前立腺がんバイオマーカー市場規模、シェア、動向分析レポート：タイプ別、用途別、最終用途別、地域別、セグメント別予測、2025年～2030年

前立腺がんバイオマーカー市場の成長と動向

Grand View Research, Inc.の最新レポートによると、世界の前立腺がんバイオマーカー市場規模は、2025～2030年にかけて13.1%のCAGRを記録し、2030年までに98億米ドルに達する見込みです。

同市場は、精密診断に対する需要の高まりと、PSA検査のような従来型スクリーニング法の限界によって急速な進化を遂げています。PSA検査は広く使用されているが、特異度が低く、しばしば過剰診断や過剰治療につながります。その結果、診断精度の向上と臨床判断の指針となる分子バイオマーカーやゲノムバイオマーカーへのシフトが顕著になっています。PCA3（Prostate Cancer Antigen 3）、4Kscore、ConfirmMDxなどの新しいバイオマーカーは、リスク層別化や生検の意思決定支援において優れた性能を示しています。これらの検査は、不必要な生検を減らし、患者の転帰を改善するために、臨床診療にますます組み込まれるようになってきています。

主要な市場の促進要因は、個別化医療への注目の高まりです。Decipher GPSやOncotype DX GPSのようなゲノム分類法は、前立腺腫瘍の悪性度を判定し、治療計画に情報を提供するのに役立ちます。リキッドバイオプシーによる技術も、その非侵襲性から注目を集めており、SelectMDxやExoDxのような尿ベースの検査は、PSA上昇患者に対して臨床的に実用的な洞察を記載しています。これらの技術革新は、従来型生検ではリスクがあったり、結論が出なかったりする場合に特に関連性が高いです。

次世代シーケンサー（NGS）とトランスクリプトミクスの技術的進歩は、バイオマーカー発見をさらに加速させています。例えば、TMPRSS2-ERGのような遺伝子融合や、BRCA1/2やATMの変異が、予後や治療指針の重要なマーカーであることが研究で同定されています。PARP阻害剤のような標的治療に対する患者の選択において、これらのバイオマーカーの使用が増加していることは、治療エコシステムにおけるコンパニオン診断の重要性の高まりを反映しています。さらに、腫瘍の進行に関連する低分子の代謝変化を分析するメタボロームバイオマーカーは、早期発見とモニタリングの有望なツールとして台頭してきています。

しかし、市場はまだいくつかの課題に直面しています。バイオマーカーアッセイ間の標準化は依然として限定的であり、どの検査をどの臨床段階で採用すべきかについて臨床医の間でコンセンサスが得られていないです。特にヘルスケア予算に制約のある地域では、償還の問題やコストへの懸念が、先進的なバイオマーカー検査の日常的な使用を妨げる可能性があります。さらに、バイオマーカー承認のための規制上の経路はしばしば長期にわたるため、市販が遅れる可能性があります。より新しい検査が市場に出回るようになったとしても、広く臨床に採用されるには、大規模な検証研究と既存の臨床ワークフローへの統合が必要です。

このような障壁にもかかわらず、前立腺がんバイオマーカー産業には注目すべき成長機会が存在します。新規バイオマーカーパネルの発見と検証を目的とした学界と産業の共同研究が活発化しています。PSA検査の限界に対する認識が高まり、価値観による医療が重視される中、より有益で侵襲の少ない診断法へとシフトする機運が強くなっています。このような状況において、進行前立腺がんにおける治療抵抗性のモニタリングに用いられるAR-V7のようなバイオマーカーは、バイオマーカーによる治療選択の可能性を示しています。

このセグメントが進歩し続けるにつれて、前立腺がん診断学はより統合的で個別化されたモデルへと移行しつつあり、そこでは分子的な洞察が早期発見だけでなく、治療法の決定や長期的な管理戦略をも導くことになります。

市場の主要参入企業としては、Exact Sciences、Myriad Genetics、Bio-Techne、Olympus Corporation、OPKO Healthなどが挙げられます。これらの企業は、世界の顧客に対応するため、製品の発売や承認など様々な戦略的取り組みを行っています。例えば、2024年12月、Myriad GeneticsのProlaris検査は、前立腺がん予後のためのAdvanced ToolとしてNational Comprehensive Cancer Network（NCCN）に引き続き承認されました。NCCNの前立腺パネルからの強い支持（>=85%）を示すカテゴリー2Aのエビデンスレベルで、引き続きNCCNガイドラインに含まれています。この分類は、腫瘍の攻撃性による治療方針の決定に役立つプロラリスの臨床的妥当性を強化するものです。

前立腺がんバイオマーカー市場レポートハイライト

• タイプ別では、タンパク質バイオマーカーが2024年に57.73%の最大売上シェアを占めました。前立腺がんバイオマーカー市場におけるタンパク質バイオマーカーセグメントは、PSA検査とPHI検査の臨床利用の普及、前立腺がん罹患率の上昇、臨床ガイドラインの強力な支持によって牽引されています。マルチプレックスアッセイや4Kscoreのようなリスク層別化ツールの技術的進歩が診断精度を高めています。さらに、非侵襲的で費用対効果の高いポイントオブケア検査ソリューションに対する需要の高まりが、先進国市場と市場の両方でこのセグメントのさらなる成長を後押ししています。
• スクリーニングと早期発見が市場を独占し、2024年には45.14％の最大シェアを占めました。スクリーニングと早期発見市場は、疾患有病率の上昇、人口の高齢化、非侵襲的検査の採用によって牽引されています。例えば、PSA検査は依然として世界標準であり、PHI（Prostate Health Index）や4Kscoreは特異度を向上させ、不要な生検を減らします。米国予防医療専門委員会（USPSTF）が55～69歳の男性にPSA検査を推奨しているようなプログラムは、さらに需要を押し上げています。社会的認知度の向上と診断サービスへのアクセスの改善も、このセグメントの成長を支えています。
• 病院と診断ラボは、患者の診断、生検評価、治療計画において中心的な役割を担っているため、前立腺がんバイオマーカー産業の主要促進要因となっています。患者数の増加、先進的診断インフラの利用可能性、PSA、PHI、ConfirmMDxのような正確な早期発見検査への需要が市場成長の燃料となっています。さらに、日常的な泌尿器科ワークフローや病院ベースのがんスクリーニングプログラムにバイオマーカー検査が統合されることで、先進地域と新興地域の両方における検査の採用と開発がさらに促進されます。
• 北米が前立腺がんバイオマーカー市場を独占しているのは、先進的診断能力、プレシジョン・メディシンの早期導入、支持的な規制枠組みによるものです。ExoDx Prostate（Bio-Techneによる尿ベースのエクソソームRNA検査）やSelectMDx（MDxHealthによるmRNA検査）などのバイオマーカーによる検査は、生検の意思決定に広く利用されています。さらに、National Comprehensive Cancer Network（NCCN）の臨床ガイドラインは、バイオマーカーの使用を推奨しています。ゲノミクスへの投資の増加や、学術センターとバイオテクノロジー企業との提携が、地域全体の技術革新とバイオマーカー採用を促進し続けています。
• アジア太平洋は、2025～2030年までの予測期間においてCAGR 14.4％で最も速い成長を遂げると予想されます。これは、中国、インド、日本などの国々におけるがんに対する意識の高まり、ヘルスケアインフラの改善、ヘルスケア支出の増加によるものです。PSA検診やPHI、4Kscoreなどの新しい検査へのアクセスの拡大が早期発見の原動力となっています。地方自治体は全国的ながん検診イニシアチブを立ち上げており、精密医療や分子診断への投資の拡大がバイオマーカーの採用を後押ししています。地域の病院とバイオテクノロジー企業との連携が、技術革新と市場拡大をさらに後押ししています。

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 前立腺がんバイオマーカー市場の変数、動向、範囲

• 前立腺がんバイオマーカー市場の系統展望
  • 親市場の展望
• 浸透と成長の展望マッピング
• パイプライン分析
  • スクリーニングと早期発見
  • 診断とリスク層別化
  • 予後と治療のモニタリング
  • コンパニオン診断
• 市場力学
  • 市場促進要因分析
  • 市場抑制要因分析
• 前立腺がんバイオマーカー：市場分析ツール
  • 産業分析-ポーターのファイブフォース分析
  • PESTLE分析

第4章 前立腺がんバイオマーカー市場：セグメント分析、タイプ別、2018～2030年

• 前立腺がんバイオマーカー市場：タイプ変動分析

第5章 前立腺がんバイオマーカー市場：セグメント分析、用途別、2018～2030年

• 前立腺がんバイオマーカー市場：用途変動分析

第6章 前立腺がんバイオマーカー市場：セグメント分析、最終用途別、2018～2030年

• 前立腺がんバイオマーカー市場：最終用途変動分析

第7章 前立腺がんバイオマーカー市場：地域別セグメント分析、2018～2030年

• 地域市場のスナップショット
• 北米
• 欧州
• アジア太平洋
• ラテンアメリカ
• 中東・アフリカ

第8章 前立腺がんバイオマーカー市場：競合分析

• 企業分類
• 戦略マッピング
  • 新製品発売
  • パートナーシップ
  • 取得
  • コラボレーション
  • 資金調達
• 2022年の企業市場シェア分析
• 企業プロファイル
  • EXACT SCIENCES CORPORATION
  • MYRIAD GENETICS, INC.
  • BIO-TECHNE
  • EXODX
  • OPKO HEALTH,INC.
  • MDXHEALTH
  • VERACYTE, INC.
  • BECKMAN COULTER, INC.
  • NUCLEIX
  • DIACARTA

List of Tables

• Table 1 List of Abbreviation
• Table 2 North America Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 3 North America Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 4 North America Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 5 U.S. Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 6 U.S. Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 7 U.S. Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 8 Canada Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 9 Canada Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 10 Canada Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 11 Mexico Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 12 Mexico Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 13 Mexico Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 11 Europe Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 12 Europe Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 13 Europe Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 14 U.K. Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 15 U.K. Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 16 U.K. Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 17 Germany Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 18 Germany Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 19 Germany Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 20 France Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 21 France Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 22 France Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 23 Italy Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 24 Italy Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 25 Italy Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 26 Spain Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 27 Spain Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 28 Spain Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 29 Denmark Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 30 Denmark Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 31 Denmark Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 32 Sweden Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 33 Sweden Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 34 Sweden Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 35 Norway Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 36 Norway Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 37 Norway Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 38 Asia Pacific Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 39 Asia Pacific Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 40 Asia Pacific Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 41 Japan Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 42 Japan Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 43 Japan Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 44 China Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 45 China Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 46 China Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 47 India Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 48 India Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 49 India Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 50 South Korea Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 51 South Korea Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 52 South Korea Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 53 Australia Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 54 Australia Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 55 Australia Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 56 Thailand Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 57 Thailand Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 58 Thailand Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 59 Latin America Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 60 Latin America Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 61 Latin America Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 62 Brazil Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 63 Brazil Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 64 Brazil Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 68 Argentina Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 69 Argentina Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 70 Argentina Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 71 MEA Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 72 MEA Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 73 MEA Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 74 South Africa Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 75 South Africa Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 76 South Africa Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 77 Saudi Arabia Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 78 Saudi Arabia Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 79 Saudi Arabia Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 80 UAE Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 81 UAE Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 82 UAE Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)
• Table 83 Kuwait Prostate Cancer Biomarkers market, by application, 2018 - 2030 (USD Million)
• Table 84 Kuwait Prostate Cancer Biomarkers market, by type, 2018 - 2030 (USD Million)
• Table 85 Kuwait Prostate Cancer Biomarkers market, by end use, 2018 - 2030 (USD Million)

