![]() |
市場調查報告書
商品編碼
1451681
2024-2032 年按測試類型、產品、可用性、應用、最終用戶和地區分類的體外診斷市場報告In Vitro Diagnostics Market Report by Test Type, Product, Usability, Application, End User, and Region 2024-2032 |
2023年,全球體外診斷市場規模達到1,109億美元。展望未來, IMARC Group預計到2032年市場規模將達到1,781億美元,2024-2032年複合年成長率(CAGR)為5.24%。慢性病和傳染病的日益普及、對個人化藥物的日益偏好、全球老年人口的不斷增加以及技術的不斷進步是推動市場發展的一些關鍵因素。
體外診斷 (IVD) 是指在活體外部(通常在實驗室環境中)使用血液、尿液、組織或其他體液等樣本進行的醫學測試和程序。這些測試旨在檢測、診斷和監測各種醫療狀況和疾病。與在活體內進行的體內診斷不同,體外診斷涉及在受控實驗室條件下檢查生物樣本。 IVD 測試是現代醫療保健不可或缺的一部分,為醫療保健專業人員提供重要資訊,以做出有關患者護理的明智決策。這些測試在疾病篩檢、早期診斷、治療選擇和監測治療進展方面發揮著至關重要的作用。它們用於各種醫學專業,包括臨床化學、微生物學、血液學、免疫學、分子診斷學等。
在慢性病和傳染病日益普及的推動下,該市場正在經歷顯著成長。隨著人口老化的加劇和生活方式的改變,糖尿病、心血管疾病和癌症等慢性疾病變得更加普遍。體外診斷為醫療保健專業人員提供了這些疾病的早期檢測和有效管理的重要見解,從而改善患者的治療結果並降低醫療成本。此外,技術進步和自動化整合已經徹底改變了 IVD 市場。自動化系統,例如即時檢測設備和分子診斷,簡化了診斷過程,從而能夠更快、更準確地獲得結果。此外,對個人化醫療和精準診斷的日益關注也增加了對專業體外診斷測試的需求。這些測試有助於根據個別患者的特定遺傳和分子特徵制定治療計劃,最佳化治療結果並最大限度地減少不良反應。
各種技術進步與自動化
技術創新的快速發展徹底改變了體外診斷 (IVD) 市場。分子診斷、新一代定序和微流體等先進技術使得測試方法更加準確和靈敏。自動化簡化了診斷流程,減少了人為錯誤並提高了效率。諸如即時檢測設備之類的自動化系統有助於更快地獲得結果,從而能夠及時制定患者護理決策。這些進步不僅提高了診斷準確性,還有助於節省成本並改善患者的治療效果。此外,自動化將診斷測試的範圍擴大到偏遠或資源有限的地區,解決了醫療保健差異並改善了患者獲得基本診斷服務的機會。人工智慧和機器學習演算法的整合進一步增強了診斷系統的分析能力,可以實現更精確和個人化的測試解釋。隨著技術不斷進步,體外診斷市場預計將持續成長,診斷測試和應用範圍不斷擴大。
慢性病盛行率不斷上升
糖尿病、心血管疾病和癌症等慢性疾病的盛行率不斷上升,一直是 IVD 市場成長的關鍵驅動力。隨著人口老化和生活方式的改變,慢性病在全球變得更加普遍。體外診斷在這些疾病的早期檢測、監測和管理中發揮著至關重要的作用。診斷測試可幫助醫療保健專業人員做出明智的治療決策,從而實現更好的疾病管理並提高患者的生活品質。此外,慢性病的流行促使人們轉向預防性醫療保健範式。早期發現和介入對於預防慢性病的進展和減輕醫療系統的負擔至關重要。體外診斷有助於早期篩檢和識別危險因素,從而能夠及時採取預防措施。對預防性醫療保健的重視促使 IVD 測試在常規健康檢查和健康計劃中被採用。
對個人化醫療的日益重視
對個人化醫療的日益關注對 IVD 市場產生了重大影響。個人化醫療旨在根據患者的基因組成、生活方式和其他因素,為患者量身定做治療方案。體外診斷,例如基因檢測和伴隨診斷,可以提供對患者獨特特徵的重要見解,從而實現標靶治療並避免不必要的治療或不良反應。透過次世代定序 (NGS) 和伴隨診斷等先進技術實現的精準診斷,有助於識別特定疾病亞型和分子標靶。隨著精準醫學的日益普及,對專業診斷測試的需求持續成長。醫療保健提供者和製藥公司擴大投資於研發,以識別新的生物標記並創建創新的診斷解決方案來支持精準醫療計劃。
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.