U.S. Molecular Biology Enzymes, Reagents And Kits Market Size, Share & Trends Analysis Report By Product (Kit and Reagents, Enzymes), By Application (Cloning, NGS, PCR), By End Use, And Segment Forecasts, 2025 - 2033

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

Recent reagent launches :

Market Concentration & Characteristics

The U.S. molecular biology enzymes, reagents and kits market is experiencing significant innovation, particularly driven by advancements in next-generation sequencing (NGS), CRISPR gene-editing tools, and synthetic biology. Companies are actively developing high-fidelity polymerases, thermostable enzymes, and recombinant reagents to improve performance, sensitivity, and reproducibility in molecular workflows. There is also increased investment in automation-friendly and lyophilized formats to support high-throughput diagnostics and point-of-care testing. For instance, in June 2024 the company launched the first lyophilized NGS library preparation kit for sequencing-by-synthesis workflows. This room-temperature stable, ready-to-use formulation (end-repair, A-tailing, ligation, amplification steps included) eliminates cold-chain requirements, supports ambient shipping and 12-month storage, enhances eco-friendliness, and reduces operational complexity and cost.

The U.S. market has witnessed a moderate but strategic level of M&A activity, aimed at expanding diagnostic portfolios and technological capabilities. A key development includes. In July 2023, Applied DNA Sciences acquired an RNA polymerase developer, Spindle Biotech, enabling vertical integration for mRNA therapeutic manufacturing a move that demonstrates the market’s strategic pivot toward RNA-based applications and vaccine development.

Regulatory frameworks in the U.S., particularly those enforced by the FDA (U.S. Food and Drug Administration) and CLIA (Clinical Laboratory Improvement Amendments), play a critical role in the market. While research-use-only (RUO) reagents face fewer regulatory constraints, diagnostic kits and enzymes intended for clinical use must comply with rigorous validation, labeling, and performance standards. The increasing shift toward companion diagnostics and personalized medicine has intensified regulatory scrutiny, especially regarding assay accuracy and clinical utility.

Product expansion in the U.S. market is being driven by the demand for customized kits, multiplexing capabilities, and reagents tailored to emerging applications such as liquid biopsy, metagenomics, and single-cell analysis. Major players are launching integrated kits that combine extraction, amplification, and detection components to streamline workflows. Furthermore, OEM (original equipment manufacturer) agreements are enabling broader distribution of proprietary enzyme and reagent technologies.

Regional expansion of molecular biology enzymes, reagents and kits in the U.S. is robust, with strong growth in the West, Midwest, and Southeast. States such as California, Texas, and Florida are experiencing high volumes of STD cases, prompting increased adoption of molecular tests in both public health settings and commercial labs. Government-funded screening initiatives, particularly in urban and underserved areas, are fueling diagnostic uptake. Additionally, regional healthcare systems are increasingly integrating rapid molecular platforms into emergency departments and urgent care centers, enhancing reach beyond traditional laboratories.

Product Insights

The kits & reagents segment held the largest revenue share of 60.22% in 2024. This dominance is largely due to their widespread use in PCR, qPCR, RT-PCR, library preparation, and gene editing workflows. A notable development in this space is the launch of lyophilized library preparation kits by U.S.-based companies, including a new NGS OnePot Pro V4 DNA Library Prep Kit by Yeasen, showcased at the AACR 2025 conference. This innovation eliminates cold-chain logistics and accelerates workflow efficiency, particularly valuable for hospital-based and field diagnostic settings. Moreover, Qiagen's announcement in June 2024 to discontinue its NeuMoDx integrated PCR systems signals a market transition away from large, centralized platforms to decentralized, kit-based solutions, further boosting the kits market.

The enzymes segment is expected to witness significant growth over the forecast period, driven by demand for high-fidelity and thermostable DNA polymerases in sequencing and diagnostics. New England Biolabs (NEB) launched its NEBNext UltraExpress DNA/RNA Library Prep kits, which incorporate next-gen polymerases optimized for rapid and efficient sequencing workflows. With the rise in mRNA therapeutics, there is increased demand for enzymes supporting reverse transcription and isothermal amplification, positioning this segment for expanded use across drug development, RNA profiling, and precision medicine.

Application Insights

The sequencing segment held the largest revenue share in 2024, reflecting the country's advanced adoption of next-generation sequencing (NGS) across oncology, personalized medicine, infectious disease surveillance, and hereditary testing. The trend is supported by increasing public-private investments, such as the NIH's All of Us program, which is generating a large genomics database to support individualized therapies. Additionally, academic institutions and reference labs are investing in high-throughput sequencing technologies, driving the need for advanced PCR kits, library prep reagents, and sequencing-grade enzymes.

The RNA therapeutics segment is expected to show notable growth during the forecast period. This is reinforced by the increasing number of mRNA-based vaccines and RNAi therapies entering late-stage clinical trials in the U.S. In early 2025, Moderna and Merck announced expansion plans for personalized mRNA cancer vaccines, which use customized sequencing and RNA processing platforms to develop tumor-specific therapeutics. This surge in RNA-based research and development is spurring innovation in enzyme technologies such as reverse transcriptases, RNases, and T7 RNA polymerases, tailored to therapeutic-grade RNA workflows. With robust FDA pipelines and a strong focus on genetic diseases and oncology, RNA therapeutics are transforming molecular biology from a research tool to a core therapeutic platform in the U.S. In addition, in September 2023, BioNTech and Pfizer received the U.S. FDA approval for mRNA-based COVID-19 vaccine COMIRNATY 2023-2024 formulation for individuals aged 12 years and older. Thus, increasing FDA approval of novel mRNA therapeutics is expected to drive the segment. The oncology segment is expected to register the highest CAGR over the forecast period

End Use Insights

The pharma & biotech segment held the largest revenue share in 2024. This dominance is primarily attributed to drug discovery, vaccine development, and the rise of synthetic biology and personalized medicine. Major pharmaceutical firms continue to integrate molecular tools into R&D pipelines. For example, in 2024, Pfizer expanded its gene therapy R&D division, focusing on precision editing and high-throughput sequencing to enhance rare disease research. Moreover, increasing collaborations between biotech startups and diagnostic kit manufacturers are facilitating the co-development of research-use and clinical-use kits, reinforcing the role of pharma/biotech in shaping product trends.

The hospital & diagnostics segment is expected to experience substantial growth during the forecast period. This is driven by the post-COVID shift toward decentralized diagnostics, U.S. hospitals are increasingly investing in point-of-care molecular tools for pathogen detection, oncology panels, and inherited disease screening. In a recent example, several academic medical centers adopted lyophilized, automation-compatible PCR and library prep kits to perform in-house genomic testing without relying on centralized labs. The American Hospital Association (AHA) also reported that molecular diagnostics accounted for a 12% increase in total lab expenditures in 2024, further highlighting this trend. As molecular tests become a standard diagnostic option, especially for oncology and infectious diseases, the hospital segment is expected to grow significantly through the forecast period, prompting vendors to customize kits and enzymes for clinical workflows.

Key U.S. Molecular Biology Enzymes, Reagents And Kits Company Insights

The U.S. molecular biology enzymes, reagents, and kits market is highly competitive and marked by the presence of several global and domestic players with well-established product portfolios and distribution networks. Thermo Fisher Scientific, Inc. maintains a dominant market position owing to its extensive product offerings, broad customer base across academia and industry, and continuous investment in R&D and acquisitions. Illumina, Inc. and QIAGEN also hold significant shares, driven by their leadership in next-generation sequencing and nucleic acid purification technologies, respectively.

Agilent Technologies, Inc. and Bio-Rad Laboratories, Inc. continue to expand their footprint through strategic innovation and targeted life sciences applications.

Companies such as Promega Corporation, New England Biolabs, and Takara Bio, Inc. are recognized for their specialized enzyme technologies and strong presence in research-oriented segments.
The market is further characterized by frequent product launches, partnerships with academic and biotech institutions, and a strong emphasis on innovation to support genomics, transcriptomics, and synthetic biology research.

Recent Developments

• ​In February 2025, Abbott received FDA 510(k) clearance for its Simpli COLLECT STI Test, a self-collection kit enabling lab-based molecular detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium. The clearance supports growing demand for at-home sample collection paired with centralized molecular testing, reflecting broader trends toward improved accessibility and patient-centered STD diagnostics.

• In September 2024, TriLink BioTechnologies (part of Maravai LifeSciences) and Alphazyme partnered to introduce CleanScribe RNA Polymerase, a DNA-dependent RNA polymerase engineered to significantly reduce double-stranded RNA (dsRNA a common impurity in in vitro transcription (IVT). This innovative enzyme lowers dsRNA formation by up to 85% compared to wild-type T7 RNA Polymerase, without compromising mRNA yield, capping efficiency, or transcript integrity. This launch reflects broader U.S. trends emphasizing safer, more potent mRNA biomanufacturing and demonstrates Maravai’s commitment to advancing IVT enzyme technologies alongside its CleanCap capping solutions and CDMO services.

• In June 2024, Meridian bioscience the company launched the first lyophilized NGS library preparation kit for sequencing-by-synthesis workflows. This room-temperature stable, ready-to-use formulation (end-repair, A-tailing, ligation, amplification steps included) eliminates cold-chain requirements, supports ambient shipping and 12-month storage, enhances eco-friendliness, and reduces operational complexity and cost.

• In January 2024, QIAGEN received FDA clearance for its NeuMoDx CT/NG Assay 2.0, designed for the direct detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). This assay is compatible with both NeuMoDx 96 and 288 Molecular Systems, offering rapid results and aiming to improve accessibility and timeliness in STI testing in the U.S.

U.S. Molecular Biology Enzymes, Reagents And Kits Market Report Scope

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, Grand View Research has segmented the U.S. molecular biology enzymes, reagents and kits market report based on product, application, and end use

Product 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