早产诊断检测套组市场规模、份额和成长分析（按检测类型、样本类型、最终用户和地区）- 产业预测 2025-2032

2023 年早产诊断检测套组市场规模为 1.522 亿美元，预计将从 2024 年的 1.6377 亿美元增长到 2032 年的 2.9426 亿美元，预计在预测期内（2025-2032 年）的复合年增长率为 7.6%。

由于早产的盛行率不断上升以及早期检测的迫切需求，全球早产诊断检测检测套组市场正在经历显着增长。这些创新的试剂套件有助于透过分析生物标记和临床指标及时评估早产的可能性。医疗保健提供者和孕妇意识的提高以及诊断技术的进步正在推动这一市场的扩张。北美和欧洲凭藉其成熟的医疗保健体系占据了市场占有率，而亚太地区则在医疗保健投资和认知度不断提高的推动下，呈现出良好的成长势头。向就地检验的转变正在提高风险评估的可及性和速度，特别是在医疗资源有限的地区，扩大了这些诊断工具的覆盖范围和影响力。

目录

介绍

• 调查目的
• 研究范围
• 定义

调查方法

• 资讯采购
• 次要和主要资料方法
• 市场规模预测
• 市场假设与限制

执行摘要

• 全球市场展望
• 供需趋势分析
• 细分机会分析

市场动态及展望

• 市场概况
• 市场规模
• 市场动态
  • 驱动因素和机会
  • 限制与挑战
• 波特的分析

主要市场考察

• 关键成功因素
• 竞争程度
• 主要投资机会
• 市场生态系统
• 市场吸引力指数（2024 年）
• PESTEL 分析
• 总体经济指标
• 价值链分析
• 定价分析
• 案例研究
• 监管格局
• 专利分析

早产诊断检测套组市场规模（依检测类型及复合年增长率） (2025-2032)

• 市场概况
• 胎儿纤连蛋白(fFN)检测套组
• 胎盘α微球蛋白-1（PAMG-1）检测套组
• 胰岛素样生长因子结合蛋白质-1（IGFBP-1）检测套组

早产诊断检测套组市场规模（依样本类型及复合年增长率）（2025-2032）

• 市场概况
• 血液样本
• 尿液样本
• 阴道分泌物样本

早产诊断检测套组市场规模（按最终用户和复合年增长率） (2025-2032)

• 市场概况
• 医院
• 诊断实验室
• 专科门诊

早产诊断检测套组市场规模（依地区划分）及复合年增长率（2025-2032）

• 北美洲
  • 美国
  • 加拿大
• 欧洲
  • 德国
  • 西班牙
  • 法国
  • 英国
  • 义大利
  • 其他欧洲国家地区
• 亚太地区
  • 中国
  • 印度
  • 日本
  • 韩国
  • 其他亚太地区
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲国家
• 中东和非洲
  • 海湾合作委员会国家
  • 南非
  • 其他中东和非洲地区

竞争资讯

• 前 5 家公司对比
• 主要企业市场定位（2024年）
• 主要市场参与者所采用的策略
• 近期市场趋势
• 公司市场占有率分析（2024 年）
• 主要企业简介
  • 公司详细信息
  • 产品系列分析
  • 公司分部份额分析
  • 收益与前一年同期比较对比（2022-2024 年）

主要企业简介

• Roche Diagnostics（Switzerland）
• Abbott Laboratories（USA）
• Siemens Healthineers（Germany）
• Thermo Fisher Scientific（USA）
• BD（Becton, Dickinson and Company）（USA）
• PerkinElmer（USA）
• bioMerieux（France）
• Hologic, Inc.（USA）
• Qiagen（Netherlands）
• Danaher Corporation（USA）
• Cepheid（USA）
• Illumina, Inc.（USA）
• Sysmex Corporation（Japan）
• Agilent Technologies（USA）
• Bio-Rad Laboratories（USA）
• GenMark Diagnostics（USA）
• Luminex Corporation（USA）
• Randox Laboratories（UK）
• NanoString Technologies（USA）
• Myriad Genetics（USA）

结论和建议

Preterm Birth Diagnostic Test Kits Market size was valued at USD 152.2 million in 2023 and is poised to grow from USD 163.77 million in 2024 to USD 294.26 million by 2032, growing at a CAGR of 7.6% during the forecast period (2025-2032).

The Global Preterm Birth Diagnostic Test Kits market is experiencing significant growth driven by an increased prevalence of preterm births and the urgent need for early detection. These innovative kits facilitate timely evaluations of potential preterm births through the analysis of biomarkers and clinical indicators. A surge in awareness among healthcare providers and expectant mothers, combined with advancements in diagnostic technology, supports this market expansion. While North America and Europe dominate in market share due to their well-established healthcare systems, the Asia-Pacific region shows promising growth fueled by rising healthcare investments and awareness. The shift towards point-of-care testing enhances the accessibility and speed of risk assessments, particularly in areas with limited healthcare resources, broadening the reach and impact of these diagnostic tools.

