COVID-19パンデミックは、IVDキットと試薬の急速かつ正確なSARS-CoV2ウイルス感染の診断に対する需要が高まる中、体外診断にスポットライトを当てました。COVID-19の発生は市場にプラスの影響を与え、体外診断はさまざまな生物学的サンプルの検査を含みました。これはCOVID-19などの感染症の診断に寄与しました。検査はCOVID-19パンデミックを制御する上で重要なステップのままでした。たとえば、WHOによると、2021年3月時点で中国では102,762件のCOVID-19症例が記録され、4,851件の死亡がありました。COVID-19パンデミックの増大する負担は、テストの高い要求をもたらし、国のIVD市場を押し上げました。しかし、中国におけるCOVID-19の安定した症例は、市場の成長を安定させると予想されました。たとえば、国家衛生健康委員会（NHC）によると、2022年12月に中国では36,061件の新しいCOVID-19感染が報告され、そのうち4,150件が症状を示し、31,911件が無症状でした。このように、COVID-19の安定した症例は、中国の体外診断市場の成長をパンデミック前の水準に戻すと予想されました。

中国の体外診断（IVD）産業概要

• 1 イントロダクション

  • 1.1 調査の前提条件と市場の定義

  • 1.2 本調査の範囲

• 2 調査手法

• 3 エグゼクティブサマリー

• 4 市場ダイナミクス

  • 4.1 市場概要

  • 4.2 市場の促進要因

    • 4.2.1 慢性疾患や感染症などの高い負担率

    • 4.2.2 POC（ポイント・オブ・ケア）診断薬の普及がIVD市場に拍車をかける

    • 4.2.3 個別化医療への認識と受容の高まり

  • 4.3 市場の抑制要因

    • 4.3.1 適切な精算の欠如

    • 4.3.2 厳格な規制フレームワーク

  • 4.4 ポーターのファイブフォース分析

    • 4.4.1 新規参入の脅威

    • 4.4.2 買い手・消費者の交渉力

    • 4.4.3 サプライヤーの交渉力

    • 4.4.4 代替品の脅威

    • 4.4.5 競合・競争状況の激しさ

• 5 市場セグメンテーション（市場規模別、金額、百万米ドル）

  • 5.1 テストタイプ別

    • 5.1.1 クリニカルケミストリー

    • 5.1.2 分子診断

    • 5.1.3 免疫診断

    • 5.1.4 ヘマトロジー

    • 5.1.5 その他のタイプ

  • 5.2 製品別

    • 5.2.1 器具

    • 5.2.2 試薬

    • 5.2.3 その他の製品

  • 5.3 ユーザビリティ別

    • 5.3.1 ディスポーザブルIVDデバイス

    • 5.3.2 リユーザブルIVDデバイス

  • 5.4 用途別

    • 5.4.1 感染症

    • 5.4.2 糖尿病

    • 5.4.3 がん／オンコロジー

    • 5.4.4 循環器内科

    • 5.4.5 自己免疫疾患

    • 5.4.6 腎臓内科

    • 5.4.7 その他の用途

  • 5.5 エンドユーザー別

    • 5.5.1 検査室

    • 5.5.2 病院・クリニック

    • 5.5.3 その他のエンドユーザー

• 6 競合情勢

  • 6.1 企業プロファイル

    • 6.1.1 Autobio Diagnostics Co

    • 6.1.2 F. Hoffmann-La Roche AG

    • 6.1.3 Becton Dickinson & Company

    • 6.1.4 Shanghai Kehua Bio-Engineering Co. Ltd

    • 6.1.5 Abbott Laboratories

    • 6.1.6 Thermofisher Scientific Inc

    • 6.1.7 QIAGEN NV

    • 6.1.8 Xiamen Boson Biotech Co. Ltd

    • 6.1.9 Maccura Biotechnology Co. Ltd

    • 6.1.10 BGI Group

    • 6.1.11 BioMerieux SA

    • 6.1.12 Bio-Rad Laboratories Inc

    • 6.1.13 Danaher Corporation

    • 6.1.14 Arkray Inc

    • 6.1.15 Mindray Medical International Limited

• 7 市場機会と今後の動向

The China In Vitro Diagnostics Market size is estimated at USD 10.61 billion in 2024, and is expected to reach USD 14.86 billion by 2029, growing at a CAGR of 6.14% during the forecast period (2024-2029).

The COVID-19 pandemic turned the spotlight on in vitro diagnostics since there was an increasing demand for IVD kits and reagents for the rapid and accurate diagnosis of SARS-CoV2 virus infection among the global population. The outbreak of COVID-19 positively impacted the market, as in vitro diagnostics involved the testing of various biological samples. This aided in the diagnosis of infectious diseases such as COVID-19. Testing remained a crucial step in controlling the COVID-19 pandemic. For instance, according to the WHO, 102,762 COVID-19 cases were recorded as of March 2021, with 4,851 deaths in China. The increasing burden of the COVID-19 pandemic led to a high requirement for tests, which boosted the IVD market in the country. However, the stabilizing cases of COVID-19 in China were expected to stabilize the growth of the market. For instance, as per the National Health Commission (NHC), in December 2022, China reported 36,061 new COVID-19 infections, of which 4,150 were symptomatic and 31,911 were asymptomatic. Thus, the stabilizing cases of COVID-19 were expected to bring the growth of China's in vitro diagnostics market back to its pre-pandemic level.

In vitro diagnostics (IVDs) play an important role in detecting infectious diseases. A large number of molecular assays and immunoassays are being used for the detection of COVID-19. China represents one of the largest in vitro diagnostics markets in the Asia-Pacific region, and this trend is expected to continue over the forecast period. Due to an increase in the geriatric population and the high burden of chronic and infectious diseases, like diabetes, cancer, and COVID-19, the market studied is slated to show significant growth, as these chronic disorders can be diagnosed and monitored using IVD products.

In May 2021, the State Council issued a guideline to implement the country's Healthy China initiative to diminish the incidence of disability among elderly people aged between 65 and 74 years by 2022 by offering medical and health services. Such initiatives by the government are expected to boost market growth during the forecast period. But a lack of proper reimbursement and strict regulations could slow the growth of the market.

Also, the increasing number of product launches with advanced features is expected to drive the market. For instance, in March 2021, OpGen announced that it had received regulatory approval from the Chinese National Medical Products Administration for its Curetis Unyvero system as an in vitro diagnostics instrument system. This application was sent in 2019 and included the Unyvero A50 Analyzer, the Unyvero L4 Lysator, and the Unyvero C8 Cockpit.

Due to these and other factors, the in vitro diagnostic market in China is expected to grow over the next few years.

China In-vitro Diagnostics (IVD) Market Trends

Molecular Diagnostics Segment Dominates the Chinese In Vitro Diagnostics Market

In diagnostics research, one of the most valuable advancements has been in the form of molecular diagnostic tools. The polymerase chain reaction is at the forefront of molecular diagnostics. The real-time PCR products simultaneously detect viruses, bacteria, fungi, and parasites, allowing molecular laboratories to operate at lower costs and ensure better outcomes.

Molecular diagnostic tests look for specific sequences in DNA or RNA, such as single nucleotide polymorphisms (SNPs), deletions, rearrangements, insertions, and others, that may or may not be linked to a disease.

Molecular diagnostics were mainly used to diagnose infectious diseases, and with the rising burden and increasing spread of the COVID-19 pandemic, the segment was at its peak in the country. To find viral RNAs that are very specific to the SARS-CoV-2 virus, which caused COVID-19, molecular diagnostic tests were used.

In addition, the rising burden of infectious disease can be attributed to the segment's growth. For instance, according to the National Health Commission, nearly 1.71 million cases of infectious diseases were reported on the mainland. Approximately 288,739 cases were classified as Class B infectious diseases. Viral hepatitis, TB, syphilis, scarlet fever, and gonorrhea accounted for 94% of these cases. Thus, owing to the rising importance given by clinical laboratories to diagnose diseases in the early stages of development, collaboration with domestic manufacturers, and new product launches, the molecular diagnostics segment is expected to witness good growth over the forecast period in China.

Cancer/Oncology Segment Dominates the Chinese In Vitro Diagnostics Market

Cancer is the second-leading cause of mortality in China. Early detection of cancer and access to effective anti-cancer treatment can result in higher survival rates and a better quality of life. In vitro diagnostics (IVDs) are tests or medical devices that examine human body specimens and provide critical data for screening, diagnosis, and treatment.

The main things that are driving market segment growth in China are the rising number of people with cancer, the rising number of products being approved and put on the market, and the rising amount of money being invested.