List of Figures

• Fig. 1 Prostate Cancer Biomarkers market segmentation
• Fig. 2 Market research process
• Fig. 3 Information procurement
• Fig. 4 Primary research pattern
• Fig. 5 Market research approaches
• Fig. 6 Value-chain-based sizing & forecasting
• Fig. 7 QFD modeling for market share assessment
• Fig. 8 Market formulation & validation
• Fig. 9 Market snapshot
• Fig. 10 Segment snapshot (Type and application)
• Fig. 11 Segment snapshot (End Use)
• Fig. 12 Competitive landscape snapshot
• Fig. 13 Biomarkers market value, 2024 (USD Million)
• Fig. 14 Prostate Cancer Biomarkers market dynamics
• Fig. 15 Prevalence of Screening and Early Detection by age group, 2024
• Fig. 16 Prostate Cancer Biomarkers market: PORTER's analysis
• Fig. 17 Prostate Cancer Biomarkers market: PESTLE analysis
• Fig. 18 Prostate Cancer Biomarkers market: Type outlook and key takeaways
• Fig. 19 Prostate Cancer Biomarkers market: Type movement analysis
• Fig. 20 Genetic Biomarkers Prostate Cancer Biomarkers market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 21 Protein Biomarkers Prostate Cancer Biomarkers market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 22 Cell-based Biomarkers Prostate Cancer Biomarkers market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 23 Metabolomic Biomarkers market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 25 Prostate Cancer Biomarkers market: Application outlook and key takeaways
• Fig. 26 Prostate Cancer Biomarkers market: Application movement analysis
• Fig. 27 Screening and Early Detection market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 28 Diagnosis and Risk Stratification market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 29 Prognosis and Treatment Monitoring market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 30 Companion Diagnostics market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 32 Prostate Cancer Biomarkers market: End Use outlook and key takeaways
• Fig. 33 Prostate Cancer Biomarkers market: End Use movement analysis
• Fig. 34 Hospitals and Diagnostic Laboratories market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 35 Academic and Research Institutes market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 36 Biopharmaceutical Companies market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 37 Prostate Cancer Biomarkers market revenue, by region, 2022 & 2030, (USD Million)
• Fig. 38 Regional marketplace: Key takeaways
• Fig. 39 Regional marketplace: Key takeaways
• Fig. 40 North America market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 41 Key country dynamics
• Fig. 42 U.S. Prostate Cancer Biomarkers market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 43 Target disease prevalence
• Fig. 44 Key country dynamics
• Fig. 45 Canada Prostate Cancer Biomarkers market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 46 Target disease prevalence
• Fig. 47 Europe Prostate Cancer Biomarkers market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 48 Key country dynamics
• Fig. 49 UK Prostate Cancer Biomarkers market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 50 Key country dynamics
• Fig. 51 Germany Prostate Cancer Biomarkers market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 52 Target disease prevalence
• Fig. 53 Key country dynamics
• Fig. 54 France Prostate Cancer Biomarkers market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 55 Key country dynamics
• Fig. 56 Italy Prostate Cancer Biomarkers market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 57 Key country dynamics
• Fig. 58 Spain Prostate Cancer Biomarkers market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 59 Key country dynamics
• Fig. 60 Denmark Prostate Cancer Biomarkers market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 61 Key country dynamics
• Fig. 62 Sweden Prostate Cancer Biomarkers market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 63 Key country dynamics
• Fig. 64 Norway Prostate Cancer Biomarkers market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 65 Target disease prevalence
• Fig. 66 Rest of Europe market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 67 Asia Pacific market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 68 Key country dynamics
• Fig. 69 Japan Prostate Cancer Biomarkers market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 70 Target disease prevalence
• Fig. 71 Key country dynamics
• Fig. 72 China Prostate Cancer Biomarkers market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 73 Key country dynamics
• Fig. 74 India Prostate Cancer Biomarkers market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 75 Target disease prevalence
• Fig. 76 Key country dynamics
• Fig. 77 Australia Prostate Cancer Biomarkers market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 78 Key country dynamics
• Fig. 79 Thailand Prostate Cancer Biomarkers market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 80 Key country dynamics
• Fig. 81 South Korea Prostate Cancer Biomarkers market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 82 Rest of Asia Pacific market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 83 Latin America Prostate Cancer Biomarkers market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 84 Key country dynamics
• Fig. 85 Brazil Prostate Cancer Biomarkers market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 86 Key country dynamics
• Fig. 87 Mexico Prostate Cancer Biomarkers market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 88 Key country dynamics
• Fig. 89 Argentina Prostate Cancer Biomarkers market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 90 Rest of Latin America Prostate Cancer Biomarkers market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 91 MEA Prostate Cancer Biomarkers market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 92 Key country dynamics
• Fig. 93 South Africa Prostate Cancer Biomarkers market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 94 Target disease prevalence
• Fig. 95 Key country dynamics
• Fig. 96 Saudi Arabia Prostate Cancer Biomarkers market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 97 Target disease prevalence
• Fig. 98 Key country dynamics
• Fig. 99 UAE Prostate Cancer Biomarkers market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 100 Target disease prevalence
• Fig. 101 Key country dynamics
• Fig. 102 Kuwait Prostate Cancer Biomarkers market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 103 Target disease prevalence
• Fig. 104 Key payors in Kuwait
• Fig. 105 Rest of MEA Prostate Cancer Biomarkers market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 106 Key company categorization
• Fig. 107 Company market positioning
• Fig. 108 Company market share analysis, 2022
• Fig. 109 Strategic framework

Prostate Cancer Biomarkers Market Growth & Trends:

The global prostate cancer biomarkers market size is expected to reach USD 9.8 billion by 2030, registering a CAGR of 13.1% from 2025 to 2030, according to a new report by Grand View Research, Inc. The market is undergoing rapid evolution driven by the increasing demand for precision diagnostics and the limitations of conventional screening methods like PSA testing. PSA, while widely used, has low specificity, often leading to overdiagnosis and overtreatment. As a result, there is a significant shift towards molecular and genomic biomarkers that can offer improved diagnostic accuracy and guide clinical decisions. Emerging biomarkers such as PCA3 (Prostate Cancer Antigen 3), 4Kscore, and ConfirmMDx have demonstrated superior performance in risk stratification and biopsy decision support. These tests are increasingly being integrated into clinical practice to reduce unnecessary biopsies and improve patient outcomes.

A key market driver is the growing focus on personalized medicine. Genomic classifiers like Decipher and Oncotype DX GPS help determine the aggressiveness of prostate tumors and inform treatment planning, especially in early-stage patients deciding between active surveillance and intervention. Liquid biopsy-based technologies are also gaining attention for their non-invasive nature, with urine-based tests like SelectMDx and ExoDx offering clinically actionable insights for patients with elevated PSA. These innovations are particularly relevant in cases where traditional biopsies carry risks or yield inconclusive results.

