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全球癌症分子诊断市场-2022-2029
市场调查报告书
商品编码
1140666

全球癌症分子诊断市场-2022-2029

Global Cancer Molecular Diagnostics Market - 2022-2029
出版日期: | 出版商: DataM Intelligence | 英文 180 Pages | 商品交期: 约2个工作天内

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简介目录

市场概览

到 2021 年，癌症分子诊断市场价值将达到 320.529 亿美元。预计在预测期间（2022-2029 年）将以 6.30% 的复合年增长率增长。

癌症的分子诊断包括检测、诊断、亚分类、预后和监测对治疗的反应。这些技术可识别与癌症相关的 DNA 或 RNA 序列的变化。分子诊断可用于分析诱发癌症的生物标誌物以及癌细胞如何表达基因。它还可以阐明癌症和良性肿瘤之间的区别，癌症所涉及的组织类型以及癌症的亚型。

分子诊断可用于设计、实施和个性化治疗以进行准确的癌症诊断。分子诊断可用于监测癌症患者的预后。这些技术确定了患癌症的风险。分子诊断可以帮助医生确定是否需要更密集的筛查或预防措施。市场以多种分子诊断技术的可用性为主导，包括聚合□链反应 (PCR)、原位杂交、等温核酸扩增技术 (INAAT)、芯片和微阵列、质谱、测序和转录介导的扩增。

市场动态

癌症发病率的增加推动市场增长

由于癌症发病率上升，市场对癌症分子诊断的需求不断增加。根据世界卫生组织 (WHO) 的数据，癌症是 2020 年全球死亡的主要原因。到 2020 年，将有大约 1000 万人死于癌症。全世界每年约有 400 万儿童患上癌症。肺癌、结肠癌、前列腺癌、乳腺癌、食道癌和胃癌是世界上最常见的癌症之一。肺癌患者数量较多，其次是乳腺癌、结肠癌、前列腺癌和胃癌。肺癌占所有癌症的11.6%（209万人），乳腺癌占所有癌症的11.6%（208万人），结直肠癌占所有癌症的10.2%（184万人），前列腺癌占10.2 %（192 万）癌症，胃癌占所有癌症的 10.2%（212 万）。 184 万）、前列腺癌（127 万）和胃癌（103 万）。

多机构和团体在癌症分子诊断方面的努力增加促进市场增长

一些机构和组织正在加紧努力开发癌症分子诊断测试。例如，美国国家癌症研究所通过临床蛋白质组学肿瘤分析联盟 (CPTAC) 和另一项倡议支持研究，以推进识别和使用蛋白质分子标记和蛋白质组信息用于癌症治疗的增加。临床蛋白质组学肿瘤分析联盟 (CPTAC) 是由各种学术机构、公司和几个联邦机构发起的一项协作努力，旨在快速、大规模地测量肿瘤中蛋白质的总补充量。我们还将这些信息与患者的基因组、影像学和临床数据相结合。

癌症分子诊断技术进步推动市场增长

用于癌症诊断、预防、治疗和管理的癌症分子诊断技术进步正在推动市场发展。一些公司、研究机构和组织致力于开发新的分子诊断方法，例如图像分析、样品製备、鸟枪测序和微卫星技术。 Promega 的 MSI 分析系统可检测与 Lynch 综合征相关的微卫星不稳定性。基于 PCR 的 MSI 分析系统使用荧光标记的引物作为多重 PCR 反应中的微卫星标记。 Enzo 基于 PCR 的 AMPIPROBE 平台使用标记有荧光报告基因和淬灭剂的 PCR 引物。它检测样品中存在的感兴趣的 DNA 或 RNA 的量。

关于睪丸细胞肿瘤基因组生物标誌物的研究正在进行中。根据美国临床肿瘤学会 (ASCO)，在 2019 年，我们揭示了基因组生物标誌物 microRNA371 (M371) 的血清水平作为评估睪丸生殖细胞肿瘤分期和对治疗反应的策略的潜力。这项研究表明，M371 测试在预测睪丸生殖细胞肿瘤的临床分期、肿瘤大小和对治疗的反应方面非常准确。 M371 测试可以成为癌症诊断和管理的有效工具。进行生殖系 BRCA 测试以确定可能受益于奥拉帕尼的乳腺癌和卵巢癌患者。

COVID-19 影响分析

全球癌症分子诊断市场受到 COVID-19 流行病的影响。这是因为越来越多的受 COVID-19 影响的人导致各种癌症的检测和诊断率下降，包括肺癌、结肠癌、卵巢癌和乳腺癌。肺癌受 COVID-19 的影响更为严重，因为 COVID-19 是一种呼吸道疾病，患者通常会向医生咨询可能被误认为是新型冠状病毒的体征和症状。带入实验室的标本数量正在减少。 COVID-19 大流行减少了在医院进行的活检数量。随着接受定期检查的患者人数减少，并且正在分配实验室资源来检测 COVID-19，癌症患者的定期检查次数正在减少。因此，癌症诊断测试□□和某些生物标誌物测试正在下降。

