According to Nova One Advisor, the global In Vitro Diagnostics (IVD) market size is calculated at 80.85 billion in 2024 and is projected to surpass USD 157.56 billion by 2034 with a remarkable CAGR of 6.9% from 2024 to 2034.
In Vitro Diagnostics Market Key Takeaways:
• Reagents held the largest revenue share of 68.0% in the market in 2024.
• Instruments held the second-largest revenue share in 2024.
• Immunoassay accounted for the largest revenue share of the market in 2024.
• Coagulation is expected to grow at the fastest rate from 2024 to 2034.
• Hospitals held the largest revenue share of the market in 2024
• The homecare segment is expected to grow at a high CAGR from 2024 to 2034.
• The infectious diseases segment dominated the market in 2024.
• The oncology segment is anticipated to grow at the fastest rate from 2024 to 2034.
• Others (lab-based tests) accounted for the largest revenue share of the market in 2024.
• The homecare segment is expected to grow at a high CAGR from 2024 to 2034.
• North America In Vitro Diagnostics market dominated the global market and accounted for a 43.0% share in 2024.
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In Vitro Diagnostics Market: An Overview and Industry Potential
The in vitro diagnostics market is carried out on a person’s tissue and blood sample. They are used to accurately test for and diagnose diseases or any underlying issues and guide in keeping a close eye on the patients. The market growth is attributed to the increasing awareness of point-of-care testing and customized medicine, the rising importance of companion diagnostics, and the increasing prevalence of infectious and chronic diseases. In addition, favorable initiatives undertaken by non-government and government bodies to enhance overall healthcare services are expected to drive the growth of the in vitro diagnostics market.
“The growth of the IVD market in emerging markets such as India, China, and Latin America is accelerating. These regions are investing heavily in healthcare infrastructure, increasing the adoption of IVD technologies for disease diagnosis. For example, in China, the government’s "Healthy China 2030" initiative has spurred significant growth in medical diagnostics and testing infrastructure.”
For instance, In November 2024, A £4.2 million MedTech accelerator program was launched, which will offer up to 140 UK small and medium-sized enterprises (SMEs) with grants to tackle regulatory challenges. The aim behind this launch was to offer and develop medical devices such as in vitro diagnostics services or products.
U.S. In Vitro Diagnostics Market Size and Growth 2024 to 2034
The U.S. In Vitro Diagnostics Market size was exhibited at USD 29.95 billion in 2024 and is projected to hit around USD 41.84 billion by 2034, growing at a CAGR of 3.4% during the forecast period 2024 to 2034.
North America In Vitro Diagnostics market dominated the global market and accounted for a 43.0% share in 2024. The market growth is attributed to the rising supportive government funding, the increasing number of novel test launches, the presence of strong players, and the rising incidence of chronic diseases.
• For instance, in October 2023, WHO, the World Health Organization released its 2023 Essential Diagnostics List, which is an evidence-based register of in vitro diagnostics (IVD) that supports countries to make national diagnostic choices. Around 1.5 million deaths have been caused by diabetes in recent years.
The FDA (U.S. Food and Drug Administration) approved a record number of in vitro diagnostic devices in 2023, highlighting the growing confidence in IVD innovations. According to the FDA, over 100 new IVDs were approved in 2023, including molecular diagnostic tests and rapid tests for various diseases like COVID-19, cancer, and genetic disorders.
Rapid Growth in Healthcare Research Sector: Asian Countries to Witness Boom
Asia Pacific is expected to grow fastest during the forecast period. The market growth in the region is fueled by rapid urbanization across the region, supportive government policies, a rapidly growing middle-class population, and the presence of stabilizing countries. For instance, in October 2023, Halodoc and Fapon partnered to increase the in vitro diagnostic product services and sales in Indonesia. In addition, major players in the region are collaborating with regional players to increase their reach in emerging countries in the region.
Major Trends in In Vitro Diagnostics Market
• The increasing prevalence of various diseases: Diseases such as neurological ailments, and cardiovascular and genetic diseases are putting a significant burden on healthcare.
• The increasing government support and funding: Government agencies, associations, and organizations motivate the use of IVD by driving market expansion and launching awareness initiatives. WHO released a model list of IVD for primary medical and healthcare facilities with clinical laboratories, to clarify the priority of diseases based on prevalence and burden.
• Focus on early disease detection: Early detection allows timely intervention, which can minimize the need for complex treatments to prevent disease progressions and help to enhance healthcare outcomes while reducing costs.
• The rising technological advancements: Innovations such as the development of highly sensitive tests, and the integration of artificial intelligence and automation are revolutionizing the in vitro diagnostics market.
Trending Applications of In-vitro Diagnostics:
Liquid biopsy is an emerging application that involves detecting cancer-related genetic mutations, tumor markers, or circulating tumor DNA (ctDNA) from a simple blood sample. This non-invasive diagnostic method holds great promise for the early detection of various cancers, as well as monitoring treatment response and detecting minimal residual disease or recurrence in cancer patients.
Point-of-care testing (POCT) is rapidly growing as a convenient and time-efficient diagnostic tool. POCT allows for the immediate results of tests in settings outside of traditional laboratories, such as in emergency rooms, clinics, or even at home. Technologies like rapid antigen tests, glucose monitors, and portable PCR systems are revolutionizing the way diagnostics are conducted, offering faster decision-making and improved patient outcomes.
Pharmacogenomics, which uses genetic testing to determine how patients will respond to specific drugs, is a rapidly expanding field within IVD. By identifying genetic variations in drug-metabolizing enzymes, doctors can tailor medication choices and dosages, reducing adverse drug reactions and improving efficacy. This trend is poised to grow as the demand for personalized medicine rises, offering more customized healthcare solutions.
In Vitro Diagnostics Market Report Scope
|
Report Attribute |
Details |
|
Market size value in 2025 |
USD 85.63 billion |
|
Revenue forecast in 2034 |
USD 157.56 billion |
|
Growth rate |
CAGR of 6.9% from 2024 to 2034 |
|
Actual data |
2019- 2023 |
|
Forecast period |
2024 - 2034 |
|
Quantitative units |
Revenue in USD million/billion, volume (number of units installed and reagents sold), and CAGR from 2024 to 2034 |
|
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
|
Segments covered |
Products, technology, application, end-use, test location, region |
|
Regional scope |
North America; Europe; Asia Pacific; Latin America; MEA |
|
Country scope |
U.S.; Canada; UK; Germany; France; Spain; Italy; Russia; Denmark; Sweden; Norway; Japan; China; India; South Korea; Australia; Thailand; Singapore; Brazil; Mexico; Argentina; South Africa; Saudi Arabia; UAE; Kuwait |
|
Key companies profiled |
Abbott; bioMérieux SA; QuidelOrtho Corporation; Siemens Healthineers AG; Bio-Rad Laboratories, Inc.; Qiagen; Sysmex Corporation; Charles River Laboratories; Quest Diagnostics Incorporated; Agilent Technologies, Inc.; Danaher Corporation; BD; F. Hoffmann-La Roche Ltd. |
|
Customization scope |
Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope. |
Benefits of In Vitro Diagnostics Market IVD is used to monitor an individual’s
overall health. It can detect and prevent diseases and other medical
conditions; it can also be used in precision medicine to identify the best
course of treatment for certain patients. Read on to understand the key
benefits of IVD tests. Early detection of diseases According to a paper by APACMed
regarding diagnostics in healthcare systems, IVD enables patients and/or
healthcare providers to detect diseases early. This allows treatment to be
administered more promptly and effectively. For example, IVD tests help with detecting
tuberculosis in a quick and accurate manner, and the results are used to make
decisions related to the treatment of the disease. Such diagnostics solutions play a key role
in slowing down or preventing the progression of diseases. Liver disease, which
is especially prevalent in the Asia-Pacific (APAC) region, is known as a
‘silent killer’ as the condition is often diagnosed after it has deteriorated
significantly. By detecting the disease earlier,
complications such as liver cancer can be better managed and even prevented,
increasing the chances of survival. In fact, mortality rates of Hepatocellular
Carcinoma (HCC), a type of cancer, has been found to decrease by 37% as a
result of earlier and more advanced diagnostics. Prevent the spread of diseases IVD tests serve as the first line of
defense against the spread of diseases. In particular, COVID-19 test kits were
used to identify patients with the disease and patients were recommended to
quarantine themselves to prevent further spread of the disease. Additionally, IVD devices are key in
preventing the re-emergence of previously eradicated diseases such as smallpox. Improve patient care and management With IVD technologies, patients can better
understand their condition and make more informed medical decisions. This
empowers them to take charge of their overall health and well-being, easing the
burden on healthcare institutions by reducing hospital stays and visits to the
emergency room (ER). For healthcare professionals, IVD offers
the opportunity to improve patient care as they can make faster, more
personalized, and more informed decisions about patients’ treatment plans. What is the difference between in vivo
and in vitro diagnostics? In vitro diagnostics refers to any
non-invasive test or experiment performed on human samples in a controlled
environment. On the other hand, in vivo diagnostics refers to tests or
experiments performed in or on living organisms like animals, plants and
humans. The following table shows a summary of
the differences between in vitro and in vivo diagnostics. In vitro
diagnostics In vivo
diagnostics Benefits Safe study of
the effects of a substance or disease without causing harm or distress to the
living being Allows new
treatments to be developed more quickly Involves a
larger sample size Able to provide
information on the effects of a substance or progression of a disease on an
entire living organism Drawbacks Inability to
replicate the conditions within a living organism’s body Results may not
accurately predict the reaction of the entire organism Can cause harm
or distress to a living being Generally
requires a longer time to derive results Involves a
smaller sample size Examples Fertility
treatments Pharmaceutical
testing Animal studies Clinical trials
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Other Markets Positively Impacted by IVD
Market: • In Vitro Diagnostics Contract
Manufacturing Market The in vitro diagnostics contract
manufacturing market growth is attributed to the increasing demand for fast and
accurate diagnostics testing and rapid developments in the healthcare industry
have led to an increase in demand for IVD to enhance the quality and speed of
prevention, detection, and diagnoses of patient care. Furthermore, the market
growth is fueled by increasing regulatory scrutiny, rising demand for
personalized medicine, and the increasing prevalence of chronic diseases. • Infectious Disease in In Vitro
Diagnostics Market The infectious disease in vitro diagnostics
market is driven by the increasing prevalence of chronic diseases and rising
technological advancements. The market is experiencing a significant number of
product launches to address the demands of consumers. The delay in treatment
and diagnosis with antibiotics before infection is further creating a
significant opportunity and escalating the prevalence of drug-resistant
bacteria in the market growth. In Vitro Diagnostics Market
Segmentation By Product Types Reagents held the largest revenue share of
68.0% in the market in 2024. The segment growth is attributed to the extensive
research and development activities undertaken by key players to develop test
kits and novel reagents. The rising R&D activities to allow faster cancer
precision medicine and cancer detection are enabling companies to concentrate
on niche profitable areas in the IVD industry. The instruments segment held the
second-largest share in 2024. Increasing approvals for novel IVD instruments are
expected to enhance segment growth. Major players are arranging their
instrument launches in line with the increasing genetic test and are further
expected to drive the segment growth. By Technology Types The immunoassay
segment accounted for the highest market share in 2024. The segment growth is
attributed to the rising need for early diagnosis and Increasing incidence of
communicable & chronic diseases. In addition, the coagulation segment is
expected to grow fastest during the forecast period. The segment growth is
fueled by the increasing prevalence of autoimmune diseases, blood-related
disorders, and cardiovascular diseases. By End-use Types The hospitals segment held the largest
market share in 2024. The segment growth is driven by rising favorable
initiatives taken by government bodies and the ongoing development of healthcare
infrastructure. The homecare segment is expected to grow
fastest during the forecast period. An increasing need for immunoassay
platforms and novel molecular
diagnostics that can guide patients in conducting self-tests. By Test Location Types The others segment held the largest share
of the market in 2023. The segment includes lab-tests as a test location, Lab
tests, which include a wide range of diagnostic procedures, remain critical for
early disease detection, disease management, and patient monitoring. As the
global population continues to age, the demand for diagnostic
testing—particularly lab tests—has surged. Older populations are more
susceptible to various health conditions, and regular lab testing is essential
for preventive care, early detection, and personalized treatment plans. Early
detection of diseases, including cancer, infectious
diseases, and genetic conditions, is a critical factor driving the
demand for lab tests. Early intervention can significantly improve patient
outcomes and reduce healthcare costs by preventing disease progression. As a
result, lab tests that enable early detection of diseases are an integral part
of preventive healthcare, contributing to the increasing share of this segment
in the IVD market. By Application Types The infectious diseases segment led the
in-vitro diagnostics market in 2024. The rise in infectious diseases, such as
HIV/AIDS, hepatitis, tuberculosis (TB), malaria, and influenza, continues to
drive demand for diagnostic tests. According to the World Health Organization
(WHO), the global incidence of these diseases remains high, especially in
developing regions, creating a constant need for diagnostic tools for both
early detection and monitoring of disease progression. ·
The Global Fund, the Centers for Disease Control
and Prevention (CDC), and other organizations have been instrumental in
facilitating access to diagnostic tools for infectious diseases, contributing
to the dominance of this segment within the IVD market. The growing trend of point-of-care
(POC) testing has been a significant factor in the infectious diseases
segment's dominance. POC tests allow for rapid, on-site diagnostics in clinics,
remote areas, and emergency settings, making them invaluable in managing
infectious outbreaks. As healthcare shifts toward more decentralized models,
the demand for POC diagnostics in infectious disease management continues to
rise. The oncology
segment is observed to grow at a rapid pace driven by the increasing global
burden of cancer and significant advancements in diagnostic technologies. As
the prevalence of cancer continues to rise worldwide, the demand for early
detection, accurate diagnosis, and personalized treatment has fueled the growth
of the oncology segment within IVD. One of the key drivers of growth in the
oncology IVD market is the discovery and validation of cancer biomarkers. These
biomarkers allow for the detection of specific types of cancer and can help in
monitoring disease progression and response to treatment. The development of
highly sensitive and specific diagnostic tests for biomarkers like genetic
mutations, tumor antigens, and circulating tumor DNA (ctDNA) has revolutionized
cancer diagnostics. These advancements have made it possible to detect cancers
earlier and with greater precision, driving the demand for specialized
diagnostic tests in oncology. Related Report - In Vitro Diagnostics Contract
Manufacturing Market- The global in
vitro diagnostics contract manufacturing market size was valued at USD
19.85 billion in 2023 and is anticipated to reach around USD 51.72 billion by
2033, growing at a CAGR of 10.05% from 2024 to 2033. Neurodiagnostics Market- The global neurodiagnostics
market size was valued at USD 18.09 billion in 2023 and is anticipated
to reach around USD 26.52 billion by 2033, growing at a CAGR of 3.9% from 2024
to 2033. U.S. In Vitro Diagnostics Market- The U.S.
In vitro diagnostics market size was valued at USD 37.19 billion in
2023 and is projected to surpass around USD 45.78 billion by 2033, registering
a CAGR of 2.1% over the forecast period of 2024 to 2033. Europe In Vitro Diagnostics Market- The europe
in vitro diagnostics market size was estimated at USD 16.36 billion in
2022 and is expected to hit around USD 26.14 billion by 2032, poised to reach
at a notable CAGR of 4.8% during the forecast period 2023 to 2032. Canada In Vitro Diagnostics Market- The canada
in vitro diagnostics market size was estimated at USD 4.6 billion in
2022 and is expected to hit around USD 6 billion by 2032, poised to reach at a
notable CAGR of 2.7% during the forecast period 2023 to 2032. In Vitro
Diagnostics (IVD) Quality Control Market- The
global In
Vitro Diagnostics (IVD) Quality Control market size was exhibited at
USD 1.97 billion in 2022 and is projected to hit around USD 2.89 billion by
2032, growing at a CAGR of 3.90% during the forecast period 2023 to 2032. North America In Vitro Diagnostics
Market- The North
America in vitro diagnostics market size was exhibited at USD 50.19
billion in 2022 and is projected to hit around USD 66.86 billion by 2032,
growing at a CAGR of 2.91% during the forecast period 2023 to 2032. Immediate Delivery Available | Buy This
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Some of the prominent players in the in
vitro diagnostics market include: • Abbott • QuidelOrtho Corporation • Siemens Healthineers AG • Qiagen • Sysmex Corporation • Charles River Laboratories • Quest Diagnostics Incorporated • Danaher Corporation • BD • F. Hoffmann-La Roche Ltd. In Vitro Diagnostics Market By Recent
Developments • In January 2024, Cepheid's Xpert
Xpress MVP received FDA clearance and CLIA waiver, offering rapid multiplex PCR
testing for Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), and Trichomoniasis
(TV), improving targeted treatment and patient outcomes in near-patient
settings. • In December 2023, ARUP
Laboratories and Medicover collaborated to provide diagnostic and healthcare
services in Europe. ARUP Laboratories has developed AAV5 DetectCDx in
collaboration with BioMarin Pharmaceutical Inc. to select therapies for severe
hemophilia A patients. • In November 2023, Veracyte joined
Illumina aimed to develop molecular tests for decentralized IVD applications.
Companies are focusing on the development of Prosigna breast cancer and
Percepta nasal swab tests of Veracyte. • In October 2023, Promega
Corporation announced its plan to develop and commercialize companion
diagnostics kits with GSK plc to identify cancer patients with MSI-H solid
tumors. • In February 2023, Unilabs
announced investing over USD 200 million in Siemens Healthineers' technology
and acquiring more than 400 laboratory analyzers to strengthen its laboratory
infrastructure. • In February 2023, F. Hoffmann-La
Roche Ltd. collaborated with Janssen Biotech Inc. to develop companion
diagnostics for targeted therapies. Companion diagnostic technologies include
digital pathology, NGS, PCR, immunoassays, and immunohistochemistry. Segments Covered in the Report This report forecasts revenue growth at
country levels and provides an analysis of the latest industry trends in each
of the sub-segments from 2021 to 2034. For this study, Nova one advisor, Inc.
has segmented the in vitro diagnostics market Product • Instruments • Reagents • Services By Technology • Immunoassay o
Instruments o
Reagents o
Services o
Instruments o
Reagents o
Services • Clinical Chemistry o
Instruments o
Reagents o
Services • Molecular Diagnostics o
Instruments o
Reagents o
Services • Coagulation o
Instruments o
Reagents o
Services • Microbiology o
Instruments o
Reagents o
Services • Others o
Instruments o
Reagents o
Services By Application • Infectious Diseases • Diabetes • Oncology • Cardiology • Nephrology • Autoimmune Diseases • Drug Testing • Others applications By Test Location • Point of Care • Home-care • Others By End-use • Hospitals • Laboratory • Home-care • Others By Regional • North America • Europe • Asia Pacific • Latin America • Middle East and Africa (MEA) Immediate Delivery Available | Buy This
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