市場調查報告書
商品編碼
1540816
2024-2032 年按產品與服務、技術(免疫組織化學、聚合酶連鎖反應、原位雜合技術、即時 PCR、基因定序等)、適應症、最終用戶和地區分類的伴隨診斷市場報告Companion Diagnostics Market Report by Product & Service, Technology (Immunohistochemistry, Polymerase Chain Reaction, In-situ Hybridization, Real-time PCR, Gene Sequencing, and Others), Indication, End User, and Region 2024-2032 |
IMARC Group年,全球伴隨診斷市場規模達到 67 億美元。癌症發生率的上升、對個人化醫療的需求不斷增加以及包括下一代定序(NGS)在內的持續技術進步是推動伴隨診斷市場成長的一些主要因素。
主要市場促進因素:對更有針對性和更有效的癌症治療的日益成長的需求正在積極影響伴隨診斷的市場前景。此外,針對患者每個獨特特徵的個人化藥物的日益使用也刺激了伴隨診斷市場的需求。
主要市場趨勢:推動伴隨診斷市場價值的新興趨勢之一是對治療各種神經、心血管和發炎性疾病的標靶療法和藥物的需求不斷成長。除此之外,診斷技術的不斷進步,例如下一代定序(NGS)的發展,是刺激伴隨診斷市場收入的成長因素。
地理趨勢:根據伴隨診斷市場研究,北美目前主導全球市場。越來越多的測試獲得包括美國食品和藥物管理局 (US FDA) 在內的管理機構的批准,正在擴大區域市場。此外,他們也專注於臨床試驗,從而刺激北美伴隨診斷市場的收入。
競爭格局:根據伴隨診斷市場概述,全球市場上的一些知名公司包括雅培實驗室、安捷倫科技、生物梅里埃、丹納赫公司、羅氏控股公司、Myriad Genetics Inc.、西門子醫療保健和賽默飛世爾科技公司。
挑戰與機會:阻礙伴隨診斷市場預測的主要挑戰之一是臨床試驗期間廣泛的藥物損耗率,這反過來又給診斷提供者帶來了財務限制。然而,伴隨診斷與治療產品的共同開發正在簡化候選藥物的商業化。
對標靶治療的需求不斷成長
在肺癌標靶治療相關治療決策中擴大採用伴隨診斷測試(CDX)正在促進市場成長。此外,在初始治療中接受伴隨診斷的患者比未接受檢測的患者有更多的生存益處。除此之外,非小細胞肺癌(NSCLC)盛行率的不斷增加導致該疾病的腫瘤學伴隨診斷測試的使用量增加。據肺癌研究基金會稱,2022 年全美估計有 236,740 人被診斷出患有肺癌,從而刺激了對肺癌伴隨診斷的需求。獲得管理當局批准的測試數量不斷增加也提振了市場。例如,2022 年 8 月,美國 FDA 批准 Thermo Fisher Scientific 的 Oncomine Dx 標靶測試作為伴隨診斷 (CDx),以識別腫瘤中存在 HER2 (ERBB2) 激活突變(SNV 和外顯子 20 插入)的個體。小細胞肺癌(NSCLC)。
伴隨診斷的有利監管環境
各國政府機構和主要公司都在關注藥物核准,以滿足未滿足的癌症治療需求。例如,2022年1月,PREMIA控股(香港)有限公司和淘大診斷有限公司在日本開發了AmoyDx泛肺癌PCR檢測試劑盒(「PLC檢測試劑盒」),作為多種抗癌藥物的報銷伴隨診斷。同樣,2021 年 10 月,美國食品和藥物管理局批准了安捷倫的 Ki-67 IHC MIB-1 pharmDx (Dako Omnis),該產品有助於識別疾病復發風險較高的早期乳癌 (EBC) 患者。此外,2023 年 8 月,安捷倫科技公司獲得了伴隨診斷檢測的歐洲 IVDR 認證。這些批准鼓勵主要參與者開發增強型伴隨診斷測試,預計在預測期內擴大全球市場。
新穎測試的開發
主要參與者正致力於透過與其他知名參與者合作推出先進的伴隨診斷測試,從而獲得更好的患者治療結果。例如,2022年2月,中國主要從事早期癌症篩檢產品、分子譜測試和伴隨診斷開發的精準腫瘤平台公司泛生子控股有限公司與HTCHMED(中國)有限公司達成協議,推出伴隨診斷產品(CDx) 。此外,主要市場參與者也在開發增強的治療選擇。例如,Labcorp 於 2021 年 7 月推出了 Therascreen KRAS PCR 突變分析,這是一種伴隨診斷,用於識別患有非小細胞肺癌 (NSCLC) 的患者是否有資格接受 LUMAKRAS (sotorasib) 治療。
The global companion diagnostics market size reached US$ 6.7 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 20.4 Billion by 2032, exhibiting a growth rate (CAGR) of 12.7% during 2024-2032. The rising incidences of cancer, the increasing demand for personalized medicine, and continuous technological advancements, including next-generation sequencing (NGS), are some of the primary factors driving the companion diagnostics market growth.
