早産診断検査キット市場規模、シェア、成長分析：検査タイプ別、サンプルタイプ別、エンドユーザー別、地域別 - 産業予測 2025～2032年

早産診断検査キット市場規模は2023年に1億5,220万米ドルと評価され、2024年の1億6,377万米ドルから2032年には2億9,426万米ドルに成長し、予測期間（2025～2032年）のCAGRは7.6%で推移する見通しです。

世界の早産診断検査キット市場は、早産の有病率の増加と早期発見の緊急ニーズによって大きな成長を遂げています。これらの革新的なキットは、バイオマーカーや臨床指標の分析を通じて、早産の可能性をタイムリーに評価することを容易にします。ヘルスケアプロバイダーや妊産婦の意識の高まりと診断技術の進歩がこの市場拡大を支えています。北米と欧州は医療制度が確立しているため市場シェアで優位を占めているが、アジア太平洋地域は医療投資と意識の高まりに後押しされて有望な成長を示しています。ポイントオブケア検査へのシフトは、特に医療資源が限られている地域におけるリスク評価のアクセシビリティとスピードを向上させ、これらの診断ツールの到達範囲と影響力を広げています。

目次

イントロダクション

• 調査の目的
• 調査範囲
• 定義

調査手法

• 情報調達
• 二次と一次データの方法
• 市場規模予測
• 市場の前提条件と制限

エグゼクティブサマリー

• 世界市場の見通し
• 供給と需要の動向分析
• セグメント別機会分析

市場力学と見通し

• 市場概要
• 市場規模
• 市場力学
  • 促進要因と機会
  • 抑制要因と課題
• ポーターの分析

主な市場の考察

• 重要成功要因
• 競合の程度
• 主な投資機会
• 市場エコシステム
• 市場の魅力指数（2024年）
• PESTEL分析
• マクロ経済指標
• バリューチェーン分析
• 価格分析
• ケーススタディ
• 規制情勢
• 特許分析

早産診断検査キット市場規模：検査タイプ別& CAGR（2025-2032）

• 市場概要
• 胎児フィブロネクチン（fFN）検査キット
• 胎盤アルファミクログロブリン-1（PAMG-1）検査キット
• インスリン様成長因子結合タンパク質-1（IGFBP-1）検査キット

早産診断検査キット市場規模：サンプルタイプ別& CAGR（2025-2032）

• 市場概要
• 血液サンプル
• 尿サンプル
• 膣分泌物サンプル

早産診断検査キット市場規模：エンドユーザー別& CAGR（2025-2032）

• 市場概要
• 病院
• 診断検査室
• 専門クリニック

早産診断検査キット市場規模：地域別& CAGR（2025-2032）

• 北米
  • 米国
  • カナダ
• 欧州
  • ドイツ
  • スペイン
  • フランス
  • 英国
  • イタリア
  • その他欧州地域
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• ラテンアメリカ
  • ブラジル
  • その他ラテンアメリカ地域
• 中東・アフリカ
  • GCC諸国
  • 南アフリカ
  • その他中東・アフリカ

競合情報

• 上位5社の比較
• 主要企業の市場ポジショニング（2024年）
• 主な市場企業が採用した戦略
• 最近の市場動向
• 企業の市場シェア分析（2024年）
• 主要企業の企業プロファイル
  • 企業の詳細
  • 製品ポートフォリオ分析
  • 企業のセグメント別シェア分析
  • 収益の前年比比較（2022-2024）

主要企業プロファイル

• 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）

結論と提言

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