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市場調查報告書
商品編碼
1987065
體外診斷市場規模、佔有率、趨勢和預測:按檢測類型、產品、用途、應用、最終用戶和地區分類,2026-2034年In Vitro Diagnostics Market Size, Share, Trends and Forecast by Test Type, Product, Usability, Application, End User, and Region, 2026-2034 |
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2025年全球體外診斷(IVD)市場規模為1,226億美元。展望未來,IMARC Group預測,該市場將以4.63%的複合年成長率(CAGR)從2026年成長至2034年,到2034年達到1866億美元。目前,北美市場佔據主導地位,預計2025年市佔率將超過42.7% 。感染疾病的蔓延、技術的不斷進步、消費者對個人化醫療的偏好變化以及人口老化是推動IVD市場成長的主要因素。
人口老化加劇正成為全球體外診斷市場成長的關鍵因素。預計2015年至2050年間,全球60歲及以上人口的比例將從12%成長至22%,幾乎翻倍。此外,到2050年,約80%的老年人預計將生活在中低收入國家。同時,由於全球預期壽命的延長,老年患者的比例也急劇增加。神經退化性疾病照護及相關疾病,例如癌症、糖尿病、心血管疾病和包括阿茲海默症在內的神經退化性疾病,目前備受關注,因為這些疾病的發病率上升與老年患者數量的增加相吻合。這些疾病需要反覆進行診斷檢測以進行早期發現和後續觀察,這進一步增加了對體外診斷產品的需求。大多數老年患者需要進行全面的健康檢查,包括從分子免疫檢測到臨床化學檢測等各種詳細診斷。例如,這些檢測有助於識別疾病標記和評估治療效果,從而改善該年齡層的健康狀況。
美國體外診斷(IVD)市場正快速崛起,成為全球主要市場之一,佔全球市場的94.01%。在美國,體外診斷市場佔有率的擴張得益於診斷技術的快速發展以及慢性病和感染疾病的普遍流行。人們對疾病早期準確檢測的需求日益成長,推動了對新型診斷工具的廣泛關注。就地檢驗的快速普及可望更及時地改善患者的治療效果。老年人口的持續成長是慢性病風險增加的因素之一,因此需要更頻繁地進行診斷。根據研究,未來40年,美國65歲及以上人口數預計將增加一倍以上,到2040年達到8,000萬人。在其他領域,個人化醫療和伴隨診斷也備受關注,因為它們為標靶治療提供了機會。支持全國診斷檢測的舉措和報銷措施正在擴大市場准入。
持續的技術進步
新一代定序、分子診斷和微流體技術等技術的進步,使得檢測手段更加強大、靈敏和精準。這些先進技術正在推動體外診斷市場的成長。例如,2023年11月,ARUP Laboratories的AAV5 DetectCDx(一種伴隨診斷試劑盒,用於篩檢重度A型血友病患者,以確定他們是否適合接受BioMarin公司的新型基因療法Roctavian)獲得了歐盟體外診斷醫療器材法規(EU-IVDR)的CE認證。另一個成長趨勢是診斷流程的自動化,這可以減少人為錯誤並提高效率。預計這一趨勢將在不久的將來繼續支撐市場發展。例如,西門子醫療推出了Atellica Solution,這是一款全自動臨床化學和免疫檢測系統。該系統具有高處理能力、廣泛的檢測範圍和高效的臨床檢查室性能。 2023年6月,東麗株式會社的Toray APOA2-iTQ(用於胰臟癌診斷)獲得了日本厚生勞動省的上市核准。此外,雅培公司已獲得美國食品藥物管理局(FDA) 的核准,在美國推出一種用於檢測創傷性腦損傷 (TBI) 的新型血液檢查。
慢性病盛行率增加
糖尿病、心血管疾病和癌症等慢性疾病的日益普及推動了體外診斷市場近期的發展機會。此外,對體外診斷在嚴重的早期檢測、監測和管理方面的需求不斷成長,也促進了市場成長。例如,根據國際糖尿病聯盟(IDF)第十版《糖尿病地圖集》,全球總合5.37億人(20-79歲)患有糖尿病。預計到2030年,全球糖尿病患者人數將達到約6.43億,到2045年將達到7.83億。此外,醫療專業人員廣泛使用體外診斷檢測來制定治療策略也對市場產生了積極影響,因為體外診斷檢測有助於早期篩檢和識別風險因素,從而能夠及時採取預防措施。例如,雅培公司推出了Panbio COVID-19 Ag快速檢測試劑盒,這是一款用於檢測新冠病毒抗原的快速檢測套組。該檢測可在15分鐘內提供結果,並在疫情期間廣泛用於篩檢和監測。此外,羅氏診斷(瑞士)推出了Cobas脈衝系統,這是一款具備行動數位健康功能的血糖管理解決方案,旨在改善患者照護。羅氏的VENTANA MMR RxDx檢測板也獲得了FDA核准,用於識別符合抗PD-1免疫療法條件的dMMR固態腫瘤患者。 2023年12月,ARUP Laboratories與Medicover合作,在歐洲提供診斷和醫療保健服務。 ARUP Laboratories與BioMarin 食品藥物管理局 Inc.合作推出了AAV5 DetectCDx,用於為A型血友病患者選擇治療方法。
人們越來越關注個人化醫療
