Molecular Diagnostics Market (By Product: Reagents, Instruments; By Technology: PCR, INAAT; By Application: Oncology, Genetic Testing; By Test Location) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2024-2033

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. The molecular diagnostics market is driven by the growing trend towards personalized medicine, point-of-care testing (POCT) demand, and rising incidence of infectious diseases.

Key Pointers

• North America dominated the market with the largest market share of 40% in 2023.
• Asia Pacific is poised for substantial growth from 2024 to 2033
• By Product, the reagents segment held the largest revenue share 63% in 2023.
• By Product, the instruments segment secured the second-largest share of revenue in 2023.
• By Technology, the polymerase chain reaction (PCR) technology segment claimed the largest share in 2023.
• By Technology, the sequencing technology segment is poised to exhibit the fastest CAGR from 2024 to 2033.
• By Application, the oncology segment is anticipated to experience a high CAGR from 2024 to 2033.

Molecular Diagnostics Market Overview

Molecular diagnostics is a rapidly evolving field within the healthcare industry that focuses on the detection and analysis of genetic material at the molecular level. This innovative approach has transformed the diagnosis and management of various diseases, offering enhanced precision and personalized treatment strategies.

Molecular Diagnostics Market Growth

The molecular diagnostics market is witnessing robust growth driven by several key factors. Technological advancements, particularly in high-throughput sequencing and polymerase chain reaction (PCR) techniques, have significantly enhanced the precision and efficiency of diagnostic tests. The rising incidence of infectious diseases globally has heightened the demand for accurate and rapid diagnostic solutions, positioning molecular diagnostics as a critical tool for timely pathogen identification. Furthermore, the industry's response to the increasing trend of personalized medicine, where treatment plans are tailored based on individual genetic makeup, has fueled market expansion. The demand for point-of-care testing (POCT) is on the rise, especially in emergency settings, contributing to the market's overall growth.

Molecular Diagnostics Market Trends

• Advent of Next-Generation Sequencing (NGS): Next-generation sequencing technologies have gained prominence, enabling the rapid and cost-effective analysis of genetic material. This trend has revolutionized molecular diagnostics, facilitating comprehensive genetic profiling.
• Rapid Expansion of Liquid Biopsy Applications: Liquid biopsy, a non-invasive diagnostic approach that analyzes biomarkers in blood or other bodily fluids, is experiencing substantial growth. This trend is particularly notable in oncology for early cancer detection and monitoring treatment response.
• Integration of Artificial Intelligence (AI) and Machine Learning: The incorporation of AI and machine learning algorithms is enhancing data analysis capabilities in molecular diagnostics. This trend allows for more accurate interpretation of complex genetic information, leading to improved diagnostic accuracy and personalized treatment strategies.
• Growing Emphasis on Companion Diagnostics: Companion diagnostics, which involve tailoring treatment decisions based on patient-specific genetic characteristics, are becoming increasingly important. This trend aligns with the broader movement towards personalized medicine.
• Expanding Applications in Infectious Disease Surveillance: Molecular diagnostics are playing a vital role in infectious disease surveillance, offering rapid and sensitive detection of pathogens. This trend is crucial for monitoring and controlling infectious disease outbreaks globally.
• Increasing Focus on Point-of-Care Molecular Testing: The demand for point-of-care molecular testing is rising, driven by the need for quick and on-site diagnostics. This trend is particularly relevant in emergency settings, where immediate results are crucial for decision-making.

Product Insights

The reagents segment was the leading force in the market, capturing a substantial 63% share of global revenue in 2023. This dominance is expected to persist throughout the forecast period, driven by the extensive application scope of reagents in both research and clinical settings, coupled with the increasing adoption of innovative tests. An illustrative example is the announcement made by Cepheid, a subsidiary of Danaher, in April 2023, outlining plans to introduce novel tests targeting various infectious diseases, such as respiratory diseases and tuberculosis. Collaborating with researchers at Rutgers University, the company developed a groundbreaking technology capable of detecting 10 independent targets in a single reaction. The anticipation of standardized results, heightened efficiency, and cost-effectiveness is poised to further fuel the growth of this segment.

The instruments segment secured the second-largest share of revenue in 2023, primarily due to the widespread utilization of instruments in various healthcare facilities for diagnosing life-threatening diseases. Additionally, the introduction of technologically advanced instruments has significantly contributed to the growth of this segment. For instance, Thermo Fisher Scientific, Inc. announced the release of the QuantStudio, Applied Biosystems, Absolute Q AutoRun dPCR Suite, a cutting-edge digital PCR research tool in February 2023. Furthermore, Sansure Biotech showcased its extensive range of In Vitro Diagnostic (IVD) products, including the iPonatic III portable molecular workstation, at EuroMedLab Rome 2023 in May 2023.

Technology Insights

In 2023, the polymerase chain reaction (PCR) technology segment claimed the largest share of revenue, driven significantly by its widespread use in detecting COVID-19 and other infectious diseases. The adoption of high-throughput PCR technology for identifying infectious diseases and genetic conditions is anticipated to fuel market growth. A noteworthy example is Molbio Diagnostics' launch of Truenat H3N2/H1N1 in April 2023, representing the initial Point-of-Care (PoC) Real-Time Polymerase Chain Reaction (PCR) test that facilitates the reliable identification of influenza infections.

Conversely, the sequencing technology segment is poised to exhibit the fastest CAGR from 2024 to 2033. This growth can be attributed to the increasing integration of technology in diagnostic applications, the introduction of innovative Next-Generation Sequencing (NGS) tests, and supportive initiatives by key industry players. Alercell's launch of the LENA Molecular Dx Leukemia Platform in April 2023, featuring 12 molecular diagnostic tests based on next-gen DNA sequencing technology, exemplifies this trend.

Application Insights

In 2023, the infectious diseases segment emerged as the leader in revenue, largely driven by the heightened usage of molecular diagnostic tests, particularly Polymerase Chain Reaction (PCR) tests, for diagnosing COVID-19. This increased application significantly contributed to the segment's expanded market share. Additionally, the rising global prevalence of infectious diseases is further amplifying the demand for innovative molecular diagnostic tests. An example of this trend is evident in the U.S. FDA's approval of 510(k) clearance for Hologic's Panther Fusion SARS-CoV-2/Flu A/B/RSV assay in May 2023. This molecular diagnostic test distinguishes between the four most common respiratory viruses. Furthermore, a strategic partnership between Oxford Nanopore and bioMérieux in April 2023, focusing on nanopore technology, aims to develop novel treatments for infectious diseases.

Conversely, the oncology segment is anticipated to experience a high CAGR from 2024 to 2033. In 2023, the American Cancer Society estimated approximately 288,300 new cases of prostate cancer and around 59,610 new cases of leukemia in the U.S. The increasing collaboration between research institutes and industry players to devise new diagnostic solutions for cancer is a key factor supporting the growth of this segment. Notably, in October 2023, QIAGEN and Myriad Genetics joined forces to develop companion diagnostic tests utilizing Polymerase Chain Reaction (PCR), digital PCR (dPCR), and Next-Generation Sequencing (NGS) technologies for cancer diagnostics.

Test Location Insights

In 2023, the central laboratories segment emerged as the dominant force in the industry, primarily due to the high volumes of procedures conducted for COVID testing and other healthcare indications within central laboratories. ELITechGroup's announcement in April 2023 regarding the introduction of a high throughput sample-to-result molecular diagnostics equipment further underlines the significance of central laboratories in meeting global testing demands. Additionally, the surge in government initiatives aimed at providing various services, including reimbursement for diagnostic tests, is expected to be a key driving factor for market growth.

A notable trend in the industry is the growing interest in the development of molecular diagnostic platforms that can be utilized over-the-counter (OTC) or in at-home settings. Consequently, several companies are designing assays and molecular diagnostic platforms that empower patients to perform tests without the assistance of healthcare professionals. For example, 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 OTC usage at home and other non-laboratory locations.

Regional Insights

In 2023, North America asserted its dominance in the market, capturing a substantial 40% share. This stronghold is attributed to the escalating prevalence of infectious and chronic diseases, prompting companies to introduce innovative molecular diagnostic tests and thereby fueling overall market growth. Notable instances include QIAGEN's U.S. FDA approval for the therascreen PDGFRA RGQ PCR kit in August 2023, aiding physicians in identifying patients with gastrointestinal stromal tumors (GIST). Furthermore, 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 Mpox virus detection. The region's high standards of living, consumer awareness regarding early diagnosis, and a well-established healthcare system collectively act as pivotal drivers for market expansion.

Moving forward, Asia Pacific is poised for substantial growth from 2024 to 2033. This anticipated growth is attributed to increased market penetration, local market players' initiatives to promote the adoption of novel diagnostic technologies, and high unmet market needs. For instance, 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.

Molecular Diagnostics 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
• 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)