Gene Panel Market Size, Share & Trends Analysis Report By Product & Services (Test Kits, Testing Services), By Technique, By Design, By Application, By End-use, By Region, And Segment Forecasts, 2022 - 2030

Report Overview

The global gene panel market size was valued at USD 750.57 million in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 15.52% from 2022 to 2030. The market is witnessing growth due to the factors such as the increasing rate of hereditary disorders and cancer, growing demand for genetic screening, and evolving recommendations for genetic screening so as to take presumptive actions to efficiently bring down the mortality rate caused by genetic disorders. Moreover, understanding the genetic predisposition of any kind of cancer or any other known genetic disorder has become clinicians’ first choice so as to take an absolute step toward disease prognostics and therapeutics.

According to the Genetic and Rare Disease (GARD) Information Centre, there are at least 7,000 diagnosed genetic conditions and the list is growing continuously. At least 200,000 people in the U.S. are survivors of some kind of known genetic disorder. On the other hand, in the U.K., at least 30,000 infants are diagnosed each year with a genetic disorder, with an accumulation of over 2.4 million survivors of different kinds of genetic conditions. Many gene panels are designed to detect genetic disorders at birth so that effective prognosis and therapeutic steps can be taken as early as possible.

For instance, BGI Xome - Targeted Monogenic Disease Examination screening panel can analyze over 2000 genes for over 1500 monogenic defects. Though there is no approved cure for any genetic disorder, the rate of incidence can be brought down drastically with strategies like early screening, analysis of risk factors, taking effective prognostic steps, and designing effective therapeutic regimes so as to lower the burden of morbidity and mortality due to genetic disorders.

The adoption of numerous pre-designed and customizable gene panels along with direct-to-consumer genetic testing kits across the U.S., Japan, and China is on the rapid rise. For instance, Infinium Custom Methylation Kit is a customizable methylation microarray used exclusively for large and commercial target studies to understand methylation patterns. The kit is customizable according to research requirements. Leveraged technological interventions, improved genetic level awareness, and moderated cost factors are likely to give a significant boost to the market in the forecast period. 

Researchers and clinicians strongly demand pre-gestational, prenatal, and neonatal screening to rule out any possibility of any kind of genetic discrepancy that could be causative of various genetic disorders, including cancer. For instance, Prequel (by Myriad Genetics) is a prenatal screen that can be taken as early as 10 weeks during gestation to understand the probability of an embryo having Down syndrome. Demand for gene panels that could perform HLA typing is also on the rise due to the rising need for transplants like kidney, liver, and bone marrow transplants across the globe. 

Furthermore, gene panels are expected to occupy substantial market space, replacing the laboratory-based conventional genetic analysis technologies. For instance, in March 2022, Illumina launched the TruSight Oncology Comprehensive test in the European region that can capably assess a total of 517 tumor genes across 30 types of cancer and biomarkers to be able to derive a specific individual molecular profile. The test evaluates unique genomic signatures, such as tumor mutational burden (TMB) and microsatellite instability (MSI), thereby ruling out the need for individual and sequential genetic analysis through numerous biopsies.

Product & Services Insights

The test kits segment held the largest revenue share of over 85.0% in 2021 and is expected to maintain its lead during the forecast period. The population across the globe is inclining towards self-utilitarianism. There is a bare minimum requirement for any laboratory personnel or laboratory setup with direct-to-consumer testing kits. Consumers can make a purchase of a kit online, place the specimens (often simple samples like blood or saliva), and mail them back to the service provider. 

Test kits also significantly cut down human errors in diagnosis, the efforts of subjects commuting to a diagnostic laboratory, the agony of undergoing a medical diagnostic test, and thereby undue expenses. For instance, 23andMe is authorized to offer direct-to-consumer genetic tests by the FDA and offers over 50 tests that can analyze risks for genetic disorders. Moreover, the Australian government is known to directly dispatch home test kits to the target population for particular types of cancers. Further, direct-to-consumer kits are available for purchase across North America, Europe, MEA, and the Asia Pacific.

Technique Insights

Amplicon-based approach dominated the market with a share of over 65.0% in 2021. Amplicon based approach is a popular target-based next-generation sequencing method that analyzes genetic discrepancy in a specific genomic region. Specific instances of utility of the amplicon-based approach include genotyping through sequencing, validation of CRISP, locating an inherited SNP, and detection of indels (insertions-deletions). There are many commercially available gene panels based on amplicon sequencing for use with NGS technology. In addition, the increasing number of product launches is likely to accelerate segment growth by 2030. For instance, in April 2021, QIAGEN introduced a new amplicon approach-based ultra-fast sequencing solution for genomic surveillance.

The outcomes of the hybridization approach are best in terms of uniformity and complexity. This is advantageous while sequencing a large number of genes. The hybridization-based approach is often used for multigene panels in various clinical applications due to reproducibility and reliability. For instance, CD Genomics offers NGS panels such as pan-cancer panels and hereditary cancer panels for the detection of cancers that could analyze several genes by the hybridization approach. 

Design Insights

The pre-designed gene panel segment led the market with a share of over 60.0% in 2021 and is expected to witness significant growth during the forecast period. Since humans are yet at the nascent level of understanding genetic predisposition to any disorder, it is always suggestible that predesigned gene panels are used for consumer genetic testing to yield a comprehensive analysis. Though the concept of customizable gene panels is fascinating, clinicians always prefer that the genetic tests they use are backed by significant research and understanding. For instance, BGI SENTIS Lung Cancer Panel capably analyzes over 20 genes with therapeutic implications for 42 targeted drugs and all kinds of genomic aberrations using samples such as tissue, biopsy, or blood samples. 

