韓国の体外診断薬 (IVD) 市場：2024年

当レポートは、韓国の体外診断薬 (IVD) 市場の概要と、市場の形成要因について包括的に分析し、2023年の韓国のIVD市場の全体的な収益額と2028年の予測を、主要セグメント別 (臨床化学、免疫測定、微生物/分子検査、ポイントオブケア (POC)、組織/細胞検査) に分類して調査すると共に、業界に影響を与える動向や、疾病の発生率、平均寿命、人口統計、経済状況、ヘルスケア利用率、その他の市場影響などの国レベルのデータなどの情報を取りまとめてお届けいたします。

本レポートは、韓国のIVD市場の概要とその影響を読者に提供することを目的としています。以下のサブセグメントの試薬・消耗品、校正物質、対照物質を含むIVD分野に焦点を当てています：

• 臨床化学：定期的な臨床検査、基質・酵素・均一免疫測定法、タンパク質、ISE (非POC)、HBA1c (非POC) 。尿検査と血液化学検査を含む。血液検査・ヘモグロビン検査もこのセグメントに含まれます。
• 免疫測定：ホルモン・甲状腺機能、腫瘍マーカー、アレルギー、貧血、新生児検査、出生前検査、インターロイキン、PCT、毒物学、一般的な感染症 (HIV、肝炎、インフルエンザ) 。
• 微生物/分子検査：手動・自動検査、培養培地 (充填済/RTU)、ラテックス検査、輸送培地、血液培養、感受性ディスク、グラム・その他の染色、MTB培養、マイコプラズマ、ウレアプラズマ、核酸検査。
• PoC (ポイントオブケア) 検査：心臓病、毒物、凝固、糖尿病、感染症に関するすべてのPOC検査。POC/非POC血液ガス、電解質を含み、またグルコース自己測定検査も含みます。
• 組織/細胞検査：PAP、HE、IHC、ISH、FISH、一次抗体と二次抗体。

調査範囲

本レポートに掲載されている情報は、2024年1月から2024年2月にかけて実施された業界関係者や代表者へのインタビューを含む1次調査と2次調査の両方を用いて収集されました。これらのインタビューは、政府関係者、医療機器規制当局、国内の流通業者、医療提供者、および世界の市場参入企業を対象としています。二次データとしては、政府機関のデータベース、企業の文献、医学雑誌、報告書などを利用しました。

市場データはすべて、韓国のメーカーレベルのIVD市場に関するものです。市場データは2023年まで、予測データは2028年まで掲載しております。また、2023年から2028年までの年間平均成長率 (CAGR) を掲載しております。

目次

第1章 エグゼクティブサマリー

第2章 韓国の概要

• 人口
• 健康指標
• 一般的な健康
• 韓国の疾病プロファイル
• 経済動向と医療費
• 医療インフラ
• 医療施設
• 病院のベッド密度
• 医師
• メディカルツーリズム
• 医療機器規制
• 規制に関するニュース
• プレシジョン・メディシンとNGS
• 韓国の医師不足

第3章 韓国のIVD市場

• 市場概要
• 臨床化学検査
• 血液検査
• ヘモグロビン検査
• 血液ガス分析
• 尿検査
• 免疫測定法
• 非感染症免疫測定法
• 感染症免疫測定法
• 血液銀行スクリーニング免疫測定法
• 微生物/分子検査
• ID/AST
• 分子診断
• 血液検査
• 注意する点
• POCグルコース検査
• POC感染症検査
• 組織検査
• HPV検査
• CTC検査

第4章 主要な市場参入企業

• Abbott Laboratories
  • 企業概要
• Becton Dickinson (BD)
• Bertis, Inc
• bioMerieux SA
• Bio-Rad Laboratories Inc.
• Danaher Corporation
• Fujirebio Inc
• Gencurix
• Roche Diagnostic Corporation
• SD Biosensor
• Seegene, Inc.
• Siemens Healthineers GmbH
• Sugentech
• Sysmex Corporation
• Thermo Fisher Scientific

The IVD Market in South Korea, 2024 offers a comprehensive overview of the in vitro diagnostics (IVD) market in South Korea and the factors shaping it. The report presents South Korea's IVD revenues for 2023 and forecasts for 2028, segmented into clinical chemistry, immunoassay, microbiology/molecular testing, point-of-care (POC), and histology/cytology. Included in the report are trends influencing the industry and country-level data including incidence of disease, life expectancy, population demographics, economic status, healthcare utilization and other market influences.

