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市场调查报告书
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1451681
2024-2032 年按测试类型、产品、可用性、应用、最终用户和地区分類的体外诊断市场报告In Vitro Diagnostics Market Report by Test Type, Product, Usability, Application, End User, and Region 2024-2032 |
2023年,全球体外诊断市场规模达到1,109亿美元。展望未来, IMARC Group预计到2032年市场规模将达到1,781亿美元,2024-2032年复合年增长率(CAGR)为5.24%。慢性病和传染病的日益普及、对个人化药物的日益偏好、全球老年人口的不断增加以及技术的不断进步是推动市场发展的一些关键因素。
体外诊断 (IVD) 是指在活体外部(通常在实验室环境中)使用血液、尿液、组织或其他体液等样本进行的医学测试和程序。这些测试旨在检测、诊断和监测各种医疗状况和疾病。与在活体内进行的体内诊断不同,体外诊断涉及在受控实验室条件下检查生物样本。 IVD 测试是现代医疗保健不可或缺的一部分,为医疗保健专业人员提供重要信息,以做出有关患者护理的明智决策。这些测试在疾病筛检、早期诊断、治疗选择和监测治疗进展方面发挥着至关重要的作用。它们用于各种医学专业,包括临床化学、微生物学、血液学、免疫学、分子诊断学等。
在慢性病和传染病日益普及的推动下,该市场正在经历显着成长。随着人口老化的加剧和生活方式的改变,糖尿病、心血管疾病和癌症等慢性疾病变得更加普遍。体外诊断为医疗保健专业人员提供了这些疾病的早期检测和有效管理的重要见解,从而改善患者的治疗结果并降低医疗成本。此外,技术进步和自动化整合已经彻底改变了 IVD 市场。自动化系统,例如即时检测设备和分子诊断,简化了诊断过程,从而能够更快、更准确地获得结果。此外,对个人化医疗和精准诊断的日益关注也增加了对专业体外诊断测试的需求。这些测试有助于根据个别患者的特定遗传和分子特征制定治疗计划,优化治疗结果并最大限度地减少不良反应。
各种技术进步与自动化
技术创新的快速发展彻底改变了体外诊断 (IVD) 市场。分子诊断、新一代定序和微流体等先进技术使得测试方法更加准确和灵敏。自动化简化了诊断流程,减少了人为错误并提高了效率。诸如即时检测设备之类的自动化系统有助于更快地获得结果,从而能够及时制定患者护理决策。这些进步不仅提高了诊断准确性,还有助于节省成本并改善患者的治疗效果。此外,自动化将诊断测试的范围扩大到偏远或资源有限的地区,解决了医疗保健差异并改善了患者获得基本诊断服务的机会。人工智慧和机器学习演算法的整合进一步增强了诊断系统的分析能力,可以实现更精确和个人化的测试解释。随着技术不断进步,体外诊断市场预计将持续成长,诊断测试和应用范围不断扩大。
慢性病盛行率不断上升
糖尿病、心血管疾病和癌症等慢性疾病的盛行率不断上升,一直是 IVD 市场成长的关键驱动力。随着人口老化和生活方式的改变,慢性病在全球变得更加普遍。体外诊断在这些疾病的早期检测、监测和管理中发挥着至关重要的作用。诊断测试可帮助医疗保健专业人员做出明智的治疗决策,从而实现更好的疾病管理并提高患者的生活品质。此外,慢性病的流行促使人们转向预防性医疗保健范式。早期发现和介入对于预防慢性病的进展和减轻医疗系统的负担至关重要。体外诊断有助于早期筛检和识别危险因素,从而能够及时采取预防措施。对预防性医疗保健的重视促使 IVD 测试在常规健康检查和健康计划中被采用。
对个人化医疗的日益重视
对个人化医疗的日益关注对 IVD 市场产生了重大影响。个人化医疗旨在根据患者的基因组成、生活方式和其他因素,为患者量身定制治疗方案。体外诊断,例如基因检测和伴随诊断,可以提供对患者独特特征的重要见解,从而实现标靶治疗并避免不必要的治疗或不良反应。透过次世代定序 (NGS) 和伴随诊断等先进技术实现的精准诊断,有助于识别特定疾病亚型和分子标靶。随着精准医学的日益普及,对专业诊断测试的需求持续成长。医疗保健提供者和製药公司越来越多地投资于研发,以识别新的生物标记并创建创新的诊断解决方案来支持精准医疗计划。
The global in vitro diagnostics market size reached US$ 110.9 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 178.1 Billion by 2032, exhibiting a growth rate (CAGR) of 5.24% during 2024-2032. The growing prevalence of chronic and infectious diseases, the rising preference for personalized medicines, the rising geriatric population across the globe, and continuous advancements in technologies represent some of the key factors driving the market.
