 41 France Herceptin market, 2018 - 2030 (USD Million)
• Fig. 42 Italy country dynamics
• Fig. 43 Italy Herceptin market, 2018 - 2030 (USD Million)
• Fig. 44 Spain country dynamics
• Fig. 45 Spain Herceptin market, 2018 - 2030 (USD Million)
• Fig. 46 Norway country dynamics
• Fig. 47 Norway Herceptin market, 2018 - 2030 (USD Million)
• Fig. 48 Sweden country dynamics
• Fig. 49 Sweden Herceptin market, 2018 - 2030 (USD Million)
• Fig. 50 Denmark country dynamics
• Fig. 51 Denmark Herceptin market, 2018 - 2030 (USD Million)
• Fig. 52 Asia-Pacific Herceptin market, 2018 - 2030 (USD Million)
• Fig. 53 Japan country dynamics
• Fig. 54 Japan Herceptin market, 2018 - 2030 (USD Million)
• Fig. 55 China country dynamics
• Fig. 56 China Herceptin market, 2018 - 2030 (USD Million)
• Fig. 57 India country dynamics
• Fig. 58 India Herceptin market, 2018 - 2030 (USD Million)
• Fig. 59 Australia country dynamics
• Fig. 60 Australia Herceptin market, 2018 - 2030 (USD Million)
• Fig. 61 South Korea country dynamics
• Fig. 62 South Korea Herceptin market, 2018 - 2030 (USD Million)
• Fig. 63 Thailand country dynamics
• Fig. 64 Thailand Herceptin market, 2018 - 2030 (USD Million)
• Fig. 65 Latin America Herceptin market, 2018 - 2030 (USD Million)
• Fig. 66 Brazil country dynamics
• Fig. 67 Brazil Herceptin market, 2018 - 2030 (USD Million)
• Fig. 68 Argentina country dynamics
• Fig. 69 Argentina Herceptin market, 2018 - 2030 (USD Million)
• Fig. 70 Middle East & Africa (MEA) Herceptin market, 2018 - 2030 (USD Million)
• Fig. 71 South Africa country dynamics
• Fig. 72 South Africa Herceptin market, 2018 - 2030 (USD Million)
• Fig. 73 Saudi Arabia country dynamics
• Fig. 74 Saudi Arabia Herceptin market, 2018 - 2030 (USD Million)
• Fig. 75 UAE country dynamics
• Fig. 76 UAE Herceptin market, 2018 - 2030 (USD Million)
• Fig. 77 Kuwait country dynamics
• Fig. 78 Kuwait Herceptin market, 2018 - 2030 (USD Million)
• Fig. 79 Company categorization
• Fig. 80 Company market position analysis
• Fig. 81 Strategic framework

Herceptin Market Growth & Trends:

The global herceptin market size is anticipated to reach USD 4.10 billion by 2030 and is projected to grow at a CAGR of 5.5% from 2025 to 2030, according to a new report by Grand View Research, Inc. The key driver of the Herceptin market is its established efficacy in treating HER2-positive cancers, particularly breast and gastric cancers. As one of the earliest and most successful targeted therapies, Herceptin revolutionized the treatment paradigm by directly inhibiting the HER2 receptor, halting tumor growth, and activating immune-mediated cytotoxicity. Its inclusion as a standard-of-care therapy in both early-stage and metastatic settings continues to anchor its global demand. Herceptin's role in combination regimens-especially with chemotherapy and newer HER2-targeted agents like pertuzumab-further boosts its therapeutic relevance. Approvals in neoadjuvant and adjuvant contexts have expanded its patient base, while real-world evidence continues to support its long-term survival benefits.

However, Herceptin's market has undergone significant transformation due to the expiration of key patents-in the U.S. (2019) and Europe (2014)-which has opened the door to a wave of biosimilar competition. This shift has led to intense pricing pressures and reduced exclusivity for the originator product, especially in price-sensitive markets. In response, Roche has implemented lifecycle management strategies, including the development of a subcutaneous (SC) formulation and the co-formulated fixed-dose combination Phesgo (pertuzumab + trastuzumab SC), aimed at improving convenience, reducing administration time, and maintaining patient loyalty. These innovations not only enhance healthcare efficiency but also offer a competitive edge against biosimilars in clinical practice.

