全球癌症分子診斷市場-2022-2029
市場調查報告書
商品編碼
1140666

全球癌症分子診斷市場-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: 約2個工作天內

價格

本網頁內容可能與最新版本有所差異。詳細情況請與我們聯繫。

簡介目錄

市場概覽

到 2021 年,癌症分子診斷市場價值將達到 320.529 億美元。預計在預測期間(2022-2029 年)將以 6.30% 的複合年增長率增長。

癌症的分子診斷包括檢測、診斷、亞分類、預後和監測對治療的反應。這些技術可識別與癌症相關的 DNA 或 RNA 序列的變化。分子診斷可用於分析誘發癌症的生物標誌物以及癌細胞如何表達基因。它還可以闡明癌症和良性腫瘤之間的區別,癌症所涉及的組織類型以及癌症的亞型。

分子診斷可用於設計、實施和個性化治療以進行準確的癌症診斷。分子診斷可用於監測癌症患者的預後。這些技術確定了患癌症的風險。分子診斷可以幫助醫生確定是否需要更密集的篩查或預防措施。市場以多種分子診斷技術的可用性為主導,包括聚合□鏈反應 (PCR)、原位雜交、等溫核酸擴增技術 (INAAT)、芯片和微陣列、質譜、測序和轉錄介導的擴增。

市場動態

癌症發病率的增加推動市場增長

由於癌症發病率上升,市場對癌症分子診斷的需求不斷增加。根據世界衛生組織 (WHO) 的數據,癌症是 2020 年全球死亡的主要原因。到 2020 年,將有大約 1000 萬人死於癌症。全世界每年約有 400 萬兒童患上癌症。肺癌、結腸癌、前列腺癌、乳腺癌、食道癌和胃癌是世界上最常見的癌症之一。肺癌患者數量較多,其次是乳腺癌、結腸癌、前列腺癌和胃癌。肺癌佔所有癌症的11.6%(209萬人),乳腺癌佔所有癌症的11.6%(208萬人),結直腸癌佔所有癌症的10.2%(184萬人),前列腺癌佔10.2 %(192 萬)癌症,胃癌佔所有癌症的 10.2%(212 萬)。 184 萬)、前列腺癌(127 萬)和胃癌(103 萬)。

多機構和團體在癌症分子診斷方面的努力增加促進市場增長

一些機構和組織正在加緊努力開發癌症分子診斷測試。例如,美國國家癌症研究所通過臨床蛋白質組學腫瘤分析聯盟 (CPTAC) 和另一項倡議支持研究,以推進識別和使用蛋白質分子標記和蛋白質組信息用於癌症治療的增加。臨床蛋白質組學腫瘤分析聯盟 (CPTAC) 是由各種學術機構、公司和幾個聯邦機構發起的一項協作努力,旨在快速、大規模地測量腫瘤中蛋白質的總補充量。我們還將這些信息與患者的基因組、影像學和臨床數據相結合。

癌症分子診斷技術進步推動市場增長

用於癌症診斷、預防、治療和管理的癌症分子診斷技術進步正在推動市場發展。一些公司、研究機構和組織致力於開發新的分子診斷方法,例如圖像分析、樣品製備、鳥槍測序和微衛星技術。 Promega 的 MSI 分析系統可檢測與 Lynch 綜合徵相關的微衛星不穩定性。基於 PCR 的 MSI 分析系統使用熒光標記的引物作為多重 PCR 反應中的微衛星標記。 Enzo 基於 PCR 的 AMPIPROBE 平台使用標記有熒光報告基因和淬滅劑的 PCR 引物。它檢測樣品中存在的感興趣的 DNA 或 RNA 的量。

關於睪丸細胞腫瘤基因組生物標誌物的研究正在進行中。根據美國臨床腫瘤學會 (ASCO),在 2019 年,我們揭示了基因組生物標誌物 microRNA371 (M371) 的血清水平作為評估睪丸生殖細胞腫瘤分期和對治療反應的策略的潛力。這項研究表明,M371 測試在預測睪丸生殖細胞腫瘤的臨床分期、腫瘤大小和對治療的反應方面非常準確。 M371 測試可以成為癌症診斷和管理的有效工具。進行生殖系 BRCA 測試以確定可能受益於奧拉帕尼的乳腺癌和卵巢癌患者。

COVID-19 影響分析

全球癌症分子診斷市場受到 COVID-19 流行病的影響。這是因為越來越多的受 COVID-19 影響的人導致各種癌症的檢測和診斷率下降,包括肺癌、結腸癌、卵巢癌和乳腺癌。肺癌受 COVID-19 的影響更為嚴重,因為 COVID-19 是一種呼吸道疾病,患者通常會向醫生諮詢可能被誤認為是新型冠狀病毒的體徵和症狀。帶入實驗室的標本數量正在減少。 COVID-19 大流行減少了在醫院進行的活檢數量。隨著接受定期檢查的患者人數減少,並且正在分配實驗室資源來檢測 COVID-19,癌症患者的定期檢查次數正在減少。因此,癌症診斷測試□□和某些生物標誌物測試正在下降。

一家地區醫院報告說,由於 COVID-19 病例激增,分子腫瘤學檢測下降了 25%。根據商業和公共支付方的數據,2020 年 3 月進行的 EGFR 測試減少了不到 4,000 次。確診結直腸癌的新病例數減少了14%。 RAF 測試減少了 9%,MSI/MMR 測試減少了 8%,RAS 測試減少了 6%。新診斷的乳腺癌下降了 8.4%。卵巢癌的新診斷減少了 8.6%。新診斷的急性髓性白血病減少了 14%。 FLT3 測試減少了 12%,IDH1 測試減少了 11%,IDH2 測試減少了 12%。

流行病學

根據世界衛生組織 (WHO) 的數據,癌症在男性中比在女性中更常見。 2018年,全球有945萬男性和862.2萬女性受到影響。歐洲佔所有癌症的 23.4% 或 422 萬,北美佔所有癌症的 13.2% 或 237 萬,亞洲佔所有癌症的 48.4% 或 875 萬。歐洲癌症死亡人數為194萬,佔總數的20.3%,北美為69萬,佔總數的7.3%,亞洲為547.7萬,佔總數的57.3%。

從全球來看,肺癌的死亡人數居高不下,其次是結直腸癌、胃癌、肝癌和乳腺癌。肺癌佔所有癌症死亡人數的 18.4%,即 176 萬;結直腸癌佔 9.2%,即 88 萬;胃癌,佔 8.2%,即 78 萬;乳腺癌佔所有癌症死亡的 8.1%。 78萬人,肝癌8.2%,78萬人,乳腺癌6.6%,62萬人。

市場細分

試劑和試劑盒有望佔據癌症分子診斷市場的最大份額

按產品分為儀器、試劑/試劑盒等。由於用於癌症診斷、管理和治療的分子診斷測試的試劑和試劑盒的高可用性,試劑和試劑盒部分預計將佔癌症分子診斷市場的最大份額。用於研究和開發的試劑和試劑盒的使用正在增加。幾家公司正在開發試劑和試劑盒。例如,Abbott Molecular Inc. 的 Vysis EGR1 FISH Probe Kit 可檢測骨髓樣本中染色體 5q 上的 LSI EGR1 探針靶標。 Vysis EGR1 FISH 探針試劑盒可用於表徵急性髓性白血病和骨髓增生異常綜合徵患者的骨髓樣本。 Qiagen 的 therascreen PIK3CA RGQ PCR Kit 使用從福爾馬林固定、石蠟包埋的乳腺癌組織或 K2EDTA 抗凝血漿中提取的 DNA 樣本,檢測了磷脂□肌醇 3-激□催化亞基 α (PIK3 CA) 基因中的 11 個突變。檢測的定性體外診斷PCR測試,其有用性得到認可。

通過技術,聚合□鍊式反應 (PCR) 細分市場有望在預測期內實現高速增長

市場根據技術分為聚合□鍊式反應 (PCR)、轉錄介導擴增 (TMA)、原位雜交、測序、等溫核酸擴增技術 (INAAT)、芯片和微陣列、質譜等. 它已經。由於廣泛採用聚合□鍊式反應來識別 DNA 或 RNA 靶基因序列,聚合□鍊式反應 (PCR) 部分預計將顯示出最高的市場增長。聚合□鍊式反應通過一系列加熱和冷卻循環放大遺傳物質。聚合□鍊式反應的發展正在不斷進步。實時熒光定量 PCR 實時監測擴增過程。實時定量逆轉錄 PCR (qRT-PCR) 可以可靠地檢測和測量在 PCR 過程的每個循環中產生的 DNA 或 RNA 中的靶基因序列。 PCR 設備的自動化正在取得進展。

