The market for molecular diagnostics in infectious diseases is projected to grow significantly, reaching approximately US$ 17,614.44 million by 2030, up from US$ 6,833.03 million in 2022. This growth represents a compound annual growth rate (CAGR) of 12.5% from 2022 to 2030.
The increasing need for improved treatment options has spurred numerous product innovations over recent decades. Below are some notable recent advancements in the molecular diagnostics sector for infectious diseases.
- In April 2023, Bruker launched new in vitro diagnostic (IVD) solutions for mycobacteria and fungi, along with a novel LiquidArray Gastrointestinal Syndromic Panel. These new IVD workflows, kits, software, and reference libraries enhance the capabilities of the established MALDI Biotyper platform, providing added value for both current and prospective customers. The LiquidArray Gastrointestinal panel offers extensive pathogen coverage, making it suitable for laboratories seeking a comprehensive screening method to identify a wide range of pathogens in a single test.
- In February 2023, Thermo Fisher Scientific introduced PCR kits for detecting infectious diseases in India. The Applied Biosystems TaqPath PCR kits, which target multi-drug-resistant tuberculosis (MDR-TB), M. tuberculosis complex, hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), and genetic analysis (HLA B27), received licensing from the Central Drugs Standard Control Organisation (CDSCO) and will be produced in collaboration with Mylab Discovery Solutions.
- In December 2021, Roche unveiled the first infectious disease tests and the cobas omni Utility Channel for the cobas 5800 System in CE Mark-accepting countries. This new utility channel allows laboratory professionals to run CE-IVD assays and develop their own laboratory-developed tests (LDTs), thereby broadening access to essential diagnostic tools that enable healthcare providers to deliver high-quality care globally, particularly in regions burdened by high disease prevalence.
Technological Advancements in Molecular Diagnostics Open New Avenues for the Market
Research in genetics and genomics has paved the way for molecular diagnostic techniques that emphasize nucleic acid detection, offering rapid methods for identifying infectious diseases. These techniques can detect multiple pathogens and analyze drug resistance genes, making them vital for the early diagnosis of infections. Molecular diagnostics are applicable across various fields of anatomic and clinical pathology, allowing for the identification of DNA or RNA sequences linked to diseases, including single nucleotide polymorphisms, deletions, rearrangements, and insertions. Traditional testing methods such as CT scans, hematological tests, and reverse transcription-PCR (RT-PCR) have limitations, particularly in the context of rising infectious diseases, which have increased the demand for swift and accurate testing solutions. CT scans, while informative, are costly and may not be available in all healthcare facilities, and they often fail to identify viral infections in asymptomatic individuals. RT-PCR, although effective, can be time-consuming and may not detect low viral loads in the early stages of infection. New molecular diagnostic techniques, including reverse transcription loop-mediated isothermal amplification (RT-LAMP), microarray detection, aptamer-based diagnostics, SHERLOCK, SHERLOCKv2, FET biosensors, cell-based potentiometric diagnostics, and molecular imprinting technology, have emerged to enhance infectious disease diagnosis. Recent FDA reports indicate that advancements in molecular testing, antigen-based testing, and serological testing have received approval, reflecting the progress in this field. Collaborative efforts among scientific communities worldwide to combat infectious diseases and reduce mortality rates have positively influenced the landscape of molecular tools and diagnostics, creating substantial opportunities for the molecular diagnostics market in infectious diseases moving forward.
The molecular diagnostics market for infectious diseases is categorized by type, disease type, infection type, application, and end user. By type, it is divided into point-of-care testing and laboratory testing. The end-user segment is similarly divided into point-of-care and laboratory testing, with point-of-care further classified into human and veterinary testing. Laboratory testing is also segmented into human and veterinary applications. In terms of application, the market is divided into point-of-care and laboratory testing, with point-of-care further segmented into single pathogen detection, multi-pathogen detection, evaluation of emerging infections, surveillance and early detection of biothreats, and antimicrobial resistance profiling. Laboratory testing is categorized into patient stratification, drug regimen selection, toxicity avoidance, therapeutic monitoring, and predisposition detection. The disease type segment includes point-of-care and laboratory testing, with point-of-care further divided into sepsis, prosthetic joint infections, endocarditis, STDs, mononucleosis, group A streptococcus (GAS), and others. Laboratory testing encompasses sepsis, prosthetic joint infections, endocarditis, STDs, chlamydia, gastrointestinal infections, tuberculosis, H1N1 virus, and more. The infection type segment is also divided into point-of-care and laboratory testing, with point-of-care further segmented into bacterial, viral, fungal, and other infections, while laboratory testing is similarly categorized.
Geographically, the market is segmented into North America, Europe, Asia Pacific, the Middle East & Africa, and South & Central America. North America currently holds the largest share of the molecular diagnostics market for infectious diseases, driven by the increasing adoption of advanced technologies, heightened research and development activities, the presence of major healthcare companies, and the growing utilization of molecular diagnostic kits for infectious disease detection. In the United States, the growth of the molecular diagnostics market is primarily fueled by the rising incidence of infectious diseases, an aging population, and numerous product launches by leading industry players.
Key primary and secondary sources utilized in the preparation of the report on the molecular diagnostics market for infectious diseases include the National Institute of Health (NIH), the Centers for Disease Control and Prevention (CDC), the European Union, and the United Nations International Children's Emergency Fund (UNICEF).