個人化醫療旨在根據每位患者的基因組成、生活方式和其他因素,為其量身定做醫療方案,其日益受到重視,這顯著推動了體外診斷市場的需求。根據個人化醫療聯盟 (PMC) 統計,2023 年,個人化醫療相關藥物占美國食品藥物管理局(FDA)核准的新藥總數的 33% 以上,這一趨勢已連續四年維持。因此,體外診斷 (IVD) 檢測,例如基因檢測和伴隨診斷,透過提供患者獨特特徵的關鍵訊息,實現標靶治療,避免不必要的治療和副作用,從而推動了市場的動態。此外,次世代定序 (NGS) 和伴隨診斷等先進技術能夠實現更精準的診斷,有助於識別特定的疾病亞型和分子標靶。例如,2023 年 8 月,精準醫療中心 (PMC) 與區域分子診斷服務中心 (RMDS) 合作,在北愛爾蘭實施基因組技術癌症診斷。此外,世界衛生組織於2023年10月發布了《基本診斷清單(EDL)》,這是一份全面的體外診斷產品清單,旨在幫助各國就診斷工具做出決策。此清單提供實證建議,並確保有需要的人能夠獲得基本產品。此外,2023年8月,非洲疾病預防控制中心與非洲發展署的非洲發展新夥伴關係(AUDA-NEPAD)合作,擴大非洲各地診斷檢測的覆蓋範圍。
The global in vitro diagnostics market size was valued at USD 122.6 Billion in 2025. Looking forward, IMARC Group estimates the market to reach USD 186.6 Billion by 2034, exhibiting a CAGR of 4.63% from 2026-2034. North America currently dominates the market, holding a market share of over 42.7% in 2025. The rising prevalence of infectious diseases, the continuous technological advancements, shifting consumer preferences towards personalized medicine, and increasing geriatric population are among the primary factors driving the in vitro diagnostics market share.
Increased geriatric population is becoming an important factor for the global in vitro diagnostics market growth. The share of the global population over the age of 60 will nearly double between the years 2015 to 2050, from 12% to 22%. In 2050 too, around 80% of geriatric people would be living in low- and middle-income countries. With this, the increased global life expectancy has led to the tremendously increasing population percentage of geriatric patients. Geriatrics and either associated morbidity such as cancer, diabetes, cardiovascular diseases, or neurodegenerative disorders including Alzheimer's disease are now on a worrying trend as their proliferation coincides with increased incidences such as cancer, diabetes, cardiovascular diseases, and neurodegenerative disorders. These diseases require recurrent use of diagnostic tests for early detection and monitoring management and create an ever intensifying need for IVD products. Most Geriatric patients will need extensive health checks covering elaborate diagnostics like; molecular diagnostics, immunoassays to clinical chemistry tests. Such tests, for example, determine disease markers and evaluate treatment response, benefiting the health outcome of the particular age group.
The U.S. IVD market is emerging as a major market, holding 94.01% of the total share. In the USA, the in vitro diagnostics market share is broadening due to hysterical advances in the technology of diagnosis, as well as the overhead predominance of chronic and infectious diseases. The increasing requirement for early and accurate detection of disease has steered the extensive attractions for newer diagnostic tools. Point of care, the emergence of testing at such a rapid pace, is expected to yield better patient outcomes within a more timely way. The steady increase in the geriatric population counts among factors that escalate the risk of chronic illness and hence necessitate more frequent diagnostics. Research indicates that older age cohorts, particularly those of 65 years in the United States, will increase to above available double numbers for the period of the next 40 years, hitting the bar of 80 million by 2040. Other areas have been directed by personalized medicine and companion diagnostics that open a window of opportunity for targeted therapy. Policy initiatives and reimbursement measures in support of national diagnostic testing extend market access.
Continuous Technological Advancements
This advancement in technologies, including next-generation sequencing, molecular diagnostics, and microfluidics, has led to a stronger and more sensitive test with more accurate results. Advanced technologies are, thus augmenting the in vitro diagnostics market statistics. For example, recently, in November 2023, ARUP Laboratories won a CE mark from EU-IVDR for its AAV5 DetectCDx, which is a companion diagnostic to select the eligibility of patients afflicted by severe hemophilia A to go for BioMarin's new gene therapy called Roctavian. Another growth trend is the automation of diagnostic processes, reducing human errors, and increasing efficiency, and this trend will support the market in the near future. For instance, Siemens Healthineers launched the Atellica Solution, a fully automated clinical chemistry and immunoassay system. The system boasts a high throughput, a wide-assay menu, and efficient clinical laboratory performance. Toray Industries, Inc. won marketing approval from Japan's Ministry of Health, Labor, and Welfare for its Toray APOA2-iTQ, used in the diagnosis of pancreatic cancer, during June 2023. Abbott also received U.S. FDA clearance for a new laboratory Traumatic Brain Injury (TBI) blood test in the U.S.
Rising Prevalence of Chronic Diseases
The rising prevalence of chronic illnesses, such as diabetes, cardiovascular disorders, and cancer is catalyzing the in vitro diagnostics market recent opportunities. Besides this, the elevating requirement for in vitro diagnostics in the early detection, monitoring, and management of severe diseases is propelling the growth of the market forward. For instance, according to the International Diabetes Federation Diabetes Atlas Tenth edition, a total of 537 Million individuals (20-79 years old) worldwide has diabetes. By 2030, there will be around 643 Million diabetics globally, and by 2045, the number is expected to reach 783 Million individuals. Moreover, the extensive utilization of IVD tests by healthcare professionals for making informed decisions in treatment, as they facilitate early screening and identification of risk factors, allowing timely preventive measures, is positively influencing the market. For example, Abbott Laboratories launched the Panbio COVID-19 Ag Rapid Test Device, a rapid antigen test for COVID-19. The test delivered the results within 15 minutes and was widely used for screening and surveillance purposes during the pandemic. Furthermore, Roche Diagnostics (Switzerland) launched the Cobas pulse system, a blood glucose management solution featuring mobile digital health capabilities designed to enhance patient care. Also, Roche received the Food and Drug Administration (FDA) approval for VENTANA MMR RxDx Panel to identify patients with dMMR solid tumors who are eligible for anti-PD-1 immunotherapy. Additionally, in December 2023, ARUP Laboratories and Medicover formed a partnership to offer diagnostic and healthcare services across Europe. ARUP Laboratories introduced AAV5 DetectCDx in collaboration with BioMarin Pharmaceutical Inc. to choose therapies for multiple hemophilia A patients.
Increasing Emphasis on Personalized Medicine
The rising focus on personalized medicine, which aims to tailor medical treatment to individual patients based on their genetic makeup, lifestyle, and other factors, is propelling the in vitro diagnostics market demand significantly. The Personalized Medicine Coalition (PMC) reports that personalized medicines represented over one-third (33%) of new U.S. Food and Drug Administration (FDA) drug approvals in 2023, continuing a trend for the fourth consecutive year. In line with this, IVD tests, such as genetic testing and companion diagnostics, provide critical insights into the unique characteristics of patients, enabling targeted therapies and avoiding unnecessary treatments or adverse reactions, which is also augmenting the market dynamics. Moreover, precision diagnostics, enabled by advanced technologies, such as Next-Generation Sequencing (NGS) and companion diagnostics, facilitate the identification of specific disease subtypes and molecular targets. For instance, in August 2023, the Precision the Medicine Centre (PMC) has partnered with the Regional Molecular Diagnostic Service (RMDS) to introduce genomic technology for cancer diagnosis in Northern Ireland. Additionally, in October 2023, the WHO published the Essential Diagnostics List (EDL), a comprehensive list of IVD products that aids countries in making decisions regarding diagnostic tools. It offers evidence-based recommendations and makes sure that essential products are accessible to target people. Furthermore, in August 2023, the Africa CDC collaborated with the Africa Development Agency-New Partnership for Africa's Development (AUDA-NEPAD) to increase access to diagnostic tests across Africa.
As per the latest in vitro diagnostics market outlook, molecular diagnostics occupies the biggest share in the market and accounts for 23.1%. It provides a greater accuracy and higher sensitivity for disease detection. Molecular diagnostics are capable of detecting low concentrations of target molecules which help them proceed with an early diagnosis and precise monitoring of illnesses. This sensitivity becomes inevitable in diseases such as infectious ones, genetic disorders, and some forms of cancers, because early intervention has a huge influence on treatment success. Advances in personalized medicine are strongly linked with molecular diagnostics. For instance, Medix Biochemica acquired 100% shares of myPOLS Biotec GmbH. By acquiring myPOLS Biotec, Medix Biochemica added to its portfolio of IVD raw materials and increased its selection of reagents for molecular diagnostics. This acquisition expanded the company's global presence and offered customers more advanced scientific and technological capabilities in molecular diagnostics.
According to the recent in vitro diagnostics market forecast, reagents and kits hold a share of around 67.2% of the market in 2025. Reagents and kits are typically the foundation structures of most diagnostic tests. They mainly contain all chemicals and consumables, which would be needed to conduct specific analyses as well as assess patient samples. Diagnostic labs and health-care facilities almost relied on the reagents and kits available to do several tests; from some routine screenings up to difficult molecular diagnostics. The in vitro diagnostics market revenue is further accelerated due to the user-friendly and standardized reagents and kits, which ensure that there are consistent and reliable results across many laboratories or test sites. These testing kits enable easier tests with less manual preparation and risk of error. For example, Bio-Rad Laboratories Inc.'s SARS-CoV-2 Droplet Digital PCR (ddPCR) test kit has been approved by the FDA with EUA. The SARS-CoV-2 Droplet Digital PCR (ddPCR) Test is performed on the Bio-Rad QX200 and QXDx ddPCR systems. Roche Ltd. also launched the Elecsys Anti-SARS-CoV-2 S antibody test that measures the anti-SARS-CoV-2 antibody spike response generated by the immune system following COVID vaccination or infection.
Disposable IVD devices are designed for single use. They are never reused once they have been used for an individual patient or test procedure. They come fully pre-sterilized and ready for use, with no need for cleaning, disinfection, or reprocessing for each use. This makes disposable IVD devices very convenient and time-saving for healthcare providers who otherwise would have to deal with complex and time-consuming procedures for reprocessing. However, due to cleaning, sterilization, and maintaining the device following each utilization, reusable IVD devices may be reused many times. It is also commonly composed of strong materials which do not readily compromise when the tests are used repeatedly but ensure functionality. Also, their use offers the advantage of allowing customization in test performance, together with parameters.
Infectious disease is leading the market with approximately 37.6% share in 2025. Infectious diseases are among the leading global health issues and outbreaks that can cause drastic effects on public health and economies. Apart from this, these diseases have a high incidence and prevalence rates, impacting millions of people globally. Some of the common infectious diseases include tuberculosis, influenza, hepatitis, etc., and continue to affect communities around the world. As a result, in vitro diagnostics provide for the prompt and easy identification of infectious agents, which means that healthcare providers can initiate proper therapies, implement infection control measures, and prevent further transmission. For example, in February 2023, BD received EUA from the U.S. FDA for a new molecular diagnostic combined test for SARS-CoV-2, Influenza A+B, and Respiratory Syncytial Virus (RSV).
Hospital laboratories are essential entities within healthcare facilities. Their tasks are to provide diagnostic test service both to inpatients and outpatients. They hold the availability of several IVD equipment and reagents necessary in doing different tests among these being clinical chemistry, hematology, microbiology, and immunology. Hospitals rely majorly on the prompt diagnosis conducted through their in-housed laboratory to help in diagnosing their patients, treating, or controlling diseases. Apart from this, clinical laboratories are standalone entities that provide diagnostic testing services to healthcare providers, hospitals, clinics, and other medical settings. They deal with high-volume and specialized tests that may not be found in all hospital laboratories. For example, in February 2023, Unilabs announced it was investing over USD 200 Million in Siemens Healthineers' technology and acquiring more than 400 laboratory analyzers to strengthen its laboratory infrastructure. Not only that, the point-of-care testing (POCT) centers are the most rapidly growing segment in the IVD market. These give diagnostic tests at or near a place where the patient cares are being delivered. The POCT centers are especially valuable in emergency rooms, ambulances, nursing homes, and other remote or resource-limited settings where speedy diagnosis is of utmost importance. Additionally, research universities and medical schools further contribute to the market growth by conducting research, development, and education. They significantly contribute to advancing diagnostic technologies, discovering new biomarkers, and evaluating the effectiveness of diagnostic tests. Patients are increasingly making decisions about their healthcare, which includes diagnostic testing.
In 2025, North America accounted for the largest market share of over 42.7%. North America holds the highest share in the market overview of in vitro diagnostics due to its developed and sophisticated healthcare infrastructure, like modern clinical laboratories, hospitals, and research centers. Moreover, the well-established medical care system along with continuous technological advancement in the IVD industry is catalyzing the growth of the market. Besides this, the increasing investments from the major companies and institutions into research and development activities for the introduction of new diagnostic methods are further driving the market growth in this region. For example, according to the CDC, chronic conditions are the biggest cause of disability and death each year in the United States. Moreover, the SARS-CoV-2 Droplet Digital PCR (ddPCR) test kit by Bio-Rad Laboratories Inc. received Emergency Use Authorization from the US FDA.
UNITED STATES IN VITRO DIAGNOSTICS MARKET ANALYSIS
Factors driving the in vitro diagnostics market in United States include technological progress, the aging population and the rising incidence of chronic diseases. Such high burdens of diseases, including cancer, diabetes, and cardiovascular conditions, increase the need for accurate, timely, and efficient diagnostics. The CDC reports that for the year 2021, there were 1,777,566 new cancer diagnoses, and in 2022, cancer took up 608,366 people's lives, which places a high demand on detection and diagnostic solutions. The surging interest in personalized medicine also means that the use of IVD technologies is stepped up by healthcare providers to provide increasingly targeted and individualized forms of treatment to patients. The FDA's attempt to ease the diagnostic regulatory processes also contributed to innovation and opened the market. The more expansive use of point-of-care testing and home diagnostics is another aspect that would influence healthcare delivery in terms of greater convenience, improved accessibility, and lower costs for the patients. As healthcare expenditure continues to rise and digital health platforms are escalating, the current trends in such dynamisms are bound to continue and shape the U.S. IVD market.
EUROPE IN VITRO DIAGNOSTICS MARKET ANALYSIS
Increasing incidence of chronic diseases, growing geriatric population, and sound infrastructure in health care in the region drives the European IVD market. Eurostat has shown that, compared with 2020, preventive healthcare expenditure in the EU has increased by 88.2% in current price terms, rising from 0.38% to 0.65% of GDP in 2021. The uptrend further accelerates the increase in interest towards early diagnosis and prevention. As more people begin suffering from health conditions that appear with aging, like diabetes and cardiovascular diseases, it is all the more imperative to require quick and precise diagnostic tools. Simplified regulatory requirements, as reflected by the European Union's In Vitro Diagnostic Regulation (IVDR), streamlined the procedures, promoting innovation and leading the growth in this market. Advances in molecular diagnostics, genomics, and next-generation sequencing are transforming the IVD landscape, making diagnostic procedures more precise. The trend toward decentralized healthcare, with greater focus on home testing and point-of-care solutions, is reshaping the market and expanding access to healthcare services across the region.
ASIA PACIFIC IN VITRO DIAGNOSTICS MARKET ANALYSIS
In the APAC region, the in vitro diagnostics (IVD) market is driven by expanding healthcare access, rising awareness about health conditions, and significant improvements in medical infrastructure. According to the Statistics Bureau of Japan, the population aged 65 years and above reached 36,227 thousand, accounting for 29.1% of the total population in 2023, highlighting the increasing demand for healthcare services tailored to an aging population. The increasing incidence of chronic diseases, such as diabetes and cardiovascular conditions, especially in countries like Japan, China, and India, is driving the demand for advanced diagnostic solutions. Additionally, investments in healthcare systems and the growing middle-class population in emerging markets are accelerating market growth. Technological advancements in diagnostic devices, including automation and artificial intelligence, are enhancing diagnostic efficiency and improving healthcare access, particularly in rural and remote areas. These factors contribute to the overall expansion of the IVD market across the region.
LATIN AMERICA IN VITRO DIAGNOSTICS MARKET ANALYSIS
In Latin America, the in vitro diagnostics (IVD) market is driven by rising healthcare awareness and an increasing emphasis on early diagnosis and preventive healthcare.In Brazil, for example, the NIH estimates that 928,000 deaths occur annually due to chronic diseases, with the high prevalence of overweight being a major contributing factor. This trend is observed across the region, as the increasing burden of chronic conditions like diabetes and cardiovascular prevalence drives the demand for advanced diagnostic tools. Governments are investing in healthcare reforms and expanding access to diagnostic services, particularly in larger countries like Brazil and Mexico, further supporting the growth of the IVD market. Technological advancements in diagnostic equipment are enhancing healthcare delivery, particularly in urban areas where infrastructure improvements are underway.
MIDDLE EAST AND AFRICA IN VITRO DIAGNOSTICS MARKET ANALYSIS
In the Middle East and Africa, the in vitro diagnostics (IVD) market is fueled by the rising prevalence of chronic diseases, increased healthcare investments, and growing health awareness. According to a survey published by PMC, the prevalence of self-reported chronic diseases in the UAE was 23.0%, with obesity, diabetes, and asthma/allergies being the most common conditions. This trend is mirrored across the region, driving the demand for advanced diagnostic solutions. In the Middle East, governments are investing in modern healthcare infrastructure, promoting the adoption of cutting-edge IVD technologies. Additionally, in Africa, initiatives aimed at improving healthcare access and the growing use of point-of-care testing are contributing to market expansion.
As per the emerging in vitro diagnostics market trends, leading players are focusing on innovation, strategic collaborations, and global expansion to strengthen their positions. Major companies are heavily investing in research and development (R&D) to launch advanced diagnostic solutions, such as molecular testing kits, point-of-care devices, and artificial intelligence (AI)-powered diagnostic tools. Firms are introducing cutting-edge technologies to enhance accuracy, speed, and reliability in disease detection and management. Partnerships and acquisitions are key strategies, as companies are acquiring smaller firms to expand their product portfolios and penetrate niche markets. Collaborations with healthcare providers and research institutions are enabling the development of targeted diagnostic solutions aligned with the growing demand for personalized medicine. Additionally, market leaders are focusing on increasing their presence in emerging economies by establishing manufacturing facilities, distribution networks, and training programs for healthcare professionals.