Major Market Drivers: The growing need for more targeted and effective cancer treatments is positively influencing the companion diagnostics market outlook. Additionally, the increasing usage of personalized medicines tailored to each unique characteristics of patients is also stimulating the companion diagnostics market demand.
Key Market Trends: One of the emerging trends propelling the companion diagnostics market value is the inflating demand for targeted therapies and drugs to treat various neurological, cardiovascular, and inflammatory conditions. Besides this, continuous advancements in diagnostic technologies, such as the development of next-generation sequencing (NGS), represent growth factors stimulating the companion diagnostics market revenue.
Geographical Trends: According to the companion diagnostics market research, North America currently dominates the global market. The increasing number of tests receiving approval from governing authorities, including the United States Food and Drug Administration (US FDA), is augmenting the regional market. Furthermore, they are also focusing on clinical trials, thereby stimulating the companion diagnostics market revenue in North America.
Competitive Landscape: According to the companion diagnostics market overview, some of the prominent companies in the global market include Abbott Laboratories, Agilent Technologies, BioMerieux, Danaher Corporation, Roche Holding AG, Myriad Genetics Inc., Siemens Healthcare, and Thermo Fisher Scientific Inc., among many others.
Challenges and Opportunities: One of the primary challenges hindering the companion diagnostics market forecast is the extensive drug attrition rate during clinical trials, which, in turn, poses financial constraints for diagnostics providers. However, the co-development of companion diagnostics, along with therapeutic products, is streamlining the commercialization of drug candidates.
Rising Need for Targeted Therapies
The increasing adoption of companion diagnostic tests (CDXs) in decision-making for treatment related to targeted therapies in lung cancer is augmenting the market growth. Additionally, patients who receive companion diagnostics as part of their initial treatment have more survival benefits than those who are not tested. Besides this, the increasing prevalence of non-small cell lung cancer (NSCLC) is inflating the usage of oncology companion diagnostic tests for the disease. According to the Lung Cancer Research Foundation, an estimated 236,740 individuals were diagnosed with lung cancer in 2022 across the United States, thereby fueling the demand for lung cancer companion diagnostics. The elevating number of tests receiving approval from governing authorities is also bolstering the market. For example, in August 2022, the U.S. FDA granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic (CDx) to identify individuals whose tumors have a HER2 (ERBB2) activating mutations (SNVs & Exon 20 Insertion) in non-small cell lung cancer (NSCLC).
Favorable Regulatory Landscape for Companion Diagnostics
Government bodies and key companies across the countries are focusing on drug approvals to cater to unmet cancer care needs. For instance, in January 2022, PREMIA Holdings (HK) Limited and Amoy Diagnostics Co. Ltd developed the AmoyDx Pan Lung Cancer PCR Panel (the 'PLC Panel') in Japan as a reimbursed companion diagnostic for numerous anti-cancer agents. Similarly, in October 2021, the United States Food and Drug Administration approved Agilent's Ki-67 IHC MIB-1 pharmDx (Dako Omnis), which helped in identifying patients with early breast cancer (EBC) at an elevating risk of disease recurrence. In addition, in August 2023, Agilent Technologies, Inc. received European IVDR certification for companion diagnostic assay. These approvals encourage key players to develop enhanced companion diagnostic tests, which are expected to augment the global market over the forecasted period.
Development of Novel Tests
Key players are focusing on launching advanced tests for companion diagnostics by collaborating with other prominent players, thereby resulting in better patient outcomes. For instance, in February 2022, Genetron Holdings Limited, a major precision oncology platform company in China specializing in early cancer screening products, molecular profiling tests, and companion diagnostics development, entered into an agreement with HUTCHMED (China) Limited to introduce a companion diagnostic (CDx). Furthermore, key market players are also developing enhanced therapeutic options. For example, in July 2021, Labcorp launched Therascreen KRAS PCR Mutation Analysis, which is a companion diagnostic to identify patients suffering from non-small cell lung cancer (NSCLC) who are eligible for therapy with LUMAKRAS (sotorasib).
IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the global, regional, and country levels for 2024-2032. Our report has categorized the market based on product & service, technology, indication, and end user.
Assays, Kits and Reagents
Software and Services
Assays, kits and reagents hold the largest market share
The report has provided a detailed breakup and analysis of the companion diagnostics market based on the product & service. This includes assays, kits and reagents, and software and services. According to the report, assays, kits, and reagents represented the largest segment.
Assays, kits, and reagents play important roles in identifying patients who are most likely to benefit from a particular therapeutic product. These diagnostic tools aid in determining the absence or presence of specific biomarkers, protein expressions, genetic mutations, etc., linked to the potential side effects and effectiveness of targeted therapies. This, in turn, is propelling the market growth in this segment.
Immunohistochemistry (IHC)
Polymerase Chain Reaction (PCR)
In-situ Hybridization (ISH)
Real-time PCR (RT-PCR)
Gene Sequencing
Others
Polymerase chain reaction (PCR) exhibits a clear dominance in the market
The report has provided a detailed breakup and analysis of the market based on the technology. This includes immunohistochemistry (IHC), polymerase chain reaction (PCR), in-situ hybridization (ISH), real-time PCR (RT-PCR), gene sequencing, and others. According to the report, polymerase chain reaction (PCR) accounted for the largest market share.
The growth in this segmentation is bolstered by the easy availability of polymerase chain reaction (PCR) kits and reagents used for companion diagnostics. Moreover, their widespread applications in detecting gene mutations with low or limited allele frequencies are contributing to their dominance in the global market.
Cancer
Lung Cancer
Breast Cancer
Colorectal Cancer
Gastric Cancer
Melanoma
Others
Neurological Diseases
Infectious Diseases
Cardiovascular Diseases
Others
Cancer currently accounts for the majority of the total market share
The report has provided a detailed breakup and analysis of the market based on the indication. This includes cancer (lung cancer, breast cancer, colorectal cancer, gastric cancer, melanoma, and others), neurological diseases, infectious diseases, cardiovascular diseases, and others. According to the report, cancer represented the largest segment.
The widespread incidence of cancer is propelling the usage of companion diagnostics, thereby fueling the market growth in this segmentation. According to the American Cancer Society, in January 2022, 1.9 million cancer cases were recorded in the U.S. Consequently, continuous product launches and approvals by government bodies are positively influencing the companion diagnostics market growth in this segmentation. For example, in October 2021, the United States Food and Drug Administration approved Agilent's Ki-67 IHC MIB-1 pharmDx (Dako Omnis), which assisted in identifying patients with early breast cancer (EBC). Besides this, according to the Lung Cancer Research Foundation, in the United States estimated 236,740 individuals were diagnosed with lung cancer in 2022, thereby propelling the need for lung cancer companion diagnostics.
Pharmaceutical & Biopharmaceutical Companies
Reference Laboratories
Contract Research Organizations
Others
Pharmaceutical & biopharmaceutical companies hold the largest market share
The report has provided a detailed breakup and analysis of the market based on the end user. This includes pharmaceutical & biopharmaceutical companies, reference laboratories, contract research organizations, and others. According to the report, pharmaceutical & biopharmaceutical companies accounted for the largest market share.
The rising adoption of companion diagnostics by pharmaceutical & biopharmaceutical companies in drug development is one of the primary factors propelling the market growth in this segmentation. Moreover, the inflating popularity of companion diagnostics biomarkers is also acting as another significant growth-inducing factor.
North America
United States
Canada
Asia Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa
North America leads the market, accounting for the largest companion diagnostics market share
The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share.
North America currently dominates the global market, with the United States emerging as a major contributor. Strategic collaborations among biopharmaceutical companies and companion diagnostic manufacturers are primarily augmenting the regional market. For example, QIAGEN and Denovo Biopharma partnered to develop a companion diagnostic test for the treatment of diffuse large B-Cell Lymphoma (DLBCL). Furthermore, the increasing drug approvals by governing authorities, such as the United States Food and Drug Administration (US FDA), are projected to bolster the companion diagnostics market in North America over the forecasted period.
Abbott Laboratories
Agilent Technologies
BioMerieux
Danaher Corporation
Roche Holding AG
Myriad Genetics Inc.
Siemens Healthcare
Thermo Fisher Scientific Inc.
(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)
March 2024: Thermo Fisher Scientific announced a collaboration with Bayer AG BAYRY to develop next-generation sequencing (NGS)-based companion diagnostic assays (CDx).
February 2024: Roche has partnered with PathAI to leverage artificial intelligence (AI) to introduce algorithms for companion diagnostics.
December 2023: A German electronics firm, Siemens, contracted to commercialize and develop companion diagnostics by Pfizer.