市场调查报告书
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恒温核酸增幅技术市场:按产品类型、应用和最终用户划分 - 2024-2030 年全球预测Isothermal Nucleic Acid Amplification Technology Market by Product, Type, Application, End-User - Global Forecast 2024-2030 |
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恒温核酸增幅技术市场规模预估2023年为37.7亿美元,2024年达42.5亿美元,预计2030年将达到92.2亿美元,复合年增长率为13.64%。
恒温核酸增幅技术在医院、学术和研究机构中的使用越来越多,在这些机构中,可以在目标分子存在的情况下在恆温下产生 DNA 或 RNA。等温扩增过程比聚合酵素链锁反应(PCR) 更有效率,具有更高的扩增产量和更少的样本製备步骤。这种恒温核酸增幅技术因其准确性和检测多种分子的能力而被广泛用作血液筛检和感染疾病诊断中的分子检测技术。此外,随着抗菌药物和感染疾病的传播,检测抗菌药物抗药性基因和包括细菌和病毒在内的各种病原体的需求也越来越大。然而,缺乏对恒温核酸增幅的认识和严格的法律规范可能会限制其在最终用途领域的使用。恒温核酸增幅技术的进步以及医疗保健监管机构对创新技术的核准预计将在市场上创造巨大的机会。
主要市场统计 | |
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基准年[2023] | 37.7亿美元 |
预测年份 [2024] | 42.5亿美元 |
预测年份 [2030] | 92.2亿美元 |
复合年增长率(%) | 13.64% |
透过产品恒温核酸增幅技术系统的进步扩展业务和工作流程自动化
测定、套件和试剂对于恒温核酸增幅过程至关重要,为反应提供必要的生化物质。这些产品通常包括在恆温下发挥作用的 DNA 和 RNA聚合酵素等酶、用于扩增的核苷酸、缓衝液以及确保扩增过程的特异性和保真度的其他试剂。在恒温核酸增幅中,系统是指促进和监控扩增过程所需的仪器和设备。这些系统旨在维持等温扩增所需的恆温,通常包括即时监控扩增过程、自动资料分析和使用者友善介面等功能。相较之下,检测、套件和试剂直接应用于技术的最终用途,对于日常业务和测试至关重要,并且通常是经常性支出。另一方面,该系统是执行这些测定的资本设备,提供等温扩增过程的自动化和进阶监控。
对于类型临床诊断,转录介导的扩增由于其快速和高扩增潜力而越来越受到青睐。
解旋酶依赖性扩增可以轻鬆整合到简单、节能的微系统中。帮助开发用于引子杂合反应和随后透过 DNA聚合酵素进行引子延伸的单链模板。恒温环型核酸扩增(LAMP)和核酸增幅检查(NAAT)在恆温和短反应时间下进行,用于筛检和鑑定病原体以诊断基于病原体的感染疾病。转录介导的扩增也会从目标核酸产生 DNA 或 RNA放大器,这可用于检测各种疾病,例如 HIV-1 和兹卡病毒。链置换扩增 (SDA) 用于扩增 DNA 和 RNA 等核酸。相较之下,LAMP 方法通常是首选,因为它简单且适合照护现场诊断。同时,HDA、SDA等其他方法也因其独特的优势而被选择。特定应用的选择受到所需的灵敏度和特异性、检测开发所需的专业知识以及设备和试剂资源的影响。
应用广泛利用恒温核酸增幅技术进行疾病诊断,改善患者预后
在血液筛检中,恒温核酸增幅技术(INAAT)对于检测致病核酸以确保输血安全至关重要。 INAAT 具有高灵敏度和特异性,可快速识别捐赠血液製品中的血源性病原体。在疾病诊断中,INAAT用于快速、准确地检测各种病原体。该技术可用于整体感染疾病,以促进早期疗育,从而改善患者的治疗结果。 INAAT 可同时快速检测披衣菌感染和淋病等性行为感染传染病。 INAAT 可以直接从临床检体中检测出来,无需复杂的处理步骤,大大增加了其在 STI筛检中的效用。病毒性肝炎感染(特别是B型和C型肝炎)的识别对于慢性肝病的管理和感染预防至关重要。 INAAT 可检测低水平的病毒遗传物质,促进早期诊断并实现病毒量监测,这对于确定治疗策略和评估治疗反应至关重要。 INAAT 有利于早期 HIV 检测,并且可以在血清转换之前识别病毒。这在婴儿检测等情况下尤其重要,因为母源抗体可能会干扰传统的爱滋病毒免疫测量。对于流感病毒引起的呼吸道疾病,INAAT 提供有效病例管理和感染控制所需的快速检测,特别是在流感季节和爆发期间。相较之下,恒温核酸增幅技术广泛应用于疾病诊断,透过早期疗育改善患者预后。
最终用户:恒温核酸增幅技术在医院透过快速且准确的诊断改善患者照护发挥着重要作用。
学术研究机构利用INAAT进行基础科学研究、研发以及分子层面上的各种疾病的研究。由于学术研究的独特性,INAAT 需要高灵敏度、特异性和适应性,才能对研究检体中的核酸进行详细、准确的检测。在医院领域,INAAT有多种用途,包括感染疾病检测、癌症诊断、遗传疾病筛检等。参考文献实验室是专门的诊断设施,可以执行各种复杂的测试,通常作为高通量 INAAT 应用的中心。我们为其他实验室、医院和诊所提供服务,提供在较小环境下无法实现的先进测试。相较之下,学术和研究机构注重弹性和成本效率进行深入研究,而医院则优先考虑快速诊断以快速治疗患者。同时,参考实验室依靠 INAAT 的高通量和可靠性来有效地服务各种外部客户。
区域洞察
美洲是一个高度开拓的地区,其市场格局的特点是诊断程序的增加以及医院和学术研究机构引入创新等温核酸解决方案的增加。印度、泰国、新加坡、马来西亚和韩国等亚太地区医疗基础设施的发展和医疗旅游的增加,正在扩大使用恒温核酸增幅技术检测病毒性疾病的需求。 2023年1月,北京大学报告称,中国已有9亿人感染冠状病毒,实验室和诊断中心扩大使用恒温核酸增幅方法检测SARS-CoV-2 RNA的情况将进一步增加。此外,感染疾病的日益普及以及政府改进诊断程序的努力正在扩大恒温核酸增幅技术在欧洲、中东和非洲地区的使用。此外,医疗保健监管机构对创新诊断技术的核准不断增加,预计将推动恒温核酸增幅技术的全球成长。
FPNV定位矩阵
FPNV定位矩阵对于评估恒温核酸增幅技术市场至关重要。我们检视与业务策略和产品满意度相关的关键指标,以对供应商进行全面评估。这种深入的分析使用户能够根据自己的要求做出明智的决策。根据评估,供应商被分为四个成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市场占有率分析
市场占有率分析是一种综合工具,可以对恒温核酸增幅技术市场供应商的现状进行深入而详细的研究。全面比较和分析供应商在整体收益、基本客群和其他关键指标方面的贡献,以便更好地了解公司的绩效及其在争夺市场占有率时面临的挑战。此外,该分析还提供了对该行业竞争特征的宝贵见解,包括在研究基准年观察到的累积、分散主导地位和合併特征等因素。这种详细程度的提高使供应商能够做出更明智的决策并制定有效的策略,从而在市场上获得竞争优势。
1. 市场渗透率:提供有关主要企业所服务的市场的全面资讯。
2. 市场开拓:我们深入研究利润丰厚的新兴市场,并分析其在成熟细分市场的渗透率。
3. 市场多元化:提供有关新产品发布、开拓地区、最新发展和投资的详细资讯。
4.竞争评估与资讯:对主要企业的市场占有率、策略、产品、认证、监管状况、专利状况、製造能力等进行全面评估。
5. 产品开发与创新:提供对未来技术、研发活动和突破性产品开发的见解。
1.恒温核酸增幅技术市场规模及预测是多少?
2.在恒温核酸增幅技术市场的预测期间内,有哪些产品、细分市场、应用和领域需要考虑投资?
3.恒温核酸增幅技术市场的技术趋势和法规结构是什么?
4.恒温核酸增幅技术市场主要厂商的市场占有率为何?
5.进入恒温核酸增幅技术市场的合适型态和策略手段是什么?
[196 Pages Report] The Isothermal Nucleic Acid Amplification Technology Market size was estimated at USD 3.77 billion in 2023 and expected to reach USD 4.25 billion in 2024, at a CAGR 13.64% to reach USD 9.22 billion by 2030.