The biosimilar landscape for trastuzumab is robust and rapidly expanding, with multiple players such as Pfizer, Amgen, Biocon Biologics, Samsung Bioepis, and Celltrion securing approvals across global markets. The growing adoption of trastuzumab biosimilars in both high-income and emerging regions has democratized access to HER2-targeted therapy, significantly lowering treatment costs. While this benefits healthcare systems and patients, it also presents market share erosion risks for Roche's branded Herceptin. Regulatory authorities worldwide have supported biosimilar adoption through clear interchangeability guidelines and incentivized procurement models, further accelerating their uptake. The increasing number of country-specific biosimilars in regions like India, China, and Latin America is intensifying competition, especially where cost containment is a priority.

Despite these headwinds, opportunities remain strong in the Herceptin market through expanding indications, strategic partnerships, and regional growth. The uptake of SC Herceptin and Phesgo in outpatient and community settings is poised to grow, particularly as healthcare systems seek more efficient delivery options. Additionally, the inclusion of trastuzumab in combination regimens with immune checkpoint inhibitors, such as pembrolizumab in HER2-positive gastric cancer, is opening new frontiers for its use. These novel combinations are being evaluated in clinical trials and could expand Herceptin's role beyond traditional HER2-positive indications. Furthermore, rising awareness, increasing screening rates, and improving access to diagnostics in low-to-middle-income countries are expected to fuel volume growth, even if unit prices decline due to biosimilar competition.

Looking ahead, the Herceptin market will likely stabilize at a new equilibrium, where originator and biosimilar coexistence is the norm. Roche's strategic pivot toward value-added products and real-world outcomes data will be critical in retaining market presence. Meanwhile, biosimilar manufacturers are poised to benefit from scale, cost leadership, and local partnerships, which will help them penetrate underserved markets. Emerging delivery innovations and digital treatment monitoring tools may also enhance trastuzumab's utility in evolving care models. Overall, while Herceptin may no longer dominate in terms of exclusivity or pricing power, it will continue to play a pivotal role in HER2-targeted oncology, especially as part of broader combination strategies and integrated care solutions.

Herceptin Market Report Highlights:

• Based on product, biosimilars dominated the Herceptin market in 2024, accounting for the largest share of 50.93%, driven by widespread adoption across both developed and emerging markets following the expiration of Herceptin's key patents in the U.S. and Europe. The availability of cost-effective trastuzumab biosimilars from multiple manufacturers has significantly improved access to HER2-targeted therapy, especially in regions with high cancer burden and cost-sensitive healthcare systems. Competitive pricing, local manufacturing, and supportive regulatory frameworks have further fueled biosimilar uptake. In contrast, the biologic/originator segment (Roche's Herceptin) holds the second-largest share but is witnessing a declining trend, as it continues to lose market exclusivity and volume to biosimilars.
• Based on application, breast cancer dominated the Herceptin market in 2024 with a share of 57.68%, driven by its established use as a first-line and adjuvant therapy in HER2-positive breast cancer. The drug's long-standing role in both early-stage and metastatic breast cancer, combined with strong clinical evidence and guideline support, has ensured continued demand. Stomach/gastric cancer is projected to grow at the fastest CAGR over the forecast period, supported by expanded approvals for HER2-positive gastric and gastroesophageal cancers and growing use in combination with checkpoint inhibitors like pembrolizumab.
• Based on payer, the commercial/private insurance segment accounted for the largest share at 91.03% in 2024, due to broad reimbursement for branded and biosimilar trastuzumab across developed markets. Access to HER2-targeted therapy is typically covered under comprehensive oncology benefit plans. The public insurance segment is expected to experience faster growth, particularly in emerging economies where national health programs are expanding access to biosimilars as cost-effective alternatives to originator biologics.
• Based on distribution channel, hospital pharmacies remained the leading segment with a 51.77% market share in 2024, reflecting the need for infusion-based administration and monitoring within oncology centers. Herceptin's IV formulation and the complexity of oncology regimens reinforce its delivery through hospital-based systems. Specialty pharmacies are projected to register the fastest CAGR, as the subcutaneous formulation of Herceptin and the combination product Phesgo (trastuzumab + pertuzumab) become more widely adopted in outpatient and home-care settings, offering greater flexibility and improved patient convenience.
• In April 2024, the FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of HER2-positive solid tumors that are unresectable or metastatic and have progressed following prior systemic treatment. This marks the first tumor-agnostic approval for a HER2-targeted therapy, expanding its use beyond traditional indications like breast and gastric cancers. The approval was based on results from the DESTINY-PanTumor02 trial, where Enhertu demonstrated meaningful response rates across multiple cancer types, including biliary tract, bladder, and endometrial cancers. This development significantly broadens the clinical utility of HER2-targeted therapies and positions Enhertu as a major player in the evolving landscape of precision oncology.

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Product
  • 1.2.2. Application
  • 1.2.3. Payer
  • 1.2.4. Distribution Channel
• 1.3. Estimates and Forecast Timeline
• 1.4. Research Methodology
• 1.5. Information Procurement
  • 1.5.1. Purchased Database
  • 1.5.2. GVR's Internal Database
  • 1.5.3. Secondary Sources
  • 1.5.4. Primary Research
• 1.6. Information Analysis
  • 1.6.1. Data Analysis Models
• 1.7. Market Formulation & Data Visualization
• 1.8. Model Details
  • 1.8.1. Commodity Flow Analysis
• 1.9. List of Secondary Sources
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Snapshot
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. Herceptin Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
  • 3.2.2. Market Restraint Analysis
• 3.3. Business Environment Analysis
  • 3.3.1. Industry Analysis - Porter's Five Forces Analysis
    • 3.3.1.1. Supplier Power
    • 3.3.1.2. Buyer Power
    • 3.3.1.3. Substitution Threat
    • 3.3.1.4. Threat of New Entrants
    • 3.3.1.5. Competitive Rivalry
  • 3.3.2. PESTLE Analysis
  • 3.3.3. Patent Expiry Analysis
  • 3.3.4. Pricing and Reimbursement Scenario
  • 3.3.5. M&A and Deals
  • 3.3.6. Impact of Generics/Biosimilars

Chapter 4. Herceptin Market: Product Business Analysis

• 4.1. Product Market Share, 2024 & 2030
• 4.2. Product Segment Dashboard
• 4.3. Market Size & Forecasts and Trend Analysis, by Product, 2018 to 2030 (USD Million)
• 4.4. Biologic
  • 4.4.1. Biologic Market, 2018 - 2030 (USD Million)
• 4.5. Biosimilar
  • 4.5.1. Biosimilar Market, 2018 - 2030 (USD Million)

Chapter 5. Herceptin Market: Application Business Analysis

• 5.1. Application Market Share, 2024 & 2030
• 5.2. Application Segment Dashboard
• 5.3. Market Size & Forecasts and Trend Analysis, by Application, 2018 to 2030 (USD Million)
• 5.4. Breast Cancer
  • 5.4.1. Breast Cancer Market, 2018 - 2030 (USD Million)
• 5.5. Stomach/Gastric Cancer
  • 5.5.1. Stomach/Gastric Cancer Market, 2018 - 2030 (USD Million)

Chapter 6. Herceptin Market: Payer Business Analysis

• 6.1. Payer Market Share, 2024 & 2030
• 6.2. Payer Segment Dashboard
• 6.3. Market Size & Forecasts and Trend Analysis, by Payer, 2018 to 2030 (USD Million)
• 6.4. Commercial/Private
  • 6.4.1. Commercial/Private Market, 2018 - 2030 (USD Million)
• 6.5. Public
  • 6.5.1. Public Market, 2018 - 2030 (USD Million)

Chapter 7. Herceptin Market: Distribution Channel Business Analysis

• 7.1. Distribution Channel Market Share, 2024 & 2030
• 7.2. Distribution Channel Segment Dashboard
• 7.3. Market Size & Forecasts and Trend Analysis, by Distribution Channel, 2018 to 2030 (USD Million)
• 7.4. Hospital Pharmacy
  • 7.4.1. Hospital Pharmacy Market, 2018 - 2030 (USD Million)
• 7.5. Specialty Pharmacy
  • 7.5.1. Specialty Pharmacy Market, 2018 - 2030 (USD Million)

Chapter 8. Herceptin Market: Regional Estimates & Trend Analysis

• 8.1. Regional Market Share Analysis, 2024 & 2030
• 8.2. Regional Market Dashboard
• 8.3. Market Size & Forecasts Trend Analysis, 2018 to 2030:
• 8.4. North America
  • 8.4.1. North America Herceptin Market Estimates And Forecasts, By Country, 2018 - 2030 (USD Million)
  • 8.4.2. U.S.
    • 8.4.2.1. Key Country Dynamics
    • 8.4.2.2. Target Disease Prevalence
    • 8.4.2.3. Regulatory Framework
    • 8.4.2.4. Reimbursement Framework
    • 8.4.2.5. U.S. Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.3. Canada
    • 8.4.3.1. Key Country Dynamics
    • 8.4.3.2. Target Disease Prevalence
    • 8.4.3.3. Regulatory Framework
    • 8.4.3.4. Reimbursement Framework
    • 8.4.3.5. Canada Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.4. Mexico
    • 8.4.4.1. Key Country Dynamics
    • 8.4.4.2. Target Disease Prevalence
    • 8.4.4.3. Regulatory Framework
    • 8.4.4.4. Reimbursement Framework
    • 8.4.4.5. Mexico Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.5. Europe
  • 8.5.1. Europe Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.2. UK
    • 8.5.2.1. Key Country Dynamics
    • 8.5.2.2. Target Disease Prevalence
    • 8.5.2.3. Regulatory Framework
    • 8.5.2.4. Reimbursement Framework
    • 8.5.2.5. UK Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.3. Germany
    • 8.5.3.1. Key Country Dynamics
    • 8.5.3.2. Target Disease Prevalence
    • 8.5.3.3. Regulatory Framework
    • 8.5.3.4. Reimbursement Framework
    • 8.5.3.5. Germany Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.4. France
    • 8.5.4.1. Key Country Dynamics
    • 8.5.4.2. Target Disease Prevalence
    • 8.5.4.3. Regulatory Framework
    • 8.5.4.4. Reimbursement Framework
    • 8.5.4.5. France Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.5. Italy
    • 8.5.5.1. Key Country Dynamics
    • 8.5.5.2. Target Disease Prevalence
    • 8.5.5.3. Regulatory Framework
    • 8.5.5.4. Reimbursement Framework
    • 8.5.5.5. Italy Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.6. Spain
    • 8.5.6.1. Key Country Dynamics
    • 8.5.6.2. Target Disease Prevalence
    • 8.5.6.3. Regulatory Framework
    • 8.5.6.4. Reimbursement Framework
    • 8.5.6.5. Spain Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.7. Denmark
    • 8.5.7.1. Key Country Dynamics
    • 8.5.7.2. Target Disease Prevalence
    • 8.5.7.3. Regulatory Framework
    • 8.5.7.4. Reimbursement Framework
    • 8.5.7.5. Denmark Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.8. Sweden
    • 8.5.8.1. Key Country Dynamics
    • 8.5.8.2. Target Disease Prevalence
    • 8.5.8.3. Regulatory Framework
    • 8.5.8.4. Reimbursement Framework
    • 8.5.8.5. Sweden Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.9. Norway
    • 8.5.9.1. Key Country Dynamics
    • 8.5.9.2. Target Disease Prevalence
    • 8.5.9.3. Regulatory Framework
    • 8.5.9.4. Reimbursement Framework
    • 8.5.9.5. Norway Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.6. Asia Pacific
  • 8.6.1. Asia Pacific Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.2. Japan
    • 8.6.2.1. Key Country Dynamics
    • 8.6.2.2. Target Disease Prevalence
    • 8.6.2.3. Regulatory Framework
    • 8.6.2.4. Reimbursement Framework
    • 8.6.2.5. Japan Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.3. China
    • 8.6.3.1. Key Country Dynamics
    • 8.6.3.2. Target Disease Prevalence
    • 8.6.3.3. Regulatory Framework
    • 8.6.3.4. Reimbursement Framework
    • 8.6.3.5. China Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.4. India
    • 8.6.4.1. Key Country Dynamics
    • 8.6.4.2. Target Disease Prevalence
    • 8.6.4.3. Regulatory Framework
    • 8.6.4.4. Reimbursement Framework
    • 8.6.4.5. India Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.5. Australia
    • 8.6.5.1. Key Country Dynamics
    • 8.6.5.2. Target Disease Prevalence
    • 8.6.5.3. Regulatory Framework
    • 8.6.5.4. Reimbursement Framework
    • 8.6.5.5. Australia Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.6. South Korea
    • 8.6.6.1. Key Country Dynamics
    • 8.6.6.2. Target Disease Prevalence
    • 8.6.6.3. Regulatory Framework
    • 8.6.6.4. Reimbursement Framework
    • 8.6.6.5. South Korea Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.7. Thailand
    • 8.6.7.1. Key Country Dynamics
    • 8.6.7.2. Target Disease Prevalence
    • 8.6.7.3. Regulatory Framework
    • 8.6.7.4. Reimbursement Framework
    • 8.6.7.5. Thailand Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.7. Latin America
  • 8.7.1. Latin America Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.7.2. Brazil
    • 8.7.2.1. Key Country Dynamics
    • 8.7.2.2. Target Disease Prevalence
    • 8.7.2.3. Regulatory Framework
    • 8.7.2.4. Reimbursement Framework
    • 8.7.2.5. Japan Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.7.3. Argentina
    • 8.7.3.1. Key Country Dynamics
    • 8.7.3.2. Target Disease Prevalence
    • 8.7.3.3. Regulatory Framework
    • 8.7.3.4. Reimbursement Framework
    • 8.7.3.5. China Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.8. Middle East and Africa
  • 8.8.1. Middle East and Africa Herceptin Market Estimates and Forecasts, 2017 - 2030 (USD Million)
  • 8.8.2. South Africa
    • 8.8.2.1. Key Country Dynamics
    • 8.8.2.2. Target Disease Prevalence
    • 8.8.2.3. Regulatory Framework
    • 8.8.2.4. Reimbursement Framework
    • 8.8.2.5. South Africa Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.8.3. Saudi Arabia
    • 8.8.3.1. Key Country Dynamics
    • 8.8.3.2. Target Disease Prevalence
    • 8.8.3.3. Regulatory Framework
    • 8.8.3.4. Reimbursement Framework
    • 8.8.3.5. Saudi Arabia Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.8.4. UAE
    • 8.8.4.1. Key Country Dynamics
    • 8.8.4.2. Target Disease Prevalence
    • 8.8.4.3. Regulatory Framework
    • 8.8.4.4. Reimbursement Framework
    • 8.8.4.5. UAE Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.8.5. Kuwait
    • 8.8.5.1. Key Country Dynamics
    • 8.8.5.2. Target Disease Prevalence
    • 8.8.5.3. Regulatory Framework
    • 8.8.5.4. Reimbursement Framework
    • 8.8.5.5. Kuwait Herceptin Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 9. Competitive Landscape

