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感染疾病

市場調查報告書

商品編碼

1736417

全球丙型肝炎檢測市場規模（按檢測套組、方法、最終用戶、區域範圍和預測）

Global Hepatitis C Testing Market Size By Test Kits (Hepatitis C Antibody Test, Hepatitis C RNA Quantitative Test), By Technique (Immunoassays, Polymerase Chain Reaction), By End-User (Hospitals, Clinics), By Geographic Scope And Forecast

出版日期: 2025年05月02日 | 出版商:

Verified Market Research | 英文 202 Pages | 商品交期: 2-3個工作天內

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簡介目錄

丙型肝炎檢測市場規模及預測

預計 2024 年丙型肝炎檢測市場規模將達到 14.8 億美元，到 2032 年將達到 25.1 億美元，2026 年至 2032 年的複合年成長率為 7.50%。

丙型肝炎檢測是控制C型肝炎病毒(HCV) 感染的關鍵環節。 HCV 是一種血源性病毒，如果不及時治療，可能導致嚴重的肝損傷。
丙型肝炎病毒感染可透過抗病毒藥物治癒。有效的治療可以治癒丙型肝炎，並阻止肝病進展。
早期診斷和治療對於預防肝硬化和肝癌等併發症至關重要。
根據美國疾病管制與預防中心 (CDC) 的數據，近三分之一的C型肝炎患者不知道自己的感染狀況。
美國疾病管制與預防中心建議對所有 18 歲或以上的成年人以及所有孕婦進行普遍丙型肝炎篩檢。
疾病預防控制中心建議對某些高風險族群進行更頻繁的檢測。

全球丙型肝炎檢測市場動態

影響全球C型肝炎檢測市場的關鍵市場動態是：

關鍵市場促進因素

丙型肝炎盛行率不斷上升：C型肝炎病毒(HCV) 感染的日益普及推動了檢測需求。根據世界衛生組織 (WHO) 估計，到 2023 年，預計將有 5,800 萬人感染疾病慢性丙型肝炎病毒 (HCV)。如此高的盛行率凸顯了廣泛檢測和早期診斷的迫切需求。
擴大宣傳和篩檢項目宣傳活動和不斷擴展的篩檢項目正在推動丙型肝炎檢測市場的成長。美國疾病管制與預防中心報告稱，2020年至2023年間，C型肝炎病毒檢測率將增加32%。這些努力對於識別未確診病例並預防進一步感染至關重要。
就地檢驗趨勢：快速就地檢驗正成為C型肝炎檢測領域的主流。美國食品藥物管理局)已於 2023 年核准三種新的C型肝炎就地檢驗，這表明這種方法的重要性日益提升。這些檢測有助於更快速地診斷和啟動治療。
診斷技術的進步：技術進步正在推動丙型肝炎檢測的創新。根據美國國家衛生實驗室的數據，包括C型肝炎病毒檢測在內的全球分子診斷市場規模預計到2026年將達到318億美元。這些創新正在提高檢測的準確性和效率。

主要問題

認知不足和恥辱感阻礙了檢測率：許多有 HCV 感染風險的人可能沒有意識到症狀或檢測的重要性，而圍繞 HCV 感染的恥辱感可能會阻止人們接受檢測或治療。
缺乏檢測設施阻礙了早期診斷：檢測設施有限會阻礙 HCV 感染的早期診斷，尤其是在服務不足的地區，這會導致治療延遲和併發症風險增加。
獲得檢測和治療的成本障礙：HCV 檢測和治療的成本對於許多人來說是一個重大障礙，特別是那些低收入者，這可能會限制獲得治療的機會並阻礙早期診斷和治療。
複雜的監管環境阻礙市場擴張：了解丙型肝炎病毒（HCV）檢測和治療的監管環境非常複雜，尤其對於在多個地區營運的醫療保健提供者和製造商。遵守監管要求會增加成本，並阻礙市場擴張。

主要趨勢

加大對丙型肝炎消除工作的重視：全球消除丙型肝炎的努力正在推動檢測舉措的擴展。世界衛生組織 (WHO) 報告稱，截至 2023 年，21 個國家預計在 2030 年前實現丙型肝炎病毒消除。這些消除計劃正在推動大規模檢測的需求。
丙型肝炎病毒檢測在基層醫療中的整合度不斷提升：丙型肝炎病毒檢測在基層醫療體系中的整合度正在快速推進。歐洲疾病預防控制中心報告稱，2021年至2023年間，基層醫療機構的C型肝炎病毒檢測數量將增加45%。這一趨勢正在改善檢測和早期診斷的可及性。
推動政府措施和資金籌措：不斷增加的政府措施和資金投入正在推動丙型肝炎檢測市場的發展。美國衛生與公眾服務部已在2024會計年度撥款3.9億美元用於病毒性肝炎的預防與治療，較2023年增加15%。這些投資對於擴大檢測項目至關重要。
多重檢測平台的採用日益增加：多重檢測平台正日益普及，用於同時檢測多種肝炎病毒。根據美國國家生物技術資訊中心的數據，2023年全球多重診斷市場（包括肝炎檢測）的價值為39億美元。這種方法提供了一種經濟高效的檢測解決方案。

Hepatitis C testing is a critical component of managing hepatitis C virus (HCV) infection. HCV is a blood-borne virus that can lead to severe liver damage if left untreated.
HCV infection is highly treatable with antiviral medications. Effective treatment can lead to a cure, preventing the progression of liver disease.
Early diagnosis and treatment are essential to prevent complications such as liver cirrhosis and liver cancer.
According to the Centers for Disease Control and Prevention (CDC), nearly one in three people with hepatitis C are unaware of their infection status.
CDC recommends universal hepatitis C screening for all adults 18 and older and all pregnant people during each pregnancy.
CDC recommends testing people in certain high-risk groups more frequently.

Global Hepatitis C Testing Market Dynamics

The key market dynamics that are shaping the global hepatitis C testing market include:

Key Market Drivers

Rising Prevalence of Hepatitis C: The increasing prevalence of Hepatitis C virus (HCV) infection is propelling the demand for testing. According to the World Health Organization, an estimated 58 million people were living with chronic HCV infection in 2023. This high prevalence underscores the urgent need for widespread testing and early diagnosis.
Growing Awareness and Screening Programs: Expanding awareness campaigns and screening programs are driving growth in the Hepatitis C testing market. The U.S. Centers for Disease Control and Prevention reported a 32% increase in HCV testing rates from 2020 to 2023. These initiatives are crucial for identifying undiagnosed cases and preventing further transmission.
Dominating Trend of Point-of-Care Testing: The shift towards rapid, point-of-care testing is dominating the Hepatitis C testing landscape. The U.S. Food and Drug Administration approved three new HCV point-of-care tests in 2023, demonstrating the growing importance of this approach. These tests enable faster diagnosis and treatment initiation.
Propelling Advancements in Diagnostic Technologies: Technological advancements are propelling innovations in Hepatitis C testing methods. The global molecular diagnostics market, which includes HCV testing, is projected to reach $31.8 billion by 2026, according to the National Institutes of Health. These innovations are improving test accuracy and efficiency.

Key Challenges:

Limited Awareness and Stigma Hindering Testing Rates: Many individuals at risk for HCV infection may not be aware of the symptoms or the importance of testing. Also, the stigma associated with HCV infection can deter individuals from seeking testing and treatment.
Lack of Access to Testing Facilities Hampering Early Diagnosis: Limited availability of testing facilities, particularly in underserved areas, can hinder early diagnosis of HCV infection. This can lead to delayed treatment and increased risk of complications.
Cost Barriers Obstructing Access to Testing and Treatment: The cost of HCV testing and treatment can be a significant barrier for many individuals, particularly in low-income communities. This can limit access to care and prevent early diagnosis and treatment.
Complex Regulatory Landscape Challenging Market Expansion: Navigating the regulatory landscape for HCV testing and treatment can be complex, especially for healthcare providers and manufacturers operating in multiple jurisdictions. Compliance with regulatory requirements can increase costs and hinder market expansion.

Key Trends

Rising Focus on Hepatitis C Elimination Efforts: Global efforts to eliminate Hepatitis C are driving increased testing initiatives. The World Health Organization reported that 21 countries were on track to achieve HCV elimination by 2030, as of 2023. These elimination programs are boosting demand for large-scale testing.
Growing Integration of HCV Testing in Primary Care: The integration of Hepatitis C testing into primary care settings is growing rapidly. The European Centre for Disease Prevention and Control reported a 45% increase in HCV testing at primary care facilities from 2021 to 2023. This trend is improving access to testing and early diagnosis.
Propelling Government Initiatives and Funding: Government initiatives and increased funding are propelling the Hepatitis C testing market forward. The U.S. Department of Health and Human Services allocated $390 million for viral hepatitis prevention and treatment in fiscal year 2024, a 15% increase from 2023. These investments are crucial for expanding testing programs.
Rising Adoption of Multiplex Testing Platforms: The adoption of multiplex testing platforms for simultaneous detection of multiple hepatitis viruses is rising. The global multiplex diagnostics market, including hepatitis testing, was valued at $3.9 billion in 2023, according to the National Center for Biotechnology Information. This approach offers cost-effective and efficient testing solutions.

Global Hepatitis C Testing Market Regional Analysis

Here is a more detailed regional analysis of the global hepatitis C testing market:

North America

North America dominates the global hepatitis C testing market, accounting for the largest share due to its advanced healthcare infrastructure and robust research ecosystem.
According to the National Institutes of Health (NIH), the U.S. invested $45.1 billion in biomedical research in fiscal year 2023, fueling innovation in the sector.
This substantial funding has led to significant advancements in areas such as gene therapy and personalized medicine.
For instance, in February 15, 2024, Moderna announced the expansion of its mRNA pipeline, including 15 new programs in rare diseases and oncology, further solidifying North America's leadership in hepatitis C testing.
The region's market dominance is also driven by a high prevalence of chronic diseases and a supportive regulatory environment.
The Centers for Disease Control and Prevention (CDC) reported that 6 in 10 adults in the U.S. have a chronic disease as of 2023, creating a strong demand for innovative biotechnology solutions.
This demand is met by cutting-edge research and development efforts from industry leaders.
For instance, on September 8, 2023, Pfizer received FDA approval for its gene therapy treatment for hemophilia B, marking a significant milestone in hepatitis C testing applications and reinforcing North America's position at the forefront of the global market.

Asia Pacific

Asia Pacific is poised to emerge as the fastest-growing region in the global hepatitis C testing market during the forecast period, driven by the high prevalence, coupled with improving healthcare infrastructure and rising awareness, thus driving the market growth.
According to the World Health Organization's Western Pacific Region office, an estimated 39 million people were living with chronic hepatitis C in the region as of 2023, highlighting the urgent need for enhanced testing efforts.
On March 8, 2024, Abbott Laboratories announced the launch of its new rapid HCV test in India, aiming to increase access to quick and accurate diagnosis in resource-limited settings.
The region's growth is further fueled by government initiatives and increasing healthcare expenditure. China's National Health Commission reported a 40% increase in hepatitis C screening rates from 2021 to 2023, demonstrating a strong commitment to disease control.
also, the emerging economies are adopting advanced testing technologies to improve diagnostic accuracy and efficiency.
On November 15, 2023, Roche Diagnostics partnered with the Malaysian Ministry of Health to provide 1 million HCV tests as part of a nationwide elimination program, showcasing the collaborative efforts between industry leaders and governments to combat hepatitis C in the Asia Pacific region.

Global Hepatitis C Testing Market: Segmentation Analysis

The Global Hepatitis C Testing Market is segmented based on Test Kits, Technique, End-User, and Geography.

Hepatitis C Testing Market, By Test Kits

Hepatitis C Antibody Test
Hepatitis C RNA Quantitative Test
Hepatitis C RNA Qualitative Test
Hepatitis C RIBA
Hepatitis C Genotype
Viral Load

Based on Test Kits, the Global Hepatitis C Testing Market is bifurcated into Hepatitis C Antibody Test, Hepatitis C RNA Quantitative Test, Hepatitis C RNA Qualitative Test, Hepatitis C RIBA, Hepatitis C Genotype, Viral Load. The hepatitis C RNA quantitative test segment is currently dominating the global hepatitis C testing market, driven by its ability to accurately measure the viral load of HCV infection. However, the hepatitis C genotype test segment is experiencing rapid growth, as understanding the HCV genotype is essential for selecting the most effective treatment regimen.

Hepatitis C Testing Market, By Technique

Immunoassays
Polymerase Chain Reaction (PCR)
Others

Based on Technique, the Global Hepatitis C Testing Market is bifurcated into Immunoassays, Polymerase Chain Reaction (PCR), Others. The immunoassay segment is currently dominating the global hepatitis C testing market, owing to its established reputation for simplicity, affordability, and high sensitivity in detecting hepatitis C antibodies. However, polymerase chain reaction (PCR) segment is experiencing rapid growth, driven by its superior accuracy and ability to directly detect the hepatitis C virus, making it a valuable tool for early diagnosis and treatment monitoring.

Hepatitis C Testing Market, By End-User

Hospitals
Clinics
Diagnostic Laboratories
Others

Based on End-User, the Global Hepatitis C Testing Market is bifurcated into Hospital and Clinics, Diagnostic Laboratories, Others. The hospitals segment is currently dominating the global hepatitis C testing market, driven by the high volume of patients seeking testing and treatment in these facilities. However, the diagnostic laboratories segment is experiencing rapid growth, as healthcare providers increasingly rely on specialized laboratories for accurate and efficient testing services.

Hepatitis C Testing Market, By Geography

North America
Europe
Asia Pacific
Rest of the world

Based on Geography, the Global Hepatitis C Testing Market is classified into North America, Europe, Asia Pacific, and the Rest of the world. North America dominates the global hepatitis C testing market, accounting for the largest share due to its advanced healthcare infrastructure and robust research ecosystem. However, Asia Pacific is poised to emerge as the fastest-growing region in the global hepatitis C testing market during the forecast period, driven by the high prevalence, coupled with improving healthcare infrastructure and rising awareness thus driving the market growth.

Key Players

The "Global Hepatitis C Testing Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are Abbott (U.S.), Bio-Rad Laboratories Inc., QIAGEN, Bayer AG, OraSure Technologies, Inc., Sysmex Corporation, Meridian Bioscience, Biogate Laboratories Ltd.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with its product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Global Hepatitis C Testing Market Key Developments

In February 2023, the Pune-based company Mylab Discovery Solutions declared that it would be launching three new rapid tests to identify STIs in a timely manner. STIs are a serious problem since, according to WHO estimates, there will be one million STI cases worldwide each day.
In September 2022, An IVD company called J Mitra unveiled the HCV Gen 4 Ag & Ab Microlisa, a fourth-generation Elisa-based HCV test. The purpose of the kit is to screen blood donors in order to identify and eliminate blood units that are contaminated. Hepatitis C can also be clinically diagnosed with this kit.

1 INTRODUCTION OF GLOBAL HEPATITIS C TESTING MARKET

1.1 Introduction of the Market
1.2 Scope of Report
1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

3.1 Data Mining
3.2 Validation
3.3 Primary Interviews
3.4 List of Data Sources

4 GLOBAL HEPATITIS C TESTING MARKET OUTLOOK

4.1 Overview
4.2 Market Dynamics
- 4.2.1 Drivers
- 4.2.2 Restraints
- 4.2.3 Opportunities
4.3 Porters Five Force Model
4.4 Value Chain Analysis

5 GLOBAL HEPATITIS C TESTING MARKET, BY TEST KITS

5.1 Overview
5.2 Hepatitis C Antibody Test
5.3 Hepatitis C RNA Quantitative Test
5.4 Hepatitis C RNA Qualitative Test
5.5 Hepatitis C RIBA
5.6 Hepatitis C Genotype
5.7 Viral Load

6 GLOBAL HEPATITIS C TESTING MARKET, BY END-USERS

6.1 Overview
6.2 Hospitals
6.3 Clinics
6.4 Diagnostic Laboratories
6.5 Others

7 GLOBAL HEPATITIS C TESTING MARKET, BY TECHNOLOGY

7.1 Overview
7.2 Immunoassays
7.3 Polymerase Chain Reaction (PCR)
7.4 Others

8 GLOBAL HEPATITIS C TESTING MARKET, BY GEOGRAPHY

8.1 Overview
8.2 North America
- 8.2.1 U.S.
- 8.2.2 Canada
- 8.2.3 Mexico
8.3 Europe
- 8.3.1 Germany
- 8.3.2 U.K.
- 8.3.3 France
- 8.3.4 Rest of Europe
8.4 Asia Pacific
- 8.4.1 China
- 8.4.2 Japan
- 8.4.3 India
- 8.4.4 Rest of Asia Pacific
8.5 Rest of the World
- 8.5.1 Latin America
- 8.5.2 Middle East and Africa

9 GLOBAL HEPATITIS C TESTING MARKET COMPETITIVE LANDSCAPE

9.1 Overview
9.2 Company Market Ranking
9.3 Key Development Strategies

10 COMPANY PROFILES

10.1 Siemens Healthineers
- 10.1.1 Overview
- 10.1.2 Financial Performance
- 10.1.3 Product Outlook
- 10.1.4 Key Developments
10.2 Abbott Laboratories
- 10.2.1 Overview
- 10.2.2 Financial Performance
- 10.2.3 Product Outlook
- 10.2.4 Key Developments
10.3 Roche Diagnostics
- 10.3.1 Overview
- 10.3.2 Financial Performance
- 10.3.3 Product Outlook
- 10.3.4 Key Developments
10.4 Bio-Rad Laboratories
- 10.4.1 Overview
- 10.4.2 Financial Performance
- 10.4.3 Product Outlook
- 10.4.4 Key Developments
10.5 Thermo Fisher Scientific
- 10.5.1 Overview
- 10.5.2 Financial Performance
- 10.5.3 Product Outlook
- 10.5.4 Key Developments
10.6 Streck
- 10.6.1 Overview
- 10.6.2 Financial Performance
- 10.6.3 Product Outlook
- 10.6.4 Key Developments
10.7 Illumina Inc.
- 10.7.1 Overview
- 10.7.2 Financial Performance
- 10.7.3 Product Outlook
- 10.7.4 Key Developments
10.8 Merck KGaA
- 10.8.1 Overview
- 10.8.2 Financial Performance
- 10.8.3 Product Outlook
- 10.8.4 Key Developments
10.9 Qiagen
- 10.9.1 Overview
- 10.9.2 Financial Performance
- 10.9.3 Product Outlook
- 10.9.4 Key Developments