by The global molecular diagnostics market size was estimated at around USD 15.23 billion in 2023 and it is projected to hit around USD 23.74 billion by 2033, growing at a CAGR of 4.54% from 2024 to 2033.
Key Pointers
- In 2023, North America held the greatest market share of 40%, dominating the industry.
- Asia Pacific is expected to have significant expansion between 2024 and 2033.
- In terms of product revenue share, the reagents section had the most share (63%), in 2023.
- In terms of sales share by product, the instruments section came in second in 2023.
- In terms of technology, the segment with the biggest share in 2023 was the polymerase chain reaction (PCR) technology.
- In terms of technology, the market for sequencing technology is expected to grow at the quickest rate between 2024 and 2033.
- According to Application, a strong CAGR is expected in the oncology area between 2024 and 2033.
Molecular Diagnostics Market Overview
With an emphasis on the identification and molecular analysis of genetic material, molecular diagnostics is a quickly developing subject within the healthcare sector. With increased accuracy and individualized treatment plans, this novel method has revolutionized the diagnosis and treatment of many illnesses.
Molecular Diagnostics Market Growth
The market for molecular diagnostics is expanding rapidly thanks to a number of important factors. The precision and efficiency of diagnostic tests have been greatly improved by technological developments, especially in high-throughput sequencing and polymerase chain reaction (PCR) procedures. Molecular diagnostics is becoming a vital tool for fast pathogen identification due to the increased demand for precise and quick diagnostic solutions brought on by the rising occurrence of infectious diseases around the world. Additionally, market expansion has been driven by the industry’s response to the growing trend of personalized medicine, in which treatment strategies are customized based on an individual’s genetic composition. Point-of-care testing (POCT) is becoming more and more in demand, particularly in emergency situations, which is fueling the market’s overall expansion.
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Product Insights
As the dominant player in the market, the reagents segment generated a hefty 63% of worldwide revenue in 2023. This dominance is anticipated to last for the duration of the projection period because to the wide range of applications that reagents have in both clinical and research settings, as well as the growing popularity of novel assays. The announcement made in April 2023 by Cepheid, a Danaher subsidiary, on plans to deliver novel tests targeting a variety of infectious diseases, including tuberculosis and respiratory ailments, serves as an instructive example. Working with Rutgers University researchers, the business created a novel device that can identify ten separate targets in one reaction. Expectations of consistent outcomes, increased productivity, and affordability are expected to drive this market’s expansion.
Because of the extensive use of instruments in many healthcare facilities for the diagnosis of life-threatening disorders, the instruments segment was able to win the second-largest proportion of revenue in 2023. Furthermore, a major factor in this segment’s rise has been the introduction of technologically sophisticated devices. Thermo Fisher Scientific, Inc., for example, announced the release in February 2023 of the state-of-the-art digital PCR research tool, the QuantStudio, Applied Biosystems, Absolute Q AutoRun dPCR Suite. Additionally, in May 2023, Sansure Biotech participated in EuroMedLab Rome 2023, where it displayed a wide array of its In Vitro Diagnostic (IVD) products, which included the iPonatic III molecular workstation.
Technology Insights
The polymerase chain reaction (PCR) technology category held the highest revenue share in 2023, primarily due to its extensive application in the detection of infectious disorders such as COVID-19. Growth in the market is expected to be fueled by the use of high-throughput PCR technology for diagnosing genetic disorders and infectious diseases. One notable instance is the introduction of Truenat H3N2/H1N1 by Molbio Diagnostics in April 2023, which is the first Point-of-Care (PoC) Real-Time Polymerase Chain Reaction (PCR) test that enables accurate diagnosis of influenza illnesses.
On the other hand, the sequencing technology market is expected to grow at the quickest rate between 2024 and 2033. This expansion is explained by the growing use of technology in diagnostic applications, the release of cutting-edge Next-Generation Sequencing (NGS) assays, and encouraging actions by major participants in the market. This trend is best illustrated by Alercell’s April 2023 launch of the LENA Molecular Dx Leukemia Platform, which includes 12 molecular diagnostic assays based on next-generation DNA sequencing technology.
Test Location Insights
In 2023, the central laboratories segment emerged as a dominant force in the industry, driven primarily by the substantial increase in procedures conducted for COVID testing and other healthcare indications within these facilities. ELITechGroup’s announcement in April 2023 regarding the introduction of high-throughput sample-to-result molecular diagnostics equipment further emphasizes the crucial role of central laboratories in meeting global testing demands. Moreover, the rise in government initiatives, particularly those facilitating reimbursement for diagnostic tests, is anticipated to significantly contribute to market growth.
A noteworthy trend in the industry is the increasing focus on the development of molecular diagnostic platforms suitable for over-the-counter (OTC) or at-home use. Consequently, numerous companies are actively designing assays and molecular diagnostic platforms empowering patients to conduct tests independently, without the need for healthcare professionals. For instance, in March 2023, Lucira Health launched the first and only at-home COVID-19 and flu tests in the U.S. This COVID-19 & Flu Home Test received the first and only Emergency Use Authorization (EUA) from the U.S. FDA for over-the-counter usage at home and other non-laboratory locations.
Regional Insights
In 2023, North America established its dominance in the market, securing a significant 40% share. This position is a result of the rising prevalence of infectious and chronic diseases, prompting companies to introduce innovative molecular diagnostic tests, consequently driving overall market growth. Notable instances include QIAGEN obtaining U.S. FDA approval for the therascreen PDGFRA RGQ PCR kit in August 2023, assisting physicians in identifying patients with gastrointestinal stromal tumors (GIST). Additionally, in January 2023, the U.S. FDA granted Emergency Use Authorization (EUA) for the VIASURE Monkeypox Virus Real-Time PCR Reagents, developed by BD and CerTest Biotec, for detecting the Mpox virus. The region’s high living standards, public awareness of early diagnosis, and a well-established healthcare system collectively serve as pivotal factors driving market expansion.
Looking ahead, Asia Pacific is positioned for substantial growth from 2024 to 2033. This anticipated expansion is attributed to increased market penetration, local market players’ initiatives promoting the adoption of novel diagnostic technologies, and significant unmet market needs. For example, in August 2023, Indian companies CrisprBits and MolBio Diagnostics formed a strategic collaboration to revolutionize Point-of-Care (POC) diagnostics by integrating CRISPR technology into POC tests for detecting pathogens and genetic markers.
Read More: https://www.heathcareinsights.com/in-vitro-diagnostics-ivd-market/
Key Companies
- BD
- bioMérieux SA
- Bio-Rad Laboratories, Inc.
- Abbott
- Agilent Technologies, Inc.
- Danaher
- Hologic Inc. (Gen Probe)
- Illumina, Inc.
- Grifols, S.A.
- QIAGEN
- F. Hoffmann-La Roche, Ltd.
- Siemens Healthineers AG
- Sysmex Corporation
Molecular Diagnostics Market Segmentations:
By Product
- Instruments
- Reagents
- Others
By Technology
- Polymerase chain reaction (PCR)
- By Type
- Multiplex PCR
- Other PCR
- By Product
- Instruments
- Reagents
- Others
- By Type
- In Situ Hybridization (ISH)
- Instruments
- Reagents
- Others
- Isothermal Nucleic Acid Amplification Technology (INAAT)
- Instruments
- Reagents
- Others
- Chips and Microarrays
- Instruments
- Reagents
- Others
- Mass Spectrometry
- Instruments
- Reagents
- Others
- Sequencing
- Instruments
- Reagents
- Others
- Transcription Mediated Amplification (TMA)
- Instruments
- Reagents
- Others
- Others
- Instruments
- Reagents
- Others
By Application
- Oncology
- Breast Cancer
- Prostate Cancer
- Colorectal Cancer
- Cervical Cancer
- Kidney Cancer
- Liver Cancer
- Blood Cancer
- Lung Cancer
- Other Cancer
- Pharmacogenomics
- Infectious Diseases
- Methicillin-resistant Staphylococcus Aureus (MRSA)
- Clostridium Difficile
- Vancomycin-resistant Enterococci (VRE)
- Carbapenem-resistant Bacteria
- Flu
- Respiratory Syncytial Virus (RSV)
- Candida
- Tuberculosis and Drug-resistant TBA
- Meningitis
- Gastrointestinal Panel Testing
- Chlamydia
- Gonorrhea
- HIV
- Hepatitis C
- Hepatitis B
- Other Infectious Diseases
- Genetic Testing
- Newborn Screening
- Predictive and Presymptomatic Testing
- Other Genetic Testing
- Neurological Disease
- Cardiovascular Disease
- Microbiology
- Others
By Test Location
- Point of Care
- Self-test or OTC
- Central Laboratories
By Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East and Africa (MEA)
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