一家地区医院报告说，由于 COVID-19 病例激增，分子肿瘤学检测下降了 25%。根据商业和公共支付方的数据，2020 年 3 月进行的 EGFR 测试减少了不到 4,000 次。确诊结直肠癌的新病例数减少了14%。 RAF 测试减少了 9%，MSI/MMR 测试减少了 8%，RAS 测试减少了 6%。新诊断的乳腺癌下降了 8.4%。卵巢癌的新诊断减少了 8.6%。新诊断的急性髓性白血病减少了 14%。 FLT3 测试减少了 12%，IDH1 测试减少了 11%，IDH2 测试减少了 12%。

流行病学

根据世界卫生组织 (WHO) 的数据，癌症在男性中比在女性中更常见。 2018年，全球有945万男性和862.2万女性受到影响。欧洲占所有癌症的 23.4% 或 422 万，北美占所有癌症的 13.2% 或 237 万，亚洲占所有癌症的 48.4% 或 875 万。欧洲癌症死亡人数为194万，占总数的20.3%，北美为69万，占总数的7.3%，亚洲为547.7万，占总数的57.3%。

从全球来看，肺癌的死亡人数居高不下，其次是结直肠癌、胃癌、肝癌和乳腺癌。肺癌占所有癌症死亡人数的 18.4%，即 176 万；结直肠癌占 9.2%，即 88 万；胃癌，占 8.2%，即 78 万；乳腺癌占所有癌症死亡的 8.1%。 78万人，肝癌8.2%，78万人，乳腺癌6.6%，62万人。

市场细分

试剂和试剂盒有望占据癌症分子诊断市场的最大份额

按产品分为仪器、试剂/试剂盒等。由于用于癌症诊断、管理和治疗的分子诊断测试的试剂和试剂盒的高可用性，试剂和试剂盒部分预计将占癌症分子诊断市场的最大份额。用于研究和开发的试剂和试剂盒的使用正在增加。几家公司正在开发试剂和试剂盒。例如，Abbott Molecular Inc. 的 Vysis EGR1 FISH Probe Kit 可检测骨髓样本中染色体 5q 上的 LSI EGR1 探针靶标。 Vysis EGR1 FISH 探针试剂盒可用于表征急性髓性白血病和骨髓增生异常综合征患者的骨髓样本。 Qiagen 的 therascreen PIK3CA RGQ PCR Kit 使用从福尔马林固定、石蜡包埋的乳腺癌组织或 K2EDTA 抗凝血浆中提取的 DNA 样本，检测了磷脂□肌醇 3-激□催化亚基 α (PIK3 CA) 基因中的 11 个突变。检测的定性体外诊断PCR测试，其有用性得到认可。

通过技术，聚合□炼式反应 (PCR) 细分市场有望在预测期内实现高速增长

市场根据技术分为聚合□炼式反应 (PCR)、转录介导扩增 (TMA)、原位杂交、测序、等温核酸扩增技术 (INAAT)、芯片和微阵列、质谱等. 它已经。由于广泛采用聚合□炼式反应来识别 DNA 或 RNA 靶基因序列，聚合□炼式反应 (PCR) 部分预计将显示出最高的市场增长。聚合□炼式反应通过一系列加热和冷却循环放大遗传物质。聚合□炼式反应的发展正在不断进步。实时荧光定量 PCR 实时监测扩增过程。实时定量逆转录 PCR (qRT-PCR) 可以可靠地检测和测量在 PCR 过程的每个循环中产生的 DNA 或 RNA 中的靶基因序列。 PCR 设备的自动化正在取得进展。

区域分析

北美地区在全球癌症分子诊断市场中占有最大的市场份额

由于癌症发病率上升，北美地区将在 2021 年主导全球癌症分子诊断市场，占据最大的市场份额。根据美国癌症协会的数据，到 2022 年，北美将有 190 万癌症病例。预计到 2022 年将有大约 609,000 人死于癌症。到 2022 年，乳腺癌将成为北美最常见的癌症类型，280,000 人，其次是肺癌 236,000 人，前列腺癌 268,000 人，结直肠癌 104,000 人。

美国拥有最高的市场份额，因为它在癌症分子诊断方面的技术进步很高。例如，由 NCI 资助的 Fred Hutchinson 癌症研究中心的研究人员使用尖端的蛋白质组学技术来指导选择用于患者的 PD 生物标誌物。贝勒医学院由 NCI 资助的研究人员创建了一个患者肿瘤特异性蛋白质组图谱，揭示了一些用于个性化结直肠癌治疗的新潜在靶点。 2020 年，由 NCI 资助的贝勒医学院 Broad 研究所的研究人员及其合作者开发了一种新的综合蛋白质组分析方法，与传统方法相比，它需要的组织量更少。对癌症分子诊断的认识正在提高。成熟的诊断基础设施和设施的存在预计将刺激市场增长。

预计亚太地区将在预测期内以最快的复合年增长率增长。

据估计，亚太地区是全球癌症分子诊断市场增长最快的地区。这是因为癌症分子诊断市场存在未满足的临床需求和一些有利可图的机会。随着受癌症影响的人数不断增加，对改进癌症分子诊断的需求也在不断增长。根据世界卫生组织 (WHO) 的数据，2020 年亚洲将有 950 万新癌症病例。到 2020 年，大约有 580 万人将死于癌症。 2020年，亚洲癌症患者人数将达到131万，是最常见的，其次是结直肠癌100万，乳腺癌102万，胃癌81万。

越来越多的公司正在开发癌症分子诊断技术。开发技术先进的癌症分子诊断的研究和开发工作正在加强。一些公共和私营公司正在增加资金和投资，用于开髮用于癌症诊断、管理和治疗的分子诊断技术。例如，2020 年 5 月，EndoPhotonics 获得了由新加坡医疗集团 (SMG)、百汇控股牵头的 850 万美元投资。这笔资金将用于推进公司早期胃癌检测系统 SPECTRA IMDx 在亚太地区的商业化，并将公司癌症检测技术的范围扩大到其他器官。

竞争格局

所研究的癌症分子诊断市场是一个分散的市场，拥有大量市场参与者。 Abbott Laboratories、Bayer Healthcare、Becton Dickinson、Danaher Corporation、Qiagen N.V.、Roche Diagnostics、Siemens Healthcare、Beckman Coulter 和 Nuvera Biosciences 是市场份额较大的主要市场参与者。公司正在采取多种增长战略，例如产品发布、收购、合併、合作伙伴关係和许可，以增加其市场占有率。例如：

合併与合作。

2020 年 3 月，全球分子诊断公司 NuProbe 与 QIAGEN 达成合作协议，开发基于下一代测序 (NGS) 的无创液体活检癌症诊断测试□□。根据协议条款，两家公司将使用 NuProbe 专有的 Blocker Displacement Amplification (BDA) 技术和 QIAGEN 的 Single Primer Extension (SPE) 技术来准确且廉价地分析具有极低比例突变等位基因的 DNA 突变，我们的目标是执行非侵入性癌症基因组分析。

2020 年 1 月，安进分别与 Guardant Health 和 QIAGEN N.V. 合作，为研究药物 AMG 510 开发基于血液和组织的伴随诊断 (CDx)。根据协议条款，两家公司最初将专注于非小细胞肺癌 (NSCLC) 的伴随诊断测试，但也将使两家公司能够进一步开髮用于安进其他癌症临床开发项目的诊断测试。

2019 年 7 月，Exact Sciences Corp. 与 Genomic Health, Inc. 合併，组建了一家全球癌症诊断公司。该公司将提供 Cologuard 和 Oncotype DX，这是癌症诊断领域最强大和增长最快的品牌。两家公司的合併将为世界各地的患者带来新的和创新的癌症诊断方法。

产品发布和批准

2021 年 8 月 25 日，BD 在其美国实验室推出了全自动高质量分子诊断平台。随着此次发布，具有 BD COR 系统扩展基因分型的 BD Onclarity HPV Assay 现在可在美国处理大多数宫颈癌标本的高质量实验室中使用。

收购

2019 年 6 月，Blue Earth Diagnostics 从领先的医疗保健公司 Syncona 手中收购了私人持有的 Blue Earth Diagnostics 的所有流通股，结算调整价估计为 4.5 亿美元至 2500 万美元。我们同意将其作为一笔交易。根据协议条款，Blue Earth Diagnostics 将成为 Bracco Imaging 的子公司。

合作伙伴关係

2020 年 6 月，Genetron Holdings Limited 与 Thermo Fisher Scientific 建立合作伙伴关係，共同打造测序仪 Genetron S5。此次合作将加强中国公立医院分子癌症诊断领域下一代测序（NGS）平台的创新、商业化和推广。

内容

第1章研究方法与范围

  • 调查方法
  • 调查目的和范围

第 2 章市场定义和概述

第 3 章执行摘要

  • 按癌症类型划分的市场细分
  • 按产品划分的市场细分
  • 按技术划分的市场细分
  • 最终用户的市场细分
  • 按地区划分的市场细分

第 4 章市场动态

  • 市场影响因素
    • 驱动程序
      • 癌症发病率增加
      • 技术进步
    • 限制因素
      • 分子生物诊断剂的批准延迟
      • 缺乏熟练的人力资源
    • 商机
    • 影响分析

第5章行业分析

  • 波特五力分析
  • 流行病学
  • 管道分析
  • 供应链分析
  • 定价分析
  • 法律法规分析
  • 保险报销分析
  • 未满足的需求分析

第 6 章 COVID-19 分析

  • COVID-19 的市场分析
    • COVID-19 之前的市场情景
    • COVID-19 的当前市场情景
    • COVID-19 后或未来情景
  • COVID-19 期间的价格动态
  • 供需范围
  • 大流行期间与市场相关的政府举措
  • 製造商的战略举措
  • 总结

第 7 章按癌症类型

  • 乳腺癌
  • 前列腺癌
  • 结肠癌
  • 宫颈癌
  • 肝癌
  • 肺癌
  • 血癌
  • 肾癌
  • 其他

第 8 章按产品分类

    • 设备
    • 试剂和试剂盒
    • 其他

第9章技术

  • 聚合□炼式反应 (PCR)
  • 转录介导的扩增 (TMA)
  • 原位杂交
  • 序列
  • 等温核酸扩增技术 (INAAT)
  • 芯片和微阵列
  • 质谱
  • 其他

第 10 章，最终用户

  • 研究所
  • 医院
  • 学术机构
  • 其他

第 11 章按地区划分

  • 北美
    • 美国
    • 加拿大
    • 墨西哥
  • 欧洲
    • 德国
    • 英国
    • 法国
    • 意大利
    • 西班牙
    • 其他欧洲
  • 南美洲
    • 巴西
    • 阿根廷
    • 其他南美洲
  • 亚太地区
    • 中国
    • 印度
    • 日本
    • 澳大利亚
    • 其他亚太地区
  • 中东和非洲

第 12 章竞争格局

  • 竞争场景
  • 市场情况/份额分析
  • 併购分析

第 13 章公司简介

  • 雅培实验室
    • 公司概况
    • 产品组合和描述
    • 主要亮点
    • 财务摘要
  • Bayer Healthcare
  • Becton Dickinson
  • Cepheid
  • Dako
  • Danaher Corporation
  • Qiagen N.V.
  • Roche Diagnostics
  • Siemens Healthcare
  • Sysmex Corporation
  • Beckman Coulter
  • bioMerieux
  • bioTheranostics
  • Genera Biosystems
  • Genomic Health
  • Genomix Biotech
  • Nuvera Biosciences
  • Orion Genomics（LIST NOT EXHAUSTIVE）

第14章 DataM

简介目录
Product Code: DMPH2791

Market Overview

Cancer Molecular Diagnostics Market size was valued at USD 32,052.90 million in 2021. It is forecasted to reach USD YY million by 2029, growing at a CAGR of 6.30% during the forecast period (2022-2029).

Cancer molecular diagnostics include the detection, diagnosis, sub-classification, prognosis, and monitoring response to therapy. These techniques identify the alterations in DNA or RNA sequences, associated with cancer. Molecular diagnostics are effective for analyzing the biological markers involved in inducing cancer and analyzing how cancer cells are expressing their genes. These techniques differentiate cancer from benign tumors, the type of tissue involved in cancer, and cancer subtypes.

Molecular diagnostics are useful for designing, implementing accurate diagnostic methods, and personalizing the treatment modalities for cancer. Molecular diagnostics are useful for monitoring the outcomes among patients with cancer. These techniques determine the risk for cancer occurrence. Molecular diagnostics are useful for physicians to decide the requirement for the more intensive screening or preventive measures. The market is dominated by the availability of several molecular diagnostics techniques such as polymerase chain reaction (PCR), in situ hybridization, isothermal nucleic acid amplification technology (INAAT), chips & microarrays, mass spectrometry, sequencing, transcription-mediated amplification, and others.

Market Dynamics

Increasing Incidence of Cancer is Driving the Growth of the Market

The market is driven by the increasing demand for cancer molecular diagnostics with the increasing incidence of cancer. According to the World Health Organization (WHO), Cancer is a leading cause of death worldwide in 2020. Around, 10 million people died due to cancer in 2020. Globally, approximately 4 million children develop cancer in each year. Lung cancer, colorectal cancer, prostate cancer, breast cancer, oesophagus cancer, and stomach cancer are the most common cancer worldwide. A large number of people are suffering from lung cancer followed by breast cancer, colorectal cancer, prostate cancer, and stomach cancer. Lung cancer accounts for 11.6% of all cancer incidence cases i.e., 2.09 million incidence cases, breast cancer accounts for 11.6% of all cancer incidence cases i.e., 2.08 million incidence cases, colorectal cancer accounts for 10.2% of all cancer incidence cases i.e., 1.84 million incidence cases, prostate cancer accounts for 7.1% of all cancer incidence cases i.e., 1.27 million incidence cases, stomach cancer accounts for 5.7% of all cancer incidence cases i.e., 1.03 million incidence cases.

Increasing initiatives by several organizations and institutes for Cancer Molecular Diagnostics is boosting the market growth

Several institutes and organizations are raising their initiatives for the development of tests for Cancer Molecular Diagnostics. For instance, National Cancer Institute is supporting the research through the clinical proteomic tumour analysis Consortium (CPTAC) and another initiative to advance the identification and use of protein molecular markers and proteogenomic information for the treatment of cancer. Clinical Proteomic Tumor Analysis Consortium (CPTAC) is the collaborative effort initiated by various academic institutions, industries, and several federal agencies for measuring the entire complement of proteins in tumours in a rapid and large-scale manner. It also combines this information with genomic, imaging, and clinical data from patients.

Technological Advancement for Cancer Molecular Diagnostics is Fueling the Market Growth

The market is witnessing technological advancement for cancer molecular diagnostics for the diagnosis, prevention, treatment and management of cancer. Several companies, institutes, and organizations are focusing on developing novel molecular diagnostics including image analysis, sample preparation, shotgun sequencing, and microsatellite technology. Promega's MSI Analysis System detects the microsatellite instability associated with the Lynch Syndrome. The PCR-based MSI Analysis System involves the use of the fluorescently labelled primers for microsatellite markers in multiplexed PCR reactions. Enzo's PCR-based AMPIPROBE platform involves the use of PCR primers labelled with fluorescent reporters and quenchers. It detects the amount of the DNA or RNA of interest present in the sample.

There is ongoing research regarding the genomic biomarkers in testicular germ-cell tumours. According to the American Society of Clinical Oncology (ASCO), in 2019, the researchers identified the potential of the serum levels of the genomic biomarker microRNA371 (M371) as a strategy to stage testicular germ-cell tumours and assess response to treatment. The studies have demonstrated that the M371 test was very accurate for predicting the clinical stage, tumour size, and response to treatment of testicular germ-cell tumours. M371 test can be an effective tool for the diagnosis and management of cancer. Germ-cell BRCA testing is performed to identify patients with breast or ovarian cancer likely to benefit from olaparib.

COVID-19 Impact Analysis

The global cancer molecular diagnostics market is impacted due to the COVID-19 pandemic as the increasing number of people affected by COVID-19 has resulted in a reduction in testing and diagnosis rate of various cancers such as lung cancer, colorectal, ovarian, breast cancers, and others. Lung cancer has been worse affected due to COVID-19 as the COVID-19 is a respiratory disease and patients would normally consult their doctor for the signs and symptoms that are potentially being mistaken for the novel coronavirus. There is a decrease in the number of samples being received in the laboratories. Fewer number biopsies are being performed in the hospitals due to the COVID-19 pandemic. Regular screening of cancer patients has witnessed a decrease in the number of regular screenings with the decrease in the number of people having medical appointments, and repurposing of lab resources toward providing COVID-19 testing. Therefore, there is a decrease in the number of diagnostic tests and specific biomarker tests for cancer.

According to one of the community hospitals, molecular oncology testing had slumped by 25% due to a rapid increase in the COVID-19 cases. According to the commercial and public payors, less than 4,000 fewer EGFR tests were performed in March 2020. There was a decrease of 14% in the number of new patients diagnosed with colorectal cancer. There were decreases in the number of the RAF test by 9%, MSI/MMR test by 8%, and RAS test by 6%. The number of new patients diagnosed with breast cancer has witnessed a decrease of 8.4%. The new diagnosis of ovarian cancer has witnessed a decrease of 8.6%. There was a decrease of 14% in the number of new patients diagnosed with acute myeloid leukaemia. There were decreases in the number of the FLT3 test by 12%, IDH1 test by 11%, and IDH2 test by 12%.

Epidemiology

According to the World Health Organization, cancer is most predominant among males in comparison to females. The total number of incidence cases of males was 9.45 million and females were 8.622 million worldwide in 2018. Europe accounts for 23.4% of all cancer incidence cases i.e., 4.22 million incidence cases, North America accounts for 13.2% of all cancer incidence cases i.e, 2.37 million incidence cases, Asia accounts for 48.4% of all cancer incidence cases i.e., 8.75 million incidence cases. Europe accounts for 20.3% of all cancer mortality cases i.e., 1.94 million mortality cases, North America accounts for 7.3% of all cancer mortality cases i.e, 0.69 million mortality cases, Asia accounts for 57.3% of all cancer mortality cases i.e., 5.477 million mortality cases.

Globally, a large number of people died due to lung cancer followed by colorectal cancer, stomach cancer, liver cancer, and breast cancer. Lung cancer accounts for 18.4% of all cancer mortality cases i.e., 1.76 million mortality cases, colorectal cancer accounts for 9.2% of all cancer mortality cases i.e., 0.88 million mortality cases, stomach cancer accounts for 8.2% of all cancer mortality cases i.e., 0.78 million mortality cases, liver cancer accounts for 8.2% of all cancer mortality cases i.e., 0.78 million mortality cases, breast cancer accounts for 6.6% of all cancer mortality cases i.e., 0.62 million mortality cases.

Market Segment Analysis

Reagents and kits segment is expected to hold the largest share in the Cancer Molecular Diagnostics market

By-Products, the market is classified as the instruments, reagents and kits, and others. The reagents and kits segment is anticipated to hold the largest share in the cancer molecular diagnostics market due to the high availability of the reagents and kits for conducting molecular diagnostic testing for diagnosis, management, and treatment of cancer. There is increasing usage of the reagents and kits for conducting research and development activities. Several companies are developing the reagents and kits. For instance, Abbott Molecular Inc.'s Vysis EGR1 FISH Probe Kit detects the LSI EGR1 probe target on chromosome 5q in bone marrow specimens. Assay of Vysis EGR1 FISH Probe Kit is effective to characterize bone marrow specimens from patients with acute myeloid leukaemia or myelodysplastic syndrome. Qiagen's therascreen PIK3CA RGQ PCR Kit is a real-time qualitative in vitro diagnostic PCR test useful for the detection of 11 mutations in the phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) gene by using a sample of DNA extracted from either formalin-fixed, paraffin-embedded (FFPE) breast tumour tissue or K2EDTA anticoagulated blood plasma.

By Technology, Polymerase Chain Reaction (PCR) Segment is Expected to Witness a High Growth Over the Forecast Period

The market is classified based on the technology as the Polymerase Chain Reaction (PCR), Transcription Mediated Amplification (TMA), In Situ Hybridization, Sequencing, Isothermal Nucleic Acid Amplification Technology (INAAT), Chips and Microarrays, Mass Spectrometry, and Others. The polymerase Chain Reaction (PCR) segment is expected to witness the highest market growth due to the high adoption of the polymerase chain reaction for identifying the target genetic sequence of DNA or RNA. Polymerase Chain Reaction amplifies the genetic material through a series of heating and cooling cycles. There is growing advancement for the development of the polymerase chain reaction. Real-time PCR monitors the amplification process in real-time. Real-Time Quantitative Reverse Transcription PCR (qRT-PCR) allows the reliable detection and measurement of the target genetic sequence of DNA or RNA generated during each cycle of the PCR process. There is rising automation of the automation of PCR instruments.

Geographical Analysis

North America region holds the largest market share global Cancer Molecular Diagnostics market

North America region is dominating the global cancer molecular diagnostics market accounted for the largest market share in 2021 owing to the increasing number of incident cases of cancer. According to the American Cancer Society, the total number of incident cases of cancer was 1.9 million in North America in 2022. Around, 0.609 million people expected died due to cancer in 2022. Breast cancer accounts for the highest incidence with 0.28 million cases followed by lung cancer with 0.236 million cases by prostate cancer with 0.268 million cases, and colorectal cancer with 0.104 million cases in North America in 2022.

The United States accounts for the highest market share due to the high technological advancement for cancer molecular diagnostics. For instance, NCI-funded researchers at Fred Hutchinson Cancer Research Center had used the cutting-edge proteomics technology to guide the selection of a PD biomarker to be used in patients. NCI-funded researchers from Baylor College of Medicine had created the patient tumour-specific proteogenomic atlases that highlighted many new potential targets for personalized colon cancer treatment. New methods of comprehensive proteomic analysis that require a smaller amount of tissue in comparison to the previous methods were developed by NCI-funded researchers at the Broad Institute, Baylor College of Medicine, and their collaborators in 2020. There is increasing awareness regarding molecular diagnostics for cancer. The presence of the well-established diagnostic infrastructure & facilities shall stimulate market growth.

Asia-Pacific region is expected to grow at the fastest CAGR during the forecast period

Asia-Pacific region is estimated to be the fastest-growing region in the global cancer molecular diagnostics market owing due to the presence of several lucrative opportunities for the cancer molecular diagnostics market with unaddressed clinical needs in the market. There is increasing demand for improved cancer molecular diagnostics with the increasing number of people suffering from cancer. According to the World Health Organization (WHO), the total number of new incident cases of cancer was 9.50 million in Asia in 2020. Around, 5.80 million people died due to cancer in 2020. Lung Cancer accounts for the highest incidence with 1.31 million cases followed by colorectal cancer with 1 million cases by breast cancer with 1.02 million cases, and stomach cancer with 0.81 million cases in Asia in 2020.

There is an increase in the number of companies developing cancer molecular diagnostics. There is rising research and development activities for the development of technological advanced molecular diagnostics for cancer. Several public and private players are raising the funding & investment for the development of molecular diagnostics for diagnosis, management, and treatment of cancer. For instance, in May 2020, Endofotonics had secured an investment of USD 8.5 million led by Singapore Medical Group (SMG), and Parkway Holdings. This funding would be used to drive the commercialization of its early gastric cancer detection system, SPECTRA IMDx, in the Asia Pacific and to expand the coverage of its cancer detection technology to other organs.

Competitive Landscape:

The cancer molecular diagnostics market studied is a fragmented market with the presence of a large number of market players. Abbott Laboratories, Bayer Healthcare, Becton Dickinson, Danaher Corporation, Qiagen N.V., Roche Diagnostics, Siemens Healthcare, Beckman Coulter, and Nuvera Biosciences are the major market players with the significant market share. Companies are adopting several growth strategies such as product launches, acquisitions, mergers, collaborations, and licensing for increasing their market presence. For instance,

Mergers & Collaborations:

In March 2020, NuProbe, a global molecular diagnostics company had entered into the collaboration agreement with QIAGEN to develop next-generation sequencing (NGS)-based cancer diagnostic tests for non-invasive liquid biopsy. Under the terms of the agreement, both companies would explore NuProbe's proprietary Blocker Displacement Amplification (BDA) technology and QIAGEN's Single Primer Extension (SPE) technology, for accurate and affordable analysis of DNA mutations with very low variant allele fractions and advanced non-invasive cancer genomic profiling.

In January 2020, Amgen had entered into the collaboration with Guardant Health, Inc. and QIAGEN N.V. to develop blood- and tissue-based companion diagnostics (CDx), respectively, for investigational cancer treatment AMG 510. Under the terms of the agreement, both companies would initially focus on companion diagnostics tests for non-small cell lung cancer (NSCLC) but allow for further development of the diagnostic tests for Amgen's other oncology clinical development programs.

In July 2019, Exact Sciences Corp. had merged with Genomic Health, Inc. to create the global cancer diagnostics company. The company would provide the Cologuard and Oncotype DX, the strongest and fastest-growing brands in cancer diagnostics. This merger of the companies would bring new innovative cancer diagnostics to patients across the globe.

Product Launch & Approvals:

On 25th August 2021, BD launched a fully automated high-quality molecular diagnostic platform in the United States laboratories. The launch will make the BD Onclarity HPV Assay with extended genotyping for the BD COR System available to the high-quality labs that process the majority of cervical cancer screening specimens in the United States.

Acquisition:

In June 2019, Blue Earth Diagnostics had agreed to acquire all outstanding shares of privately-held Blue Earth Diagnostics from leading healthcare company Syncona for USD 450 million-plus closing adjustment estimated at USD 25 million. Under the terms of the agreement, Blue Earth Diagnostics would be the subsidiary of Bracco Imaging.

Partnerships

In June 2020, Genetron Holdings Limited had entered into a partnership with Thermo Fisher Scientific to build on the sequencer Genetron S5. This partnership would enhance innovation, commercialization and promotion of next-generation sequencing (NGS) platforms in the field of molecular cancer diagnosis in China's public hospitals.

Table of Contents

1. Methodology and Scope

  • 1.1. Research Methodology
  • 1.2. Research Objective and Scope of the Report

2. Market Definition and Overview

3. Executive Summary

  • 3.1. Market Snippet by Cancer Type
  • 3.2. Market Snippet by Products
  • 3.3. Market Snippet by Technology
  • 3.4. Market Snippet by End-Users
  • 3.5. Market Snippet by Region

4. Market Dynamics

  • 4.1. Market Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Increasing Incidence of Cancers
      • 4.1.1.2. Technology Advancement
      • 4.1.1.3. XX
    • 4.1.2. Restraints:
      • 4.1.2.1. Delayed Approval of Molecular Diagnostics
      • 4.1.2.2. Lack of Skilled People
      • 4.1.2.3. XX
    • 4.1.3. Opportunity
    • 4.1.4. Impact Analysis

5. Industry Analysis

  • 5.1. Porter's Five Forces Analysis
  • 5.2. Epidemiology
  • 5.3. Pipeline Analysis
  • 5.4. Supply Chain Analysis
  • 5.5. Pricing Analysis
  • 5.6. Regulatory Analysis
  • 5.7. Reimbursement Analysis
  • 5.8. Unmet Needs

6. COVID-19 Analysis

  • 6.1. Analysis of Covid-19 on the Market
    • 6.1.1. Before COVID-19 Market Scenario
    • 6.1.2. Present COVID-19 Market Scenario
    • 6.1.3. After COVID-19 or Future Scenario
  • 6.2. Pricing Dynamics Amid Covid-19
  • 6.3. Demand-Supply Spectrum
  • 6.4. Government Initiatives Related to the Market During Pandemic
  • 6.5. Manufacturers Strategic Initiatives
  • 6.6. Conclusion

7. By Cancer Type

  • 7.1. Introduction
  • 7.2. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Cancer Type Segment
  • 7.3. Market Attractiveness Index, By Cancer Type Segment
    • 7.3.1. Breast Cancer*
      • 7.3.1.1. Introduction
      • 7.3.1.2. Market Size Analysis, and Y-o-Y Growth Analysis (%)
    • 7.3.2. Prostate Cancer
    • 7.3.3. Colorectal Cancer
    • 7.3.4. Cervical Cancer
    • 7.3.5. Liver Cancer
    • 7.3.6. Lung Cancer
    • 7.3.7. Blood Cancer
    • 7.3.8. Kidney Cancer
    • 7.3.9. Others

8. By-Products

  • 8.1. Introduction
  • 8.2. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Products
  • 8.3. Market Attractiveness Index, By Products Segment
    • 8.3.1. Instruments*
      • 8.3.1.1. Introduction
      • 8.3.1.2. Market Size Analysis, and Y-o-Y Growth Analysis (%)
    • 8.3.2. Reagents & Kits
    • 8.3.3. Others

9. By Technology

  • 9.1. Introduction
  • 9.2. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Technology
  • 9.3. Market Attractiveness Index, By Technology Segment
    • 9.3.1. Polymerase Chain Reaction (PCR)*
      • 9.3.1.1. Introduction
      • 9.3.1.2. Market Size Analysis, and Y-o-Y Growth Analysis (%)
    • 9.3.2. Transcription Mediated Amplification (TMA)
    • 9.3.3. In Situ Hybridization
    • 9.3.4. Sequencing
    • 9.3.5. Isothermal Nucleic Acid Amplification Technology (INAAT)
    • 9.3.6. Chips and Microarrays
    • 9.3.7. Mass Spectrometry
    • 9.3.8. Others

10. By End-Users

  • 10.1. Introduction
  • 10.2. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-Users
  • 10.3. Market Attractiveness Index, By End-Users Segment
    • 10.3.1. Research Laboratories*
      • 10.3.1.1. Introduction
      • 10.3.1.2. Market Size Analysis, and Y-o-Y Growth Analysis (%)
    • 10.3.2. Hospitals
    • 10.3.3. Institutes & Academics
    • 10.3.4. Others

11. By Region

  • 11.1. Introduction
  • 11.2. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Region
  • 11.3. Market Attractiveness Index, By Region
  • 11.4. North America
    • 11.4.1. Introduction
    • 11.4.2. Key Region-Specific Dynamics
    • 11.4.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Cancer Type
    • 11.4.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Products
    • 11.4.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Technology
    • 11.4.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-Users
    • 11.4.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
      • 11.4.7.1. U.S.
      • 11.4.7.2. Canada
      • 11.4.7.3. Mexico
  • 11.5. Europe
    • 11.5.1. Introduction
    • 11.5.2. Key Region-Specific Dynamics
    • 11.5.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Cancer Type
    • 11.5.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Products
    • 11.5.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Technology
    • 11.5.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-Users
    • 11.5.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
      • 11.5.7.1. Germany
      • 11.5.7.2. U.K.
      • 11.5.7.3. France
      • 11.5.7.4. Italy
      • 11.5.7.5. Spain
      • 11.5.7.6. Rest of Europe
  • 11.6. South America
    • 11.6.1. Introduction
    • 11.6.2. Key Region-Specific Dynamics
    • 11.6.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Cancer Type
    • 11.6.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Products
    • 11.6.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Technology
    • 11.6.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-Users
    • 11.6.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
      • 11.6.7.1. Brazil
      • 11.6.7.2. Argentina
      • 11.6.7.3. Rest of South America
  • 11.7. Asia Pacific
    • 11.7.1. Introduction
    • 11.7.2. Key Region-Specific Dynamics
    • 11.7.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Cancer Type
    • 11.7.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Products
    • 11.7.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Technology
    • 11.7.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-Users
    • 11.7.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
      • 11.7.7.1. China
      • 11.7.7.2. India
      • 11.7.7.3. Japan
      • 11.7.7.4. Australia
      • 11.7.7.5. Rest of Asia Pacific
  • 11.8. Middle East and Africa
    • 11.8.1. Introduction
    • 11.8.2. Key Region-Specific Dynamics
    • 11.8.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Cancer Type
    • 11.8.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Products
    • 11.8.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Technology
    • 11.8.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-Users

12. Competitive Landscape

  • 12.1. Competitive Scenario
  • 12.2. Market Positioning/Share Analysis
  • 12.3. Mergers and Acquisitions Analysis

13. Company Profiles

  • 13.1. Abbott Laboratories*
    • 13.1.1. Company Overview
    • 13.1.2. Product Portfolio and Description
    • 13.1.3. Key Highlights
    • 13.1.4. Financial Overview
  • 13.2. Bayer Healthcare
  • 13.3. Becton Dickinson
  • 13.4. Cepheid
  • 13.5. Dako
  • 13.6. Danaher Corporation
  • 13.7. Qiagen N.V.
  • 13.8. Roche Diagnostics
  • 13.9. Siemens Healthcare
  • 13.10. Sysmex Corporation
  • 13.11. Beckman Coulter
  • 13.12. bioMerieux
  • 13.13. bioTheranostics
  • 13.14. Genera Biosystems
  • 13.15. Genomic Health
  • 13.16. Genomix Biotech
  • 13.17. Nuvera Biosciences
  • 13.18. Orion Genomics (LIST NOT EXHAUSTIVE)

14. DataM Intelligence

  • 14.1. Appendix
  • 14.2. About Us and Services
  • 14.3. Contact Us