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Diagnostic Testing Market Size Worth USD 272.98 Billion by 2034 Fueled by NGS and Personalized Healthcare Demand - BioSpace

Jul 01, 2025Jul 01, 2025

In 2026, the diagnostic testing market is projectedto 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 in2024 to $264.12 billion in 2033. Rising demand for early disease detection,personalized care, and at-home diagnostic solutions is driving steady growth inthe diagnostic testing market.

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Diagnostic Testing MarketHighlights:

🔹In terms of revenue, theglobal diagnostic testing market was valued at USD 203.24 billion in 2024.

🔹It is projected to reachUSD 272.98 billion by 2034.

🔹The market is expected togrow at a CAGR of 3% from 2025 to 2034.

🔹 The U.S. diagnostictesting market has been calculated at $69.91 billion by 2025

🔹North America led theglobal diagnostic testing market with the largest revenue share of 41% in 2024.

🔹Europe accounted for thesecond largest revenue share of 27% in 2024.

🔹By approach, the in vitrodiagnostic instrument segment contributed the largest revenue share in 2024.

🔹By application, thecardiology segment held the major revenue share in 2024.

🔹By technology, the next-generation sequencing segment accounted for thehighest revenue share in 2024.

DiagnosticTesting 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

Thediagnostic testing market is expected to see steady growth owing to the increasedawareness of diseases and the early detection of diseases in recent years. Also,individuals are increasingly following the regular test lineups for diseaseslike infections, genetic conditions, cancer, and other critical diseases.

Moreover,in the current industry environment, technology plays the ideal role whilemaking these tests faster, affordable, and more accurate, as per the recentobservation. Also, the sudden lifestyle changes and other modern factors havedriven the industry's growth in the past few years.

Also Read 👉 What’s Driving the Cancer DiagnosticsMarket?

Market’sOpportunity: Portable Kits Drive the Future of Personalized Healthcare

Thedevelopment of advanced home diagnostic kits is expected tocreate lucrative opportunities for manufacturers during the forecast period. Moreover,individuals are increasingly preferring convenience, privacy, and resultaccuracy in conditions such the diabetes, fertility issues, and infections in recentyears. Thus, manufacturers can offer them their advanced portable diagnostickits, which will provide immense industry attention in the coming years, as perfuture market expectations.

Also Read👉 What's Next for Rapid Diagnostic Kits?

Whatis the Largest Challenge in Diagnostic Testing Market?

RegulatoryBarriers Challenge Diagnostic Manufacturers

Thestricter regulations from the government authorities for the approval of the diagnostickits are expected to hamper the industry's growth during the forecast period. Someof the authorities have very strict regulations, like the FDA and EMA, whichcan lead to growth barriers, like product delays and increased product costs.Moreover, small and mid-sized manufacturers can face these challenges in theupcoming years. However, the manufacturer can overcome these challenges byapplying expertise, better financial investment, and patience.

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Areaof 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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DiagnosticTesting Market Top Companies and their Contributions:

🔹F. Hoffmann-La Roche Ltd.Roche is a global leader in in-vitro diagnostics, contributing significantlythrough innovations like the cobas diagnostic platform, which offershigh-throughput, automated molecular testing solutions for infectious diseases,oncology, and women’s health.

🔹Danaher CorporationDanaher plays a pivotal role in advancing diagnostic testing through itssubsidiaries like Cepheid, which specializes inrapid molecular diagnostic platforms for point-of-care use, particularly inrespiratory, sexually transmitted, and hospital-acquired infections.

🔹BD (Becton, Dickinson andCompany)BD contributes extensively to diagnostics by developing automated blood culturesystems, molecular testing kits, and microbiology solutions that improve diagnosticspeed and accuracy across clinical laboratories worldwide.

🔹Thermo Fisher ScientificInc.Thermo Fisher offers a broad diagnostic portfolio, including next-generation sequencing(NGS), immunoassays, and molecular diagnostictools,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 flowand immunoassay technologies, providing accessible solutions for glucosemonitoring, infectious disease screening, and drug testing globally.

🔹Hemosure, Inc. (US)Hemosure focuses on non-invasivefecal 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 microbialidentification,offering high-accuracy diagnostics for complex infections, especially thoseresistant to traditional culture methods.

🔹Grifols, S.A. (Spain)Grifols contributes through its clinical diagnostics division, providing advancedsystems for bloodtyping, immunohematology, and plasma-derived biomarker testing, widely used in hospitalsand blood banks.

