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市場調查報告書
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1887994

人體生物檢體市場－全球及區域分析：依樣本類型、應用程式、採購類型、最終使用者和地區分類－分析與預測（2025-2035）

Human Biospecimen Market - A Global and Regional Analysis: Focus on Specimen Type, Application, Procurement Type, End User, and Regional Analysis - Analysis and Forecast, 2025-2035
出版日期: | 出版商: BIS Research | 英文 167 Pages | 商品交期: 1-5個工作天內

價格

人體生物檢體是指從人體收集的用於科學或臨床研究的生物材料，例如組織、血液、體液和分子衍生物。

它們保留了真實的疾病特徵，對於研究分子路徑、檢驗診斷方法和開發標靶治療至關重要。透過標準化的採集、處理和儲存，生物檢體能夠保持完整性並與臨床數據關聯，從而支持精準的轉化研究，並推動精準醫學的進步。

關鍵市場統計數據
預測期 2025-2035
2025 年評估 35.533億美元
2035 年預測 81.789億美元
複合年成長率 8.69%

市場概覽

全球人類生物樣本市場預計將迎來顯著成長，到2035年將達到81.789億美元。推動這一成長的主要因素是全球癌症、罕見疾病、感染疾病和慢性病負擔日益加重，這些疾病都需要基於基因組學和精準醫學的研究。人類生物檢體，包括組織、血漿/血清、周邊血單核細胞（PBMC）、原代細胞、DNA、RNA、外泌體和其他分子衍生物，目前是藥物發現、生物標記開發、下一代診斷和轉化醫學的關鍵投入。

市場擴張的驅動力在於市場對高品質、臨床註釋、多體學學生物樣本的需求成長，以及預分析標準化、自動化生物樣本庫和數位化樣本追蹤平台的進步。領先供應商獲得 ISO 20387 和 CAP ISO 15189 認證，以及人工智慧驅動的生物樣本資料平台的推出等關鍵進展，反映出監管系統日益成熟，以及客戶對可追溯性、知情同意和可重複性的期望不斷提高。

另一個主要促進因素是對國家生物樣本庫和人群基因組學計畫（例如英國生物樣本庫和美國的「我們所有人」研究計畫）的投資不斷成長，這些計畫共同管理著數百萬個生物樣本，並實現了大規模的泛組學整合。隨著製藥和生物技術公司在腫瘤學、免疫學、代謝性疾病和罕見遺傳疾病領域拓展其研發管線，這進一步加速了對特徵明確的患者樣本的需求，這些樣本對於靶點檢驗、伴隨診斷和核准後監測至關重要。

儘管北美和歐洲目前憑藉成熟的生物銀行網路和雄厚的研究經費在生物樣本精準醫療領域處於領先地位，但亞太地區正迅速崛起為高成長區域。中國將佔據最大佔有率，而印度預計將憑藉其不斷擴展的臨床研究生態系統和大規模的患者群體實現最快成長。同時，拉丁美洲和中東市場也日益關注生物樣本相關的精準醫療舉措，從而創造了新的商業機會。

儘管已取得顯著進展，但仍面臨諸多挑戰，包括分析前變異性、高成本的低溫儲存基礎設施、跨境資料傳輸障礙以及資源匱乏地區高品質樣本取得困難等。然而，產業界、學術界和政府機構之間日益密切的合作正逐步克服這些挑戰，從而建立規模更大、種類更豐富、管理更符合倫理規範的檢體網路。

BioIVT、Crown Bioscience、Precision Medicine Group、Boca Biolistics、ABS Bio 和 Reprocell 等主要企業正透過擴大全球採購、人工智慧驅動的臨床數據整合以及疾病特異性隊列的開發來增強其競爭優勢。隨著精準醫療、多組體學研究和先進治療方法的加速發展，人類生物檢體市場已成為未來生物醫學創新的核心驅動力，促進臨床應用並改善全球患者的治療效果。

對產業的影響

人類生物檢體產業正成為精準醫療的重要基石，它能夠提供高品質、具有臨床意義的生物材料，用於生物標記發現、臨床試驗招募和診斷方法開發。隨著癌症、代謝失調、中樞神經系統疾病和罕見疾病等疾病成為全球研發的驅動力，製藥、生物技術和診斷領域對高註釋組織、相應生物體液和活性原代細胞的需求呈指數級成長。

像 Crown Bioscience、BioIVT LLC、Precision Medicine Group, LLC 和 Grifols, SA 這樣的知名供應商正在通過提供具有強大監管鏈的多基質、縱向、基因組學生物樣本來重新構想研究工作流程，從而減少實驗變異性，簡化檢測檢驗，並加速藥物開發決策，尤其是在腫瘤學領域，超過 55% 的臨床標誌是由生物開發的決策，尤其是在腫瘤學領域由 55% 的臨床開發領域由生物主導。

市場也在推動樣本採集、處理和記錄方法的改進，越來越多的公司開始遵循正式的品質和監管標準，例如 CAP ISO 15189 和 ISO 20387。這確保了生物樣本來源符合倫理規範，品質優良，並適用於診斷、臨床研究和先進療法。商業生物樣本庫、學術醫療中心和政府資助的人群基因組學計畫之間的策略合作，正在擴大獲取不同患者群體（包括高價值的腫瘤和罕見疾病樣本）的機會。這些夥伴關係加強了全球生物檢體管道，減少了獲取瓶頸，並支持去中心化的細胞和基因治療 (CGT) 及轉化研究生態系統。

總體而言，人類生物檢體市場正在改變生命科學工具的格局，將可靠且數據豐富的樣本定位為治療成功的核心決定因素。透過與受監管的工作流程和高影響力發現平台的深度整合，該行業正在直接提高臨床開發效率，推動個人化醫療策略，並加速將科學創新轉化為切實的患者獲益。

市場區隔:

類別 1：依樣本類型

  • 組織檢體
  • 生物體液
  • 細胞材料
  • 核酸
  • 其他

以樣本類型分類，組織檢體仍將是全球人類生物樣本市場的主要細分市場，預計2024年將佔據41.30%的市場。從2025年到2035年，受其在癌症研究、精準醫療、數位病理學和空間體學等領域的關鍵作用推動，組織樣本預計將以7.48%的複合年成長率成長。高價值的FFPE組織塊、冷凍組織和切除標本將繼續支持生物標記發現、伴隨診斷開發和腫瘤-正常組織測序分析，使組織成為最具盈利的類別。受液態生物檢體活體組織切片、基於ctDNA的診斷和免疫腫瘤學計畫發展推動，血漿、血清、周邊血單核細胞（PBMC）和尿液等生物體液的複合年成長率更高。人們對微創採樣和長期患者監測的日益青睞預計將進一步增強生物體液生物檢體對市場成長的貢獻。

細分 2：按應用

  • 生物醫學研究
  • 診斷
  • 治療研發
  • 臨床試驗

按應用領域分類，生物醫學研究領域在2024年引領全球人類生物樣本市場，佔45.00%的市場。這一主導地位得益於藥物發現研究、轉化醫學計畫和生物標記開發中對高品質組織、生物體液和原代細胞的持續需求。基因組學、蛋白質組學、代謝體學和空間生物學等多體學平台的日益普及，進一步鞏固了生物醫學研究作為帶註釋生物樣本主要消費領域的地位。

隨著液態生物檢體檢測、伴隨診斷驅動的藥物核准以及全球監管檢測檢驗的興起，診斷和臨床開發應用正在迅速擴展。生物製藥公司依賴特徵明確的人體樣本進行患者分層、分析性能評估和真實世界證據生成。隨著精準醫療的加速普及，生物樣本在診斷、免疫腫瘤學、神經病學和罕見疾病研究中的應用預計將在2035年之前推動強勁成長，並提高該領域對整體市場收入的貢獻。

細分3：依採購類型

  • 預收款項（按需收）
  • 回顧性檢體

按採集類型分類，到2024年，全球人類生物檢體市場將以回顧性樣本為主導，佔據55.00%的市場佔有率。這得歸功於現有的龐大樣本庫，例如FFPE組織塊、冷凍組織、血漿/血清、周邊血單核細胞（PBMC）以及其他保存在醫院生物樣本庫和國家研究網路中的生物體液。這些樣本具有獲取迅速、批量通量高以及涵蓋多種疾病群體（包括腫瘤、代謝性疾病和感染疾病）等優勢，使其成為藥物發現研究、轉化研究和早期診斷開發的重要來源。

同時，前瞻性（按需）樣本採集雖然目前佔比不高，卻是成長最快的領域。其成長主要受精準監測需求的驅動，包括嚴格的納入和排除標準、基因譜分析、新鮮組織採集、罕見兒童疾病的樣本採集以及與真實世界臨床數據關聯的縱向樣本採集。隨著生物標記驅動的臨床試驗、多組體學研究以及精準醫療研發管線的擴展，預計到2035年，前瞻性樣本採集的貢獻將顯著成長。

細分 4：按最終用戶

  • 製藥和生物技術公司
  • 合約研究組織（CRO）
  • 學術研究機構
  • 醫院和生物樣本庫
  • 診斷實驗室
  • 政府和非營利組織

從終端用戶來看，到2024年，全球人類生物檢體市場將由製藥和生技公司主導，佔48.00%的市場。這些公司是藥物研發生命週期中，對註釋完善的人體組織、生物體液和細胞材料需求量最大、最穩定的使用者。它們推動了對高品質疾病特異性隊列、多基質相容樣本以及符合監管要求的生物樣本的檢驗，以支持目標發現、轉化研究、生物標記驗證、伴隨診斷開發和臨床進展。

細分5：按地區

  • 北美洲
    • 美國
    • 加拿大
  • 歐洲
    • 德國
    • 英國
    • 法國
    • 義大利
    • 西班牙
    • 其他
  • 亞太地區
    • 日本
    • 印度
    • 中國
    • 澳洲
    • 韓國
    • 其他
  • 其他地區

亞太地區的人類生物檢體市場正在擴張。中國佔大規模的人口規模、較高的癌症和代謝性疾病負擔、對生物樣本庫基礎設施的大力投資，以及精準醫療和多組體學計畫的快速發展。印度是成長最快的市場，這主要得益於臨床試驗活動的增加、手術和病理樣本獲取量的提高，以及不斷完善的數位醫療基礎設施，從而能夠從不同的患者群體中大規模獲取樣本。

日本和韓國透過先進的國家生物樣本庫網路和基因組研究舉措，提供高品質、註釋詳盡的生物樣本。澳洲擁有強大的轉化研究能力和廣泛的臨床實踐，而新加坡和馬來西亞則作為數據互聯的物流樞紐，支持全球生物樣本交換。印尼、越南和菲律賓等東南亞市場正在逐步擴張，但仍受到基礎設施、監管差異和低溫運輸限制等因素的限制。

亞太地區幅員遼闊，疾病種類繁多，種族構成複雜，因此成為全球生物檢體的重要來源地，以支持腫瘤學、代謝性疾病、神經病學和罕見病研究。

人類生物檢體市場的最新趨勢

  • 2025 年 10 月，BioIVT 收購了總部位於西班牙的 BeCytes Biotechnologies，以加強其在歐洲的生物銀行規模，並擴大獲得符合倫理的人類生物檢體的途徑，以支持新型方法調查方法(NAM)。
  • 2025 年 2 月，Crown Bioscience 與 Indivimed Services 合併，將兩家公司的生物樣本和多體學平台結合起來，透過整合人類生物樣本解決方案來加強腫瘤藥物發現研究。
  • 2025 年 6 月，iProcess Global Research 與 ViewsML 合作，整合 AI 驅動的虛擬 IHC 生物標記測試，以增強基於生物樣本的數位病理學和組織存檔生物標記分析，用於研究和診斷。
  • 2025 年 9 月，ABS Bio 的生物樣本採購和生物銀行營運獲得了 ISO 20387 認證，進一步鞏固了其對高品質、符合倫理的人類生物樣本和全球生物庫標準的承諾。
  • 2025 年 8 月，Logical Biological 與 Bcell Design 合作開發了模擬天然人體生物檢體樣本的疾病狀態血漿材料，為診斷和研究應用提供了一種永續的高性能替代方案。
  • 2025 年 1 月，Reprocell 推出了 ReproRegistry，這是一個志願者登記系統，旨在將擁有健康或患病皮膚的個人聯繫起來，用於研究目的，從而獲取用於皮膚病學和藥物發現的人類皮膚樣本。
  • 2024 年 9 月，Discovery Life Sciences 整合了 Lunaphor 的 COMET 平台，以擴展其用於臨床生物樣本分析的多重空間生物學能力。

需求——促進因素、挑戰與機遇

市場需求促進因素：附註的人類生物檢體日益普及

精準醫療的興起顯著提升了對高品質、經臨床註釋的人類生物檢體的需求，這些樣本能夠準確反映真實世界的疾病生物學特徵。如今，製藥和生物技術公司依靠腫瘤-正常組織對照樣本、ctDNA匹配的血漿、定序級核酸以及疾病特異性免疫細胞亞群，來實現生物標記主導的藥物發現和開發、分層臨床試驗入組以及伴隨診斷檢驗。腫瘤學領域正處於這一變革的前沿，生物標記指導的臨床試驗比例已從2000年的約15%成長到如今的55%以上，目前已有超過60種獲得FDA核准的療法與檢驗診斷檢測相結合。

在腫瘤學領域之外，罕見疾病研究也推動了對特徵明確、可直接用於患者的生物樣本的需求，包括初代細胞、纖維母細胞、神經肌肉組織、兒童組織以及來自小規模、​​基因明確的隊列的血液樣本。全國基因組檢測項目，例如英國國家醫療服務體系（NHS）的ctDNA癌症篩檢計畫（預計每年將惠及約15,000名患者），凸顯了精準醫療與穩健的生物樣本供應鏈之間日益緊密的聯繫。這些進展需要嚴格的預分析處理、縱向臨床註釋以及可靠的可追溯性框架，以確保多體學應用中資料品質的一致性。

隨著製藥企業將標靶治療項目列為優先事項並減少後期臨床試驗失敗率，獲取臨床上豐富的標準化生物樣本已成為一項戰略要務。預計這種依賴性將持續成長，帶有註釋的人類生物樣本將成為下一代藥物發現、轉化科學和監管決策的核心驅動力。

市場挑戰：分析前變異性與生物檢體品質差距

分析前變異性仍然是人類生物檢體市場中最主要的阻礙因素之一，因為即使在採集、處理、運輸和儲存過程中出現微小偏差，也可能導致不可逆的分子劣化。處理時間、試管類型、抗凝血劑、離心參數、凍融循環次數以及儲存溫度（-20 度C與 -80 度C）的差異都會顯著改變 DNA、RNA、蛋白質和代謝物的譜圖，直接影響其在新一代定序 (NGS)、蛋白質組學、代謝體學和空間體學中的適用性。諸如 SPIDIA-RNA 等大規模品質評估表明，只有不到一半的參與實驗室能夠始終滿足 RNA 完整性要求，高達 28% 的實驗室在多個參數上出現「失控」結果，凸顯了整個市場普遍存在的不一致性。