The usage of isothermal nucleic acid amplification technology is increasing across hospitals and academic & research institutes, which enables the creation of DNA and RNA in the presence of a target molecule at constant temperatures. The isothermal amplification processes have greater efficiency, produce higher amplification yields, and need fewer sample preparation steps than polymerase chain reaction (PCR). This isothermal nucleic acid amplification technology is widely used as a molecular detection technique in blood screening and infectious disease diagnosis owing to its accuracy and ability to detect various molecules. Furthermore, the growing prevalence of antimicrobial and infectious diseases has increased the need to detect antimicrobial resistance genes and various pathogens, including bacteria and viruses. However, a lack of awareness and a stringent regulatory framework for isothermal nucleic acid amplification may limit their use in end-use sectors. The advancement in isothermal nucleic acid amplification techniques and approvals from healthcare regulatory authorities for innovative technologies are expected to create immense opportunities for the market.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 3.77 billion |
Estimated Year [2024] | USD 4.25 billion |
Forecast Year [2030] | USD 9.22 billion |
CAGR (%) | 13.64% |
Product: Advancements in isothermal nucleic acid amplification technology systems to scale up their operations and automate their workflows
Assays, kits, and reagents are vital in the isothermal nucleic acid amplification process, providing the necessary biochemical substances for reactions. These products typically include enzymes such as DNA and RNA polymerases that function at a constant temperature, nucleotides for amplification, buffers, and other reagents that ensure the specificity and fidelity of the amplification process. Systems in the context of isothermal nucleic acid amplification refer to the instruments and devices needed to facilitate and monitor the amplification process. These systems are engineered to maintain the constant temperature required for isothermal amplification and often come with features such as real-time monitoring of the amplification process, automated data analysis, and user-friendly interfaces. In comparison, assays, kits, & reagents are often seen as recurring spend with direct application to the technology's end-use, making them integral for routine operations and testing. On the other hand, systems are capital equipment that enables these assays to be performed, offering automation and sophisticated monitoring of the isothermal amplification processes.
Type: Growing preference for transcription-mediated amplification in clinical diagnostics for its rapid and high amplification capacity
Helicase-dependent amplification is easily integrated into simple and low-energy consumption microsystems. It helps to develop single-stranded templates for primer hybridization and subsequent primer extension by a DNA polymerase. Loop-mediated isothermal amplification (LAMP) and nucleic acid amplification testing (NAAT) methods are carried out at a constant temperature with a short reaction time and used to screen and identify a pathogen for diagnosing pathogen-based infections. Moreover, transcription-mediated amplification produces DNA and RNA amplicon from a target nucleic acid and helps detect various diseases, such as HIV-1 and Zika virus. Strand displacement amplification (SDA) is used to amplify nucleic acids, such as DNA and RNA. In comparison, LAMP is often favored for its simplicity and suitability for point-of-care diagnostics. At the same time, other methods, such as HDA and SDA, are selected for their unique advantages. Selection for a specific application is influenced by required sensitivity and specificity, the expertise needed for assay development, and equipment and reagent resources.
Application: Extensive utilization of isothermal nucleic acid amplification technology for disease diagnoses for promoting better patient outcomes
In blood screening, isothermal nucleic acid amplification technology (INAAT) is crucial in detecting pathogenic nucleic acids to ensure the safety of blood transfusions. INAAT provides high sensitivity and specificity, allowing for the rapid identification of bloodborne pathogens in donated blood products. In the context of disease diagnosis, INAAT is leveraged to detect various pathogens promptly and accurately. This technology is utilized across infectious diseases, promoting better patient outcomes through early intervention. INAAT offers rapid and simultaneous detection of sexually transmitted infections such as chlamydia and gonorrhea. INAAT's ability to work directly from clinical samples without complex processing steps significantly enhances its utility in STI screening. Identifying viral hepatitis infections (notably Hepatitis B and C) is essential for managing chronic liver diseases and preventing transmission. INAAT detects low levels of viral genetic material, facilitating early diagnosis and monitoring of viral load, which is integral to treatment decisions, and assessing response to therapy. INAAT is beneficial in early-stage HIV detection, where it may identify the virus before seroconversion. This is particularly important in scenarios such as infant testing, where maternal antibodies can interfere with traditional HIV immunoassays. For respiratory illnesses, such as those caused by influenza viruses, INAAT offers the rapid detection necessary for effective patient management and infection control measures, especially during flu seasons or outbreaks. In comparison, the isothermal nucleic acid amplification technology is widely utilized in disease diagnosis for promoting better patient outcomes through early intervention.
