Market Size & Trends
The U.S. molecular biology enzymes, reagents and kits market size was estimated at USD 5.95 billion in 2024 and is projected to grow at a CAGR of 9.65% from 2025 to 2033. The market is driven by growing burden of chronic diseases and infectious diseases such as sexually transmitted diseases (STDs) across the U.S. According to the Centers for Disease Control and Prevention (CDC), STDs such as chlamydia, gonorrhea, and syphilis have been increasing steadily over the past decade, with over 2.5 million cases reported in recent years. The expanding application of molecular technologies in research, diagnostics, and therapeutics.According to the American Cancer Society, over 2 million new cancer cases are projected to be diagnosed in the U.S. in 2024, excluding basal and squamous cell skin cancers and noninvasive carcinoma in situ, except for urinary bladder cases. This rising disease burden is expected to sustain the country's leadership in the market.
In November 2024, the California Department of Public Health (CDPH) confirmed the first case of clade I mpox in the U.S. through laboratory testing. The diagnosis was made in a patient who had recently traveled to an outbreak region. PCR testing identified non-variola orthopoxvirus and confirmed clade I mpox, with further analysis conducted by the CDC. The emergence of clade I mpox underscores the necessity for rapid and precise molecular diagnostics, fostering investment in next-generation PCR and sequencing technologies.
This market encompasses a broad range of products, including polymerases, ligases, nucleases, buffers, and specialized reagent kits designed for processes such as PCR, qPCR, RT-PCR, cloning, sequencing, and gene expression analysis. Furthermore, enterovirus also majorly affects the population with ages less than 5 years, of which around 41% of the infected toddlers require supplemental oxygen. In addition, according to the article published by the National Library of Medicine in May 2021, around 40 % of the U.S. population in the U.S. is affected by H. pylori infection every year.
The presence of government support in the form of approvals and funding is anticipated to fuel the market growth over the forecast period. For instance, in May 2022, Abbot received approval for its Alinity m STI Assay from the U.S. FDA. The test is capable of differentiating and detecting STIs. In addition, in 2020, ASPR’s Biomedical Advanced Research and Development Authority and NIH’s National Institute of Allergy and Infectious Diseases organized the Antimicrobial Resistance Diagnostic Challenge in which Visby Medical’s rapid PCR test won USD 19 million in federal funding.
In addition, in September 2022, Redbud Medicine raised USD 10 million in Series A funding. Federal funding also helps local and state laboratories increase their capacity and allows them to keep up with increasing demand. Similarly, in June 2023, Accelerate Diagnostics, Inc. received USD 24 million to accelerate the development of the Wave platform and novel rapid testing. Molecular diagnostics test menus for infectious diseases cannot afford to be static or superficial due to the diverse nature of infectious diseases and the building resistance of causative agents.
Furthermore, local presence of key players such as Promega Corporation and Thermo Fisher Scientific, which offer cost-effective, high-quality, & a wide range of enzymes to be used in diagnosis, is driving the U.S. market. These companies offer enzymes that can be used in biosensors, diabetes meters, point-of-care devices, and in vitro diagnosis of liver, cardiovascular, renal, and other disorders. Promega introduced a novel enzyme variant in September 2024 that cuts stutter in forensic DNA analysis, highlighting innovation in polymerase kits. Meanwhile, qPCR and RT-PCR kits remain strong, supported by PCR system upgrades and high-throughput lab adoption. In addition, in February 2021, Agilent Technologies Inc. launched the Agilent Dako SARS-CoV-2 IgG enzyme-linked immunosorbent assay kit. It detects IgG antibodies to SARS-CoV-2 in human blood serum or plasma.
Key reagents used in diagnostic assays include fluorescent tags, washing buffers, specific antibodies, and protein biomarkers for immunochemistry tests, along with essential chemicals like dNTP and primer mixes for PCR testing. In molecular diagnostics, fluorescent-labeled nucleotides and primers are frequently utilized, particularly by industry leaders such as Abbott, Illumina, Inc., and Roche Diagnostics.
Regulatory approvals for COVID-19-related reagents have also fueled the market. The U.S. FDA granted 510(k) clearance for the BioFire Respiratory Panel 2.1 in March 2021, enabling the detection of multiple respiratory infections, including COVID-19. Similarly, in April 2020, Ortho Clinical Diagnostics received an Emergency Use Authorization (EUA) for the VITROS Immunodiagnostic Anti-SARS-CoV-2 Total Reagent Pack and Calibrators, which operate on the VITROS diagnostic systems. Such approvals allow healthcare professionals to better manage and prevent COVID-19, even amidst temporary shortages that occurred early in the pandemic. These shortages were eventually mitigated through governmental interventions, restored supply chains, and the launch of alternative products
U.S. Molecular Biology Enzymes, Reagents And Kits 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, the analyst has segmented the U.S. molecular biology enzymes, reagents and kits market report based on product, application, and end useProduct Outlook (Revenue, USD Million, 2021 - 2033)
- Kits & Reagents
- PCR Kits
- qPCR Kits
- RT-PCR Kits
- Library Preparation Kits
- Cloning Kits
- Purification Kits
- Gene Editing Kits
- Other Kits
- Enzymes
- Polymerases
- DNA Polymerases
- High Fidelity DNA Polymerases
- Pfu DNA Polymerases
- Phusion DNA Polymerases
- Hot Start DNA Polymerases
- Taq DNA Polymerases High Fidelity
- Others
- Thermostable DNA Polymerases
- Standard Taq DNA Polymerases
- Tth DNA Polymerases
- Others
- Strand-displacing DNA Polymerases
- Bst DNA Polymerases
- Phi29 DNA Polymerases
- Others
- RNA Polymerases
- T7 RNA Polymerase
- SP6 RNA Polymerase
- T3 RNA Polymerase
- Other RNA Polymerase
- Reverse Transcriptase (RTs)
- M-MLV RT
- AMV RT
- Thermostable RT
- Template Switch
- TGIRT
- Induro
- MarathonRT
- Ligases
- DNA Ligases
- T4 DNA Ligases
- E coli DNA Ligase
- Taq DNA Ligase
- Others
- RNA Ligases
- Nucleases
- DNase I
- RNase A, RNase H
- Nickases
- Restriction Nucleases
- TdTs
- Endonucleases
- EndoQ
- AP Nuclease
- Kinases
- Phosphatases
- CRISPR-associated Enzymes
- Cas9
- Cas12a (Cpf1)
- Cas13
- Specialty Enzymes
- Others
Application Outlook (Revenue, USD Million, 2021 - 2033)
- Cloning
- Sequencing
- PCR
- Epigenetics
- Genotyping
- RCA/MDA
- RNA Therapeutics
- Transcriptomics
- Proteomics
- Liquid Biopsy
- Other Applications
End Use Outlook (Revenue, USD Million, 2021 - 2033)
- Pharma & Biotech
- Research
- Therapeutics/Production
- Academic & Research
- Hospital & Diagnostics
- Others
Why should you buy this report?
- Comprehensive Market Analysis: Gain detailed insights into the global market across major regions and segments.
- Competitive Landscape: Explore the market presence of key players worldwide.
- Future Trends: Discover the pivotal trends and drivers shaping the future of the global market.
- Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.
This report addresses:
- Market intelligence to enable effective decision-making
- Market estimates and forecasts from 2018 to 2030
- Growth opportunities and trend analyses
- Segment and regional revenue forecasts for market assessment
- Competition strategy and market share analysis
- Product innovation listing for you to stay ahead of the curve
- COVID-19's impact and how to sustain in these fast-evolving markets
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Table of Contents
Chapter 1. Methodology and Scope
Chapter 2. Executive Summary
Chapter 3. Molecular Biology Enzymes, Reagents And Kits Market Variables, Trends & Scope
Chapter 4. Molecular Biology Enzymes, Reagents And Kits Market: Product Estimates & Trend Analysis
Chapter 5. Molecular Biology Enzymes, Reagents And Kits Market: Application Estimates & Trend Analysis
Chapter 6. Molecular Biology Enzymes, Reagents And Kits Market: End use Estimates & Trend Analysis
Chapter 7. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
- Thermo Fisher Scientific, Inc.
- Illumina, Inc.
- Agilent Technologies, Inc.
- QIAGEN
- Promega Corporation
- New England Biolabs
- Merck KGaA
- F. Hoffmann-La Roche Ltd.
- Bio-Rad Laboratories, Inc.
- Takara Bio, Inc.
- LGC Limited
