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市場調查報告書
商品編碼
1790449
血液學和腫瘤學檢測市場規模、佔有率和趨勢分析報告:按產品、癌症、技術、最終用途、地區和細分市場預測,2025-2030 年Hemato Oncology Testing Market Size, Share & Trends Analysis Report By Product (Assay Kits & Reagents, Services), By Cancer (Leukemia, Lymphoma), By Technology, By End-use, By Region, And Segment Forecasts, 2025 - 2030 |
血液學和腫瘤學檢測市場概覽
2024 年全球血液腫瘤檢測市場規模估計為 36 億美元,預計到 2030 年將達到 74.4 億美元,2025 年至 2030 年的複合年成長率為 12.99%。血液腫瘤學涉及血液相關癌症和疾病的治療、診斷和預防。
淋巴瘤和骨髓瘤盛行率的上升、個人化治療需求的不斷成長、血液系統惡性腫瘤診斷先進分子技術的普及以及藥物和診斷聯合開發的增多,是預測期內預計將推動血液腫瘤學發展的一些關鍵因素。分子診斷技術的快速發展改變了血液腫瘤學的格局,為各種血癌的檢測、診斷、預後和治療提供了精準且個人化的方法。這些最尖端科技顯著提高了我們對疾病生物學和治療反應的理解,從而改善了患者的預後並提高了臨床工作流程的效率。
骨髓惡性腫瘤的分子診斷通常依賴即時PCR、螢光原位雜合反應(FISH) 和次世代定序(NGS) 等技術來檢測特定的基因變異。例如,慢性骨髓性白血病(CML) 通常使用基於 PCR 的檢測或針對 BCR:ABL1 融合基因的 FISH 檢測進行診斷。 BCR/ABL 檢測的國際標準化使得各實驗室能夠更輕鬆、更準確地診斷 CML。同樣,急性骨髓性白血病(AML) 和急性淋巴細胞白血病 (ALL) 也受益於分子診斷,NGS 檢測組能夠同時識別多種基因突變,包括 FLT3-ITD、NPM1 和 TP53,這些突變對於風險分層和治療選擇至關重要。在淋巴瘤中,T細胞克隆性分析、標靶FISH和IgVH分析等技術已被廣泛應用,而JAK2 V617F突變是高風險患者真性紅血球增多症診斷的重要標誌。
最近的進展帶來了更複雜的工具,包括單細胞定序、光學基因組圖譜 (OGM) 和長讀定序。單細胞定序在細胞層面提供了前所未有的解析度,有助於深入了解克隆多樣性和腫瘤演化。 《分子診斷學雜誌》最近發表的一項研究表明,OGM 能夠有效識別結構突變和拷貝數變異,即使在低產量細胞群中也能對包括多發性骨髓瘤在內的腫瘤進行全面的細胞遺傳學分析。這種泛基因組方法減少了對單一標記物特異性檢測的需求,簡化了工作流程並提高了診斷準確性。裡爾大學醫院的一項研究證實,OGM 可以減少完成基因組分析所需的細胞數量,與常規 FISH 檢測的五種標記物的一致性達到 93%,並識別出超過 22 種額外的目標基因組突變。
2024年,牛津基因技術公司 (OGT) 推出了 SureSeq 髓系融合基因檢測板 (SureSeq Myeloid Fusion Panel),這是一款基於 RNA 的突破性 NGS 工具,旨在全面識別 AML 中的融合基因。該檢測板由該公司與髓系癌領域的頂尖專家合作開發,涵蓋 30 多個主要疾病相關融合基因,包括 KMT2A 和 MECOM,其配套的基因不可知方法能夠在單次檢測中檢測稀有和新型融合基因。將此檢測板整合到端對端 NGS 工作流程中,顯著提高了樣本分類能力,減少了對大量生物資訊資源的需求,並縮短了臨床實驗室的周轉時間。
此外,Pacific Biosciences 和 Oxford Nanopore 等公司開發的長讀長定序技術正在徹底改變這一領域,它們能夠提供複雜基因組區域的完整且無誤的讀出結果。這些平台克服了短讀長 NGS 的局限性,能夠以無與倫比的精度檢測結構變異、複雜的重排和拷貝數變異。
總的來說,這些先進的分子技術正在重塑血液腫瘤學的診斷格局,為臨床醫生提供個人化醫療的強大工具。該領域的持續創新有望進一步提高癌症診斷的準確性、速度和成本效益,最終改善患者的治療效果並制定更個人化的治療策略。
此外,淋巴瘤和骨髓瘤是美國最常見和臨床上最重要的骨髓惡性腫瘤之一,對整體癌症負擔有重大影響。
Hemato Oncology Testing Market Summary
The global hemato oncology testing market size was estimated at USD 3.60 billion in 2024 and is projected to reach USD 7.44 billion by 2030, growing at a CAGR of 12.99% from 2025 to 2030. Hemato oncology is associated with the treatment, diagnosis, and prevention of blood-related cancers and diseases.
