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市場調查報告書
商品編碼
1372932

伴隨診斷市場 - 2018-2028 年全球產業規模、佔有率、趨勢、機會和預測，按產品和服務、技術、疾病適應症、按應用、最終用戶、地區和競爭細分

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個工作天內

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簡介目錄

2022 年全球伴隨診斷市場價值為58.5 億美元，預計在預測期內將出現令人印象深刻的成長，到2028 年年複合成長率為12.29%。伴隨診斷是與治療藥物結合使用的醫療設備，用於評估治療藥物的影響和適用性。針對特定個體的藥物。這些診斷方法與藥物一起開發，以根據患者的特徵識別對治療有反應或不適合治療的患者群體。醫療保健專業人員利用該設備來評估特定治療對患者的有效性。

2020年，羅氏的Cobas EGFR突變測試v2伴隨診斷獲得FDA批准，此診斷有助於確定EGFR酪胺酸激酶抑制劑在肺癌治療中的適當使用。伴隨診斷 (CDx) 是與治療藥物共同開發的臨床測試，用於識別對藥物有反應或無反應的患者。它能夠識別可以或不能用相應藥物治療的患者群體。 CDx 可協助從業人員評估治療藥物的益處、副作用和相關風險，確保患者安全。

全球伴隨診斷市場的促進因素包括患者對客製化治療的需求不斷增加、個人化藥物的應用範圍擴大、慢性病盛行率上升以及藥物相關過敏發生率上升等。這些因素有助於客製化伴隨診斷的發展，促進市場成長。此外，CDx 測試具有成本效益、高靈敏度以及在更短的時間內快速準確地獲得結果等優勢，進一步推動了伴隨診斷市場的成長。

市場概況
預測期 2024-2028
2022 年市場規模 58.5億美元
2028 年市場規模 117.3億美元
2023-2028 年年複合成長率 12.29%
成長最快的細分市場 製藥與生物技術公司
最大的市場 北美洲

主要市場促進因素

對基於 NGS 的技術的需求不斷增加

對次世代定序 (NGS) 技術日益成長的需求及其識別罕見變異的卓越能力，對於伴隨診斷解決方案在伴隨診斷市場中的持續成功和更廣泛分佈發揮關鍵作用。透過利用 NGS 組合，單一測試有可能幫助治療多種類型的癌症，為個人化醫療提供更全面的方法。

標靶抗癌藥物的伴隨診斷

臨床研究表明，很大比例（高達 75%）的癌症患者對同一種處方抗癌藥物沒有良好反應。這凸顯了對伴隨診斷測試的迫切需求，這些測試在識別分子標靶的存在以及發現治療的任何脫靶效應方面發揮著至關重要的作用。透過這樣做，這些測試可以預測與藥物相關的毒性和不良反應，最終有助於個人化治療方法。

值得注意的是，超過 90% 的全球批准的伴隨診斷 (CDx) 測試與標靶癌症治療特別相關。這種癌症基因組特徵的伴隨診斷方法不僅可以幫助醫生識別驅動患者癌症生長的特定改變，還使他們能夠探索以前可能沒有考慮過的有針對性的治療方案。這種全面且量身定做的癌症治療方法在改善患者治療效果和徹底改變腫瘤學領域方面具有巨大潛力。

最新科技的進步

基於次世代定序（NGS）的伴隨指示性測試旨在解鎖每個個體基因組的核訊息，以指導各種疾病的治療決策。與其他定序方法相比，透過利用先進的定序技術，NGS 可以在更短的時間內識別多種生物標記。這種綜合方法可以在一次測試中評估生物標記物，可能有利於多種疾病的治療。此外，NGS 技術的不斷進步為市場參與者提供了比 PCR、ICH 和 ISH 等替代技術的競爭優勢。因此，主要產業參與者積極參與基於NGS的伴隨診斷產品的開發，利用這一創新領域帶來的機會。

個人化醫療的使用不斷增加

個人化醫療的日益普及是伴隨診斷市場成長的關鍵驅動力。個人化醫療包括多方面的患者照護方法，不僅提高診斷和治療疾病的能力，而且能夠在早期階段識別疾病，促進更有效的治療。個人化醫療的日益普及源於其基於個人遺傳特徵的有針對性的方法。在美國，相當多的尋求醫療照護的人都經歷過誤診，這可能導致診斷延遲和不準確。

此外，伴隨診斷在開發用於早期疾病檢測和選擇精確治療方法的個人化藥物方面越來越重要，最終有助於降低死亡率。準確評估個體的遺傳組成對於確定其健康狀況和對嚴重疾病的易感性起著至關重要的作用。提高對遺傳疾病的認知將進一步促進專門針對這些疾病的個人化藥物的開發和商業化。此外，由於對患者準確診斷的需求和個人化醫療的進步，預計在整個預測期內對伴隨診斷測試的需求將會上升。

主要市場挑戰

缺乏意識且伴隨診斷技術成本高

雖然免疫療法在治療癌症方面顯示出巨大的前景，但其高昂的成本限制了患者的廣泛使用。因此，醫生可能會選擇聯合治療，這可以將治療持續時間從五個月延長至三年以上。治療持續時間越長，經濟負擔就越大，因為個人化免疫療法的成本也很高。事實上，癌症免疫療法的成本可能遠遠超過化療或放射療法等其他治療方案。因此，免疫腫瘤治療的高成本被認為阻礙了伴隨診斷市場的成長。這項財務障礙凸顯了持續研究和創新的必要性，以便為癌症患者開發更實惠、更容易取得的免疫療法。

欠已開發國家缺乏資源

伴隨診斷測試的每一步都需要一絲不苟，以確保成功執行和可重複的結果。這些科學領域面臨的重大挑戰之一是缺乏技術熟練和訓練有素的人員。伴隨診斷測試的複雜性通常需要複雜的技術和儀器，例如在某些分析程序中的影像處理。對於生物製藥公司、學術機構、研發實驗室和組織來說，擁有熟練、經驗豐富、技術能力強的員工至關重要。

然而，針對實驗室專業人員的全面培訓計畫有所減少，因為他們面臨著加快週轉時間的過度壓力。因此，對實驗室管理人員的培訓或讓他們成為專家的關注不夠。此外，提供的薪酬方案缺乏競爭力，導致人員流動率較高。這些因素，加上對實驗室專業人員重要性缺乏認知和理解，導致該領域專業人員數量不斷減少。預計這一趨勢將在預測期內持續下去，可能抵消市場關注的成長。

主要市場趨勢

促銷活動的重要性日益增加

促銷活動的重要性日益增強，代表了伴隨診斷市場的一個主要趨勢。伴隨診斷由於其特異性僅適用於特定藥物，因此不像市場上其他可用的測試套件和設備那樣廣泛銷售。因此，更加重視改善分銷網路和提高最終用戶的產品可用性至關重要。就廣告來源而言，網路管道和搜尋引擎是最重要的，因為它們的知名度較高，而其他媒體的投資回報和知名度有限。

此外，除了促進銷售外，重點還放在產品的功能、準確性和供應商的售後服務上，而行銷傳播則退居次位。有限的促銷活動為進入目標市場和了解公司的競爭地位帶來了挑戰。為了吸引客戶造訪公司網站，發布多個部落格和電子報可能會有所幫助。這種方法使企業能夠長期維持行銷活動並吸引回頭客。隨著市場不斷見證產品的增強，供應商越來越認知到促銷活動的重要性，而這一趨勢預計將獲得動力，從而支持全球伴隨診斷市場在整個預測期內的成長。

生物製劑不斷進步

伴隨診斷市場高度整合，主要參與者包括 F. Hoffmann-La Roche Ltd.（瑞士）、Agilent Technologies, Inc.（美國）、Qiagen NV（德國）、Thermo Fisher Scientific, Inc.（美國） ）和雅培公司（美國）在2020年共同佔據了相當大的市場佔有率。市場參與者之間競爭激烈，只有大公司才有能力承擔在資本、研發和製造方面的大量投資。因此，這個市場對新競爭者的進入構成了巨大的障礙。

細分市場洞察

技術洞察

聚合酶鍊式反應 (PCR) 領域目前在市場佔有率中佔據主導地位，預計在整個預測期內將出現顯著成長。這可以歸因於其成本效益、高靈敏度和特異性，這是推動市場擴張的關鍵因素。此外，PCR 可以在簡單的自動化平台上使用，進一步增強了其吸引力。此外，PCR 在確定各種疾病的未知病因的定序方面發揮著至關重要的作用，使其成為該領域不可或缺的驅動力。它準確識別病原體基因組成的能力有助於更好地了解和診斷疾病。

另一方面，下一代定序領域預計將在預測期內快速成長。這主要是由於其關鍵優勢，例如檢測低頻變異的靈敏度更高、分析大樣本量的周轉時間更短，以及同時對數百至數千個基因或基因區域進行測序的能力。這些優點使次世代定序成為一種有前途的技術，在基因組學和個人化醫療領域的各種應用中具有巨大的潛力。

最終使用者見解

伴隨診斷市場分為各個細分市場，包括製藥和生物技術公司、研究實驗室、合約研究組織等。其中，製藥與生技公司細分市場佔有最大的市場佔有率。這可以歸因於伴隨診斷在藥物開發中的使用不斷增加以及伴隨診斷生物標記的重要性日益增加。伴隨診斷在個人化醫療中發揮著至關重要的作用，有助於識別最有可能從特定治療中受益的患者。這不僅改善了患者的治療效果，也提高了藥物開發過程的效率和有效性。隨著技術的進步和對精準醫療的日益關注，對伴隨診斷的需求預計在未來幾年將進一步成長。

區域洞察

就收入佔有率而言，預計北美將在預測期內佔據市場主導地位。這可以歸因於多種因素，包括慢性病的高盛行率、完善的臨床實驗室和伴隨診斷供應商的存在，以及先進儀器和設備的可用性。此外，該地區還受益於老年人口的成長、可支配收入的增加、伴隨診斷意識的提高以及研發活動的增加。這些額外因素預計將在未來幾年進一步推動北美市場的收入成長。北美佔據伴隨診斷市場的最大佔有率。北美伴隨診斷市場的成長可歸因於眾多領先的伴隨診斷供應商和公共臨床研究中心的存在、技術先進的設備和儀器的容易獲得以及美國和加拿大高度發達的醫療保健系統。

伴隨診斷的使用被認為是各種腫瘤藥物的重要治療選擇工具，這一分類反映在 FDA 對這些測試的風險評估中。

目錄

第 1 章：產品概述

  • 市場定義
  • 市場範圍
    • 涵蓋的市場
    • 研究年份
    • 主要市場區隔

第 2 章：研究方法

  • 研究目的
  • 基線方法
  • 主要產業夥伴
  • 主要協會和二手資料來源
  • 預測方法
  • 數據三角測量與驗證
  • 假設和限制

第 3 章：執行摘要

  • 市場概況
  • 主要市場細分概述
  • 主要市場參與者概述
  • 重點地區/國家概況
  • 市場促進因素、挑戰、趨勢概述

第 4 章：客戶之聲

第 5 章：全球伴隨診斷市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 按產品和服務（試劑盒和試劑、檢測、軟體和服務）
    • 按技術（PCR、NGS、原位雜合技術、免疫組織化學等）
    • 依疾病適應症（腫瘤學、神經學、心臟科、傳染病等）
    • 按應用（體外診斷、藥物發現等）
    • 按最終用戶（製藥和生物技術公司、研究實驗室、合約研究組織等）
    • 按地區
    • 按公司分類 (2022)
  • 市場地圖

第 6 章：北美伴隨診斷市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 按產品和服務
    • 依技術
    • 按疾病適應症
    • 按應用
    • 按最終用戶
    • 按國家/地區
  • 北美：國家分析
    • 美國
    • 加拿大
    • 墨西哥

第 7 章：歐洲伴隨診斷市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 按產品和服務
    • 依技術
    • 按疾病適應症
    • 按應用
    • 按最終用戶
    • 按國家/地區
  • 歐洲：國家分析
    • 德國
    • 英國
    • 義大利
    • 法國
    • 西班牙

第 8 章：亞太地區伴隨診斷市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 按產品和服務
    • 依技術
    • 按疾病適應症
    • 按應用
    • 按最終用戶
    • 按國家/地區
  • 亞太地區：國家分析
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳洲

第 9 章：南美洲伴隨診斷市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 按產品和服務
    • 依技術
    • 按疾病適應症
    • 按應用
    • 按最終用戶
    • 按國家/地區
  • 南美洲：國家分析
    • 巴西
    • 阿根廷
    • 哥倫比亞

第 10 章：中東和非洲伴隨診斷市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 按產品和服務
    • 依技術
    • 按疾病適應症
    • 按應用
    • 按最終用戶
    • 按國家/地區
  • MEA：國家分析
    • 南非伴隨診斷
    • 沙烏地阿拉伯同儕診斷
    • 阿拉伯聯合大公國伴隨診斷

第 11 章：市場動態

  • 促進要素
  • 挑戰

第 12 章：市場趨勢與發展

  • 近期發展
  • 併購
  • 產品發布

第 13 章：全球伴隨診斷市場：SWOT 分析

第 14 章：波特的五力分析

  • 產業競爭
  • 新進入者的潛力
  • 供應商的力量
  • 客戶的力量
  • 替代產品的威脅

第15章：競爭格局

  • 商業概覽
  • 服務內容
  • 最近的發展
  • 主要人員
  • 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：策略建議

第 17 章：關於我們與免責聲明

簡介目錄
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