Molecular Diagnostics Market Report and Forecast 2025-2034

The global molecular diagnostics market was valued at USD 20.57 Billion in 2024, driven by rising innovation in molecular diagnostic technologies and their widespread application across the globe. The market is expected to grow at a CAGR of 8.20% during the forecast period of 2025-2034, with the values likely to reach USD 45.24 Billion by 2034.

Global Molecular Diagnostics Market Overview

Molecular diagnostics are laboratory techniques used to analyze biological markers in the genome and proteome to help detect a disease or the risk of developing a disease. It involves studying DNA and RNA to analyze and identify caution points that indicate the potential emergence of a specific disease. The rising prevalence of infectious diseases and growing cancer cases are the major factors impacting the market demand. Moreover, the market growth is driven by increasing significant advancements in molecular diagnostic technologies (such as next-generation sequencing (NGS), polymerase chain reaction, and microarrays), the growing demand for personalized medicine, and favorable regulatory policies that accelerate the approval of new molecular diagnostic tests.

Global Molecular Diagnostics Market Growth Drivers

Continuous Advancements in Molecular Diagnostic Technologies Support Market Growth

The market is further expected to experience continuous advancements and innovation to enhance the existing molecular diagnostic technologies such as nucleic acid detection in various diagnostic settings in the early detection of diseases. For instance, Changchun Liu, professor of Biomedical Engineering at UConn Health, has developed a new method that improves existing diagnostic technology for a more rapid, sensitive, and deployable approach to molecular diagnostics. The research discovered new potential for simple and sensitive nucleic acid detection in various diagnostic settings, including early cancer diagnostics and infectious disease detection using new and improved clustered regularly interspaced short palindromic repeats (CRISPR) technology. Such research efforts aimed at improving the capabilities of molecular diagnostic tests are expected to elevate the market value in the forecast period.

Strategic Collaborations to Meet Rising Molecular Diagnostics Market Demand

The market for molecular diagnostics is one of the fastest-growing markets in the healthcare sector. The increasing awareness about the potential of early diagnosis and personalized medicine/treatments is collectively contributing to the market growth. For instance, in January 2023, Alveo signed a Memorandum of Understanding (MOU) with the Barbados Investment and Development Corporation (Export Barbados (BIDC)) to co-develop its novel molecular sensing platform, while contributing to the growth of the life sciences industry in the Caribbean nation. Such collaborations are anticipated to expand the market reach while sharing assets to co-develop novel solutions in the molecular diagnostics market.

Global Molecular Diagnostics Market Trends

The market is witnessing several trends and developments to improve the current global scenario. Some of the notable trends are as follows:

Growing Emphasis on Personalized Medicine

The rising emphasis on personalized medicine is significantly influencing the demand for molecular diagnostics, as these technologies facilitate the identification of individual genetic profiles that can guide targeted treatment approaches. This trend is expanding the use of molecular diagnostics in routine medical practices, improving patient outcomes, and impacting the development of targeted therapies.

Rising Demand for Point-of-Care Testing

The expansion of point-of-care (POC) testing is making molecular diagnostics more accessible and convenient. Such tests can be used in non-laboratory environments such as clinics and homes. This allows rapid diagnosis and treatment, which is particularly crucial in managing infectious diseases and during health emergencies like the COVID-19 pandemic. The rising patient inclination towards POC molecular tests is expected to augment molecular diagnostics market demand.

Increasing Application in Oncology

Molecular diagnostics are increasingly used in oncology for early detection and monitoring. The rising collaborations between research institutions and diagnostic companies also increase the demand for advanced molecular diagnostics. This trend is poised to facilitate the development of new cancer diagnostics, aiding in early and more precise cancer detection needed for effective treatment.

Favorable Regulatory Policies

Supportive government policies and faster regulatory approvals for molecular diagnostic tests are essential for the rapid introduction of innovative molecular diagnostic tests in clinical settings. This not only helps in responding swiftly to public health challenges but also encourages investment and innovation within the molecular diagnostics sector, further fueling the market expansion.

Global Molecular Diagnostics Market Segmentation

Molecular Diagnostics Market Report and Forecast 2025-2034 offers a detailed analysis of the market based on the following segments:

Market Breakup by Product & Service

• Instruments
• Reagents & Kits
• Services & Software

Market Breakup by Test Location

• Point-of-Care
• Self-test or Over the Counter
• Central Laboratories

Market Breakup by Technology

• Polymerase Chain Reaction (PCR)
• In Situ Hybridization
• Isothermal Nucleic Acid Amplification Technology (INAAT)
• Chips and Microarrays
• Mass Spectrometry
• Sequencing
• Transcription Mediated Amplification
• Others

Market Breakup by Application

• Oncology
• Breast Cancer
• Colorectal Cancer
• Lung Cancer
• Prostate Cancer
• Other Cancers
• Pharmacogenomics
• Infectious Diseases
• Hepatitis
• HIV
• CT/NG
• Hospital Acquired Infections (HAI)
• HPV
• Tuberculosis
• Influenza
• Other Infectious Diseases
• Genetic Testing
• Neurological Diseases
• Cardiovascular Diseases
• Microbiology
• Others

Market Breakup by End User

• Diagnostic Laboratories
• Hospitals & Clinics
• Other End Users

Market Breakup by Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa

Global Molecular Diagnostics Market Share

Market Segmentation Based on Application is Poised to Witness Substantial Growth

Based on application, the market oncology (breast cancer, colorectal cancer, lung cancer, prostate cancer, other cancers), pharmacogenomics, infectious diseases (hepatitis, HIV, CT/NG, hospital acquired infections (HAI), HPV, tuberculosis, influenza, other infectious diseases), genetic testing, neurological diseases, cardiovascular diseases, and microbiology, among others.

The infectious disease segment is valued at USD 9.399 billion in 2023, dominating the application market segment. Infectious diseases are ranked as one of the leading causes of mortality and morbidity globally, accounting for around 33% of deaths every year. Additionally, it is reported that almost half of the world's population is considered at risk of emerging and re-emerging infectious diseases. Thus, the rising burden of infectious diseases propels the demand for effective molecular diagnostic solutions to facilitate early detection and appropriate interventions. Consequently, this will lead to increased molecular diagnostics market demand.

Polymerase Chain Reaction Technology to Lead the Market Share Based on Technology

The market segmentation by technologies includes polymerase chain reaction (PCR), in situ hybridization, isothermal nucleic acid amplification technology (INAAT), chips and microarrays, mass spectrometry, sequencing, and transcription mediated amplification, among others.

Polymerase chain reaction leads the segment, with the market size expected to rise from USD 16.083 billion in 2024 to USD 29.832 billion in 2032. The increasing adoption of digital PCR assays with automated and multiplexed capabilities is influencing the market dynamics. Additionally, the integration of PCR technologies in point-of-care settings and the surge in the introduction of advanced PCR products are contributing to its growing market presence.

Global Molecular Diagnostics Market Analysis by Region

Based on the geographic analysis of the market, North America, particularly, the United States dominates the regional market with the market size valued at USD 13.061 billion in 2023. The rising prevalence of infectious diseases and growing preference for personalized medicine are some of the key factors likely to drive the market growth during the forecast period.

Further, the increasing research and development activities are also boosting the market share in the region. For instance, in July 2023, a group of researchers at Queensland University of Technology (QUT) developed a new approach for designing molecular ON-OFF switches based on proteins with widespread application in biotechnological, biomedical, and bioengineering. The research team mentioned that this novel approach will enable them to develop diagnostic tests for the early detection of diseases that are designed and built faster and with more accuracy. Such developments are anticipated to propel advancements in molecular diagnostic methods, thereby elevating the market value.

Leading Players in the Global Molecular Diagnostics Market

The key features of the market report include patent analysis, grants analysis, clinical trials analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:

• BioMérieux SA
• BD (Becton, Dickinson and Company)
• Bio-Rad Laboratories, Inc.
• Abbott
• Agilent Technologies, Inc.
• Hologic Inc.
• Danaher Corporation
• DiaSorin
• Illumina, Inc.
• Johnson & Johnson Services, Inc.
• QIAGEN N.V.
• F. Hoffmann-La Roche, Ltd.
• PerkinElmer, Inc.
• Siemens Healthineers
• Thermo Fisher Scientific Inc.

Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.

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