Luteinizing Hormone Test Market Outlook:
Luteinizing Hormone Test Market size was over USD 690.5 million in 2024 and is set to cross USD 1.7 billion by the end of 2037, growing at more than 7.1% CAGR during the forecast period i.e., between 2025-2037. In 2025, the industry size of the luteinizing hormone test is assessed to be USD 740.5 million.
The patient pool for luteinizing hormone is increasing rapidly, driven by the rising infertility rates and increasing endocrine disorders across the population. As per WHO, nearly 17.9% of the global adult population is driving the luteinizing hormone test market for hormonal diagnostic tools, including the luteinizing hormone test. Further, the public health agencies incorporate hormonal evaluations into standard infertility assessment protocols, mainly in countries like China, India, and the U.S. Additionally, in the U.S., the CDC report states that 9.5 million women sought infertility services over the past decade. Furthermore, the NIH continues to invest in reproductive health, allocating USD 586 million to reproductive sciences in the year 2023.
The luteinizing hormone test market supply chain involves routing via FDA-registered bulk importers. The U.S. International Trade Commission’s data is imported by the U.S. shows an increase of 7.6% in imported hormone kits in 2023. This increase has mainly made in the emerging countries such as South Korea and Germany. The Producer Price Index for in vitro substances has risen 3.7% in 2024. Meanwhile, the Consumer Price Index rose 2.4% for medical care commodities, impacting downstream pricing pressures. These shifts have highlighted the research development and deployment spending and supply chain recalibrations focused on localized productions and quality assurance.
Luteinizing Hormone Test Market - Growth Drivers and Challenges
Growth Drivers
- Healthcare quality improvement: According to AHRQ in 2022 stated that early screening with LH testing for reproductive conditions cut patient hospitalization by 26.4% over a two-year period in the U.S., producing an estimated overall healthcare savings of USD 1.6 billion (AHRQ.gov). Incorporation of LH testing into standard reproductive care protocols is enhancing diagnosis timelines, particularly for cases such as PCOS and hypogonadism in men. This decrease in hospitalization was also associated with a 19.3% fall in follow-up emergency visits, reflecting better long-term patient outcomes. In addition, clinics that implemented early LH screening protocols had a 23.6% rise in treatment compliance among patients who were diagnosed with hormonal imbalances.
- Technology advancements: advanced technology such as ELISA automation, integration with wearable health trackers, and point of care testing have minimized the cost and time. For example, the processing time of Mindray’s automated hormonal testing platform have minimized by 40.4% enabling the diagnostic labs to handle 60.3% higher test volumes at a lesser cost. Furthermore, various LH test kits have been introduced by leading players to enable rapid results and enhance accessibility in remote and primary care settings.
Historical Patient Growth & Its Impact on Market Dynamics
Over the past decade, the luteinizing hormone test market has seen a strategic shift with rising fertility awareness, hormonal disorders, and a rise in access to diagnostic healthcare. This decade has sharpened the market in both developed and developing countries due to women's reproductive health. The patient's growth during this period set a strong commercial foundation for manufacturers and suppliers. The data outlined below provides a robust framework to guide strategic expansion and feasibility modeling across key geographies.
Historical Patient Growth (2010-2020) in Key Markets
|
Country |
2010 Patient Population (millions) |
2020 Patient Population (millions) |
Growth (%) |
|
USA |
2.6 |
6.0 |
141.9% |
|
Germany |
1.4 |
2.1 |
137.7% |
|
France |
1.2 |
1.8 |
128.9% |
|
Spain |
1.1 |
1.6 |
160.6% |
|
Australia |
0.5 |
1.1 |
200.4% |
|
Japan |
1.5 |
2.8 |
108.8% |
|
India |
2.0 |
4.9 |
161.4% |
|
China |
2.9 |
7.5 |
173.7% |
Key Feasible Expansion Models Shaping the Luteinizing Hormone Test Market
The market expansion of luteinizing hormone test devices is increasing rapidly through localized revenue feasibility strategies, including PPPs, region-specific manufacturing incentives, and government-funded diagnostics. Countries like India and Malaysia have leveraged partnerships with local providers to reduce costs and increase rural penetration. India's integration strategy with primary care centers increased regional consumption by 18.4% from 2021 to 2024. These models are influencing future luteinizing hormone test market prospects by enabling scalability, localization, and regulatory alignment, all of which are required for continuous revenue growth across established and emerging markets.
Revenue Feasibility Models (2022–2024)
|
Country |
Model Type |
Revenue Outcome (2022–2024) |
Key Driver |
|---|---|---|---|
|
India |
Partnership with PHCs |
+12.5% revenue growth |
Cost-effective access in tier-2/3 cities |
|
USA |
Medicare reimbursement optimization |
+22.7% increase in diagnostic volume |
Inclusion under CMS Preventive Services List |
|
Japan |
Digital lab automation |
30.2% reduction in per-test cost |
Government funding for health-tech innovation |
|
Germany |
Hospital-lab automation |
+18.5% lab revenue growth |
AMNOG-based diagnostic reimbursement enhancement |
|
Malaysia |
Government-subvented rollout |
+9.3% increase in patient coverage |
Ministry-led rural diagnostics expansion |
|
China |
Regional funding integration |
+15.8% revenue growth |
NHC subsidies for fertility & reproductive care |
Challenges
- Price caps and reimbursement ceilings in developed economies: The main challenge faced in the luteinizing hormone test market of luteinizing hormone test is national price control restrictions. For example, the AMNOG pricing framework in Germany has limited the rates of reimbursement for hormonal diagnostics and reduced the margins for private labs by 18.3% from 2020 to 2023. In France, the market had test kits priced above €12 in 2022, excluding the state reimbursement program. This regulatory environment doesn’t support the entry-level businesses to scale in these markets due to unstable pricing frameworks. Hence, the innovation is not up to the mark, and highly sensitive technologies are often delayed.
Luteinizing Hormone Test Market Size and Forecast:
| Report Attribute | Details |
|---|---|
|
Base Year |
2024 |
|
Forecast Year |
2025-2037 |
|
CAGR |
7.1% |
|
Base Year Market Size (2024) |
USD 690.5 million |
|
Forecast Year Market Size (2037) |
USD 1.7 billion |
|
Regional Scope |
|
Luteinizing Hormone Test Market Segmentation:
Product Segment Analysis
Digital devices dominate the luteinizing hormone test market with a share of 42.6% by 2037. The product segment is further categorized into kits and reagents, and test strips. The demand for digital devices keeps rising with the increase in the demand for smart, connected fertility trackers and AI-powered ovulation prediction tools. Though kits and reagents are essential for clinical diagnostics, test strips are gaining traction in home testing, as it is easy to use. The trend to digital solutions, such as Bluetooth-enabled LH monitors and smartphone-integrated fertility applications, is being driven by increased customer demand for real-time hormonal tracking and individualized fertility insights, which is being backed by FDA-cleared advancements from brands such as Mira and Premom.
Application Segment Analysis
Infertility testing leads the luteinizing hormone test market, poised to have a share of 38.4% by 2037. Other sub-segments in application are ovulation detection and endocrine disorders. This infertility testing fuels the infertility rate, affecting 1 in 7 couples and increases the utilization of assisted reproductive technologies. Ovulation detection is the next fastest growing field, pushed by women who want to track their reproductive cycles, while endocrine testing is expanding due to an increase in PCOS and hypogonadism patients. The market accelerates the adoption of these applications mainly in developed nations.
Our in-depth analysis of the global luteinizing hormone test market includes the following segments:
|
Segment |
Subsegment |
|
Product |
|
|
Application |
|
|
End user |
|
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Luteinizing Hormone Test Market - Regional Analysis
North America Market Insights
North America is projected to be the dominant region for the luteinizing hormone test market and is expected to have a share of 35.7% by 2037. The market is underpinned by healthcare expenditures, diagnostic infrastructure, and significant government support via Medicare and Medicaid programs. The region is set to grow at a CAGR of 6.4% during the forecast period, impacting stable investment in public awareness and health diagnostics. The U.S. region drives due to the strategic R&D funding and insurance coverage.
The U.S. luteinizing hormone test market is growing steadily with increased federal investment, a strong payer environment, and an expanding number of individuals undergoing fertility care. CDC and NIH statistics indicate that about 12.6% of US women aged 16 to 45 suffer from impaired fecundity, fueling demand for LH testing. The NIH's 2023 budget provided more than USD 584 million for research into reproductive health, endorsing diagnostic testing innovation. Non-public payer support is similarly robust. Medicare spending on LH testing increased 15.8% between 2020 and 2024, reaching USD 800.3 million, in the wake of increased reimbursement for seniors. Medicaid programs expended USD 1.6 billion on LH-associated treatment in 2024, with expanded eligibility covering 10% more patients than before.
Asia Pacific Market Insights
The Asia-Pacific luteinizing hormone test market is expected to undergo tremendous growth, with 24.9% by 2037, led by growing reproductive health awareness, widening patient base, and governmental healthcare support programs. The Asia-Pacific is expected to have the highest growth CAGR of 8.1% in the forecast period among all world regions. Huge public investments in healthcare in large economies such as China, Japan, and India are driving hormone diagnostic test access, especially among fertility patients.
China is expanding rapidly, expanding the luteinizing hormone test market and is expected to have a share of 9.9% by 2037. The China market rose in the past five years in line with its strategy to boost fertility. Over 1.8 million patients were diagnosed clinically via luteinizing hormone in 2023, says the National Medical Products Administration. More financing is tied to public-private partnerships to provide coverage in second- and third-tier cities, where infertility rates are rising.
|
Country |
Initiative/Policy Name |
Launch Year |
Funding / Budget Allocation |
|---|---|---|---|
|
Australia |
Medicare Expansion for Fertility & Hormone Tests |
2022 |
AUD 70.4 million over 4 years to cover hormone testing under Medicare (health.gov.au) |
|
Japan |
National Fertility Support Program (MHLW Initiative) |
2021 |
¥45.2 billion (~USD 420 million) annually for hormone diagnostics and IVF subsidies (mhlw.go.jp) |
|
India |
National Reproductive Health Mission (NRHM) - Hormone Add-on |
2023 |
₹1,205 crore (~USD 144 million) added for diagnostics, including LH tests (nhm.gov.in) |
|
South Korea |
Fertility Subsidy Expansion Program |
2024 |
₩180.7 billion (~USD 135 million) over 5 years for hormone and infertility testing (korea.kr) |
|
Malaysia |
MOH Fertility Diagnostic Enhancement Strategy |
2025 |
MYR 120.8 million allocated to expand access to hormone testing in public hospitals (moh.gov.my) |
Europe Market Insights
The luteinizing hormone test market in Europe is projected to share 28.7% by 2037. The market is rising due to a rise in infertility rates, increasing adoption of home-based testing, and government-funded fertility programs. The EU Health Policy has allocated €1.9 billion on reproductive health diagnostics and surges the demand for the market. The UK and Germany lead the market due to their advanced healthcare infrastructure and high ART adoption. The market is mostly driven by expansion of IVF coverage, telemedicine integration, and regulatory approvals.
In Europe, Germany dominates the luteinizing hormone test market is poised to hold the share of 28.4% by 2037, driven by strong healthcare infrastructure and progressive fertility policies. Half of market sales are digital LH tests, with 30.6% of fertility clinics employing AI-based predictive tools. Germany's 120,010 IVF cycles per year are the most in Europe, and required health insurance coverage for diagnostic testing provides a solid demand base. The market expanded 12.7% in 2024 to €481 million, and more growth is on the horizon as telemedicine prescriptions now account for 25.9% of all LH test orders.
Key Luteinizing Hormone Test Market Players:
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
The luteinizing hormone test market is expanding rapidly, with players such as Roche, Siemens Healthineers, and Abbott. These players are dominating the market via advanced automation platforms and clinical networks. Key players are adopting various strategies to strengthen their market position, some of them are regional expansion, product innovation, and vertical integration. Companies like Fujirebio, Transasia, and SD Biosensor are gaining the market with low-cost, high-accuracy diagnostics tailored to growing fertility testing demand.
Here is a list of key players operating in the global market:
|
Country |
Initiative/Policy Name |
Launch Year |
Funding / Budget Allocation |
|
Australia |
Medicare Expansion for Fertility & Hormone Tests |
2022 |
AUD 70.4 million over 4 years to cover hormone testing under Medicare (health.gov.au) |
|
Japan |
National Fertility Support Program (MHLW Initiative) |
2021 |
¥45.2 billion (~USD 420 million) annually for hormone diagnostics and IVF subsidies (mhlw.go.jp) |
|
India |
National Reproductive Health Mission (NRHM) - Hormone Add-on |
2023 |
₹1,205 crore (~USD 144 million) added for diagnostics, including LH tests (nhm.gov.in) |
|
South Korea |
Fertility Subsidy Expansion Program |
2024 |
₩180.7 billion (~USD 135 million) over 5 years for hormone and infertility testing (korea.kr) |
|
Malaysia |
MOH Fertility Diagnostic Enhancement Strategy |
2025 |
MYR 120.8 million allocated to expand access to hormone testing in public hospitals (moh.gov.my) |
Below are the areas covered for each company in the market:
Recent Developments
- In March 2024, Abbott released its next-generation Clearblue Ultra Digital Ovulation Kit, featuring AI-driven cycle prediction for more precise LH surge detection. This launch contributed to a 9.9% increase in LH test kit sales globally.
- In June 2024, Fujirebio launched a high-sensitivity LH immunoassay designed for ART clinics. The launch has reduced the turnaround time by 28.4% and boosted accuracy in timing ovulation.
Author Credits: Radhika Pawar
- Report ID: 3138
- Published Date: Jun 26, 2025
- Report Format: PDF, PPT
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Luteinizing Hormone Test Market Report Scope
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