Genotyping Market

Market Overview

The global genotyping market size was valued at USD 14.22 billion in 2022. It is estimated to reach USD 53.24 billion by 2031, growing at a CAGR of 15.8% during the forecast period (2023–2031).

Genotyping is a process of analysis that looks at DNA sequences to ascertain the genetic makeup of the genotypes of living things, such as people, plants, animals, and microorganisms. The technology detects small genetic differences that can contribute to significant phenotypic changes, including the physical differences that make one unique and the pathological changes underlying the disease. Genotyping identifies genetic complement differences by comparing the DNA sequence of one sample to that of another or a reference sequence. It identifies minor genetic sequence variations within populations, such as single-nucleotide polymorphisms (SNPs).

Genetic testing enables researchers to examine a range of genetic abnormalities, including changes in DNA structure and single nucleotide polymorphisms, by identifying genetic variances through biological assays. Using this data makes it possible to compare how different people are while learning more about a person's genetic background. On the other hand, identifying the cause of bacterial and viral infections through the genomic analysis of microorganisms such as viruses and bacteria aids in the prevention of the spread of pathogens. It has numerous applications in fundamental scientific research, medicine, and agriculture.

Highlights

• Others dominate thetechnology segment
• Diagnostics and personalized medicine dominate the application segment
• Diagnostics and research laboratories dominate the end-user segment
• North America is the highest shareholder in the global market

Market Dynamics

Global Genotyping Market Drivers

Technological Advancements and Decreasing Cost of the DNA Sequencing

Technological advances have enabled miniaturization, automation, overall cost reductions, operational flexibility, and the incorporation of multi-parameter testing. Many of these have significantly improved the versatility and uses of DNA sequencing, freeing doctors to concentrate on important choices like identifying and selecting therapeutic targets through diverse genotyping investigations. As a result, technologies like capillary electrophoresis, microarrays, PCR, sequencing, and sequencing have increased use in areas like clinical research and drug development.

Rapid, accurate sequencing has been made possible by technological advancements in DNA sequencing, such as NGS, leading to high productivity. According to the National Human Genome Institute, this has also decreased the price of DNA sequencing, which has resulted in a USD 2,500 reduction in the entire cost of genomic and genotyping projects within a year. Therefore, DNA sequencing costs are decreasing due to technological advancements, driving market growth.

Expanding Application Areas of Genotyping

There are several potential uses for genotyping platforms, including pharmacogenomics, diagnostic research, customized medicine, and forensics. This technology is also suitable for various veterinary requirements, food safety and quality testing, and environmental conditions in rural and industrial settings. Human diagnostics and pharmacogenomics now provide enormous market potential as both fields necessitate large-scale, quick genotyping analysis to develop better treatment options for their prevalent diseases. Technologies like NGS are being modified to meet this objective. Businesses like QIAGEN and Freenome (US) have partnered to develop NGS-based precision medicine assays, fueling the market expansion.

Global Genotyping Market Restraint

High Expense of Genotyping Equipment 

The acquisition of instruments necessary for conducting genotyping tests entails a significant financial burden, as high costs characterize them. Moreover, their utilization necessitates a substantial initial capital outlay. qPCR systems, for instance, cost between USD 20,000 and USD 30,000, whereas dPCR systems cost between USD 65,000 and USD 70,000 for manual dPCR and exceed USD 100,000 for automated dPCR. As a result of their sophisticated features and functionalities, genotyping instruments are expensive.

Pharmaceutical companies and research laboratories require several of these systems, necessitating substantial expenditures for acquiring multiple expensive genotyping instruments. Maintenance costs and several other indirect expenditures, such as sample and labor costs, increase the total cost of ownership for these instruments. Therefore, the installation/expansion of sophisticated research facilities, such as NGS technology, is hindered in academic and research institutes in developing nations in Asia and the Middle East and Africa, hampering market growth.

Global Genotyping Market Opportunities

Rising Initiatives by Government and Key Players

Several opportunities for the global genotyping market are anticipated to arise from the government's increasing support for genotyping research. Governments from all around the world are working hard to put into place a variety of programs to aid organizations that research personalized medicine. For instance, the National Institutes of Health granted USD 28.6 million to the "All of Us Research Program" in September 2018 to develop three genome centers across the United States that would be used for precision medicine research.

The strategic initiatives important players implement are also anticipated to accelerate the market's growth. As an illustration, the NovaSeq X Series of new production-scale sequencers was introduced in September 2022 by Illumina, a pioneer in DNA sequencing technologies. Illumina recently released a platform intending to push the boundaries of genetic medicine by making it more efficient, durable, and potent. The company's innovative technology enables the production of over 20,000 genomes annually.

Regional Analysis

North America Dominates the Global Market

Based on region, the global genotyping market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America is the most significant global genotyping market shareholder and is anticipated to exhibit a CAGR of 17.6% during the forecast period. North America is expected to grow at a lucrative pace over the forecast period due to its highly regulated and well-established healthcare infrastructure. This has led to an increase in the need for early diagnosis of these diseases. Some key players in this region are also expanding their businesses due to the high demand for direct-to-consumer diagnostics. For instance, in July 2021, 23andMe, a genomic diagnostics company, announced that it would be providing services in eight new regions in North America. These factors are boosting market growth. High demand for genotyping products is one factor stimulating the growth of this market.

Additionally, high awareness and rising healthcare expenditure in the region are some factors expected to present this market with future growth opportunities. The local presence of regulatory agencies in North American countries is expected to boost the growth of genotyping-based drug development.

Europe is predicted to exhibit a CAGR of 17.5% over the forecast period. The growing prevalence of cardiovascular disorders and genetic disorders and increasing investments in genotyping research are expected to contribute to market growth. However, the European economic crisis and uneven reimbursement policies may restrain market growth. In 2017, a new regulation was issued regarding IVD and medical devices in European countries, likely to be updated by 2022. The new regulation is expected to offer a more sustainable and robust framework for compliance with genotyping and diagnostic devices. Furthermore, introducing novel products and the increasing importance of SNP genotyping in drug development are among the major factors responsible for market growth. Increasing government funding, genetic counseling program by the government, and growing investments in the healthcare sector are some of the high-impact rendering drivers in Europe.

Asia-Pacific is one of the lucrative and fastest-growing markets for genotyping due to a large population suffering from chronic diseases like cancer and genetic disorders. Hospitals receive reimbursement from governments for treatment and diagnostic tests in some of the more developed economies in the Asia-Pacific. Underdeveloped economies provide little to no reimbursement. However, these countries are expected to change their guidelines over the forecast period. Companies in this area should benefit financially from improving healthcare reimbursement guidelines, a sizable target population, and high unmet diagnostic needs. The presence of market participants and the introduction of technologically advanced instruments increased demand for genotyping products. The increasing number of government initiatives aimed at bettering the population's health is also anticipated to hasten market expansion over the forecast period.

In Latin America, the increasing prevalence of neurological disorders, different types of cancer, such as cervical cancer, breast cancer and other chronic diseases, and growing demand for highly advanced genotyping instruments are expected to boost the genotyping market. Moreover, a rise in private-public partnerships to promote research on personalized medicines is expected to drive regional growth. Technological developments are also expected to contribute to market growth. In addition, increased government spending, the presence of skilled healthcare professionals, a rise in the focus of multinational pharmaceutical companies on developing advanced and novel products, and an increase in patient awareness are likely to drive market growth in Latin America.

Segmental Analysis

The global genotyping market is segmented by technology, application, and end-user.

Based on technology, the global genotyping market is bifurcated into direct PCR and others. 

The other segment dominates the global market and is projected to exhibit a CAGR of 17.91% over the forecast period. Some other prominent technologies used in genotyping are capillary electrophoresis, Mass Spectrometry (MS), sequencing, and DNA microarray. Capillary electrophoresis is one of the emerging technologies that have the potential to be automated, which would enhance the speed of genotyping procedures. Despite its popularity, slab-gel electrophoresis has several drawbacks compared to its more modern capillary counterpart. Detection can be fully automated, which enables rapid separation and low waste generation. The process requires tiny quantities of samples. In addition, quantitative information is made available in a single step in combination with computer collection of the data.

The direct PCR technique omitted the nucleic acid isolation and purification step, and the sample is directly used for amplification. In high-volume applications such as genotyping, this approach helps save experimental time and expense. Since the step of nucleic acid isolation and purification is omitted, it is a better alternative when dealing with small amounts of samples where the purification stage could result in sample loss. The tailored buffer used in direct PCR is the fundamental difference between this and conventional PCR. In addition, direct PCR is more efficient compared to conventional PCR. It takes less process time because it omits the purification step in the upstream and downstream processing of the sample. It is less expensive, as DNA extraction and purification steps are not involved, which reduces the overall cost of the process.

Based on application, the global genotyping market is segmented into diagnostics and personalized medicine, pharmacogenomics, agricultural biotechnology, animal genetics, and others. 

The diagnostics and personalized medicine segment owns the highest market share and is estimated to exhibit a CAGR of 18.1% during the forecast period. Genotyping techniques using PCR, in situ hybridization, and nucleotide sequencing for DNAs and RNAs find significant applications in molecular testing for several viral, bacterial, and parasitic pathogens and genetic irregularities in cancer-affected cells that can be further used in personalized medications. Early cancer detection and other disease diagnosis are among the most important of these uses. In situ, hybridization and PCR through genotyping find significant applications in genetic testing, including diagnosis of inherited DNA abnormalities and determination of parentage and ancestry. In the present market, specific tests are available for various genetic diseases. They are used for newborn screening, testing for chromosomal conditions, testing for possible carriers, and prenatal diagnosis of genetic disorders.

Applying genotyping techniques in pharmacogenomics involves high-throughput testing of new chemical entities (NCE) viable for novel drug development specific to a particular genetic profile. Analysis of individual drug responses helps gain insights into the correlation between nucleotide polymorphism and drug metabolism. In addition, population subsets with varied genetic makeups can benefit from individualized treatment by being identified as responsive or nonresponsive. This enables the formulation of medication specific to a population subset suffering from a particular disease, which paves the way for personalized medicine.

Based on end-user, the global genotyping market is divided into pharmaceutical and biopharmaceutical companies, diagnostics and research laboratories, academic institutes, and others. 

The diagnostics and research laboratories segment is the largest contributor to the market and is expected to exhibit a CAGR of 18.21% during the forecast period. Increased awareness about personalized medicine, a rise in demand for affordable services, and technological advancements are key factors expected to boost segment growth. The growing incidence of cancer and the rising demand for diagnostic tests like cancer genotyping assays are expected to drive the market. There is also increased demand for automated and efficient products in the market, which is expected to increase diagnostic research. Moreover, initiatives undertaken by the government to provide support and funding to research organizations are other major factors anticipated to drive the market. For instance, in August 2019, NIH funded USD 4.6 million in initial grants for precision medicine initiatives and development to Color, a health technology company.

Biopharmaceutical and pharmaceutical companies segment is expected to exhibit lucrative demand over the forecast period. The FDA's recommendations to incorporate pharmacogenomics studies and genotyping in drug discovery and the growing need for pharmacogenomics in drug development are predicted to fuel market expansion. Pharmacogenomics is a tool that businesses frequently employ to create new medications. For instance, bluebird bio, Inc. has several gene therapy products in its R&D and clinical phases, such as betibeglogene autotemcel gene therapy and Lentiglobin gene therapy, which are in Phase III clinical trials. Thus, all such treatments based on pharmacogenomics are likely to boost market growth.

Recent Developments

• January 2023- Thermo Fisher Scientific, a world leader in offering scientific services, announced the release of its CE-IVD marked Applied Biosystems TaqPath Seq HIV-1 Genotyping Kit. This Sanger sequencing-based assay analyzes HIV-positive samples to find genetic variants that may resist conventional antiretroviral therapies.
• December 2022- OmicsVeu, a fully owned subsidiary of BioGenex, announced the release of a wide range of Multiplex Multi-Omics products for spatial biology, including a fully automated instrument called NanoVIP® with optimized protocols, ready-to-use reagents for SuperPlex Phenotyping, Genotyping & Phenotyping kits, miRNA, mRNA, and DNA FISH probes and kits, and an in situ sequencing system.