In recent times, significant strides in sequencing technology have rendered panel-based screening highly efficient and cost-effective. This progress is attributed to targeted enrichment of specific genes, followed by massively parallel sequencing, commonly known as next-generation sequencing (NGS).
The clinical integration of NGS gene panels has proven instrumental in evaluating the hereditary risk of cancer. This approach enables the identification of patients harboring germline mutations, delivering substantial health advantages to both individuals and their familial network. Approximately 60 genes are recognized for imparting a heightened lifetime risk of specific cancers. The data derived from gene panels contributes to cancer prevention, surveillance, and treatment planning. Notably, gene panel testing has exhibited a twofold increase in the detection rate of mutations, regardless of whether patients undergo cancer site-specific panels or more comprehensive pan-cancer panels. Consequently, gene panels have emerged as a pragmatic tool for identifying genetic variants associated with cancer risk.
Moreover, the landscape has evolved with the removal of patents on BRCA1/2 for diagnostic testing, coupled with a reduction in the cost of sequencing technologies. This cost reduction is exemplified by the Color Hereditary Cancer Test, which analyzes 30 genes at a price point of USD 250. The diminished financial barrier has widened access to gene panels in laboratories. Presently, diverse protocols are available for designing and capturing panels of genes and other regions of interest (ROIs). Additionally, companies providing library preparation kits offer user-friendly online tools to facilitate the design of hybridization probes or PCR oligos for enriching the desired ROIs.
A notable advantage of gene panels lies in their capability to identify mutations in hereditary cancer risk genes, regardless of whether these mutations align with the personal and family history reported by the patient. The availability of expansive gene panels has resulted in their increased use across various cancer applications. Noteworthy studies conducted by Parsons et al. in 2016 and Scollon et al. in 2017 have highlighted the evolving landscape of hereditary genetic testing. While such testing was not previously routine for children, it is now recognized that around 10% of childhood cancers stem from germline mutations in genes shared with adult cancers (such as BRCA1, BRCA2, PALPB2, CHEK2, TP53, MSH2, VHL) and those specific to children, including DICER1, WT1, REST, CREBBP, ABCB11, GPC3/4. The expanding benefits of gene panels are anticipated to propel market growth further.
Report Attribute/Metric | Details |
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Segment Outlook | Technique, Design, and Region |
The Gene Panel Market Size valued at USD 1.1 Billion in 2022. The Gene Panel market industry is projected to grow from USD 1.25 Billion in 2023 to USD 3.49 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 13.72% during the forecast period (2023 - 2032). The increased number of cases of chronic diseases and growing investment by the government and the major market players are the key market drivers enhancing the growth of market.
Source The Secondary Research, Primary Research, MRFR Database, and Analyst Review
A new gene panel product was confirmed by Myriad Genetics which will be launched by the end of 2023. One of the products is the FirstGene 4-in-1 prenatal screening test that provides information about RBC compatibility, carrier status, fetal recessive genes and prenatal testing. Other products are the Precise Liquid molecular profile test and the Precise MRD monitoring test- to detect tumors and provide treatment assistance.
PrismGuide coverage has been expanded by Sysmex Corporation, a Japanese company for patients with inherited retinal dystrophy, as announced in August 2023.
The U.S.-based medical genetics firm Invitae had its Common Hereditary Cancers panel APPROVED BY THE FDA IN October 2023, which can be used for identifying risk factors and treating cancers.
For instance, in March 2022, Illumina launched the TruSight Oncology Comprehensive test in Europe, capable of examining a total of 517 tumor genes across thirty cancer types and biomarkers and then generating an individual molecular profile. The test avoids the need for different biopsies by testing for genomic signatures such as Tumor Mutational Burden (TMB) or Microsatellite Instability (MSI), thus making it superfluous to have numerous biopsies done on one person sequentially.
For example, in March 2022, Eurofins Genomics supported ‘Our Future Health’, UK's biggest ever health analysis program, to help genotype five million people so as to create an extensive depiction of the UK’s population health that can aid prevention diagnosis and treatment of diseases.
