시장보고서
상품코드
1987065

체외진단(IVD) 시장 규모, 점유율, 동향 및 예측 : 검사 유형별, 제품, 사용성, 용도, 최종사용자, 지역별(2026-2034년)

In Vitro Diagnostics Market Size, Share, Trends and Forecast by Test Type, Product, Usability, Application, End User, and Region, 2026-2034

발행일: | 리서치사: 구분자 IMARC | 페이지 정보: 영문 145 Pages | 배송안내 : 2-3일 (영업일 기준)

    
    
    




※ 본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문 목차를 참고해주시기 바랍니다.

2025년 세계의 체외진단(IVD) 시장 규모는 1,226억 달러로 평가되었습니다. IMARC Group은 2026-2034년 CAGR 4.63%로 성장을 지속하여 2034년에는 시장 규모가 1,866억 달러에 달할 것으로 예측했습니다. 현재 북미가 시장을 독점하고 있으며, 2025년에는 42.7% 이상의 시장 점유율을 차지했습니다. 감염성 질환의 확산, 지속적인 기술 발전, 개인 맞춤형 의료에 대한 소비자 선호도 변화, 고령 인구 증가 등이 체외진단(IVD) 시장의 성장을 견인하는 주요 요인으로 작용하고 있습니다.

고령 인구 증가는 전 세계 체외진단(IVD) 시장의 성장에 중요한 요인으로 작용하고 있습니다. 세계 인구 중 60세 이상 인구가 차지하는 비율은 2015-2050년 사이에 12%에서 22%로 거의 두 배로 증가할 것으로 예측됩니다. 또한, 2050년에는 고령자의 약 80%가 중저소득 국가에서 생활하게 될 것으로 예측됩니다. 이에 따라 전 세계적으로 평균 수명이 연장되면서 노인 환자의 비율이 비약적으로 증가하고 있습니다. 노인의료와 암, 당뇨, 심혈관질환, 혹은 알츠하이머병을 포함한 신경퇴행성 질환과 같은 관련 질환은 그 증가가 암, 당뇨, 심혈관질환, 신경퇴행성 질환 등의 발병률 증가와 맞물려 현재 우려되는 추세입니다. 이러한 질환은 조기 발견 및 경과 관찰 관리를 위해 반복적인 진단 검사가 필요하며, IVD 제품에 대한 수요가 점점 더 높아지고 있습니다. 대부분의 고령 환자는 분자진단, 면역 측정법에서 임상 화학 검사에 이르기까지 상세한 진단을 포함한 광범위한 건강 검진을 필요로 합니다. 예를 들어, 이러한 검사는 질병 마커를 식별하고 치료 효과를 평가하여 해당 연령대의 건강 결과를 개선하는 데 기여합니다.

미국 IVD 시장은 전체 시장의 94.01%를 차지하며 주요 시장으로 부상하고 있습니다. 미국에서는 진단 기술의 비약적인 발전과 더불어 만성질환과 감염성 질환이 압도적으로 많은 상황에서 체외진단(IVD) 시장 점유율이 확대되고 있습니다. 질병의 조기 및 정확한 진단에 대한 수요가 증가함에 따라 새로운 진단 도구에 대한 관심이 높아지고 있습니다. 현장 진료 검사가 빠르게 확산되고 있는 것은 보다 적시에 환자의 결과를 개선할 수 있을 것으로 기대되고 있습니다. 고령 인구의 꾸준한 증가는 만성질환의 위험을 높이는 요인 중 하나이며, 그 결과 더 빈번한 진단이 필요하게 되었습니다. 조사에 따르면, 미국의 65세 이상 노인 인구는 향후 40년 동안 현재의 2배 이상 증가하여 2040년까지 8,000만 명에 달할 것으로 예측되고 있습니다. 다른 분야에서는 맞춤의료와 동반진단이 주목받고 있으며, 이는 표적치료의 길을 열어줄 수 있는 기회로 작용하고 있습니다. 국가의 진단 검사를 지원하는 정책적 이니셔티브와 상환 조치로 인해 시장 접근성이 확대되고 있습니다.

체외진단(IVD) 시장 동향

끊임없는 기술 발전

차세대 시퀀싱, 분자진단, 마이크로플루이딕스 기술 등 이러한 기술의 발전으로 더욱 강력하고 민감하며 정확한 결과를 제공하는 검사가 가능해졌습니다. 이러한 첨단 기술은 체외진단(IVD) 시장의 통계를 끌어올리고 있습니다. 예를 들어, 2023년 11월 ARUP Laboratories는 중증 A형 혈우병 환자가 바이오마린의 신규 유전자 치료제 'Roctavian'의 적응증을 선별하기 위한 동반진단제인 'AAV5 DetectCDx'에 대해 EU-IVDR로부터 CE 마크를 획득했습니다. CE 마크를 획득하였습니다. 또 다른 성장 추세는 진단 프로세스의 자동화이며, 이를 통해 인적 오류를 줄이고 효율성을 향상시킬 수 있습니다. 이러한 추세는 가까운 미래에 시장을 지탱할 것으로 보입니다. 예를 들어, 지멘스 헬스인어스(Siemens Healthineers)는 완전 자동화된 임상 화학 및 면역 측정 시스템인 'Atellica Solution'을 출시했습니다. 이 시스템은 높은 처리 능력, 다양한 검사 메뉴, 효율적인 임상검사실 성능을 자랑합니다. Toray Industries Inc. 주식회사는 2023년 6월 췌장암 진단에 사용되는 'Toray APOA2-iTQ'에 대해 일본 후생노동성으로부터 판매 허가를 취득했습니다. 또한, Abbott는 미국에서 외상성 뇌손상(TBI)에 대한 새로운 혈액 검사에 대해 미국 식품의약국(FDA)의 승인을 획득했습니다.

만성질환 유병률 증가

당뇨병, 심혈관 질환, 암과 같은 만성질환의 유병률 증가는 최근 체외진단(IVD) 시장의 기회를 촉진하고 있습니다. 이와 더불어, 중증 질환의 조기 발견, 모니터링 및 관리에 대한 체외 진단에 대한 수요가 증가하면서 시장 성장을 견인하고 있습니다. 예를 들어, 국제당뇨병연맹(IDF)의 '당뇨병 아틀라스' 10판에 따르면, 전 세계적으로 총 5억 3,700만 명(20-79세)이 당뇨병을 앓고 있다고 합니다. 2030년까지 전 세계 당뇨병 환자 수는 약 6억 4,300만 명, 2045년에는 7억 8,300만 명에 달할 것으로 예측됩니다. 또한, 의료진이 치료 방침을 결정할 때 IVD 검사를 널리 활용하고 있는 것도 시장에 긍정적인 영향을 미치고 있습니다. IVD 검사는 조기 검진 및 위험 요소의 식별을 용이하게 하고 적시에 예방 조치를 취할 수 있도록 하기 위함입니다. 예를 들어, Abbott Laboratories는 코로나19 신속 항원 검사 키트 'Panbio COVID-19 Ag Rapid Test Device'를 출시했습니다. 이 검사는 15분 이내에 결과를 확인할 수 있으며, 코로나19 기간 동안 검진 및 모니터링 목적으로 널리 사용되었습니다. 또한, 로슈진단(스위스)은 모바일 디지털 헬스 기능을 갖춘 혈당 관리 솔루션 '코바스 펄스 시스템(Cobas pulse system)'을 출시하여 환자 관리의 질을 향상시켰습니다. 또한, 로슈는 미국 식품의약국(FDA)으로부터 항 PD-1 면역치료 대상 dMMR 고형암 환자를 선별하기 위한 '벤타나 MMR RxDx 패널'에 대한 승인을 획득했습니다. 또한, 2023년 12월에는 ARUP Laboratories와 Medicover가 제휴하여 유럽 전역에 진단 및 의료 서비스를 제공하기로 했습니다. ARUP Laboratories는 BioMarin Pharmaceutical Inc.와 공동으로 A형 혈우병 환자의 치료제 선택을 위한 'AAV5 DetectCDx'를 도입했습니다.

개인 맞춤형 의료에 대한 관심 증가

유전적 구성, 생활습관, 기타 요인에 따라 환자 개개인에게 맞춤화된 의료를 제공하고자 하는 개인 맞춤형 의료에 대한 관심이 높아지고 있으며, 이는 체외진단(IVD) 시장 수요를 크게 증가시키고 있습니다. 맞춤형 의료연합(PMC)의 보고서에 따르면, 2023년 미국 식품의약국(FDA)이 승인한 신약 중 맞춤형 의료 관련 의약품이 3분의 1 이상(33%)을 차지했으며, 이러한 추세는 4년 연속 지속되고 있습니다. 이에 따라 유전자 검사 및 동반 진단과 같은 IVD 검사는 환자의 고유한 특성에 대한 중요한 정보를 제공하여 표적 치료를 가능하게 하고 불필요한 치료와 부작용을 피할 수 있게 함으로써 시장 역학을 촉진하고 있습니다. 또한, 차세대 염기서열 분석(NGS) 및 동반진단과 같은 첨단 기술로 가능해진 정밀 진단은 특정 질병 아형 및 분자 표적의 식별을 용이하게 합니다. 예를 들어, 2023년 8월 정밀의학센터(PMC)는 지역 분자진단 서비스(RMDS)와 제휴하여 북아일랜드에 암 진단용 유전체 기술을 도입했습니다. 또한, 2023년 10월에는 WHO가 '필수 진단 목록(EDL)을 발표했습니다. 각국이 진단 도구에 대한 의사결정을 내릴 때 도움이 될 수 있는 IVD 제품의 종합적인 목록입니다. 이 목록은 증거에 기반한 권장 사항을 제공하고, 필수 제품이 대상자에게 제공될 수 있도록 보장합니다. 또한, 2023년 8월에는 아프리카 CDC가 아프리카 개발청-아프리카 개발을 위한 새로운 파트너십(AUDA-NEPAD)과 협력하여 아프리카 전역의 진단 검사에 대한 접근성을 확대했습니다.

목차

제1장 서문

제2장 조사 범위와 조사 방법

제3장 주요 요약

제4장 서론

제5장 세계의 체외진단(IVD) 시장

제6장 시장 분석 : 검사 유형별

제7장 시장 분석 : 제품별

제8장 시장 분석 : 사용성별

제9장 시장 분석 : 용도별

제10장 시장 분석 : 최종사용자별

제11장 시장 분석 : 지역별

제12장 SWOT 분석

제13장 밸류체인 분석

제14장 Porter의 Five Forces 분석

제15장 가격 분석

제16장 경쟁 구도

LSH 26.04.14

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.

IN VITRO DIAGNOSTICS [IVD] MARKET TRENDS:

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.

IN VITRO DIAGNOSTICS INDUSTRY SEGMENTATION:

Analysis by Test Type:

  • Clinical Chemistry
  • Molecular Diagnostics
  • Immunodiagnostics
  • Hematology
  • Others

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.

Analysis by Product:

  • Reagents and Kits
  • Instruments

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.

Analysis by Usability:

  • Disposable IVD Devices
  • Reusable IVD Devices

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.

Analysis by Application:

  • Infectious Disease
  • Diabetes
  • Cancer/Oncology
  • Cardiology
  • Autoimmune Disease
  • Nephrology
  • Others

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).

Analysis by End User:

  • Hospitals Laboratories
  • Clinical Laboratories
  • Point-of-care Testing Centers
  • Academic Institutes
  • Patients
  • Others

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.

Regional Analysis:

  • 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

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.

KEY REGIONAL TAKEAWAYS:

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.

COMPETITIVE LANDSCAPE:

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.

The report provides a comprehensive analysis of the competitive landscape in the in vitro diagnostics market with detailed profiles of all major companies, including:

  • Abbott Laboratories
  • Agilent Technologies, Inc.
  • Beckman Coulter, Inc.
  • bioMerieux
  • Bio-Rad Laboratories, Inc.
  • F. Hoffmann-La Roche Ltd
  • Illumina, Inc.
  • Qiagen N.V
  • Shimadzu Corporation
  • Siemens Healthineers AG
  • Sysmex Corporation
  • Thermo Fisher Scientific Inc.

KEY QUESTIONS ANSWERED IN THIS REPORT

1. What is the IVD market?

2. What is the global outlook on the in vitro diagnostics industry?

3. What is the market size of in vitro diagnostics?

4. What are the key factors driving the in vitro diagnostics market?

5. Which region accounts for the largest in vitro diagnostics market share?

6. Which are the leading companies in the global in vitro diagnostics market?

Table of Contents

1 Preface

2 Scope and Methodology

  • 2.1 Objectives of the Study
  • 2.2 Stakeholders
  • 2.3 Data Sources
    • 2.3.1 Primary Sources
    • 2.3.2 Secondary Sources
  • 2.4 Market Estimation
    • 2.4.1 Bottom-Up Approach
    • 2.4.2 Top-Down Approach
  • 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

  • 4.1 Overview
  • 4.2 Key Industry Trends

5 Global In Vitro Diagnostics Market

  • 5.1 Market Overview
  • 5.2 Market Performance
  • 5.3 Impact of COVID-19
  • 5.4 Market Forecast

6 Market Breakup by Test Type

  • 6.1 Clinical Chemistry
    • 6.1.1 Market Trends
    • 6.1.2 Market Forecast
  • 6.2 Molecular Diagnostics
    • 6.2.1 Market Trends
    • 6.2.2 Market Forecast
  • 6.3 Immunodiagnostics
    • 6.3.1 Market Trends
    • 6.3.2 Market Forecast
  • 6.4 Hematology
    • 6.4.1 Market Trends
    • 6.4.2 Market Forecast
  • 6.5 Others
    • 6.5.1 Market Trends
    • 6.5.2 Market Forecast

7 Market Breakup by Product

  • 7.1 Reagents and Kits
    • 7.1.1 Market Trends
    • 7.1.2 Market Forecast
  • 7.2 Instruments
    • 7.2.1 Market Trends
    • 7.2.2 Market Forecast

8 Market Breakup by Usability

  • 8.1 Disposable IVD Devices
    • 8.1.1 Market Trends
    • 8.1.2 Market Forecast
  • 8.2 Reusable IVD Devices
    • 8.2.1 Market Trends
    • 8.2.2 Market Forecast

9 Market Breakup by Application

  • 9.1 Infectious Disease
    • 9.1.1 Market Trends
    • 9.1.2 Market Forecast
  • 9.2 Diabetes
    • 9.2.1 Market Trends
    • 9.2.2 Market Forecast
  • 9.3 Cancer/Oncology
    • 9.3.1 Market Trends
    • 9.3.2 Market Forecast
  • 9.4 Cardiology
    • 9.4.1 Market Trends
    • 9.4.2 Market Forecast
  • 9.5 Autoimmune Disease
    • 9.5.1 Market Trends
    • 9.5.2 Market Forecast
  • 9.6 Nephrology
    • 9.6.1 Market Trends
    • 9.6.2 Market Forecast
  • 9.7 Others
    • 9.7.1 Market Trends
    • 9.7.2 Market Forecast

10 Market Breakup by End User

  • 10.1 Hospitals Laboratories
    • 10.1.1 Market Trends
    • 10.1.2 Market Forecast
  • 10.2 Clinical Laboratories
    • 10.2.1 Market Trends
    • 10.2.2 Market Forecast
  • 10.3 Point-of-care Testing Centers
    • 10.3.1 Market Trends
    • 10.3.2 Market Forecast
  • 10.4 Academic Institutes
    • 10.4.1 Market Trends
    • 10.4.2 Market Forecast
  • 10.5 Patients
    • 10.5.1 Market Trends
    • 10.5.2 Market Forecast
  • 10.6 Others
    • 10.6.1 Market Trends
    • 10.6.2 Market Forecast

11 Market Breakup by Region

  • 11.1 North America
    • 11.1.1 United States
      • 11.1.1.1 Market Trends
      • 11.1.1.2 Market Forecast
    • 11.1.2 Canada
      • 11.1.2.1 Market Trends
      • 11.1.2.2 Market Forecast
  • 11.2 Asia-Pacific
    • 11.2.1 China
      • 11.2.1.1 Market Trends
      • 11.2.1.2 Market Forecast
    • 11.2.2 Japan
      • 11.2.2.1 Market Trends
      • 11.2.2.2 Market Forecast
    • 11.2.3 India
      • 11.2.3.1 Market Trends
      • 11.2.3.2 Market Forecast
    • 11.2.4 South Korea
      • 11.2.4.1 Market Trends
      • 11.2.4.2 Market Forecast
    • 11.2.5 Australia
      • 11.2.5.1 Market Trends
      • 11.2.5.2 Market Forecast
    • 11.2.6 Indonesia
      • 11.2.6.1 Market Trends
      • 11.2.6.2 Market Forecast
    • 11.2.7 Others
      • 11.2.7.1 Market Trends
      • 11.2.7.2 Market Forecast
  • 11.3 Europe
    • 11.3.1 Germany
      • 11.3.1.1 Market Trends
      • 11.3.1.2 Market Forecast
    • 11.3.2 France
      • 11.3.2.1 Market Trends
      • 11.3.2.2 Market Forecast
    • 11.3.3 United Kingdom
      • 11.3.3.1 Market Trends
      • 11.3.3.2 Market Forecast
    • 11.3.4 Italy
      • 11.3.4.1 Market Trends
      • 11.3.4.2 Market Forecast
    • 11.3.5 Spain
      • 11.3.5.1 Market Trends
      • 11.3.5.2 Market Forecast
    • 11.3.6 Russia
      • 11.3.6.1 Market Trends
      • 11.3.6.2 Market Forecast
    • 11.3.7 Others
      • 11.3.7.1 Market Trends
      • 11.3.7.2 Market Forecast
  • 11.4 Latin America
    • 11.4.1 Brazil
      • 11.4.1.1 Market Trends
      • 11.4.1.2 Market Forecast
    • 11.4.2 Mexico
      • 11.4.2.1 Market Trends
      • 11.4.2.2 Market Forecast
    • 11.4.3 Others
      • 11.4.3.1 Market Trends
      • 11.4.3.2 Market Forecast
  • 11.5 Middle East and Africa
    • 11.5.1 Market Trends
    • 11.5.2 Market Breakup by Country
    • 11.5.3 Market Forecast

