In 2026, the diagnostic testing market is projected
to be valued at USD 213.03 billion, reflecting a compound annual growth rate
(CAGR) of 3% since 2024. The market is expected to grow from $203.24 billion in
2024 to $264.12 billion in 2033. Rising demand for early disease detection,
personalized care, and at-home diagnostic solutions is driving steady growth in
the diagnostic testing market.
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Diagnostic Testing Market Highlights:
🔹In terms of revenue, the global diagnostic testing market was valued at USD 203.24 billion in 2024.
🔹It is projected to reach USD 272.98 billion by 2034.
🔹The market is expected to grow at a CAGR of 3% from 2025 to 2034.
🔹 The U.S. diagnostic testing market has been calculated at $69.91 billion by 2025
🔹North America led the global diagnostic testing market with the largest revenue share of 41% in 2024.
🔹Europe accounted for the second largest revenue share of 27% in 2024.
🔹By approach, the in vitro diagnostic instrument segment contributed the largest revenue share in 2024.
🔹By application, the cardiology segment held the major revenue share in 2024.
🔹By technology, the next-generation sequencing segment accounted for the highest revenue share in 2024.
Diagnostic Testing Market Revenue Analysis by Regions, 2020 to 2024 (USD Million)
|
Region |
2020 |
2021 |
2022 |
2023 |
2024 |
|
North America |
73,199.93 |
83,664.69 |
92,763.77 |
87,881.59 |
84,344.67 |
|
Europe |
46,332.00 |
53,153.27 |
59,081.80 |
56,210.97 |
54,165.95 |
|
APAC |
39,613.72 |
46,054.80 |
51,845.15 |
49,941.89 |
48,725.98 |
|
LA |
7,686.84 |
8,856.64 |
9,902.12 |
9,447.46 |
9,133.02 |
|
MEA |
5,699.22 |
6,565.41 |
7,350.95 |
7,065.56 |
6,873.07 |
|
Total |
1,72,531.72 |
1,98,294.82 |
2,20,943.79 |
2,10,547.47 |
2,03,242.70 |
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Smarter Tools, Healthier Populations: The Diagnostic Boom
The diagnostic testing market is expected to see steady growth owing to the increased awareness of diseases and the early detection of diseases in recent years. Also, individuals are increasingly following the regular test lineups for diseases like infections, genetic conditions, cancer, and other critical diseases.
Moreover, in the current industry environment, technology plays the ideal role while making these tests faster, affordable, and more accurate, as per the recent observation. Also, the sudden lifestyle changes and other modern factors have driven the industry's growth in the past few years.
Also Read 👉 What’s Driving the Cancer Diagnostics Market?
Market’s Opportunity: Portable Kits Drive the Future of Personalized Healthcare
The development of advanced home diagnostic kits is expected to create lucrative opportunities for manufacturers during the forecast period. Moreover, individuals are increasingly preferring convenience, privacy, and result accuracy in conditions such the diabetes, fertility issues, and infections in recent years. Thus, manufacturers can offer them their advanced portable diagnostic kits, which will provide immense industry attention in the coming years, as per future market expectations.
Also Read 👉 What's Next for Rapid Diagnostic Kits?
What is the Largest Challenge in Diagnostic Testing Market?
Regulatory Barriers Challenge Diagnostic Manufacturers
The stricter regulations from the government authorities for the approval of the diagnostic kits are expected to hamper the industry's growth during the forecast period. Some of the authorities have very strict regulations, like the FDA and EMA, which can lead to growth barriers, like product delays and increased product costs. Moreover, small and mid-sized manufacturers can face these challenges in the upcoming years. However, the manufacturer can overcome these challenges by applying expertise, better financial investment, and patience.
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Area of Diagnostic Testing Market Influence
|
Report Coverage |
Key Statistics |
|
Market Size in 2024 |
USD 203.24 Billion |
|
Market Size in 2025 |
USD 207.96 Billion |
|
Market Size in 2030 |
USD 238.49 Billion |
|
Market Size in 2032 |
USD 255.68 Billion |
|
Market Size by 2034 |
USD 272.98 Billion |
|
CAGR (2025–2034) |
3% |
|
Leading Market Region |
North America |
|
Fastest Growing Region |
Asia-Pacific |
|
Base Year |
2024 |
|
Forecast Years |
2025-2034 |
|
Key Market Trends |
- Growth in self-diagnosis kits - Increasing prevalence of lifestyle-related diseases - Expansion of retail diagnostics - Adoption of cloud-based health record integration |
|
Regulatory Influence |
Evolving global regulations and favorable reimbursement models are enabling wider access, especially in underserved markets |
|
Segments Covered |
Type, Application, Approach, Solution, Technology, Mode of Testing, Sample Type, Testing Type, Age, Distribution Channel, End User, and Regions |
|
Regions Covered |
North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa |
|
Key Companies Covered |
F-Hoffman La-Rcohe Ltd. (Switzerland), Danaher (US), BD (US), Thermo Fisher Scientific Inc. (US), ACON Laboratories Inc. (US), Hemosure, Inc. (US), MicroGen Diagnostics (US), Grifols, S.A (Spain), BODITECH MED INC. (South Korea), Chembio Diagnostic Systems, Inc. (US), Nanoentek (South Korea), DiaSorin S.p.A. (Italy), Bio-Rad Laboratories, Inc. (US), BIOMEDOMICS INC (US), EKF Diagnostics Holdings plc (UK), Siemens Healthcare GmbH (Germany), PerkinElmer Inc. (US), bioMérieux SA (France), ARKRAY USA, Inc. (US), Biohit Oyj (Finland), Quidel Corporation (US), Illumina, Inc. (US) |
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Diagnostic Testing Market Top Companies and their Contributions:
🔹F. Hoffmann-La Roche Ltd.
Roche is a global leader in in-vitro diagnostics, contributing significantly
through innovations like the cobas diagnostic platform, which offers
high-throughput, automated molecular testing solutions for infectious diseases,
oncology, and women’s health.
🔹Danaher Corporation
Danaher plays a pivotal role in advancing diagnostic testing through its
subsidiaries like Cepheid, which specializes in
rapid molecular diagnostic platforms for point-of-care use, particularly in
respiratory, sexually transmitted, and hospital-acquired infections.
🔹BD (Becton, Dickinson and
Company)
BD contributes extensively to diagnostics by developing automated blood culture
systems, molecular testing kits, and microbiology solutions that improve diagnostic
speed and accuracy across clinical laboratories worldwide.
🔹Thermo Fisher Scientific
Inc.
Thermo Fisher offers a broad diagnostic portfolio, including next-generation sequencing
(NGS), immunoassays, and molecular diagnostic
tools,
enabling precise detection of genetic disorders, infectious diseases, and cancer biomarkers.
🔹ACON Laboratories Inc. (US)
ACON Laboratories specializes in cost-effective rapid diagnostic tests, including lateral flow
and immunoassay technologies, providing accessible solutions for glucose
monitoring, infectious disease screening, and drug testing globally.
🔹Hemosure, Inc. (US)
Hemosure focuses on non-invasive
fecal immunochemical tests (FIT) for colorectal cancer screening,
playing a critical role in early cancer detection and preventive diagnostics,
especially in population health programs.
🔹MicroGen Diagnostics (US)
MicroGen Diagnostics pioneers next-generation DNA sequencing (NGS) for microbial
identification,
offering high-accuracy diagnostics for complex infections, especially those
resistant to traditional culture methods.
🔹Grifols, S.A. (Spain)
Grifols contributes through its clinical diagnostics division, providing advanced
systems for blood
typing, immunohematology, and plasma-derived biomarker testing, widely used in hospitals
and blood banks.
🔹BODITECH MED INC. (South
Korea)
BODITECH MED is known for its point-of-care immunoassay analyzers and test kits, offering
rapid diagnostics for cardiovascular, infectious, and hormone-related diseases,
and expanding access to decentralized testing.
🔹Chembio Diagnostic Systems,
Inc. (US)
Chembio specializes in rapid point-of-care diagnostic tests for infectious diseases
such as HIV, syphilis, and COVID-19, utilizing proprietary DPP® technology that
ensures fast and accurate results in resource-limited settings.
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Diagnostic Testing Market Key Regional Analysis:
What Makes North America a Hub for Cutting-Edge Diagnostics?
North America held the dominant share of 41% in the diagnostic testing market in 2024, owing to modern and advanced healthcare infrastructure in the current period. Moreover, the regional governments are increasingly seen as putting heavy investments into modernizing the infrastructure and giving priority to strong healthcare services in recent years. Moreover, the regions have observed the heavy adoption of the latest technologies, which has promoted the industry growth in the past few years.
What is the current U.S. Diagnostic Testing Market Size?
According to Precedence Research, the U.S. diagnostic testing market is projected to grow y from USD 69.91 billion in 2025 to approximately USD 86.37 billion by 2034, growing at a compound annual growth rate (CAGR) of 2.30% from 2025 to 2034.
U.S. Diagnostic Testing Market Trends:
• For instance, USD 2.4 million was allocated to modernize syphilis testing, aiming for faster, direct-detection methods via mass spectrometry or aptamer-based assays
• Through its Pandemic Influenza and Emerging Infectious Disease divisions, BARDA backs diagnostics for public health emergencies and biothreats, reinforcing the national stockpile and testing capabilities
• Post-COVID, emergency and chronic-care settings now routinely use POC tests (troponin, CRP, flu/COVID), reducing triage times by 35‑45 minutes
• Regulatory advancements aim to enhance safety and accuracy, while federal programs ensure continued investment in innovative testing.
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What to Expect from Asian Countries in Diagnostic Testing Market?
Asia Pacific is expected to expand notably during the forecast period, owing to a sudden increase in healthcare spending with technology implementation in recent years. Regional countries such as China, India, and Japan are observed as having a heavy upgrade of their healthcare infrastructure, specifically after the major disease outbreaks like COVID and Fleu. Moreover, the rising disposable income is supporting the affordability of regular health checkups in the middle-class population in the region, which can create significant opportunities for the industry in the coming years, as per the regional observation.
Top Asian Countries to Contribute in Diagnostic Testing Market:
|
Country |
Contribution/Investments/Innovation |
|
China |
The government launched large-scale screening programs: over 60 million high-risk cancer screenings (gastric, cervical, colorectal) between 2020–2023, and about 1.2 million cholera rapid tests deployed to 14 countries in 2024 |
|
India |
The Viral Research and Diagnostic Laboratories (VRDL) network expanded to over 105 labs by 2019, now central to outbreak response |
|
Japan |
AI integration is enhancing test accuracy, especially in imaging, pathology, and molecular diagnostics. Example: MONCAD CTLN AI lung cancer detection tool launched in early 2025 |
|
Thailand |
National tuberculosis and infectious-disease surveillance programs are increasingly employing molecular tests.
|
|
South Korea |
South Korea is a leader in rapid molecular diagnostics for HAIs, with adoption of AI-based surveillance systems to manage MRSA and pneumonia |
Diagnostic Testing Market Segmentation Analysis:
By Type Analysis:
The clinical diagnostic segment held the largest share of the diagnostic testing market in 2024, owing high rate of trust in the accuracy of the hospitals and lab testing. Moreover, the advantages, like professional staff and advanced machinery, have provided a sophisticated consumer base to the segment in recent years. Also, these setups are seen in quick diagnostic reporting without any delays and issues in recent years, which is leading to the segment's potential.
On the other hand, the home diagnostic segment is expected to grow significantly during the forecast period due to allowing patients or users to do many tests on-site at their homes. These test kits are generally used to monitor a previous medical condition, identify a medical disease that has gone undetected, or provide information about a person's specific health characteristics. The continuous efforts to increase people's involvement in their healthcare benefit greatly from these tests. It is crucial that the findings are precise and simple for people to understand.
Also Read 👉 Immunoprotein Diagnostic Testing Across Point-of-Care Settings – Growth Insights
By Application Analysis:
The cardiology segment held the largest share of the diagnostic testing market in 2024. The majority of cardiovascular disorders require diagnostic testing to be identified and treated. Cardiovascular diagnostic testing can reveal details about the electrical activity of the heart, the rhythm of the heartbeat, the efficiency with which blood pumps through the heart's chambers and valves, the ease with which blood flows through the coronary arteries to the heart muscle, and the presence of tumours or structural abnormalities in the cardiovascular system. The risk factors for heart disease are found via laboratory testing.
On the other hand, the oncology segment is expected to grow at a notable rate, akin to the sudden increase in cancer patients worldwide. Moreover, in these major diseases, the healthcare professionals are often recommended the early diagnostic tests, which are expected to drive the segment growth in the coming years. As people become more aware of cancer screening in recent years, it is projected to provide a wide consumer base to the segment in the upcoming years.
By Approach Analysis:
The in vitro diagnostic instrument segment led the diagnostic testing market in 2024. Tests for in vitro diagnostics are conducted using human blood or tissue samples. This kind of diagnostic testing is mostly used to find infections, illnesses, and disorders. In-vitro diagnostics are used in precision medicine today to identify individuals who need certain medications or treatments. With the availability of trained experts and infrastructure development, in vitro diagnostics tests are often performed in laboratories and healthcare institutions. In the upcoming years, a growing number of pathology laboratories and services outfitted with cutting-edge diagnostic equipment are anticipated to fuel market expansion.
On the other hand, the molecular diagnostic instrument segment is seen to grow at the fastest rate during the forecast period, owing to the ability to detect diseases at the genetic level. By providing accurate information about bacteria, viruses, and even mutations, molecular diagnostic instruments have gained major popularity in recent years. As these advantages are expected to lead the segment in the upcoming years, as per expectations.
By Technology Analysis:
The next-generation sequencing segment held a significant share of the diagnostic testing market in 2024, because it can analyse large amounts of genetic data quickly and at lower costs than older methods. NGS helps in detecting rare diseases, cancers, and inherited conditions by reading DNA sequences. Doctors use it to understand how diseases develop and to create personalized treatment plans. As genetics becomes a key part of healthcare, NGS has become the go-to technology for advanced diagnostics. Its ability to find precise changes in genes has made it a powerful tool in research and clinical settings, leading to its dominance in the diagnostic testing market.
Related Topics You May Find Useful:
🔸Molecular Diagnostics Market: The global molecular diagnostics market size was valued at USD 43.68 billion in 2024 and it is expected to hit around USD 63.86 billion by 2034 with a registered CAGR of 3.87% from 2025 to 2034.
🔸Diagnostic Imaging Market: The global diagnostic imaging market size was estimated at USD 47.81 billion in 2024 and is anticipated to reach around USD 76.69 billion by 2034, expanding at a CAGR of 4.84% from 2025 to 2034.
🔸Infectious Disease Diagnostics Market: The global infectious disease diagnostics market size was accounted for USD 32.99 billion in 2024, and is expected to reach around USD 66.73 billion by 2034, expanding at a CAGR of 7.3% from 2025 to 2034
🔸U.S. In Vitro Diagnostics Market: The U.S. in vitro diagnostics market size is estimated at USD 34.98 billion in 2024 and is predicted to surpass around USD 42.63 billion by 2034, growing at a CAGR of 2% between 2024 and 2034.
🔸Artificial Intelligence in Diagnostics Market: The global artificial intelligence in diagnostics market size was estimated at USD 1.61 billion in 2024 and is anticipated to reach around USD 10.28 billion by 2034, expanding at a CAGR of 20.37% from 2025 to 2034.
🔸Rapid Diagnostics Market: The global rapid diagnostics market size was estimated at USD 42.32 billion in 2024 and is predicted to increase from USD 51.12 billion in 2025 to approximately USD 280.03 billion by 2034, expanding at a CAGR of 20.80% from 2025 to 2034.
🔸Precision Diagnostics Market: The global precision diagnostics market size was estimated at USD 85.85 billion in 2024 and is predicted to increase from USD 97.11 billion in 2025 to approximately USD 288.00 billion by 2034, expanding at a CAGR of 12.87% from 2025 to 2034.
🔸Tissue Diagnostics Market: The global tissue diagnostics market size was estimated at USD 5.41 billion in 2024 and is predicted to increase from USD 5.77 billion in 2025 to approximately USD 10.34 billion by 2034, expanding at a CAGR of 6.69% from 2025 to 2034.
What is Going Around the Globe?
• In 2025, Amazon introduced its latest at-home diagnostic services. Also, these services will collect the sample within 60 minutes and offer the lab results within 6 hours, as per the report published by the company.
Link- https://www.aboutamazon.in/news/retail/amazon-at-home-diagnostics-service-launch
• In 2025, SEKISUI Diagnostic unveiled its latest launch of the test, which is called the OSOM RSV. These newly launched tests are mainly for the detection of respiratory syncytial virus, and it is a rapid test, according to the report published by the company.
Link- https://www.biospace.com/press-releases/sekisui-diagnostics-announces-launch-of-the-osom-rsv-test
Diagnostic Testing Market Segmentation:
By Type
• Clinical Diagnostic
• Home Diagnostic
By Application
• Cardiology
• Oncology
• Neurology
• Orthopedics
• Gastroenterology
• Gynecology
• Odontology
• Others
By Approach
• Molecular Diagnostic Instrument
• In-Vitro Diagnostic Instrument
• Point Of Care Testing Instrument
By Solution
• Services
• Products
By Technology
• Immunoassay-Based
• PCR-Based
• Next-generation Sequencing
• Spectroscopy-Based
• Chromatography-Based
• Microfluidics
• Substrate Technology
• Others
By Mode of Testing
• Prescription-Based Testing
• OTC Testing
By Sample Type
• Urine
• Saliva
• Blood
• Hair
• Sweat
• Others
By Testing Type
• Biochemistry
• Hematology
• Microbiology
• Histopathology
• Others
By Age
• Pediatric
• Adult & Geriatric
By Distribution Channel
• Direct Tenders
• Retail Sales
• Online Sales
By End User
• Hospitals, Diagnostic Center
• Research Labs and Institutes
• Research Institute
• Homecare
• Blood Banks
• Specialty Clinics
• Ambulatory Surgical Centers
• Others
By Geography
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa (MEA)
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