According to the report titled "Cancer Statistics in China and the United States, 2022: Profiles, Trends, and Determinants," published in February 2022, compared to the 4,689,754 new cancer cases in China in 2020, the predicted number of new cancer cases for 2022 is 4,820,000. This increase in new cases will directly increase the demand for early diagnosis, thus helping the market grow during the study period. Also, as per the report titled "Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020," published in April 2021, China is expected to experience 6.85 million new cancer cases and 5.07 million deaths in 2040. So, over the next few years, the market will be driven by the rise in cancer cases in China.

Additionally, the growing number of product launches in the region and the high concentration of key players in China act as major factors in driving the market. For instance, in August 2022, the cervical cancer screening test GynTect will be available to physicians and patients in China, the world's most populous country. In China, this is the first methylation test that has been approved for triage of HPV-positive cases.

Because of all of these factors, the market segment is expected to grow a lot in China over the next few years.

China In-vitro Diagnostics (IVD) Industry Overview

The Chinese in vitro diagnostic market is moderately competitive and consists of some major players. Many players in this market are trying to expand their product portfolios in order to increase their global market share. These companies focus on strategies such as mergers and acquisitions, collaborations, and new product developments. Key players in the Chinese in vitro diagnostics market are Abbott Laboratories, Shanghai Kehua Bio-Engineering Co., Ltd., Autobio Diagnostics Co., Mindray Medical International Limited, and Maccura Biotechnology, among others.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

• 1 INTRODUCTION

  • 1.1 Study Assumptions and Market Definition

  • 1.2 Scope of the Study

• 2 RESEARCH METHODOLOGY

• 3 EXECUTIVE SUMMARY

• 4 MARKET DYNAMICS

  • 4.1 Market Overview

  • 4.2 Market Drivers

    • 4.2.1 High Burden of Chronic Diseases and Infectious Diseases

    • 4.2.2 Increasing Use of Point-of-Care (POC) Diagnostics Spurring the IVD Market

    • 4.2.3 Increasing Awareness and Acceptance of Personalized Medicine

  • 4.3 Market Restraints

    • 4.3.1 Lack of Proper Reimbursement

    • 4.3.2 Stringent Regulatory Framework

  • 4.4 Porter's Five Forces Analysis

    • 4.4.1 Threat of New Entrants

    • 4.4.2 Bargaining Power of Buyers/Consumers

    • 4.4.3 Bargaining Power of Suppliers

    • 4.4.4 Threat of Substitute Products

    • 4.4.5 Intensity of Competitive Rivalry

• 5 MARKET SEGMENTATION (Market Size by Value - USD million)

  • 5.1 By Test Type

    • 5.1.1 Clinical Chemistry

    • 5.1.2 Molecular Diagnostics

    • 5.1.3 Immunodiagnostics

    • 5.1.4 Hematology

    • 5.1.5 Other Types

  • 5.2 By Product

    • 5.2.1 Instrument

    • 5.2.2 Reagent

    • 5.2.3 Other Products

  • 5.3 By Usability

    • 5.3.1 Disposable IVD Devices

    • 5.3.2 Reusable IVD Devices

  • 5.4 By Application

    • 5.4.1 Infectious Disease

    • 5.4.2 Diabetes

    • 5.4.3 Cancer/Oncology

    • 5.4.4 Cardiology

    • 5.4.5 Autoimmune Disease

    • 5.4.6 Nephrology

    • 5.4.7 Other Applications

  • 5.5 By End-User

    • 5.5.1 Diagnostic Laboratories

    • 5.5.2 Hospitals and Clinics

    • 5.5.3 Other End-Users

• 6 COMPETITIVE LANDSCAPE

  • 6.1 Company Profiles

    • 6.1.1 Autobio Diagnostics Co

    • 6.1.2 F. Hoffmann-La Roche AG

    • 6.1.3 Becton Dickinson & Company

    • 6.1.4 Shanghai Kehua Bio-Engineering Co. Ltd

    • 6.1.5 Abbott Laboratories

    • 6.1.6 Thermofisher Scientific Inc

    • 6.1.7 QIAGEN NV

    • 6.1.8 Xiamen Boson Biotech Co. Ltd

    • 6.1.9 Maccura Biotechnology Co. Ltd

    • 6.1.10 BGI Group

    • 6.1.11 BioMerieux SA

    • 6.1.12 Bio-Rad Laboratories Inc

    • 6.1.13 Danaher Corporation

    • 6.1.14 Arkray Inc

    • 6.1.15 Mindray Medical International Limited

• 7 MARKET OPPORTUNITIES AND FUTURE TRENDS