According to Nova one advisor, the global molecular diagnostics market size was valued at USD 43.09 billion in 2023 and is projected to reach USD 63.17 billion by 2033, registering a CAGR of 3.9% from 2024 to 2033. The U.S. molecular diagnostics industry size was valued at USD 14.02 billion in 2023.
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Molecular diagnostics, encompassing a range of widely applied, powerful, and sensitive techniques, are driving market growth by identifying biologic markers in genomes and proteomes. These methodologies, such as PCR-based techniques for detecting bacterial genes and enzyme-linked immunosorbent assay (ELISA) and proteomics for measuring infection-specific proteins, enhance the precision and effectiveness of diagnostics. The ability to accurately identify and measure these biomarkers has significantly advanced the field, fostering increased adoption and expansion of the molecular diagnostics market.
The molecular diagnostics market is experiencing rapid growth, driven by advancements in molecular pathology, which involves analyzing DNA or RNA sequences to identify potential disease markers. This field has expanded significantly with the advent of genome sequencing, which deciphers the order of approximately 3 billion DNA bases in a person complete DNA. Molecular diagnostics employ a suite of powerful and sensitive techniques, such as PCR-based methods for detecting bacterial genes and enzyme-linked immunosorbent assays (ELISA) and proteomics for measuring infection-specific proteins. These advancements enable precise identification of biologic markers in genomes and proteomes, significantly enhancing diagnostic capabilities and driving market expansion.
· In June 2024, Cayman Chemical expanded its molecular diagnostic research offerings through a partnership with PCRassays.com.
· In April 2024, Bosch and R-Biopharm announced plans to strengthen the Vivalytic analysis platform through an additional partnership.
Molecular Diagnostics Market Key Takeaways
- North America dominated the market and accounted for a 40% share in 2023.
- Asia Pacific is anticipated to exhibit significant growth from 2024 to 2033
- The reagents segment dominated the market and accounted for a share of 66% of the global revenue in 2023
- The polymerase chain reaction technology segment accounted for the largest revenue share in 2023.
- The infectious diseases segment accounted for the largest revenue share of 78% in 2023.
- The central laboratories segment dominated the industry in 2023
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Why has North America dominated the Molecular Diagnostics market?
North America held a dominant share in the molecular diagnostics market, driven by advanced healthcare technology and regulatory frameworks. In Canada, an international exposé of flawed regulations for medical implants has led to significant regulatory reforms announced by the health minister. The Canadian laboratory regulatory system involves a mix of public and private entities, operating under the oversight of provincial governments, nongovernmental organizations, and professional societies. In the United States, the integration of new medical technologies ranging from drugs and biological devices to surgical procedures is a cornerstone of the healthcare system. The cost-effective delivery of evidence-based healthcare remains paramount, positioning North America as a leader in the adoption and advancement of molecular diagnostics.
- North America molecular diagnostics market was valued at USD 16.85 billion in 2023, and it is expected to reach around USD 23.3 billion by 2033.
- The U.S. molecular diagnostics market size was valued at USD 14.02 billion in 2023 and is anticipated to reach around USD 19.03 billion by 2033, growing at a CAGR of 3.1% from 2024 to 2033.
- Europe molecular diagnostics market size was estimated at USD 11.7 billion in 2023 and it is predicted to hit around USD 16.34 billion by 2033.
- Asia Pacific molecular diagnostics market size was reached at USD 10.59 billion in 2023 and it is projected to surpass around USD 16.92 billion by 2033.
- Latin America molecular diagnostics market accounted for USD 1.76 billion in 2023 and it is expanding to around USD 2.54 billion by 2033.
- MEA molecular diagnostics market was valued at USD 1.4 billion in 2023 and it is expanding by around USD 2.18 billion by 2033.
Report Highlights
By Product, the Reagent Segment Led the Market in 2023
The reagent segment commands the largest share in the molecular diagnostics market, driven by the demand for high-quality molecular reagents across various industries. These reagents are crucial for diagnosing and treating diseases, discovering new therapeutics, and developing safety tests for environmental, food, and cosmetic applications. Key products in this segment include PCR and RT-PCR enzymes, ultra-pure dNTPs, and specialized buffer systems for in vitro diagnostic (IVD) assay development and optimization. The consistent requirement for superior quality reagents to ensure the reliability and accuracy of molecular diagnostic assays and kits underpins the dominant market position of the reagent segment.
Global Molecular Diagnostics Market Revenue, By Product, 2023-2033 (US$ Million)
Product | 2023 | 2024 | 2030 | 2033 |
Instruments | 11,037.71 | 11,348.83 | 13,945.20 | 15,809.40 |
Reagents | 28,001.71 | 29,042.24 | 36,271.22 | 41,548.31 |
Others | 3,217.30 | 3,284.70 | 3,680.22 | 3,930.76 |
By Location, the Central Laboratories Segment Held the Largest Share of the Market
Central laboratories hold the largest market share in the molecular diagnostics sector, driven by their critical role in clinical trials. These labs process laboratory samples from study participants, providing essential data on the efficacy, side effects, and patient-specific benefits of new therapeutics. Beyond sample analysis, central labs are integral to developing sample collection protocols and managing procedures for handling, transportation, and storage. Their involvement extends to clinical trial management, where they offer valuable support and advice on laboratory-related activities, solidifying their dominant position in the molecular diagnostics market.
Global Molecular Diagnostics Market Revenue, By Location, 2023-2033 (US$ Million)
Location | 2023 | 2024 | 2030 | 2033 |
POC | 5,580.12 | 5,886.10 | 8,207.03 | 9,887.79 |
Self testing/OTC | 2,021.63 | 2,213.58 | 3,861.16 | 5,157.90 |
Central Labs | 34,654.97 | 35,576.08 | 41,828.46 | 46,242.79 |
By Application, the Infectious Diseases Segment is Observed to Sustain the Dominance
The infectious diseases segment commands the largest revenue share in the molecular diagnostics market, leveraging molecular methods to assess microbial loads and evaluate pathogen genotypes. This capability is crucial for monitoring therapeutic responses and providing prognostic insights into disease progression based on viral load data. Molecular techniques are increasingly integral to epidemiological and clinical investigations, particularly in identifying and managing viral infections like human papillomavirus (HPV), which can lead to dysplasia, intraepithelial neoplasia, and carcinoma in the female genital tract. The segment’s focus on precise diagnostic capabilities and therapeutic monitoring underscores its significant contribution to the expanding field of molecular diagnostics.
The oncology segment is anticipated to achieve a high compound annual growth rate (CAGR) during the forecast period within the molecular diagnostics market. Molecular testing plays a crucial role in oncology by complementing procedures such as biopsies to aid in cancer diagnosis, treatment planning, therapeutic monitoring, prognosis determination, and predicting disease recurrence or metastasis. Personalized cancer therapy, guided by molecular testing to identify actionable mutations, has become integral to optimizing treatment outcomes. The increasing adoption of molecular diagnostics in oncology underscores its pivotal role in advancing cancer care through tailored and effective therapeutic strategies.
Global Molecular Diagnostics Market Revenue, By Application, 2023-2033 (US$ Million)
Application | 2023 | 2024 | 2030 | 2033 |
Oncology | 3,503.51 | 3,830.52 | 6,728.34 | 8,705.32 |
Pharmacogenomics | 860.97 | 922.82 | 1,454.02 | 1,819.46 |
Infectious Diseases | 33,087.01 | 33,757.00 | 37,435.45 | 40,347.07 |
Genetic Testing | 2,989.71 | 3,250.97 | 5,560.32 | 7,137.94 |
Others | 1,815.52 | 1,914.47 | 2,718.51 | 3,278.69 |
By Technology, the PCR Segment is Observed to Remain as a Leader for the Market
Polymerase chain reaction (PCR) technology is poised to drive significant growth in the molecular diagnostics market. PCR offers an efficient and cost-effective method to amplify specific DNA or RNA sequences, crucial for detecting various infectious diseases and genetic disorders. This technology enables the rapid replication of millions of copies of nucleic acid fragments from organisms such as plants, animals, bacteria, and viruses. PCR’s ability to amplify target sequences quickly and accurately makes it indispensable in clinical settings for diagnosing diseases, monitoring treatment efficacy, and conducting genetic testing. The expanding application of PCR technology underscores its pivotal role in advancing molecular diagnostics through enhanced precision and efficiency.
Global Molecular Diagnostics Market Revenue, By Technology, 2023-2033 (US$ Million)
Technology | 2023 | 2024 | 2030 | 2033 |
PCR | 31,920.34 | 32,769.86 | 36,698.55 | 38,104.32 |
ISH | 2,559.86 | 2,855.62 | 6,060.23 | 9,073.29 |
INAAT | 1,687.54 | 1,688.53 | 1,709.20 | 1,741.31 |
Sequencing | 2,460.26 | 2,649.42 | 4,856.13 | 7,059.43 |
TMA | 2,956.58 | 3,005.37 | 3,571.67 | 4,123.69 |
Others | 672.14 | 706.96 | 1,000.86 | 1,186.43 |
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Market Dynamics
Clinical Adoption of Molecular a Major Driver for the Market
Recent advances in molecular diagnostics are transitioning from basic research to clinical application, offering cost-effective and widely used diagnostic tests. Techniques such as the quantification of specific proteins, including β-human chorionic gonadotropin for pregnancy detection and cardiac troponin for myocardial infarction diagnosis, are now commonplace in hospitals globally. The CRP test, a universally utilized blood biomarker test for clinical infections and periprosthetic joint infections (PJIs), exemplifies the clinical integration of molecular diagnostics. Occasional nonspecificity due to elevated CRP levels from other inflammatory processes, the widespread adoption and proven utility of these tests are driving significant growth opportunities in the molecular diagnostics market.
High Cost and Resource Constraints Restraint for the Market
Molecular methodologies, while advanced, are typically more expensive than traditional approaches, with equipment and reagent costs proving prohibitive for some laboratories. Laboratory accreditation requirements and specific testing methodologies may necessitate personnel with specialized qualifications, which can be a limiting factor. Molecular amplification methods also require dedicated space, which may not be available in all clinical laboratories. These financial and logistical challenges constrain the growth potential of the molecular diagnostics market.
Rapid Technological Advancements to Create Opportunity for the Market
Molecular diagnostics (MDx) is a swiftly evolving sector of laboratory medicine, focusing on the investigation of human, viral, and microbial genomes and their encoded products. The increasing importance of molecular diagnostic techniques and platforms across anatomic and clinical pathology has led to a significant expansion in the range of DNA and RNA-based tests available in clinical laboratories over the past decade. The rapid technological advancements transitioning from research to clinical applications have created substantial growth opportunities in the molecular diagnostics market, driving innovation and expanding the scope of diagnostic capabilities.
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Molecular Diagnostics Market Top 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 Recent Developments
- In January 2024, Illumina collaborated with Janssen to develop a molecular residual disease liquid biopsy test. The company plans to develop a cost-effective whole-genome sequencing multi-cancer test to detect ctDNA
- In November 2023, Co-Diagnostics, Inc. received a grant of 8.97 million from the Bill & Melinda Gates Foundation to develop a novel tuberculosis test to be run on the Co-Dx PCR platform
- In July 2023, T2 Biosystems received the Breakthrough Device designation from the U.S. FDA for its C. Auris direct-from-blood molecular diagnostic test
- In March 2023, F. Hoffmann-La Roche Ltd. and Lilly announced their partnership to improve early Alzheimer’s disease diagnosis
- In February 2023, Thermo Fisher Scientific Inc. partnered with MyLab to procure RT-PCR kits for various infectious diseases, such as tuberculosis & HIV
- In January 2023, Agilent Technologies Inc. and Quest Diagnostics to launch ctDx FIRST liquid biopsy NGS test in the U.S.
Molecular Diagnostics Market Report Segmentation
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Molecular Diagnostics market.
By Product
- Instruments
- Reagents
- Services & Software
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 End User
- Diagnostic Laboratories
- Hospitals & Clinics
- Others
By Region
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East & Africa (MEA)
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