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市场调查报告书
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1433347
2023-2030 年全球多重检测市场Global Multiplex Assays Market 2023-2030 |
预计在预测期内(2023-2030 年),全球多重检测市场将以 14.8% 的CAGR成长。市场的成长归因于免疫疗法的不断进步。免疫疗法,特别是嵌合抗原受体 (CAR) T 细胞疗法在癌症治疗中的使用增加,增加了对 CAR-T 细胞精确测量和监测的需求。多重数位 PCR 检测可透过提供确定治疗成功所需的准确、全面的分析来满足需求。例如,2023 年6 月,BioPharma Services, Inc. 推出了新的多重数位PCR 检测,用于对多种CAR-T 细胞进行全面定量,这是一种癌症免疫疗法,涉及对T 细胞进行基因改造以识别和消灭某些癌症。该分析基于 Qiagen QIAcuity 数位 PCR 方法,该方法透过其独特的奈米板方法提供强大而简单的数位 PCR 体验。
全球多重检测市场按类型、技术和最终用户进行细分。根据类型,市场细分为蛋白质多重检测、基于核酸的多重检测和基于细胞的多重检测。根据技术,市场细分为多重即时 PCR、Luminex 微珠技术、流式细胞仪等。此外,根据最终用户,市场细分为製药和生物製药公司、CRO、研究和学术机构等。在这些类型中,基于核酸的多重检测子类别预计将占据很大一部分市场份额。这归因于基于核酸的多重测定的使用和基于核酸的多重测定的研究的增加。
在这些技术中,多重即时 PCR 子领域预计将在全球多重检测市场中占据相当大的份额。部门成长归因于测试效率的提升。多重检测透过在单一回应中检测多个目标来简化测试。在一次反应中识别两个 N 基因标靶序列的能力减少了测试时间,提高了通量,并提高了诊断实验室效率。例如,2020 年 5 月,Gold Standard Diagnostics 推出了针对 SARS-CoV-2 的多重即时 PCR 检测。 GSD NovaPrime SARS-CoV-2 (COVID-19) 是一种即时 PCR 检测,旨在检测 SARS-CoV-2。这是一种多重测试,可在一次反应中检测 N 基因的两个目标序列,并在 2 小时内提供结果。试剂包括萃取/抑制对照和阳性对照。
全球多重检测市场根据地理位置进一步细分,包括北美(美国和加拿大)、欧洲(英国、义大利、西班牙、德国、法国和欧洲其他地区)、亚太地区(印度、中国、日本) 、韩国和亚洲其他地区)以及世界其他地区(中东和非洲以及拉丁美洲)。其中,由于患有慢性和传染病的人数不断增加,以及对多重检测产品和服务的使用意识不断提高,预计北美将在全球市场中占据显着份额。
在所有地区中,北美地区预计在预测期内将以相当大的CAGR成长。区域成长归因于大流行的防范和监测。主要驱动因素是迫切需要精确、高效的血清学检测,以检测先前的感染情况并追踪 COVID-19 大流行期间的人群暴露率。具有高特异性和敏感性的多重检测(例如这种血清学检测)对于人群层面的监测至关重要。据美国国立卫生研究院 (NIH.gov) 称,2022 年 1 月,使用两组康復者的血清样本开发并验证了一种血清学 COVID-19 多重检测方法;以及那些尚未被感染的人。在测试了多种潜在抗原后,选择 SARS-CoV-2 核衣壳蛋白 (NP) 和刺突蛋白的受体结合域 (RBD) 进行人类 COVID-19 多重检测。合成的 RBD 蛋白与哺乳动物表现的 RBD 蛋白的比较显示了哺乳动物表现的优势。 NP 和 RBD 特异性 IgG 和 IgA 的检测在区分患者和对照组方面具有出色的性能(AUC > 0.90),并且 IgG 检测具有更宽的动态范围。该测定用于评估居住在纽约州伊萨卡低发病率社区的人们的 SARS-CoV-2 血清阳性率。 2020 年采样的 332 名健康志愿者中,1.2-5.7% 的 NP 或 RBD 检测呈阳性,高于该县报告的 0.16% 的发病率。此测定可用于监测社区暴露率以及感染或疫苗接种后免疫反应的持续时间。
服务全球多重检测市场的主要公司包括 Bio-Rad Laboratories, Inc.、Merck Group、PerkinElmer US LLC、Quansys Biosciences Inc.、Thermo Fisher Scientific Inc. 等。市场参与者透过各种策略(包括併购、合作、合作、融资和新产品发布),为市场成长做出了巨大贡献,以保持市场竞争力。例如,2023年7月,EDP Biotech与New Day Diagnostics合併,成立一家垂直整合的诊断公司,以推进诊断测试的开发和商业化。 EDP 提供 ColoPlex 体外诊断测定,有助于早期检测癌前息肉和大肠直肠癌。
Global Multiplex assays Market Size, Share & Trends Analysis Report by Type (Protein Multiplex Assays, Nucleic Acid-Based Multiplex Assays, and Cell-based Multiplex Assays), by Technology (Multiplex Real-Time PCR, Luminex Bead Technology, Flow Cytometry, and Others), and by End-User (Pharmaceutical and Biopharmaceutical Companies, Contract Research Organizations (CROs), Research and Academic Institutions, Others), Forecast Period (2023-2030)
The global multiplex assays market is anticipated to grow at a CAGR of 14.8% during the forecast period (2023-2030). The market's growth is attributed to the increasing advancements in immunotherapy. The increased use of immunotherapy, particularly chimeric antigen receptor (CAR) T cell therapy, for cancer treatment increases the need for accurate measurement and monitoring of CAR-T cells. Multiplex digital PCR assays satisfy the demand by delivering accurate, comprehensive analysis necessary for determining therapy success. For instance, in June 2023, BioPharma Services, Inc., launched new multiplex digital PCR assays for comprehensive quantification of multiple CAR-T cells, a type of cancer immunotherapy that involves genetically modifying T-cells to recognize and destroy certain cancers. The analysis is based on the Qiagen QIAcuity digital PCR methodology, that offers a powerful yet simple digital PCR experience with its unique nanoplate methodology.
The global multiplex assays market is segmented on the type, technology, and end-user. Based on the type, the market is sub-segmented into protein multiplex assays, nucleic acid-based multiplex assays, and cell-based multiplex assays. Based on the technology, the market is sub-segmented into multiplex real-time PCR, Luminex bead technology, flow cytometry, and others. Further, based on the end-user, the market is sub-segmented into pharmaceutical and biopharmaceutical companies, CROs, research and academic institutions, and others. Among the type, the nucleic acid-based multiplex assays subcategory is expected to capture a significant portion of the market share. This is attributed to the increase in the usage of nucleic acid-based multiplex assays and research on nucleic acid-based multiplex assays.
Among the technology, the multiplex real-time PCR sub-segment is expected to hold a considerable share of the global multiplex assays market. The segmental growth is attributed to the enhanced testing efficiency. Multiplex assays simplify testing by detecting several targets in a single response. The capacity to recognize two N-gene target sequences in a single reaction decreases testing time, boosts throughput, and enhances diagnostic laboratory efficiency. For instance, in May 2020, Gold Standard Diagnostics Launched Multiplex Real-Time PCR Assay for SARS-CoV-2. GSD NovaPrime SARS-CoV-2 (COVID-19) is a real-time PCR test designed to detect SARS-CoV-2. It is a multiplex test which detects two target sequences of the N-gene in one reaction, providing results in 2 hours. The reagents include an extraction/ inhibition control and a positive control.
The global multiplex assays market is further segmented based on geography including North America (the US, and Canada), Europe (UK, Italy, Spain, Germany, France, and the Rest of Europe), Asia-Pacific (India, China, Japan, South Korea, and Rest of Asia), and the Rest of the World (the Middle East & Africa, and Latin America). Among these, North America is anticipated to hold a prominent share of the market around the globe, owing to the increasing number of individuals suffering from chronic and infectious diseases, in addition to increased awareness of the usage of multiplex assay products and services.
Among all regions, the North America region is anticipated to grow at a considerable CAGR over the forecast period. Regional growth is attributed to the pandemic preparedness and surveillance. A primary driving element is the urgent need for precise and efficient serological assays to detect prior infections and track population exposure rates during the COVID-19 pandemic. Multiplex assays with high specificity and sensitivity, such as this serological assay, are essential in population-level surveillance. According to the National Institute of Health (NIH.gov), in January 2022, a serological COVID-19 multiplex assay was developed and validated using serum samples from 2 groups of recovered people; and those who had not yet been infected. After testing multiple potential antigens, the SARS-CoV-2 nucleocapsid protein (NP) and receptor-binding domain (RBD) of the spike protein were selected for the human COVID-19 multiplex assay. A comparison of synthesized and mammalian expressed RBD proteins showed the advantages of mammalian expression. Detection of NP and RBD specific IgG and IgA had excellent performance (AUC > 0.90) for distinguishing patients from controls, with the IgG assay having a wider dynamic range. This assay was used to evaluate seroprevalence to SARS-CoV-2 in people living in a low-incidence community in Ithaca, NY. Of the 332 healthy volunteers sampled 2020, 1.2-5.7% tested positive for either NP or RBD, which was higher than the county's reported incidence rate of 0.16%. This assay can be used to monitor community exposure rates and the duration of immune response following infection or vaccination.
The major companies serving the global multiplex assays market include Bio-Rad Laboratories, Inc., Merck Group, PerkinElmer U.S. LLC, Quansys Biosciences Inc., Thermo Fisher Scientific Inc., and others. The market players are considerably contributing to the market growth by the adoption of various strategies including mergers and acquisitions, partnerships, collaborations, funding, and new product launches, to stay competitive in the market. For instance, in July 2023, EDP Biotech merged with New Day Diagnostics to form a vertically integrated diagnostic company to advance the development and commercialization of diagnostic tests. EDP offers the ColoPlex in vitro diagnostic assay, that assists in the early detection of pre-cancerous cancer polyps and colorectal cancer.