Technological advancements in next-generation sequencing (NGS) and transcriptomics are further accelerating biomarker discovery. For example, studies have identified gene fusions such as TMPRSS2-ERG and mutations in BRCA1/2 and ATM as significant markers for prognosis and therapeutic guidance. The increasing use of these biomarkers in selecting patients for targeted therapies like PARP inhibitors reflects the rising importance of companion diagnostics in the treatment ecosystem. Moreover, metabolomic biomarkers, which analyze small-molecule metabolic changes associated with tumor progression, are emerging as promising tools for early detection and monitoring.

However, the market still faces several challenges. Standardization across biomarker assays remains limited, and there is a lack of consensus among clinicians regarding which tests to adopt and at what clinical stages. Reimbursement issues and cost concerns can hinder the routine use of advanced biomarker tests, particularly in regions with constrained healthcare budgets. Furthermore, regulatory pathways for biomarker approval are often lengthy, which can delay commercial availability. Even as newer tests enter the market, widespread clinical adoption requires large-scale validation studies and integration into existing clinical workflows.

Despite these barriers, the prostate cancer biomarker industry presents notable growth opportunities. Collaborations between academia and industry are intensifying, aimed at discovering and validating novel biomarker panels. With increasing awareness of the limitations of PSA and growing emphasis on value-based care, there is strong momentum to shift toward more informative, less invasive diagnostics. In this context, biomarkers like AR-V7, used for monitoring treatment resistance in advanced prostate cancer, illustrate the potential of biomarker-guided therapy selection.

As the field continues to advance, prostate cancer diagnostics are moving toward a more integrated and individualized model, where molecular insights guide not only early detection but also therapeutic decisions and long-term management strategies.

Some of the key players in the market are Exact Sciences, Myriad Genetics, Bio-Techne, Olympus Corporation, OPKO Health. These players are involved in various strategic initiatives such as product launch and approval in order to cater to a global clientele. For instance, in December 2024, Myriad Genetics' Prolaris test continues to be recognized by the National Comprehensive Cancer Network (NCCN) as an Advanced Tool for prostate cancer prognosis. It remains included in the NCCN guidelines with a Category 2A evidence level, indicating strong support (>=85%) from the NCCN prostate panel. This classification reinforces Prolaris' clinical relevance in helping guide treatment decisions based on tumor aggressiveness.

Prostate Cancer Biomarker Market Report Highlights:

• Based on type, protein biomarkersaccounted for largest revenue share of 57.73% in 2024. The protein biomarkers segment in the prostate cancer biomarkers market is driven by the widespread clinical use of PSA and PHI tests, rising prostate cancer prevalence, and strong clinical guideline support. Technological advances in multiplex assays and risk stratification tools like the 4Kscore enhance diagnostic accuracy. Additionally, increased demand for non-invasive, cost-effective, and point-of-care testing solutions fuels further growth in this segment across both developed and emerging markets.
• Based on application screening and early detection dominated the market and accounted for the largest share of 45.14% in 2024.The screening and early detection segment in the market is driven by rising disease prevalence, aging populations, and adoption of non-invasive tests. For example, PSA testing remains a global standard, while PHI (Prostate Health Index) and the 4Kscore offer improved specificity, reducing unnecessary biopsies. Programs like the U.S. Preventive Services Task Force (USPSTF) recommendation for PSA testing in men aged 55-69 further boost demand. Increased public awareness and improved access to diagnostic services also support growth in this segment.
• Based on end use, hospitals and diagnostic laboratories segment dominated the market and accounted for the largest share of 63.24% in 2024.Hospitals and diagnostic laboratories are key drivers in the prostate cancer biomarker industry due to their central role in patient diagnosis, biopsy evaluation, and treatment planning. Increasing patient volumes, availability of advanced diagnostic infrastructure, and demand for accurate, early-stage detection tests like PSA, PHI, and ConfirmMDx fuel market growth. Additionally, integration of biomarker testing into routine urology workflows and hospital-based cancer screening programs further enhances test adoption and market expansion in both developed and emerging regions.
• North America dominates the prostate cancer biomarkers market due to advanced diagnostic capabilities, early adoption of precision medicine, and supportive regulatory frameworks. Biomarker-based tests such as ExoDx Prostate (urine-based exosomal RNA test by Bio-Techne) and SelectMDx (mRNA test by MDxHealth) are widely utilized for biopsy decision-making. Additionally, clinical guidelines from the National Comprehensive Cancer Network (NCCN) endorse biomarker usage. Growing investment in genomics and partnerships between academic centers and biotech firms continue to drive innovation and biomarker adoption across the region.
• Asia Pacific region is expected to witness fastest growth with a CAGR of 14.4% over the forecast period from 2025 to 2030, due to increasing cancer awareness, improving healthcare infrastructure, and rising healthcare expenditure in countries like China, India, and Japan. Expanding access to PSA screening and newer tests such as PHI and 4Kscore is driving early detection. Local governments are launching national cancer screening initiatives, and growing investments in precision medicine and molecular diagnostics are boosting biomarker adoption. Collaborations between regional hospitals and biotech firms are further fueling innovation and market expansion.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market Segmentation and Scope
  • 1.1.1 Segment Definition
    • 1.1.1.1 Application Segment
    • 1.1.1.2 Type Segment
    • 1.1.1.3 End Use Segment
• 1.2 Regional Scope
• 1.3 Estimates and Forecast Timeline
• 1.4 Objectives
  • 1.4.1 Objective - 1
  • 1.4.2 Objective - 2
  • 1.4.3 Objective - 3
• 1.5 Research Methodology
• 1.6 Information Procurement
  • 1.6.1 Purchased Database
  • 1.6.2 Gvr's Internal Database
  • 1.6.3 Secondary Sources
  • 1.6.4 Primary Research
• 1.7 Information or Data Analysis
  • 1.7.1 Data Analysis Models
• 1.8 Market Formulation & Validation
• 1.9 Model Details
  • 1.9.1 Commodity Flow Analysis
• 1.10 List of Secondary Sources
• 1.11 List of Abbreviations

