市场调查报告书
商品编码
1540816
2024-2032 年按产品与服务、技术(免疫组织化学、聚合酶连锁反应、原位杂交、即时 PCR、基因定序等)、适应症、最终用户和地区分類的伴随诊断市场报告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,全球伴随诊断市场规模达到 67 亿美元。癌症发生率的上升、对个人化医疗的需求不断增加以及包括下一代定序(NGS)在内的持续技术进步是推动伴随诊断市场成长的一些主要因素。
主要市场驱动因素:对更有针对性和更有效的癌症治疗的日益增长的需求正在积极影响伴随诊断的市场前景。此外,针对患者每个独特特征的个人化药物的日益使用也刺激了伴随诊断市场的需求。
主要市场趋势:推动伴随诊断市场价值的新兴趋势之一是对治疗各种神经、心血管和发炎性疾病的标靶疗法和药物的需求不断增长。除此之外,诊断技术的不断进步,例如下一代定序(NGS)的发展,是刺激伴随诊断市场收入的成长因素。
地理趋势:根据伴随诊断市场研究,北美目前主导全球市场。越来越多的测试获得包括美国食品和药物管理局 (US FDA) 在内的管理机构的批准,正在扩大区域市场。此外,他们也专注于临床试验,从而刺激北美伴随诊断市场的收入。
竞争格局:根据伴随诊断市场概述,全球市场上的一些知名公司包括雅培实验室、安捷伦科技、生物梅里埃、丹纳赫公司、罗氏控股公司、Myriad Genetics Inc.、西门子医疗保健和赛默飞世尔科技公司。
挑战与机会:阻碍伴随诊断市场预测的主要挑战之一是临床试验期间广泛的药物损耗率,这反过来又给诊断提供者带来了财务限制。然而,伴随诊断与治疗产品的共同开发正在简化候选药物的商业化。
对标靶治疗的需求不断增长
在肺癌标靶治疗相关治疗决策中越来越多地采用伴随诊断测试(CDX)正在促进市场成长。此外,在初始治疗中接受伴随诊断的患者比未接受检测的患者有更多的生存益处。除此之外,非小细胞肺癌(NSCLC)盛行率的不断增加导致该疾病的肿瘤学伴随诊断测试的使用量增加。据肺癌研究基金会称,2022 年全美估计有 236,740 人被诊断出患有肺癌,从而刺激了对肺癌伴随诊断的需求。获得管理当局批准的测试数量不断增加也提振了市场。例如,2022 年 8 月,美国 FDA 批准 Thermo Fisher Scientific 的 Oncomine Dx 标靶测试作为伴随诊断 (CDx),以识别肿瘤中存在 HER2 (ERBB2) 激活突变(SNV 和外显子 20 插入)的个体。小细胞肺癌(NSCLC)。
伴随诊断的有利监管环境
各国政府机构和主要公司都在关注药物审批,以满足未满足的癌症治疗需求。例如,2022年1月,PREMIA控股(香港)有限公司和淘大诊断有限公司在日本开发了AmoyDx泛肺癌PCR检测试剂盒(「PLC检测试剂盒」),作为多种抗癌药物的报销伴随诊断。同样,2021 年 10 月,美国食品和药物管理局批准了安捷伦的 Ki-67 IHC MIB-1 pharmDx (Dako Omnis),该产品有助于识别疾病復发风险较高的早期乳癌 (EBC) 患者。此外,2023 年 8 月,安捷伦科技公司获得了伴随诊断检测的欧洲 IVDR 认证。这些批准鼓励主要参与者开发增强型伴随诊断测试,预计在预测期内扩大全球市场。
新颖测试的开发
主要参与者正致力于透过与其他知名参与者合作推出先进的伴随诊断测试,从而获得更好的患者治疗结果。例如,2022年2月,中国主要从事早期癌症筛检产品、分子谱测试和伴随诊断开发的精准肿瘤平台公司泛生子控股有限公司与HTCHMED(中国)有限公司达成协议,推出伴随诊断产品(CDx) 。此外,主要市场参与者也在开发增强的治疗选择。例如,Labcorp 于 2021 年 7 月推出了 Therascreen KRAS PCR 突变分析,这是一种伴随诊断,用于识别患有非小细胞肺癌 (NSCLC) 的患者是否有资格接受 LUMAKRAS (sotorasib) 治疗。
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.