キイトルーダの市場規模、シェア、動向分析レポート：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

キイトルーダ市場の成長と動向

Grand View Research, Inc.の最新レポートによると、キイトルーダの世界市場規模は2030年までに266億3,000万米ドルに達すると予測され、2025年から2030年までのCAGRは-3.23%で減少すると予測されています。

同市場は、成長軌道が若干低下しています。しかし、化学療法、標的薬剤、その他の免疫療法と併用することで治療成績が向上する併用療法の有効性により、市場は前進しています。現在進行中の臨床試験では、特にバイオマーカー主導型の治療アプローチにおいて、さらなるがん適応症での有効性が評価されています。トリプルネガティブ乳がん、肺がん、尿路上皮がんなどの課題がんにおける無増悪生存期間を延長する薬剤の能力は、市場での存在感をさらに高めています。さらに、早期がんにおけるキイトルーダの価値を評価する規制当局の動きも活発化しており、ネオアジュバントおよびアジュバント療法におけるキイトルーダの採用が加速しています。

キイトルーダは市場で確固たる地位を築いているもの、2028年に特許満了を迎えることを主因とする課題に直面しています。バイオシミラー競合の導入により価格圧力が生じ、市場独占性が低下することが予想されます。これに対抗するため、メルクは静脈内投与に代わるより簡便な皮下投与製剤の開発など、ライフサイクルマネジメント戦略に積極的に取り組んでいます。最近の第3相臨床試験では、SC製剤のキイトルーダが同等の有効性と安全性を維持することが確認されており、商業的利用可能性が拡大する可能性があります。

競合情勢も進化しており、オプジーボやテセントリクなどのライバルPD-1/PD-L1阻害薬が市場シェアを争っています。さらに、次世代免疫療法や新規治療法がキイトルーダの優位性を脅かす可能性があります。しかし、メルクの研究開発への継続的な投資と戦略的提携により、キイトルーダはがん領域で存在感を維持できると期待されます。メルクは、適応症の拡大、新たな併用レジメンの検討、革新的な製剤による患者への利便性の向上に継続的に取り組むことが、免疫・腫瘍市場におけるリーダーシップを維持する上で極めて重要です。

キイトルーダが直面している最大の課題の1つは、2028年の特許満了が迫っていることであり、これにより市場はバイオシミラー競争にさらされることになります。その結果、複数の製薬企業がバイオシミラー医薬品の開発に積極的に取り組んでおり、メルクのキイトルーダによる企業収益に大きな影響を与える可能性があります。独占的販売権の喪失に伴い、特にコストに敏感な市場において、価格圧力と償還の課題が強まることが予想されます。さらに、バイオシミラー承認をめぐる規制上のハードルや訴訟により、市場の不確実性が生じる可能性があります。こうしたリスクを軽減するため、メルクは、バイオシミラー参入後も需要を維持するための新剤形や適応症の拡大開発など、ライフサイクル・マネジメント戦略に注力しています。

同時に、キイトルーダには、特に併用療法や早期治療ラインにおける大きなビジネスチャンスが残されています。キイトルーダが特定の遺伝的・分子的マーカーを有する患者において有効性を実証し続けていることから、個別化医療およびバイオマーカー主導型のがん治療へのシフトは大きな成長の道を示しています。キイトルーダと抗体薬物複合体や次世代免疫チェックポイント阻害薬などの新規薬剤との併用療法を検討する臨床試験は、キイトルーダの治療ポテンシャルをさらに高める可能性があります。さらに、ネオアジュバントおよびアジュバント療法での承認により、治療期間が延長され、対象となる患者層が拡大し、継続的な需要が見込まれます。

メルクのもう1つの重要なビジネスチャンスは、患者の利便性とアクセスを向上させることを目的としたキイトルーダの皮下（SC）製剤の開発にあります。この製剤が承認されれば、輸液センターへのアクセスが制限されるなど、静脈内投与の障壁に直面している患者にとって代替となる可能性があります。また、SC製剤は、バイオシミラーの影響を遅らせる可能性のある差別化された製品を提供することで、キイトルーダの市場独占権の延長に貢献する可能性があります。さらに、アジア太平洋およびラテンアメリカの新興がん市場は、がん罹患率の上昇とヘルスケアインフラの改善により、先進的な免疫療法に対する需要が高まるため、市場拡大のチャンスとなります。メルクは、新たな適応症、併用レジメン、革新的なドラッグデリバリー方法への戦略的投資により、今後の課題にもかかわらず、キイトルーダが世界の免疫腫瘍学市場で確固たるプレゼンスを維持できるよう取り組んでいます。