• 9.1. Participant Overview
• 9.2. Company Market Position Analysis
• 9.3. Company Categorization
• 9.4. Strategy Mapping
• 9.5. Company Profiles/Listing
  • 9.5.1. Roche Holding AG (Genentech)
    • 9.5.1.1. Overview
    • 9.5.1.2. Financial Performance
    • 9.5.1.3. Product Benchmarking
    • 9.5.1.4. Strategic Initiatives
  • 9.5.2. Pfizer Inc.
    • 9.5.2.1. Overview
    • 9.5.2.2. Financial Performance
    • 9.5.2.3. Product Benchmarking
    • 9.5.2.4. Strategic Initiatives
  • 9.5.3. Samsung Bioepis Co., Ltd.
    • 9.5.3.1. Overview
    • 9.5.3.2. Financial Performance
    • 9.5.3.3. Product Benchmarking
    • 9.5.3.4. Strategic Initiatives
  • 9.5.4. Amgen Inc.
    • 9.5.4.1. Overview
    • 9.5.4.2. Financial Performance
    • 9.5.4.3. Product Benchmarking
    • 9.5.4.4. Strategic Initiatives
  • 9.5.5. Celltrion Healthcare Co., Ltd.
    • 9.5.5.1. Overview
    • 9.5.5.2. Financial Performance
    • 9.5.5.3. Product Benchmarking
    • 9.5.5.4. Strategic Initiatives
  • 9.5.6. Biocon Limited
    • 9.5.6.1. Overview
    • 9.5.6.2. Financial Performance
    • 9.5.6.3. Product Benchmarking
    • 9.5.6.4. Strategic Initiatives
  • 9.5.7. Mylan N.V. (Viatris)
    • 9.5.7.1. Overview
    • 9.5.7.2. Financial Performance
    • 9.5.7.3. Product Benchmarking
    • 9.5.7.4. Strategic Initiatives
  • 9.5.8. Prestige Biopharma
    • 9.5.8.1. Overview
    • 9.5.8.2. Financial Performance
    • 9.5.8.3. Product Benchmarking
    • 9.5.8.4. Strategic Initiatives
  • 9.5.9. Shanghai Henlius Biotech, Inc.
    • 9.5.9.1. Overview
    • 9.5.9.2. Financial Performance
    • 9.5.9.3. Product Benchmarking
    • 9.5.9.4. Strategic Initiatives
  • 9.5.10. AryoGen Pharmed
    • 9.5.10.1. Overview
    • 9.5.10.2. Financial Performance
    • 9.5.10.3. Product Benchmarking
    • 9.5.10.4. Strategic Initiatives
  • 9.5.11. Dr. Reddy's Laboratories
    • 9.5.11.1. Overview
    • 9.5.11.2. Financial Performance
    • 9.5.11.3. Product Benchmarking
    • 9.5.11.4. Strategic Initiatives