區域分析

北美地區在全球癌症分子診斷市場中佔有最大的市場份額

由於癌症發病率上升,北美地區將在 2021 年主導全球癌症分子診斷市場,佔據最大的市場份額。根據美國癌症協會的數據,到 2022 年,北美將有 190 萬癌症病例。預計到 2022 年將有大約 609,000 人死於癌症。到 2022 年,乳腺癌將成為北美最常見的癌症類型,280,000 人,其次是肺癌 236,000 人,前列腺癌 268,000 人,結直腸癌 104,000 人。

美國擁有最高的市場份額,因為它在癌症分子診斷方面的技術進步很高。例如,由 NCI 資助的 Fred Hutchinson 癌症研究中心的研究人員使用尖端的蛋白質組學技術來指導選擇用於患者的 PD 生物標誌物。貝勒醫學院由 NCI 資助的研究人員創建了一個患者腫瘤特異性蛋白質組圖譜,揭示了一些用於個性化結直腸癌治療的新潛在靶點。 2020 年,由 NCI 資助的貝勒醫學院 Broad 研究所的研究人員及其合作者開發了一種新的綜合蛋白質組分析方法,與傳統方法相比,它需要的組織量更少。對癌症分子診斷的認識正在提高。成熟的診斷基礎設施和設施的存在預計將刺激市場增長。

預計亞太地區將在預測期內以最快的複合年增長率增長。

據估計,亞太地區是全球癌症分子診斷市場增長最快的地區。這是因為癌症分子診斷市場存在未滿足的臨床需求和一些有利可圖的機會。隨著受癌症影響的人數不斷增加,對改進癌症分子診斷的需求也在不斷增長。根據世界衛生組織 (WHO) 的數據,2020 年亞洲將有 950 萬新癌症病例。到 2020 年,大約有 580 萬人將死於癌症。 2020年,亞洲癌症患者人數將達到131萬,是最常見的,其次是結直腸癌100萬,乳腺癌102萬,胃癌81萬。

越來越多的公司正在開發癌症分子診斷技術。開發技術先進的癌症分子診斷的研究和開發工作正在加強。一些公共和私營公司正在增加資金和投資,用於開髮用於癌症診斷、管理和治療的分子診斷技術。例如,2020 年 5 月,EndoPhotonics 獲得了由新加坡醫療集團 (SMG)、百匯控股牽頭的 850 萬美元投資。這筆資金將用於推進公司早期胃癌檢測系統 SPECTRA IMDx 在亞太地區的商業化,並將公司癌症檢測技術的範圍擴大到其他器官。

競爭格局

所研究的癌症分子診斷市場是一個分散的市場,擁有大量市場參與者。 Abbott Laboratories、Bayer Healthcare、Becton Dickinson、Danaher Corporation、Qiagen N.V.、Roche Diagnostics、Siemens Healthcare、Beckman Coulter 和 Nuvera Biosciences 是市場份額較大的主要市場參與者。公司正在採取多種增長戰略,例如產品發布、收購、合併、合作夥伴關係和許可,以增加其市場佔有率。例如:

合併與合作。

2020 年 3 月,全球分子診斷公司 NuProbe 與 QIAGEN 達成合作協議,開發基於下一代測序 (NGS) 的無創液體活檢癌症診斷測試□□。根據協議條款,兩家公司將使用 NuProbe 專有的 Blocker Displacement Amplification (BDA) 技術和 QIAGEN 的 Single Primer Extension (SPE) 技術來準確且廉價地分析具有極低比例突變等位基因的 DNA 突變,我們的目標是執行非侵入性癌症基因組分析。

2020 年 1 月,安進分別與 Guardant Health 和 QIAGEN N.V. 合作,為研究藥物 AMG 510 開發基於血液和組織的伴隨診斷 (CDx)。根據協議條款,兩家公司最初將專注於非小細胞肺癌 (NSCLC) 的伴隨診斷測試,但也將使兩家公司能夠進一步開髮用於安進其他癌症臨床開發項目的診斷測試。

2019 年 7 月,Exact Sciences Corp. 與 Genomic Health, Inc. 合併,組建了一家全球癌症診斷公司。該公司將提供 Cologuard 和 Oncotype DX,這是癌症診斷領域最強大和增長最快的品牌。兩家公司的合併將為世界各地的患者帶來新的和創新的癌症診斷方法。

產品發布和批准

2021 年 8 月 25 日,BD 在其美國實驗室推出了全自動高質量分子診斷平台。隨著此次發布,具有 BD COR 系統擴展基因分型的 BD Onclarity HPV Assay 現在可在美國處理大多數宮頸癌標本的高質量實驗室中使用。

收購

2019 年 6 月,Blue Earth Diagnostics 從領先的醫療保健公司 Syncona 手中收購了私人持有的 Blue Earth Diagnostics 的所有流通股,結算調整價估計為 4.5 億美元至 2500 萬美元。我們同意將其作為一筆交易。根據協議條款,Blue Earth Diagnostics 將成為 Bracco Imaging 的子公司。

合作夥伴關係

2020 年 6 月,Genetron Holdings Limited 與 Thermo Fisher Scientific 建立合作夥伴關係,共同打造測序儀 Genetron S5。此次合作將加強中國公立醫院分子癌症診斷領域下一代測序(NGS)平台的創新、商業化和推廣。

內容

第1章研究方法與範圍

  • 調查方法
  • 調查目的和範圍

第 2 章市場定義和概述

第 3 章執行摘要

  • 按癌症類型劃分的市場細分
  • 按產品劃分的市場細分
  • 按技術劃分的市場細分
  • 最終用戶的市場細分
  • 按地區劃分的市場細分

第 4 章市場動態

  • 市場影響因素
    • 驅動程序
      • 癌症發病率增加
      • 技術進步
    • 限制因素
      • 分子生物診斷劑的批准延遲
      • 缺乏熟練的人力資源
    • 商機
    • 影響分析

第5章行業分析

  • 波特五力分析
  • 流行病學
  • 管道分析
  • 供應鏈分析
  • 定價分析
  • 法律法規分析
  • 保險報銷分析
  • 未滿足的需求分析

第 6 章 COVID-19 分析

  • COVID-19 的市場分析
    • COVID-19 之前的市場情景
    • COVID-19 的當前市場情景
    • COVID-19 後或未來情景
  • COVID-19 期間的價格動態
  • 供需範圍
  • 大流行期間與市場相關的政府舉措
  • 製造商的戰略舉措
  • 總結

第 7 章按癌症類型

  • 乳腺癌
  • 前列腺癌
  • 結腸癌
  • 宮頸癌
  • 肝癌
  • 肺癌
  • 血癌
  • 腎癌
  • 其他

第 8 章按產品分類

    • 設備
    • 試劑和試劑盒
    • 其他

第9章技術

  • 聚合□鍊式反應 (PCR)
  • 轉錄介導的擴增 (TMA)
  • 原位雜交
  • 序列
  • 等溫核酸擴增技術 (INAAT)
  • 芯片和微陣列
  • 質譜
  • 其他

第 10 章,最終用戶

  • 研究所
  • 醫院
  • 學術機構
  • 其他

第 11 章按地區劃分

  • 北美
    • 美國
    • 加拿大
    • 墨西哥
  • 歐洲
    • 德國
    • 英國
    • 法國
    • 意大利
    • 西班牙
    • 其他歐洲
  • 南美洲
    • 巴西
    • 阿根廷
    • 其他南美洲
  • 亞太地區
    • 中國
    • 印度
    • 日本
    • 澳大利亞
    • 其他亞太地區
  • 中東和非洲

第 12 章競爭格局

  • 競爭場景
  • 市場情況/份額分析
  • 併購分析

第 13 章公司簡介

  • 雅培實驗室
    • 公司概況
    • 產品組合和描述
    • 主要亮點
    • 財務摘要
  • 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

簡介目錄
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