by The global molecular diagnostics market value stood at USD 15.23 billion in 2023 and it is predicted to rise to USD 23.74 billion by 2033 with growing at a CAGR of 4.54% from 2024 to 2033.
Molecular diagnostics is analyzing molecules such as DNA, RNA, or proteins in a tissue sample in a laboratory to diagnose a disease or a risk of developing it such as cancer. Molecular diagnostics include various tests such as biomarker tests, liquid biopsies, tumor sensing tests, and genetic tests. It is also called molecular pathology. Doctors can conduct a molecular test for a common inherited hereditary malignancy. For example, in breast cancer, they can look for specific hereditary abnormalities in the BRCA1 and BRCA2 genes that may raise the patient’s risk of ovarian and breast cancer.
Apart from diagnosis, a variety of tests are critical for evaluating therapy efficacy and detecting medication resistance. For example, in HIV treatment, quantitative molecular assays monitor viral load. A large increase in viral load may suggest resistance to the present treatment. In such circumstances, doctors can do DNA sequencing on the patient’s HIV strain to uncover resistance-associated alterations. This information enables for a quick switch to other drugs, ensuring that the infection remains under control.
We are still in the early stages of understanding the meaning of these genetic changes and their involvement in illness development. While the ability to analyze DNA sequences for disease detection has greatly improved, a better understanding of these changes is required. We have a wealth of information, but the problem now is to successfully interpret it and translate it into actionable insights. This ongoing study focused on unraveling the complexities of diseases, holds tremendous promise for establishing more precise diagnostics and personalized treatment strategies.
Molecular Diagnostics Market Highlights:
- North America led the market with the largest share of 40% in 2023.
- Asia Pacific is expected to see significant growth from 2024 to 2033.
- In terms of product, the reagents segment captured the largest revenue share of 63% in 2023.
- The instruments segment ranked second in revenue share for 2023.
- Among technologies, polymerase chain reaction (PCR) technology held the largest market share in 2023.
- The sequencing technology segment is projected to exhibit the highest compound annual growth rate (CAGR) from 2024 to 2033.
- For applications, the oncology segment is expected to experience the highest CAGR from 2024 to 2033.
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Molecular Diagnostics Market Regional Study
In 2023, North America solidified its market leadership with a significant 40% share. This dominance is largely due to the rising incidence of infectious and chronic diseases, which has spurred companies to develop innovative molecular diagnostic tests, driving overall market growth. Key developments include QIAGEN’s FDA approval in August 2023 for the therascreen PDGFRA RGQ PCR kit, designed to help physicians identify gastrointestinal stromal tumors (GIST). Additionally, in January 2023, the FDA granted Emergency Use Authorization (EUA) to BD and CerTest Biotec’s VIASURE Monkeypox Virus Real-Time PCR Reagents for detecting the Mpox virus. The region’s high living standards, strong consumer awareness about early diagnosis, and a robust healthcare system are crucial factors propelling market expansion.
Looking ahead, Asia Pacific is expected to experience significant growth between 2024 and 2033. This anticipated growth is driven by increased market penetration, efforts by local players to advance novel diagnostic technologies, and substantial unmet needs in the region. For example, in August 2023, Indian firms CrisprBits and MolBio Diagnostics formed a strategic partnership to innovate Point-of-Care (POC) diagnostics by incorporating CRISPR technology into POC tests for detecting pathogens and genetic markers.
Some of the FDA Approved Molecular Diagnostic (COVID-19) Tests by April 2023:
- 34 Pooling
- 69 Asymptomatic single-use screening
- 8 Serial screening
- 28 Multi-analyte (i.e., SARS-CoV-2 + Influenza)
- 25 Point-of-care
- 78 Home collection
- 16 Direct-to-consumer
- 6 Multi-analyte
- 15 Saliva home collection
- 21 Standalone home collection kits
- 3 Standalone saliva collection devices
- 1 Prescription at-home test
- 5 Over-the-counter (OTC) at-home tests
Early Disease Diagnosis with Molecular Diagnostics
Molecular diagnostics have emerged as a sensitive and largely accurate method for early detection of infectious diseases. The COVID-19 pandemic accelerated the adoption of such methods as the need for early disease detection was very crucial. Monitoring the efficacy of treatment modalities, early diagnosis, and predictive medicine are some of the potential applications of molecular diagnostics to improve patient outcomes. Molecular diagnostics comes with an advantage that its solution can detect biomarkers at very low concentrations which ultimately leads to enable early disease detection or diagnosis. These tests are affordable and can be done at the point of care. The tests’ detection methods include DNA sequencing, microarrays, fluorescent probes, and Fluorescence In-Situ Hybridization.
Infants born to HIV-positive moms have a significant challenge in early diagnosis. Maternal antibodies that cross the placenta can interfere with antibody-based HIV tests for up to 18 months, delaying a definite diagnosis. This delay is especially concerning because such infants have a high death and morbidity rate within the first two years.
Fortunately, qualitative nucleic acid testing has become the predominant method for identifying HIV infection in young infants. These assays directly identify viral components such as HIV pro-viral DNA or RNA, avoiding the problem of maternal antibodies. For instance, one such test is the COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test. This test requires only 70 µl of whole blood or a dry blood spot and accurately detects specific sections (gag and LTR) of the HIV-1 genome. Rising demand for the use of such tests is adding to the growth of the molecular diagnostics market.
Successful treatment and improved patient survival rate are significantly possible with molecular diagnostics which in turn fosters the molecular diagnostics market growth. Diagnostic biomarkers enable the identification of diseases as earliest possible which further enables and eases the onset of reliable treatment for the diagnosed disease.
Globally in 2020, a WHO-recommended rapid molecular test was utilized as the initial diagnostic test for 1.9 million (33%) of the 5.8 million people newly diagnosed with tuberculosis, up from 28% in 2019. There was significant diversity across countries. Of the 5.8 million people newly diagnosed with tuberculosis worldwide in 2020, 73% had a recorded HIV test result, up from 70% in 2019. Regionally, the largest percentages were attained in the WHO African and European regions.
Recent Advances in Molecular Diagnostics Fueling Market Growth
Molecular diagnostics has transformed healthcare by allowing for very accurate and sensitive diagnosis of diseases at the molecular level. Recent advances are moving this sector forward, resulting in significant growth in the molecular diagnostics market. Here’s a breakdown of major advancements and their influence.
Next-generation sequencing enables parallel analysis of entire genomes or focused gene panels, allowing for more thorough genetic profiling for illness diagnosis, personalized medicine, and drug resistance testing. In addition, digital PCR outperforms classical PCR in terms of sensitivity and precision, allowing for the discovery of uncommon mutations and minimal residual illness. Miniaturizing diagnostic assays using microfluidic chips allows for portable, point-of-care (POC) examinations in decentralized settings, resulting in faster and more accessible diagnostics. Furthermore, CRISPR has enormous potential for disease identification, antimicrobial resistance (AMR) studies, and gene editing for therapeutic purposes.
Impact on Market Growth:
- Molecular diagnostics’ applications are expanding to include infectious diseases, genetic disorders, oncology, pharmacogenomics, and personalized medicine. This diversification contributes to market growth.
- Improved Accuracy and Speed lead to earlier and more accurate diagnoses, resulting in better patient outcomes and increased use of these technologies.
- Rapid POC tests speed up decision-making in critical care circumstances and increase patient management efficiency.
- Molecular diagnostics enables personalized medicine by providing insights into an individual’s genetic makeup and drug responses, resulting in tailored medicines and improved treatment outcomes.
- POC testing and developments such as microfluidics make diagnostics more accessible in resource-constrained environments, contributing to global market expansion.
Examples:
- Molecular technologies such as PCR and LAMP testing have been useful in the fight against COVID-19, demonstrating the power of quick diagnostics in pandemic response.
- Non-invasive prenatal testing (NIPT) uses NGS-based analysis of fetal DNA in maternal blood to detect chromosomal abnormalities, providing a safer and more accurate alternative to standard amniocentesis.
- These are just a few examples of how new developments are moving the molecular diagnostics market ahead. As technology advances, we should expect even more inventive solutions to transform disease diagnostics, personalized therapy, and overall healthcare delivery.
Increased Demand for Cancer and Infectious Disease Detection Boosts Molecular Diagnostics
Cancer and infectious diseases pose significant global health threats. According to the World Health Organization (WHO), cancer ranks as the second leading cause of death worldwide, while infectious diseases remain a major cause of illness and death, particularly in low-income countries.
Factors such as an aging population, lifestyle changes, and the emergence of new infections are driving the rising prevalence of these diseases.
Importance of Early Detection:
Early diagnosis of cancer and infectious diseases is crucial for improving patient outcomes and reducing mortality rates. Molecular diagnostics play a key role in early detection, offering tools that can identify specific genetic alterations or pathogens at the molecular level, often before symptoms appear. This allows for earlier intervention and treatment, significantly enhancing the chances of successful outcomes.
Benefits of Molecular Diagnostics:
- Enhanced Sensitivity: Molecular diagnostics can detect minimal quantities of cancer cells or pathogens, leading to more accurate diagnoses and reducing the need for unnecessary biopsies or delays in treatment.
- Comprehensive Analysis: These tests can simultaneously analyze multiple targets, providing detailed insights into the disease and potential resistance profiles, particularly for infectious diseases.
- Minimally Invasive: Many molecular diagnostics use blood or other easily obtained samples, minimizing the need for invasive procedures.
Examples:
- Liquid Biopsies: These less invasive blood tests can identify circulating tumor DNA (ctDNA), facilitating early cancer detection and monitoring.
- Rapid Diagnostic Tests: These tests can quickly identify specific pathogens responsible for infections, enabling targeted antibiotic treatments and helping to prevent the spread of resistance.
Read More@ https://www.heathcareinsights.com/ai-in-medical-imaging-market/
Molecular Diagnostics Market Top 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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