Genotyping Assay Market Size, Share, By Offerings (Reagents & Kits, Instruments, Software, and Services), Techniques (Microarray, DNA Sequencing, Polymerase Chain Reaction (PCR), Mass Spectrometry, Electrophoresis, and Others), Application (Genetic Disease Diagnosis, Forensic Analysis, Pharmacogenomics, Agriculture, and Others), End-User (Diagnostics & Research Laboratories, Academic Institutes, Pharmaceutical & Biotechnological Companies, and Others), and Region - Trends, Analysis, and Forecast till 2035

• By 2035, the target market is expected to increase at a rate of USD 73.9 Billion.
• In 2024, the genotyping assay market size was worth USD 20.0 Billion.
• The market is expanding at a CAGR of 14.1%.

Genotyping assay is a biological test that identifies genetic variations in an individual. Genotyping assay is used to compares target DNA sequence to a reference sequence or another sample to determine differences in their genetic makeup. It is essentially determining their genotype a particular genetic locus, which gives information about potential disease risks, traits and relationships between individuals.

Genotyping assay contains methods, such as PCR with specialized probes that can differentiate between different DNA at specific site. Genotyping assay market includes the development, production and sale of kits, instruments, and services that used to analyze an individual’s DNA sequence. The increasing applications in diagnosis, pharmacogenomics, agricultural research and animal breeding, help to drive genotyping assay market growth.

Impact of AI on Genotyping Assay Market:

Artificial Intelligence (AI) significantly impacts genotyping assay market by improving the speed, accuracy, and efficiency of genetic data analysis, allowing for faster diagnosis, personalized medicine and identification of novel genetic variations associated with diseases. AI algorithms can analyze large amounts of genomic data much faster than traditional methods, and help to reduce genotyping assay errors.

Key Drivers of Target Market:

Technological Advancement in Genotyping Assay Products is Expected to Drive Market Growth

Technological advancement in genotyping assay have significantly enhanced the accuracy and speed by reducing cost for the sequencing. Technological advancement allow for the simultaneous amplification of multiple genetic markers, analysis of complex genetic variations, increase sensitivity for detection mutation through advancing techniques, such as PCR, real-time PCR, digital PCR, and next-generation sequencing. These techniques are widely applicable in clinical diagnostics, personalized medicine and others, resulting to drive target market growth in upcoming years.

• For instance, in September 2023, Bio-Rad launched PTC Tempo 48/48 and PTC Tempo 384 Thermal Cyclers products. These products designed to support PCR application in basic and translational research, process development, and quality control. The PTC Tempo Thermal Cyclers are aimed to build with refreshed, instinctive user interface and flexible connectivity features for streamlining protocol management, including monitoring capabilities on the cloud platform.

Increasing Demand for Personalized Medicine is anticipated to Drive Market Growth

Personalized medicine aims to giver treatment to an individual’s genetic profile and genotyping assays which are crucial for identifying genetic variations. Personalized medicine are depends on drug response, disease susceptibility and treatment outcomes. The increasing burden of chronic diseases, such as cancer, cardiovascular diseases and diabetes, increase demand for personalized medicine to manage better conditions according to patient’s genetic information.

Restraints:

Complexity of Data Interpretation Disrupt Target Market Growth

Genotyping assay generate vast and complex datasets that require significant professionals to interpret and analyze data as per requirement. The need for highly trained professionals, advanced computational tools and bioinformatics support may limit the some laboratories ability to interpret complex data.

• Counterbalance Statements: Integration of artificial intelligence (AI) and machine learning (ML) tools into the genotyping process which help to simplify data analysis and interpretation. AI can automatically identify patterns, reduce human error and provide increased efficiency of genotyping assays.

Opportunities & Market Trends:

Integration of Genotyping Assay in Clinical Diagnostics Hold Largest Market Share

Genotyping assays are widely used in a diagnostic to detect genetic mutations linked to specific disease. The integrating genetic testing into clinical care such as cancer genotyping, pharmacogenomics drive the target market growth. Genotyping assay is continuously used in oncology by enabling precision cancer care by early detection of genetic mutation in tumors. It is used to identify targeted therapies and monitor treatment response. Resulting to drive genotyping assay market share growth.

The genotyping assay is segmented into offerings, techniques, application, end-user, and region.

Offerings:

By offerings, genotyping assay market is segmented into reagents & kits, instruments, software, and services. The reagents & kits segment is dominate in the target market, due to it is key component used in laboratory process that analyze DNA to determine certain variants if present. Genotyping reagents contains, DNA polymerases, primers and others, while kits include, genotyping kits, BeadChip kit and others. These reagents or kits uses target DNA sequence which is compared to the ideal DNA sequence to identify loci of the sequence.

• For instance, in April 2024, Bio-Rad launched multiplexed digital PCR assay for breast cancer mutation detection, known as ddPLEX ESr1 Mutation Detection Kit. The assay aimed to give highly sensitive and multiplexed mutation detection assays aid translational research, therapy selection, and disease monitoring. This new kit provides oncology researchers with technologies that enables biomarker discovery and clinical trials, which improves patient monitoring.