Increasing prevalence of lymphoma & myeloma, growing demand for personalized therapy, availability of advanced molecular techniques for hemato-oncology diagnostics, and increasing drug-diagnostics co-development are some of the major factors anticipated to boost the growth of the market during the forecast period. The rapid evolution of molecular diagnostics has transformed the landscape of hemato-oncology, offering precise and personalized approaches for the detection, diagnosis, prognosis, and treatment of various blood cancers. These cutting-edge techniques have significantly improved the understanding of disease biology and therapeutic response, leading to better patient outcomes and more efficient clinical workflows.
Molecular diagnostics in hematologic malignancies often rely on methods like real-time PCR, fluorescence in situ hybridization (FISH), and next-generation sequencing (NGS) to detect specific genetic alterations. For instance, chronic myeloid leukemia (CML) is routinely diagnosed using PCR-based tests targeting the BCR::ABL1 fusion gene or FISH assays. Standardization of BCR/ABL measurement internationally has facilitated easier and more accurate diagnosis of CML across laboratories. Similarly, acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) benefit from molecular diagnostics, with NGS panels enabling the identification of multiple gene mutations simultaneously, including FLT3-ITD, NPM1, and TP53, which are critical for risk stratification and treatment selection. In lymphomas, techniques like T-cell clonality assays, targeted FISH, and IgVH analysis are widely employed, while the JAK2 V617F mutation serves as a critical marker for diagnosing polycythemia vera in high-risk patients.
Recent advancements have introduced more sophisticated tools such as single-cell sequencing, optical genome mapping (OGM), and long-read sequencing. Single-cell sequencing provides unprecedented resolution at the cellular level, offering insights into clonal diversity and tumor evolution. OGM, as demonstrated in a recent study published in The Journal of Molecular Diagnostics, enables comprehensive cytogenomic profiling of tumors, including multiple myeloma, by efficiently identifying structural variants and copy number changes even in low-yield cell populations. This pan-genomic approach reduces the need for separate, marker-specific tests, streamlining workflows and improving diagnostic accuracy. The study at Lille University Hospital confirmed that OGM can reduce the number of cells required for complete genomic profiling, showing 93% concordance with traditional FISH on five tested markers and identifying over 22 additional genomic variants of interest.
In 2024, Oxford Gene Technology (OGT) introduced the SureSeq Myeloid Fusion Panel, a groundbreaking RNA-based NGS tool designed for the comprehensive identification of fusion genes in AML. This panel, developed in collaboration with leading myeloid cancer experts, covers over 30 key disease-associated fusions, including KMT2A and MECOM, and employs a partner-gene agnostic approach to detect rare and novel fusions in a single assay. The integration of this panel into end-to-end NGS workflows has significantly enhanced the ability to classify samples, reducing the need for extensive bioinformatics resources and improving turnaround times in clinical laboratories.
Moreover, long-read sequencing technologies, such as those developed by Pacific Biosciences and Oxford Nanopore, are revolutionizing the field by providing complete, error-free readouts of complex genomic regions. These platforms are overcoming the limitations of short-read NGS, enabling the detection of structural variants, complex rearrangements, and copy number changes with unparalleled precision.
Collectively, these advanced molecular technologies are reshaping the diagnostic landscape in hemato-oncology, providing clinicians with powerful tools for personalized medicine. The continuous innovation in this space promises to further enhance the accuracy, speed, and cost-effectiveness of cancer diagnostics, ultimately leading to better patient outcomes and more personalized treatment strategies.
In addition, lymphoma and myeloma are among the most common and clinically significant hematologic malignancies in the United States, contributing significantly to the overall cancer burden.
Global Hemato Oncology Testing Market Report Segmentation
This report forecasts revenue growth and provides an analysis on the market trends in each of the sub-markets from 2018 to 2030. For this study, Grand View Research has segmented the global hemato oncology testing market report based on cancer, product, technology, end use, and region: