세계의 자간전증 진단 시장의 평가 : 검사 유형별, 제품 유형별, 최종 사용자별, 지역별, 기회, 예측(2017-2031년)

Global preeclampsia diagnostics market is projected to witness a CAGR of 3.23% during the forecast period 2024-2031, growing from USD 1077.00 million in 2023 to USD 1388.87 million in 2031. The market demand for preeclampsia diagnostic products is anticipated to rise in the forecast period due to the increased prevalence of preeclampsia, rising awareness of women's health safety, and various technological advancements that contribute to the growth of the market.

Preeclampsia, also known as Toxemia, is a multi-system disorder that is specific to pregnancy and is characterized by the new onset of high blood pressure, often with significant amounts of protein in the urine, or by the new onset of high blood pressure along with a significant end-organ damage, the disorder might occur with or without the proteinuria. When the condition appears, it starts at 20 weeks of gestation. In more severe stages of the disease, there can also be red blood cell breakdown and low levels of blood platelets, as well as dysfunction of the liver, kidney insufficiency, edema, shortness of breath due to pulmonary edema, or visual disturbance. Pre-eclampsia is diagnosed as a hypertensive disorder of pregnancy; its global prevalence is approximately 1-5% of pregnancies, and this condition is recognized to be one of the leading causes of maternal mortality.

Hypertensive disorders of pregnancy (including pre-eclampsia) are the second most frequent cause of death in maternity-related cases all over the world and are estimated to result in 62,000-77,000 deaths each year. Rising awareness about this disorder and its diagnostic procedure in pregnant women are anticipated factors for the growth of the preeclampsia diagnostic market in the forecast period. For instance, on 19 May 2023, Thermo Fisher Scientific Inc. announced its approval from the U.S. Food and Drug Administration (USFDA) for the first blood test to predict preeclampsia in pregnant women. This blood test is meant for women in their 23rd to 35th weeks of pregnancy.

Increasing Prevalence of Preeclampsia to Drive Market Growth

The increasing incidence of preeclampsia is a major growth factor for the preeclampsia diagnostics market. Factors contributing to the increase include more pregnancies among older women who are at higher risk of developing preeclampsia and lifestyles that have led to obesity and chronic conditions such as diabetes and hypertension. Increased access and availability of prenatal care compounds and socioeconomic factors lead to a high percentage of conditions being undiagnosed or poorly treated. An increase in knowledge about preeclampsia and its life-threatening complications has led to more aggressive action from healthcare providers to screen and monitor the condition early in pregnancy, stressing the need for early intervention to avoid poor outcomes for the mother and child. This increasing prevalence calls for the need to find effective ways of preventing preeclampsia and ensuring healthier pregnancies. For instance, on 31 May 2023, CSEM announced a collaboration with MOMM Diagnostics to develop a cutting-edge point-of-care solution for preeclampsia diagnostics.

Technological Advancements to Drive the Preeclampsia Diagnostics Market Growth

Technological advancements are a key driver for the growth of the preeclampsia diagnostic market as they change how practitioners diagnose and manage this life-threatening condition. Based on innovation, research into biomarkers has led to tests that are sensitive and specific enough to enable the diagnosis of preeclampsia earlier and with greater accuracy than in the past. Moreover, advancements in imaging technologies such as ultrasound and Doppler assessments make it increasingly easier to check fetal well-being and placental health. Integrating artificial intelligence and machine learning makes predictive analytics more personalized about risk, enabling selective interventions. These technological improvements would make the diagnostic process faster and enable healthcare professionals to make more informed decisions, ultimately leading to better maternal and fetal health outcomes. For instance, on 23 September 2024, Unitaid published a report on tools and interventions for the diagnosis and management of pre-eclampsia. The report identifies several new diagnostic tools with promise, holding out the prospect of identifying a woman's risk of contracting pre-eclampsia or even the worsening of the condition. There are two blood biomarker-based SFlt-1 tests, and the placental growth factor can easily be adapted for low-resource settings and further improve treatment options for women diagnosed with a risk of preeclampsia.

Testing Segment to Dominate the Preeclampsia Diagnostics Market Share

The testing segment is expected to dominate the market throughout the forecast period due to its key role in early diagnosis and management of the disease. Increasing numbers of testing modalities, such as blood tests for biomarkers soluble fms-like tyrosine kinase (sFlt-1) and placental growth factor (PIGF) levels and urine tests to determine protein levels, are routinely offered during the standard prenatal care process. Such tests will help healthcare providers identify the risks patients face and provide early intervention time that would improve their maternal and fetal health. Other than this, personalized medicine has resulted in the formulation of testing protocols that are gradually designed and tailored to the risk profile of individuals. As education about preeclampsia disseminates and healthcare providers increasingly adopt these advanced technologies for testing, the demand for innovative, time-saving diagnostic solutions will continue to increase. For instance, in July 2022, PerkinElmer, Inc., a global leader in innovation, announced that a placental growth factor (PlGF) measurement using its DELFIA Xpress PlGF 1-2-3TM kit (CE-IVD) and a soluble fms-like tyrosine kinase 1 (sFlt-1)/PlGF ratio using its DELFIA Xpress sFlt-1 kit (CE-IVD), have been included in updated diagnostic guidance issued by the United Kingdom's National Institute for Health and Care Excellence (NICE) to help diagnose suspected preterm pre-eclampsia.

North America Dominates the Preeclampsia Diagnostics Market Share

North America dominates the share of the preeclampsia diagnostics market, driven by a combination of advanced healthcare infrastructure with higher levels of awareness, along with significant investment in research. Preeclampsia is a pregnancy-specific disease that affects 2-8% of all pregnancies and is the most significant cause of morbidity and mortality among mothers and neonates in the United States. It has well-established healthcare providers with state-of-the-art diagnostic technologies, thus allowing for relatively prompt and accurate identification of cases of preeclampsia. Another driving force behind the demand for effective diagnostic solutions is the growing attention to antenatal care and early intervention, coupled with governmental efforts to improve maternal health outcomes. The rising prevalence of risk factors such as obesity and advanced maternal age in North America also contributes to the increase in the prevalence of preeclampsia. With a high emphasis on keeping the mother's health as the top priority, it is found that North America still dominates the preeclampsia diagnostics market. For instance, on 31 January 2024, LabCorp, a global leader in innovative and comprehensive laboratory services, announced the US Food and Drug Administration's approval for blood tests for risk assessment and clinical management of severe preeclampsia.

Future Market Scenario (2024-2031F)

The future market scenario of the preeclampsia diagnostics market appears quite promising because of ongoing technological advancements and the growing interest in maternal health. Continued research to identify new biomarkers and methodologies for testing improve diagnostics substantially in terms of accuracy and reliability. Predictive analytics based on artificial intelligence and machine learning approaches can facilitate more personalized and proactive management approaches in risk management for preeclampsia. It will increase awareness of primary caregivers and expectant mothers for earlier interventions. It opens new market opportunities for new therapeutic interventions and better diagnostics to change the matrix of maternal care, facilitating improved results for mother and child. As health systems worldwide move forward and focus on more prenatal care than ever, the preeclampsia diagnostics market will grow in the forecast years due to innovation, collaboration, and a goal towards improved standards in maternal health. For instance, in August 2024, ARUP Laboratories announced its Food and Drug Administration approval for blood-based biomarkers tests to assess risk for preeclampsia. This test quantitates the ratio between two angiogenic factors released by the placenta implicated in the pathophysiology of preeclampsia.

Key Players Landscape and Outlook

The global preeclampsia diagnostics market is highly dynamic, driven by key players engaged in strategic business agreements, collaborations, and regulatory product approvals. Additionally, smaller companies are an integral part of the market landscape, often leveraging partnerships with established players to enhance their reach and address broader market needs. This collaborative environment fosters innovation and supports market growth, meeting the expanding demand for diagnostic solutions.

On 25 September 2024, Trinity Biotech plc, a commercial-stage biotechnology company, announced that it acquired Metabolomics Diagnostics, an Irish deep-tech company specializing in the development of novel biomarker-based diagnostic solutions for predicting the risk of preeclampsia in pregnant women.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. Global Preeclampsia Diagnostics Market Outlook, 2017-2031F

• 4.1. Market Size Analysis & Forecast
  • 4.1.1. By Value
• 4.2. Market Share Analysis & Forecast
  • 4.2.1. By Test Type
    • 4.2.1.1. Blood Tests
    • 4.2.1.2. Urine Analysis
    • 4.2.1.3. Others
  • 4.2.2. By Product
    • 4.2.2.1. Instruments
    • 4.2.2.2. Consumables
  • 4.2.3. By End-user
    • 4.2.3.1. Hospitals
    • 4.2.3.2. Diagnostic Centers
    • 4.2.3.3. Specialty Clinics
    • 4.2.3.4. Others
  • 4.2.4. By Region
    • 4.2.4.1. North America
    • 4.2.4.2. Europe
    • 4.2.4.3. Asia-Pacific
    • 4.2.4.4. South America
    • 4.2.4.5. Middle East and Africa
  • 4.2.5. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2023)
• 4.3. Market Map Analysis, 2023
  • 4.3.1. By Test Type
  • 4.3.2. By Product
  • 4.3.3. By End-user
  • 4.3.4. By Region

5. North America Preeclampsia Diagnostics Market Outlook, 2017-2031F*

• 5.1. Market Size Analysis & Forecast
  • 5.1.1. By Value
• 5.2. Market Share Analysis & Forecast
  • 5.2.1. By Test Type
    • 5.2.1.1. Blood Tests
    • 5.2.1.2. Urine Analysis
    • 5.2.1.3. Others
  • 5.2.2. By Product
    • 5.2.2.1. Instruments
    • 5.2.2.2. Consumables
  • 5.2.3. By End-user
    • 5.2.3.1. Hospitals
    • 5.2.3.2. Specialty Clinics
    • 5.2.3.3. Diagnostic Centers
    • 5.2.3.4. Others
  • 5.2.4. By Country Share
    • 5.2.4.1. United States
    • 5.2.4.2. Canada
    • 5.2.4.3. Mexico
• 5.3. Country Market Assessment
  • 5.3.1. United States Preeclampsia Diagnostics Market Outlook, 2017-2031F*
    • 5.3.1.1. Market Size Analysis & Forecast
      • 5.3.1.1.1. By Value
    • 5.3.1.2. Market Share Analysis & Forecast
      • 5.3.1.2.1. By Test Type
        • 5.3.1.2.1.1. Blood Tests
        • 5.3.1.2.1.2. Urine Analysis
        • 5.3.1.2.1.3. Others
      • 5.3.1.2.2. By Product
        • 5.3.1.2.2.1. Instrument
        • 5.3.1.2.2.2. Consumables
      • 5.3.1.2.3. By End-user
        • 5.3.1.2.3.1. Hospitals
        • 5.3.1.2.3.2. Specialty Clinics
        • 5.3.1.2.3.3. Diagnostic Centers
        • 5.3.1.2.3.4. Others
  • 5.3.2. Canada
  • 5.3.3. Mexico

All segments will be provided for all regions and countries covered

6. Europe Preeclampsia Diagnostics Market Outlook, 2017-2031F

• 6.1. Germany
• 6.2. France
• 6.3. Italy
• 6.4. United Kingdom
• 6.5. Russia
• 6.6. Netherlands
• 6.7. Spain
• 6.8. Poland

7. Asia-Pacific Preeclampsia Diagnostics Market Outlook, 2017-2031F

• 7.1. India
• 7.2. China
• 7.3. Japan
• 7.4. Australia
• 7.5. Vietnam
• 7.6. South Korea
• 7.7. Indonesia
• 7.8. Philippines

8. South America Preeclampsia Diagnostics Market Outlook, 2017-2031F

• 8.1. Brazil
• 8.2. Argentina

9. Middle East and Africa Preeclampsia Diagnostics Market Outlook, 2017-2031F

• 9.1. Saudi Arabia
• 9.2. UAE
• 9.3. South Africa
• 9.4. Israel

10. Demand Supply Analysis

11. Value Chain Analysis

12. Porter's Five Forces Analysis

13. PESTLE Analysis

14. Pricing Analysis

15. Market Dynamics

• 15.1. Market Drivers
• 15.2. Market Challenges

16. Market Trends and Developments

17. Regulatory Framework and Innovation

• 17.1. Clinical Trials
• 17.2. Regulatory Approvals

18. Patent Landscape

19. Case Studies

20. Competitive Landscape

• 20.1. Competition Matrix of Top 5 Market Leaders
• 20.2. SWOT Analysis for Top 5 Players
• 20.3. Key Players Landscape for Top 10 Market Players
  • 20.3.1. Thermo Fisher Scientific, Inc.
    • 20.3.1.1. Company Details
    • 20.3.1.2. Key Management Personnel
    • 20.3.1.3. Products and Services
    • 20.3.1.4. Financials (As Reported)
    • 20.3.1.5. Key Market Focus and Geographical Presence
    • 20.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisitions
  • 20.3.2. Diabetomics, Inc.
  • 20.3.3. BioCheck.
  • 20.3.4. Sera Prognostics.
  • 20.3.5. Bayer, AG.
  • 20.3.6. Siemens Healthineers AG.
  • 20.3.7. QuidelOrtho Corporation.
  • 20.3.8. Beckman Coulter, Inc.
  • 20.3.9. PerkinElmer, Inc.
  • 20.3.10. Biora Therapeutics, Inc.

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

21. Strategic Recommendations

22. About Us and Disclaimer