元資料報告不足進一步加劇了這個問題。許多儲存的樣本缺乏必要的分析前資訊，例如處理前的時間、溶血指數或凍融歷史，導致它們無法用於符合監管要求的生物標記研究或需要高靈敏度和可重複性的多體學學研究。因此，現有生物樣本庫中相當一部分樣本無法支持精準醫療應用，尤其是那些年代久遠且記錄不全的樣本庫。

為了保持競爭力，生物樣本供應商現在必須實施基於SPREC的文件記錄、統一的標準操作規程（SOP）以及貫穿生物樣本生命週期的嚴格即時品質監控。這種標準化趨勢增加了營運成本，提高了能力門檻，有利於擁有成熟品管系統的大型供應商，同時限制了小規模、標準化程度較低的供應商進入市場。

市場機會：疾病特異性罕見疾病隊列的商業化

目前已知的罕見疾病和超罕見疾病超過10,000種，但核准的治療方法卻寥寥無幾。因此，高品質、與疾病相符的生物樣本對於支持診斷創新、生物標記發現和治療方法研發至關重要。許多罕見疾病缺乏成熟的樣本庫，且患者群體分佈分散，嚴重限制了相關隊列的取得。製藥公司越來越需要特殊的生物樣本，例如纖維母細胞、神經肌肉組織、神經肌肉組織、腦脊髓液樣本以及相應的時序樣本，以表徵疾病進展並檢驗基因靶點，尤其是在代謝性疾病、兒童疾病和遺傳性疾病領域。

監管政策的發展進一步推動了這項機會。雖然孤兒藥認定和加速核准流程的興起提高了研發對罕見疾病適應症的關注度，但可靠生物樣本的短缺仍然是一大瓶頸。諸如美國國立衛生研究院罕見疾病治療加速器計畫等國家級舉措，凸顯了對能夠將生物學變化與臨床結果聯繫起來的多時間點資料集和註釋完善的樣本的需求。

這為能夠建立疾病特異性登記庫、實施精準招募策略並創建包含表現型特徵、基因組數據和追蹤時間線等資訊且已獲得受試者同意的、數據豐富的資料庫的專業生物樣本供應商創造了巨大的商業機會。隨著罕見疾病研發管線的不斷擴展，提供此類高價值材料的能力將成為關鍵的商業性，而具備相應能力的供應商將把自己定位為加速為服務不足的患者群體開發精準藥物的重要合作夥伴。

市場趨勢：產品發布和監管核准不斷增加

在產品創新和監管進步的推動下，人類生物檢體市場正從傳統的交易型樣本供應模式轉型為高價值、合規驅動的結構化生態系統。供應商正在加速推出各類專業產品，包括針對特定適應症的組織樣本、多基質生物生物檢體盒、針對特定疾病的外周血單核細胞 (PBMC)、符合 GMP 標準的細胞材料，以及由供體主導的登記系統，例如專注於皮膚病學的 ReproRegistry。數位化也在快速發展，人工智慧驅動的數據平台整合了生物檢體元資料、臨床結果和基因組圖譜，從而提升了可追溯性、樣本選擇和研究相關性。

同時，標準化的分析前流程、檢驗的工作流程和受監管的生物樣本庫作業正在轉變，越來越多的供應商獲得了 CAP ISO 15189 (2022) 和 ISO 20387 等認證。這種發展使得生物樣本能夠支援受監管的工作流程，例如診斷檢驗、伴隨診斷配對和臨床試驗執行，從而推動了製藥、生物技術和體外診斷開發人員的需求。

然而，這項變化也提高了競爭門檻。高品質的文件、完整的監管鍊和合規基礎設施如今已成為基本要求，而非增值差異化因素。擁有完善品質管治系統的大型營運商和專業平台將從中受益最多，而缺乏監管成熟度的傳統供應商則可能被限制在利潤率低、同質化的市場細分領域。

主要市場參與企業及競爭摘要

入選公司名單是根據初步研究結果、產品組合的全面性、監管認證和全球生物樣本採購能力來選擇的。

Crown Bioscience、Grifols SA、BioIVT LLC 和 Precision Medicine Group, LLC 等成熟供應商擁有強大的市場地位，其生物樣本庫規模大規模且來源符合倫理規範，並擁有 CAP/ISO 認證的生物銀行營運體系，以及與製藥、生物技術和診斷公司建立的長期夥伴關係。它們不斷擴展的多體學學樣本庫和豐富的數據資源為先進的轉化醫學和精準醫學研究提供了支持。

同時，像 Logical Biological 和 Labtoo 這樣的新興企業正在透過靈活的採購模式、疾病特異性樣本解決方案和數位化採購平台來擴大其業務範圍（尤其是在歐洲和亞太地區），從而簡化研究人員在全球範圍內獲取生物樣本的途徑。

這些公司攜手合作，正在加強全球生物檢體供應鏈，增加樣本多樣性，推動提高可追溯性和監管合規性，並引領市場走向高品質、臨床註釋的資源，以支持藥物發現和診斷開發。

該市場的一些主要企業包括：

  • BioIVT LLC.
  • Crown Bioscience
  • Precision Medicine Group, LLC
  • Grifols, SA

目錄

執行摘要

第1章 全球人類生物檢體市場：產業展望

  • 市場概覽
  • 市場趨勢
  • 供應鏈概覽
  • 監管狀態
  • 市場動態

2. 全球人類生物檢體市場（依樣本類型分類）

  • 概述
  • 組織標本
  • 生物體液
  • 細胞材料
  • 核酸
  • 其他

第3章 全球人類生物檢體市場（依應用分類）

  • 概述
    • 生物醫學研究
    • 診斷
    • 治療研發
    • 臨床試驗

4. 全球人類生物檢體市場（依採購類型分類）

  • 概述
    • 專業特定係列（按需系列）
    • 回顧性樣本

5. 全球人類生物檢體市場（依最終用戶分類）

  • 概述
    • 製藥和生物技術公司
    • CRO
    • 學術研究機構
    • 醫院和生物樣本庫
    • 診斷檢查室
    • 政府和非營利組織

第6章 區域

  • 區域摘要
  • 北美洲
    • 區域概覽
    • 市場成長促進因素
    • 影響市場的因素
    • 市場規模及預測
    • 美國
    • 加拿大
  • 歐洲
    • 區域概覽
    • 市場成長促進因素
    • 成長抑制因素
    • 市場規模及預測
    • 英國
    • 德國
    • 法國
    • 義大利
    • 西班牙
    • 其他
  • 亞太地區
    • 區域概覽
    • 市場成長促進因素
    • 成長抑制因素
    • 市場規模及預測
    • 中國
    • 日本
    • 印度
    • 澳洲
    • 韓國
    • 其他
  • 其他地區
    • 區域概覽
    • 市場成長促進因素
    • 成長抑制因素
    • 市場規模及預測

第7章 競爭基準化分析與公司概況

  • 2020-2025年主要策略與發展
  • 2020-2025年關鍵發展分析（按年份分類）
  • 關鍵發展分析（依公司分類），2020-2025 年
  • 公司簡介
    • BioIVT LLC.
    • Crown Bioscience
    • iProcess Global Research Inc.
    • ABS Bio, Inc.
    • Precision Medicine Group, LLC
    • REPROCELL Inc.
    • LifeNet Health LifeSciences
    • Logical Biological
    • Europa Biosite
    • Discovery Life Sciences
    • Boca Biolistics, LLC
    • ProteoGenex
    • US Biolab Corporation, Inc.
    • Bay Biosciences
    • Grifols, SA

第8章調查方法

Product Code: BHP3398SA

This report can be delivered within 1 working day.

