PUBLISHER: Grand View Research | PRODUCT CODE: 1908155
PUBLISHER: Grand View Research | PRODUCT CODE: 1908155
The global molecular diagnostics market size was estimated at USD 18.85 billion in 2025 and is projected to reach USD 25.59 billion by 2033, growing at a CAGR of 4.06% from 2026 to 2033. Key drivers of this growth include ongoing technological advancements, a steadily aging population, and rising demand for precise, efficient genetic testing solutions.
In addition, the increasing adoption of Point-of-Care (POC) testing driven by the need for convenient self-diagnostic tools and greater patient awareness of the benefits of rapid results is encouraging companies to innovate and introduce new testing products.
As demand for point-of-care testing (POCT) continues to grow, several emerging trends are reshaping the market and strengthening its role within molecular diagnostics. One major shift is the increasing specialization of clinical departments, prompting the development of tailored POCT solutions for diverse medical applications. This aligns with the broader movement toward healthcare decentralization, where advanced diagnostic technologies are becoming more accessible in smaller facilities. As a result, POCT systems are being designed with greater precision, speed, and cost-efficiency.
Market players are actively developing innovative POCT products to capitalize on new opportunities. For example, in November 2024, Texas launched a pilot program focused on self-collected HPV screening to expand access to cervical cancer testing in underserved regions. Conducted at Su Clinica Federally Qualified Health Center (FQHC) in collaboration with The University of Texas MD Anderson Cancer Center, the initiative aims to evaluate the real-world effectiveness of self-collection screening. Using the FDA-approved BD Onclarity HPV Assay, the program addresses geographic and socioeconomic barriers to cervical cancer detection and examines strategies to improve healthcare delivery. By demonstrating the practicality of self-collection methods in resource-limited environments, the program supports broader adoption of POCT solutions and reinforces trust among providers and policymakers.
Companies such as Sigma Aldrich and QIAGEN are leveraging advanced technologies like TMA and LAMP for tumor diagnostics, while next-generation sequencing (NGS) remains one of the fastest-growing segments due to its widespread use in genomic research. The introduction of new systems-such as Thermo Fisher's 5500x1 genetic analyzer and Illumina's NextSeq CN500-along with the rising use of multiplex and real-time PCR platforms (e.g., QIAGEN's EpiTect Methyl II PCR) continues to stimulate market expansion.
Through focused R&D and strategic collaborations, leading manufacturers are broadening their portfolios of qPCR and disease-specific diagnostic tests. Notable advancements in oncology and infectious disease testing include Roche's Cobas HPV assay and Cepheid's GeneXpert Xpert assay for tuberculosis. Adoption of technologies such as FISH and ELISA is also increasing, enhancing diagnostic diversity and expanding clinical applications.
The persistent burden of infectious diseases continues to elevate the need for rapid molecular diagnostics. During the COVID-19 pandemic, RT-PCR and sequencing played a crucial role in virus detection, supported by innovations such as Biosciences' Lyo-Ready RT-qPCR mix and Novacyt's RUO coronavirus assay. Interest in liquid biopsy techniques is also rising, driven by breakthroughs like the 2024 blood test developed by researchers at the University of Chicago and Northwestern University, capable of detecting cancer through circulating DNA fragments.
Molecular diagnostic tools are essential for identifying biomarkers linked to chronic diseases at early stages, enabling timely interventions and improved patient outcomes. According to the CDC, an estimated 129 million Americans were living with at least one major chronic condition in 2024, including heart disease, cancer, diabetes, obesity, or hypertension. Furthermore, 42% of the population manages two or more chronic illnesses, while 12% face five or more. These conditions account for roughly 90% of the nation's annual USD 4.1 trillion healthcare expenditure. With chronic disease prevalence steadily rising, the demand for effective diagnostic and management solutions will continue to climb. Growing cases of cancer, cardiovascular, neurological, and genetic disorders are expected to further drive market growth.
External funding for molecular diagnostics research also plays a vital role in accelerating product innovation. In September 2025, South Korea's Seegene Inc., in collaboration with Springer Nature, launched the 2025-2026 "Nature Awards MDx Impact Grants," offering financial support and access to syndromic PCR assays for developing diagnostics targeting antibiotic-resistant urinary tract infections. Likewise, in April 2023, Promega Corporation awarded USD 15,000 to support academic research using qPCR. Continuous updates to molecular diagnostic test menus are essential, given the evolving nature of infectious diseases and increasing antimicrobial resistance. The COVID-19 outbreak-declared a global health emergency by the WHO in January 2020-underscored the importance of rapid advancements in diagnostic technologies.
Global Molecular Diagnostics Market Report Segmentation
This report forecasts revenue growth and provides an analysis on the latest trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global molecular diagnostics market report based on product, test location, technology, application, and region: