Market Size - By Test Type (Human Chorionic Gonadotropin (HCG) Hormone Test, Thyroid Stimulating Hormone (TSH) Test, Insulin Test, Progesterone Test, Luteinizing Hormone (LH) Test, Prolactin Test, Other Test Types), By Technology (Immunoassay, Mass Spectroscopy, Chromatography, Nucleic Acid Based, Other Technologies), and By End Use (Clinical Laboratories, Hospitals, Diagnostic Centers, Other End Users), Growth Forecast. The market forecasts are provided in terms of revenue (USD Million).
Report ID: GMI5653
|
Published Date: August 2026
|
Report Format: PDF
Download Free PDF
Endocrine Testing Market Size
The global endocrine testing market was valued at USD 3.4 billion in 2025 and is projected to reach USD 7.4 billion by 2035, representing a CAGR of approximately 8.2% during 2026–2035.
Endocrine testing covers assays, instruments, reagents, and associated laboratory workflows used to measure hormones and related biomarkers across thyroid, metabolic, reproductive, adrenal, and pituitary pathways. Routine immunoassays support high-volume TSH, hCG, insulin, LH, progesterone, and prolactin testing, while liquid chromatography-tandem mass spectrometry (LC-MS/MS) addresses applications in which steroid-hormone specificity and low-concentration accuracy are clinically consequential. Published clinical validation work has found material divergence between immunoassay and LC-MS/MS results for some steroids, including bias exceeding 65% for selected analytes [1].
The market's economics are shaped by a recurring consumables model. Analyzer placement, reagent rental agreements, calibrators, controls, and assay-menu expansion make installed-platform retention as important as initial instrument sales. This structure favors suppliers that can combine broad endocrine menus with automation, laboratory informatics, and service coverage. It also differentiates routine testing, where throughput and cost per reportable result dominate procurement, from specialty testing, where analytical specificity, workflow design, and laboratory expertise carry greater weight.
Regulation is raising the cost of sustaining an assay portfolio. The EU In Vitro Diagnostic Regulation requires a risk-based conformity framework and expanded performance-evidence obligations for IVD manufacturers [2]. In the United States, recent FDA clearances for Beckman Coulter's Access Intact PTH and Access Thyroglobulin assays, as well as Siemens Healthineers' Dimension LOCI TSH and FT4 cartridges, demonstrate continued investment in regulated endocrine assay menus [3], . These requirements can strengthen the position of established suppliers with clinical-evidence resources while increasing development and compliance pressure on smaller assay developers.
GMI Analyst View
The moderation from the historic ~10.8% CAGR to a ~8.2% forecast CAGR reflects a larger revenue base and persistent price discipline in mature laboratory markets, rather than a weakening clinical need for endocrine testing. Diabetes, thyroid disease, reproductive monitoring, and obesity-related metabolic risk sustain recurring test demand; meanwhile, the mix of that demand is changing. High-throughput immunoassay remains indispensable for routine panels, but LC-MS/MS is gaining relevance where antibody cross-reactivity or low-analyte concentrations can affect clinical interpretation.
Key Drivers
Driver Impact Table
Driver
(~) % Impact on CAGR Forecast
Geographic Relevance
Impact Timeline
Technological Advancements in Endocrine Diagnostics
+0.9%
North America, Europe, Asia Pacific
Short term (≤ 2 years)
Healthcare Expansion in APAC
+0.7%
Asia Pacific, particularly India and China
Medium term (2–4 years)
E-commerce & Retail Accessibility
+0.5%
Global
Short term (≤ 2 years)
Chronic metabolic and endocrine disease burden
Diabetes creates recurring demand for insulin measurement, C-peptide testing, and related metabolic assessment. The International Diabetes Federation estimated that 589 million adults aged 20–79 were living with diabetes globally in 2024 and projected that number to reach 853 million by 2050 [4]. In the United States, 40.1 million people had diabetes in 2023, equivalent to 12.0% of the population [5]. The testing opportunity is broader than diagnosed diabetes: diagnostic workup, treatment monitoring, insulin-resistance assessment, and screening of high-risk populations each create distinct laboratory demand.
Obesity strengthens this demand pathway because it increases the population exposed to metabolic and reproductive endocrine dysfunction. More than 1 billion people were living with obesity in 2022, and adult obesity prevalence had more than doubled globally since 1990 [6]. In the European Union, 50.6% of adults aged 16 years and older were overweight in 2022 [7]. The commercial implication is sustained volume for routine metabolic and thyroid testing, even where reimbursement and tendering constrain revenue per assay.
Higher-throughput platforms and more specific specialty testing
Automation reduces the operational burden of expanding endocrine menus. Abbott's Alinity i platform uses CHEMIFLEX chemiluminescent technology and can process up to 200 tests per hour [8], while the company's Alinity ci-series integrates chemistry and immunoassay workflows at throughput of up to 1,550 tests per hour . Siemens Healthineers' Atellica Solution provides broad assay-menu coverage and supports rapid STAT handling [9]. These capabilities make endocrine-panel consolidation more attractive for laboratories balancing turnaround-time requirements against labor availability.
LC-MS/MS is widening the addressable specialty-testing market because it offers greater analytical specificity for structurally similar steroid hormones than conventional immunoassays . Roche received CE mark approval in December 2024 for its cobas Mass Spec solution, including the cobas i 601 analyzer and initial Ionify steroid-hormone assays . Its planned menu expansion beyond steroid hormones indicates a move to place clinical mass spectrometry within the same automation and procurement environment as routine immunoassays.
Consumer access and reproductive-health testing
Consumer-accessible testing is lowering the distance between hormonal-health awareness and initial test use. FDA records include a digital pregnancy test clearance in August 2024 and an at-home FSH menopause test listing in September 2024 . These products do not replace laboratory confirmation in complex clinical pathways, but they expand entry points into pregnancy, fertility, and menopause-related testing. In parallel, fertility services and endocrine specialty practices sustain clinical demand for quantitative hCG, progesterone, LH, prolactin, and related panels.
Key Restraints
Restraint Impact Table
Restraint
(~) % Impact on CAGR Forecast
Geographic Relevance
Impact Timeline
High Cost of Testing Technology Development
-0.5%
Global
Long term (> 4 years)
Lack of Awareness in Emerging Markets
-0.4%
Latin America, MEA, parts of Asia Pacific
Medium term (2–4 years)
Capital intensity and specialist operating requirements
The clinical case for LC-MS/MS does not eliminate its deployment constraints. Sample preparation, chromatographic separation, validation, maintenance, and specialist staffing remain material requirements for laboratories considering high-complexity hormone panels. SCIEX markets the Citrine, 4500MD, and 3200MD clinical IVD mass-spectrometry systems for these applications [10]. The resulting economics favor centralized reference laboratories and large academic or hospital facilities that can aggregate sufficient specimen volume and technical expertise.
EU IVDR adds a second layer of cost for assay developers, requiring more comprehensive performance documentation and conformity assessment than the prior framework . Larger suppliers can spread regulatory, service, and analyzer-placement costs over extensive installed bases. Smaller reagent manufacturers may face longer development cycles or reduced capacity to support broad endocrine menus, particularly where price-sensitive tenders limit the ability to recover compliance costs.
Underdiagnosis and uneven testing access
Disease prevalence does not translate automatically into testing volume. The IDF estimated that 251.7 million adults with diabetes globally were undiagnosed in 2024, or 42.8% of adults with diabetes . This gap reflects constraints in awareness, primary-care pathways, laboratory access, and affordability. It is especially consequential in markets where metabolic disease is widespread but routine endocrine workup is not systematically embedded in preventive care.
The mismatch is visible across regions with substantial risk exposure. The WHO reported that adult overweight prevalence reached 67% in the Region of the Americas , while the IDF reported a 19.9% world-standardized diabetes prevalence in the Middle East and North Africa region in 2024 . These epidemiological conditions support long-term demand potential, but realizing it depends on reimbursement, public-health screening, referral behavior, and accessible laboratory capacity rather than population risk alone.
GMI Analyst View
The market's growth drivers operate at different points in the testing pathway. Diabetes and obesity enlarge the potential testing population , , while automation lowers the operational cost of serving that population through centralized laboratory networks , , . Consumer products can increase initial engagement, but their commercial significance depends on whether healthcare systems convert awareness into clinical confirmation, follow-up, and recurring monitoring .
Endocrine Testing Market Segment Analysis
Test type
hCG hormone testing is the largest test-type segment, valued at USD 1.044.20 million in 2025 and projected to reach USD 2,186.36 million by 2035 at ~7.7% CAGR. Its scale reflects use across pregnancy detection, serial pregnancy monitoring, emergency medicine, fertility care, and consumer channels. The FDA's 2024 digital pregnancy-test clearance illustrates continuing product development in consumer-accessible formats , while quantitative laboratory hCG remains important where clinical monitoring requires measurement rather than a qualitative result.
TSH testing is valued at USD 994.88 million in 2025 and is projected to rise to USD 2,299.30 million by 2035 at ~8.7% CAGR. Its growth is tied to its role as the principal entry assay for thyroid-function assessment and long-term monitoring. Platform investment remains active: Siemens Healthineers' Dimension LOCI TSH cartridge received FDA clearance in April 2025 . The segment benefits from its use in routine clinical pathways, where reflex testing can expand the value of an initial TSH result into a broader thyroid panel.
Insulin testing is projected to grow at ~9.0% CAGR, from USD 414.90 million in 2025 to USD 982.83 million by 2035. Its faster trajectory is consistent with the expanding diabetes burden and the increasing need to distinguish among metabolic conditions, evaluate endogenous insulin secretion, and investigate hypoglycemia , . QuidelOrtho states that its VITROS insulin reagent has no cross-reactivity to C-peptide or proinsulin and negligible cross-reactivity to insulin analogs, illustrating the analytical specificity expected in insulin measurement [11].
Progesterone testing is projected to increase from USD 338.90 million in 2025 to USD 767.66 million by 2035 at ~8.5% CAGR. Demand is linked to ovulation assessment, assisted-reproduction monitoring, and early-pregnancy evaluation. LH testing is forecast to rise from USD 232.60 million to USD 493.96 million at ~7.8% CAGR, supported by fertility workup, ovulation prediction, and puberty-related assessment. Beckman Coulter's reproductive-health menu includes automated AMH assays and broader reproductive hormone testing, demonstrating the importance of integrated fertility menus rather than isolated assays [12].
Prolactin testing is projected to expand from USD 186.22 million in 2025 to USD 372.76 million by 2035 at ~7.2% CAGR. It remains important in infertility, amenorrhea, galactorrhea, pituitary, and hypogonadism workups, but its narrower use profile limits growth relative to screening-oriented TSH or metabolically linked insulin testing. Other test types, including cortisol, testosterone, estradiol, PTH, DHEA-S, growth hormone, and IGF-1, are projected to grow from USD 143.71 million to USD 278.50 million at ~6.8% CAGR. Siemens Healthineers reports that its Atellica IM Testosterone II assay has retained CDC HoST-TT certification since 2019 , reflecting the emphasis on traceability and performance in testosterone testing.
Technology
Immunoassay is the largest technology segment, valued at USD 1,340.48 million in 2025 and projected to reach USD 2,823.38 million by 2035 at ~7.7% CAGR. Its leading position derives from throughput, broad assay menus, established clinical workflows, and favorable reagent economics. Automated systems allow laboratories to process endocrine assays alongside chemistry, infectious-disease, and other immunoassay workloads, making endocrine testing part of a larger analyzer-utilization model rather than a standalone capital purchase , , .
Mass spectrometry is projected to grow from USD 846.57 million in 2025 to USD 2,002.57 million by 2035 at ~9.0% CAGR. Its advantage is most pronounced for steroid hormones and other analytes where specificity, low-level measurement, and multiplexing matter . Roche's cobas Mass Spec launch introduces an integrated option for laboratories seeking to add specialty analysis without building an entirely separate vendor relationship . The adoption barrier remains workflow complexity and technical staffing, which explains the continuing concentration of the technology in reference laboratories and advanced clinical centers .
Chromatography is projected to grow from USD 539.88 million in 2025 to USD 1,239.33 million by 2035 at ~8.7% CAGR. Its role is particularly relevant in HbA1c measurement and selected catecholamine or endocrine applications. Tosoh Bioscience's AIA immunoassay family combines unit-dose test-cup reagents with 90-day calibration stability, while the company also has a longstanding position in HbA1c testing workflows [13]. Nucleic acid-based testing is expected to rise from USD 350.30 million to USD 718.95 million at ~7.4% CAGR, reflecting specialized applications such as hereditary endocrine tumor testing and thyroid molecular profiling. Other technologies, including ELISA, residual radioimmunoassay, biosensor, lateral-flow, and microfluidic formats, are projected to increase from USD 278.16 million to USD 597.15 million at ~7.9% CAGR.
End use
Clinical laboratories are the largest end-use segment, valued at USD 1,631.23 million in 2025 and projected to reach USD 3,747.16 million by 2035 at ~8.7% CAGR. Centralized laboratories can spread analyzer, quality-control, and specialist-labor costs across high specimen volumes, making them particularly suited to complex hormone panels and LC-MS/MS workflows. Their growth rate also reflects the migration of higher-complexity testing from smaller hospital laboratories to specialized networks.
Hospitals are projected to expand from USD 1,304.92 million in 2025 to USD 2,752.51 million by 2035 at ~7.7% CAGR. Their endocrine-testing demand is tied to acute presentations, inpatient monitoring, and the need for rapid integration with hospital information systems. Diagnostic centers are forecast to grow from USD 289.57 million to USD 622.25 million at ~7.9% CAGR, supported by fertility clinics, endocrinology practices, and independent diagnostic chains. Other end users, including physician offices, home testing, and research settings, are expected to increase from USD 129.69 million to USD 259.46 million at ~7.2% CAGR; consumer-accessible hCG and FSH products contribute to this channel .
GMI Analyst View
Segment growth is concentrated where chronic-disease testing and operational efficiency overlap. Insulin testing at ~9.0% CAGR and TSH testing at ~8.7% CAGR sit close to the core pathways for metabolic and thyroid care, respectively. Their growth is not solely a function of individual assay demand; it also reflects the ability of high-throughput platforms to absorb endocrine panels into routine laboratory operations.
Endocrine Testing Market Regional Analysis
North America
North America is the largest regional market, projected to grow from USD 1,458.59 million in 2025 to USD 2,972.48 million by 2035 at ~7.4% CAGR. The U.S. accounts for USD 1,333.15 million in 2025 and is projected to reach USD 2,666.31 million by 2035 at ~7.2% CAGR. Its position reflects high diabetes prevalence, a developed reference-laboratory sector, broad use of automated immunoassay, and continuing FDA-cleared menu expansion , , . The large installed base supports dependable consumables demand, although market maturity limits the pace of percentage growth.
Canada is projected to grow from USD 125.44 million in 2025 to USD 306.17 million by 2035 at ~9.3% CAGR. Its smaller starting base creates greater room for expansion in specialty endocrinology, fertility, and higher-complexity hormone testing. Provincial health-system coverage supports standard endocrine panels, while advanced steroid and reproductive profiles are more dependent on assessment, laboratory-capability, and referral pathways.
Europe
Europe is projected to increase from USD 893.98 million in 2025 to USD 1,936.36 million by 2035 at ~8.0% CAGR. The IVDR transition is a defining market condition because it increases conformity and performance-evidence obligations for IVD suppliers . The burden is commercially significant for manufacturers serving European laboratory systems: large suppliers can use established regulatory resources and broad portfolios to preserve continuity, whereas smaller providers may face more difficult certification and lifecycle-management decisions.
Germany's developed laboratory infrastructure and academic medical centers support specialty LC-MS/MS adoption, while Roche's 2024 cobas Mass Spec launch targets laboratories seeking automated clinical mass-spectrometry capability . In the United Kingdom, centralized laboratory networks favor scale and can accelerate adoption once validation and procurement thresholds are met. France, Spain, Italy, and the Netherlands each support demand through different combinations of public reimbursement, hospital-centered testing, fertility care, and university medical-center reference programs.
Asia Pacific
Asia Pacific is projected to grow from USD 737.68 million in 2025 to USD 1,847.93 million by 2035 at ~9.6% CAGR, the fastest among the major regions. The opportunity rests on a large metabolic-disease burden, growing healthcare access, and still-developing diagnostic capacity. India is among the countries with the largest adult diabetes populations globally , while China combines large test volumes with a regulatory environment that increasingly emphasizes domestic clinical data for imported IVD products.
Domestic suppliers are increasingly relevant in this environment. Snibe's MAGLUMI CLIA menu lists 278 parameters, including endocrine assays [14]. Its high-throughput analyzer offerings illustrate how local manufacturers can address price-sensitive laboratory expansion while multinational suppliers compete on menu depth, automation, and established clinical support. Japan, Australia, and South Korea add demand through developed laboratory systems, aging populations, reimbursement-supported testing, and advanced endocrine care.
Latin America
Latin America is projected to increase from USD 143.81 million in 2025 to USD 344.41 million by 2035 at ~9.1% CAGR. Brazil and Mexico anchor regional demand through their large populations, public-sector procurement, private laboratory networks, and substantial metabolic-risk burden. The WHO's finding that adult overweight prevalence reached 67% in the Region of the Americas indicates a broad long-term risk pool for diabetes and related endocrine conditions .
The region's growth is tempered by purchasing constraints. Public tenders and variable reimbursement can favor lower-cost assay configurations, locally assembled products, or distributors with strong service coverage. For suppliers, the critical issue is not merely market entry but maintaining reagent availability, instrument uptime, and price discipline across fragmented healthcare systems.
Middle East and Africa
The Middle East and Africa market is projected to grow from USD 121.33 million in 2025 to USD 280.20 million by 2035 at ~8.7% CAGR. The Middle East and North Africa region had the highest world-standardized diabetes prevalence among IDF regions in 2024, at 19.9% . This creates a strong underlying case for metabolic and endocrine testing, particularly as public-health programs and hospital investments expand chronic-disease management.
GMI Analyst View
Regional growth rates reflect a balance between market maturity and the capacity to convert disease burden into testing. North America's ~7.4% CAGR is lower than Asia Pacific's ~9.6%, but its 2025 base makes it the largest source of absolute market value. Its installed laboratory infrastructure also provides the clearest near-term environment for integrated immunoassay and mass-spectrometry adoption , .
Competition is organized around analyzer installed bases, proprietary reagent ecosystems, assay-menu breadth, service infrastructure, and the ability to support both routine and specialty endocrine workflows. Abbott, Roche, Siemens Healthineers, Beckman Coulter, Thermo Fisher Scientific, and SCIEX compete across combinations of immunoassay, laboratory automation, and mass spectrometry. The market also includes specialized endocrinology suppliers, quality-control providers, and regional IVD manufacturers that compete through focused menus, cost positioning, or local reach.
Abbott competes through its Core Laboratory diagnostics business and Alinity platforms. The Alinity i uses CHEMIFLEX chemiluminescent technology and can process up to 200 tests per hour , while the Alinity ci-series provides integrated clinical chemistry and immunoassay throughput of up to 1,550 tests per hour . The company's strength lies in embedding thyroid, reproductive, and metabolic testing in a high-throughput routine laboratory platform. Published evaluation of the Alinity i TRAb assay supports its role in Graves' disease diagnostics [15], and subsequent thyroid-function test validation further supports platform-based assay adoption [16].
Roche combines its Elecsys immunoassay brand and cobas analyzer family with a strategic move into clinical mass spectrometry. Its Elecsys TSH assay uses electrochemiluminescence immunoassay technology on cobas e analyzers . The December 2024 CE-marked cobas Mass Spec solution extends Roche's offering into steroid-hormone analysis, initially through the cobas i 601 analyzer and Ionify reagents . The strategic value is integration: laboratories can evaluate routine immunoassay and specialty mass-spectrometry requirements through a more unified automation and vendor framework.
Beckman Coulter offers the Access immunoassay platform and reproductive-health testing portfolio, including automated AMH testing and assays across fertility and endocrine pathways . FDA clearances for Access Intact PTH and Access Thyroglobulin in 2024 demonstrate continued assay-menu investment . Its competitive position is reinforced by access to a broad installed base and by its relevance in reproductive endocrine testing.
DiaSorin participates through its LIAISON platform and specialty endocrine and autoimmune-thyroid portfolio. In September 2025, the company announced commercial launch of its LIAISON TSH-R Ab assay in CE-mark-recognizing countries, using a double-bridge sandwich immunoassay format for Graves' disease diagnosis and monitoring .
SCIEX supplies IVD mass-spectrometry systems including Citrine, 4500MD, and 3200MD platforms . Its relevance is concentrated in high-complexity endocrine applications, particularly steroid-hormone panels handled by reference and specialized laboratories.
Siemens Healthineers competes through the Atellica Solution and endocrine immunoassay menu . Its Atellica IM Testosterone II assay has maintained CDC HoST-TT certification since 2019 , and its FDA-cleared Dimension LOCI TSH and FT4 cartridges demonstrate ongoing investment in thyroid testing .
Thermo Fisher Scientific participates through mass-spectrometry instrumentation and clinical-diagnostics capabilities used in specialty endocrine testing. Its position is most relevant where laboratories require analytical flexibility for complex hormone panels.
Tosoh Bioscience serves clinical laboratories through the AIA automated immunoassay family, which uses unit-dose test-cup dry reagents and offers 90-day calibration stability . Its established presence in HbA1c and immunoassay workflows supports its relevance to the metabolic component of endocrine diagnostics.
QuidelOrtho provides VITROS diabetes solutions, including insulin and C-peptide assays , and specialty thyroid testing through THYRETAIN bioassays. The THYRETAIN Turbo TSI Stimulating Reporter BioAssay and TBI Blocking Reporter BioAssay address functional differentiation of thyroid autoantibodies in Graves' disease .
Bio-Rad supports the endocrine-testing ecosystem through quality-control materials used by laboratories to monitor assay performance across hormone-testing workflows. Snibe Diagnostic offers the MAGLUMI CLIA platform and a broad IVD menu that includes endocrine assays , giving it relevance in China and other price-sensitive markets. Autobio supplies immunoassay and ELISA-based IVD solutions with a focus on APAC and emerging-market customers.
DRG International, Monobind, and Merck participate through specialty endocrine kits, ELISA and radioimmunoassay formats, reagents, reference standards, and laboratory-chemistry inputs. Their roles differ from the broad-platform competitors: they address specialty testing needs, lower-throughput laboratories, research settings, and the assay-development supply chain rather than competing solely for integrated analyzer placements.
Recent Industry Developments
Roche receives CE mark for cobas Mass Spec solution
On December 18, 2024, Roche announced CE mark approval for its cobas Mass Spec solution, including the cobas i 601 analyzer and the first Ionify reagent pack covering four steroid-hormone assays . Roche stated that the menu is intended to expand to more than 60 analytes, including steroid hormones, vitamin D metabolites, immunosuppressants, and therapeutic-drug-monitoring applications. The development is significant because it links mass-spectrometry capability with Roche's broader cobas automation environment, potentially simplifying procurement and workflow integration for laboratories adopting specialty hormone testing.
DiaSorin launches LIAISON TSH-R Ab assay
On September 19, 2025, DiaSorin announced the launch of its LIAISON TSH-R Ab assay in countries recognizing the CE mark . The assay is intended to support diagnosis and monitoring of suspected Graves' disease and uses a double-bridge sandwich immunoassay design. The launch expands DiaSorin's thyroid and autoimmune-thyroid offering by adding TSH receptor-antibody testing to a platform already used for broader thyroid workup.
Need a specific section of this report?
Purchase regional analysis, country-level analysis, company profiles, or any other segment-level insights separately
based on your research needs.
Authors: Mariam Faizullabhoy, Gauri Wani
Endocrine Testing Market Scope
Endocrine Testing Market Size
Endocrine Testing Market Trends
Endocrine Testing Market Analysis
Endocrine Testing Market Share
Report Content
Chapter 1 Research Methodology
1.1 Research approach
1.2 Quality commitments
1.2.1 GMI AI policy & data integrity commitment
1.2.1.1 Source consistency protocol
1.3 Research trail & confidence scoring
1.3.1 Research trail components
1.3.2 Scoring components
1.4 Data collection
1.4.1 Partial list of primary sources
1.5 Data mining sources
1.5.1 Paid sources
1.5.1.1 Sources, by region
1.6 Base estimates and calculations
1.6.1 Base year calculation
1.7 Forecast model
1.7.1 Quantified market impact analysis
1.7.1.1 Mathematical impact of growth parameters on forecast
1.8 Research transparency addendum
1.8.1 Source attribution framework
1.8.2 Quality assurance metrics
1.8.3 Our commitment to trust
Chapter 2 Executive Summary
2.1 Industry 360° synopsis
2.2 Key market trends
2.2.1 Regional trends
2.2.2 Test type trends
2.2.3 Technology trends
2.2.4 End use trends
2.3 CXO perspectives: Strategic imperatives
Chapter 3 Industry Insights
3.1 Industry ecosystem analysis
3.2 Industry impact forces
3.2.1 Growth drivers
3.2.1.1 Increasing prevalence of diabetes, thyroid, and obesity
3.2.1.2 Rising prevalence of endocrine disorders
3.2.1.3 Supportive government funding initiatives
3.2.1.4 Technological advancements
3.2.1.5 Growing awareness of routine health monitoring
3.2.2 Industry pitfalls and challenges
3.2.2.1 High cost for the development of testing technologies
3.2.2.2 Lack of awareness
3.2.3 Opportunities
3.2.3.1 Expansion of point?of?care and rapid endocrine testing
3.3 Growth potential analysis
3.4 Regulatory landscape
3.4.1 North America
3.4.2 Europe
3.4.3 Asia Pacific
3.4.4 Latin America
3.4.5 MEA
3.5 Technology and innovation landscape (Driven by Primary Research)
3.5.1 Current technological trends
3.5.2 Emerging technologies
3.6 Future market trends (Driven by Primary Research)
3.7 Impact of AI & Generative AI on the Market (Driven by Primary Research)
3.8 Pricing analysis, 2025
3.9 Patent analysis
3.10 Consumer insights
3.11 Porter's analysis
3.12 PESTEL analysis
Chapter 4 Competitive Landscape, 2025
4.1 Introduction
4.2 Company matrix analysis
4.3 Company market share analysis (Driven by Primary Research)
4.3.1 Global
4.3.2 North America
4.3.3 Europe
4.3.4 Asia Pacific
4.4 Competitive analysis of major market players
4.5 Competitive positioning matrix
4.6 Key developments
4.6.1 Mergers & acquisitions
4.6.2 Partnerships & collaborations
4.6.3 New product launches
4.6.4 Expansion plans
Chapter 5 Market Estimates and Forecast, By Test Type, 2022 - 2035 ($ Mn)
5.1 Key trends
5.2 Human chorionic gonadotropin (hCG) hormone test
5.3 Thyroid stimulating hormone (TSH) test
5.4 Insulin test
5.5 Progesterone test
5.6 Luteinizing hormone (LH) test
5.7 Prolactin test
5.8 Other test types
Chapter 6 Market Estimates and Forecast, By Technology, 2022 - 2035 ($ Mn)
6.1 Key trends
6.2 Immunoassay
6.3 Mass spectroscopy
6.4 Chromatography
6.5 Nucleic acid based
6.6 Other technologies
Chapter 7 Market Estimates and Forecast, By End Use, 2022 - 2035 ($ Mn)
7.1 Key trends
7.2 Clinical laboratories
7.3 Hospitals
7.4 Diagnostic centers
7.5 Other end users
Chapter 8 Market Estimates and Forecast, By Region, 2022 - 2035 ($ Mn)
8.1 Key trends
8.2 North America
8.2.1 U.S.
8.2.2 Canada
8.3 Europe
8.3.1 Germany
8.3.2 UK
8.3.3 France
8.3.4 Spain
8.3.5 Italy
8.3.6 Netherlands
8.4 Asia Pacific
8.4.1 China
8.4.2 Japan
8.4.3 India
8.4.4 Australia
8.4.5 South Korea
8.5 Latin America
8.5.1 Brazil
8.5.2 Mexico
8.5.3 Argentina
8.6 Middle East and Africa
8.6.1 South Africa
8.6.2 Saudi Arabia
8.6.3 UAE
Chapter 9 Company Profiles
9.1 Abbott
9.2 Autobio
9.3 BECKMAN COULTER
9.4 BIO RAD
9.5 Diasorin
9.6 DRG International
9.7 Merck
9.8 Monobind
9.9 OuidelOrtho
9.10 Roche
9.11 SCIEX
9.12 SIEMENS Healthineers
9.13 Snibe Diagnostic
9.14 Thermo Fisher SCIENTIFIC
9.15 TOSOH BIOSCIENCE
Don't see your key competitors?
The companies listed in this report are a curated selection - not the full competitive universe.
Our market revenue calculations use a bottom-up methodology that accounts for all players across all regions - including manufacturers, distributors, and specialists not individually profiled. The profiles section spotlights strategically significant players; it does not define the scope of our market sizing.
Your competitive landscape may also include
Regional or domestic-only leaders not in the global top tier
Distributors and channel partners who control market access
Emerging disruptors, startups, or adjacent-industry entrants
Niche players focused on a specific application or end-use
Free customization - up to 20% of report value
Need specific data? Request customization and get the insights tailored to your exact requirements.
Authors: Mariam Faizullabhoy, Gauri Wani
For inquiries regarding discounts, bulk purchases, or customization requests, please contact us at[email protected]
Explore our licensing options:
Starting at: $2,450
Premium Report Details
Base Year: 2025
Companies Profiled: 15
Tables and Figures: 120
Countries covered: 19
Pages: 130
Download Free PDF
Premium Report Details
Base Year: 2025
Companies Profiled: 15
Tables and Figures: 120
Countries covered: 19
Pages: 130
Download Free PDF
Share Content
Add Citations
Mariam Faizullabhoy. 2026, August. Endocrine Testing Market – By Test Type, By Technology, By End Use - Global Forecast, 2026 - 2035 (Report ID: GMI5653). Global Market Insights Inc. Retrieved August 28, 2026, from https://www.gminsights.com/toc/details/endocrine-testing-market
Endocrine Testing Market
Get a free sample of this report
Get a free sample of this report Endocrine Testing Market
Is your requirement urgent? Please give us your business email for a speedy delivery!
Endocrine Testing Market Size
The global endocrine testing market was valued at USD 3.4 billion in 2025 and is projected to reach USD 7.4 billion by 2035, representing a CAGR of approximately 8.2% during 2026–2035.
Endocrine testing covers assays, instruments, reagents, and associated laboratory workflows used to measure hormones and related biomarkers across thyroid, metabolic, reproductive, adrenal, and pituitary pathways. Routine immunoassays support high-volume TSH, hCG, insulin, LH, progesterone, and prolactin testing, while liquid chromatography-tandem mass spectrometry (LC-MS/MS) addresses applications in which steroid-hormone specificity and low-concentration accuracy are clinically consequential. Published clinical validation work has found material divergence between immunoassay and LC-MS/MS results for some steroids, including bias exceeding 65% for selected analytes [1].
The market's economics are shaped by a recurring consumables model. Analyzer placement, reagent rental agreements, calibrators, controls, and assay-menu expansion make installed-platform retention as important as initial instrument sales. This structure favors suppliers that can combine broad endocrine menus with automation, laboratory informatics, and service coverage. It also differentiates routine testing, where throughput and cost per reportable result dominate procurement, from specialty testing, where analytical specificity, workflow design, and laboratory expertise carry greater weight.
Regulation is raising the cost of sustaining an assay portfolio. The EU In Vitro Diagnostic Regulation requires a risk-based conformity framework and expanded performance-evidence obligations for IVD manufacturers [2]. In the United States, recent FDA clearances for Beckman Coulter's Access Intact PTH and Access Thyroglobulin assays, as well as Siemens Healthineers' Dimension LOCI TSH and FT4 cartridges, demonstrate continued investment in regulated endocrine assay menus [3], . These requirements can strengthen the position of established suppliers with clinical-evidence resources while increasing development and compliance pressure on smaller assay developers.
GMI Analyst View
The moderation from the historic ~10.8% CAGR to a ~8.2% forecast CAGR reflects a larger revenue base and persistent price discipline in mature laboratory markets, rather than a weakening clinical need for endocrine testing. Diabetes, thyroid disease, reproductive monitoring, and obesity-related metabolic risk sustain recurring test demand; meanwhile, the mix of that demand is changing. High-throughput immunoassay remains indispensable for routine panels, but LC-MS/MS is gaining relevance where antibody cross-reactivity or low-analyte concentrations can affect clinical interpretation.
Key Drivers
Driver Impact Table
Chronic metabolic and endocrine disease burden
Diabetes creates recurring demand for insulin measurement, C-peptide testing, and related metabolic assessment. The International Diabetes Federation estimated that 589 million adults aged 20–79 were living with diabetes globally in 2024 and projected that number to reach 853 million by 2050 [4]. In the United States, 40.1 million people had diabetes in 2023, equivalent to 12.0% of the population [5]. The testing opportunity is broader than diagnosed diabetes: diagnostic workup, treatment monitoring, insulin-resistance assessment, and screening of high-risk populations each create distinct laboratory demand.
Obesity strengthens this demand pathway because it increases the population exposed to metabolic and reproductive endocrine dysfunction. More than 1 billion people were living with obesity in 2022, and adult obesity prevalence had more than doubled globally since 1990 [6]. In the European Union, 50.6% of adults aged 16 years and older were overweight in 2022 [7]. The commercial implication is sustained volume for routine metabolic and thyroid testing, even where reimbursement and tendering constrain revenue per assay.
Higher-throughput platforms and more specific specialty testing
Automation reduces the operational burden of expanding endocrine menus. Abbott's Alinity i platform uses CHEMIFLEX chemiluminescent technology and can process up to 200 tests per hour [8], while the company's Alinity ci-series integrates chemistry and immunoassay workflows at throughput of up to 1,550 tests per hour . Siemens Healthineers' Atellica Solution provides broad assay-menu coverage and supports rapid STAT handling [9]. These capabilities make endocrine-panel consolidation more attractive for laboratories balancing turnaround-time requirements against labor availability.
LC-MS/MS is widening the addressable specialty-testing market because it offers greater analytical specificity for structurally similar steroid hormones than conventional immunoassays . Roche received CE mark approval in December 2024 for its cobas Mass Spec solution, including the cobas i 601 analyzer and initial Ionify steroid-hormone assays . Its planned menu expansion beyond steroid hormones indicates a move to place clinical mass spectrometry within the same automation and procurement environment as routine immunoassays.
Consumer access and reproductive-health testing
Consumer-accessible testing is lowering the distance between hormonal-health awareness and initial test use. FDA records include a digital pregnancy test clearance in August 2024 and an at-home FSH menopause test listing in September 2024 . These products do not replace laboratory confirmation in complex clinical pathways, but they expand entry points into pregnancy, fertility, and menopause-related testing. In parallel, fertility services and endocrine specialty practices sustain clinical demand for quantitative hCG, progesterone, LH, prolactin, and related panels.
Key Restraints
Restraint Impact Table
Capital intensity and specialist operating requirements
The clinical case for LC-MS/MS does not eliminate its deployment constraints. Sample preparation, chromatographic separation, validation, maintenance, and specialist staffing remain material requirements for laboratories considering high-complexity hormone panels. SCIEX markets the Citrine, 4500MD, and 3200MD clinical IVD mass-spectrometry systems for these applications [10]. The resulting economics favor centralized reference laboratories and large academic or hospital facilities that can aggregate sufficient specimen volume and technical expertise.
EU IVDR adds a second layer of cost for assay developers, requiring more comprehensive performance documentation and conformity assessment than the prior framework . Larger suppliers can spread regulatory, service, and analyzer-placement costs over extensive installed bases. Smaller reagent manufacturers may face longer development cycles or reduced capacity to support broad endocrine menus, particularly where price-sensitive tenders limit the ability to recover compliance costs.
Underdiagnosis and uneven testing access
Disease prevalence does not translate automatically into testing volume. The IDF estimated that 251.7 million adults with diabetes globally were undiagnosed in 2024, or 42.8% of adults with diabetes . This gap reflects constraints in awareness, primary-care pathways, laboratory access, and affordability. It is especially consequential in markets where metabolic disease is widespread but routine endocrine workup is not systematically embedded in preventive care.
The mismatch is visible across regions with substantial risk exposure. The WHO reported that adult overweight prevalence reached 67% in the Region of the Americas , while the IDF reported a 19.9% world-standardized diabetes prevalence in the Middle East and North Africa region in 2024 . These epidemiological conditions support long-term demand potential, but realizing it depends on reimbursement, public-health screening, referral behavior, and accessible laboratory capacity rather than population risk alone.
GMI Analyst View
The market's growth drivers operate at different points in the testing pathway. Diabetes and obesity enlarge the potential testing population , , while automation lowers the operational cost of serving that population through centralized laboratory networks , , . Consumer products can increase initial engagement, but their commercial significance depends on whether healthcare systems convert awareness into clinical confirmation, follow-up, and recurring monitoring .
Endocrine Testing Market Segment Analysis
Test type
hCG hormone testing is the largest test-type segment, valued at USD 1.044.20 million in 2025 and projected to reach USD 2,186.36 million by 2035 at ~7.7% CAGR. Its scale reflects use across pregnancy detection, serial pregnancy monitoring, emergency medicine, fertility care, and consumer channels. The FDA's 2024 digital pregnancy-test clearance illustrates continuing product development in consumer-accessible formats , while quantitative laboratory hCG remains important where clinical monitoring requires measurement rather than a qualitative result.
TSH testing is valued at USD 994.88 million in 2025 and is projected to rise to USD 2,299.30 million by 2035 at ~8.7% CAGR. Its growth is tied to its role as the principal entry assay for thyroid-function assessment and long-term monitoring. Platform investment remains active: Siemens Healthineers' Dimension LOCI TSH cartridge received FDA clearance in April 2025 . The segment benefits from its use in routine clinical pathways, where reflex testing can expand the value of an initial TSH result into a broader thyroid panel.
Insulin testing is projected to grow at ~9.0% CAGR, from USD 414.90 million in 2025 to USD 982.83 million by 2035. Its faster trajectory is consistent with the expanding diabetes burden and the increasing need to distinguish among metabolic conditions, evaluate endogenous insulin secretion, and investigate hypoglycemia , . QuidelOrtho states that its VITROS insulin reagent has no cross-reactivity to C-peptide or proinsulin and negligible cross-reactivity to insulin analogs, illustrating the analytical specificity expected in insulin measurement [11].
Progesterone testing is projected to increase from USD 338.90 million in 2025 to USD 767.66 million by 2035 at ~8.5% CAGR. Demand is linked to ovulation assessment, assisted-reproduction monitoring, and early-pregnancy evaluation. LH testing is forecast to rise from USD 232.60 million to USD 493.96 million at ~7.8% CAGR, supported by fertility workup, ovulation prediction, and puberty-related assessment. Beckman Coulter's reproductive-health menu includes automated AMH assays and broader reproductive hormone testing, demonstrating the importance of integrated fertility menus rather than isolated assays [12].
Prolactin testing is projected to expand from USD 186.22 million in 2025 to USD 372.76 million by 2035 at ~7.2% CAGR. It remains important in infertility, amenorrhea, galactorrhea, pituitary, and hypogonadism workups, but its narrower use profile limits growth relative to screening-oriented TSH or metabolically linked insulin testing. Other test types, including cortisol, testosterone, estradiol, PTH, DHEA-S, growth hormone, and IGF-1, are projected to grow from USD 143.71 million to USD 278.50 million at ~6.8% CAGR. Siemens Healthineers reports that its Atellica IM Testosterone II assay has retained CDC HoST-TT certification since 2019 , reflecting the emphasis on traceability and performance in testosterone testing.
Technology
Immunoassay is the largest technology segment, valued at USD 1,340.48 million in 2025 and projected to reach USD 2,823.38 million by 2035 at ~7.7% CAGR. Its leading position derives from throughput, broad assay menus, established clinical workflows, and favorable reagent economics. Automated systems allow laboratories to process endocrine assays alongside chemistry, infectious-disease, and other immunoassay workloads, making endocrine testing part of a larger analyzer-utilization model rather than a standalone capital purchase , , .
Mass spectrometry is projected to grow from USD 846.57 million in 2025 to USD 2,002.57 million by 2035 at ~9.0% CAGR. Its advantage is most pronounced for steroid hormones and other analytes where specificity, low-level measurement, and multiplexing matter . Roche's cobas Mass Spec launch introduces an integrated option for laboratories seeking to add specialty analysis without building an entirely separate vendor relationship . The adoption barrier remains workflow complexity and technical staffing, which explains the continuing concentration of the technology in reference laboratories and advanced clinical centers .
Chromatography is projected to grow from USD 539.88 million in 2025 to USD 1,239.33 million by 2035 at ~8.7% CAGR. Its role is particularly relevant in HbA1c measurement and selected catecholamine or endocrine applications. Tosoh Bioscience's AIA immunoassay family combines unit-dose test-cup reagents with 90-day calibration stability, while the company also has a longstanding position in HbA1c testing workflows [13]. Nucleic acid-based testing is expected to rise from USD 350.30 million to USD 718.95 million at ~7.4% CAGR, reflecting specialized applications such as hereditary endocrine tumor testing and thyroid molecular profiling. Other technologies, including ELISA, residual radioimmunoassay, biosensor, lateral-flow, and microfluidic formats, are projected to increase from USD 278.16 million to USD 597.15 million at ~7.9% CAGR.
End use
Clinical laboratories are the largest end-use segment, valued at USD 1,631.23 million in 2025 and projected to reach USD 3,747.16 million by 2035 at ~8.7% CAGR. Centralized laboratories can spread analyzer, quality-control, and specialist-labor costs across high specimen volumes, making them particularly suited to complex hormone panels and LC-MS/MS workflows. Their growth rate also reflects the migration of higher-complexity testing from smaller hospital laboratories to specialized networks.
Hospitals are projected to expand from USD 1,304.92 million in 2025 to USD 2,752.51 million by 2035 at ~7.7% CAGR. Their endocrine-testing demand is tied to acute presentations, inpatient monitoring, and the need for rapid integration with hospital information systems. Diagnostic centers are forecast to grow from USD 289.57 million to USD 622.25 million at ~7.9% CAGR, supported by fertility clinics, endocrinology practices, and independent diagnostic chains. Other end users, including physician offices, home testing, and research settings, are expected to increase from USD 129.69 million to USD 259.46 million at ~7.2% CAGR; consumer-accessible hCG and FSH products contribute to this channel .
GMI Analyst View
Segment growth is concentrated where chronic-disease testing and operational efficiency overlap. Insulin testing at ~9.0% CAGR and TSH testing at ~8.7% CAGR sit close to the core pathways for metabolic and thyroid care, respectively. Their growth is not solely a function of individual assay demand; it also reflects the ability of high-throughput platforms to absorb endocrine panels into routine laboratory operations.
Endocrine Testing Market Regional Analysis
North America
North America is the largest regional market, projected to grow from USD 1,458.59 million in 2025 to USD 2,972.48 million by 2035 at ~7.4% CAGR. The U.S. accounts for USD 1,333.15 million in 2025 and is projected to reach USD 2,666.31 million by 2035 at ~7.2% CAGR. Its position reflects high diabetes prevalence, a developed reference-laboratory sector, broad use of automated immunoassay, and continuing FDA-cleared menu expansion , , . The large installed base supports dependable consumables demand, although market maturity limits the pace of percentage growth.
Canada is projected to grow from USD 125.44 million in 2025 to USD 306.17 million by 2035 at ~9.3% CAGR. Its smaller starting base creates greater room for expansion in specialty endocrinology, fertility, and higher-complexity hormone testing. Provincial health-system coverage supports standard endocrine panels, while advanced steroid and reproductive profiles are more dependent on assessment, laboratory-capability, and referral pathways.
Europe
Europe is projected to increase from USD 893.98 million in 2025 to USD 1,936.36 million by 2035 at ~8.0% CAGR. The IVDR transition is a defining market condition because it increases conformity and performance-evidence obligations for IVD suppliers . The burden is commercially significant for manufacturers serving European laboratory systems: large suppliers can use established regulatory resources and broad portfolios to preserve continuity, whereas smaller providers may face more difficult certification and lifecycle-management decisions.
Germany's developed laboratory infrastructure and academic medical centers support specialty LC-MS/MS adoption, while Roche's 2024 cobas Mass Spec launch targets laboratories seeking automated clinical mass-spectrometry capability . In the United Kingdom, centralized laboratory networks favor scale and can accelerate adoption once validation and procurement thresholds are met. France, Spain, Italy, and the Netherlands each support demand through different combinations of public reimbursement, hospital-centered testing, fertility care, and university medical-center reference programs.
Asia Pacific
Asia Pacific is projected to grow from USD 737.68 million in 2025 to USD 1,847.93 million by 2035 at ~9.6% CAGR, the fastest among the major regions. The opportunity rests on a large metabolic-disease burden, growing healthcare access, and still-developing diagnostic capacity. India is among the countries with the largest adult diabetes populations globally , while China combines large test volumes with a regulatory environment that increasingly emphasizes domestic clinical data for imported IVD products.
Domestic suppliers are increasingly relevant in this environment. Snibe's MAGLUMI CLIA menu lists 278 parameters, including endocrine assays [14]. Its high-throughput analyzer offerings illustrate how local manufacturers can address price-sensitive laboratory expansion while multinational suppliers compete on menu depth, automation, and established clinical support. Japan, Australia, and South Korea add demand through developed laboratory systems, aging populations, reimbursement-supported testing, and advanced endocrine care.
Latin America
Latin America is projected to increase from USD 143.81 million in 2025 to USD 344.41 million by 2035 at ~9.1% CAGR. Brazil and Mexico anchor regional demand through their large populations, public-sector procurement, private laboratory networks, and substantial metabolic-risk burden. The WHO's finding that adult overweight prevalence reached 67% in the Region of the Americas indicates a broad long-term risk pool for diabetes and related endocrine conditions .
The region's growth is tempered by purchasing constraints. Public tenders and variable reimbursement can favor lower-cost assay configurations, locally assembled products, or distributors with strong service coverage. For suppliers, the critical issue is not merely market entry but maintaining reagent availability, instrument uptime, and price discipline across fragmented healthcare systems.
Middle East and Africa
The Middle East and Africa market is projected to grow from USD 121.33 million in 2025 to USD 280.20 million by 2035 at ~8.7% CAGR. The Middle East and North Africa region had the highest world-standardized diabetes prevalence among IDF regions in 2024, at 19.9% . This creates a strong underlying case for metabolic and endocrine testing, particularly as public-health programs and hospital investments expand chronic-disease management.
GMI Analyst View
Regional growth rates reflect a balance between market maturity and the capacity to convert disease burden into testing. North America's ~7.4% CAGR is lower than Asia Pacific's ~9.6%, but its 2025 base makes it the largest source of absolute market value. Its installed laboratory infrastructure also provides the clearest near-term environment for integrated immunoassay and mass-spectrometry adoption , .
Endocrine Testing Market Share & Competitive Landscape
Competition is organized around analyzer installed bases, proprietary reagent ecosystems, assay-menu breadth, service infrastructure, and the ability to support both routine and specialty endocrine workflows. Abbott, Roche, Siemens Healthineers, Beckman Coulter, Thermo Fisher Scientific, and SCIEX compete across combinations of immunoassay, laboratory automation, and mass spectrometry. The market also includes specialized endocrinology suppliers, quality-control providers, and regional IVD manufacturers that compete through focused menus, cost positioning, or local reach.
Abbott competes through its Core Laboratory diagnostics business and Alinity platforms. The Alinity i uses CHEMIFLEX chemiluminescent technology and can process up to 200 tests per hour , while the Alinity ci-series provides integrated clinical chemistry and immunoassay throughput of up to 1,550 tests per hour . The company's strength lies in embedding thyroid, reproductive, and metabolic testing in a high-throughput routine laboratory platform. Published evaluation of the Alinity i TRAb assay supports its role in Graves' disease diagnostics [15], and subsequent thyroid-function test validation further supports platform-based assay adoption [16].
Roche combines its Elecsys immunoassay brand and cobas analyzer family with a strategic move into clinical mass spectrometry. Its Elecsys TSH assay uses electrochemiluminescence immunoassay technology on cobas e analyzers . The December 2024 CE-marked cobas Mass Spec solution extends Roche's offering into steroid-hormone analysis, initially through the cobas i 601 analyzer and Ionify reagents . The strategic value is integration: laboratories can evaluate routine immunoassay and specialty mass-spectrometry requirements through a more unified automation and vendor framework.
Beckman Coulter offers the Access immunoassay platform and reproductive-health testing portfolio, including automated AMH testing and assays across fertility and endocrine pathways . FDA clearances for Access Intact PTH and Access Thyroglobulin in 2024 demonstrate continued assay-menu investment . Its competitive position is reinforced by access to a broad installed base and by its relevance in reproductive endocrine testing.
DiaSorin participates through its LIAISON platform and specialty endocrine and autoimmune-thyroid portfolio. In September 2025, the company announced commercial launch of its LIAISON TSH-R Ab assay in CE-mark-recognizing countries, using a double-bridge sandwich immunoassay format for Graves' disease diagnosis and monitoring .
SCIEX supplies IVD mass-spectrometry systems including Citrine, 4500MD, and 3200MD platforms . Its relevance is concentrated in high-complexity endocrine applications, particularly steroid-hormone panels handled by reference and specialized laboratories.
Siemens Healthineers competes through the Atellica Solution and endocrine immunoassay menu . Its Atellica IM Testosterone II assay has maintained CDC HoST-TT certification since 2019 , and its FDA-cleared Dimension LOCI TSH and FT4 cartridges demonstrate ongoing investment in thyroid testing .
Thermo Fisher Scientific participates through mass-spectrometry instrumentation and clinical-diagnostics capabilities used in specialty endocrine testing. Its position is most relevant where laboratories require analytical flexibility for complex hormone panels.
Tosoh Bioscience serves clinical laboratories through the AIA automated immunoassay family, which uses unit-dose test-cup dry reagents and offers 90-day calibration stability . Its established presence in HbA1c and immunoassay workflows supports its relevance to the metabolic component of endocrine diagnostics.
QuidelOrtho provides VITROS diabetes solutions, including insulin and C-peptide assays , and specialty thyroid testing through THYRETAIN bioassays. The THYRETAIN Turbo TSI Stimulating Reporter BioAssay and TBI Blocking Reporter BioAssay address functional differentiation of thyroid autoantibodies in Graves' disease .
Bio-Rad supports the endocrine-testing ecosystem through quality-control materials used by laboratories to monitor assay performance across hormone-testing workflows. Snibe Diagnostic offers the MAGLUMI CLIA platform and a broad IVD menu that includes endocrine assays , giving it relevance in China and other price-sensitive markets. Autobio supplies immunoassay and ELISA-based IVD solutions with a focus on APAC and emerging-market customers.
DRG International, Monobind, and Merck participate through specialty endocrine kits, ELISA and radioimmunoassay formats, reagents, reference standards, and laboratory-chemistry inputs. Their roles differ from the broad-platform competitors: they address specialty testing needs, lower-throughput laboratories, research settings, and the assay-development supply chain rather than competing solely for integrated analyzer placements.
Recent Industry Developments
Roche receives CE mark for cobas Mass Spec solution
On December 18, 2024, Roche announced CE mark approval for its cobas Mass Spec solution, including the cobas i 601 analyzer and the first Ionify reagent pack covering four steroid-hormone assays . Roche stated that the menu is intended to expand to more than 60 analytes, including steroid hormones, vitamin D metabolites, immunosuppressants, and therapeutic-drug-monitoring applications. The development is significant because it links mass-spectrometry capability with Roche's broader cobas automation environment, potentially simplifying procurement and workflow integration for laboratories adopting specialty hormone testing.
DiaSorin launches LIAISON TSH-R Ab assay
On September 19, 2025, DiaSorin announced the launch of its LIAISON TSH-R Ab assay in countries recognizing the CE mark . The assay is intended to support diagnosis and monitoring of suspected Graves' disease and uses a double-bridge sandwich immunoassay design. The launch expands DiaSorin's thyroid and autoimmune-thyroid offering by adding TSH receptor-antibody testing to a platform already used for broader thyroid workup.
Need a specific section of this report?
Purchase regional analysis, country-level analysis, company profiles, or any other segment-level insights separately
based on your research needs.