Top-down and bottom-up approaches were used to estimate and validate the size of the Preterm Birth Diagnostic Test Kits market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Preterm Birth Diagnostic Test Kits Market Segments Analysis

Global Preterm Birth Diagnostic Test Kits Market is segmented by Test Type, Sample Type, End User and region. Based on Test Type, the market is segmented into Fetal Fibronectin (fFN) Test Kits, Placental Alpha Microglobulin-1 (PAMG-1) Test Kits and Insulin-Like Growth Factor Binding Protein-1 (IGFBP-1) Test Kits. Based on Sample Type, the market is segmented into Blood Sample, Urine Sample and Vaginal Discharge Sample. Based on End User, the market is segmented into Hospitals, Diagnostic Laboratories and Specialty Clinics. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Preterm Birth Diagnostic Test Kits Market

Preterm birth, which occurs when a baby is born before 37 weeks of gestation, poses a substantial global health challenge. The rising prevalence of preterm deliveries is fueling the necessity for precise and dependable diagnostic test kits that can effectively identify and forecast instances of preterm labor. This growing demand is anticipated to continue as healthcare professionals and governmental bodies prioritize strategies aimed at decreasing preterm birth rates while enhancing the health outcomes for both mothers and newborns. As a result, the market for preterm birth diagnostic test kits is expected to expand significantly in response to these needs.

Restraints in the Preterm Birth Diagnostic Test Kits Market

The market for preterm birth diagnostic test kits faces significant constraints due to the stringent regulations imposed on the medical diagnostic industry, aimed at safeguarding patient safety and product effectiveness. The process of developing and launching new diagnostic test kits, particularly those associated with pregnancy and neonatal care, necessitates extensive testing and navigating complex approval pathways. These regulatory challenges can lead to delays in bringing innovative test kits to market, ultimately affecting their accessibility and widespread adoption among healthcare providers. As a result, the long and arduous approval process can hinder advancements and limit the options available to patients and clinicians alike.

Market Trends of the Preterm Birth Diagnostic Test Kits Market

The preterm birth diagnostic test kits market is experiencing a notable trend towards technological advancements, driven by the increasing need for accurate risk assessment of preterm deliveries. Recent innovations have led to the development of highly sensitive and specific tests, utilizing an array of biomarkers, genetic analysis, and proteomics. These enhancements allow healthcare professionals to better predict preterm birth risks, improving patient outcomes through early intervention. As a result, the market is expected to expand significantly, fostering greater adoption of these advanced diagnostic tools in clinical settings. This trend aligns with broader healthcare goals of personalized medicine and improved maternal-fetal health management.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Drivers & Opportunities
  • Restraints & Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Market Attractiveness Index, 2024
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis
• Case Studies
• Regulatory Landscape
• Patent Analysis

Global Preterm Birth Diagnostic Test Kits Market Size by Test Type & CAGR (2025-2032)

• Market Overview
• Fetal Fibronectin (fFN) Test Kits
• Placental Alpha Microglobulin-1 (PAMG-1) Test Kits
• Insulin-Like Growth Factor Binding Protein-1 (IGFBP-1) Test Kits

Global Preterm Birth Diagnostic Test Kits Market Size by Sample Type & CAGR (2025-2032)

• Market Overview
• Blood Sample
• Urine Sample
• Vaginal Discharge Sample

Global Preterm Birth Diagnostic Test Kits Market Size by End User & CAGR (2025-2032)

• Market Overview
• Hospitals
• Diagnostic Laboratories
• Specialty Clinics

Global Preterm Birth Diagnostic Test Kits Market Size & CAGR (2025-2032)

• North America (Test Type, Sample Type, End User)
  • US
  • Canada
• Europe (Test Type, Sample Type, End User)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Test Type, Sample Type, End User)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Test Type, Sample Type, End User)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Test Type, Sample Type, End User)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2024
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2024
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

• Roche Diagnostics (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Abbott Laboratories (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Siemens Healthineers (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Thermo Fisher Scientific (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• BD (Becton, Dickinson and Company) (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• PerkinElmer (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• bioMerieux (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Hologic, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Qiagen (Netherlands)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Danaher Corporation (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Cepheid (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Illumina, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sysmex Corporation (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Agilent Technologies (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Bio-Rad Laboratories (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• GenMark Diagnostics (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Luminex Corporation (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Randox Laboratories (UK)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• NanoString Technologies (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Myriad Genetics (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations