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Next Generation Molecular Assay Market Size and Forecast, by Type (Enzyme-Linked Immuno-Sorbent Assay, Gene Expression Profiling Assays, Polymerase Chain Reaction); Application (Hospital, Pharmaceutical Companies, Biotech Companies) - Growth Trends, Key Players, Regional Analysis 2026-2035

  • Report ID: 6159
  • Published Date: Dec 01, 2025
  • Report Format: PDF, PPT

Next Generation Molecular Assay Market Outlook:

Next Generation Molecular Assay Market size was valued at USD 5.51 billion in 2025 and is set to exceed USD 9.23 billion by 2035, expanding at over 5.3% CAGR during the forecast period i.e., between 2026-2035. In the year 2026, the industry size of next generation molecular assay is estimated at USD 5.77 billion.

Next Generation Molecular Assay Market Size
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With the increasing technological advancements in the healthcare infrastructure, the demand for innovative early disease detection testing tools is growing simultaneously boosting the next generation molecular assay market.

Moreover, evolving advanced methods such as polymerase chain reaction are helpful in achieving precise detections compared to traditional detecting methods. Polymerase chain reaction excels in identifying genetic material responsible for infection. For instance, polymerase chain reaction tests helped in the detection of SARS-CoV-2 and rescued many patients from the infection at an early stage.

Key Next Generation Molecular Assay Market Insights Summary:

  • Regional Insights:

    • By 2035, North America is projected to command a 40% revenue share in the next generation molecular assay market, stemming from strong industry leadership and advanced healthcare standards.
    • By the end of 2035, Asia Pacific is expected to capture over 28% revenue share, underpinned by government initiatives, rising R&D spending, and expanding pharmaceutical capabilities.

  • Segment Insights:

    • By 2035, the polymerase chain reaction segment is set to account for around 41% share in the next generation molecular assay market, propelled by its essential involvement in sequencing workflows.
    • Across 2026–2035, the pharmaceutical segment is forecast to grow at around 6% CAGR, enabled by the use of PCR–ELISA integrations in complex disease detection and vaccine and drug development.

  • Key Growth Trends:

    • Technological advancements in the healthcare industry
    • Rising demand for genetic testing

  • Major Challenges:

    • Budget restraints
    • Ethical approval

  • Key Players: Thermo Fisher Scientific Inc., Bio-rad Laboratories, Inc., Qiagen, Illumina, Charles River Laboratories.

Global Next Generation Molecular Assay Market Forecast and Regional Outlook:

  • Market Size & Growth Projections:

    • 2025 Market Size: USD 5.51 billion
    • 2026 Market Size: USD 5.77 billion
    • Projected Market Size: USD 9.23 billion by 2035
    • Growth Forecasts: 5.3%

  • Key Regional Dynamics:

    • Largest Region: North America (40% Share by 2035)
    • Fastest Growing Region: Asia Pacific
    • Dominating Countries: United States, China, Germany, United Kingdom, Japan
    • Emerging Countries: India, South Korea, Brazil, Singapore, Australia

    • Last updated on : 1 December, 2025

Growth Drivers

  • Technological advancements in the healthcare industry: New technologies are changing traditional healthcare techniques and patients are now able to access cutting-edge treatment. Also, advancement in technology has improved the communication between patients and healthcare professionals as with video call feature a patient can easily connect to their respective doctor and ask for advice.

    Moreover, research and development in biotechnology is also evolving and the next generation molecular assay market holds the potential to face challenges in the future since it showed a rapid response to COVID-19 in the past.
     
  • Rising demand for genetic testing: Demand for personalized medicine is increasing day by day, eventually leading to the demand for genetic testing. Genetic testing provides information about diseases such as cancer and diabetes by analyzing the DNA. In November 2022, 0.08 million genetic cases were registered under the genetic testing registry. Once early detection is done, healthcare experts prescribe medicines and treatments as per the report

    Because of the increased awareness about health risks, genetic testing is considered one of the top-notch detection tools accelerating the next generation molecular assay market.
     
  • Increase of infectious diseases in animals: One of the main reasons behind the increase of infectious diseases among animals is industrial farming. Zoonotic diseases not only affect animals but humans too. Most of the diseases known to the human beings are caused by animals. We often get in touch with animals for different purposes and fall prey to zoonotic diseases.

    In the USA, the CDC works actively to keep zoonotic diseases away from humans, keeping animal health in mind and according to them 3 out of 4 infectious diseases affecting humans arrive from animals.

Challenges

  • Budget restraints - Many academic institutes are facing capital deficiency in research and development programs worldwide which is severely impacting the growth of new techniques and tools.
     
  • Ethical approval – It is another issue emerging as a restraint for next generation molecular assay market. The research and development programs are often delayed due to pending consent formalities from committees.

Next Generation Molecular Assay Market Size and Forecast:

Report Attribute Details

Base Year

2025

Forecast Year

2026-2035

CAGR

5.3%

Base Year Market Size (2025)

USD 5.51 billion

Forecast Year Market Size (2035)

USD 9.23 billion

Regional Scope

  • North America (U.S., and Canada)
  • Asia Pacific (Japan, China, India, Indonesia, Malaysia, Australia, South Korea, Rest of Asia Pacific)
  • Europe (UK, Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Latin America (Mexico, Argentina, Brazil, Rest of Latin America)
  • Middle East and Africa (Israel, GCC North Africa, South Africa, Rest of the Middle East and Africa)
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Next Generation Molecular Assay Market Segmentation:

Technique Segment Analysis

 By the end of 2035, polymerase chain reaction segment is expected to dominate around ~41% next generation molecular assay market share. PCR assay plays a fundamental role in sequencing as the methods for sequence-ready NGS libraries involve PCR steps, making it a useful and effective technique for next generation molecular assay. When a PCR test was performed on brucellosis (a zoonotic disease) for rapid diagnosis, the results obtained showed that 7% of cases had positive PCR. Moreover, PCR assays are considered to be more accurate than serological tests and blood culture techniques.

Application Segment Analysis

Pharmaceutical segment in the next generation molecular assay market is set to exhibit CAGR of around 6% from 2026 to 2035. PCR and ELISA when combined help in the identification of challenging disease agents where clinical signs are not visible and are also used in the R&D of new vaccines and drugs by pharmaceutical companies.ELISA test is performed to detect blood-borne diseases such as HIV. 

Our in-depth analysis of the market includes the following segments: 

          Technique
  • Enzyme Linked Immuno- Sorbent Assays
  • Gene Expression Profiling Assay
  • Polymerase Chain Reaction

          Application
  • Hospital
  • Pharmaceutical Companies
  • Biotech Companies

          Type

  • Virus testing
  • HPV testing
  • HIV testing
  • Influenza testing
  • HCV testing
  • Blood Testing
  • Genetic Testing
  • Oncological Testing
  • STD Testing
Vishnu Nair
Vishnu Nair
Head - Global Business Development

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Next Generation Molecular Assay Market - Regional Analysis

North America Market Insights

North America industry is predicted to account for largest revenue share of 40% by 2035, The region is growing due to the presence of top industry leaders, regulatory standards, and a progressive healthcare sector.

The US has one of the best key players in the market such as BostonGene, a leading provider of AI-powered cloud-based and immune profiling services. In 2023, for improving patient response and making advancements in the medicines, BostonGene along with NEC corporation and Japan Industry Provider announced the launch of a new Tokyo-based joint venture named BostonGene Japan Inc. For ensuring quality and safety of pharmaceutical products Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Manufacturing Practices (GMP) are being followed by under the region.

The Canadian healthcare sector is progressing and the PCR technique is one of the most common molecular testing techniques, driving growth in the next generation molecular assay market. As per a recent analysis, the healthcare expenditure in Canada was over USD 21 million in 2023.

Asia Pacific Market Insights

By the end of 2035, Asia Pacific region in next generation molecular assay market is set to account for more than ~28% revenue share. The region is thriving owing to government initiatives, R&D investments, a growing pharmaceutical sector, and improved medical practices. India has executed various initiatives to meet the demands of the health sector and thereby, also invested USD 1 Billion in biotechnology for research and development. The healthcare sector in China is promising and competitive providing a clear space for the Market to flourish. According to the International Trade Administration, the pharmaceutical sector of China was estimated to hold a value of USD 161.8 Billion in 2023. Korea has an extensive medical network and efficient medical device availability. The Korean healthcare management systems are very appreciative and the service is accessible 24/7. and the pharmaceutical industry of South Korea was estimated to be around 30 trillion won in 2022.

Next Generation Molecular Assay Market Share
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Next Generation Molecular Assay Market Players:

    The next generation molecular assay market is dominated by key market players who are gaining traction in the market by investments in R&D.

    • Thermo Fisher Scientific, Inc
    • Company Overview 
    • Business Strategy 
    • Key Product Offerings 
    • Financial Performance 
    • Key Performance Indicators 
    • Risk Analysis 
    • Recent Development 
    • Regional Presence 
    • SWOT Analysis 
    • Bio-Rad Laboratories, Inc
    • Qiagen
    • Charles River Laboratories
    • Illumina
    • Oxford Nanopore Technologies
    • F Hoffman-La Roche
    • Agilent Technologies Inc
    • PerkinElmer Inc
    • BGI Genomics Co. Ltd.

Recent Developments

  • Bio-Rad laboratories announced its partnership with Allegheny Health Network Cancer Institute in April 2024 to advance the molecular residue disease monitoring of solid tumor cancers with Bio-Rad’s Droplet Digital™ PCR (ddPCR™).
  • US Health offered BRAF Gene Mutation Assay and Microsatellite Instability Assay, two in-house molecular oncology tests which means faster results and faster treatment. These tests are capable of detecting the mutation from tumor tissue and cytology specimens in cancer patients.
  • CMIC has joined LC Scrum AP screening project on non-small cell lung cancer, being run by National Cancer Center Hospital East and Precision Medicine Asia (PREMIA). CMIC is a leading innovator in the industry and, became the first contract research organization to join this project.
  • Novogene made a big announcement for providing flexibility to researchers along with enhancing research strategies. At the 44th Annual Meeting of the Molecular Biological Society of Japan (MSBJ), Novogene, well known for its genomic services announced the launch of single cell sequencing on-site services for Japan-specific customers.
  • Report ID: 6159
  • Published Date: Dec 01, 2025
  • Report Format: PDF, PPT
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Frequently Asked Questions (FAQ)

In the year 2026, the industry size of next generation molecular assay is estimated at USD 5.77 billion.

The global next generation molecular assay market size was around USD 5.51 billion in 2025 and is likely to expand at a CAGR of more than 5.3%, surpassing USD 9.23 billion revenue by 2035.

Key players in the market include Thermo Fisher Scientific Inc., Bio-rad Laboratories, Inc., Qiagen, Illumina, Charles River Laboratories.

Next Generation Molecular Assay Market Report Scope

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