キイトルーダ市場レポートハイライト

• 用途別では、非小細胞肺がん（NSCLC）および小細胞肺がん（SCLC）のファーストライン治療薬として広く採用されていることから、肺がんが2024年のキイトルーダ市場を27.4%の最大売上シェアで支配しました。一方、乳がんは、キイトルーダがトリプルネガティブ乳がん（TNBC）で使用されるようになり、他の乳がんサブタイプでの有効性を検討する臨床試験が進行していることから、予測期間中に最も速いCAGRで成長すると予測されます。
• 支払者別では、新興国市場における免疫腫瘍学治療に対する強力な償還支援により、2024年には商業保険/民間保険セグメントが91.0%の最大シェアを占めました。しかし、公的保険分野は、政府のヘルスケアプログラムや国の償還政策によって高額ながん治療へのアクセスが拡大するため、安定した成長が見込まれています。
• 流通チャネル別では、病院薬局が2024年に51.8%のシェアを獲得して圧倒的なセグメントとなり、がん治療センターにおける管理投与と専門医の監督の必要性から最も高い売上シェアを占めています。一方、専門薬局は、外来免疫療法へのシフトが進んでいることや、従来の病院外でのアクセス性を向上させるキイトルーダ皮下注製剤が承認される可能性があることから、予測期間中に最も速いCAGRを記録すると予測されます。
• 2025年2月、米国食品医薬品局（FDA）は、切除可能な局所進行頭頸部扁平上皮がん（LA-HNSCC）患者に対する周術期治療として標準治療と併用するキイトルーダ（ペムブロリズマブ）のメルクの生物製剤追加承認申請（sBLA）に優先審査を付与しました。この決定は、キイトルーダレジメンを投与された患者において、標準治療単独と比較して無イベント生存期間（EFS）および主要病理学的奏効（mPR）が統計学的に有意に改善した第3相KEYNOTE-689試験に基づいています。FDAは本申請の目標アクション日を2025年6月23日に設定しています。

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 キイトルーダ市場の変数、動向、および範囲

• 市場系統の見通し
• 市場力学
  • 市場促進要因分析
  • 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 キイトルーダ市場：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）
• 肺がん
• 乳がん
• ホジキンリンパ腫
• 頭頸部がん
• 胃がん
• 尿路上皮がん
• その他

第5章 キイトルーダ市場：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
• 市場規模と予測および動向分析（支払者別、2018～2030年）
• 商業/個人
• 公共

第6章 キイトルーダ市場：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7章 キイトルーダ市場：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
• 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8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
  • Merck &Co., Inc.
  • Bristol-Myers Squibb Company
  • F. Hoffmann-La Roche Ltd.
  • Regeneron Pharmaceuticals, Inc. &Sanofi SA
  • Pfizer Inc. &Seagen Inc.
  • Amgen Inc.
  • Samsung Bioepis Co., Ltd.
  • Bio-Thera Solutions, Ltd.

List of Tables

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

List of Figures

• Fig. 1 Keytruda 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 Keytruda market dynamics
• Fig. 12 Keytruda market: Porter's five forces analysis
• Fig. 13 Keytruda market: PESTLE analysis
• Fig. 14 Keytruda market revenue by application, 2018 - 2030
• Fig. 15 Lung cancer market outlook (USD Million)
• Fig. 16 Breast cancer market growth trend (USD Million)
• Fig. 17 Melanoma treatment market analysis (USD Million)
• Fig. 18 Hodgkin lymphoma treatment market size (USD Million)
• Fig. 19 Head and neck cancer Keytruda market share (USD Million)
• Fig. 20 Gastric cancer Keytruda market revenue (USD Million)
• Fig. 21 Urothelial cancer Keytruda market demand (USD Million)
• Fig. 22 Other cancer applications for Keytruda (USD Million)
• Fig. 23 Keytruda market revenue by payer type, 2018 - 2030
• Fig. 24 Commercial/private insurance market share for Keytruda (USD Million)
• Fig. 25 Public insurance market growth for Keytruda (USD Million)
• Fig. 26 Keytruda market revenue by distribution channel, 2018 - 2030
• Fig. 27 Hospital pharmacy Keytruda market analysis (USD Million)
• Fig. 28 Specialty pharmacy Keytruda market growth trend (USD Million)
• Fig. 29 Keytruda market revenue, by region
• Fig. 30 Regional marketplace: Key takeaways
• Fig. 31 North America Keytruda market, 2018 - 2030 (USD Million)
• Fig. 32 U.S. country dynamics
• Fig. 33 U.S. Keytruda market, 2018 - 2030 (USD Million)
• Fig. 34 Canada country dynamics
• Fig. 35 Canada Keytruda market, 2018 - 2030 (USD Million)
• Fig. 36 Mexico country dynamics
• Fig. 37 Mexico Keytruda market, 2018 - 2030 (USD Million)
• Fig. 38 Europe Keytruda market, 2018 - 2030 (USD Million)
• Fig. 39 UK country dynamics
• Fig. 40 UK Keytruda market, 2018 - 2030 (USD Million)
• Fig. 41 Germany country dynamics
• Fig. 42 Germany Keytruda market, 2018 - 2030 (USD Million)
• Fig. 43 France country dynamics
• Fig. 44 France Keytruda market, 2018 - 2030 (USD Million)
• Fig. 45 Italy country dynamics
• Fig. 46 Italy Keytruda market, 2018 - 2030 (USD Million)
• Fig. 47 Spain country dynamics
• Fig. 48 Spain Keytruda market, 2018 - 2030 (USD Million)
• Fig. 49 Norway country dynamics
• Fig. 50 Norway Keytruda market, 2018 - 2030 (USD Million)
• Fig. 51 Sweden country dynamics
• Fig. 52 Sweden Keytruda market, 2018 - 2030 (USD Million)
• Fig. 53 Denmark country dynamics
• Fig. 54 Denmark Keytruda market, 2018 - 2030 (USD Million)
• Fig. 55 Asia-Pacific Keytruda market, 2018 - 2030 (USD Million)
• Fig. 56 Japan country dynamics
• Fig. 57 Japan Keytruda market, 2018 - 2030 (USD Million)
• Fig. 58 China country dynamics
• Fig. 59 China Keytruda market, 2018 - 2030 (USD Million)
• Fig. 60 India country dynamics
• Fig. 61 India Keytruda market, 2018 - 2030 (USD Million)
• Fig. 62 Australia country dynamics
• Fig. 63 Australia Keytruda market, 2018 - 2030 (USD Million)
• Fig. 64 South Korea country dynamics
• Fig. 65 South Korea Keytruda market, 2018 - 2030 (USD Million)
• Fig. 66 Thailand country dynamics
• Fig. 67 Thailand Keytruda market, 2018 - 2030 (USD Million)
• Fig. 68 Latin America Keytruda market, 2018 - 2030 (USD Million)
• Fig. 69 Brazil country dynamics
• Fig. 70 Brazil Keytruda market, 2018 - 2030 (USD Million)
• Fig. 71 Argentina country dynamics
• Fig. 72 Argentina Keytruda market, 2018 - 2030 (USD Million)
• Fig. 73 Middle East & Africa (MEA) Keytruda market, 2018 - 2030 (USD Million)
• Fig. 74 South Africa country dynamics
• Fig. 75 South Africa Keytruda market, 2018 - 2030 (USD Million)
• Fig. 76 Saudi Arabia country dynamics
• Fig. 77 Saudi Arabia Keytruda market, 2018 - 2030 (USD Million)
• Fig. 78 UAE country dynamics
• Fig. 79 UAE Keytruda market, 2018 - 2030 (USD Million)
• Fig. 80 Kuwait country dynamics
• Fig. 81 Kuwait Keytruda market, 2018 - 2030 (USD Million)
• Fig. 82 Company categorization
• Fig. 83 Company market position analysis
• Fig. 84 Strategic framework

Keytruda Market Growth & Trends:

The global Keytruda market size is anticipated to reach USD 26.63 billion by 2030 and is projected to decline at a CAGR of -3.23% from 2025 to 2030, according to a new report by Grand View Research, Inc. The market is experiencing a slight decline in the growth trajectory. However, the market is moving ahead due to its effectiveness in combination therapies, enhancing outcomes when used alongside chemotherapy, targeted agents, and other immunotherapies. Ongoing clinical trials are evaluating its efficacy in additional cancer indications, particularly in biomarker-driven treatment approaches. The drug's ability to extend progression-free survival in challenging cancers such as triple-negative breast cancer, lung cancer, and urothelial carcinoma further strengthens its market presence. Additionally, regulatory bodies are increasingly recognizing the value of Keytruda in early-stage cancers, fueling its adoption in neoadjuvant and adjuvant settings.

Despite its strong market foothold, Keytruda faces challenges, primarily due to its upcoming patent expiration in 2028. The introduction of biosimilar competition is expected to create pricing pressures and reduce market exclusivity. To counter this, Merck is actively working on lifecycle management strategies, including the development of a subcutaneous (SC) formulation that offers a more convenient alternative to the intravenous (IV) version. Recent Phase 3 trials have confirmed that SC Keytruda maintains comparable efficacy and safety, potentially extending its commercial viability.

The competitive landscape is also evolving, with rival PD-1/PD-L1 inhibitors, such as Opdivo and Tecentriq, vying for market share. Additionally, next-generation immunotherapies and novel treatment modalities pose potential threats to Keytruda's dominance. However, Merck's ongoing investments in research and development, coupled with strategic collaborations, are expected to sustain Keytruda's relevance in the oncology space. The company's continued efforts to expand indications, explore new combination regimens, and enhance patient accessibility through innovative drug formulations will be crucial in maintaining its leadership in the immuno-oncology market.

One of the biggest challenges Keytruda faces is its impending patent expiration in 2028, which will open the market to biosimilar competition. As a result, several pharmaceutical companies are actively developing biosimilar versions, which could significantly impact Merck's revenue from Keytruda. With the loss of exclusivity, pricing pressures and reimbursement challenges are expected to intensify, particularly in cost-sensitive markets. Additionally, regulatory hurdles and litigation over biosimilar approvals could create market uncertainties. To mitigate these risks, Merck is focusing on life cycle management strategies, including the development of new formulations and expanded indications to sustain demand even after biosimilar entry.

At the same time, opportunities remain strong for Keytruda, particularly in combination therapies and earlier treatment lines. The shift toward personalized medicine and biomarker-driven oncology treatments presents a significant growth avenue, as Keytruda continues to demonstrate efficacy in patients with specific genetic and molecular markers. Clinical trials exploring Keytruda in combination with novel agents, such as antibody-drug conjugates and next-generation immune checkpoint inhibitors, could further enhance its therapeutic potential. Moreover, approvals in neoadjuvant and adjuvant settings are expected to increase treatment durations and expand the eligible patient pool, ensuring continued demand.

Another key opportunity for Merck lies in the development of the subcutaneous (SC) formulation of Keytruda, which aims to improve patient convenience and access. If approved, this version could offer an alternative for patients who face barriers to IV administration, such as limited access to infusion centers. The SC formulation could also help extend Keytruda's market exclusivity by offering a differentiated product that may delay the impact of biosimilars. Additionally, emerging oncology markets in Asia-Pacific and Latin America present expansion opportunities, as rising cancer prevalence and improving healthcare infrastructure drive demand for advanced immunotherapies. With strategic investments in new indications, combination regimens, and innovative drug delivery methods, Merck is positioning Keytruda to maintain its strong presence in the global immuno-oncology market, despite the challenges ahead.

Keytruda Market Report Highlights:

• Based on application, lung cancer dominated the Keytruda market in 2024 with the largest revenue share of 27.4%, due to its widespread adoption as a first-line treatment for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Meanwhile, breast cancer is projected to grow at the fastest CAGR over the forecast period, driven by Keytruda's increasing use in triple-negative breast cancer (TNBC) and ongoing clinical trials exploring its efficacy in other breast cancer subtypes.
• Based on payer, the commercial/private insurance segment held the largest share of 91.0% in 2024, owing to strong reimbursement support for immuno-oncology therapies in developed markets. However, the public insurance segment is expected to see steady growth as government healthcare programs and national reimbursement policies expand access to costly cancer treatments.
• Based on distribution channel, hospital pharmacies emerged as the dominant segment with a share of 51.8% in 2024, accounting for the highest revenue share due to the need for controlled administration and specialist supervision in oncology treatment centers. Meanwhile, specialty pharmacies are projected to witness the fastest CAGR over the forecast period, driven by the growing shift towards outpatient immunotherapy administration and potential approval of the subcutaneous Keytruda formulation, which could improve accessibility outside traditional hospital settings.
• In February 2025, the U.S. Food and Drug Administration (FDA) granted Priority Review to Merck's supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab) in combination with standard care as a perioperative treatment for patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC). This decision is based on the Phase 3 KEYNOTE-689 trial, which demonstrated a statistically significant improvement in event-free survival (EFS) and major pathological response (mPR) for patients receiving the Keytruda regimen compared to standard treatment alone. The FDA has set a target action date of June 23, 2025, for this application.

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Application
  • 1.2.2. Payer
  • 1.2.3. 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. Keytruda 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. Keytruda Market: Application Business Analysis

• 4.1. Application Market Share, 2024 & 2030
• 4.2. Application Segment Dashboard
• 4.3. Market Size & Forecasts and Trend Analysis, by Application, 2018 to 2030 (USD Million)
• 4.4. Lung Cancer
  • 4.4.1. Lung Cancer Market, 2018 - 2030 (USD Million)
• 4.5. Breast Cancer
  • 4.5.1. Breast Cancer Market, 2018 - 2030 (USD Million)
• 4.6. Hodgkin Lymphoma
  • 4.6.1. Hodgkin Lymphoma Market, 2018 - 2030 (USD Million)
• 4.7. Head and Neck Cancer
  • 4.7.1. Head and Neck Cancer Market, 2018 - 2030 (USD Million)
• 4.8. Gastric Cancer
  • 4.8.1. Gastric Cancer Market, 2018 - 2030 (USD Million)
• 4.9. Urothelial Cancer
  • 4.9.1. Urothelial Cancer Market, 2018 - 2030 (USD Million)
• 4.10. Others
  • 4.10.1. Others Market, 2018 - 2030 (USD Million)

Chapter 5. Keytruda Market: Payer Business Analysis

• 5.1. Payer Market Share, 2024 & 2030
• 5.2. Payer Segment Dashboard
• 5.3. Market Size & Forecasts and Trend Analysis, by Payer, 2018 to 2030 (USD Million)
• 5.4. Commercial/Private
  • 5.4.1. Commercial/Private Market, 2018 - 2030 (USD Million)
• 5.5. Public
  • 5.5.1. Public Market, 2018 - 2030 (USD Million)

Chapter 6. Keytruda Market: Distribution Channel Business Analysis

• 6.1. Distribution Channel Market Share, 2024 & 2030
• 6.2. Distribution Channel Segment Dashboard
• 6.3. Market Size & Forecasts and Trend Analysis, by Distribution Channel, 2018 to 2030 (USD Million)
• 6.4. Hospital Pharmacy
  • 6.4.1. Hospital Pharmacy Market, 2018 - 2030 (USD Million)
• 6.5. Specialty Pharmacy
  • 6.5.1. Specialty Pharmacy Market, 2018 - 2030 (USD Million)

Chapter 7. Keytruda Market: Regional Estimates & Trend Analysis

• 7.1. Regional Market Share Analysis, 2024 & 2030
• 7.2. Regional Market Dashboard
• 7.3. Market Size & Forecasts Trend Analysis, 2018 to 2030
• 7.4. North America
  • 7.4.1. North America Keytruda Market Estimates And Forecasts, By Country, 2018 - 2030 (USD Million)
  • 7.4.2. U.S.
    • 7.4.2.1. Key Country Dynamics
    • 7.4.2.2. Target Disease Prevalence
    • 7.4.2.3. Regulatory Framework
    • 7.4.2.4. Reimbursement Framework
    • 7.4.2.5. U.S. Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.4.3. Canada
    • 7.4.3.1. Key Country Dynamics
    • 7.4.3.2. Target Disease Prevalence
    • 7.4.3.3. Regulatory Framework
    • 7.4.3.4. Reimbursement Framework
    • 7.4.3.5. Canada Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.4.4. Mexico
    • 7.4.4.1. Key Country Dynamics
    • 7.4.4.2. Target Disease Prevalence
    • 7.4.4.3. Regulatory Framework
    • 7.4.4.4. Reimbursement Framework
    • 7.4.4.5. Mexico Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.5. Europe
  • 7.5.1. Europe Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.2. UK
    • 7.5.2.1. Key Country Dynamics
    • 7.5.2.2. Target Disease Prevalence
    • 7.5.2.3. Regulatory Framework
    • 7.5.2.4. Reimbursement Framework
    • 7.5.2.5. Uk Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.3. Germany
    • 7.5.3.1. Key Country Dynamics
    • 7.5.3.2. Target Disease Prevalence
    • 7.5.3.3. Regulatory Framework
    • 7.5.3.4. Reimbursement Framework
    • 7.5.3.5. Germany Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.4. France
    • 7.5.4.1. Key Country Dynamics
    • 7.5.4.2. Target Disease Prevalence
    • 7.5.4.3. Regulatory Framework
    • 7.5.4.4. Reimbursement Framework
    • 7.5.4.5. France Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.5. Italy
    • 7.5.5.1. Key Country Dynamics
    • 7.5.5.2. Target Disease Prevalence
    • 7.5.5.3. Regulatory Framework
    • 7.5.5.4. Reimbursement Framework
    • 7.5.5.5. Italy Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.6. Spain
    • 7.5.6.1. Key Country Dynamics
    • 7.5.6.2. Target Disease Prevalence
    • 7.5.6.3. Regulatory Framework
    • 7.5.6.4. Reimbursement Framework
    • 7.5.6.5. Spain Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.7. Denmark
    • 7.5.7.1. Key Country Dynamics
    • 7.5.7.2. Target Disease Prevalence
    • 7.5.7.3. Regulatory Framework
    • 7.5.7.4. Reimbursement Framework
    • 7.5.7.5. Denmark Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.8. Sweden
    • 7.5.8.1. Key Country Dynamics
    • 7.5.8.2. Target Disease Prevalence
    • 7.5.8.3. Regulatory Framework
    • 7.5.8.4. Reimbursement Framework
    • 7.5.8.5. Sweden Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.9. Norway
    • 7.5.9.1. Key Country Dynamics
    • 7.5.9.2. Target Disease Prevalence
    • 7.5.9.3. Regulatory Framework
    • 7.5.9.4. Reimbursement Framework
    • 7.5.9.5. Norway Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.6. Asia Pacific
  • 7.6.1. Asia Pacific Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.2. Japan
    • 7.6.2.1. Key Country Dynamics
    • 7.6.2.2. Target Disease Prevalence
    • 7.6.2.3. Regulatory Framework
    • 7.6.2.4. Reimbursement Framework
    • 7.6.2.5. Japan Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.3. China
    • 7.6.3.1. Key Country Dynamics
    • 7.6.3.2. Target Disease Prevalence
    • 7.6.3.3. Regulatory Framework
    • 7.6.3.4. Reimbursement Framework
    • 7.6.3.5. China Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.4. India
    • 7.6.4.1. Key Country Dynamics
    • 7.6.4.2. Target Disease Prevalence
    • 7.6.4.3. Regulatory Framework
    • 7.6.4.4. Reimbursement Framework
    • 7.6.4.5. India Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.5. Australia
    • 7.6.5.1. Key Country Dynamics
    • 7.6.5.2. Target Disease Prevalence
    • 7.6.5.3. Regulatory Framework
    • 7.6.5.4. Reimbursement Framework
    • 7.6.5.5. Australia Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.6. South Korea
    • 7.6.6.1. Key Country Dynamics
    • 7.6.6.2. Target Disease Prevalence
    • 7.6.6.3. Regulatory Framework
    • 7.6.6.4. Reimbursement Framework
    • 7.6.6.5. South Korea Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.7. Thailand
    • 7.6.7.1. Key Country Dynamics
    • 7.6.7.2. Target Disease Prevalence
    • 7.6.7.3. Regulatory Framework
    • 7.6.7.4. Reimbursement Framework
    • 7.6.7.5. Thailand Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.7. Latin America
  • 7.7.1. Latin America Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.7.2. Brazil
    • 7.7.2.1. Key Country Dynamics
    • 7.7.2.2. Target Disease Prevalence
    • 7.7.2.3. Regulatory Framework
    • 7.7.2.4. Reimbursement Framework
    • 7.7.2.5. Japan Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.7.3. Argentina
    • 7.7.3.1. Key Country Dynamics
    • 7.7.3.2. Target Disease Prevalence
    • 7.7.3.3. Regulatory Framework
    • 7.7.3.4. Reimbursement Framework
    • 7.7.3.5. China Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.8. Middle East and Africa
  • 7.8.1. Middle East and Africa Keytruda Market Estimates and Forecasts, 2017 - 2030 (USD Million)
  • 7.8.2. South Africa
    • 7.8.2.1. Key Country Dynamics
    • 7.8.2.2. Target Disease Prevalence
    • 7.8.2.3. Regulatory Framework
    • 7.8.2.4. Reimbursement Framework
    • 7.8.2.5. South Africa Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.8.3. Saudi Arabia
    • 7.8.3.1. Key Country Dynamics
    • 7.8.3.2. Target Disease Prevalence
    • 7.8.3.3. Regulatory Framework
    • 7.8.3.4. Reimbursement Framework
    • 7.8.3.5. Saudi Arabia Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.8.4. UAE
    • 7.8.4.1. Key Country Dynamics
    • 7.8.4.2. Target Disease Prevalence
    • 7.8.4.3. Regulatory Framework
    • 7.8.4.4. Reimbursement Framework
    • 7.8.4.5. UAE Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.8.5. Kuwait
    • 7.8.5.1. Key Country Dynamics
    • 7.8.5.2. Target Disease Prevalence
    • 7.8.5.3. Regulatory Framework
    • 7.8.5.4. Reimbursement Framework
    • 7.8.5.5. Kuwait Keytruda Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Participant Overview
• 8.2. Company Market Position Analysis
• 8.3. Company Categorization
• 8.4. Strategy Mapping
• 8.5. Company Profiles/Listing
  • 8.5.1. Merck & Co., Inc.
    • 8.5.1.1. Overview
    • 8.5.1.2. Financial Performance
    • 8.5.1.3. Product Benchmarking
    • 8.5.1.4. Strategic Initiatives
  • 8.5.2. Bristol-Myers Squibb Company
    • 8.5.2.1. Overview
    • 8.5.2.2. Financial Performance
    • 8.5.2.3. Product Benchmarking
    • 8.5.2.4. Strategic Initiatives
  • 8.5.3. F. Hoffmann-La Roche Ltd.
    • 8.5.3.1. Overview
    • 8.5.3.2. Financial Performance
    • 8.5.3.3. Product Benchmarking
    • 8.5.3.4. Strategic Initiatives
  • 8.5.4. Regeneron Pharmaceuticals, Inc. & Sanofi S.A.
    • 8.5.4.1. Overview
    • 8.5.4.2. Financial Performance
    • 8.5.4.3. Product Benchmarking
    • 8.5.4.4. Strategic Initiatives
  • 8.5.5. Pfizer Inc. & Seagen Inc.
    • 8.5.5.1. Overview
    • 8.5.5.2. Financial Performance
    • 8.5.5.3. Product Benchmarking
    • 8.5.5.4. Strategic Initiatives
  • 8.5.6. Amgen Inc.
    • 8.5.6.1. Overview
    • 8.5.6.2. Financial Performance
    • 8.5.6.3. Product Benchmarking
    • 8.5.6.4. Strategic Initiatives
  • 8.5.7. Samsung Bioepis Co., Ltd.
    • 8.5.7.1. Overview
    • 8.5.7.2. Financial Performance
    • 8.5.7.3. Product Benchmarking
    • 8.5.7.4. Strategic Initiatives
  • 8.5.8. Bio-Thera Solutions, Ltd.
    • 8.5.8.1. Overview
    • 8.5.8.2. Financial Performance
    • 8.5.8.3. Product Benchmarking
    • 8.5.8.4. Strategic Initiatives