12 SWOT Analysis

  • 12.1 Overview
  • 12.2 Strengths
  • 12.3 Weaknesses
  • 12.4 Opportunities
  • 12.5 Threats

13 Value Chain Analysis

14 Porters Five Forces Analysis

  • 14.1 Overview
  • 14.2 Bargaining Power of Buyers
  • 14.3 Bargaining Power of Suppliers
  • 14.4 Degree of Competition
  • 14.5 Threat of New Entrants
  • 14.6 Threat of Substitutes

15 Price Analysis

16 Competitive Landscape

  • 16.1 Market Structure
  • 16.2 Key Players
  • 16.3 Profiles of Key Players
    • 16.3.1 Abbott Laboratories
      • 16.3.1.1 Company Overview
      • 16.3.1.2 Product Portfolio
      • 16.3.1.3 Financials
      • 16.3.1.4 SWOT Analysis
    • 16.3.2 Agilent Technologies, Inc.
      • 16.3.2.1 Company Overview
      • 16.3.2.2 Product Portfolio
      • 16.3.2.3 Financials
      • 16.3.2.4 SWOT Analysis
    • 16.3.3 Beckman Coulter, Inc.
      • 16.3.3.1 Company Overview
      • 16.3.3.2 Product Portfolio
      • 16.3.3.3 Financials
      • 16.3.3.4 SWOT Analysis
    • 16.3.4 bioMerieux
      • 16.3.4.1 Company Overview
      • 16.3.4.2 Product Portfolio
      • 16.3.4.3 Financials
      • 16.3.4.4 SWOT Analysis
    • 16.3.5 Bio-Rad Laboratories, Inc.
      • 16.3.5.1 Company Overview
      • 16.3.5.2 Product Portfolio
      • 16.3.5.3 Financials
      • 16.3.5.4 SWOT Analysis
    • 16.3.6 F. Hoffmann-La Roche Ltd
      • 16.3.6.1 Company Overview
      • 16.3.6.2 Product Portfolio
      • 16.3.6.3 SWOT Analysis
    • 16.3.7 Illumina, Inc.
      • 16.3.7.1 Company Overview
      • 16.3.7.2 Product Portfolio
      • 16.3.7.3 Financials
      • 16.3.7.4 SWOT Analysis
    • 16.3.8 Qiagen N.V
      • 16.3.8.1 Company Overview
      • 16.3.8.2 Product Portfolio
      • 16.3.8.3 Financials
      • 16.3.8.4 SWOT Analysis
    • 16.3.9 Shimadzu Corporation
      • 16.3.9.1 Company Overview
      • 16.3.9.2 Product Portfolio
      • 16.3.9.3 Financials
      • 16.3.9.4 SWOT Analysis
    • 16.3.10 Siemens Healthineers AG
      • 16.3.10.1 Company Overview
      • 16.3.10.2 Product Portfolio
    • 16.3.11 Sysmex Corporation
      • 16.3.11.1 Company Overview
      • 16.3.11.2 Product Portfolio
      • 16.3.11.3 Financials
      • 16.3.11.4 SWOT Analysis
    • 16.3.12 Thermo Fisher Scientific Inc.
      • 16.3.12.1 Company Overview
      • 16.3.12.2 Product Portfolio
      • 16.3.12.3 Financials
      • 16.3.12.4 SWOT Analysis
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