Introduction of Human Biospecimen

Human biospecimens are biological materials such as tissues, blood, biofluids, and molecular derivatives collected from the human body for scientific and clinical investigation. They retain real-world disease characteristics and are essential for studying molecular pathways, validating diagnostics, and developing targeted therapies. With standardized collection, processing, and storage that preserve integrity and link clinical data, biospecimens enable accurate translational research and drive advancements in precision medicine.

KEY MARKET STATISTICS
Forecast Period2025 - 2035
2025 Evaluation$3,553.3 Million
2035 Forecast$8,178.9 Million
CAGR8.69%

Market Introduction

The global human biospecimen market is expected to witness significant growth, projected to reach $8,178.9 million by 2035, supported by the rising global burden of cancer, rare diseases, infectious diseases, and chronic conditions that require genomic and precision-based research. Human biospecimens, including tissues, plasma/serum, PBMCs, primary cells, and molecular derivatives such as DNA, RNA, and exosomes, now serve as mission-critical inputs for drug discovery, biomarker development, next-generation diagnostics, and translational medicine.

Market expansion has been driven by the shift toward high-quality, clinically annotated, and multi-omic-ready biospecimens, alongside advancements in pre-analytical standardization, biorepository automation, and digital sample-tracking platforms. Key developments such as ISO 20387 and CAP ISO 15189 accreditations across leading providers, and the launch of AI-enabled biospecimen data platforms, reflect increasing regulatory maturity and rising customer expectations for traceability, consent compliance, and reproducibility.

Strong momentum also stems from growing investments in national biobanks and population-genomics programs, including the U.K. Biobank and the U.S. All of Us Research Program, which collectively manage millions of biospecimens and enable pan-omics integration at scale. Pharmaceutical and biotechnology companies further accelerate demand as they expand pipelines in oncology, immunology, metabolic diseases, and rare genetic disorders, where deeply characterized patient samples are essential for target validation, companion diagnostics, and post-approval monitoring.

While North America and Europe currently lead in adoption due to mature biobanking networks and robust research funding, Asia-Pacific is rapidly emerging as a high-growth region with China holding the largest share and India projected to grow the fastest, driven by expanding clinical research ecosystems and access to large patient populations. Meanwhile, Latin America and the Middle East markets are increasingly focusing on biospecimen-linked precision-medicine initiatives, presenting new commercialization opportunities.

Despite strong progress, challenges persist, including pre-analytical variability, high-cost cryogenic infrastructure, cross-border data-transfer barriers, and limited access to high-quality samples in lower-resource settings. However, increased collaboration among industry, academia, and government bodies is steadily overcoming these gaps and enabling larger, more diverse, and ethically governed specimen networks.

Leading companies such as BioIVT, LLC, Crown Bioscience, Precision Medicine Group, LLC, Boca Biolistics, ABS Bio, and Reprocell are strengthening competitive positioning through global sourcing expansion, AI-powered clinical-data integration, and disease-specific cohort development. As precision medicine, multi-omics research, and advanced therapies accelerate, the human biospecimen market is positioned as a core enabler of future biomedical innovation, unlocking faster clinical translation and improved patient outcomes worldwide.

Industrial Impact

The human biospecimen industry is becoming an essential backbone of precision medicine by enabling access to high-quality, clinically contextualized biological materials needed for biomarker discovery, clinical trial enrollment, and diagnostic development. With cancer, metabolic disorders, CNS diseases, and rare diseases driving global R&D, demand for deeply annotated tissues, matched biofluids, and viable primary cells is rising sharply across pharmaceutical, biotech, and diagnostic segments.

Established providers such as Crown Bioscience, BioIVT LLC, Precision Medicine Group, LLC, and Grifols, S.A. are reshaping research workflows by delivering multi-matrix, longitudinal, and genomics-ready biospecimens with robust chain-of-custody documentation. These offerings reduce experimental variability, streamline assay validation, and accelerate drug development decision-making, particularly in oncology, where >55% of clinical trials are now biomarker-guided.

The market is also driving improvements in how samples are collected, processed, and documented, with more companies following formal quality and regulatory standards such as CAP ISO 15189 and ISO 20387. This ensures that biospecimens are ethically sourced, high-quality, and suitable for use in diagnostics, clinical research, and advanced therapies. Strategic collaborations between commercial biobanks, academic medical centers, and government-funded population-genomics programs are expanding access to diverse patient cohorts, including high-value oncology and rare-disease samples. These partnerships strengthen global biospecimen pipelines, reduce access bottlenecks, and support decentralized CGT and translational-research ecosystems.

Overall, the human biospecimen market has been transforming the life-science tools landscape, making reliable, data-rich human samples a core determinant of therapeutic success. By deepening integration with regulated workflows and high-impact discovery platforms, the industry is directly improving clinical-development efficiency, advancing personalized-medicine strategies, and accelerating the translation of scientific innovation into real-world patient benefit.

Market Segmentation:

Segmentation 1: By Specimen Type

  • Tissue Specimens
  • Biofluids
  • Cellular Material
  • Nucleic Acids
  • Others

Tissue specimens remain the leading segment by specimen type in the global human biospecimen market, holding 41.30% market share in 2024, with a projected CAGR of 7.48% during 2025-2035, driven by their essential role in oncology research, precision medicine, and the growth of digital pathology and spatial omics. High-value FFPE blocks, fresh-frozen tissues, and resection specimens continue to support biomarker discovery, companion diagnostics development, and tumor-normal sequencing, making tissues the highest revenue-generating category. Biofluids, including plasma, serum, PBMCs, and urine, are growing at a higher CAGR, supported by the rise of liquid biopsy testing, ctDNA-based diagnostics, and immuno-oncology programs. The growing preference for minimally invasive sampling and longitudinal patient monitoring is expected to strengthen the future contribution of biofluid-based biospecimens to market growth.

Segmentation 2: By Application

  • Biomedical Research
  • Diagnostics
  • Therapeutic Development
  • Clinical Trials

Based on application, the global human biospecimen market was led by the biomedical research segment, which accounted for 45.00% share in 2024. This dominance has been driven by sustained demand for high-quality tissues, biofluids, and primary cells across discovery biology, translational programs, and biomarker development. The growing adoption of multi-omics platforms, including genomics, proteomics, metabolomics, and spatial biology, further strengthens biomedical research as the primary consumer of annotated biospecimens.

Diagnostics and clinical development applications are expanding rapidly as liquid biopsy testing, CDx-linked drug approvals, and regulated assay validation increase globally. Biopharma sponsors rely on deeply characterized human samples for patient stratification, analytical performance evaluation, and real-world evidence generation. As precision-medicine adoption accelerates, biospecimen utilization in diagnostics, immuno-oncology, neurology, and rare-disease studies is expected to drive strong future growth and enhance this segment's contribution to overall market revenue through 2035.

Segmentation 3: By Procurement Type

  • Prospective Collection (On-Demand Collection)
  • Retrospective Samples

Based on procurement type, the global human biospecimen market was led by retrospective samples, which held a 55.00% share in 2024, supported by vast existing repositories of FFPE blocks, frozen tissues, plasma/serum, PBMCs, and other archived biofluids stored across hospital biobanks and national research networks. These samples offer rapid accessibility, high batch volumes, and coverage across multiple disease cohorts, including oncology, metabolic disorders, and infectious diseases, making them the primary source for discovery biology, translational studies, and early diagnostic development.

Prospective (on-demand) collections command a smaller share today but represent the fastest-growing segment. Their growth has been driven by precision research requirements, including strict inclusion/exclusion criteria, genetic profiling, fresh tissue acquisition, pediatric rare-disease sampling, and longitudinal collections linked with real-world clinical data. As biomarker-guided trials, multi-omics studies, and precision-medicine pipelines scale, the contribution of prospective collections is expected to expand significantly through 2035.

Segmentation 4: By End User

  • Pharmaceutical and Biotechnology Companies
  • Contract Research Organizations (CROs)
  • Academic and Research Institutes
  • Hospitals and Biobanks
  • Diagnostic Laboratories
  • Government and Non-Profit Organizations

Based on end user, the global human biospecimen market was led by pharmaceutical and biotechnology companies, which held a 48.00% share in 2024, as they represent the largest and most consistent consumers of well-annotated human tissues, biofluids, and cellular materials across the drug development life cycle. These organizations drive premium-value demand for disease-specific cohorts, multi-matrix matched samples, and regulatory-ready biospecimens that support target discovery, translational programs, biomarker validation, companion diagnostic development, and clinical progression.

Segmentation 5: By Region

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • U.K.
    • France
    • Italy
    • Spain
    • Rest-of-Europe
  • Asia-Pacific
    • Japan
    • India
    • China
    • Australia
    • South Korea
    • Rest-of-Asia-Pacific
  • Rest-of-the-World

The human biospecimen market in the Asia-Pacific region is expanding. China accounts for the highest market share, driven by large population size, high cancer and metabolic disease burden, strong investment in biobank infrastructure, and rapid growth in precision-medicine and multi-omics programs. India is the fastest-growing market, supported by expanding clinical-trial activity, increasing availability of surgical and pathology samples, and improving digital-health infrastructure that enables scalable sourcing from diverse patient cohorts.

Japan and South Korea contribute high-quality, deeply annotated biospecimens through advanced national biobank networks and genomics initiatives. Australia offers strong translational research capabilities and procedure-rich clinical environments, while Singapore and Malaysia serve as data-linked logistics hubs supporting global biospecimen exchange. Southeast Asian markets such as Indonesia, Vietnam, and the Philippines are gradually expanding but remain constrained by infrastructure, regulatory variability, and cold-chain limitations.

Collectively, APAC offers unmatched scale, disease diversity, and multi-ethnic representation, making it a priority region for globally sourced biospecimens supporting oncology, metabolic disorders, neurology, and rare diseases research.

Recent Developments in the Human Biospecimen Market

  • In October 2025, BioIVT acquired Spain-based BeCytes Biotechnologies to strengthen its European biobanking footprint and expand access to ethically sourced human biospecimens supporting new approach methodologies (NAMs).
  • In February 2025, Crown Bioscience merged with Indivumed Services, combining their biospecimen and multi-omics platforms to enhance oncology drug discovery through integrated human biospecimen solutions.
  • In June 2025, iProcess Global Research partnered with ViewsML to integrate AI-powered virtual IHC biomarker testing, enhancing biospecimen-based digital pathology and tissue-sparing biomarker analysis for research and diagnostics.
  • In September 2025, ABS Bio earned ISO 20387 accreditation for its biospecimen procurement and biobanking operations, reinforcing its commitment to high-quality, ethically sourced human biospecimens and global biorepository standards.
  • In August 2025, Logical Biological partnered with Bcell Design to develop engineered disease state plasma materials replicating native human biospecimens, ensuring sustainable and high-performance alternatives for diagnostic and research applications.
  • In January 2025, Reprocell launched ReproRegistry, a volunteer registry connecting individuals with healthy or diseased skin for research, enabling human skin sample procurement for dermatology and drug discovery.
  • In September 2024, Discovery Life Sciences integrated Lunaphore's COMET platform to expand multiplexed spatial biology capabilities for clinical biospecimen analysis.

Demand - Drivers, Challenges, and Opportunities

Market Demand Drivers: Rising Adoption of Annotated Human Biospecimens

The shift toward precision medicine is significantly increasing demand for high-quality, clinically annotated human biospecimens that accurately reflect real-world disease biology. Pharmaceutical and biotechnology companies now depend on tumor-normal matched tissues, ctDNA-ready plasma, sequencing-grade nucleic acids, and disease-specific immune cell subsets to enable biomarker-driven drug development, stratified clinical trial enrollment, and companion diagnostic validation. Oncology has been at the forefront of this transformation, with biomarker-guided trials rising from roughly 15% in 2000 to over 55% today, and more than 60 FDA-approved therapies now linked to a validated CDx assay.

Beyond oncology, rare-disease research has amplified the need for deeply characterized, patient-matched biospecimens, including primary cells, fibroblasts, neuromuscular and pediatric tissues, and blood samples from small, genetically defined cohorts. National genomic-testing programs such as NHS England's ctDNA cancer screening initiative, projected to benefit around 15,000 patients annually, further highlight the growing link between precision healthcare delivery and robust biospecimen supply chains. These advancements require rigorous pre-analytics, longitudinal clinical annotation, and reliable traceability frameworks to ensure consistent data quality across multi-omics applications.

As pharmaceutical sponsors continue to prioritize targeted therapy programs and reduce late-stage clinical failures, access to clinically rich, standardized biospecimens has become a strategic necessity. This reliance is expected to intensify, making annotated human biospecimens a central enabler of next-generation drug discovery, translational science, and regulatory decision-making.

Market Challenges: Pre-Analytical Variability and Biospecimen Quality Gaps

Pre-analytical variability remains one of the most critical restraints in the human biospecimen market because even minor deviations during collection, processing, transport, or storage can cause irreversible molecular degradation. Differences in handling timelines, tube types, anticoagulants, centrifugation parameters, freeze-thaw cycles, and storage temperatures (-20°C vs. -80°C) significantly alter DNA, RNA, protein, and metabolite profiles, directly impacting suitability for NGS, proteomics, metabolomics, and spatial omics. Large-scale quality assessments such as SPIDIA-RNA have demonstrated that fewer than half of participating laboratories consistently meet RNA integrity requirements, and up to 28% show multiple parameters "out of control," highlighting widespread inconsistency across the market.

Compounding this issue is inadequate metadata reporting. Many archived samples lack essential pre-analytical details such as time-to-processing, hemolysis indices, and freeze-thaw history, making them unusable for regulatory-aligned biomarker research or multi-omics studies requiring high sensitivity and reproducibility. As a result, significant portions of legacy biobank inventory, particularly older, poorly documented collections, cannot support precision-medicine applications.

To remain competitive, biospecimen providers must now adopt SPREC-based documentation, harmonized SOPs, and stringent, real-time quality monitoring throughout the biospecimen lifecycle. This push toward standardization increases operational costs and raises capability thresholds, favoring large-scale and quality-mature vendors while limiting participation from small, unstandardized suppliers.

Market Opportunities: Commercialization of Disease-Specific Rare-Disease Cohorts

With more than 10,000 known rare and ultra-rare diseases and very few approved therapies, there is a critical unmet need for high-quality, disease-matched biospecimens to support diagnostic innovation, biomarker discovery, and therapeutic development. Many rare conditions lack established sample repositories, and patient populations are geographically dispersed, making access to relevant cohorts extremely limited. Pharmaceutical sponsors increasingly require specialized biospecimens such as fibroblasts, neuromuscular and pediatric tissues, CSF samples, and matched longitudinal aliquots to characterize disease progression and validate genetic targets, particularly in metabolic, neuromuscular, and inherited disorders.

Regulatory momentum further reinforces this opportunity. Rising orphan-drug designations and accelerated approval pathways have intensified R&D focus on uncommon indications, but the scarcity of reliable biospecimens remains a major bottleneck. National initiatives like the NIH Rare Disease Cures Accelerator highlight the demand for multi-timepoint datasets and deeply annotated samples capable of linking biological changes with clinical outcomes.

This creates a strong commercial opportunity for specialized biospecimen providers that can establish disease-specific registries, deploy targeted recruitment strategies, and build consent-ready, data-rich repositories that include phenotypic profiles, genomic data, and follow-up timelines. As rare-disease pipelines continue expanding, the ability to deliver these high-value materials will become a key differentiator, positioning capable vendors as essential partners in accelerating precision therapy development for the underserved patient population.

Market Trends: Increasing Product Launches and Regulatory Approvals

Product innovation and regulatory alignment are reshaping the human biospecimen market from a transactional sample-supply model into a structured ecosystem of higher-value, compliance-driven offerings. Vendors are accelerating launches of specialty products such as indication-specific tissue panels, multi-matrix biospecimen kits, disease-state PBMCs, GMP-grade cell materials, and donor-driven registries like dermatology-focused ReproRegistry. Digital enablement is also advancing rapidly, with AI-powered data platforms now integrating biospecimen metadata, clinical outcomes, and genomic profiles to improve traceability, sample selection, and research relevance.

Simultaneously, more providers are obtaining accreditations such as CAP ISO 15189:2022 and ISO 20387, signaling a move toward standardized pre-analytics, validated workflows, and regulatory-compatible biorepository operations. This evolution is enabling biospecimens to support regulated workflows, including diagnostic validation, companion-diagnostic alignment, and clinical trial execution, expanding demand across pharma, biotech, and IVD developers.

However, this shift is also raising the competitive bar; high-quality documentation, chain-of-custody integrity, and compliance infrastructure are now baseline requirements rather than value-added differentiators. Scale players and specialized platforms with strong quality governance stand to benefit most, while traditional suppliers without regulatory maturity risk being limited to lower-margin, commoditized market segments.

How can this report add value to an organization?

Product/Innovation Strategy: The report offers in-depth insights into the latest technological advancements in human biospecimens, enabling organizations to drive innovation and develop cutting-edge products tailored to market needs.

Growth/Marketing Strategy: By providing comprehensive market analysis and identifying key growth opportunities, the report equips organizations with the knowledge to craft targeted marketing strategies and expand their market presence effectively.

Competitive Strategy: The report includes a thorough competitive landscape analysis, helping organizations understand their competitors' strengths and weaknesses and allowing them to strategize effectively to gain a competitive edge in the market.

Regulatory and Compliance Strategy: It provides updates on evolving regulatory frameworks, approvals, and industry guidelines, ensuring organizations stay compliant and accelerate market entry for new human biospecimens.

Investment and Business Expansion Strategy: By analyzing market trends, funding patterns, and partnership opportunities, the report assists organizations in making informed investment decisions and identifying potential M&A opportunities for business growth.

Methodology

Key Considerations and Assumptions in Market Engineering and Validation

  • The base year considered for the calculation of the market size is 2024. A historical year analysis has been done for the period FY2023. The market size has been estimated for FY2024 and projected for the period FY2025-FY2035.
  • The scope of this report has been carefully derived from extensive interactions with experts and stakeholders across leading biospecimen companies, clinical research institutions, and biobanking networks worldwide. This report provides a comprehensive market analysis of the human biospecimen ecosystem, covering specimen types, procurement models, end-user demand dynamics, regulatory and ethical frameworks, and emerging technology integrations such as multi-omics data enablement and digitalized biobanking operations.
  • Revenues of the companies have been referenced from their annual reports for FY2023 and FY2024. For private companies, revenues have been estimated based on factors such as inputs obtained from primary research, funding history, market collaborations, and operational history.
  • The market has been mapped based on the available human biospecimen products. All the key companies with significant offerings in this field have been considered and profiled in this report.

Primary Research

The primary sources involve industry experts in human biospecimen, including the market players offering products and services. Resources such as CEOs, vice presidents, marketing directors, and technology and innovation directors have been interviewed to obtain and verify both qualitative and quantitative aspects of this research study.

The key data points taken from the primary sources include:

  • Validation and triangulation of all the numbers and graphs
  • Validation of the report's segmentation and key qualitative findings
  • Understanding the competitive landscape and business model
  • Current and proposed production values of a product by market players
  • Validation of the numbers of the different segments of the market in focus
  • Percentage split of individual markets for regional analysis

Secondary Research

Open Sources

  • Certified publications, articles from recognized authors, white papers, directories, and major databases, among others
  • Annual reports, SEC filings, and investors' presentations of the leading market players
  • Company websites and a detailed study of their product portfolio
  • Gold standard magazines, journals, white papers, press releases, and news articles
  • Paid databases

The key data points taken from the secondary sources include:

  • Segmentations and percentage shares
  • Data for market value
  • Key industry trends of the top players in the market
  • Qualitative insights into various aspects of the market, key trends, and emerging areas of innovation
  • Quantitative data for mathematical and statistical calculations

Key Market Players and Competition Synopsis

Profiled companies have been selected based on primary insights, portfolio coverage, regulatory accreditations, and global biospecimen sourcing capabilities.

Established providers such as Crown Bioscience, Grifols S.A., BioIVT LLC, and Precision Medicine Group, LLC hold strong market positions with large, ethically sourced biospecimen inventories, CAP/ISO-certified biobanking operations, and long-standing partnerships with pharmaceutical, biotechnology, and diagnostics companies. Their expanding multi-omic-ready sample collections and data-rich offerings support advanced translational and precision-medicine research.

Emerging players, including Logical Biological and Labtoo, are gaining traction through flexible procurement models, disease-specific sample solutions, and digital sourcing platforms that simplify researchers' access to global biospecimens, especially within Europe and Asia-Pacific.

Together, these companies are strengthening global biospecimen supply chains, enhancing sample diversity, and improving traceability and regulatory compliance, driving the market toward higher-quality, clinically annotated resources that support drug discovery and diagnostic development.

Some prominent names established in this market are:

  • BioIVT LLC.
  • Crown Bioscience
  • Precision Medicine Group, LLC
  • Grifols, S.A.

Table of Contents

Executive Summary

Scope and Definition

1 Global Human Biospecimen Market: Industry Outlook

  • 1.1 Market Overview
    • 1.1.1 Market Overview and Market Trends
  • 1.2 Market Trends
    • 1.2.1 Impact Analysis
    • 1.2.2 Increasing Product Launches and Regulatory Approvals
    • 1.2.3 Increasing Collaboration between Players, Government Bodies, and Academia
  • 1.3 Supply Chain Overview
  • 1.4 Regulatory Landscape
    • 1.4.1 North America
      • 1.4.1.1 U.S.
      • 1.4.1.2 Canada
    • 1.4.2 Europe
      • 1.4.2.1 Germany
      • 1.4.2.2 U.K.
    • 1.4.3 Asia-Pacific
      • 1.4.3.1 China
      • 1.4.3.2 Japan
      • 1.4.3.3 Singapore
      • 1.4.3.4 Australia
      • 1.4.3.5 India
    • 1.4.4 Rest-of-the-World
      • 1.4.4.1 Latin America
      • 1.4.4.2 Africa
      • 1.4.4.3 Middle East and Other Emerging Regions
  • 1.5 Market Dynamics
    • 1.5.1 Drivers, Restraints, and Opportunities: Current and Future Impact Assessment
    • 1.5.2 Market Drivers
      • 1.5.2.1 Rising Adoption of Annotated Human Biospecimens
      • 1.5.2.2 Expansion of Biobanks and National Population Genomics Programs
      • 1.5.2.3 Surge in Cell and Gene Therapies, CAR-T, and Advanced Modalities
    • 1.5.3 Market Restraints
      • 1.5.3.1 Pre-Analytical Variability and Poor Biospecimen Quality
      • 1.5.3.2 Logistical, Storage, and Operational Challenges across the Biospecimen Lifecycle
    • 1.5.4 Market Opportunities
      • 1.5.4.1 Commercialization of Disease-Specific Rare-Disease Cohorts

2 Global Human Biospecimen Market, by Specimen Type

  • 2.1 Overview
  • 2.2 Tissue Specimens
    • 2.2.1 Formalin-Fixed Paraffin-Embedded (FFPE) Tissue
    • 2.2.2 Fresh Frozen Tissue
    • 2.2.3 Disease Tissue Sample
    • 2.2.4 Normal Tissue Sample
  • 2.3 Biofluids
    • 2.3.1 Whole Blood
    • 2.3.2 Plasma
    • 2.3.3 Serum
    • 2.3.4 Urine
    • 2.3.5 Saliva
    • 2.3.6 Cerebrospinal Fluid (CSF)
    • 2.3.7 Others
  • 2.4 Cellular Material
    • 2.4.1 Peripheral Blood Mononuclear Cells (PBMCs)
    • 2.4.2 Buccal Cells
    • 2.4.3 Stem Cells
    • 2.4.4 Primary Human Cells
    • 2.4.5 Purified Immune Cell Subsets
    • 2.4.6 Others
  • 2.5 Nucleic Acids
    • 2.5.1 Genomic DNA
    • 2.5.2 RNA
    • 2.5.3 ctDNA/cfDNA
  • 2.6 Others

3 Global Human Biospecimen Market (by Application)

  • 3.1 Overview
    • 3.1.1 Biomedical Research
    • 3.1.2 Diagnostics
    • 3.1.3 Therapeutic Development
    • 3.1.4 Clinical Trials

4 Global Human Biospecimen Market (by Procurement Type)

  • 4.1 Overview
    • 4.1.1 Prospective Collection (On-Demand Collection)
    • 4.1.2 Retrospective Samples

5 Global Human Biospecimen Market (by End User)

  • 5.1 Overview
    • 5.1.1 Pharmaceutical and Biotechnology Companies
    • 5.1.2 Contract Research Organizations (CROs)
    • 5.1.3 Academic and Research Institutes
    • 5.1.4 Hospitals and Biobanks
    • 5.1.5 Diagnostic Laboratories
    • 5.1.6 Government and Non-Profit Organizations

6 Region

  • 6.1 Regional Summary
  • 6.2 North America
    • 6.2.1 Regional Overview
    • 6.2.2 Driving Factors for Market Growth
    • 6.2.3 Factors Challenging the Market
    • 6.2.4 Market Sizing and Forecast
    • 6.2.5 U.S.
      • 6.2.5.1 Country Overview
      • 6.2.5.2 Market Sizing and Forecast
    • 6.2.6 Canada
      • 6.2.6.1 Country Overview
      • 6.2.6.2 Market Sizing and Forecast
  • 6.3 Europe
    • 6.3.1 Regional Overview
    • 6.3.2 Driving Factors for Market Growth
    • 6.3.3 Factors Challenging the Market
    • 6.3.4 Market Sizing and Forecast
    • 6.3.5 U.K.
      • 6.3.5.1 Country Overview
      • 6.3.5.2 Market Sizing and Forecast
    • 6.3.6 Germany
      • 6.3.6.1 Country Overview
      • 6.3.6.2 Market Sizing and Forecast
    • 6.3.7 France
      • 6.3.7.1 Country Overview
      • 6.3.7.2 Market Sizing and Forecast
    • 6.3.8 Italy
      • 6.3.8.1 Country Overview
      • 6.3.8.2 Market Sizing and Forecast
    • 6.3.9 Spain
      • 6.3.9.1 Country Overview
      • 6.3.9.2 Market Sizing and Forecast
    • 6.3.10 Rest-of-the- Europe
      • 6.3.10.1 Country Overview
      • 6.3.10.2 Market Sizing and Forecast
  • 6.4 Asia Pacific
    • 6.4.1 Regional Overview
    • 6.4.2 Driving Factors for Market Growth
    • 6.4.3 Factors Challenging the Market
    • 6.4.4 Market Sizing and Forecast
    • 6.4.5 China
      • 6.4.5.1 Country Overview
      • 6.4.5.2 Market Sizing and Forecast
    • 6.4.6 Japan
      • 6.4.6.1 Country Overview
      • 6.4.6.2 Market Sizing and Forecast
    • 6.4.7 India
      • 6.4.7.1 Country Overview
      • 6.4.7.2 Market Sizing and Forecast
    • 6.4.8 Australia
      • 6.4.8.1 Country Overview
      • 6.4.8.2 Market Sizing and Forecast
    • 6.4.9 South Korea
      • 6.4.9.1 Country Overview
      • 6.4.9.2 Market Sizing and Forecast
    • 6.4.10 Rest-of-the-Asia Pacific
      • 6.4.10.1 Country Overview
      • 6.4.10.2 Market Sizing and Forecast
  • 6.5 Rest-of-the-World
    • 6.5.1 Regional Overview
    • 6.5.2 Driving Factors for Market Growth
    • 6.5.3 Factors Challenging the Market
    • 6.5.4 Market Sizing and Forecast

7 Competitive Benchmarking and Company Profiles

  • 7.1 Key Strategies and Developments, 2020-2025
  • 7.2 Key Developments Analysis (by Year), 2020-2025
  • 7.3 Key Developments Analysis (by Company), 2020-2025
  • 7.4 Company Profiles
    • 7.4.1 BioIVT LLC.
      • 7.4.1.1 Overview
    • 7.4.2 Crown Bioscience
      • 7.4.2.1 Overview
    • 7.4.3 iProcess Global Research Inc.
      • 7.4.3.1 Overview
    • 7.4.4 ABS Bio, Inc.
      • 7.4.4.1 Overview
    • 7.4.5 Precision Medicine Group, LLC
      • 7.4.5.1 Overview
    • 7.4.6 REPROCELL Inc.
      • 7.4.6.1 Overview
    • 7.4.7 LifeNet Health LifeSciences
      • 7.4.7.1 Overview
    • 7.4.8 Logical Biological
      • 7.4.8.1 Overview
    • 7.4.9 Europa Biosite
      • 7.4.9.1 Overview
    • 7.4.10 Discovery Life Sciences
      • 7.4.10.1 Overview
    • 7.4.11 Boca Biolistics, LLC
      • 7.4.11.1 Overview
    • 7.4.12 ProteoGenex
      • 7.4.12.1 Overview
    • 7.4.13 US Biolab Corporation, Inc.
      • 7.4.13.1 Overview
    • 7.4.14 Bay Biosciences
      • 7.4.14.1 Overview
    • 7.4.15 Grifols, S.A.
      • 7.4.15.1 Overview

8 Research Methodology

  • 8.1 Data Sources
    • 8.1.1 Primary Data Sources
    • 8.1.2 Secondary Data Sources
    • 8.1.3 Inclusion and Exclusion
    • 8.1.4 Data Triangulation
  • 8.2 Market Estimation and Forecast

List of Figures

  • Figure 1: Global Human Biospecimen Market (by Scenario), $Million, 2024, 2028, and 2035
  • Figure 2: Global Human Biospecimen Market, 2024 and 2035
  • Figure 3: Top Countries, Global Human Biospecimen Market, $Million, 2024
  • Figure 4: Global Human Biospecimen Market Snapshot
  • Figure 5: Global Human Biospecimen Market, $Million, 2024 and 2035
  • Figure 6: Human Biospecimen Market (by Specimen Type), $Million, 2024, 2028, and 2035
  • Figure 7: Human Biospecimen Market (by Application), $Million, 2024, 2028, and 2035
  • Figure 8: Human Biospecimen Market (by Procurement Type), $Million, 2024, 2028, and 2035
  • Figure 9: Human Biospecimen Market (by End User), $Million, 2024, 2028, and 2035
  • Figure 10: Human Biospecimen Market Segmentation
  • Figure 11: Supply Chain Flow
  • Figure 12: Global Human Biospecimen Market (by Tissue Specimens), $Million, 2024, 2028, and 2035
  • Figure 13: Global Human Biospecimen Market (Formalin-Fixed Paraffin-Embedded (FFPE) Tissue), $Million, 2024-2035
  • Figure 14: Global Human Biospecimen Market (Fresh Frozen Tissue), $Million, 2024-2035
  • Figure 15: Global Human Biospecimen Market (Disease Tissue Sample), $Million, 2024-2035
  • Figure 16: Global Human Biospecimen Market (Normal Tissue Sample), $Million, 2024-2035
  • Figure 17: Global Human Biospecimen Market (by Biofluids), $Million, 2024, 2028, and 2035
  • Figure 18: Global Human Biospecimen Market (Whole Blood), $Million, 2024-2035
  • Figure 19: Global Human Biospecimen Market (Plasma), $Million, 2024-2035
  • Figure 20: Global Human Biospecimen Market (Serum), $Million, 2024-2035
  • Figure 21: Global Human Biospecimen Market (Urine), $Million, 2024-2035
  • Figure 22: Global Human Biospecimen Market (Saliva), $Million, 2024-2035
  • Figure 23: Global Human Biospecimen Market (Cerebrospinal Fluid (CSF)), $Million, 2024-2035
  • Figure 24: Global Human Biospecimen Market (Others), $Million, 2024-2035
  • Figure 25: Global Human Biospecimen Market (by Cellular Material), $Million, 2024, 2028, and 2035
  • Figure 26: Global Human Biospecimen Market, PBMCs (Peripheral Blood Mononuclear Cells (PBMCs)), $Million, 2024-2035
  • Figure 27: Global Human Biospecimen Market (Buccal Cells), $Million, 2024-2035
  • Figure 28: Global Human Biospecimen Market (Stem Cells), $Million, 2024-2035
  • Figure 29: Global Human Biospecimen Market (Primary Human Cells), $Million, 2024-2035
  • Figure 30: Global Human Biospecimen Market (Purified Immune Cell Subsets), $Million, 2024-2035
  • Figure 31: Global Human Biospecimen Market (Others), $Million, 2024-2035
  • Figure 32: Global Human Biospecimen Market (by Nucleic Acids), $Million, 2024, 2028, and 2035
  • Figure 33: Global Human Biospecimen Market (Genomic DNA), $Million, 2024-2035
  • Figure 34: Global Human Biospecimen Market (RNA), $Million, 2024-2035
  • Figure 35: Global Human Biospecimen Market (ctDNA/cfDNA), $Million, 2024-2035
  • Figure 36: Global Human Biospecimen Market (Others), $Million, 2024-2035
  • Figure 37: Global Human Biospecimen Market (by Application Type), $Million, 2024, 2028, and 2035
  • Figure 38: Global Human Biospecimen Market (Biomedical Research), $Million, 2024-2035
  • Figure 39: Global Human Biospecimen Market (Diagnostics), $Million, 2024-2035
  • Figure 40: Global Human Biospecimen Market (Therapeutic Development), $Million, 2024-2035
  • Figure 41: Global Human Biospecimen Market (Clinical Trials), $Million, 2024-2035
  • Figure 42: Global Human Biospecimen Market (by Procurement Type), $Million, 2024, 2028, and 2035
  • Figure 43: Global Human Biospecimen Market (Prospective Collection (On-Demand Collection)), $Million, 2024-2035
  • Figure 44: Global Human Biospecimen Market (Retrospective Samples), $Million, 2024-2035
  • Figure 45: Global Human Biospecimen Market (by End User), $Million, 2024, 2028, and 2035
  • Figure 46: Global Human Biospecimen Market (Pharmaceutical and Biotechnology Companies), $Million, 2024-2035
  • Figure 47: Global Human Biospecimen Market (Contract Research Organizations (CROs)), $Million, 2024-2035
  • Figure 48: Global Human Biospecimen Market (Academic and Research Institutes), $Million, 2024-2035
  • Figure 49: Global Human Biospecimen Market (Hospitals and Biobanks), $Million, 2024-2035
  • Figure 50: Global Human Biospecimen Market (Diagnostic Laboratories), $Million, 2024-2035
  • Figure 51: Global Human Biospecimen Market (Government and Non-Profit Organizations), $Million, 2024-2035
  • Figure 52: North America Human Biospecimen Market, $Million, 2024-2035
  • Figure 53: U.S. Human Biospecimen Market, $Million, 2024-2035
  • Figure 54: Canada Human Biospecimen Market, $Million, 2024-2035
  • Figure 55: Europe Human Biospecimen Market, $Million, 2024-2035
  • Figure 56: U.K. Human Biospecimen Market, $Million, 2024-2035
  • Figure 57: Germany Human Biospecimen Market, $Million, 2024-2035
  • Figure 58: France Human Biospecimen Market, $Million, 2024-2035
  • Figure 59: Italy Human Biospecimen Market, $Million, 2024-2035
  • Figure 60: Spain Human Biospecimen Market, $Million, 2024-2035
  • Figure 61: Rest-of-Europe Human Biospecimen Market, $Million, 2024-2035
  • Figure 62: Asia-Pacific Human Biospecimen Market, $Million, 2024-2035
  • Figure 63: China Human Biospecimen Market, $Million, 2024-2035
  • Figure 64: Japan Human Biospecimen Market, $Million, 2024-2035
  • Figure 65: India Human Biospecimen Market, $Million, 2024-2035
  • Figure 66: Australia Human Biospecimen Market, $Million, 2024-2035
  • Figure 67: South Korea Human Biospecimen Market, $Million, 2024-2035
  • Figure 68: Rest-of-Asia-Pacific Human Biospecimen Market, $Million, 2024-2035
  • Figure 69: Rest-of-the-World Human Biospecimen Market, $Million, 2024-2035
  • Figure 70: Key Strategies and Developments, 2020-2025
  • Figure 71: Key Strategies and Developments, 2020-2025
  • Figure 72: Inclusion and Exclusion Criteria for the Global Human Biospecimen Market
  • Figure 73: Data Triangulation
  • Figure 74: Top-Down and Bottom-Up Approach
  • Figure 75: Assumptions and Limitations

List of Tables

  • Table 1: Market Snapshot
  • Table 2: Key Market Trends
  • Table 3: Product Launches and Regulatory Approvals in the Human Biospecimen Market
  • Table 4: Collaborations in the Human Biospecimen Market
  • Table 5: Global Human Biospecimen Market (by Region), $Million, 2024-2035
  • Table 6: Global Human Biospecimen Market (by Region), $Million, 2024-2035
  • Table 7: Key Strategies and Developments, 2020-2025