市场调查报告书
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1466340
组织诊断市场:按产品、技术、适应症和最终用户划分 - 全球预测 2024-2030Tissue Diagnostics Market by Product (Accessories, Consumables, Instruments), Technology (Digital Pathology & Workflow, Immunohistochemistry, In Situ Hybridization), Indications, End-User - Global Forecast 2024-2030 |
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预计2023年组织诊断市场规模为83亿美元,2024年将达89.4亿美元,2030年将达140.2亿美元,复合年增长率为7.76%。
组织诊断是一个医学领域,透过测试和分析从患者体内采集的组织样本来诊断疾病和状况。它对于各种医疗状况的诊断和治疗极为重要,包括癌症和其他组织相关疾病。组织诊断剂应用于多个临床领域,在有助于疾病早期检测的个人化医疗中极为重要。全球癌症发生率上升和人口老化正在推动对组织诊断服务的需求。基因组学的进步导致了许多与疾病相关的生物标记的鑑定,进一步增加了对准确诊断测试的需求。然而,与诊断设备和服务相关的高成本可能会阻碍小型医疗保健提供者和资源匮乏的环境的采用。由于缺乏能够解释复杂测试结果的熟练专业人员以及全球病理学家的短缺,市场扩张也可能受到阻碍。人工智慧 (AI) 与数位病理学的整合等技术进步正在为市场参与者创造新的机会。基于人工智慧的演算法可以帮助病理学家检测组织内容易被忽略的细微型态变化。此外,政府和私人组织对医疗保健基础设施投资的增加预计将进一步为该行业的成长铺平道路。
主要市场统计 | |
---|---|
基准年[2023] | 83亿美元 |
预测年份 [2024] | 89.4亿美元 |
预测年份 [2030] | 140.2亿美元 |
复合年增长率(%) | 7.76% |
扩大组织处理系统的使用,以有效地处理和分析产品组织样本
配件透过补充设备和耗材的功能,对于确保准确的组织诊断至关重要。配件通常是指与初级组织诊断仪器和设备一起使用的各种辅助产品和组件。这些配件可提高组织诊断工具和设备的效能、效率和功能。耗材可检测组织样本製备、染色、分析和储存各个步骤所必需的特定生物标记。它对于组织诊断实验室的日常业务至关重要。组织诊断市场包括用于收集、处理、分析和诊断组织样本的各种仪器和设备。这些仪器对于准确评估组织标本至关重要,并在病理学、组织学和临床诊断等领域发挥重要作用。组织学诊断软体解决方案可以处理、储存和分析从扫描载玻片获得的数位影像。机器学习演算法和人工智慧正在用于诊断程序,以促进病理学家之间的远端咨询。这些先进技术提供更准确和精确的诊断,确保改善患者照护和治疗结果。
技术 采用数位病理技术,利用电脑技术管理数位化组织学样本
数位病理学使用电脑技术来管理数位化组织学样本产生的资讯。数位病理系统可实现数位切片的高效诊断、解释、影像分析、储存和共用。它提高的准确性和缩短的周转时间使其成为世界各地病理学家的重要工具。免疫组织化学(IHC)是一种利用酵素标记抗体作为标记物,透过抗原抗体交互作用来检测组织样本中特定蛋白质的方法。此方法透过识别与癌细胞和周围组织相关的特异性生物标记物,在癌症等各种疾病的诊断中发挥重要作用。原位杂交 (ISH) 是一种检测组织样本细胞内特定 RNA 或 DNA 序列的技术。此方法可用于评估基因表现模式、染色体畸变和拷贝数变化。萤光原位杂合反应利用萤光探针进行检测。特殊的染色技术可视化特定的细胞成分或突出组织学样本中的特定结构。 IHC 和 ISH 对于了解组织的分子特性和检测特异性生物标记至关重要。特殊的染色技术提供了使用传统方法无法看到的细胞结构的额外洞察。
适应症:组织诊断剂在多种癌症类型的检测和表征中的快速普及
组织诊断在乳癌的早期检测和表征中发挥着至关重要的作用,从而实现个人化治疗以改善患者预后。免疫组织化学 (IHC) 和萤光原位杂合反应(FISH) 等技术广泛用于识别荷尔蒙受体状态,指导标靶治疗决策。使用组织学诊断剂鑑定胃癌的不同亚型有助于临床医生预测预后并选择治疗方法。 IHC 通常用于检测 HER2 过度表达等分子生物标记,并指导曲妥珠单抗等标靶治疗的使用。由于淋巴瘤是一组涉及免疫系统细胞的异质性恶性,因此准确的诊断和分型对于适当的治疗计划至关重要。组织学诊断技术可以识别特异性的细胞标记以区分何杰金氏淋巴瘤和非何杰金氏淋巴瘤,甚至可以识别这些类别中的亚型。组织诊断可以帮助识别 EGFR 突变、ALK 重排和 PD-L1 表达水平等基因变化,以指南治疗决策。摄护腺癌是全世界男性第二常见的癌症。组织学诊断剂对于使用格里森评分来确定肿瘤的病理恶性以及评估 Ki-67 和 PTEN 缺乏等预后标记极为重要。
最终使用者:在临床病理实验室中使用组织诊断可以提高病患照护的品质。
临床病理实验室对组织诊断试剂的主要需求是在分子层面检测和诊断各种疾病。免疫组织化学 (IHC)、原位杂合反应(ISH) 和苏木精 (H&E) 染色等技术可以帮助病理学家识别与特定疾病相关的生物标记。委外研发机构(CRO) 需要为製药和生物技术公司提供临床前和临床试验的研究服务。这些组织在选择组织诊断解决方案时优先考虑成本效益、扩充性和周转时间。组织诊断对于医院的患者诊断、治疗选择和疾病监测至关重要。医院需要可靠的诊断解决方案,在最短的周转时间内提供准确的结果,以提高患者照护质量,同时最大限度地降低成本。製药公司需要解决方案来利用组织诊断进行药物开发和临床试验、确定精准医疗的目标族群、优化患者分层并即时评估治疗反应。学术和研究机构需要尖端的组织诊断解决方案来研究疾病机制、发现新的生物标记并推进治疗开发。这些研究机构更喜欢支持高通量分析和多重功能的创新技术。
区域洞察
由于先进的医疗基础设施和领先製造商为诊断测试开发提供的大量研究资金,美洲在市场格局中占据重要地位。该地区的製造商因组织诊断技术的创新而获得了 FDA 颁发的多项专利。在欧洲、中东和非洲地区,组织诊断市场将呈现新兴市场的面貌,因为各国政府正在大力投资以改善诊断技术并支持癌症等疾病早期诊断的研究和开发。有关组织诊断耗材安全和品质的政府标准和法规也促进了该地区的市场成长。南非是非洲大陆的创新中心,正在进行多项研究倡议,重点是开发有效的诊断工具,以应对当地疾病的爆发模式。新兴市场 由于技术进步、对尖端组织诊断技术研发的投资、癌症发病率的增加以及政府鼓励本地生产诊断设备和促进国家创新的努力,亚太地区正在成为一个新兴市场。
FPNV定位矩阵
FPNV 定位矩阵对于评估组织诊断市场至关重要。我们检视与业务策略和产品满意度相关的关键指标,以对供应商进行全面评估。这种深入的分析使用户能够根据自己的要求做出明智的决策。根据评估,供应商被分为四个成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市场占有率分析
市场占有率分析是一种综合工具,可以对组织诊断市场供应商的现状进行深入而深入的研究。全面比较和分析供应商在整体收益、基本客群和其他关键指标方面的贡献,以便更好地了解公司的绩效及其在争夺市场占有率时面临的挑战。此外,该分析还提供了对该行业竞争特征的宝贵见解,包括在研究基准年观察到的累积、分散主导地位和合併特征等因素。详细程度的提高使供应商能够做出更明智的决策并制定有效的策略,从而在市场上获得竞争优势。
1. 市场渗透率:提供有关主要企业所服务的市场的全面资讯。
2. 市场开拓:我们深入研究利润丰厚的新兴市场,并分析其在成熟细分市场的渗透率。
3. 市场多元化:提供有关新产品发布、开拓地区、最新发展和投资的详细资讯。
4.竞争评估与资讯:对主要企业的市场占有率、策略、产品、认证、监管状况、专利状况、製造能力等进行全面评估。
5. 产品开发与创新:提供对未来技术、研发活动和突破性产品开发的见解。
1.组织诊断市场的市场规模与预测为何?
2.在组织诊断市场的预测期间内,有哪些产品、细分市场、应用和领域需要考虑投资?
3.组织诊断市场的技术趋势和法规结构是什么?
4.组织诊断市场主要厂商的市场占有率为何?