In vitro diagnostics (IVD) refers to medical tests and procedures that are performed outside the living organism, typically in a laboratory setting, using samples such as blood, urine, tissue, or other body fluids. These tests are designed to detect, diagnose, and monitor various medical conditions and diseases. Unlike in vivo diagnostics, which are conducted within the living body, in vitro diagnostics involve the examination of biological specimens in controlled laboratory conditions. IVD tests are an integral part of modern healthcare, providing crucial information to healthcare professionals for making informed decisions about patient care. These tests play a vital role in disease screening, early diagnosis, treatment selection, and monitoring treatment progress. They are used across various medical specialties, including clinical chemistry, microbiology, hematology, immunology, molecular diagnostics, and more.
The market is experiencing significant growth, driven by the increasing prevalence of chronic diseases and infectious conditions. With the rise in aging populations and lifestyle changes, chronic diseases such as diabetes, cardiovascular disorders, and cancer have become more prevalent. In vitro diagnostics provide healthcare professionals with essential insights into the early detection and effective management of these conditions, leading to improved patient outcomes and reduced healthcare costs. Moreover, advancements in technology and the integration of automation have revolutionized the IVD market. Automated systems, such as point-of-care testing devices and molecular diagnostics, have streamlined the diagnostic process, enabling faster and more accurate results. Additionally, the growing focus on personalized medicine and precision diagnostics has boosted the demand for specialized in vitro diagnostic tests. These tests help tailor treatment plans to individual patients' specific genetic and molecular characteristics, optimizing therapeutic outcomes and minimizing adverse reactions.
Various technological advancements and automation
The rapid pace of technological innovation has revolutionized the In vitro diagnostics (IVD) market. Advanced technologies, such as molecular diagnostics, next-generation sequencing, and microfluidics, have enabled more accurate and sensitive testing methods. Automation has streamlined diagnostic processes, reducing human errors and increasing efficiency. Automated systems like point-of-care testing devices have facilitated faster results, enabling timely decision-making in patient care. These advancements not only enhance diagnostic accuracy but also contribute to cost savings and improved patient outcomes. Moreover, automation has extended the reach of diagnostic testing to remote or resource-limited areas, addressing healthcare disparities and improving patient access to essential diagnostic services. The integration of artificial intelligence and machine learning algorithms has further enhanced the analytical capabilities of diagnostic systems, allowing for more precise and personalized test interpretations. As technology continues to advance, the In vitro diagnostics market is expected to witness continued growth, with an ever-expanding range of diagnostic tests and applications.
The increasing prevalence of chronic diseases
The rising prevalence of chronic diseases, such as diabetes, cardiovascular disorders, and cancer, has been a key driver in the growth of the IVD market. With aging populations and lifestyle changes, chronic conditions have become more prevalent globally. In vitro diagnostics play a crucial role in the early detection, monitoring, and management of these diseases. Diagnostic tests assist healthcare professionals in making informed treatment decisions, leading to better disease management and improved quality of life for patients. Moreover, the prevalence of chronic diseases has prompted a paradigm shift towards preventive healthcare. Early detection and intervention are essential in preventing the progression of chronic conditions and reducing the burden on healthcare systems. In vitro diagnostics facilitate early screening and identification of risk factors, enabling timely preventive measures. This emphasis on preventive healthcare has spurred the adoption of IVD tests in routine health check-ups and wellness programs.
The growing emphasis on personalized medicine
The growing focus on personalized medicine has significantly impacted the IVD market. Personalized medicine aims to tailor medical treatment to individual patients based on their genetic makeup, lifestyle, and other factors. In vitro diagnostics, such as genetic testing and companion diagnostics, provide critical insights into patients' unique characteristics, enabling targeted therapies and avoiding unnecessary treatments or adverse reactions. Precision diagnostics, enabled by advanced technologies like Next-Generation Sequencing (NGS) and companion diagnostics, facilitate the identification of specific disease subtypes and molecular targets. As precision medicine gains prominence, the demand for specialized diagnostic tests continues to rise. Healthcare providers and pharmaceutical companies are increasingly investing in research and development to identify new biomarkers and create innovative diagnostic solutions to support precision medicine initiatives.
IMARC Group provides an analysis of the key trends in each segment of the global in vitro diagnostics market report, along with forecasts at the global, regional and country levels from 2024-2032. Our report has categorized the market based on test type, product, usability, application and end user.
Clinical Chemistry
Molecular Diagnostics
Immunodiagnostics
Hematology
Others
Molecular diagnostics represents the most popular test type
The report has provided a detailed breakup and analysis of the market based on test type. This includes clinical chemistry, molecular diagnostics, immunodiagnostics, hematology, and others. According to the report, molecular diagnostics represented the largest segment.
Molecular diagnostics offer high levels of accuracy and sensitivity in disease detection. They can identify even low concentrations of target molecules, enabling early diagnosis and precise monitoring of diseases. This level of sensitivity is particularly crucial in the detection of infectious diseases, genetic disorders, and certain types of cancer, where early intervention is vital for successful treatment. Moreover, molecular diagnostics play a key role in the advancement of personalized medicine. By analyzing an individual's genetic makeup or specific biomarkers, these tests can tailor treatment plans to each patient's unique characteristics. This approach optimizes therapeutic outcomes, minimizes adverse effects, and enhances overall patient care, contributing to the growing demand for personalized healthcare solutions.
Reagents and Kits
Instruments
Reagents and kits represent the leading segment
A detailed breakup and analysis of the market based on the product has also been provided in the report. This includes reagents and kits and instruments. According to the report, reagents and kits hold the largest market share.
Reagents and kits are fundamental components of diagnostic tests. They contain the necessary substances and chemicals required to perform specific assays and analyze patient samples. Diagnostic laboratories and healthcare facilities rely heavily on reagents and kits to conduct a wide range of tests, from routine screenings to complex molecular diagnostics. Moreover, Reagents and kits are designed to be user-friendly and standardized, ensuring consistent and reliable results across different laboratories and testing sites. They simplify the testing process, reducing the need for extensive manual preparation and minimizing the risk of errors. Standardization also facilitates inter-laboratory comparability, making it easier for healthcare providers to interpret and act upon test results.
Disposable IVD Devices
Reusable IVD Devices
The report has provided a detailed breakup and analysis of the market based on usability. This includes disposable IVD devices and reusable IVD devices.
Disposable IVD devices are designed for single-use and are discarded after a single patient interaction or testing procedure. They are pre-sterilized and come in a ready-to-use format, which eliminates the need for cleaning, disinfection, or reprocessing after each use. Healthcare providers find disposable IVD devices convenient and time-saving, as they eliminate the need for complex and time-consuming reprocessing procedures. This is especially advantageous in high-volume testing environments.
Reusable IVD devices, as the name suggests, can be used multiple times after appropriate cleaning, sterilization, and maintenance. They are made of durable materials that can withstand repeated use without compromising their performance. They also offer greater flexibility in terms of test customization and parameter adjustments, making them suitable for research and specialized testing needs.
Infectious Disease
Diabetes
Cancer/Oncology
Cardiology
Autoimmune Disease
Nephrology
Others
Infectious diseases currently dominate the market
A detailed breakup and analysis of the market based on the application has also been provided in the report. This includes infectious disease, diabetes, cancer/oncology, cardiology, autoimmune disease, nephrology, and others. According to the report, infectious diseases accounted for the largest market share.
Infectious diseases pose significant global health challenges, and outbreaks or pandemics can have severe consequences on public health and economies. The COVID-19 pandemic, for example, has highlighted the critical role of diagnostic testing in controlling the spread of infectious diseases. Besides, infectious diseases have a high incidence and prevalence rate, affecting millions of people worldwide. Common infectious diseases such as influenza, tuberculosis, hepatitis, and sexually transmitted infections continue to impact communities across the globe. Moreover, in vitro diagnostics offer a rapid and reliable way to identify infectious agents, allowing healthcare providers to initiate appropriate therapies, implement infection control measures, and prevent further transmission.
Hospitals Laboratories
Clinical Laboratories
Point-of-care Testing Centers
Academic Institutes
Patients
Others
A detailed breakup and analysis of the market based on the end user has also been provided in the report. This includes hospitals laboratories, clinical laboratories, point-of-care testing centers, academic institutes, patients, and others.
Hospital laboratories are an essential part of healthcare facilities, providing diagnostic testing services to inpatients and outpatients. These laboratories are equipped with a wide range of IVD instruments and reagents to perform various tests, including clinical chemistry, hematology, microbiology, and immunology. Hospitals rely on timely and accurate diagnostic results from their in-house laboratories to aid in patient diagnosis, treatment, and disease management.
Clinical laboratories, also known as independent or reference laboratories, are separate entities that offer diagnostic testing services to healthcare providers, hospitals, clinics, and other healthcare settings. They often handle high-volume and specialized tests that may not be available in all hospital laboratories. Clinical laboratories serve as centralized testing facilities, supporting multiple healthcare facilities with their comprehensive testing capabilities.
Point-of-care testing (POCT) centers represent a rapidly growing segment in the IVD market. These centers provide diagnostic tests at or near the location where patient care is delivered. POCT devices offer rapid results, allowing for immediate treatment decisions and interventions. Point-of-care testing centers are especially valuable in emergency rooms, ambulances, nursing homes, and remote or resource-limited settings where quick diagnosis is critical.
Academic institutes, including research universities and medical schools, contribute to the IVD market through research, development, and education. They play a pivotal role in advancing diagnostic technologies, discovering new biomarkers, and evaluating the effectiveness of diagnostic tests. Academic institutes often collaborate with diagnostic companies to conduct clinical trials and validate the performance of novel diagnostic assays.
Patients are becoming increasingly involved in their healthcare decisions, including diagnostic testing. The IVD market caters to the direct-to-consumer testing trend, where patients can access certain diagnostic tests without a healthcare provider's prescription. These tests allow individuals to monitor their health status, identify risk factors, and take proactive steps towards better health management.
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 accounts for the majority of market share
The report has also provided a comprehensive analysis of all the major regional markets, which includes 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); and the Middle East and Africa. According to the report, North America was the largest market for in vitro diagnostics.
North America boasts a well-developed and advanced healthcare infrastructure, including modern hospitals, clinical laboratories, and research institutions. The region's robust healthcare system supports a high volume of diagnostic testing, driving the demand for IVD products and services. Besides, North America is at the forefront of technological innovations in the IVD industry. The region is home to many leading diagnostic companies and research institutions that invest heavily in research and development, leading to the creation of cutting-edge diagnostic technologies and products. Moreover, the region has stringent regulatory standards for diagnostic products, ensuring safety and efficacy. Companies operating in the region must comply with rigorous quality control measures, which helps build trust in the reliability of IVD products.
The competitive landscape of the In vitro diagnostics (IVD) market is characterized by a diverse and highly competitive environment, with numerous companies vying for market share. They are developing advanced technologies, novel biomarkers, and point-of-care testing devices to meet the evolving needs of the healthcare industry. They are engaging in mergers and acquisitions (M&As) to expand their product portfolios, gain access to new markets, and enhance their technological capabilities. They are also expanding their market presence by establishing distribution networks in new regions or countries. Moreover, companies are embracing digitalization and investing in digital diagnostic solutions. This includes the development of digital pathology, remote monitoring, and telehealth solutions to enhance diagnostic efficiency and accessibility.
Abbott Laboratories
Agilent Technologies Inc.
Biomerieux SA
Bio-Rad Laboratories Inc.
F. Hoffmann-La Roche Ltd
Fujifilm Holdings Corporation
Illumina Inc.
Qiagen N.V
Quest Diagnostics
Shimadzu Corporation
Siemens Healthcare GmbH
Sysmex Corporation
Roche Ltd. launched the Elecsys Anti-SARS-CoV-2 S antibody test, which measures the level of antibodies against the spike protein of the SARS-CoV-2 virus. The test aids in assessing a person's immune response after COVID-19 vaccination or infection.
Abbott Laboratories launched the Panbio COVID-19 Ag Rapid Test Device, a rapid antigen test for COVID-19. The test delivers results within 15 minutes and has been widely used for screening and surveillance purposes during the pandemic.
Siemens Healthineers introduced the Atellica Solution, a fully automated clinical chemistry and immunoassay system. The system offers high throughput, broad assay menu, and enhanced efficiency for clinical laboratories.