Molecular Diagnostics Market Size, Share, Growth Analysis, By Product & Service(Reagents & Kits, Instruments, Services & Software), By Test Type(Lab Tests, PoC Tests), By Sample Type(Blood, Serum, & Plasma, Urine), By Technology(Polymerase Chain Reaction, Isothermal Nucleic Acid Amplification Technology, DNA Sequencing & Next- Generation Sequencing, In Situ Hybridization), By Application(Infectious Disease Diagnostics (Hepatitis, HIV, CT/NG, HAI), By End User(Diagnostic Laboratories, Hospitals & Clinics, and Other End Users), By Region - Industry Forecast 2025-2032

Global Molecular Diagnostics Market size was valued at USD 14.00 billion in 2022 and is poised to grow from USD 15.60 billion in 2023 to USD 37.00 billion by 2031, growing at a CAGR of 11.4% during the forecast period (2024-2031).

In the constantly shifting landscape of the molecular diagnostics market, companies are engaged in cut-throat competition and the process is characterized by innovations and strategies that can help the players gain a competitive edge over others. Some of the big players continue to dominate these markets through a broad portfolio of diagnostic services, mergers, and acquisitions, and broad sales and franchise networks. Also, the cooperation and collaboration between large-scaled companies and new entrant startups further intensify competition and innovation dynamics and the competition remained constant in bringing innovative technologies into the market thus maintaining a healthy market ecosystem with opportunities and threats simultaneously. 'F. Hoffmann-La Roche Ltd. (Switzerland) ', 'Hologic, Inc. (US) ', 'Abbott Laboratories (US) ', 'Illumina, Inc. (US) ', 'Thermo Fisher Scientific Inc. (US) ', 'bioMérieux (France) ', 'QIAGEN (Netherlands) ', 'Agilent Technologies Inc. (US) ', 'Becton Dickinson And Company (US) ', 'Grifols S.A. (Spain) ', 'Siemens AG (Siemens Healthineers) (Germany) ', 'Bio-Rad Laboratories, Inc. (US) ', 'Sysmex Corporation (Japan) ', 'Quidel Corporation (US) ', 'Biocartis (Belgium) ', 'DiaSorin (Italy) ', 'Myriad Genetics (US) ', 'Revvity (US) ', 'MDxHealth (Belgium) ', 'OncoCyte Corporation (US)', ' In May 2024, Bruker Corporation completed the acquisition of ELITechGroup for €870 million in cash excluding ELITech clinical chemistry business. A molecular diagnostics MDx, biomedical systems/specialty IVDs, Microbiology solutions and services provider ELITech posted near about EUR 150 million of FY 2023 revenues and over 80% by Consumable. The acquisition by Bruker is impressive since it brings changes and expansion to the company and situates it as an innovative infectious disease company in the IVD industry. Bruker’s MALDI Biotyper extended its portfolio in molecular diagnostics through the partnership with ELITech, which provides MDx platforms and niche MDx assays targeting niche markets.   ', ' In February 2024, Eurofins Scientific completed the purchase deal of Diatherix Laboratories, Inc. for about US$50 million with an earn out provision for specific kinds of revenue and profitability at the end of the purchase amount. This deal is expected to be closed in 30 days (about 4 and a half weeks) and will post Eurofins’ decisive step on the way to strengthening its positions in the sphere of specialty clinical diagnostics. Based in Huntsville, Alabama, Diatherix focuses has a specialized molecular diagnostics company employing the TEM-PCR™ testing of infectious diseases, providing accurate information quickly.  ', ' In April 2024, Bosch Healthcare and Randox disclosed, they will be working jointly to develop the Vivalytic analysis platform with $159 million (€150 million). With this partnership, the parties intend to create brand-new tests for the Bosch point of care molecular diagnostic device that has a record-fast PCR test turnaround. Attention will be paid to the development of a fast sepsis diagnostics approach. As part of a strategic collaboration, both companies will work together to expand joint research and development and sales and marketing projects. Point of care molecular diagnostics is a promising market where Bosch is targeting to position as a market leader. The chairman of Bosch, Stefan Hartung said, “With technologies developed in house and finest production line in our company we aim at establishing long term cooperation with partners in diagnostics sector". '

The PCR (Polymerase Chain Reaction), NGS (Next-Generation Sequencing), and microarray technologies have developed rapidly and evolved the entire molecular diagnostic technology, thus contributing to the enhanced market. Advancements in this diagnostic equipment have continued to develop better accuracy, sensitivity and speed thus contributing to market expansion. 

Shift towards Point-of-Care Testing: There is a growing trend towards point-of-care molecular testing, driven by the need for rapid diagnosis and treatment monitoring in various healthcare settings, including clinics, emergency rooms, and ambulances. Miniaturized and portable molecular diagnostic devices are being developed to enable real-time testing outside traditional laboratory settings, enhancing patient care and healthcare efficiency. 

North America come up as the largest market and held a 39% share in 2023. This can be attributed to the increasing incidence of both infectious and chronic diseases; such trends make companies develop new molecular diagnostic tests to help drive the market further. For instance, in August 2023, QIAGEN recently got approval through the U. S FDA for Thera screen PDGFRA RGQ PCR kit; this helps physicians identify patients with gastrointestinal stromal tumor (GIST). In addition, in the year of January 2023, the FDA has granted EUA for the VIASURE Monkeypox Virus Real-Time PCR Reagents manufactured by BD and CerTest Biotec for identifying the Mpox virus. In addition, increased consumer awareness and health consciousness, high standards of living and specifically, well developed healthcare infrastructure can be said to be the factors that are driving this growth.