5.进入组织诊断市场合适的型态和策略手段是什么?
[196 Pages Report] The Tissue Diagnostics Market size was estimated at USD 8.30 billion in 2023 and expected to reach USD 8.94 billion in 2024, at a CAGR 7.76% to reach USD 14.02 billion by 2030.
Tissue diagnostics is a medical field that involves examining and analyzing tissue samples from a patient's body to diagnose diseases or conditions. It is crucial in diagnosing and treating various medical conditions, including cancer and other tissue-related diseases. Tissue diagnostics has applications across several clinical areas and is crucial in personalized medicine for assisting in early disease detection. An increase in global cancer prevalence rates and an aging population drive the demand for tissue diagnostic services. Advancements in genomics have led to the identification of numerous biomarkers associated with diseases, which have further spurred the need for accurate diagnostic tests. However, high costs associated with diagnostic instruments and services might impede their adoption by small-scale healthcare providers or low-resource settings. The lack of skilled professionals capable of interpreting complex test results and insufficient pathologists worldwide could hinder market expansion. Technological advances such as artificial intelligence (AI) integration with digital pathology have opened up new opportunities for the market players. AI-based algorithms can aid pathologists in detecting subtle morphological changes within tissues that may be easily overlooked. Additionally, growing investments from governments and private organizations towards healthcare infrastructure are expected to provide more avenues for growth in this sector.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 8.30 billion |
Estimated Year [2024] | USD 8.94 billion |
Forecast Year [2030] | USD 14.02 billion |
CAGR (%) | 7.76% |
Product: Proliferating use of tissue-processing systems for efficient processing and analyzing diagnosing tissue samples
Accessories are crucial in ensuring precise tissue diagnosis by complementing the function of instruments and consumables. Accessories typically refer to a wide range of supplementary products and components used with the primary tissue diagnostic instruments and equipment. These accessories enhance tissue diagnostic tools and devices' performance, efficiency, and functionality. Consumable products detect specific biomarkers essential for various steps in tissue sample preparation, staining, analysis, and storage. They are integral to the day-to-day operations of tissue diagnostic laboratories. The tissue diagnostics market encompasses various instruments and equipment for collecting, processing, analyzing, and diagnosing tissue samples. These instruments are essential for accurately assessing tissue specimens and play a crucial role in fields such as pathology, histology, and clinical diagnostics. Tissue diagnostic software solutions enable the processing, storing, and analyzing digital images obtained from scanned slides. Machine learning algorithms and artificial intelligence are utilized in diagnostics programs to facilitate remote consultations between pathologists. These advanced technologies provide more accurate and precise diagnoses, ensuring enhanced patient care and treatment outcomes.
Technology: Adoption of digital pathology technology for the management of digitized histological samples through computer technology
Digital pathology uses computer technology to manage information generated from digitized histological samples. Digital pathology systems enable efficient diagnosis, interpretation, image analysis, storage, and sharing of digital slides. The increased accuracy and reduced turnaround time make it an essential tool for pathologists worldwide. Immunohistochemistry (IHC) is a method utilized to detect specific proteins in tissue samples through antigen-antibody interactions using enzyme-labeled antibodies as markers. This method plays a vital role in diagnosing various diseases, such as cancer, by identifying specific biomarkers associated with tumor cells or surrounding tissues. In situ hybridization (ISH) is a technique that detects specific RNA or DNA sequences within cells in tissue samples. This method helps evaluate gene expression patterns, chromosomal abnormalities, and copy number variations. Fluorescence in situ hybridization utilizes fluorescent probes for detection. Special staining techniques visualize specific cellular components or highlight certain structures within histological samples. Digital pathology offers significant advantages in terms of efficiency, accuracy, and collaboration potential, while IHC and ISH are crucial for understanding the molecular characteristics of tissues and detecting specific biomarkers. Special staining techniques provide additional insights into cellular structures not visible through conventional methods.
