Molecular Quality Controls Market Size, Share, and Industry Analysis, By Product Type (Third-party independent controls, Instrument/assay-specific controls, Custom/OEM controls and validation panels, and Others), By Technology (PCR/qPCR, Multiplex PCR syndromic panels, NGS, and Others), By Application (Infectious Disease, Oncology & Hereditary Testing, Transplant, Pharmacogenomics, and Others), By End User (Clinical labs & hospitals, Reference Labs, IVD Manufacturers, and Others), and Regional Forecast 2026-2034

The molecular quality controls market size was valued at USD 0.25 billion in 2025. The market is projected to grow from USD 0.28 billion in 2026 to USD 0.80 billion by 2034, exhibiting a CAGR of 13.8% during the forecast period.

The molecular quality controls market is expected to grow in line with the increasing adoption of molecular diagnostics for infectious diseases, expanding research into precision medicines, and other factors. These innovative therapies and diagnostics utilize advanced techniques, such as NGS and PCR, and other modalities that require frequent testing due to their high sensitivity. These factors lead to higher consumption of molecular quality controls, driving the market's growth. Several key companies are launching new products to cater to this growing market.

• For instance, in May 2023, ZeptoMetrix launched PROtrol TM, a new line of products designed for antigen-based diagnostic methods. These materials mimic a true clinical specimen and are used to evaluate and monitor the performance of antigen-based assays, including lateral flow immunoassays for infectious diseases.

Furthermore, strategic partnerships, mergers, and collaborations, as well as acquisitions, are expected to solidify the market dominance of key companies.

Molecular Quality Controls Market Driver

Expansion of NGS in Oncology and Inherited Disease Testing to Drive Market Growth

The expansion of next-generation sequencing techniques in oncology and inherited disease testing is driving the growth of the molecular quality controls market. An increasing number of laboratories are adopting multi-gene panels to guide treatment decisions and confirm hereditary risk. As these complex workflows, including NGS workflows, add more steps (extraction, library preparation, sequencing, and bioinformatics), the chance of variability increases. Therefore, labs and IVD developers rely more on well-characterized reference materials and controls to validate assays, monitor run-to-run performance, and prove accuracy for technically challenging variants. This cause-and-effect dynamic—more NGS testing in high-stakes use cases leading to higher validation and monitoring needs—directly increases routine consumption and purchasing of molecular QC materials.  

• For instance, in February 2025, Revvity, Inc. launched three Mimix reference standards for IVD use, designed for monitoring of next-generation sequencing (NGS) or droplet digital polymerase chain reacting (ddPCR) assays designed to detect somatic mutations in genomic DNA (gDNA) from human sample to support monitoring test performance, assay variation, and to help identify increases in random or systemic errors.

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In March 2025, NIH published a report titled ‘The expanding global genomics landscape: Converging priorities from national                 programs’ that highlighted average funding for various genomics programs.

Molecular Quality Controls Market Restraint

Stringent Regulatory Requirements Increasing Compliance Costs and Reducing Profitability to Hamper Market Growth

Stringent regulatory requirements are hindering the growth of the molecular quality controls market. The new and evolving frameworks, such as the EU IVDR, require manufacturers to invest more time and resources in generating clinical evidence, revalidation, and ongoing compliance. As regulatory scrutiny increases, the cost of developing and maintaining molecular quality control products rises. These factors result in a higher compliance burden, leading to increased operating costs and delayed product availability. Such factors reduce profitability for suppliers and discourage the expansion of product portfolios, which in turn slows overall market growth.

• For instance, in August 2022, Greiner Bio-One GmbH discontinued its product portfolio in the diagnostics division. The regulatory requirements, increasing with the new in Vitro Diagnostics Regulation (IVDR), put the economic viability of the portfolio at risk. These factors discourage key companies from investing and limit their production, thereby restraining market growth opportunities.

Molecular Quality Controls Market Opportunity

Expanding Use of Molecular QC in Biopharma Manufacturing and Advanced Therapies to Offer Lucrative Market Growth Opportunity

A key market growth opportunity is the expansion of molecular quality controls into biopharma quality control, particularly in cell and gene therapy (CGT) manufacturing. As more precision medicine programs transition from development to commercial-scale production, demand for quality control kits for these therapies will increase. Manufacturers must release batches more quickly while still ensuring safety, consistency, and regulatory compliance to support process development, batch release testing, and ongoing monitoring. These factors drive higher adoption and repeat adoption of quality control products, prompting key companies to launch innovative products and offer a diverse range of product offerings.

• For instance, in April 2025, QIAGEN expanded its QIAcuity digital PCR offering with new lentivirus solutions designed to enhance the quality control of cell and gene therapies. The development highlighted the growth in cell and gene therapy, which has elevated demand for molecular quality control workflows.

Segmentation

Key Insights

The report covers the following key insights:

• Key Industry Developments
• Overview: Advancements in Molecular Quality Controls
• New Product Launches, By Key Players

Analysis by Product Type

Based on product type, the global molecular quality controls market is segmented into third-party independent controls, instrument/assay-specific controls, custom/OEM controls, and validation panels.  

The third-party independent controls segment is anticipated to hold a leading market share. The segment dominated the market as laboratories require an unbiased way to verify assay performance. As molecular testing volumes rise and labs run multiple instruments and assay brands, the risk of systematic bias, batch variation, or workflow drift increases. This results in labs preferring independent controls that help detect issues earlier and standardize performance across sites. Various key players are focusing on new product launches for the segment and supporting the growth.

• For instance, in July 2022, ZeptoMetrix launched two new vaginal molecular QC controls, NATVPOS-6C Vaginal Positive Control and NATVNEG-6C Vaginal Negative Control, for in vitro diagnostic use. These molecular controls provided additional confidence in the quality and reliability of clinical laboratory testing.

Analysis by Technology

Based on technology, the global molecular quality controls market is segmented into PCR/qPCR, Multiplex PCR syndromic panels, NGS, and Others.

PCR/qPCR is expected to hold a leading market share. PCR/qPCR typically dominates as it remains the most widely deployed molecular technology, is used for routine diagnostics, and has high testing volumes. As labs run PCR/qPCR at large volumes for infectious disease and other applications, the usage of quality control also scales directly. These factors position them as the leading technology for molecular controls. Many key companies are directing their resources toward new product launches in the segment, underscoring its growth potential.

• For instance, in July 2025, Bio-Rad Laboratories, Inc., launched four new Droplet Digital PCR (ddPCR) platforms. The increasing availability of platforms for PCR/qPCR techniques heightens the need for efficient quality controls in this segment.

Analysis by Application

Based on application, the global molecular quality controls market is segmented into Infectious Disease, Oncology & Hereditary Testing, Transplant, Pharmacogenomics, and Others.

The infectious disease segment dominated the global market. A high share is attributed to this segment as it drives the highest volume of routine molecular tests and requires consistent performance to avoid false positives/negatives. As respiratory and other pathogen testing expands and seasonal surges create workload spikes, laboratories increase external controls to monitor and detect contamination, maintaining confidence across changing targets and variants. Such factors, including higher infectious disease testing and more frequent quality control, make infectious disease the largest application for molecular controls.

• For instance, in July 2020, LGC SeraCare launched AccuPlex SARS-CoV-2 Reference Material Kit v2 for in vitro diagnostic use for infectious disease testing. The development signifies that the AccuPlex SARS-CoV-2 Molecular Controls Kit met extensive design control requirements. These factors are expected to drive the segmental growth.

Analysis by End User

Among the end user, the global molecular quality controls market is segmented into clinical labs & hospitals, reference labs, IVD manufacturers, and others.

Clinical labs and hospitals are expected to hold a leading share of the global market. These settings primarily run molecular tests daily at scale and are directly accountable for releasing patient results. As hospital networks expand their in-house molecular capabilities and adopt faster multiplex testing to support urgent clinical decisions, they require routine quality control to maintain stable turnaround times and ensure reliable results across all sites. Building on these advantages, key companies are also launching new products that cater to the demand of clinical labs.

• For instance, in February 2020, Bio-Rad Laboratories, Inc. launched EDX RP Positive Run Control, an unassayed external quality control intended to monitor the performance of clinical respiratory assays. Routine use of EDX RP Positive Run Control allowed laboratories to meet their individualized quality control goals, including evaluation of reagent lot changes and new shipments. Such developments are expected to drive the segmental growth.

Regional Analysis

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By region, the market is categorized into Europe, North America, Asia Pacific, Latin America, and the Middle East & Africa.

North America accounted for approximately 40% of the global molecular quality controls market in 2025. The market in North America is growing as clinical labs and hospital networks are running high volumes of PCR and other molecular tests. Higher molecular testing throughput, resulting in increased routine quality control consumption and tighter standardization requirements, is driving strong demand. Underscoring this growing demand, key companies are also expanding their product offering for the segment to capitalize on market growth.

• For instance, in May 2021, Microbix Biosystems Inc. appointed SDT Molecular Pte Ltd (SDT), a U.S.-based company, as the distributor of Microbix’s quality assessment products (QAPs) for four Asia Pacific territories. Such developments drive the market growth in the region.

Europe is expected to grow at a significant CAGR during the forecast period. The growth in the region is attributed to the growing adoption of cancer genomics, pharmacogenomics, and broader molecular testing. More advanced molecular testing in the region supports the diagnosis of infectious diseases, leading to greater monitoring needs and accelerating QC demand.

• For instance, in September 2024, LGC partnered with AccuGenomics, a pioneer in the development of molecular diagnostics. This collaboration aimed to drive innovation in clinical diagnostic tools by combining LGC’s expertise in quality control solutions with AccuGenomics’ advanced next-generation sequencing (NGS) monitoring technologies. Such developments increase the demand for molecular quality control and drive growth in the region.

Asia Pacific is expected to grow at the fastest CAGR during the forecast period as genomics infrastructure is expanding quickly. More hospitals, research centers, and diagnostic labs are adopting NGS for oncology and inherited diseases, which increases the need for reliable run control and assay standardization to support quality. The growing network for DNA sequencing and other technologies drives market growth in the region.

• For instance, in August 2023, Illumina Inc., a global leader in DNA sequencing and array-based technologies, announced the opening of a new office and state-of-the-art Illumina Solutions Center in Bengaluru, India. Such developments are expected to boost market demand.

Key Players covered

The global molecular quality controls market reflects a semi-consolidated competitive structure, with a few players capturing a significant market share.

The report includes the profiles of the following key players.

• Bio-Rad Laboratories, Inc. (U.S.)
• Thermo Fisher Scientific Inc. (U.S.)
• LGC Limited (U.S.)
• ZeptoMetrix (U.S.)
• Microbiologics, Inc. (U.S.)
• SDT Molecular Pte Ltd. (Singapore)
• Randox Laboratories Ltd (U.K.)
• Hoffmann-La Roche Ltd. (Switzerland)
• Abbott (U.S.)
• Siemens Healthineers AG (Germany)

Key Industry Developments

• August 2025: bioMérieux launched GENE-UP PRO HRM, a DNA-based test developed to detect heat-resistant molds at the molecular level.
• June 2025: QuidelOrtho Corporation announced a refocusing of its molecular diagnostics strategy. This strategy entails the intention to acquire full ownership of LEX Diagnostics following clearance by the U.S. FDA through the 510 (k) process.