Techniques:

Microarray, DNA sequencing, polymerase chain reaction (PCR), mass spectrometry, electrophoresis, are the technique segments in target market. The PCR hold the largest genotyping assay market share due to its high accuracy, speed and cost. The increasing demand for advanced diagnostic technique, rising number of chronic disease disorders, forensic & research laboratories and growing prevalence of genetic disorder resulting to drive genotyping assay market growth.

• For instance, the article published by Elsevier B.V., in February 2024, this article highlights the, study was conducted by researchers from the University of Cambridge and involved collaboration with the National Health Service (NHS) and other public health institutions in the UK. Researchers designed specific RT-PCR assays that target the genetic markers associated with SARS-CoV-2 variants. These assays aimed to identify key mutation in the spike protein, by comparing the genotyping and whole genome sequencing of variant to give sensitive and specific value.

Application:

By application, genotyping assay market is divided into genetic disease diagnosis, forensic analysis, pharmacogenetics, agriculture, and others. The genetic disease diagnosis segment dominate the target market due to rising adoption of genotype products for research and growing need for genetic disease diagnosis. Genetic testing allow to identify genetic disorder at early stage and help to identify best treatment according to individual genetic condition, resulting to drive genotyping assay market growth.

End-User:

Genotyping assay market, by end-user, is divided into diagnostics & research laboratories, academic institutes, pharmaceutical & biotechnological companies, and others. The research & academic institutes hold the largest share in target market due to extensive use of DNA sequencing in research laboratories to get understanding of genomic expressions, variations, and functions. Genotypic mutations help to examine complex biological challenges, disease mechanisms, and evolutionary studies, help to drive genotyping assay market.

Region:

Geographically, the market is studied across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

North America: This region is the dominating region in genotyping assay market share due to the presence of well-established healthcare infrastructure, high healthcare awareness and increasing prevalence of chronic diseases. The major biopharmaceutical companies and sequencing services are present in this region, resulting to drive Genotyping Assay market share growth.

• For instance, in July 2024, Illumina, a global leader in NGS technology, had announced acquisition with Fluent BioSciences, to accelerate Illumina’s ability to expand its single-cell analysis capabilities and expand its customer base. Single-cell analysis is rapidly growing area that focused on researchers to gain deeper insights into complex biological process and perform assay at the point of sample collection.

Europe: This is the second-leading region in the target market. The factors, such as the proliferation of academic institutes, increased healthcare infrastructure and rising demand for the personalized therapy resulting to drive genotyping assay market. The Germany and U.K. genotyping market was the fastest-growing market in the European region.

Genotyping Assay Market Report Scope:

Segmentation:

By Offering:

• Reagents and Kits
• Instruments
• Software
• Services

By Techniques

• Microarray
• DNA Sequencing
• Polymerase Chain Reaction (PCR)
• Mass Spectrometry
• Electrophoresis
• Others

By Application:

• Genetic Disease Diagnosis
• Forensic Analysis
• Pharmacogenomics
• Agriculture  
• Others

By End-User:

• Hospitals and Clinics
• Academic and Research Institutes
• Pharmaceutical & Biotechnological Companies
• Others 

By Region:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • U.K.
  • France
  • Russia
  • Italy
  • Spain
  • Netherlands
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • Indonesia
  • Malaysia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East & Africa
  • GCC
  • Israel
  • South Africa
  • Rest of Middle East & Africa

The key players operating in the genotyping assay market include Illumina, Inc., Thermo Fisher scientific Inc., Agilent Technologies, Inc., and others. These key players are focusing on product launch, product approvals and enhancement through partnerships, agreements and collaborations adoption, production capabilities, company’s strength and weakness, resulting to genotyping assay market growth.

List of Key Players in the Market:

• Illumina, Inc
• QIAGEN
• Agilent Technologies, Inc
• GE Healthcare
• Standard BioTools
• Adaptive Biotechnologies
• Oxford Nanopore Technologies plc
• F. Hoffmann-La Roche Ltd
• PerkinElmer
• Thermo Fisher Scientific Inc.
• Twist Bioscience
• Bio-Rad Laboratories, Inc
• Macrogen, Inc.
• Eurofins Scientific

• In November 2024, BD Company introduced transforming cervical cancer protection with the BD Onclarity HPV assay. This assay was approved by FDA, includes extended genotyping, which differentiated HPV types based on risk levels. This precision enables targeted follow-up care, where individuals with high-risk of genotypes such as HPV 16 or 18 can proceed directly to colposcopy.
• In May 2021, Bio-Rad launched the SEQuoia RiboDeplation kit for next generation sequencing. This kit aimed to improve assay efficiency by eliminating irrelevant ribosomal RNA fragments from an RNA/DNA-seq library. This kit helps to retains rare transcripts commonly lost from a pre-library RNA depletion process and enables the pooling of multiple libraries into depletion reaction to save time and reduce costs.

Analyst View:

Genotyping assay market is significantly driven by expanding applications of next-generation sequencing in clinical diagnostics, research and personalized medicine. The rising demand for automated tools and AI-driven platforms to interpret complex genomic data and have ability to handle large-scale of data generated by next-generation sequencing help to drive market growth. The increasing demand for genomic data analysis across industries, such as oncology, immunology, stem cell research, and others resulting to drive Genotyping Assay market growth.

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