Indications: Exponential use of tissue diagnostics in the detection and characterization of numerous cancer types
Tissue diagnostics play a pivotal role in the early detection and characterization of breast cancer, allowing personalized therapies to improve patient outcomes. Techniques such as immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) are widely used to identify hormone receptor status, guiding targeted therapy decisions. Identifying different subtypes of gastric cancer using tissue diagnostics assists clinicians with prognosis prediction and therapy selection. IHC is commonly employed to detect molecular biomarkers such as HER2 overexpression that directs the use of targeted therapies such as trastuzumab. Accurate diagnosis and subtyping of lymphoma are crucial for appropriate treatment planning since it comprises a heterogeneous group of malignancies involving immune system cells. Tissue diagnostic techniques can identify specific cell markers to differentiate between Hodgkin's and non-Hodgkin's lymphomas or even identify subtypes within these categories. Tissue diagnostics helps identify genetic alterations such as EGFR mutations, ALK rearrangements, and PD-L1 expression levels that can guide treatment decisions. Prostate cancer is the second most common cancer among men globally. Tissue diagnostics are crucial for determining the pathological grade of tumors through Gleason scoring and evaluating prognostic markers such as Ki-67 and PTEN loss.
End-User: Significant utilization of tissue diagnostics in clinical pathology laboratories to improve patient care quality
The primary need for tissue diagnostics in clinical pathology laboratories is to detect and diagnose various diseases at the molecular level. It helps pathologists identify biomarkers associated with specific diseases using techniques such as immunohistochemistry (IHC), in situ hybridization (ISH), and hematoxylin (H&E) staining. Contract research organizations (CROs) require tissue diagnostics services for preclinical and clinical research studies for pharmaceutical companies and biotechnology firms. These organizations prioritize cost-effectiveness, scalability, and turnaround times in choosing tissue diagnostic solutions. Tissue diagnostics are critical for patient diagnosis, treatment selection, and disease monitoring in hospital settings. Hospitals require reliable diagnostic solutions that provide accurate results with a minimal turnaround time to improve patient care quality while minimizing costs. Pharmaceutical companies utilize tissue diagnostics for drug development and clinical trials, necessitating solutions that identify target populations for precision medicine, optimize patient stratification, and evaluate treatment response in real-time. Academic and research institutions require cutting-edge tissue diagnostic solutions to investigate disease mechanisms, discover novel biomarkers, and advance therapeutic development. These laboratories prefer innovative technologies supporting high-throughput analysis and multiplexing capabilities.
Regional Insights
The Americas has a significant landscape in the tissue diagnostics market owing to advanced healthcare infrastructure and extensive research funding by the key manufacturers in the development of diagnostics tests. The manufacturers in the region have observed numerous patents issued by the FDA for innovations in tissue diagnostics technology. The EMEA region has observed a developing landscape in the tissue diagnostics market due to significant investments made by the government to support research initiatives for early diagnosis of diseases such as cancer to improve diagnostic techniques. Government standards and regulations on the safety and quality of tissue diagnostics consumables have also contributed to the market growth in the region. South Africa is a hub for innovation within the African continent, with several ongoing research initiatives focused on developing efficient diagnostic tools that cater to local disease prevalence patterns. APAC region in the market has a developing growth due to technological advancements, investment in research and development of state-of-the-art tissue diagnostic technologies, increasing cancer incidence, and government initiatives encouraging local manufacturing of diagnostic equipment, fostering innovation within the country's tissue diagnostics industry.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Tissue Diagnostics Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Tissue Diagnostics Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Tissue Diagnostics Market, highlighting leading vendors and their innovative profiles. These include Abbott Laboratories, Abcam Plc, Agilent Technologies, Inc., Atlas Antibodies AB, Bio-Rad Laboratories, Inc., Bio-Techne Corporation, Biogenex Laboratories Inc., BioIVT, LLC, bioMerieux SA, Cardinal Health, Inc., Castle Biosciences, Inc., Cell Signaling Technology, Inc., Diagnostic BioSystems Inc., F. Hoffmann-La Roche Ltd, Leica Biosystems by Danaher Corporation, McKesson Corporation, Merck KGaA, MILESTONE MEDICAL Srl, PathAI, Inc., Pfizer Inc., PROGEN Biotechnik GmbH, QIAGEN N.V., Quest Diagnostics Incorporated, Sekisui Diagnostics, LLC, Siemens Healthineers AG, SLEE medical GmbH, and Thermo Fisher Scientific Inc..
Market Segmentation & Coverage
1. Market Penetration: It presents comprehensive information on the market provided by key players.
2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
1. What is the market size and forecast of the Tissue Diagnostics Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Tissue Diagnostics Market?
3. What are the technology trends and regulatory frameworks in the Tissue Diagnostics Market?
4. What is the market share of the leading vendors in the Tissue Diagnostics Market?
5. Which modes and strategic moves are suitable for entering the Tissue Diagnostics Market?