Molecular Diagnostics Market Industry Trends and Global Forecasts to 2035: Distribution by Test Type, Type of Offering, Type of Sample, Type of Technology, Therapeutic Area, End Users, and Geographical Regions

The global molecular diagnostics market is estimated to grow from USD 15.9 billion in 2025, to USD 30.9 billion by 2035, at a CAGR of 6.2% during the forecast period, till 2035.

Molecular Diagnostics Market: Growth and Trends 

Molecular diagnostic tests are advanced techniques and tools used to analyze biological markers in the genome and proteome. These diagnostic solutions are essential for detecting and monitoring diseases, identifying genetic abnormalities, and guiding personalized treatment plans. The primary technologies used in the molecular diagnostics domain include polymerase chain reaction, next-generation sequencing and microarrays. While PCR is a highly specific technique that enables the amplification and detection of trace amounts of DNA or RNA, NGS allows for high-throughput sequencing of entire genomes. Thus, molecular diagnostic solutions are pivotal across various medical fields, including oncological disorders, infectious diseases, genetic testing, and personalized medicine. These solutions enhance the accuracy of diagnosis, enable and support tailored treatment strategies aiming to ultimately improve diagnostic outcomes and advancing public health. In addition, it is worth mentioning that more than 70% of the healthcare decisions are made based on laboratory test results, which reflects the importance of such diagnostic tools in patient care.  

Furthermore, owing to the several benefits offered by these molecular diagnostic solutions, such as providing rapid testing, reducing turnaround times and enabling quicker decision-making, the market is expected to grow at a healthy compounded annual growth rate (CAGR) during the forecast period.

Molecular Diagnostics Market: Key Insights

The report delves into the current state of the molecular diagnostics market and identifies potential growth opportunities within industry.

Some key findings from the report include:

• The molecular diagnostic domain features a dynamic market landscape of players that utilize various types of advanced technologies in order to offer a variety of diagnostic applications.
• A number of leading players considered in this analysis were established during 1951 to 2000; 60% of such players are based in North America.

• Owing to its diverse portfolio of molecular diagnostics solutions and strong financial performance in recent fiscal year, Roche emerged as the most competent company among the leading players in this domain.
• In order to study the impact of various trends in the molecular diagnostics market, we developed our proprietary research methodology to analyze different parameters under Porter’s Five Forces framework.
• The molecular diagnostics market is fueled by growing awareness towards preventive healthcare; however, factors, such as navigating through regulatory complexities remain significant hurdles for industry players.
• Driven by the increasing prevalence of chronic disorders across the globe, the global molecular diagnostics market is expected to grow at a healthy growth rate of 6.2% during the forecast period.

• The anticipated future opportunity is expected to be well distributed across multiple segments, such as test type, sample type, therapeutic area, and end users.

The market sizing and opportunity analysis has been segmented across the following parameters:

Test Type

• Laboratory Testing
• Point-of-Care Testing

Type of Offering

• Reagents
• Instruments
• Services

Type of Sample

• Blood, Serum and Plasma
• Urine
• Others

Type of Technology

• Polymerase Chain Reaction (PCR)
• In situ Hybridization
• Isothermal Nucleic Acid Amplification Technology
• Next Generation Sequencing
• Microarrays
• Mass Spectrometry
• Others

Therapeutic Area

• Cardiovascular Diseases
• Genetic Diseases
• Infectious Diseases
• Neurological Diseases
• Oncological Diseases
• Others

End Users

• Hospitals
• Laboratories
• Others

Key Geographical Regions

• North America (US, Canada)
• Europe (Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland, UK, Rest of the Europe)
• Asia (China, India, Indonesia, Japan, Singapore, South Korea, Thailand, Rest of Asia)
• Latin America (Argentina, Brazil, Mexico, Rest of Latin America)
• Middle East and North Africa (Egypt, Israel, Saudi Arabia, Rest of Middle East and North Africa)
• Rest of the World (Australia and New Zealand)

Molecular Diagnostics Market: Key Segments

Laboratory Testing Segment holds the Largest Share of the Molecular Diagnostics Market

Based on the test type, the market is segmented into laboratory testing and point-of-care testing. At present, the laboratory testing segment holds the maximum share of the molecular diagnostics market. This trend is likely to remain the same in the coming future. Further, the molecular diagnostics market for point-of-care testing segment is expected to show the highest market growth potential during the forecast period.

By Type of Offering, Reagents is the Fastest Growing Segment of the Global Molecular Diagnostics Market

Based on the type of offering, the market is segmented into reagents, instruments and services. At present, the reagents segment holds the maximum share of the global molecular diagnostics market. Further, owing to the fact that reagents are required to be replenished frequently, which contributes to the recurrent revenues, the market for reagents segment is expected to grow at a higher CAGR during the forecast period.