🔹BODITECH MED INC. (SouthKorea)BODITECH MED is known for its point-of-care immunoassay analyzers and test kits, offeringrapid 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 diseasessuch as HIV, syphilis, and COVID-19, utilizing proprietary DPP® technology thatensures 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 diagnostictesting market in 2024, owing to modern and advanced healthcare infrastructurein the current period. Moreover, the regional governments are increasingly seen asputting heavy investments into modernizing the infrastructure and giving priorityto strong healthcare services in recent years. Moreover, the regions haveobserved the heavy adoption of the latest technologies, which has promoted theindustry growth in the past few years.

What is the current U.S. Diagnostic Testing Market Size?

According to Precedence Research, the U.S. diagnostic testingmarket is projected to grow y from USD 69.91 billion in 2025 to approximatelyUSD 86.37 billion by 2034, growing at a compound annual growth rate (CAGR) of2.30% from 2025 to 2034.

U.S. Diagnostic Testing Market Trends:

• For instance, USD 2.4million was allocated to modernize syphilis testing, aiming forfaster, direct-detection methods via mass spectrometry or aptamer-based assays

• Through its Pandemic Influenza and Emerging InfectiousDisease divisions, BARDA backs diagnostics for public health emergencies andbiothreats, reinforcing the national stockpile and testing capabilities

• Post-COVID, emergency and chronic-care settings nowroutinely use POC tests (troponin, CRP, flu/COVID), reducing triage times by 35‑45minutes

• Regulatory advancements aim to enhance safety andaccuracy, while federal programs ensure continued investment in innovativetesting.

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What to Expectfrom Asian Countries in Diagnostic Testing Market?

Asia Pacific is expected to expand notably during the forecastperiod, owing to a sudden increase in healthcare spending with technologyimplementation in recent years. Regional countries such as China, India, andJapan are observed as having a heavy upgrade of their healthcareinfrastructure, specifically after the major disease outbreaks like COVID andFleu. Moreover, the rising disposable income is supporting the affordability ofregular health checkups in the middle-class population in the region, which cancreate significant opportunities for the industry in the coming years, as perthe 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 TypeAnalysis:

The clinical diagnostic segment held the largest share of the diagnostictesting market in 2024, owing high rate of trust in the accuracy of thehospitals and lab testing. Moreover, the advantages, like professional staffand advanced machinery, have provided a sophisticated consumer base to the segmentin recent years. Also, these setups are seen in quick diagnostic reporting withoutany delays and issues in recent years, which is leading to the segment'spotential.

On the other hand, the home diagnostic segment is expected to growsignificantly during the forecast period due to allowingpatients or users to do many tests on-site at their homes. These test kits are generallyused to monitor a previous medical condition, identify a medical disease thathas gone undetected, or provide information about a person's specific healthcharacteristics. The continuous efforts to increase people's involvement intheir healthcare benefit greatly from these tests. It is crucial that thefindings are precise and simple for people to understand.

Also Read👉 Immunoprotein Diagnostic Testing AcrossPoint-of-Care Settings – Growth Insights

By Application Analysis:

The cardiology segment held the largest share of the diagnostictesting market in 2024. The majority of cardiovascular disorders require diagnostic testingto be identified and treated. Cardiovascular diagnostic testing can revealdetails about the electrical activity of the heart, the rhythm of theheartbeat, the efficiency with which blood pumps through the heart's chambersand valves, the ease with which blood flows through the coronary arteries tothe heart muscle, and the presence of tumours or structural abnormalities inthe cardiovascular system. The risk factors for heart disease are found vialaboratory testing.

On the other hand, the oncology segment is expected to grow at anotable rate, akin to the sudden increase in cancer patients worldwide.Moreover, in these major diseases, the healthcare professionals are often recommendedthe early diagnostic tests, which are expected to drive the segment growth inthe coming years. As people become more aware of cancer screening in recentyears, it is projected to provide a wide consumer base to the segment in theupcoming years.

By Approach Analysis:

The in vitro diagnostic instrument segment led the diagnostictesting market in 2024. Tests for in vitro diagnostics are conductedusing human blood or tissue samples. This kind of diagnostic testing is mostlyused to find infections, illnesses, and disorders. In-vitro diagnostics areused in precision medicine today toidentify individuals who need certain medications or treatments. With theavailability of trained experts and infrastructure development, in vitrodiagnostics tests are often performed in laboratories and healthcareinstitutions. In the upcoming years, a growing number of pathology laboratoriesand services outfitted with cutting-edge diagnostic equipment are anticipatedto fuel market expansion.

Onthe other hand, the molecular diagnostic instrument segment is seen to grow atthe fastest rate during the forecast period, owing to the ability to detectdiseases at the genetic level. By providing accurate information about bacteria,viruses, and even mutations, molecular diagnostic instruments have gained majorpopularity in recent years. As these advantages are expected to lead thesegment in the upcoming years, as per expectations.

By Technology Analysis:

The next-generation sequencing segment held a significant share ofthe diagnostic testing market in 2024, because it can analyselarge amounts of genetic data quickly and at lower costs than older methods.NGS helps in detecting rare diseases, cancers, and inherited conditions byreading DNA sequences. Doctors use it to understand how diseases develop and tocreate personalized treatment plans. As genetics becomes a key part ofhealthcare, NGS has become the go-to technology for advanced diagnostics. Itsability to find precise changes in genes has made it a powerful tool inresearch and clinical settings, leading to its dominance in the diagnostictesting market.

Related Topics You May Find Useful:

🔸MolecularDiagnostics Market: The global moleculardiagnostics market size was valued at USD 43.68 billion in 2024 andit is expected to hit around USD 63.86 billion by 2034 with a registered CAGRof 3.87% from 2025 to 2034.

🔸DiagnosticImaging Market: The global diagnostic imagingmarket size was estimated at USD 47.81 billion in 2024 and is anticipated toreach around USD 76.69 billion by 2034, expanding at a CAGR of 4.84% from 2025to 2034.

🔸InfectiousDisease Diagnostics Market: The global infectious diseasediagnostics 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 CAGRof 7.3% from 2025 to 2034

🔸U.S. In VitroDiagnostics Market: The U.S. in vitro diagnosticsmarket size is estimated at USD 34.98 billion in 2024 and is predicted tosurpass around USD 42.63 billion by 2034, growing at a CAGR of 2% between 2024and 2034.

🔸ArtificialIntelligence in Diagnostics Market: The global artificialintelligence in diagnostics market size was estimated at USD 1.61billion 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.

🔸RapidDiagnostics Market: The global rapid diagnosticsmarket size was estimated at USD 42.32 billion in 2024 and is predicted toincrease from USD 51.12 billion in 2025 to approximately USD 280.03 billion by2034, expanding at a CAGR of 20.80% from 2025 to 2034.

🔸PrecisionDiagnostics Market: The global precisiondiagnostics market size was estimated at USD 85.85 billion in 2024and is predicted to increase from USD 97.11 billion in 2025 to approximatelyUSD 288.00 billion by 2034, expanding at a CAGR of 12.87% from 2025 to 2034.

🔸TissueDiagnostics Market: The global tissue diagnosticsmarket size was estimated at USD 5.41 billion in 2024 and is predicted toincrease from USD 5.77 billion in 2025 to approximately USD 10.34 billion by2034, 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 thelab 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 thedetection of respiratory syncytial virus, and it is a rapid test, according tothe 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 DiagnosticInstrument

• In-Vitro DiagnosticInstrument

• Point Of Care TestingInstrument

By Solution

• Services

• Products

By Technology

• Immunoassay-Based

• PCR-Based

• Next-generationSequencing

• Spectroscopy-Based

• Chromatography-Based

• Microfluidics

• Substrate Technology

• Others

By Mode of Testing

• Prescription-BasedTesting

• 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, DiagnosticCenter

• Research Labs andInstitutes

• Research Institute

• Homecare

• Blood Banks

• Specialty Clinics

• Ambulatory SurgicalCenters

• Others

By Geography

• North America

• Europe

• Asia Pacific

• Latin America

• Middle East& Africa (MEA)

Thanks for reading you can also getindividual chapter-wise sections or region-wise report versions such as NorthAmerica, Europe, or Asia Pacific.

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F. Hoffmann-La Roche Ltd.cobas diagnostic platformDanaher CorporationCepheidBD (Becton, Dickinson andCompany)automated blood culturesystems, molecular testing kits, and microbiology solutionsThermo Fisher ScientificInc.next-generation sequencing(NGS), , and molecular diagnostictools🔹ACON Laboratories Inc. (US)cost-effective rapid diagnostic tests🔹Hemosure, Inc. (US)non-invasivefecal immunochemical tests (FIT)🔹MicroGen Diagnostics (US)next-generation DNA sequencing (NGS) for microbialidentification🔹Grifols, S.A. (Spain)clinical diagnostics divisionbloodtyping, immunohematology, and plasma-derived biomarker testingBODITECH MED INC. (SouthKorea)point-of-care immunoassay analyzersChembio Diagnostic Systems,Inc. (US) tests🧠 Power Your Decisions withData🔍 View Subscription OptionsHere 👉 USD 2.4million60 million high-risk cancer screenings1.2 million cholera rapid testsViral Research and Diagnostic Laboratories (VRDL)105 labs by 2019AI-based surveillance systems