체외진단(IVD) 시장은 질병의 조기발견에 중점을 두어 헬스케어 성과 향상과 비용 절감에 기여하고 있습니다. 이에 따라 조기 발견에 대한 중요성이 강조되면서 시장 규모는 2024년 1,089억 7,000만 달러를 넘어 2032년에는 1,633억 4,000만 달러에 달할 것으로 예측됩니다.
환자 개개인프로파일에 맞는 치료를 위한 맞춤 의료에 대한 수요가 증가함에 따라 IVD 솔루션의 채택이 가속화되고 있습니다. 이러한 개인 맞춤형 의료로의 전환으로 인해 시장은 2026-2032년 연평균 복합 성장률(CAGR) 5.19%를 보일 것으로 예측됩니다.
체외진단(IVD) 시장 정의/개요
체외진단은 혈액, 소변, 조직 등의 생체 샘플을 대상으로 진단 검사를 실시하여 다양한 질병 및 건강 상태를 확인하고 모니터링하는 데 필수적인 의료기기입니다. 이러한 검사는 감염성 질환, 자가면역질환, 기타 질병을 감지하는 데 중요한 역할을 하며, 개별 환자의 약물 요법을 조정하고 최적화하기 위해 사용되는 경우가 많아지고 있으며, IVD 산업의 중요한 트렌드는 분자진단학의 성장입니다. 분자진단은 유전 물질, 단백질 및 기타 분자를 분석하여 질병을 정확하게 진단하고 관리하는 데 초점을 맞추었습니다.
분자진단학, 특히 유전체학 및 단백질체학의 발전은 특정 유전자 변이 및 특정 질병과 관련된 바이오마커의 검출을 가능하게 하여 체외 진단의 능력을 변화시켰습니다. 이러한 치료법의 개발은 보다 정확하고 개인화된 진단을 가능하게 하고, 개인화된 치료 계획의 개발로 이어집니다. 분자진단학은 종양학, 감염성 질환, 유전성 질환과 같은 중요한 분야에서 질병 관리에 큰 영향을 미치고 있으며, 질병 마커의 정확한 식별은 개인화된 치료 접근법을 위한 지침이 되고 있습니다. 체외진단 분야에서 분자진단의 지속적인 확대는 조기 진단, 정보에 입각한 의사결정, 환자 예후 개선을 지원하며, 헬스케어의 비약적인 발전을 의미합니다.
고령화 인구 증가와 만성질환 증가는 체외진단(IVD) 시장의 성장을 가속화하고 있으며, 세계보건기구(WHO)는 2020-2023년에 60세 이상 노인의 비율이 14억 명으로 증가할 것이라고 보고하고 있습니다. UN의 World Population Prospects 2022에 따르면, 2050년까지 전 세계 인구 6명 중 1명이 65세 이상이 될 것이라고 합니다. CDC는 2022년 미국 성인 10명 중 6명이 적어도 한 가지 이상의 만성질환을 앓고 있다고 보고했으며, 이 계층은 더 빈번한 진단 검사와 질병 모니터링이 필요합니다. 국제당뇨병연맹에 따르면 2021년 전 세계적으로 약 5억 3,700만 명의 성인이 당뇨병을 앓고 있습니다. 미국심장협회는 2021년 미국 성인의 48%가 심혈관계 질환을 앓고 있으며, FDA는 2020-2022년 사이에 120개 이상의 새로운 체외 진단 검사 및 장치를 승인했다고 발표했습니다. 포인트 오브 케어 검사 시장은 2020-2023년 CAGR 15%를 보일 것으로 예측됩니다. 분자진단 부문은 팬데믹 기간(2020-2021년) 동안 30% 성장
세계보건기구(WHO)의 추산에 따르면, 2021년 전 세계적으로 20억 건 이상의 코로나19 검사가 실시되었습니다. 세계 분자진단 시장은 2022년 362억 달러에 달했으며, CDC의 보고에 따르면 코로나19 검사 인프라는 다른 전염병 검사를 위한 검사실 능력을 40% 향상시켰습니다고 합니다. 미국의 의료비 지출은 2021년 4조 3,000억 달러에 달했고, WHO의 보고서에 따르면 전 세계 의료비 지출은 2020-2022년 11% 증가하였습니다. 메디케어의 진단 검사에 대한 지출은 2020-2022년 사이에 23% 증가하였습니다.
높은 장비 및 유지보수 비용이 체외진단(IVD) 시장의 성장을 저해하는 요인으로 작용하고 있습니다. 하이엔드 분자진단 시스템의 평균 비용은 2022년 기준 10만-50만 달러에 달할 전망입니다. 연간 유지보수 비용은 일반적으로 초기 장비 구매 가격의 10-15%를 차지하며, 2022년 헬스케어 비용 분석에 따르면 소규모 검사실은 연간 약 15만-20만 달러의 IVD 장비 유지보수 비용을 지출하고 있습니다. 또한 숙련된 인력의 부족도 시장 성장에 걸림돌이 되고 있습니다. 미국임상검사학회는 2022년 검사실 공석률이 7%를 보일 것이라고 보고했습니다. 노동통계국에 따르면 2022년에는 약 2만 5,000명의 검사 기술자가 부족할 것으로 예측됩니다. 2021년 임상병리사 1인당 교육 비용은 평균 40,000-60,000달러로 나타났습니다.
FDA의 보고서에 따르면 2022년 체외진단 승인에 걸리는 평균 기간은 9-12개월로, 업계에서 엄격한 규제 요건과 상환 문제가 시장 과제로 작용할 것으로 보입니다. 규제 준수 비용은 2020-2022년 사이 25% 증가했습니다. 기업들은 2022년 IVD 기기당 평균 25만-50만 달러를 규제 당국에 제출하는 데 지출할 것으로 예측됩니다. 메디케어는 2022년 특정 진단 검사에 대해 15-20% 인하할 예정이며, CMS 데이터에 따르면 2020년-2022년 사이 임상 검사 보수는 평균 10% 감소할 것으로 예측됩니다. 진단 검사에 대한 보험 청구 거절은 2020년 대비 2021년 23% 증가하였습니다.
A strong emphasis on early disease detection is a major driver in the in-vitro diagnostics (IVD) market, contributing to improved healthcare outcomes and reduced costs. Thus, the growing emphasis on early detection surged the growth of the market size, surpassing USD 108.97 Billion in 2024 to reach a valuation of USD 163.34 Billion by 2032.
The rising demand for personalized medicine, which tailors treatment to individual patient profiles, has also accelerated the adoption of IVD solutions. Thus, the shift toward personalized care enables the market to grow at a CAGR of 5.19% from 2026 to 2032.
In Vitro Diagnostics Market: Definition/ Overview
In-vitro diagnostics (IVD) are essential medical devices that conduct diagnostic tests on biological samples, including blood, urine, and tissue, to identify and monitor various diseases and health conditions. These tests play a vital role in detecting infectious diseases, autoimmune disorders, and other medical conditions, and they are increasingly used to adjust and optimize drug therapies for individual patients. A significant trend in the IVD industry is the growth of molecular diagnostics, which focuses on analyzing genetic material, proteins, and other molecules to diagnose and manage diseases with high precision.
Advancements in molecular diagnostics, particularly within genomics and proteomics, have transformed IVD capabilities by enabling the detection of specific gene mutations and biomarkers linked to particular diseases. This progress allows for more accurate and tailored diagnoses, leading to the development of personalized treatment plans. Molecular diagnostics has profoundly impacted disease management in critical areas like oncology, infectious diseases, and genetic disorders, where precise identification of disease markers can guide individualized treatment approaches. The ongoing expansion of molecular diagnostics within the IVD field represents a leap forward in healthcare, supporting early diagnosis, informed decision-making, and improved patient outcomes.
The increasing aging population and growing chronic disorders cases surge the growth of in vitro diagnostics market. The WHO reported that between 2020 and 2023, the proportion of people aged 60+ years increased to 1.4 billion. According to the UN's World Population Prospects 2022, by 2050, 1 in 6 people worldwide will be over 65 years old. This demographic requires more frequent diagnostic testing and disease monitoring. The CDC reported in 2022 that 6 in 10 American adults have at least one chronic disease. Diabetes affected approximately 537 million adults worldwide in 2021 according to the International Diabetes Federation. The American Heart Association stated that 48% of US adults had some form of cardiovascular disease in 2021. The FDA approved over 120 new IVD tests and devices between 2020-2022. The point-of-care testing market saw a 15% CAGR from 2020-2023. Molecular diagnostics segment grew by 30% during the pandemic period (2020-2021)
Over 2 billion COVID-19 tests were performed globally in 2021 according to WHO estimates. The global molecular diagnostics market reached USD 36.2 Billion in 2022. CDC reported that COVID-19 testing infrastructure improved laboratory capabilities for other infectious disease testing by 40%. The US healthcare spending reached USD 4.3 Trillion in 2021. The WHO reported global healthcare spending grew by 11% between 2020 and 2022. Medicare spending on diagnostic testing increased by 23% from 2020 to 2022.
The high cost of equipment and maintenance hamper the growth of the in vitro diagnostics market. The average cost of a high-end molecular diagnostic system ranges from $100,000 to $500,000 as of 2022. Annual maintenance costs typically represent 10-15% of the initial equipment purchase price. According to a 2022 healthcare cost analysis, smaller laboratories spend approximately $150,000-$200,000 annually on IVD equipment maintenance. Also, the lack of skilled labor hinders market growth. The American Society for Clinical Laboratory Science reported a 7% vacancy rate for laboratory positions in 2022. According to the Bureau of Labor Statistics, there was a shortage of approximately 25,000 laboratory professionals in 2022. Training costs per laboratory technician averaged $40,000-$60,000 in 2021.
The stringent regulatory requirements and the reimbursement challenges in the industry act as a challenge for the market. FDA reported that the average time for IVD device approval increased to 9-12 months in 2022. Regulatory compliance costs increased by 25% between 2020 and 2022. Companies spent an average of $250,000-$500,000 per IVD device for regulatory submissions in 2022. Medicare reduced reimbursement rates for certain diagnostic tests by 15-20% in 2022. According to CMS data, laboratory test reimbursements decreased by an average of 10% between 2020-2022. Insurance claim denials for diagnostic tests increased by 23% in 2021 compared to 2020
The reagents & kits segment dominates the in vitro diagnostics (IVD) market owing to their vital role in performing accurate and efficient diagnostic tests. These products are essential for identifying and measuring biomarkers, pathogens, and other analytes across a range of biological samples, making them indispensable in diagnostics. A notable example of innovation within this segment occurred in February 2022, when Invitae Corporation introduced its CE-IVD-certified cancer testing kits, FusionPlex Dx and LiquidPlex Dx, in Europe. These advanced kits are tailored to enhance precision oncology, enabling more reliable cancer detection and management solutions, which respond to the increasing demand for effective diagnostic tools in the European healthcare market.
With continuous advancements and product launches, the Reagents & Kits segment reinforces its importance within the IVD field. Such innovations drive market growth and support the broader shift toward personalized medicine, which seeks to improve patient outcomes by providing tailored diagnostic and treatment options. By facilitating high-quality diagnostics, reagents and kits contribute significantly to expanding possibilities for individualized patient care, reinforcing their position as a cornerstone in the evolving IVD landscape.
The infectious diseases segment holds a dominant in the in vitro diagnostics (IVD) market, driven by the increasing prevalence of infectious diseases such as HIV, tuberculosis, influenza, and hepatitis. The global demand for early and accurate diagnostics has grown significantly as healthcare systems prioritize rapid identification and treatment of these diseases to prevent widespread transmission. Moreover, the need for swift diagnostics and large-scale screening is amplified by government initiatives focused on controlling outbreaks and reducing disease impact. This focus has bolstered investment and innovation within the infectious disease diagnostics space.
With a particular emphasis on diseases like hepatitis, pneumonia, HIV-AIDS, and tuberculosis. As the incidence of these conditions rises globally, key industry players are accelerating efforts to develop innovative diagnostic systems designed to improve the speed, accuracy, and accessibility of testing. These advancements address the rising infectious disease burden and support effective response measures in urban and remote healthcare settings. As a result, the infectious diseases segment continues to play a pivotal role in the IVD landscape, addressing public health needs and reinforcing its dominance through ongoing technological progress and strategic initiatives.
North America substantially dominates the in vitro diagnostic market driven by the high healthcare expenditure & advanced healthcare infrastructure. According to the Centers for Medicare & Medicaid Services, U.S. healthcare spending reached USD 4.3 Trillion in 2021, representing 18.3% of GDP. According to the American Hospital Association, as of 2022, there were over 6,000 hospitals in the U.S. with sophisticated diagnostic laboratories. Canada's healthcare spending exceeded USD 300 Billion in 2021, with significant investments in diagnostic infrastructure.
In addition, the rising prevalence of chronic diseases also contributes to the growth of in vitro diagnostics market. According to the CDC (2022), 6 in 10 Americans live with at least one chronic disease. According to the report of National Diabetes Statistics diabetes affected approximately 37.3 million Americans (11.3% of the population) in 2022. Cancer diagnoses in the U.S. were projected to reach 1.9 million new cases in 2023.
The growing elderly population requiring regular diagnostics propels the adoption of the in vitro diagnostics market in the region. The U.S. population aged 65 and older grew from 54.1 million in 2019 to nearly 57 million in 2021. By 2030, all baby boomers will be 65 or older, expanding the elderly population to 73 million. Medicare spending on clinical laboratory services reached USD 9.2 Billion in 2020.
Asia Pacific is anticipated to witness the fastest growth in the in vitro diagnostic market during the forecast period owing to the large population base with a high disease burden. China and India together account for approximately 2.8 billion people (36% of the global population) as of 2022. In 2021, China reported 4.07 million new cancer cases with growing demand for early diagnostics. India recorded over 77 million diabetes cases in 2021, the second highest globally.
In addition, the rising healthcare expenditure & infrastructure development propel the growth of the market. China's healthcare spending reached 7.12 trillion yuan (USD 1.1 Trillion) in 2021, rising 13.5% from 2020. Japan's healthcare expenditure increased to 44.2 trillion yen (USD 333 Billion) in 2021. India allocated USD 10.6 Billion for healthcare infrastructure in the 2022-23 budget, with a significant focus on diagnostic capabilities
Also, the growing aging population & chronic disease management enhance the growth of market growth. According to the Statistics Bureau of Japan. Japan's elderly population (65+ years) reached 29.1% of total population in 2021. South Korea's elderly population is expected to reach 20.3% by 2025. China's 60+ population exceeded 267 million in 2021 (National Bureau of Statistics), creating increased demand for diagnostic services.
The In Vitro Diagnostics (IVD) Market is a highly competitive landscape dominated by a few major players and numerous smaller, specialized companies. Key factors driving competition include technological advancements, regulatory approvals, product innovation, and strategic partnerships.
The organizations are focusing on innovating their product line to serve the vast population in diverse regions. Some of the prominent players operating in the in vitro diagnostics market include: