Molecular Quality Control Market, By Product Type (Independent Control and Instrument Specific Control), By Analyte Type (Single-Analyte Controls and Multi-Analyte Controls), By Application (Infectious Disease Diagnostics, Oncology Testing, Genetic Testing, Microbiology, and Other Applications), By End Users (Clinical & Diagnostic Laboratories, Hospitals and Clinics, Academic and Research Institutes, Contract Research Organizations, and Others), By Geography (North America, Latin America, Asia Pacific, Europe, Middle East, and Africa)

Published In : Dec 2024

Code : CMI2674

Pages :140

Formats :

Excel and PDF

Industry : Medical Devices

Regional Analysis

Molecular Quality Control Market Regional Insights

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Dominating Region- North America

North America dominates the molecular quality control industry with an estimated market share of 36.2% in 2024, due to robust research funding and presence of leading global players like Bio-Rad Laboratories, Inc. in the region. High adoption of precision medicine and companion diagnostics along with advanced healthcare infrastructure boosts the market growth.

Fastest-Growing Region- Asia Pacific

Asia Pacific region exhibits the fastest growth due to increasing healthcare expenditure, growing focus on pharmaceutical and biotech R&D, and expanding patient pool in countries like China and India. Improving regulatory guidelines are also encouraging global players to tap into opportunities in Asia Pacific.

Molecular Quality Control Market Outlook for Key Regions

U.S.- Dominance Driven by Large Patient Pool and High Infectious Disease Prevalence

The U.S. dominates the North America’s molecular quality control industry due to various factors. The country has a large and growing patient pool, particularly in infectious diseases such as HIV. In August 2024, according to the U.S. Department of Health & Human Services, approximately 38,000 new HIV infections occur annually in the U.S. and its dependent areas, leading to a rapid spread of various infectious diseases, including meningitis and urinary tract infections.

Japan- Growth Driven by Advancements in Diagnostic Technologies and Regulatory Approvals

Japan’s molecular quality control market is growing due to advancements in diagnostic technologies and stringent regulatory standards. For instance, on June 13, 2024, ELITechGroup announced the successful approval of its Blood Borne Virus (BBV) panel by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). The BBV panel includes assays for Human Immunodeficiency Virus (HIV-1), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV), offering fully automated Polymerase Chain Reaction (PCR) solutions for monitoring these viruses.

India- Market Leadership Fueled by Growing Healthcare Infrastructure and Rising Diagnostic Demand

India is dominant in the molecular quality control market due to its growing healthcare infrastructure, rising demand for diagnostic solutions, and increasing investments in biotechnology and pharmaceuticals. In July 2020, Thermo Fisher Scientific introduced the Thermo Scientific MAS Omni Infectious Disease quality control sets for serological assays, covering HIV 1&2, Hepatitis B & C, Syphilis, and HTLV I/II. These third-party, independent external controls help assess assay performance and support the growing demand for serology testing in infectious disease diagnosis, monitoring, and treatment.