End-User: Significant role of isothermal nucleic acid amplification technology in hospitals for rapid and accurate diagnostics to improve patient care
Academic and research institutes utilize INAAT for basic scientific research, method development, and the study of various diseases at the molecular level. The inherent nature of academic research demands high sensitivity, specificity, and adaptability of the technology, enabling detailed and accurate detection of nucleic acids in research specimens. In the hospital sector, INAAT is utilized for various applications such as infectious disease detection, cancer diagnostics, and genetic disorder screening. Reference laboratories are specialized diagnostic facilities that conduct a wide range of complex tests, often serving as the hubs for high-throughput INAAT applications. They serve other laboratories, hospitals, and clinics, providing sophisticated testing that may not be feasible in smaller settings. In comparison, academic and research institutes focus on flexibility and cost-efficiency for in-depth research, whereas hospitals prioritize rapid diagnostics for immediate patient care. On the other hand, reference laboratories rely on the high throughput and reliability of INAAT to serve various external clients efficiently.
Regional Insights
Americas represents a highly developing landscape for the isothermal nucleic acid amplification technology market characterized by an increasing number of diagnostic procedures across hospitals and academic & research institutes and an increasing introduction of innovative isothermal nucleic acid solutions. The development in healthcare infrastructure and increasing medical tourism in various Asia-Pacific regions, such as India, Thailand, Singapore, Malaysia, and South Korea, are expanding the need for isothermal nucleic acid amplification technology to detect viral diseases. In January 2023, Peking University reported that 900 million individuals had been infected with the coronavirus in China, and has further expected to expand the usage of isothermal nucleic acid amplification for the detection of SARS-CoV-2 RNA in research laboratories and diagnostic centers. Moreover, increasing the prevalence of infectious diseases and government initiatives for improving diagnostic procedures are subsequently expanding the use of isothermal nucleic acid amplification technology in the EMEA region. Additionally, rising approvals from healthcare regulatory authorities for innovative diagnostic technologies are expected to encourage the growth of isothermal nucleic acid amplification technology worldwide.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Isothermal Nucleic Acid Amplification Technology Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Isothermal Nucleic Acid Amplification Technology Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Isothermal Nucleic Acid Amplification Technology Market, highlighting leading vendors and their innovative profiles. These include Abbott Laboratories, AtilaBiosystems, Beijing SBS Genetech Co., Ltd., bioMerieux SA, Biosearch Technologies by LGC Limited, DiaSorin S.p.A., Eiken Chemical Co., Ltd., Fortis Life Sciences, LLC, GENOMTEC S.A., GenoSensor Corporation, Grifols S.A., highQu GmbH, Hologic, Inc., Illumina, Inc., Jena Bioscience GmbH, Life Sciences Advanced Technologies, Inc., Mast Group Ltd., Meridian Bioscience Inc. by SD Biosensor, Inc., New England Biolabs, Inc., OptiGene Limited, PCR Biosystems Ltd., QIAGEN GmbH, Quidel Corporation, Tecan Trading AG, Thermo Fisher Scientific Inc., Ustar Biotechnologies (Hangzhou) Ltd, Xiamen Jiqing Biomedical Technology Co., Ltd., Zhengzhou Laboao Instrument Equipment CO., LTD, and Zhuhai Biori Biotechnology Co., Ltd..
Market Segmentation & Coverage
1. Market Penetration: It presents comprehensive information on the market provided by key players.
2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
1. What is the market size and forecast of the Isothermal Nucleic Acid Amplification Technology Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Isothermal Nucleic Acid Amplification Technology Market?
3. What are the technology trends and regulatory frameworks in the Isothermal Nucleic Acid Amplification Technology Market?
4. What is the market share of the leading vendors in the Isothermal Nucleic Acid Amplification Technology Market?
5. Which modes and strategic moves are suitable for entering the Isothermal Nucleic Acid Amplification Technology Market?
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