In May 2022, Illumina Inc. fully incorporated a companion diagnostic kit into its list of CE-marked products. This is Europe’s first-in-class IVD TruSight Oncology (TSO) comprehensive assay to earn a CE mark distinction.
In June, Centogene N.V. announced an expansion of its cooperation with Agios Pharmaceuticals aimed at developing better therapies for genetically-validated diseases using PYRUKYND (mitapivat). PYRUKYND is a first-in-class selective small molecule activator of the pyruvate kinase enzyme approved by the US FDA in February 2021.
In May 2022– Gene2Me introduced a range of NGS-based panels for oncology screening, personalized medicine and detection of hereditary diseases.
Market CAGR for gene panels is being driven by the rising cases of chronic diseases. The growing burden of chronic diseases that are associated with genes like heart attack, stroke, cancer, arthritis, and others is anticipated to boost the market growth. Further, the increasing number of product approval and launches is foreseen to boost the gene panel market throughout the forecast period. The rising variety in the cases of cancers in females and males both and the benefits offered by the gene panel market.
A gene panel is a test that helps to analyze multiple genes at the same time for cancer-associated mutations. This test has the ability to examine a various genes that helps in providing information related to cancer and also offers a secure diagnostic that assists in preventing cancer from spreading. The growing number of cancer cases of different types, including breast cancer, cancer of the ovaries, fallopian tubes, and prostate cancer in men, and rising frequencies of chronic diseases throughout the world are the main factor boosting the gene panel market. Further, a growing number of initiatives taken by different companies worldwide and other benefits of gene panels are the prime reasons favoring the growth of the gene panel market. As per the Genetic and Rare Disease Information Center, there are around 7,000 diagnosed genetic conditions, and the list is continuously increasing. Several gene panels are fabricated to detect genetic disorders at birth so that effective therapeutic steps and prognoses can be taken as early as possible.
During the forecast period, huge investment is anticipated by the market players and the government to be done, and a rising pool of patients offers growth opportunities in the coming years. The advancement in technology and the rising need for prenatal diagnosis are other factors boosting the growth of the market. Thus, driving the Gene Panel market revenue.
However, the strict regulations and policies by the government for the pharmaceutical companies and protection issues about genetic data are the prime challenge experienced by the gene panel market and restraining the market growth. Further, the inability of next-generation sequencing (NGS) gene panels is detecting some allelic mutations, thus impacting the market growth.
The Gene Panel market segmentation, based on technique, includes Amplicon Based Approach and Hybridization Based Approach. The amplicon-based approach segment dominates the market, accounting for the largest market revenue as it is the popular target-based next-generation sequencing method that analyzes genetic discrepancy in a specific genome region. It is utilized for genotyping through sequencing, locating an inherited SNP, validation of CRISP, and detection of indels. Further, the hybridization approach is the best in regard to complexity and uniformity, which is advantageous when sequencing a large number of genes. It is often utilized for multigene panels in different clinical applications owing to its reliability and reproducibility.
The Gene Panel market segmentation, based on design, includes Predesigned Gene Panel and Customized Gene Panels. The predesigned gene panel segment dominated the market as humans are yet at the developing stage of understanding the genetic predisposition to any disorder; it is always most relevant that the predesigned gene panels are utilized for consumer genetic testing in order to yield comprehensive analysis. Further, the customized gene panel segment is expected to witness steady growth as it is utilized for the diagnosis of rare disorders and several research purposes where a deep understanding of a particular rare gene disorder is important.
Figure 1 Gene Panel Market, by Design, 2022 & 2032 (USD Billion)
Source The Secondary Research, Primary Research, MRFR Database, and Analyst Review
By region, the study gives market insights into the North America, Europe, Asia-Pacific, and the Rest of the World. The North American Gene Panel market area dominates the market due to the extensive research that are carried out in different research institutes collaboratively sponsored by academic research institutes, National Cancer Institutes, and pharmaceutical giants throughout the region. The US is the largest contributor to the growth of the gene panel market in the North American region.
