Product Code: 36136
Hepatitis C Testing Market Size And Forecast
Hepatitis C Testing Market size was valued at USD 1.48 Billion in 2024 and is projected to reach USD 2.51 Billion by 2032, growing at a CAGR of 7.50% from 2026 to 2032.
- 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.
TABLE OF CONTENTS
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
11 KEY DEVELOPMENTS
- 11.1 Product Launches/Developments
- 11.2 Mergers and Acquisitions
- 11.3 Business Expansions
- 11.4 Partnerships and Collaborations
12 Appendix