U.S. Genotyping Market Size to Hit USD 23.33 Bn by 2033

U.S. Genotyping Market Size, Future Outlook and Company Analysis Report

The U.S. genotyping market was valued at US$ 6.45 billion in 2023 and is predicted to reach US$ 23.33 billion by the end of 2033, representing an impressive CAGR of 13.72% from 2024 to 2033. The increasing importance of genotyping in biotechnology and healthcare is driving the market’s growth.

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Key Takeaways

• By product, the reagents & kits segment has contributed more than 62% of revenue share in 2023. 
• By product, the services segment is expected to grow at a significant CAGR of 13.62% during the forecast period. 
• By technology, the sequencing segment has held a major revenue share of 23% in 2023. 
• By technology, the PCR segment held the second-largest share of the market in 2023. 
• By application, the diagnostics and personalized medicine segment has generated more than 35% of revenue share in 2023. 
• By application, the pharmacogenomics segment is projected to grow at the fastest CAGR of 14.52% during the forecast period. 
• By end-use, the diagnostics and research laboratories segment has recorded more than 37% of revenue share in 2023. 

Industry at a Glance

Custom genotyping, genetic counseling, genotyping assay, Sanger sequencing, fragment length analysis, and genotyping data analysis services are among the services that generate income for the U.S. genotyping market. The process known as genotyping identifies minute genetic variations that can result in significant phenotypic alterations, encompassing both the anatomical distinctions that distinguish us from one another and the pathological modifications that underlie illness. It has several applications in fundamental science, medicine, and agriculture. Genotyping compares a DNA sequence to a reference sequence or another sample to identify variations in the genetic complement. It detects minute differences in DNA sequence among populations.

Through genotyping, researchers may investigate genetic variations, including major structural changes in DNA and variations in copy number and single nucleotide patterns. Numerous genetic targets may contribute to a given illness. Therefore, flexibility and precision are necessary for analysis. Tools for analyzing genotyping data may identify sample outliers and evaluate findings for millions of markers and probes, giving researchers insight into the functional effects of genetic diversity. All these factors contribute to the growth of the U.S. genotyping market.

Top Companies in the U.S. Genotyping Market

• Bio-Rad Laboratories Inc.
• GE Healthcare Inc.
• Eurofins Scientific Inc.
• Agilent Technologies
• Danaher Corporation
• Fluidigm Corporation
• F. Hoffmann-La Roche Ltd.
• QIAGEN
• Thermo Fisher Scientific Inc.
• Illumina Inc.

Contribution of Thermo Fisher Scientific Inc. in the U.S. Genotyping Market Growth

Contribution of Bio-Rad Laboratories Inc. in the U.S. Genotyping Market Growth

Increasing Prevalence of Genetic Disorders is Driving the U.S. Genotyping Market

In addition to the well over 6,000 known genetic disorders, there are now many new genetic ailments being described in the medical literature. Numerous rare genetic illnesses exist that have gotten significantly less attention and could not have been correctly recognized. Both manufactured and natural environments include a multitude of compounds that might be harmful to an individual's DNA. These agents can be viruses, compounds made by bacteria, fungi, or plants; they can also be industrial chemicals, combustion products, alcohol, UV and ionizing radiation, and even oxygen.

Due to the prolonged nature of many of these chemicals, humans have evolved defense systems to lessen the harm they do, as well as techniques for mending the harm that cannot be avoided. The U.S. genotyping market is growing due to different factors that are contributing to the increasing number of genetic disorders in the U.S.

For instance,

• The most frequent chromosomal disorder to be diagnosed in the US is Down syndrome. Approximately 5,700 newborns born in the United States each year are affected by Down syndrome. This indicates that around 1 in 640 newborns are born with Down syndrome.
• It is estimated that between 70,000 and 100,000 Americans suffer from sickle cell disease, the most prevalent kind of hereditary blood illness. While the remaining 3% to 9% are thought to be Hispanic or Latino, the majority are Black or African American, who make up over 90%. More than 20 years are predicted to be lost from the average life expectancy for Americans with sickle cell disease (SCD).
• In the U.S., one in 300 persons has hereditary hemochromatosis. Approximately one million persons in the U.S. suffer from type 1 hemochromatosis, one of the most prevalent hereditary illnesses.

Privacy and Ethical Concerns can Restraint the Market’s Growth

There are ethical and privacy concerns associated with genetic data, which can restrict the growth of the U.S. genotyping market. Informed consent, privacy and secrecy are possible ethical issues. Concerns regarding privacy and confidentiality include violations that might result in stigmatization and discrimination against members of particular racial groups or individuals in the workplace or health insurance market, as well as whether or not to notify family members of a genetic marker for a disease, particularly in cases where the original participant donor (proband) is unwilling to provide the information.

Integration of AI Creates Growth Opportunities for the U.S. Genotyping Market

In the realm of DNA analysis, artificial intelligence (AI) has quickly become a game-changer, opening up new avenues and improving speed and accuracy in the complex code that makes life. The development of AI computational tools to swiftly and effectively diagnose genetic illnesses in patients and offer the data foundation for precision medicine therapies is accelerated due to the growing quantity and complexity of genomic sequencing data as well as other biological data points. Deep learning techniques have a lot of promise in identifying genomic variations, such as inherited genetic variants, that are correlated with certain traits or illnesses. It has been demonstrated that by automating the identification of genetic diseases, AI-based technologies may greatly reduce expenses and speed up case reviews. Personalized medicine is one of the main fields in which genotyping finds use. AI is able to examine an individual's genetic composition and forecast how they would react to particular drugs.

Report Highlights

Product Insights

By product insights, the reagents & kits segment dominated the U.S. genotyping market in 2023. Products for molecular biology applications, including consumables, kits and solutions. Includes supplies for the production, extraction, isolation, purification, labeling, and analysis of nucleic acids, as well as DNA vectors, buffers, reagents, enzymes, controls, and reagent supplies. Numerous companies provide a range of genotyping kits. These goods provide a practical and trustworthy way to look at genetic diversity within and between people, animals, plants, and individual genes. Amplitude fragment length polymorphism (AFLP), SNP genotyping, animal DNA extraction, high-resolution melt analysis (HRM), and qPCR genotyping tools are a few of these.

By product insights, the software and services segment is expected to grow at a significant rate during the forecast period. Software and services play a key role in the growth of the U.S. genotyping market. A large number of services are associated with genotyping that are helpful in genetic data analysis and can be further used for research, disease analysis, treatment, and other aspects. Different services that come under genotyping include SNP genotyping, genome-wide association studies, whole genome amplification, biomarker determination and validation, copy number variation, pharmacogenomics, population genetics, and targeted sequencing. Apart from this, various software are also used for data processing, storage, and analysis. Such software is useful in improving efficiency, accuracy, productivity, and overall performance.

Technology Insights

By technology insights, the sequencing segment dominated the U.S. genotyping market in 2023. Genome sequencing means sequencing an organism's whole genome. Technologies for data management and high-throughput sequencing have been developed in large numbers. Both whole genome shotgun sequencing and the clone-by-clone approach are popular methods for sequencing genomes. A growing number of fundamental studies, translational medicine and vaccine development, and clinical diagnostics and research are using genome sequencing as a tool. An earlier genetic diagnosis has a stronger influence on medical care, may result in more possibilities for appropriate treatment, and can reduce harm by reducing the number of pointless diagnostic procedures or useless therapies.

By technology insights, the PCR segment held the second-largest share of the U.S. genotyping market in 2023. Numerous genotyping techniques and methods make use of the polymerase chain reaction (PCR). When tracking a known genetic sequence, like in the case of identifying model organisms with a transgene, simple PCR can be employed for genotyping. When an animal's DNA contains the precise sequence that scientists have added, PCR primers may be made to exclusively amplify the result. In recent times, real-time PCR-based SNP genotyping techniques have become more and more common in research and diagnostic labs because of their many benefits, which include lower labor costs, increased throughput, and a lower chance of crossover contamination.

Application Insights

By application insights, the diagnostics and personalized medicine segment dominated the U.S. genotyping market in 2023. Researchers are experimenting with integrating the enormous quantity of data that genomics and genetics advances have produced with patient medical histories and genomes. The ability to anticipate a person's risk of disease and how medicine will react by genetic profiling will help us understand the pathophysiology of disease and make genuinely personalized medicine and treatment possible. We now have a better grasp of disease states and treatment responses because of the search for genetic information. Creating tailored treatments would lower the overall expense of medication development and guarantee that patients receive the right treatments using a more evidence-based methodology.

By application insights, the pharmacogenomics segment is estimated to grow at the fastest rate during the forecast period. Pharmacogenomics, the study of human genetic composition in pharmaceutical settings, is gradually moving from bench to bedside, opening the door to personalized therapy. With consideration for the patient's genotype, pharmacogenomics seeks to rationally tailor pharmacological therapy to maximize effectiveness while minimizing side effects. Pharmacogenomics has potential applications in pain treatment, cardiology, cancer, and psychiatry, among other medical fields. Pharmacogenomics has a number of uses, such as decreasing adverse drug reactions and increasing drug safety, creating customized medications based on each patient's genetic predisposition, determining the ideal dosage, enhancing drug discovery aimed at treating human illness, and enhancing proof of principle for efficacy trials. The expansion of the category in the U.S. genotyping market is facilitated by all of these factors.

For instance,

• In March 2024, Igentify, a digital health firm that streamlines the genetic testing process, announced that its Non-Invasive Prenatal Testing (NIPT) and Pharmacogenomics (PGx) services are now available via the DA platform. They are including this extra roll-out into their Expanded Carrier Screening (ECS) service. Using its unique video technology, Igentify provides highly customized educational videos for each patient as part of the NIPT procedure. The patient web app expedites the patient intake process, including the consenting process, which complies with ACOG guidelines. The Digital Genetic Assistant provides speedy triaging and return of low-risk findings, as well as tailored videos with the option to reveal fetal sex and clinician-facing features.

End-use Insights

By end-use insights, the diagnostics and research laboratories segment dominated the U.S. genotyping market in 2023 and is expected to grow at the fastest rate during the forecast period. Over the past 20 years, genetic testing has been utilized more and more widely worldwide. The U.S. established the Genetic Testing Registry in response to the swift advancement of genetic testing, with the aim of facilitating open access to data on genetic tests and the associated labs. Over the past 20 years, precision medicine has evolved to assist illness screening and diagnosis, forecast disease risk, guide patient treatment response, and comprehend individual heritage.

There were 76,326 genetic tests available on GTR as of November 2022, with 76,083 (99.7%) of those tests being clinical and 243 (0.3%) being for research. Out of the 76,326 tests that are now available, 37,289 (48.91%) belonged to U.S. laboratories; 99.56 percent (37,124) and 0.44% (165) of the tests were conducted for clinical and research purposes, respectively. 200 laboratories in the U.S. have completed 37,124 clinical tests using the interactive database; 29 of those laboratories have carried out whole exome sequencing (WES), and 17 of those laboratories have carried out whole genome sequencing (WGS). As of November 2022, 129,624 genetic tests have been created and registered with the genetic testing registry in the U.S.. 51,803 new genetic tests have become accessible in the U.S. within the last ten years. 13,315 of the 51,803 newly developed genetic tests have a clinical or research indication. 39 (0.3%) and 13,276 (99.7%) of the examinations were for research purposes.

Recent Developments

• In January 2024, for population-scale illness investigations and pharmacogenomic research, Thermo Fisher Scientific unveiled the AxiomTM PangenomiX Array*, its biggest and most ethnically varied array to date. This array offers the best genetic coverage available. The goal of this new array is to better account for the more nuanced picture of genetic diversity in humans.
• In August 2023, through the establishment of marker-assisted selection society (MAS) capacity in breeding programs, the Vaccinium Coordinated Agricultural Project (VacCAP), funded by the US Department of Agriculture's National Institute of Food and Agriculture Specialty Crop Research Initiative (USDA-NIFA-SCRI) program, seeks to address significant bottlenecks impeding the growth of the cranberry and blueberry industries in the U.S.. The research integrates genetics, genomics, plant physiology, socioeconomics, and consumer sensory evaluations to investigate fruit quality attributes in a transdisciplinary manner.

Segments Covered in U.S. Genotyping Market Report

By Product

• Instruments
• Reagents & Kits
• Software and Services

By Technology

• PCR
• Capillary Electrophoresis
• Microarrays
• Sequencing
• Mass Spectrometry
• Others

By Application

• Pharmacogenomics
• Diagnostics and Personalized Medicine
• Agricultural Biotechnology
• Animal Genetics
• Others

By End-use

• Pharmaceutical and Biopharmaceutical Companies
• Diagnostics and Research Laboratories
• Academic Institutes
• Others