Molecular Diagnostics Companies

The molecular diagnostics market is valued at an estimated USD 19.48 billion in 2025 and is projected to reach USD 30.74 billion by 2030 at a CAGR of 9.6%. The molecular diagnostics market is experiencing significant growth, driven by technological advancements and rising healthcare needs. Increasing prevalence of infectious diseases, cancer, and genetic disorders is fueling the demand for accurate and early diagnostic solutions. Technological innovations in PCR, next-generation sequencing (NGS), and isothermal amplification have enhanced test speed, sensitivity, and versatility, supporting broader clinical adoption. Additionally, expanding access to healthcare in emerging markets, increasing investment in research and development, and rising awareness of preventive health further contribute to market expansion.

In May 2025, Illumina, Inc. received approval from the Ministry of Health, Labour and Welfare (MHLW) for TruSightTM Oncology (TSO) Comprehensive for Class III/IV Medical Device (Specially Controlled Medical Device) in Japan. Likewise, in December 2024, F. Hoffmann-La Roche Ltd. (Switzerland) received CE certification for its new cobas 6800/8800 systems 2.0. This updated version brings major efficiency gains for laboratories by optimizing resource use, minimizing downtime, consolidating test menus, and boosting throughput. These enhancements aim to deliver a more seamless and effective diagnostic experience for healthcare providers and patients.

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The key players in the molecular diagnostics market are Danaher Corporation (US), F. Hoffmann-La Roche Ltd. (Switzerland), Hologic, Inc. (US), Illumina, Inc. (US), Abbott (US), bioMérieux (France), Thermo Fisher Scientific Inc. (US), QIAGEN N.V. (Netherlands), Revvity, Inc. (US), Myriad Genetics, Inc. (US), Siemens Healthineers AG (Germany), Becton, Dickinson and Company (BD) (US), Grifols, S.A. (Spain), QuidelOrtho Corporation (US), DiaSorin S.p.A. (Italy), Exact Sciences Corporation (US), Genetic Signatures (Australia), Agilent Technologies, Inc. (US), MDxHealth (Belgium), Biocartis (Belgium), Bruker (US), TBG Diagnostics Limited (Australia), Amoy Diagnostics Co., Ltd. (China), Vela Diagnostics (Singapore), Molbio Diagnostics Limited (India), geneOmbio Technologies (India), Savyon Diagnostics (Israel), and Uniogen OY (Finland).

Danaher (US) has emerged as a leading player in the global molecular diagnostics market, backed by a robust US presence and a well-defined international expansion strategy. Its established footprint in the US provides a strong base for penetration into high-growth emerging economies, enabling the company to broaden its global reach. Danaher remains focused on product innovation to meet the evolving demands of a diverse international customer base, reinforcing its leadership position in the industry. Its competitive advantage is further strengthened by sustained investments in research and development, alongside streamlined supply chain operations. The company actively pursues organic growth through product launches and regulatory approvals. Beyond product development, Danaher leverages strategic partnerships and acquisitions to complement its technology portfolio and expand its customer base. With a strong innovation pipeline, operational excellence, and a strategic focus on unmet clinical needs, Danaher remains well-positioned to sustain its leadership in the molecular diagnostics landscape.

F. Hoffmann-La Roche Ltd. (Switzerland) holds a significant share of the global molecular diagnostics market, driven by its expansive geographic presence and strategic growth initiatives. The company’s well-established distribution network spans North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa, ensuring consistent product availability across key markets and reducing exposure to regional demand volatility. Roche reinforces its market leadership through targeted acquisitions to enhance its technological portfolio. These strategic investments enable the company to strengthen its position in high-demand segments in the molecular diagnostics market.

Illumina, Inc. (US) is prominent in the molecular diagnostics market, supported by its leadership in next-generation sequencing (NGS) technologies. The company has strategically accelerated its global expansion through targeted investments and partnerships in high-growth emerging markets. This international push diversifies revenue streams and enhances accessibility to advanced genomic diagnostics worldwide. Illumina offers a broad portfolio of FDA- and CE-cleared products that support a range of clinical applications, including oncology, reproductive health, rare genetic disorders, and infectious disease testing. Laboratories and hospitals widely use their sequencing platforms for accurate, high-throughput molecular analysis. Backed by a strong innovation pipeline and global reach, Illumina is well-positioned to sustain its leadership in the molecular diagnostics space.

Market Ranking

The top five players in the molecular diagnostics market are Danaher Corporation (US), F. Hoffmann-La Roche Ltd. (Switzerland), Illumina, Inc. (US), bioMérieux (France), and Hologic, Inc. (US), each contributing to market growth through innovation, global presence, and broad product offerings. Danaher continues to strengthen its position through consistent product development, regulatory clearances, and global expansion efforts. Roche leverages its extensive diagnostics infrastructure and high-throughput molecular platforms to deliver reliable solutions across clinical settings. Illumina plays a vital role in advancing genomic diagnostics through next-generation sequencing technologies, improving the accuracy and efficiency of molecular testing. bioMérieux focuses on molecular solutions for infectious disease detection and syndromic testing, supporting timely decision-making in clinical environments. Hologic remains a key player in women’s health diagnostics, offering high-throughput systems and a strong test menu. Together, these companies drive the evolution of the molecular diagnostics market through technological leadership and global accessibility

Related Reports:

Molecular Diagnostics Market by Product & Service (Kits, Instruments, Software), Test Type (Lab, PoC), Sample (Blood, Urine), Technology (PCR, NGS, ISH), and Application (Infectious (Hepatitis, HIV, HAI, Flu), Cancer (Breast, Lung)) - Global Forecast to 2030

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