The report is designed to provide the reader with an overview of the IVD market in South Korea and its influences. The focus is on the IVD discipline including reagents, consumables, calibrators, and controls of the following sub-segments:

• Clinical Chemistry: routine lab testing; substrates, enzymes, homogeneous immunoassays, proteins, ISE (non-POC), HBA1c (non-POC). Includes urinalysis and blood chemistry testing. Hematology and hemoglobin tests are also included in this segment.
• Immunoassays: hormones and thyroid function, tumor markers, allergy, anemia, neonatal tests, prenatal tests, interleukins, PCT, toxicology and common infectious diseases (HIV, hepatitis, influenza).
• Microbiology and Molecular Testing: manual and automated tests, culture media (to be prepared or ready to use), latex tests, transport media, blood culture, sensitivity discs, Gram and other stains, MTB culture, Mycoplasma, Ureaplasma, nucleic acid testing.
• Point-of-Care Testing: all POC tests for cardiology, toxicology, coagulation, diabetes, infectious diseases. Includes POC and non-POC blood gas and electrolytes. Also includes glucose self-monitoring tests.
• Histology/Cytology: PAP, HE, IHC, ISH, FISH, primary and secondary antibodies.

Scope

The information in the report was gathered using both primary and secondary research methods including interviews with industry participants and representatives, completed during the period of January 2024 and February 2024. These interviews were with government officials, medical device regulators, domestic-based distributors, health care providers and global market participants. Secondary data included the use of government databases, company literature, medical journals and reports.

All market data pertains to the South Korean IVD market at the manufacturers' level. Market data is presented for the 2023 year with forecast data provided for 2028. Compound annual growth rates (CAGRs) are provided for the 2023-2028 period.

Table of Contents

Chapter 1: Executive Summary

• Industry Overview
• Scope and Methodology
• South Korea IVD Market Summary
  • Figure 1-1: South Korea In Vitro Diagnostic Sales by Market Segment, 2023-2028 ($M)
• Company Profiles

Chapter 2: South Korea Overview

• Population
  • Table 2-1: Total Midyear Population by Broad Age Group: South Korea, 2010-2050 (million persons)
  • Figure 2-1: Total Midyear Population by Broad Age Group: South Korea, 2010-2050 (million persons)
  • Figure 2-2: Total Number of Births in South Korea, by Year, 1990-2010 and Forecast 2020-2050
  • Figure 2-3: South Korea Life Expectancy at Birth in Years, 2010-2050
• Health Indicators
• General Health
• Disease Profiles in South Korea
  • Table 2-2: Number of Deaths Attributed to Non-Communicable Diseases, by Type of Disease, All Sexes, 2019
  • Table 2-3: Top 5 Cancers Affecting South Korean Population (ranked by total number of cases), 2020
  • Figure 2-4: Tuberculosis - New and Relapse Case Notifications, 2000-2021
• Economy and Health Spending
  • Figure 2-5: South Korea GDP, GDP (PPP) and Health Spending, 1990-2020 ($B)
  • Figure 2-6: South Korea Distribution of Income or Consumption by Quintile, 2011-2016
• Health Infrastructure
  • Figure 2-7: Healthcare System in Korea
• Medical Facilities
• Hospital Bed Density
  • Figure 2-8: Hospital Bed Density per 1,000 Population, by Country, 2023 Estimates
• Physicians
  • Figure 2-9: Physician Density per 1,000 Population, by Country, 2023 Estimates
• Medical Tourism
  • Figure 2-10: South Korea Medical Tourism Visits Reported, 2009-2021 (# of patients)
• Medical Device Regulation
  • Figure 2-11: Medical Device Approval Process, South Korea
• Regulatory News
• Precision Medicine and NGS
• Physician Shortage in South Korea
  • Table 2-4: Market Divers and Inhibitors for Entering South Korea's Medical Device Market
  • Figure 2-12: South Korea Medical Device Market Growth as a Global Comparison, 2023-2028 CAGR (%)

Chapter 3: IVD Markets in South Korea

• Market Summary
  • Table 3-1: South Korea In Vitro Diagnostic Sales, by Extracted Market Segment (Blood Bank Screening Immunoassays, Blood Gas Analysis, Blood Screening NAT, CTC, General Chemistry, Hematology, Hemoglobin, HPV, ID/AST, Infectious Disease Immunoassays, Microbiology Molecular, Non-infectious Disease Immunos, Other Histology, POC Glucose, POC Infectious Disease, POC Other, Urinalysis, Others), 2023-2028 ($M)
  • Figure 3-1: South Korea In Vitro Diagnostic Sales, by Broad Market Segment (Clinical Chemistry, Histology, Immunoassay, Microbiology, POC, Other), 2023-2028 ($M)
  • Figure 3-2: South Korea In Vitro Diagnostic Sales, by Broad Market Segment (Clinical Chemistry, Histology, Immunoassay, Microbiology, POC, Other), 2023 Market Distribution (%)
• Clinical Chemistry
• Hematology
• Hemoglobin
• Blood Gas Analysis
• Urinalysis
  • Figure 3-3: South Korea - Clinical Chemistry Market (Blood Gas Analysis, General Chemistries, Hematology, Hemoglobin, Urinalysis), 2023-2028
• Immunoassay
• Non Infectious Disease Immunoassays
• Infectious Disease Immunoassays
  • Figure 3-4: South Korea Immunoassay Infectious Disease Market Distribution, by Disease (Blook Bank Screening Immunos, HAIs/Sepsis, Hepatitis, HIV, Mycology, Parasitology, Respiratory [w/ COVID], STD, ToRCH, Other [EBV, Chagas, Dengue, Malaria, etc.]), 2023 (%)
• Blood Bank Screening Immunoassays
  • Figure 3-5: South Korea - Immunoassay Market Value, by Segment (Blood Bank Screening, Infectious Disease, Non-infectious Disease), 2023-2028 ($M)
• Microbiology/Molecular
• ID/AST
  • Figure 3-6: South Korea ID/AST Manual, Auto Market Distribution, 2023 (%)
• Molecular Diagnostics
  • Figure 3-7: South Korea Molecular Infectious Disease Market Distribution, by Segment (Molecular Blood Screening - NAT, Molecular HAI [c. diff/sepsis, MRSA, VRE, others], Molecular Hepatitis, Molecular HIV, Molecular Mycobacteria/TB, Molecular Other Microbiology, Molecular STD, Respiratory w/ COVID), 2023 (%)
• Blood Screening
  • Figure 3-8: South Korea Microbiology/Molecular Testing Market Value, by Segment (Blood Screening-NAT, ID/AST, Molecular Dx), 2023-2028 ($M)
• Point-of-Care
• POC Glucose
• POC Infectious Disease
  • Figure 3-9: South Korea POC Market Value, by Segment (Glucose, Infectious Disease, Other POC), 2023-2028 ($M)
• Histology
• HPV
• CTC
  • Figure 3-10: South Korea - Histology Market (HPV, CTC, Others), 2023-2028 ($M)

Chapter 4: Major Market Participants

• Abbott Laboratories
  • Table 4-1: Abbott Corporate Summary
  • Company Overview
• Becton Dickinson (BD)
  • Table 4-2: BD Corporate Summary
  • Company Overview
• Bertis, Inc
  • Table 4-3: Bertis Corporate Summary
  • Company Overview
• bioMerieux SA
  • Table 4-4: bioMerieux SA Corporate Summary
  • Company Overview
• Bio-Rad Laboratories Inc.
  • Table 4-5: Bio-Rad Labs Corporate Summary
  • Company Overview
• Danaher Corporation
  • Table 4-6: Danaher Corporation Summary
  • Company Overview
• Fujirebio Inc
  • Table 4-7: Fujirebio Corporate Summary
  • Company Overview
• Gencurix
  • Table 4-8: Gencurix Corporation Summary
  • Company Overview
• Roche Diagnostic Corporation
  • Table 4-9: Roche Diagnostic Corporate Summary
  • Company Overview
• SD Biosensor
  • Table 4-10: SD Biosensor Corporate Summary
  • Company Overview
• Seegene, Inc.
  • Table 4-11: Seegene Corporate Summary
  • Company Overview
• Siemens Healthineers GmbH
  • Table 4-12: Siemens Healthineers Corporate Summary
  • Company Overview
• Sugentech
  • Table 4-13: Sugentech Corporate Summary
  • Company Overview
• Sysmex Corporation
  • Table 4-14: Sysmex Corporate Summary
  • Company Overview
• Thermo Fisher Scientific
  • Table 4-15: Thermo Fisher Corporate Summary
  • Company Overview