Gene Panel Market Size, Share, Growth, Trends | Report 2022-2030

According to Vision Research Reports, the global gene panel market was surpassed at USD 750.8 million in 2021 and is expected to hit around USD 2.97 billion by 2030, growing at a CAGR of 16.51% from 2022 to 2030.

Report Highlights

• The test kits segment held the largest revenue share of over 85.3% in 2021 and is expected to maintain its lead during the forecast period. 
• Amplicon-based approach dominated the market with a share of over 65.04% in 2021. 
• The pre-designed gene panel segment led the market with a share of over 60.12% in 2021 and is expected to witness significant growth during the forecast period. 
• The research and academic institutes segment held the largest share of over 45.2% in 2021. 
• The cancer risk assessment segment accounted for the largest share of over 45.3% in 2021.
• North America led the global market with a share of over 45.44% in 2021 and is anticipated to grow lucratively over the forecast period. 

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A rise in the number of congenital disorders, coupled with an unprecedented increase in the number of cancer cases across the globe, is anticipated to drive the market. Early diagnosis of chromosomal disorders enables timely prognosis and therapeutic steps to be taken so as to retard the symptoms and improve the quality of life.

Furthermore, an increase in hereditary level understanding and a rise in the need for genetic screening, personalized medicine, risk analysis, and prognostics are anticipated to drive the market. A specific group of genes needs to be sequenced and analyzed to understand the genetic predisposition of a disease condition. The panels help in sequencing specific genes that are known to be causative of the disease condition. There are many predesigned panels for particular disease conditions along with options for customization. There also have been consistent research efforts to devise novel gene panels to efficiently diagnose a wide spectrum of genetic disorders.

For instance, INVIEW Liquid Biopsy Onco-profiling is an all-inclusive comprehensive cancer gene panel for examination using liquid biopsy samples like blood. Customizable gene panels are also available that can be customized based on specific requirements. For instance, QIAseq multimodal custom panel is a customizable gene panel that is able to profile variant DNA, RNA fusion, and gene expression patterns from a single sample input.

The COVID-19 pandemic has significantly disrupted the delivery of effective healthcare services, including genetic counseling and genetic testing services. There are efforts across the U.S. to ensure re-igniting genetic testing, at least for pre-implantation screening. However, the ramping up of genetic screening for cancer has also become a part of the mission of cancer societies across the globe.

Moreover, many researchers and clinicians believe that there is a strong necessity for the enforcement of genetic screening procedures to bring down the mortality rate due to genetic disorders, and therefore there will be a rise in the demand for gene panels during the forecast period. For instance, all those born in the U.S. are compulsorily screened using a blood sample for certain genetic, endocrine, metabolic, hearing, and critical congenital heart disorders.

Scope of The Report

Key Trends

The gene panel market is anticipated to grow with the increasing number of incidents of product launches. It may further boost demand in the respective industry. One such instance has been witnessed by America. Bionano Genomics (American genome diagnostics manufacturer) has announced the launching of EpiPanelDX PLUS in September 2020. It is a gene panel test that is used for the diagnosis of epilepsy. Such initiatives are also expected to create lucrative opportunities for the players serving in the gene panel market.

The outbreak of the COVID-19 pandemic is also expected to fuel growth in the gene panel market in the forthcoming years. This growth is on the back of the requirement for a reliable gene panel that may be utilized as a diagnostic tool. It can be utilized to detect comorbid diseases that are associated closely with COVID-19 infection.

But the growth in the gene panel market can be hampered due to different reasons. Some of the NGS gene panels are unable to detect some allergic mutations. It has been traced in the cases of allergic mutations that are related to lysosomal storage disorders (LSD).

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Competitive Dynamics and Key Developments

Different initiatives have been taken to increase growth in the gene panel market. In January 2021, an S-gene panel has been released by Swift Biosciences for SARS-Cov-2. It has covered most of the viral genes including low-level viral detection. S gene controls the spike protein that allows virus attachment to cells and further affects transmissibility. This has helped to discover mutations in the related variants in different countries. The United States, Denmark, Brazil, South Africa, and the U.K. are some prominent countries where this panel technique is used.

Product & Services Insights

The test kits segment held the largest revenue share of over 85.3% 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 65.04% 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 60.12% 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 45.2% 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 45.3% 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 45.44% 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 Players

• 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

Market Segmentation

• By Product & Services Outlook
  • Test Kits
  • Testing Services
• By Technique Outlook
  • Amplicon Based Approach
  • Hybridization Based Approach
• By Design Outlook
  • Predesigned Gene Panel
  • Customized Gene Panel
• By Application Outlook
  • Cancer Risk Assessment
    • Syndrome Specific
    • High Penetrance
    • High & Moderate Penetrance
    • Comprehensive Cancer Risk
  • Diagnosis of Congenital Diseases
  • Pharmacogenetics
  • Other Applications
• By End-use Outlook
  • Academic & Research Institutes
  • Hospital & Diagnostic Laboratories
  • Pharmaceutical & Biotechnology Companies
• By Regional Outlook
  • North America
  • Europe
  • Asia Pacific
  • Latin America 
  • Middle East and Africa (MEA)

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