Chapter 2 Executive Summary

• 2.1 Market Outlook
• 2.2 Application and Type Snapshot
• 2.3 End Use Snapshot
• 2.4 Competitive Landscape Snapshot

Chapter 3 Prostate Cancer Biomarkers Market Variables, Trends, and Scope

• 3.1 Prostate Cancer Biomarkers Market Lineage Outlook
  • 3.1.1 Parent Market Outlook
• 3.2 Penetration and Growth Prospect Mapping
• 3.3 Pipeline Analysis
  • 3.3.1 Screening And Early Detection
  • 3.3.2 Diagnosis And Risk Stratification
  • 3.3.3 Prognosis And Treatment Monitoring
  • 3.3.4 Companion Diagnostics
• 3.4 Market Dynamics
  • 3.4.1 Market Driver Analysis
    • 3.4.1.1 Rising prevalence of prostate cancer
    • 3.4.1.2 Advancements in Genomic and Proteomic Technologies
    • 3.4.1.3 Supportive Government and Research Initiatives
  • 3.4.2 Market Restraint Analysis
    • 3.4.2.1 High Cost of Biomarker-Based Tests
    • 3.4.2.2 Uneven Access to Advanced Diagnostic Infrastructure
• 3.5 Prostate Cancer Biomarkers: Market Analysis Tools
  • 3.5.1 Industry Analysis - Porter's
  • 3.5.2 Pestle Analysis

Chapter 4 Prostate Cancer Biomarkers Market: Segment Analysis, By Type, 2018 - 2030 (USD Million)

• 4.1 Prostate Cancer Biomarkers Market: Type Movement Analysis
  • 4.1.1 Genetic Biomarkers
    • 4.1.1.1 Genetic Biomarkers Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
  • 4.1.2 Protein Biomarkers
    • 4.1.2.1 Protein Biomarkers Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
  • 4.1.3 Cell-Based Biomarkers
    • 4.1.3.1 Cell-Based Biomarkers Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
  • 4.1.5 Metabolomic Biomarkers
    • 4.1.5.1 Metabolomic Biomarkers Prostate Cancer Biomarkers Market, 2018 - 2030, USD Million

Chapter 5 Prostate Cancer Biomarkers Market: Segment Analysis, By Application, 2018 - 2030 (USD Million)

• 5.1 Prostate Cancer Biomarkers Market: Application Movement Analysis
  • 5.1.1 Screening And Early Detection
    • 5.1.1.1 Screening And Early Detection Market, 2018 - 2030 (USD Million)
  • 5.1.2 Diagnosis And Risk Stratification
    • 5.1.2.1 Diagnosis And Risk Stratification Market, 2018 - 2030 (USD Million)
  • 5.1.3 Prognosis And Treatment Monitoring
  • 5.3.1 Prognosis And Treatment Monitoring Market, 2018 - 2030 (USD Million)
  • 5.1.4 Companion Diagnostics
    • 5.1.4.1 Companion Diagnostics Market, 2018 - 2030 (USD Million)