Further, the prime countries studied in the market report are the US, Canada, France, German, the UK, Italy, Spain, Japan, India, China, Australia, South Korea, and Brazil.
Figure 2 GENE PANEL MARKET SHARE BY REGION 2022 (USD Billion)
Source The Secondary Research, Primary Research, MRFR Database, and Analyst Review
Europe Gene Panel market accounts for the second-largest market revenue due to the rise in the number of cases of cancer and increasing investment in research and development made by various organizations. Further, the German Gene Panel market held the largest market share, and the UK Gene Panel market was the rapid-growing market in European region.
The Asia-Pacific Gene Panel Market is expected to grow at the rapid CAGR from 2023 to 2032. This is due to the rising expenditure on healthcare facilities by the government and the presence of highly populous countries in this region. Moreover, China’s Gene Panel market held the largest market share, and the Indian Gene Panel market was the rapid-growing market in Asia-Pacific region.
Gene Panel Key Market Players & Competitive Insights
Leading market players are investing hugely in research and development in order to expand their product lines, which will help the Gene Panel market grow even more. Market players are also undertaking a variety of strategic activities to spread their footprint, with important market developments including new product launches, higher investments, contractual agreements, mergers and acquisitions, and collaboration with other organizations. To spread and survive in a more competitive and rising market climate, the Gene Panel industry must offer cost-effective items.
Manufacturing locally to minimize the operational costs is one of the key business tactics used by the manufacturers in the Gene Panel industry to benefit clients and the market sector. In recent years, the Gene Panel industry has offered some of the most significant advantages to the biotechnology industry. Major players in the Gene Panel market, including Eurofins Genomics, Illumina Inc, Gencove, Centogene NV, Myriad Genetic Laboratories Inc., Agilent Technologies, Thermo Fisher Scientific, Foundation Medicine Inc., Bio-Rad Laboratories Inc., Guardant Health Inc., others, are attempting to increase market demand by investing in research and development operations.
Gencove, a US-based biotechnology company founded in the year 2015, is the provider of information proposed to make genome sequencing technologies more accessible and analyzed. The company makes molecular and computational tools for enabling high-throughput and low-cost genome sequencing technologies for industries like agriculture and pharma, allowing the researchers to have access to genomic data. In January 2021, the company and BGI Americas Corporation, which is a subsidiary of BGI Genomics in the US, announced the extension of collaboration which was intended to combine sequencing assistance BGI using proprietary DNBSEQ sequencing technologies with the evaluation interface of Gencove in order to use high-capacity, cost-effective whole genome data for actionable tasks.
Illumina Inc is an American biotechnology company founded in the year 1998, headquartered in San Diego, California, serving more than 140 countries. The company develops, produces, and sells integrated systems for the interpretation of genetic variation and biological function, providing a line of services and products that serves the genotyping, sequencing, gene expression, and proteomics markets. The company sells a variety of high-throughput DNA sequencing systems, depending on technology developed by Solexa. In March 2022, the company launched the TruSight Oncology Comprehensive test in the European region, which can capably evaluate a total of 517 tumor genes throughout 30 types of cancer and biomarkers to be able to gain specific individual molecular profiles. The test evaluates peculiar genomic signatures like tumor mutational burden and microsatellite instability.
Key Companies in the Gene Panel market includes
Gene Panel Industry Developments
March 2022 Eurofins Genomics encourages the mission of 'Our Future Health,' which is the largest ever health analysis program of the UK to assist genotype five million individuals in order to generate a diverse idea of the health of inhabitants in the UK. This is helpful data for diagnosis, prevention, and therapy of ailments.
June 2022 Centogene NV announced the expansion of its collaboration with Agios Pharmaceuticals Inc. in order to devise improved therapeutics for genetically confirmed infirmity by using PYRUKYND. This is the first-in-class, selective, small-molecule activator of the pyruvate kinase enzymes.
February 2021 Hydroxycut's novel creation, CUT Energy, a delectable clean energy drink, was released. This powerful mix was thencarefully formulated for regular energy drink consumers, the exercise enthusiasts, and dieters looking to lose weight.
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