North America Molecular Diagnostics Market (2025-2032)
The North America Molecular Diagnostics Market is expected to reach $18.13 billion by 2032 at a CAGR of 5.3% from 2025 to 2032.
- Published
- Jan 2025
- Pages
- 150
- Format
- PDF + Excel
- Report ID
- MR-959
- Base year
- 2024
- 2032 · FORECAST
- $18.13B
- 2032
- $18.13B
- CAGR 2025–2032
- 5.3%
2024 baseline · 2025–2032 forecast at 5.3% CAGR · hover a bar for the value
Key highlights
In 2025, the Kits & Reagents Segment is Expected to Dominate this Market
Sequencing Technology Segment is Expected to Grow at Highest CAGR During Forecast Period
In 2025, the Laboratory Test Segment is Estimated to Account for the Largest Share of the Market
The Oncology Segment is Expected to Grow at Highest CAGR During Forecast Period
In 2025, the Hospitals & Clinics Segment is Expected to Dominate this Market
Report summary
| Particulars | Details |
|---|---|
| Base Year | 2024 |
| Estimated Year | 2025 |
| Forecast Period | 2025–2032 |
| Market Size (2032) | USD 18.13 billion |
| CAGR (2025–2032) | 5.3% |
| Format | PDF, Excel & Cloud Portal · 150 pages |
| Segments Covered | By Product: Reagents & Kits, Systems, Software · By Test Type: Lab, PoC · By Technology: PCR, ISH, INAAT, Sequencing, Microarray · By Application: Infectious Diseases, Oncology, Neurological · By End User |
| Key Companies | Hologic, Inc. (U.S.), Danaher Corporation (U.S.), BioMérieux S.A., Becton, Dickinson and Company (U.S.), Siemens Healthineers AG, DiaSorin S.p.A, Abbott Laboratories (U.S.), Thermo Fisher Scientific Inc. (U.S.), Agilent Technologies, Inc. (U.S.), Illumina, Inc. (U.S.), F. Hoffmann-La Roche, QIAGEN N.V., Seegene, Inc. |
Report overview
Segments covered: product, test type, technology, application, end user.
Molecular diagnostics help detect the targeted genetic material in human, viral, and bacterial genomes. Molecular diagnostic tests are increasingly being used in many areas, including testing infectious diseases, oncology, and clinical genetics. Advancements in molecular diagnostics will continue to improve the accuracy and speed of diagnosis and will become an essential aspect of patient-tailored interventions and therapeutics. Polymerase chain reaction (PCR) and microarray technology offer high throughput and more accurate tests. Additionally, sequencing has emerged as an alternative molecular diagnostic technology with diverse applications.
The growth of the North America molecular diagnostics market is driven by several factors, including the rising geriatric population, the increasing prevalence of communicable & non-communicable diseases, technological advancements in molecular diagnostics, and rising healthcare expenditures. However, unfavorable regulatory frameworks and the high costs of molecular diagnostic tests restrain the growth of this market.
Furthermore, increasing focus on companion diagnostics and the rising popularity of direct-to-consumer (DTC) genetic testing are expected to create growth opportunities for the players in this market. However, the shortage of skilled professionals is a major challenge for market growth. Additionally, the rising integration of artificial intelligence & machine learning is a prominent trend in the molecular diagnostics market.
Other Technologies (Note: Other technologies include electrophoresis, southern blotting, northern blotting, and ligase chain reaction (LCR).)
Other Cancer Types (Note: Other cancer types include bladder cancer, melanoma, kidney cancer, stomach cancer, ovarian cancer, thyroid cancer, and chest cancer.)
Other End Users (Note: Other end users include blood banks, ambulatory care centers, nursing homes, home care facilities, self-testing, the food & beverage industry, and forensic and environmental testing laboratories)
Report infographic
Market dynamics
2 factors across 2 forcesTechnological Advancements in Molecular Diagnostics is Driving the Growth of this Market
The healthcare landscape is constantly changing due to innovations in medical technologies. In recent years, companies have focused on developing advanced diagnostic kits that yield faster results than traditional kits. These advanced kits allow healthcare providers and caregivers to make crucial medical decisions promptly. For instance, companies have been developing ultra-fast PCR kits to minimize the time required to generate test results.
Moreover, traditional PCR tests have transitioned to incorporate multiplex capabilities, including simultaneously detecting two or more pathogens. Multiplex diagnostic tests provide higher accuracy for critical care, which leads to pathogen-specific treatment. Also, the CLIA-waived molecular PoC platform is widely accepted, as traditional POC tests lack sensitivity.
Traditional tests can be replaced by rapid molecular diagnostic tests that are simple, easy to use, and highly accurate. Market players are launching PoC molecular PCR tests. For instance, in June 2021, Thermo Fisher Scientific (U.S.) developed the innovative and portable Accula SARS-CoV-2 Test offering gold-standard Reverse Transcription Polymerase Chain Reaction (RT-PCR) detection of SARS-CoV-2 in a point-of-care format. The test delivers results in 30 minutes, whereas the conventional RT PCR method takes around 2–3 days to produce results. The product uses a cartridge (lateral flow technology) that can be directly used to analyze samples, unlike conventional RT PCR tests, where nucleic acid extraction takes a significant amount of time.
Table of contents
13 chapters · 104 sections · 150 pages · click to expandSegmental analysis
| Segment | Largest share (2025) | Fastest growth (2025–2032) |
|---|---|---|
| By Product & Service | Kits & Reagents | — |
| By Technology | — | Sequencing |
| By Test Type | Laboratory Test | — |
| By Application | — | Oncology |
| By End User | Hospitals & Clinics | — |
| By Product | — | — |
By Product & Service
- The kits & reagents segment is expected to account for the largest share of the market.
- The large market share of this segment is attributed to factors such as the commercial availability of a diverse range of diagnostic reagents & consumables, the availability of disease-specific test kits & assays, growing awareness regarding early disease diagnosis, and the outbreak of COVID-19.
- Moreover, the emergence of various POC tests and assays is creating significant opportunities for suppliers of molecular diagnostic kits & reagents.
By Technology
- Sequencing Technology Segment is Expected to Grow at Highest CAGR During Forecast Period
- The sequencing segment is expected to register the highest CAGR during the forecast period.
- The growth of this segment is attributed to the advantages of sequencing, including the detection of low-frequency variants with higher sensitivity rates, comprehensive genomic coverage, detection at a lower limit of samples, and simultaneous sequencing of multiple genes or gene regions.
- In January 2020, the Centers for Medicare & Medicaid Services (CMS) approved the use of Medicare coverage of next-generation sequencing tests for inherited ovarian and breast cancers, expanding the coverage of NGS as a diagnostic tool in the U.S.
- Isothermal Nucleic Acid Amplification Technology (INAAT)
- Microarrays
- Sequencing
By Test Type
- The Laboratory Test Segment is Estimated to Account for the Largest Share of the Market
- The laboratory tests segment is expected to account for the largest share of the market.
- The large market share of this segment is attributed to the wide availability of laboratory tests in hospitals, diagnostic laboratories, academic institutions, and research centers.
- Furthermore, laboratory tests are often the preferred choice among patients for diagnostic purposes.
- Companies’ efforts to launch new solutions for laboratory tests also contribute to the segment’s growth.
- For instance, in June 2022, Becton, Dickinson and Company (U.S.) launched its BD MAX Respiratory Viral Panel (RVP) assay for the BD MAX System.
- This RT-PCR assay is a combination test for SARS-CoV-2, Influenza A + B, and Respiratory Syncytial Virus (RSV).
By Application
- The oncology segment is expected to register the highest CAGR during the forecast period.
- The increasing prevalence of cancer, the rising mortality rate, and the need for early diagnosis drive the segment’s growth.
- In the U.S., the overall number of cancer cases is estimated to reach 2,727,182 in 2032 from 2,281,658 in 2020.
- (Source: GLOBOCAN).
- The product approval for the oncology molecular diagnostic tests also supports the market growth.
- For instance, in October 2020, F.
- Hoffmann-La Roche Ltd (Switzerland) received U.S. Food and Drug Administration (FDA) approval for the cobas EGFR Mutation Test v2.
- This real-time PCR test is used to qualitatively detect EGFR gene mutations in non-small cell lung cancer (NSCLC) patients.
- Infectious Diseases COVID-19
- Other Infectious Diseases (Note: Other infectious diseases include meningococcal disease, norovirus (stomach flu), tropical diseases, hand, foot, and mouth disease (HFMD), and pertussis)
By End User
- The hospitals & clinics segment is expected to account for the largest share of the market.
- The large market share of this segment is attributed to the increased number of hospitalizations due to various diseases requiring molecular diagnosis and the proliferation of hospitals and clinics in emerging countries, leading to growth in the utilization of molecular diagnostic products.
- For instance, in 2021, hospital expenditures in the U.S. grew by 4.4% compared to 2020, reaching USD 1,323.9 billion.
By Product
- Reagents & Kits
- Instruments/Systems
- Software & Services
Geographic analysis
North America
Fastest growthThe U.S. is expected to register the highest CAGR during the forecast period. The market growth in the U.S. is attributed to the large number of laboratory tests performed annually in the country, the country’s highly developed healthcare infrastructure, the rising prevalence of chronic diseases, the aging population, and the presence of large diagnostics companies. For instance, according to the American Association for Clinical Chemistry, around 13 billion laboratory tests are performed annually in the U.S. Moreover, the demand for molecular diagnostics has increased significantly since the emergence of the COVID-19 pandemic. U.S.: Fastest Growing Market Lab Tests PoC Tests Canada
Competitive landscape
- Hologic, Inc. (U.S.)
- Danaher Corporation (U.S.)
- BioMérieux S.A. · France
- Becton
- Dickinson and Company (U.S.)
- Siemens Healthineers AG · Germany
- DiaSorin S.p.A · Italy
- Abbott Laboratories (U.S.)
- Thermo Fisher Scientific Inc. (U.S.)
- Agilent Technologies, Inc. (U.S.)
- Illumina, Inc. (U.S.)
- F. Hoffmann-La Roche · Switzerland
- QIAGEN N.V. · Netherlands
- Seegene, Inc. · South Korea
Frequently asked questions
The North America Molecular Diagnostics Market study covers the market sizes & forecasts for various molecular diagnostics products used in the healthcare sector. The report involves the value analysis of various segments and subsegments of the molecular diagnostics market at the country level.
Cite this report
Meticulous Research. (2025). North America Molecular Diagnostics Market - Opportunity Analysis And Industry Forecast (2025-2032) (Report No. MR-959). Meticulous Market Research Pvt. Ltd. https://www.meticulousresearch.com/product/north-america-molecular-diagnostics-market-5642