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市场调查报告书
商品编码
1722443
2025 年至 2033 年分子诊断市场报告(按产品、技术(聚合酶炼式反应、杂交、DNA 定序、微阵列、等温核酸扩增技术等)、应用、最终用户和地区划分)Molecular Diagnostics Market Report by Product, Technology (Polymerase Chain Reactions, Hybridization, DNA Sequencing, Microarray, Isothermal Nucleic Acid Amplification Technology, and Others), Application, End Users, and Region 2025-2033 |
2024年全球分子诊断市场规模达209亿美元。展望未来, IMARC Group预计到2033年市场规模将达到354亿美元,2025-2033年期间的成长率(CAGR)为5.75%。传染病和遗传疾病的日益流行、聚合酶链反应(PCR)技术的进步、老龄化人口的不断增长、早期疾病检测意识的不断增强以及政府的支持倡议都是影响市场发展轨蹟的因素。
主要市场驱动因素:分子诊断市场正在扩大,主要是由于慢性病和传染病的增加,这反过来又导致对准确诊断方法的需求不断增长。此外,基因组学和个人化医疗的不断进步也促进了分子诊断市场的成长。
主要市场趋势:实质趋势包括对 PCR 的需求(因为它准确且快速)以及由于新方法和诊断技术导致的试剂和试剂盒的增加。此外,非侵入性、早期诊断方法的发展也支持了这项需求。
地理趋势:北美由于拥有先进的医疗基础设施、更多的研发投资以及对个人化医疗的高度重视而处于世界领先地位。此外,亚太地区透过增加资源使用量以及增加与健康相关的知识和支出,面临快速发展。
竞争格局:持续为市场做出贡献的主要竞争公司包括罗氏诊断、雅培实验室、凯杰、Bio-Rad 实验室、西门子医疗、赛默飞世尔科技等。这些企业大力投资新技术和合作伙伴关係,以保持分子诊断市场份额并占领新领域。
挑战与机会:障碍在于分子诊断的监管复杂性与资金。伴随着挑战,新兴市场日益增长的医疗保健需求以及持续的技术进步也为医疗保健提供者带来了新的机会,这些进步有望提供更好的诊断并扩大市场。
慢性病和传染病症率不断上升
市场呈现出惊人的成长率,这主要是由于急性和慢性疾病病例的增加。癌症、心臟病和感染等疾病发生率的增加凸显了分子诊断在快速正确诊断疾病方面的重要作用。这个属性可以带来更好的患者治疗效果,并制定个人化治疗计划,从而增加了市场对分子诊断的需求。随着世界各地健康状况的日益复杂,对新型分子诊断设备的需求也不断增加,这反过来又推动了市场的成长。根据卫生部报告,2016年非传染性疾病占全国死亡人数的61%,占残疾人数的55%。
基因组学和个人化医疗的技术进步
该行业正在经历基因组学和个人化医疗的发展,这对全球分子诊断市场趋势至关重要。 DNA 定序、基因表现和 RNA 等下一代 DNA 定序的基因分析创新至关重要,它们改变了诊断方式并允许识别特定的疾病标记和遗传倾向。个人化医疗的利用,即根据个人的基因特征制定治疗方案,需要能够准确解读复杂基因资讯的复杂诊断技术。先进技术与个人化治疗之间的持续合作正在扩大市场份额。
根据个人化医疗报道,2015年,美国总统欧巴马启动了精准医疗计画(PMI)。该计划为研究人员提供了安全存取大量基因组资料的机会,这些数据从数千个开始,可能扩展到一百万个基因组序列,以进行深入的科学研究。
人口老化加剧,对针对性诊断的需求
由于老年族群中神经退化性疾病和心血管疾病等疾病的增多,对有效诊断方法的需求也在增加。分子诊断具有早期检测健康状况的宝贵功能,从而为便捷且改善疗效的治疗提供了清晰的途径。这一人口结构的成长趋势显着增加了对晶片实验室(LOA)技术等非侵入性和精确工具的需求,这表明越来越多的细分市场倾向于适应这一新的健康需求。这种人口转变对分子诊断市场分析有重大贡献。
试剂和试剂盒占据市场主导地位
由于分子诊断扩展到各个专业医疗领域,市场正在经历显着成长,特别是在试剂和试剂盒领域。研究的新范式和新发明产生了新的分析和测试方法,这些分析和测试方法需要适当的试剂和试剂盒才能实现。慢性病数量的不断增加使得对快速可靠的诊断工具的需求变得更加重要,从而推动了慢性病数量的成长。大型公司与研究机构的合作也对新试剂和试剂盒的开发产生了影响,因此在增加分子诊断市场收入方面发挥了重要作用。
聚合酶炼式反应(PCR)占据市场主导地位
PCR 领域在分子诊断市场前景中占据主导地位。 PCR技术改进的出现,包括qPCR和dPCR的设计和构建,推动了扩增的生化过程,从而提高了灵敏度、准确性和速度。 PCR 的进步使其成为分子诊断中不可或缺的工具。精确分析基因图谱对于个人化医疗和标靶治疗至关重要。此外,即时诊断技术的进步和 PCR 平台的引入使医疗专业人员和患者能够更轻鬆地进行分子检测,从而扩大其在医疗环境中的整合。
传染病诊断占市场主导地位
分子诊断市场概况解释说,市场动态与传染病的快速传播一致,包括病毒、细菌和真菌感染。疾病的迅速传播,特别是那些有可能使世界陷入大流行病的疾病,迫切需要早期检测机制和使用可行的遏制策略。分子生物学和免疫测定技术在诊断领域的出现彻底改变了这一领域,提高了病原体检测和抗药性分类的准确性和速度。这项突破为分子诊断创造了一个有前景的市场,并预示着预防性保健和监测项目成长的强劲趋势。这些措施对医疗介入、阻止疫情蔓延发挥了重要作用。
北美占据明显优势,占最大的分子诊断市场份额
市场研究报告也对所有主要区域市场进行了全面分析,包括北美(美国和加拿大);欧洲(德国、法国、英国、义大利、西班牙、俄罗斯等);亚太地区(中国、日本、印度、韩国、澳洲、印尼等);拉丁美洲(巴西、墨西哥等);以及中东和非洲。根据报告,北美是分子诊断最大的区域市场。
根据分子诊断市场预测期,北美市场因持续研发创新的强大文化而不断成长。随着癌症、心血管疾病、糖尿病等慢性疾病的发生率不断上升,需要快速且可靠的检测方法。医疗专业人员和患者对个人化医疗理解程度的提高以及其他因素正在推动市场成长。政府对医疗保健现代化的援助以及分子诊断技术的建立是业务成长的主要经济驱动力。此外,DTC基因检测也是提高消费者互动程度和支持分子诊断市场近期机会的重要组成部分。
(请注意,这只是关键参与者的部分列表,完整列表在报告中提供。)
主要的分子诊断公司正在参与该行业的最新趋势,例如雅培实验室和安捷伦科技公司。领先的生物製药公司透过推出更新、更精确、经过更好测试的产品来推动诊断技术的改进。此外,全球巨头正透过收购、合併和不同的合作方式继续扩大其在各个地区的影响力,以增加其市场份额并促进进入新市场。这些策略倡议扩大了他们的产品线并提高了他们的活动质量,满足了客製化和即时诊断的持续需求。分子诊断的最新发展包括人工智慧和机器学习技术的融合,可以更好地促进资料分析并提高诊断的准确性。
2023年5月,美国碧迪医疗公司宣布投资8,000万美元在华雷斯城兴建第三家工厂。
2023 年 1 月,安捷伦科技与 Akoya Biosciences 合作开发用于组织分析的多重免疫组织化学诊断产品。两家公司也同意在临床研究市场推广多重检测的端到端工作流程解决方案。
2023 年 4 月,雅培宣布收购心血管系统公司 (CSI),这是一家医疗器材公司,拥有用于治疗週边和冠状动脉疾病的创新动脉粥状硬化切除系统。
The global molecular diagnostics market size reached USD 20.9 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 35.4 Billion by 2033, exhibiting a growth rate (CAGR) of 5.75% during 2025-2033. The increasing prevalence of infectious diseases and genetic disorders, technological advancements in polymerase chain reaction (PCR), growing aging population, surging awareness of early disease detection, and supportive government initiatives are factors shaping the market's trajectory.
Major Market Drivers: The market for molecular diagnostics is expanding primarily due to rise in chronic and infectious illnesses which in turn is leading to growing demand for accurate diagnostics methods. In addition, the continual advancements in genomic and personalized medicine are contributing to the molecular diagnostics market growth.
Key Market Trends: Substantial trends include the demand for PCR as it is accurate and fast and the increase in reagents and kits due to the new methodologies and diagnostic technologies. Besides, the movement towards non-invasive, early diagnosis approaches is also supporting the demand.
Geographical Trends: North America is the leader in the world, due to the presence of advanced medical infrastructure, more investments in R&D and a great emphasis on personalized medicine. In addition, Asia-Pacific faces a fast development through increasing resource usage and more health-related knowledge and spendings.
Competitive Landscape: The key competitive companies that are constantly contributing to the market are Roche Diagnostics, Abbott Laboratories, QIAGEN, Bio-Rad Laboratories, Siemens Healthineers, and Thermo Fisher Scientific and others. These enterprises invest heavily in the new technologies and partnerships to maintain the molecular diagnostics market share and occupy new territories.
Challenges and Opportunities: The barriers are regulatory intricacies and finances of the molecular diagnostics. Along with the challenges, new opportunities emerge for healthcare providers from the growing healthcare needs in the emerging markets and from the constant technological advances which promise better diagnostics and expand the market.
Increasing prevalence of chronic and infectious diseases
The market is exhibiting an outstanding growth rate which is mainly due to the increasing cases of acute and chronic illnesses. This increase in disease occurrence, including cancer, heart diseases, and infection focuses on the significant role of the molecular diagnostics in giving fast and proper diagnosis of the disease. This attribute enables the better patient outcomes and also constitutes individual response personalized treatment plans, which increases the molecular diagnostics demand in the market. Along with the expanding complexities of health conditions all over the world, the demand for newfangled molecular diagnostic equipment is rising, which in turn perpetuates the market growth. According to a report by the ministry of health, in 2016, non-communicable diseases (NCDs) accounted for 61% of all mortalities and 55% of disability cases.
Technological advancements in genomics and personalized medicine
The sector is experiencing developments in genomics and personalized medicine that are crucial for the global molecular diagnostics market trends. Genetic profiling innovations for DNA sequencing, gene expression, and next-generation DNA sequencing such as RNA are essential and changing the ways of diagnosis and allowing the identification of specific disease markers and genetic predispositions. The utilization of personalized medicine, which entails to tailoring treatment based on the individual's genetic profile, is creating a need for sophisticated diagnostic technologies, that is able to decipher complex genetic information accurately. The rising cooperation between sophisticated technologies and tailored treatments is expanding the market share.
According to the personalized medicine report, in 2015, U.S. President Barack Obama launched the precision medicine initiative (PMI). This initiative offers researchers secure access to an extensive array of genomic data, starting with thousands and potentially expanding to one million genome sequences, for in-depth scientific research.
Rising aging population and demand for targeted diagnostics
The demand for efficient diagnostic method is rising due to rising illnesses, such as neurodegenerative disorders and cardiovascular problems in geriatric populations. Molecular diagnostics offer a valuable functionality of early detection of health conditions, thus providing a clear path for treatment at convenient and improved outcomes. The growing trend of this demographic is significantly increasing demand for non-invasive and accurate tools such as lab-on-a-chip (LOA) technology which is indicative of an increasing market segment's inclination to adapt to this new health requirement. This population shift is a significant contributing to the molecular diagnostics market analysis.