Chapter 6 Prostate Cancer Biomarkers Market: Segment Analysis, By End Use, 2018 - 2030 (USD Million)

• 6.1 Prostate Cancer Biomarkers Market: End Use Movement Analysis
  • 6.1.1 Hospitals And Diagnostic Laboratories
    • 6.1.1.1 Hospitals And Diagnostic Laboratories Market, 2018 - 2030 (USD Million)
  • 6.1.2 Academic And Research Institutes
    • 6.1.2.1 Academic And Research Institutes Market, 2018 - 2030 (USD Million)
  • 6.1.3 Biopharmaceutical Companies
    • 6.1.3.1 Biopharmaceutical Companies Market, 2018 - 2030 (USD Million)

Chapter 7 Prostate Cancer Biomarkers Market: Segment Analysis, By Region, 2018 - 2030 (USD Million)

• 7.1 Regional Market Snapshot
• 7.2 North America
  • 7.2.1 North America Prostate Cancer Biomarkers Market Estimates And Forecast, 2018 - 2030 (USD Million)
  • 7.2.2 U.S.
    • 7.2.2.1 U.S. Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.2.2.2 Key Country Dynamics
    • 7.2.2.3 Regulatory Framework
    • 7.2.2.4 Reimbursement Scenario
  • 7.2.3 Canada
    • 7.2.3.1 Canada Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.2.3.2 Key Country Dynamics
    • 7.2.3.3 Regulatory Framework
    • 7.2.3.4 Reimbursement Scenario
  • 7.2.4 Mexico
    • 7.2.4.1 Mexico Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.2.4.2 Key Country Dynamics
    • 7.2.4.3 Regulatory Framework
    • 7.2.4.4 Reimbursement Scenario
• 7.3 Europe
  • 7.3.1 Europe Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
  • 7.3.2 UK
    • 7.3.2.1 UK Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.3.2.2 Key Country Dynamics
    • 7.3.2.3 Regulatory Framework
    • 7.3.2.4 Reimbursement Scenario
  • 7.3.3 Germany
    • 7.3.3.1 Germany Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.3.3.2 Key Country Dynamics
    • 7.3.3.3 Regulatory Framework
    • 7.3.3.4 Reimbursement Scenario
  • 7.3.4 Spain
    • 7.3.4.1 Spain Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.3.4.2 Key Country Dynamics
    • 7.3.4.3 Regulatory Framework
    • 7.3.4.4 Reimbursement Scenario
  • 7.3.5 France
    • 7.3.5.1 France Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.3.5.2 Key Country Dynamics
    • 7.3.5.3 Regulatory Framework
    • 7.3.5.4 Reimbursement Scenario
  • 7.3.6 Italy
    • 7.3.6.1 Italy Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.3.6.2 Key Country Dynamics
    • 7.3.6.3 Regulatory Framework
    • 7.3.6.4 Reimbursement Scenario
  • 7.3.7 Denmark
    • 7.3.7.1 Denmark Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.3.7.2 Key Country Dynamics
    • 7.3.7.3 Regulatory Framework
    • 7.3.7.4 Reimbursement Scenario
  • 7.3.8 Sweden
    • 7.3.8.1 Sweden Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.3.8.2 Key Country Dynamics
    • 7.3.8.3 Regulatory Framework
    • 7.3.8.4 Reimbursement Scenario
  • 7.3.9 Norway
    • 7.3.9.1 Norway Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.3.9.2 Key Country Dynamics
    • 7.3.9.3 Regulatory Framework
    • 7.3.9.4 Reimbursement Scenario
• 7.4 Asia Pacific
  • 7.4.1 Asia-Pacific Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
  • 7.4.2 Japan
    • 7.4.2.1 Japan Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.4.2.2 Key Country Dynamics
    • 7.4.2.3 Regulatory Framework
    • 7.4.2.4 Reimbursement Scenario
  • 7.4.3 China
    • 7.4.3.1 China Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.4.3.2 Key Country Dynamics
    • 7.4.3.3 Regulatory Framework
    • 7.4.3.4 Reimbursement Scenario
  • 7.4.4 India
    • 7.4.4.1 India Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.4.4.2 Key Country Dynamics
    • 7.4.4.3 Regulatory Framework
    • 7.4.4.4 Reimbursement Scenario
  • 7.4.5 South Korea
    • 7.4.5.1 South Korea Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.4.5.2 Key Country Dynamics
    • 7.4.5.3 Regulatory Framework
    • 7.4.5.4 Reimbursement Scenario
  • 7.4.6 Thailand
    • 7.4.6.1 Thailand Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.4.6.2 Key Country Dynamics
    • 7.4.6.3 Regulatory Framework
    • 7.4.6.4 Reimbursement Scenario
  • 7.4.7 Australia
    • 7.4.7.1 Australia Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.4.7.2 Key Country Dynamics
    • 7.4.7.3 Regulatory Framework
    • 7.4.7.4 Reimbursement Scenario
• 7.5 Latin America
  • 7.5.1 Latin America Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
  • 7.5.2 Brazil
    • 7.5.2.1 Brazil Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.5.2.2 Key Country Dynamics
    • 7.5.2.3 Regulatory Framework
    • 7.5.2.4 Reimbursement Scenario
  • 7.5.3 Argentina
    • 7.5.3.1 Argentina Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.5.3.2 Key Country Dynamics
    • 7.5.3.3 Regulatory Framework
    • 7.5.2.4 Reimbursement Scenario
• 7.6 MEA
  • 7.6.1 MEA Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
  • 7.6.2 South Africa
    • 7.6.2.1 South Africa Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.6.2.2 Key Country Dynamics
    • 7.6.2.3 Regulatory Framework
    • 7.6.2.4 Reimbursement Scenario
  • 7.6.3 Saudi Arabia
    • 7.6.3.1 Saudi Arabia Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.6.3.2 Key Country Dynamics
    • 7.6.3.3 Regulatory Framework
    • 7.6.3.4 Reimbursement Scenario
  • 7.6.4 UAE
    • 7.6.4.1 UAE Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.6.4.2 Key Country Dynamics
    • 7.6.4.3 Regulatory Framework
    • 7.6.2.4 Reimbursement Scenario
  • 7.6.5 Kuwait
    • 7.6.5.1 Kuwait Prostate Cancer Biomarkers Market, 2018 - 2030 (USD Million)
    • 7.6.5.2 Key Country Dynamics
    • 7.6.5.3 Regulatory Framework
    • 7.6.5.4 Reimbursement Scenario

Chapter 8 Prostate Cancer Biomarkers Market: Competitive Analysis

• 8.1 Company Categorization
• 8.2 Strategy Mapping
  • 8.2.1 New product launch
  • 8.2.2 Partnerships
  • 8.2.3 Acquisition
  • 8.2.4 Collaboration
  • 8.2.5 Funding
• 8.3 Company Market Share Analysis, 2022
• 8.4 Company Profiles
  • 8.4.1 EXACT SCIENCES CORPORATION
    • 8.4.1.1 Company overview
    • 8.4.1.2 Financial performance
    • 8.4.1.3 Product benchmarking
    • 8.4.1.4 Strategic initiatives
  • 8.4.2 MYRIAD GENETICS, INC.
    • 8.4.2.1 Company overview
    • 8.4.2.2 Financial performance
    • 8.4.2.3 Product benchmarking
    • 8.4.2.4 Strategic initiatives
  • 8.4.3 BIO-TECHNE
    • 8.4.3.1 Company overview
    • 8.4.3.2 Financial performance
    • 8.4.3.3 Product benchmarking
    • 8.4.3.4 Strategic initiatives
  • 8.4.4 EXODX
    • 8.4.4.1 Company overview
    • 8.4.4.2 Product benchmarking
    • 8.4.4.3 Product benchmarking
    • 8.4.4.4 Strategic initiatives
  • 8.4.5 OPKO HEALTH,INC.
    • 8.4.5.1 Company overview
    • 8.4.5.2 Product benchmarking
    • 8.4.5.3 Strategic initiatives
  • 8.4.6 MDXHEALTH
    • 8.4.6.1 Company overview
    • 8.4.6.2 Financial performance
    • 8.4.6.3 Product benchmarking
    • 8.4.6.4 Strategic initiatives
  • 8.4.7 VERACYTE, INC.
    • 8.4.7.1 Company overview
    • 8.4.7.2 Financial performance
    • 8.4.7.3 Product benchmarking
    • 8.4.7.4 Strategic initiatives
  • 8.4.8 BECKMAN COULTER, INC.
    • 8.4.8.1 Company overview
    • 8.4.8.2 Product benchmarking
  • 8.4.9 NUCLEIX
    • 8.4.9.1 Company overview
    • 8.4.9.2 Financial performance
    • 8.4.9.3 Product benchmarking
    • 8.4.9.4 Strategic initiatives
  • 8.4.10 DIACARTA
    • 8.4.10.1 Company overview
    • 8.4.10.2 Product benchmarking
    • 8.4.10.3 Strategic initiatives