Molecular Diagnostics Market Size, Share, Growth, Trends, and Global Industry Analysis: By Product Type (Kits and Reagents, and Instruments) Application (Infectious Diseases, Oncology, Respiratory Diseases, Gastrointestinal (GI) Diseases, Sexually Transmitted Diseases (STD), Cervical Health, Transplant, and Others) By End user (Public (University Hospitals/Central Labs and Standalone Hospitals), Private (Diagnostic Laboratories and Hospitals)) and Region Forecast 2020-2031

Molecular Diagnostics Market was valued at US$ 10.1 billion in 2024 and is projected to reach US$ 14.3 billion by 2031 at a CAGR of 5.1% from 2025-2031. Moreover, the U.S. Molecular Diagnostics Market is projected to grow significantly, reaching an estimated value of US$ xx billion by 2031.The market is witnessing rapid growth, primarily fueled by the rising worldwide infectious and chronic disease burden. According to the World Health Organization (WHO), infectious illnesses are responsible for an estimated 17 million deaths annually worldwide. Worldwide tuberculosis cases alone totaled 10.6 million in 2022, and there were over 38 million living with HIV.

Moreover, the COVID-19 pandemic abruptly accelerated the use of molecular tests with over 6.8 billion tests conducted globally as of the end of 2021. In the oncology realm, cancer continues to be one of the leading causes of death among individuals globally, accounting for nearly 10 million deaths in 2020, and the most frequent are breast, lung, colorectal, and prostate cancers. The incidence of cancer globally is expected to rise to over 28.4 million new cases by the year 2040, estimated by GLOBOCAN.

The startling number underscores the need for faster, more accurate, and more convenient diagnostic tests, which molecular diagnostics are particularly well-positioned to provide. Paired with expanding technology and increasing pressure for more personalized treatment solutions, the market promises robust expansion. However, barriers such as high costs, regulatory issues, and infrastructure lags in emerging markets can temper growth. However, opportunities in liquid biopsy, point-of-care diagnostics, and AI-driven diagnostic solutions are increasingly opening up new opportunities for patient-empowering care.

Facts & Figures

• Approximately 10.6 million people developed TB in 2022 globally. About 1.3 million people died from TB in 2022, including 167,000 among HIV-positive individuals.
• About 39 million people were living with HIV globally in 2022. Approximately 1.3 million people acquired HIV in 2022. Around 630,000 people died from HIV-related illnesses in 2022. An estimated 7 million people are unaware of their HIV-positive status.
• Influenza causes up to 1 billion cases globally each year, with 3–5 million severe cases and up to 650,000 deaths. RSV (Respiratory Syncytial Virus) leads to 33 million acute lower respiratory infections annually in children under 5, with over 100,000 deaths.

Key Developments

• In Feb 2024, Hologic AI-powered cancer screening system wins FDA approval Genius Digital Diagnostics System. The digital cytology system uses volumetric imaging and deep learning artificial intelligence to detect precancerous lesions and cervical cancer cells.
• In Nov 2023, Abbott received FDA Approval for HPV Test to Run on Alinity m, Offering Primary HPV Screening and Assessment of High-Risk Cancer-Causing Types of HPV. In accordance with established medical recommendations, the Alinity m high risk (HR) HPV assay is authorized for use as a test for HPV identification and for routine cervical cancer screening. For patients and doctors who would rather utilize both tests together, the assay is also authorized for use in conjunction with a Pap test; this procedure is known as co-testing.
• In Sep 2022, QIAGEN adds new assays with CE-IVD certification for NeuMoDx integrated PCR system, which include CE-marked tests for cytomegalovirus (CMV), BK Virus (BKV), human adenovirus (hAdV) as well as herpes simplex virus type 1 (HSV-1) and/or herpes simplex virus type 2 (HSV-2). 
• In June 2022, Polish diagnostics firm Genomtec announced that it has received CE-IVD marking for the Genomtec ID Respiratory Panel 5-Plex, a point-of-care molecular diagnostic panel for five respiratory infections including Mycoplasma pneumoniae.
• In 2022, CerTest Biotec and BD launched the molecular respiratory assay VIASURE Bordetella Real-Time PCR Detection Kit for the BD MAX System which can detect and differentiate B. pertussis, B. parapertussis, and B. holmesii in respiratory samples

Molecular Diagnostics Market Segmentation

Based on the product type

• Kits
• Reagents and Instruments

Reagents (e.g., enzymes, primers) and instruments (PCR machines, sequencers) are core components in molecular diagnostics. Reagents generate recurring revenue due to frequent usage, while instruments are one-time investments that enable high-throughput testing in labs.

Based on the application

• Infectious Diseases
• Oncology
• Respiratory Diseases
• Gastrointestinal (GI) Diseases
• Sexually Transmitted Diseases (STD)
• Cervical Health
• Transplant
• Others

 Oncology diagnostics identify cancer-specific mutations using tools like NGS and liquid biopsy. These tests support targeted therapy decisions and early detection. Rising global cancer cases (20M+ annually) are driving demand for molecular cancer testing.

Based on the end user

• Public
  • University Hospitals/Central Labs
  • Standalone Hospitals
• Private
  • Diagnostic Laboratories
  • Hospitals

Private labs perform large volumes of molecular tests for infectious diseases, cancer, and genetics. Their speed, specialization, and role in outsourced lab services make them key players in expanding diagnostic access, especially in urban and semi-urban areas.