By Type of Sample, Blood, Serum and Plasma Segment Accounts for the Largest Share of the Global Molecular Diagnostics Market

Based on the type of sample, the market is segmented into blood, serum and plasma, urine, and other samples. Currently, the blood, serum and plasma segment capture the highest proportion of the global molecular diagnostics market. However, the urine segment is expected to grow at a higher CAGR during the forecast period.

The Polymerase Chain Reaction (PCR) Segment by Type of Technology Occupy the Largest Share of the Molecular Diagnostics Market

Based on the type of technology, the market is segmented into Polymerase Chain Reaction (PCR), in situ hybridization, isothermal nucleic acid amplification technology, next generation sequencing, microarrays, mass spectrometry and others. While the polymerase chain reaction (PCR) segment is expected to be the primary driver of the overall market, it is worth highlighting that the global molecular diagnostics market for next generation sequencing segment is likely to grow at a relatively higher CAGR. This can be attributed to the several benefits offered by next generation sequencing, such as high-throughput, improved accuracy, and the capability to simultaneously sequence multiple genes.

By Therapeutic Area, Infectious Disease Segment is Likely to Dominate the Molecular Diagnostics Market

Based on the therapeutic area, the market is segmented into cardiovascular diseases, genetic diseases, infectious diseases, neurological diseases, oncological diseases and others. At present the infectious diseases segment holds the maximum share of the molecular diagnostics market.  Additionally, the neurological diseases segment is expected to show the highest growth potential during the forecast period, growing at a higher CAGR, compared to the other segments.

Currently, Hospitals Segment Holds the Largest Share of the Molecular Diagnostics Market

Based on end users, the global market is segmented into hospitals, laboratories, and others. Currently, the hospitals segment holds the largest market share. However, the molecular diagnostics market for laboratories segment is expected to witness substantial growth in the coming years.

North America Accounts for the Largest Share of the Market

Based on key geographical regions, the market is segmented into North America, Europe, Asia, Latin America, Middle East and North Africa, and Rest of the World. Currently, North America dominates the global molecular diagnostics market and accounts for the largest revenue share. Further, the market in Asia-Pacific is likely to grow at a higher CAGR in the coming future.

Example Players in the Molecular Diagnostics Market Include:

• Abbott Laboratories
• Agilent Technologies
• Becton Dickinson
• BGI Genomics
• bioMérieux
• Bio-Rad
• Danaher
• DiaSorin
• Grifols
• Hologic
• Illumina
• Qiagen
• QuidelOrtho
• Revvity
• Roche
• Sansure
• Seegene
• Siemens Healthineers
• Sysmex
• Thermo Fisher Scientific

Molecular Diagnostics Market: Research Coverage

• Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the global molecular diagnostics market, focusing on key market segments, including test type, type of offering, type of sample, type of technology, therapeutic area, end users and key geographical regions.
• Market Impact Analysis: A thorough analysis of various factors, such as drivers, restraints, opportunities, and existing challenges that are likely to impact market growth.
• Market Landscape: A comprehensive evaluation of the leading molecular diagnostics companies, based on several relevant parameters, such as year of establishment, company size, company ownership and location of the headquarters. Further, the section includes a comprehensive evaluation of molecular diagnostic solutions, focusing on the parameters, such as type of technology used and diagnostic applications.
• Company Competitiveness Analysis: A comprehensive competitive analysis of molecular diagnostic companies, examining factors, such as years of experience and company competitiveness.
• Regulatory Landscape for Medical Devices: A comprehensive discussion of the various guidelines established by major regulatory bodies for medical device approval across different countries. Additionally, a multi-dimensional bubble analysis was done, focusing on the comparison of contemporary regulatory scenario in key geographies across the globe.
• Company Profiles: In-depth profiles of key players that specialize in molecular diagnostic solutions, focusing on overview of the company, financial information, molecular diagnostic offerings and recent developments and an informed future outlook.
• Porter’s Five Forces Analysis: A qualitative assessment of Porter's Five Forces framework based on the five competitive forces, including threats to new entrants, bargaining power of product providers, bargaining power of buyers, threat of substitute products and rivalry among existing competitors.

Key Questions Answered in this Report

• How many companies are currently engaged in this market?
• Which are the leading companies in this market?
• What factors are likely to influence the evolution of this market?
• What is the current and future market size?
• What is the CAGR of this market?
• How is the current and future market opportunity likely to be distributed across key market segments?

Reasons to Buy this Report

• The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
• Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
• The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

Additional Benefits

• Complimentary Excel Data Packs for all Analytical Modules in the Report
• 15% Free Content Customization
• Detailed Report Walkthrough Session with Research Team
• Free Updated report if the report is 6-12 months old or older