封面
市场调查报告书
商品编码
1372932

伴随诊断市场 - 2018-2028 年全球产业规模、份额、趋势、机会和预测,按产品和服务、技术、疾病适应症、按应用、最终用户、地区和竞争细分

Companion Diagnostic Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented By Product and Services, By Technology, By Disease Indication, By Application, By End User, By Region and Competition

出版日期: | 出版商: TechSci Research | 英文 178 Pages | 商品交期: 2-3个工作天内

价格

We offer 8 hour analyst time for an additional research. Please contact us for the details.

简介目录

2022 年全球伴随诊断市场价值为58.5 亿美元,预计在预测期内将出现令人印象深刻的增长,到2028 年复合年增长率为12.29%。伴随诊断是与治疗药物结合使用的医疗设备,用于评估治疗药物的影响和适用性。针对特定个体的药物。这些诊断方法与药物一起开发,以根据患者的特征识别对治疗有反应或不适合治疗的患者群体。医疗保健专业人员利用该设备来评估特定治疗对患者的有效性。

2020年,罗氏的Cobas EGFR突变测试v2伴随诊断获得FDA批准,此诊断有助于确定EGFR酪胺酸激酶抑制剂在肺癌治疗中的适当使用。伴随诊断 (CDx) 是与治疗药物共同开发的临床测试,用于识别对药物有反应或无反应的患者。它能够识别可以或不能用相应药物治疗的患者群体。 CDx 可协助从业人员评估治疗药物的益处、副作用和相关风险,确保患者安全。

全球伴随诊断市场的驱动因素包括患者对客製化治疗的需求不断增加、个人化药物的应用范围扩大、慢性病盛行率上升以及药物相关过敏发生率上升等。这些因素有助于客製化伴随诊断的发展,促进市场成长。此外,CDx 测试具有成本效益、高灵敏度以及在更短的时间内快速准确地获得结果等优势,进一步推动了伴随诊断市场的成长。

市场概况
预测期 2024-2028
2022 年市场规模 58.5亿美元
2028 年市场规模 117.3亿美元
2023-2028 年复合年增长率 12.29%
成长最快的细分市场 製药与生物技术公司
最大的市场 北美洲

主要市场驱动因素

对基于 NGS 的技术的需求不断增加

对次世代定序 (NGS) 技术日益增长的需求及其识别罕见变异的卓越能力,对于伴随诊断解决方案在伴随诊断市场中的持续成功和更广泛分布发挥关键作用。透过利用 NGS 组合,单一测试有可能帮助治疗多种类型的癌症,为个人化医疗提供更全面的方法。

标靶抗癌药物的伴随诊断

临床研究表明,很大比例(高达 75%)的癌症患者对同一种处方抗癌药物没有良好反应。这凸显了对伴随诊断测试的迫切需求,这些测试在识别分子标靶的存在以及发现治疗的任何脱靶效应方面发挥着至关重要的作用。透过这样做,这些测试可以预测与药物相关的毒性和不良反应,最终有助于个人化治疗方法。

值得注意的是,超过 90% 的全球批准的伴随诊断 (CDx) 测试与标靶癌症治疗特别相关。这种癌症基因组特征的伴随诊断方法不仅可以帮助医生识别驱动患者癌症生长的特定改变,还使他们能够探索以前可能没有考虑过的有针对性的治疗方案。这种全面且量身定制的癌症治疗方法在改善患者治疗效果和彻底改变肿瘤学领域方面具有巨大潜力。

最新科技的进步

基于次世代定序(NGS)的伴随指示性测试旨在解锁每个个体基因组的核讯息,以指导各种疾病的治疗决策。与其他定序方法相比,透过利用先进的定序技术,NGS 可以在更短的时间内识别多种生物标记。这种综合方法可以在一次测试中评估生物标记物,可能有利于多种疾病的治疗。此外,NGS 技术的不断进步为市场参与者提供了比 PCR、ICH 和 ISH 等替代技术的竞争优势。因此,主要产业参与者积极参与基于NGS的伴随诊断产品的开发,利用这一创新领域带来的机会。

个人化医疗的使用不断增加

个人化医疗的日益普及是伴随诊断市场成长的关键驱动力。个人化医疗包括多方面的患者照护方法,不仅提高诊断和治疗疾病的能力,而且能够在早期阶段识别疾病,促进更有效的治疗。个人化医疗的日益普及源于其基于个人遗传特征的有针对性的方法。在美国,相当多的寻求医疗照护的人都经历过误诊,这可能导致诊断延迟和不准确。

此外,伴随诊断在开髮用于早期疾病检测和选择精确治疗方法的个人化药物方面越来越重要,最终有助于降低死亡率。准确评估个体的遗传组成对于确定其健康状况和对严重疾病的易感性起着至关重要的作用。提高对遗传疾病的认识将进一步促进专门针对这些疾病的个人化药物的开发和商业化。此外,由于对患者准确诊断的需求和个人化医疗的进步,预计在整个预测期内对伴随诊断测试的需求将会上升。

主要市场挑战

缺乏意识且伴随诊断技术成本高

虽然免疫疗法在治疗癌症方面显示出巨大的前景,但其高昂的成本限制了患者的广泛使用。因此,医生可能会选择联合治疗,这可以将治疗持续时间从五个月延长至三年以上。治疗持续时间越长,经济负担就越大,因为个人化免疫疗法的成本也很高。事实上,癌症免疫疗法的成本可能远远超过化疗或放射疗法等其他治疗方案。因此,免疫肿瘤治疗的高成本被认为阻碍了伴随诊断市场的成长。这项财务障碍凸显了持续研究和创新的必要性,以便为癌症患者开发更实惠、更容易取得的免疫疗法。

欠已开发国家缺乏资源

伴随诊断测试的每一步都需要一丝不苟,以确保成功执行和可重复的结果。这些科学领域面临的重大挑战之一是缺乏技术熟练和训练有素的人员。伴随诊断测试的复杂性通常需要复杂的技术和仪器,例如在某些分析程序中的影像处理。对于生物製药公司、学术机构、研发实验室和组织来说,拥有熟练、经验丰富、技术能力强的员工至关重要。

然而,针对实验室专业人员的全面培训计画有所减少,因为他们面临着加快週转时间的过度压力。因此,对实验室管理人员的培训或让他们成为专家的关注不够。此外,提供的薪酬方案缺乏竞争力,导致人员流动率较高。这些因素,加上对实验室专业人员重要性缺乏认识和理解,导致该领域专业人员数量不断减少。预计这一趋势将在预测期内持续下去,可能抵消市场关注的成长。

主要市场趋势

促销活动的重要性日益增加

促销活动的重要性日益增强,代表了伴随诊断市场的一个主要趋势。伴随诊断由于其特异性仅适用于特定药物,因此不像市场上其他可用的测试套件和设备那样广泛销售。因此,更加重视改善分销网络和提高最终用户的产品可用性至关重要。就广告来源而言,网路管道和搜寻引擎是最重要的,因为它们的知名度较高,而其他媒体的投资回报和知名度有限。

此外,除了促进销售外,重点还放在产品的功能、准确性和供应商的售后服务上,而行销传播则退居次位。有限的促销活动为进入目标市场和了解公司的竞争地位带来了挑战。为了吸引客户造访公司网站,发布多个部落格和电子报可能会有所帮助。这种方法使企业能够长期维持行销活动并吸引回头客。随着市场不断见证产品的增强,供应商越来越认识到促销活动的重要性,而这一趋势预计将获得动力,从而支持全球伴随诊断市场在整个预测期内的成长。

生物製剂不断进步

伴随诊断市场高度整合,主要参与者包括 F. Hoffmann-La Roche Ltd.(瑞士)、Agilent Technologies, Inc.(美国)、Qiagen NV(德国)、Thermo Fisher Scientific, Inc.(美国) )和雅培公司(美国)在2020年共同占据了相当大的市场份额。市场参与者之间竞争激烈,只有大公司才有能力承担在资本、研发和製造方面的大量投资。因此,这个市场对新竞争者的进入构成了巨大的障碍。

细分市场洞察

技术洞察

聚合酶炼式反应 (PCR) 领域目前在市场份额中占据主导地位,预计在整个预测期内将出现显着增长。这可以归因于其成本效益、高灵敏度和特异性,这是推动市场扩张的关键因素。此外,PCR 可以在简单的自动化平台上使用,进一步增强了其吸引力。此外,PCR 在确定各种疾病的未知病因的定序方面发挥着至关重要的作用,使其成为该领域不可或缺的驱动力。它准确识别病原体基因组成的能力有助于更好地了解和诊断疾病。

另一方面,下一代定序领域预计将在预测期内快速成长。这主要是由于其关键优势,例如检测低频变异的灵敏度更高、分析大样本量的周转时间更短,以及同时对数百至数千个基因或基因区域进行测序的能力。这些优点使次世代定序成为一种有前途的技术,在基因组学和个人化医疗领域的各种应用中具有巨大的潜力。

最终使用者见解

伴随诊断市场分为各个细分市场,包括製药和生物技术公司、研究实验室、合约研究组织等。其中,製药与生技公司细分市场占有最大的市场份额。这可以归因于伴随诊断在药物开发中的使用不断增加以及伴随诊断生物标记的重要性日益增加。伴随诊断在个人化医疗中发挥着至关重要的作用,有助于识别最有可能从特定治疗中受益的患者。这不仅改善了患者的治疗效果,也提高了药物开发过程的效率和有效性。随着技术的进步和对精准医疗的日益关注,对伴随诊断的需求预计在未来几年将进一步增长。

区域洞察

就收入份额而言,预计北美将在预测期内占据市场主导地位。这可以归因于多种因素,包括慢性病的高盛行率、完善的临床实验室和伴随诊断供应商的存在,以及先进仪器和设备的可用性。此外,该地区还受益于老年人口的增长、可支配收入的增加、伴随诊断意识的提高以及研发活动的增加。这些额外因素预计将在未来几年进一步推动北美市场的收入成长。北美占据伴随诊断市场的最大份额。北美伴随诊断市场的成长可归因于众多领先的伴随诊断供应商和公共临床研究中心的存在、技术先进的设备和仪器的容易获得以及美国和加拿大高度发达的医疗保健系统。

伴随诊断的使用被认为是各种肿瘤药物的重要治疗选择工具,这一分类反映在 FDA 对这些测试的风险评估中。

目录

第 1 章:产品概述

  • 市场定义
  • 市场范围
    • 涵盖的市场
    • 考虑学习的年份
    • 主要市场区隔

第 2 章:研究方法

  • 研究目的
  • 基线方法
  • 主要产业伙伴
  • 主要协会和二手资料来源
  • 预测方法
  • 数据三角测量与验证
  • 假设和限制

第 3 章:执行摘要

  • 市场概况
  • 主要市场细分概述
  • 主要市场参与者概述
  • 重点地区/国家概况
  • 市场驱动因素、挑战、趋势概述

第 4 章:客户之声

第 5 章:全球伴随诊断市场展望

  • 市场规模及预测
    • 按价值
  • 市占率及预测
    • 按产品和服务(试剂盒和试剂、检测、软体和服务)
    • 按技术(PCR、NGS、原位杂交、免疫组织化学等)
    • 依疾病适应症(肿瘤学、神经学、心臟科、传染病等)
    • 按应用(体外诊断、药物发现等)
    • 按最终用户(製药和生物技术公司、研究实验室、合约研究组织等)
    • 按地区
    • 按公司划分 (2022)
  • 市场地图

第 6 章:北美伴随诊断市场展望

  • 市场规模及预测
    • 按价值
  • 市占率及预测
    • 按产品和服务
    • 依技术
    • 按疾病适应症
    • 按应用
    • 按最终用户
    • 按国家/地区
  • 北美:国家分析
    • 美国
    • 加拿大
    • 墨西哥

第 7 章:欧洲伴随诊断市场展望

  • 市场规模及预测
    • 按价值
  • 市占率及预测
    • 按产品和服务
    • 依技术
    • 按疾病适应症
    • 按应用
    • 按最终用户
    • 按国家/地区
  • 欧洲:国家分析
    • 德国
    • 英国
    • 义大利
    • 法国
    • 西班牙

第 8 章:亚太地区伴随诊断市场展望

  • 市场规模及预测
    • 按价值
  • 市占率及预测
    • 按产品和服务
    • 依技术
    • 按疾病适应症
    • 按应用
    • 按最终用户
    • 按国家/地区
  • 亚太地区:国家分析
    • 中国
    • 印度
    • 日本
    • 韩国
    • 澳洲

第 9 章:南美洲伴随诊断市场展望

  • 市场规模及预测
    • 按价值
  • 市占率及预测
    • 按产品和服务
    • 依技术
    • 按疾病适应症
    • 按应用
    • 按最终用户
    • 按国家/地区
  • 南美洲:国家分析
    • 巴西
    • 阿根廷
    • 哥伦比亚

第 10 章:中东和非洲伴随诊断市场展望

  • 市场规模及预测
    • 按价值
  • 市占率及预测
    • 按产品和服务
    • 依技术
    • 按疾病适应症
    • 按应用
    • 按最终用户
    • 按国家/地区
  • MEA:国家分析
    • 南非伴随诊断
    • 沙乌地阿拉伯同侪诊断
    • 阿联酋伴随诊断

第 11 章:市场动态

  • 司机
  • 挑战

第 12 章:市场趋势与发展

  • 近期发展
  • 併购
  • 产品发布

第 13 章:全球伴随诊断市场:SWOT 分析

第 14 章:波特的五力分析

  • 产业竞争
  • 新进入者的潜力
  • 供应商的力量
  • 客户的力量
  • 替代产品的威胁

第15章:竞争格局

  • 商业概览
  • 服务内容
  • 最近的发展
  • 主要人员
  • SWOT分析
    • Abbott Laboratories Inc.
    • Agilent Technologies Inc.
    • F.Hoffmann-La Roche Ltd
    • Biomerieux SA
    • Qiagen NV
    • Siemens Healthcare
    • Thermo Fisher Scientific Inc.
    • Danaher Corporation (Beckman Coulter Inc.)
    • Myriad Genetics Inc.
    • Illumina Inc.

第 16 章:策略建议

第 17 章:关于我们与免责声明

简介目录
Product Code: 4536

Global Companion Diagnostic Market has valued at USD 5.85 Billion in 2022 and is anticipated to project impressive growth in the forecast period with a CAGR of 12.29% through 2028. Companion diagnostics are medical devices used in conjunction with therapeutic drugs to assess the impact and suitability of drugs for specific individuals. These diagnostics are developed alongside drugs to identify patient groups that respond to or are not suitable for the therapy based on their characteristics. Healthcare professionals utilize this device to evaluate the effectiveness of a particular treatment for a patient.

In 2020, Roche obtained FDA approval for the Cobas EGFR Mutation Test v2 companion diagnostic, which assists in determining the appropriate use of EGFR tyrosine kinase inhibitors for lung cancer treatment. Companion Diagnostic (CDx) is a clinical test co-developed with a therapeutic drug to identify patients who will respond or not respond to the drug. It enables the identification of patient groups that can or cannot be treated with the corresponding drug. CDx helps practitioners evaluate the benefits, side effects, and associated risks of therapeutic drugs, ensuring patient safety.

The global Companion Diagnostics Market is driven by factors such as increasing patient demand for tailored therapy, expanded applications of personalized medications, higher prevalence of chronic diseases, and growing incidence of medication-related allergies. These factors contribute to the development of customized CDx, promoting market growth. Additionally, CDx tests offer advantages such as cost-effectiveness, high sensitivity, and rapid and accurate results within shorter time frames, further fueling the growth of the Companion Diagnostics Market.

Market Overview
Forecast Period2024-2028
Market Size 2022USD 5.85 Billion
Market Size 2028USD 11.73 Billion
CAGR 2023-202812.29%
Fastest Growing SegmentPharmaceutical & Biotechnology Companies
Largest MarketNorth America

Key Market Drivers

Increasing Demand for NGS-Based Technology

The growing demand for next-generation sequencing (NGS) technology, with its exceptional capability to identify rare variants, plays a critical role in the continued success and wider distribution of companion diagnostics solutions in the companion diagnostics market. By utilizing NGS panels, a single test has the potential to aid in the treatment of numerous types of cancers, offering a more comprehensive approach to personalized medicine.

For instance, in July 2022, Almac Diagnostic forged a strategic partnership with AstraZeneca, a leading pharmaceutical company, to collaboratively develop and commercialize multiple companion diagnostic (CDx) products. These innovative CDx solutions will be based on cutting-edge NGS (next-generation sequencing) and qPCR-based (quantitative polymerase chain reaction) technologies, further advancing the field of precision medicine and enhancing patient care. Through this collaboration, Almac Diagnostic and AstraZeneca aim to improve the accuracy and effectiveness of diagnostics, enabling targeted therapies and personalized treatment plans for patients. This partnership demonstrates the commitment of both companies to drive innovation in the field of companion diagnostics and contribute to the advancement of precision medicine.

By leveraging the power of NGS and qPCR technologies, Almac Diagnostic and AstraZeneca envision a future where companion diagnostics play a pivotal role in guiding treatment decisions and improving patient outcomes across various therapeutic areas. This collaboration represents a significant step forward in the development of advanced diagnostic solutions that will revolutionize the way diseases are diagnosed and treated. With the combination of cutting-edge technologies and strategic partnerships, the field of precision medicine is poised to make significant strides in improving patient care and transforming healthcare on a global scale.

Companion Diagnostics for the Targeted Cancer Drugs

Clinical studies have shown that a significant percentage, up to 75%, of cancer patients do not respond favorably to the same prescribed cancer drug. This highlights the pressing need for companion diagnostic tests, which play a crucial role in identifying the presence of a molecular target and also uncovering any off-target effects of a therapeutic. By doing so, these tests can predict toxicities and adverse effects associated with a drug, ultimately aiding in personalized treatment approaches.

It is worth noting that over 90% of globally approved companion diagnostic (CDx) tests are specifically associated with targeted cancer therapeutics. This CDx approach to cancer genomic characterization not only helps physicians identify the specific alterations driving the growth of a patient's cancer but also enables them to explore targeted treatment options that may not have been previously considered. This comprehensive and tailored approach to cancer treatment holds immense potential in improving patient outcomes and revolutionizing the field of oncology.

Advancements in The Latest Technologies

Next-generation sequencing (NGS) based companion indicative tests aim to unlock nuclear information from the genome of each individual to guide treatment decisions for various diseases. By utilizing advanced sequencing techniques, NGS can identify multiple biomarkers in a shorter timeframe compared to other sequencing methods. This comprehensive approach allows for the assessment of biomarkers in a single test, potentially benefiting the treatment of a wide range of illnesses. Furthermore, the continuous advancements in NGS technology provide market players with a competitive edge over those offering alternative technologies such as PCR, ICH, and ISH. As a result, key industry players are actively engaged in the development of companion diagnostic products based on NGS, capitalizing on the opportunities presented by this innovative field.

Rising Use of Personalized Medicine

The increasing utilization of personalized medicine is a key driver behind the growth of the companion diagnostic market. Personalized medicine encompasses a multifaceted approach to patient care, enhancing not only the ability to diagnose and treat diseases but also enabling the identification of diseases at earlier stages, facilitating more effective treatment. The growing popularity of personalized medical care stems from its targeted approach based on individuals' genetic characteristics. In the United States, a considerable number of individuals seeking medical care experience misdiagnosis, which can result in delayed and inaccurate diagnoses.

Furthermore, companion diagnostics are gaining prominence in the development of personalized medicines for early disease detection and the selection of precise treatment methods, ultimately contributing to reduced mortality rates. Accurate assessment of an individual's genetic composition plays a vital role in determining their health status and susceptibility to severe diseases. Increasing awareness about genetic diseases will further facilitate the development and commercialization of personalized medicines, specifically tailored to address these conditions. Moreover, the demand for companion diagnostic tests is anticipated to rise throughout the forecast period, driven by the need for accurate patient diagnosis and the advancement of personalized medicine.

Key Market Challenges

Lack of Awareness and High Cost of Companion Diagnostics Techniques

While immunotherapy has shown significant promise in the treatment of cancer, its high cost has limited widespread patient access. As a result, physicians may opt to combine treatments, which can extend the duration of treatment from five months to over three years. With longer treatment duration comes a greater financial burden, as the cost of personalized immunotherapies is also substantial. In fact, the cost of cancer immunotherapies can far exceed that of other treatment options such as chemotherapy or radiation therapy. Consequently, the high cost of immuno-oncology treatments is believed to impede the growth of the companion diagnostics market. This financial barrier highlights the need for continued research and innovation to develop more affordable and accessible immunotherapies for cancer patients.

Lack of Resources in Underdeveloped Nations

Companion diagnostic tests require meticulous attention at every step to ensure successful execution and reproducible results. One of the significant challenges in these scientific fields is the scarcity of technically skilled and trained personnel. The complexity of companion diagnostic tests often demands sophisticated techniques and instruments, such as image processing, in certain analytical procedures. The presence of proficient and experienced staff with strong technical capabilities is paramount for biopharma companies, academic institutions, R&D laboratories, and organizations.

However, there is a decline in comprehensive training programs for laboratory professionals as they face undue pressure to deliver faster turnaround times. Consequently, the focus on training laboratory managers or preparing them to become experts is insufficient. Moreover, the compensation package offered is not competitive, leading to a high turnover rate. These factors, combined with the lack of recognition and understanding of the importance of laboratory professionals, contribute to the diminishing number of professionals in this field. This trend is expected to continue during the forecast period, potentially offsetting the market growth in focus.

Key Market Trends

Growing Importance of Promotional Activities

The increasing significance of promotional activities represents a key trend in the companion diagnostics market. Companion diagnostics, due to their specificity in being applicable only to particular drugs, are not as extensively marketed as other available test kits and devices in the market. Therefore, it is crucial to give greater attention to improving the distribution network and enhancing the availability of products to end users. In terms of advertising sources, internet channels and search engines are among the most vital, considering their higher visibility and the limited return on investment and visibility of other media.

Furthermore, besides boosting sales, emphasis is placed on product functionality, accuracy, and vendors' after-sales services, while marketing communication takes a back seat. Limited promotion activities pose challenges in reaching the target market and understanding a company's competitive position. To attract customers to a company website, the publication of multiple blogs and newsletters can be beneficial. This approach allows businesses to sustain their marketing campaigns over an extended period and attract repeat visitors. As the market continues to witness product enhancements, vendors are increasingly recognizing the importance of promotional activities, and this trend is expected to gain momentum, thereby supporting the growth of the global companion diagnostics market throughout the forecast period.

Growing advancements in biologics

The companion diagnostics market is highly consolidated, with key players such as F. Hoffmann-La Roche Ltd. (Switzerland), Agilent Technologies, Inc. (the US), Qiagen N.V. (Germany), Thermo Fisher Scientific, Inc. (the US), and Abbott Laboratories, Inc. (the US) collectively holding a significant market share in 2020. Intense competition exists among market players, and only major corporations can afford the substantial investment in capital, research and development, and manufacturing. Consequently, this market poses significant barriers to entry for new competitors.

Segmental Insights

Technology Insights

The Polymerase Chain Reaction (PCR) segment is currently dominating the market share and is expected to experience significant growth throughout the forecast period. This can be attributed to its cost-effectiveness, high sensitivity, and specificity, which are crucial factors driving the expansion of the market. Moreover, PCR can be employed on simple automated platforms, further enhancing its appeal. Furthermore, PCR plays a vital role in determining the sequencing of unknown etiologies for various diseases, making it an indispensable driver of this segment. Its ability to accurately identify the genetic makeup of pathogens contributes to better understanding and diagnosis of diseases.

On the other hand, the next-generation sequencing segment is projected to grow rapidly in the forecast period. This is primarily due to its key advantages, such as higher sensitivity in detecting low-frequency variants, shorter turnaround time for analyzing large sample volumes, and the ability to simultaneously sequence hundreds to thousands of genes or gene regions. These advantages make next generation sequencing a promising technology with immense potential for various applications in the field of genomics and personalized medicine.

End User Insights

The companion diagnostics market is fragmented into various segments, including Pharmaceutical & Biotechnology Companies, Research Laboratories, Contract Research Organizations, and Others. Among these, the Pharmaceutical & Biotechnology Companies segment holds the largest market share. This can be attributed to the growing utilization of companion diagnostics in drug development and the increasing significance of companion diagnostic biomarkers. Companion diagnostics play a crucial role in personalized medicine, helping to identify patients who are most likely to benefit from a specific treatment. This not only improves patient outcomes but also enhances the efficiency and effectiveness of the drug development process. With advancements in technology and the increasing focus on precision medicine, the demand for companion diagnostics is expected to further rise in the coming years.

Regional Insights

In terms of revenue share, North America is projected to dominate the market during the forecast period. This can be attributed to several factors, including the high prevalence of chronic diseases, the presence of well-established clinical laboratories and companion diagnostic vendors, and the availability of advanced instruments and devices. Moreover, the region benefits from a growing geriatric population, high disposable income, increasing awareness about companion diagnostics, and a rising number of research and development activities. These additional factors are expected to further fuel the revenue growth of the North America market in the coming years. North America accounted for the largest share of the companion diagnostics market. The growth of the companion diagnostics market in North America can be attributed to the presence of numerous leading companion diagnostics vendors and public clinical research centers, the easy availability of technologically advanced devices and instruments, and the highly developed healthcare system in the US and Canada.

The utilization of companion diagnostics is considered a significant treatment option tool for various oncology drugs, a classification reflected in the FDA's assessment of these tests in terms of risk.

Key Market Players

  • Abbott Laboratories Inc.
  • Agilent Technologies Inc.
  • F.Hoffmann-La Roche Ltd
  • Biomerieux SA
  • Qiagen NV
  • Siemens Healthcare
  • Thermo Fisher Scientific Inc.
  • Danaher Corporation (Beckman Coulter Inc.)
  • Myriad Genetics Inc.
  • Illumina Inc.

Report Scope:

In this report, the Global Companion Diagnostic Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Companion Diagnostic Market, By Product and Services:

  • Kits and Reagents
  • Assays
  • Software
  • Services

Companion Diagnostic Market, By Technology:

  • PCR
  • NGS
  • In-Situ Hybridization
  • Immunohistochemistry
  • Others

Companion Diagnostic Market, By Disease Indication:

  • Oncology
  • Neurology
  • Cardiology
  • Infectious Diseases
  • Others

Companion Diagnostic Market, By Application:

  • In-Vitro Diagnostics
  • Drug Discovery
  • Others

Companion Diagnostic Market, By End User:

  • Pharmaceutical & Biotechnology Companies
  • Research Laboratories
  • Contract Research Organization Others

Companion Diagnostic Market, By Region:

  • North America
  • United States
  • Canada
  • Mexico
  • Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
  • Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
  • South America
  • Brazil
  • Argentina
  • Colombia
  • Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait
  • Turkey
  • Egypt

Competitive Landscape

  • Company Profiles: Detailed analysis of the major companies present in the Global Companion Diagnostic Market.

Available Customizations:

  • Global Companion Diagnostic market report with the given market data, Tech Sci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validations
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Companion Diagnostic Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Product and Services (Kits and Reagents, Assays, Software, and Services)
    • 5.2.2. By Technology (PCR, NGS, In-Situ Hybridization, Immunohistochemistry, and Others)
    • 5.2.3. By Disease Indication (Oncology, Neurology, Cardiology, Infectious Diseases, and Others)
    • 5.2.4. By Application (In-Vitro Diagnostics, Drug Discovery, and Others)
    • 5.2.5. By End User (Pharmaceutical & Biotechnology Companies, Research Laboratories, Contract Research Organization, and Others)
    • 5.2.6. By Region
    • 5.2.7. By Company (2022)
  • 5.3. Market Map

6. North America Companion Diagnostic Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Product and Services
    • 6.2.2. By Technology
    • 6.2.3. By Disease Indication
    • 6.2.4. By Application
    • 6.2.5. By End User
    • 6.2.6. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Companion Diagnostic Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Product and Services
        • 6.3.1.2.2. By Technology
        • 6.3.1.2.3. By Disease Indication
        • 6.3.1.2.4. By Application
        • 6.3.1.2.5. By End User
    • 6.3.2. Canada Companion Diagnostic Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Product and Services
        • 6.3.2.2.2. By Technology
        • 6.3.2.2.3. By Disease Indication
        • 6.3.2.2.4. By Application
        • 6.3.2.2.5. By End User
    • 6.3.3. Mexico Companion Diagnostic Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Product and Services
        • 6.3.3.2.2. By Technology
        • 6.3.3.2.3. By Disease Indication
        • 6.3.3.2.4. By Application
        • 6.3.3.2.5. By End User

7. Europe Companion Diagnostic Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Product and Services
    • 7.2.2. By Technology
    • 7.2.3. By Disease Indication
    • 7.2.4. By Application
    • 7.2.5. By End User
    • 7.2.6. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. Germany Companion Diagnostic Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Product and Services
        • 7.3.1.2.2. By Technology
        • 7.3.1.2.3. By Disease Indication
        • 7.3.1.2.4. By Application
        • 7.3.1.2.5. By End User
    • 7.3.2. United Kingdom Companion Diagnostic Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Product and Services
        • 7.3.2.2.2. By Technology
        • 7.3.2.2.3. By Disease Indication
        • 7.3.2.2.4. By Application
        • 7.3.2.2.5. By End User
    • 7.3.3. Italy Companion Diagnostic Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecasty
        • 7.3.3.2.1. By Product and Services
        • 7.3.3.2.2. By Technology
        • 7.3.3.2.3. By Disease Indication
        • 7.3.3.2.4. By Application
        • 7.3.3.2.5. By End User
    • 7.3.4. France Companion Diagnostic Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Product and Services
        • 7.3.4.2.2. By Technology
        • 7.3.4.2.3. By Disease Indication
        • 7.3.4.2.4. By Application
        • 7.3.4.2.5. By End User
    • 7.3.5. Spain Companion Diagnostic Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Product and Services
        • 7.3.5.2.2. By Technology
        • 7.3.5.2.3. By Disease Indication
        • 7.3.5.2.4. By Application
        • 7.3.5.2.5. By End User

8. Asia-Pacific Companion Diagnostic Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Product and Services
    • 8.2.2. By Technology
    • 8.2.3. By Disease Indication
    • 8.2.4. By Application
    • 8.2.5. By End User
    • 8.2.6. By Country
  • 8.3. Asia-Pacific: Country Analysis
    • 8.3.1. China Companion Diagnostic Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Product and Services
        • 8.3.1.2.2. By Technology
        • 8.3.1.2.3. By Disease Indication
        • 8.3.1.2.4. By Application
        • 8.3.1.2.5. By End User
    • 8.3.2. India Companion Diagnostic Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Product and Services
        • 8.3.2.2.2. By Technology
        • 8.3.2.2.3. By Disease Indication
        • 8.3.2.2.4. By Application
        • 8.3.2.2.5. By End User
    • 8.3.3. Japan Companion Diagnostic Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Product and Services
        • 8.3.3.2.2. By Technology
        • 8.3.3.2.3. By Disease Indication
        • 8.3.3.2.4. By Application
        • 8.3.3.2.5. By End User
    • 8.3.4. South Korea Companion Diagnostic Market Outlook
      • 8.3.4.1. Market Size & Forecast
        • 8.3.4.1.1. By Value
      • 8.3.4.2. Market Share & Forecast
        • 8.3.4.2.1. By Product and Services
        • 8.3.4.2.2. By Technology
        • 8.3.4.2.3. By Disease Indication
        • 8.3.4.2.4. By Application
        • 8.3.4.2.5. By End User
    • 8.3.5. Australia Companion Diagnostic Market Outlook
      • 8.3.5.1. Market Size & Forecast
        • 8.3.5.1.1. By Value
      • 8.3.5.2. Market Share & Forecast
        • 8.3.5.2.1. By Product and Services
        • 8.3.5.2.2. By Technology
        • 8.3.5.2.3. By Disease Indication
        • 8.3.5.2.4. By Application
        • 8.3.5.2.5. By End User

9. South America Companion Diagnostic Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Product and Services
    • 9.2.2. By Technology
    • 9.2.3. By Disease Indication
    • 9.2.4. By Application
    • 9.2.5. By End User
    • 9.2.6. By Country
  • 9.3. South America: Country Analysis
    • 9.3.1. Brazil Companion Diagnostic Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Product and Services
        • 9.3.1.2.2. By Technology
        • 9.3.1.2.3. By Disease Indication
        • 9.3.1.2.4. By Application
        • 9.3.1.2.5. By End User
    • 9.3.2. Argentina Companion Diagnostic Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Product and Services
        • 9.3.2.2.2. By Technology
        • 9.3.2.2.3. By Disease Indication
        • 9.3.2.2.4. By Application
        • 9.3.2.2.5. By End User
    • 9.3.3. Colombia Companion Diagnostic Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Product and Services
        • 9.3.3.2.2. By Technology
        • 9.3.3.2.3. By Disease Indication
        • 9.3.3.2.4. By Application
        • 9.3.3.2.5. By End User

10. Middle East and Africa Companion Diagnostic Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Product and Services
    • 10.2.2. By Technology
    • 10.2.3. By Disease Indication
    • 10.2.4. By Application
    • 10.2.5. By End User
    • 10.2.6. By Country
  • 10.3. MEA: Country Analysis
    • 10.3.1. South Africa Companion Diagnostic Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Product and Services
        • 10.3.1.2.2. By Technology
        • 10.3.1.2.3. By Disease Indication
        • 10.3.1.2.4. By Application
        • 10.3.1.2.5. By End User
    • 10.3.2. Saudi Arabia Companion Diagnostic Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Product and Services
        • 10.3.2.2.2. By Technology
        • 10.3.2.2.3. By Disease Indication
        • 10.3.2.2.4. By Application
        • 10.3.2.2.5. By End User
    • 10.3.3. UAE Companion Diagnostic Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Product and Services
        • 10.3.3.2.2. By Technology
        • 10.3.3.2.3. By Disease Indication
        • 10.3.3.2.4. By Application
        • 10.3.3.2.5. By End User

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Recent Development
  • 12.2. Mergers & Acquisitions
  • 12.3. Product Launches

13. Global Companion Diagnostic Market: SWOT Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Products

15. Competitive Landscape

  • 15.1. Business Overview
  • 15.2. Service Offerings
  • 15.3. Recent Developments
  • 15.4. Key Personnel
  • 15.5. SWOT Analysis
    • 15.5.1. Abbott Laboratories Inc.
    • 15.5.2. Agilent Technologies Inc.
    • 15.5.3. F.Hoffmann-La Roche Ltd
    • 15.5.4. Biomerieux SA
    • 15.5.5. Qiagen NV
    • 15.5.6. Siemens Healthcare
    • 15.5.7. Thermo Fisher Scientific Inc.
    • 15.5.8. Danaher Corporation (Beckman Coulter Inc.)
    • 15.5.9. Myriad Genetics Inc.
    • 15.5.10. Illumina Inc.

16. Strategic Recommendations

17. About Us & Disclaimer