Reagents and kits dominate the market
The market is experiencing a significant increase, particularly in the reagents and kits segment, due to the expansion of molecular diagnostics reach into various medical areas of specialization. Fresh paradigms in research and novel inventions generate novel assays and testing methods that require the appropriate reagents and kits to be feasible. The growing number of chronic diseases make the need for fast and dependable diagnostic tools more crucial, driving the increase. Involvement of the major companies with research institutions also has an impact on the development of new reagents and kits, and hence plays a significant part in increasing the molecular diagnostics market revenue.
Polymerase chain reactions (PCR) dominate the market
The PCR segment is dominating the molecular diagnostics market outlook. The advent of PCR technology refinements, including the designing and constructing of qPCR and dPCR, propel the amplification's biochemical process, thereby improves the sensitivity, accuracy, and speed. Such advancement of PCR has made it an indispensable instrument in molecular diagnostics. Precise analysis of genetic profiles which can be used in personalized medicine and targeted therapies is now essential to these treatments. Besides, the point-of-care diagnostics advancement and PCR platform introduction into both of the healthcare professionals and patients make molecular testing more available this leads broaden its integration among healthcare environments.
Infectious diseases diagnostics dominate the market
The molecular diagnostics market overview explains that the market dynamics are in line with rapid spread of infectious diseases, encompassing viral, bacterial, and fungal infections. The rapid spread of diseases, especially those which have the potential to plunge the world into pandemics, has caused an urgent need for early detection mechanism and the use of viable containment strategies. The advent of molecular biology and immunoassay technologies in diagnostics revolutionized this landscape by enhancing the accuracy and speed of pathogen detection and typing for their resistances. This breakthrough has led to the creation of a promising market for molecular diagnostics and indicates a strong trend of the growth of preventive health and surveillance projects. These measures play an important role in the medical involvement and stopping the spread of infections.
North America exhibits a clear dominance, accounting for the largest molecular 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); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America represents the largest regional market for molecular diagnostics.
North America market is growing due to the strong culture of perpetual research and development innovation, as per the molecular diagnostics market forecast period. With the increase in the development of chronic diseases, such as cancer, cardiovascular diseases and diabetes, the rapid and reliable detection methods are required. The increased level of personalized medicine understanding in healthcare professionals and patients alongside other factors is propelling the market growth. Development of government aid in the healthcare modernization and the establishment of molecular diagnostics techniques are the major economies drivers in the business growth. Furthermore, DTC genetic testing is also a significant part which improves the level of consumer interaction and supports the molecular diagnostics market recent opportunities.
(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)
Key molecular diagnostics companies are getting involved in the latest trends in the industry, such as Abbott Laboratories and Agilent Technologies Inc. Leading bio-pharmaceutical firms drive the improvements in diagnostic technology through introduction of newer, more precise, and better tested products. Besides, global giants are continuing to grow their presence across various regions with acquisitions, mergers, and different partnerships in order to increase their market share and facilitating the access to new markets. These strategic moves expand their product lines and improve the quality of their activity, catering to the all-time demand for a customized and point-of-care diagnoses. Molecular diagnostics recent developments include a merger of AI and machine learning technologies that better facilitate data analysis and enhance the accuracy of diagnostics.
In May 2023, Becton Dickinson and Company announced to invest US$ 80 million in the construction of its third plant in Ciudad Juarez.
In January 2023, Agilent Technologies and Akoya Biosciences collaborated to develop multiplex-immunohistochemistry diagnostic products for tissue analysis. The companies also agreed to market end-to-end workflow solutions for multiplex assays in the clinical research market.
In April 2023, Abbott announced the acquisition of Cardiovascular Systems, Inc. (CSI), a medical device company with an innovative atherectomy system used in treating peripheral and coronary artery disease.