Customized gene panels are expected to register a comparatively lower CAGR as compared to pre-designed ones during the forecast period. Customized gene panels are used for the diagnosis of rare disorders and various research purposes where a deeper understanding of a particular rare gene disorder is necessary. A clinician or a researcher may choose to add a known gene to the gene panel for the analysis of its contribution to the disease condition. 

End-use Insights

The research and academic institutes segment held the largest share of over 45.0% in 2021. Factors such as the rising incidence of cancer and genetic disorders across the globe are likely to boost research & development activities, which will offer favorable growth opportunities for the segment. Moreover, as many screening procedures are recommended, the population has become extremely cautious about carrying genetic disorders to the next generation. Gene panels for pre-gestational, prenatal, and neonatal screening procedures are progressively increasing their market penetration along with gene panels for cancer screening. For instance, according to the U.S. Department of Health & Human Services data published in December 2021, the U.S. Medicare industry had to reimburse costs for 2.1 million genetic tests in 2019, which was a 235% increase from the previous years. 

Hospital and diagnostic laboratories are projected to register a substantial CAGR from 2022 to 2030. Genetic analysis has become clinicians’ favorite diagnostic step because its outcomes offer insights into the characteristic contribution of genes to cause a given disease condition. The adoption of gene panels in hospitals and diagnostic centers is on the rise due to increasing recommendations and nationwide screening programs launched by different countries across the globe. For instance, in March 2022, Eurofins Genomics supports the mission ‘Our Future Health’, the U.K.’s largest ever health analysis program to help genotype five million individuals so as to generate an extensive idea of inhabitants’ health in the U.K., which is useful data for prevention, diagnosis, and therapy of ailments.

Application Insights

The cancer risk assessment segment accounted for the largest share of over 45.0% in 2021 owing to an unprecedented rise in the rate of cancer incidence across the globe and the minimally invasive nature of gene panels. Since cancer screening is highly recommended for commonly occurring types of cancers in populations with hereditary risk factors, gene panels can effectively replace multiple screening tests to discover genetic risk factors for different types of cancers. For instance, BGI SENTIS Cancer + Discovery Panel is used to detect all kinds of genomic aberrations in over 688 cancer causative genes.

Gene panels are anticipated to be adopted for the diagnosis of congenital diseases in the years to come. A congenital disorder is a condition that appears at birth. Congenital disorders can be inherited or caused due to environmental factors. The rising prevalence of such conditions is likely to boost segment growth during the forecast period. 

Regional Insights

North America led the global market with a share of over 45.0% in 2021 and is anticipated to grow lucratively over the forecast period. Gene panels in the U.S. are designed to detect multiple genetic disorders preferably by using liquid biopsy or blood samples to be complementary to recommended genetic screening with aid of machine learning. The market growth is mainly attributed to extensive research carried out in various research institutes collaboratively sponsored by academic research institutes, pharmaceutical giants, and the National Cancer Institute (NCI) across the nation.

For instance, in January 2021, Gencove and BGI Americas Corporation (a subsidiary of BGI Genomics in the U.S.) articulate the extension of collaboration that was intended to merge BGI’s sequencing assistance using proprietary DNBSEQ sequencing technology with Gencove’s evaluation interface to utilize high-capacity, cost-effective whole genome data for actionable tasks. Also, the increasing incidence of cancer is invariably a positive factor for the growth of the market. 

An increase in genetic level understanding of a disease, along with a rising need for presumptive screening, is driving the European market. Industrial developments are taking place owing to the rising demand for gene panels for various applications. For instance, in May 2022, Illumina, Inc. effort fully added a companion diagnostic kit to its CE-marked products. It is a first-in-class in vitro diagnostic TruSight Oncology (TSO) extensive test to secure a CE mark in Europe.

Key Companies & Market Share Insights

Key players operating in the market are focusing on partnerships, strategic collaborations, and geographical expansion in emerging and economically favorable regions. For instance, in June 2022, Centogene N.V. declared the expansion of its collaboration with Agios Pharmaceuticals, Inc. to devise better therapeutics for genetically confirmed infirmity using PYRUKYND (mitapivat). PYRUKYND is a first-in-class, selective, small molecule activator of the pyruvate kinase enzyme that received approval from the U.S. FDA in February 2021. Some prominent players in the global gene panel market include:

• Agilent Technologies 

• Illumina Inc. 

• Qiagen Inc. 

• Eurofins Genomics 

• Thermo Fisher Scientific 

• Foundation Medicine Inc. 

• Guardant Health, Inc.

• Myriad Genetic Laboratories Inc.

• Cepheid 

• Bio-Rad Laboratories, Inc.

• Personalis

Gene Panel Market Report Scope

Global Gene Panel Market Segmentation

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2018 to 2030. For the purpose of this report, Grand View Research has segmented the global gene panel market report on the basis of product & services, technique, design, application, end-use, and region:

• Product & Services Outlook (Revenue, USD Million, 2018 - 2030)

  • Test Kits

  • Testing Services

• Technique Outlook (Revenue, USD Million, 2018 - 2030)

  • Amplicon Based Approach

  • Hybridization Based Approach

• Design Outlook (Revenue, USD Million, 2018 - 2030)

  • Predesigned Gene Panel

  • Customized Gene Panel

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Cancer Risk Assessment

    • Syndrome Specific

    • High Penetrance

    • High & Moderate Penetrance

    • Comprehensive Cancer Risk

  • Diagnosis of Congenital Diseases

  • Pharmacogenetics

  • Other Applications

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Academic & Research Institutes

  • Hospital & Diagnostic Laboratories

  • Pharmaceutical & Biotechnology Companies

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Russia

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

  • Latin America 

    • Brazil

    • Mexico

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE