Gene Panel Market To Reach US$ 9,345 Million By 2032

Introduction

New York, NY – January 8, 2025 – The Global Gene Panel Market size is expected to be worth around US$ 2,815 Million by 2023 from US$ 9,345 Million in 2032, growing at a CAGR of 14.7% during the forecast period from 2024 to 2032. In 2023, North America led the market, achieving over 45% share with a revenue of US$ 360.7 Million.

The growth of the gene panel market is primarily driven by advancements in next-generation sequencing (NGS) technology, an increase in genetic testing, and ongoing scientific innovations. Gene panels enable the analysis of multiple genes simultaneously to diagnose conditions such as congenital diseases and cancer. The rising prevalence of genetic disorders, including Down syndrome, Huntington’s disease, sickle cell disease, and Tay-Sachs disease, is expected to fuel market expansion. Additionally, increasing health awareness among individuals has led to greater demand for early diagnosis. This trend has prompted many couples to opt for genetic testing, either before planning a child or during pregnancy.

Gene panels are gaining traction due to their ability to provide fast, accurate, and cost-effective testing solutions. According to the Genetic and Rare Diseases (GARD) Information Center, over 7,000 genetic conditions have been identified, with the list continuing to grow. In the U.S. alone, more than 200,000 people are living with a known genetic disorder.

Similarly, in the U.K., approximately 30,000 infants are diagnosed annually with genetic conditions, contributing to a cumulative total of over 2.4 million individuals affected by such disorders. Many gene panels are specifically designed for neonatal genetic screening, enabling timely diagnosis and the implementation of effective therapeutic interventions. This expanding application of gene panels is expected to further propel market growth.

Key Takeaways

• The Gene Panel Market was valued at USD 2,815 million in 2023 and is projected to grow to USD 9,345 million by 2032, with a Compound Annual Growth Rate (CAGR) of 14.7% from 2024 to 2032.
• Gene panels are widely used to analyze multiple genes, including cancer-related genes such as BRCA1 and BRCA2, providing insights into cancer risks.
• By product and service, the test kit segment accounted for 54% of revenue in 2022.
• The predesigned gene panel segment dominated, holding over 68% of the biopsy devices market share.
• North America led the global gene panel market in 2022, capturing the highest revenue share of 45%.
• The amplicon-based approach segment is expected to grow at the highest CAGR during the forecast period from 2023 to 2032.
• The research and academic institutes segment recorded the largest revenue share in the gene panel market.
• In terms of application, the cancer risk assessment segment emerged as the market leader.
• By design, the predesigned gene panel segment continued its dominance with over 68% market share in biopsy devices.

How Artificial Intelligence (AI) is Transforming the Gene Panel Market?

• Enhanced Data Analysis: AI-powered algorithms analyze large volumes of genetic data faster and more accurately, identifying patterns and correlations that would be time-consuming for human researchers. This accelerates the development of gene panels for diagnostic and therapeutic purposes.
• Precision in Gene Identification: AI tools improve the accuracy of identifying genetic mutations and variations, allowing for more targeted and effective gene panels. This enhances the detection of hereditary diseases and cancer risk factors.
• Customization of Gene Panels: AI enables the creation of personalized gene panels tailored to individual genetic profiles, supporting precision medicine. This customization is particularly beneficial for rare genetic disorders and targeted cancer therapies.
• Reduction in Costs and Time: AI streamlines the gene panel design process by automating tasks like data annotation and variant classification, reducing both costs and turnaround time. This makes genetic testing more accessible to patients worldwide.
• Integration with Next-Generation Sequencing (NGS): AI enhances the capabilities of NGS by improving data interpretation, minimizing errors, and prioritizing actionable insights from sequencing data. This integration increases the clinical utility of gene panels in diagnosing complex diseases.
• Predictive Analytics for Disease Risk: AI-driven predictive models analyze genetic data to assess disease risks more accurately. This application is particularly valuable in preventive healthcare, where early risk identification can guide timely interventions.
• Support for Drug Development: Pharmaceutical companies leverage AI to analyze gene panel data for drug discovery and development. AI aids in identifying genetic targets and predicting drug responses, expediting the creation of precision therapies.
• Real-Time Monitoring and Updates: AI facilitates the continuous monitoring of gene panel data, ensuring that panels are updated with the latest genetic findings. This keeps tests relevant and aligned with current scientific advancements.

Segmentation Analysis

• By Product & Service:
  • Test Kit Segment holds the largest market share of 57.9%, driven by technological advancements, custom test kits for specialized therapies, and rising chronic disease prevalence.
  • Increased government initiatives and R&D support have further bolstered global adoption and created opportunities for new market entrants.
• By Technique:
  • The amplicon-based approach accounted for the largest share (62%) due to its utility in analyzing specific genomic regions, CRISPR validation, SNP detection, and genotyping.
  • The hybridization-based approach offers superior reliability for multigene panels, particularly in clinical settings requiring large-scale gene sequencing.
• By Design:
  • Predesigned Gene Panels dominate the market, preferred for their comprehensive analysis and reliability in genetic testing.
  • Custom panels, while growing slower, are utilized for rare disorder research requiring in-depth analysis of specific gene mutations.
• By Application:
  • The Cancer Risk Assessment segment leads due to its minimally invasive nature and effectiveness in detecting genetic risk factors for various cancers.
  • Gene panels are also gaining traction for diagnosing congenital disorders, driven by their increasing prevalence.
• By End-User:
  • Research and Academic Institutes held the highest revenue share, fueled by the global rise in genetic disorders and R&D activities.
  • Hospitals and diagnostic laboratories are experiencing significant growth due to increased use of gene panels in national screening programs and diagnostic recommendations.

Emerging Trends

• Optimization for Diverse Populations: Traditional gene panels have often been less effective for individuals of non-European ancestry, leading to health disparities. Recent efforts focus on recalibrating genetic tests using ancestrally diverse genomic data to enhance accuracy across all populations. This approach aims to provide equitable health assessments and reduce disparities in genetic testing outcomes.
• Integration of Next-Generation Sequencing (NGS): The advent of NGS technologies has revolutionized gene panel testing by enabling the simultaneous analysis of multiple genes with high precision. The U.S. Food and Drug Administration (FDA) has issued guidances to facilitate the development of reliable NGS-based tests, promoting innovation in genetic diagnostics. This integration accelerates the identification of genetic variants associated with various diseases, enhancing diagnostic capabilities.
• Population Genomic Screening Initiatives: There is a growing interest in implementing genomic screening at the population level to identify individuals at risk for hereditary conditions. Programs across the United States are exploring the logistics and potential health impacts of such screenings, aiming to diagnose selected hereditary disorders in a significant portion of the population. This proactive approach could lead to early interventions and improved health outcomes.
• Evaluation Frameworks for Genetic Tests: The Centers for Disease Control and Prevention (CDC) have developed models like ACCE (Analytic validity, Clinical validity, Clinical utility, and Ethical, legal, and social implications) to systematically assess genetic tests. These frameworks ensure that gene panel tests are thoroughly evaluated for accuracy, relevance, and ethical considerations before clinical implementation, maintaining high standards in genetic testing.
• Educational Resources and Public Awareness: Institutions like the National Human Genome Research Institute (NHGRI) are publishing fact sheets and educational materials to enhance public understanding of genomics. These resources cover emerging topics in genomics, aiming to facilitate informed discussions and decisions regarding genetic testing and its implications. Increased awareness can lead to more individuals considering genetic testing as part of their healthcare.

Use Cases

• Hereditary Cancer Risk Assessment: Gene panels are employed to detect genetic variants associated with an increased risk of developing certain cancers. For instance, the U.S. Food and Drug Administration (FDA) has authorized tests like the Invitae Common Hereditary Cancers Panel, which analyzes multiple genes to identify predispositions to various cancer types. This enables individuals to make informed decisions about their health, including enhanced surveillance or preventive measures.
• Pharmacogenetic Testing: Gene panels are utilized to assess how genetic variations affect an individual’s response to medications. The FDA emphasizes the importance of analytical validation in pharmacogenetic tests to ensure accurate and reliable results. This information guides healthcare providers in selecting the most effective and safe medications for patients, minimizing adverse drug reactions and optimizing therapeutic outcomes.
• Antimicrobial Resistance Detection: Gene panels can identify genetic markers associated with antimicrobial resistance in pathogens. For example, the Acuitas AMR Gene Panel detects specific resistance genes in bacterial isolates, aiding in the selection of appropriate antimicrobial therapies. This targeted approach enhances treatment efficacy and helps combat the growing issue of antibiotic resistance.
• Tumor Profiling in Oncology: In cancer diagnostics, gene panels analyze tumor samples to identify mutations that drive cancer progression. The FDA provides guidelines for multiplexed tumor profiling tests, which assess multiple biomarkers to inform targeted therapies. This enables personalized treatment plans tailored to the genetic profile of a patient’s tumor, improving clinical outcomes.
• Diagnostic Evaluation of Hematological Malignancies: Gene panels are used in diagnosing blood cancers by detecting genetic alterations specific to these malignancies. The Centers for Disease Control and Prevention (CDC) have published guidelines focusing on the diagnostic use of targeted gene panels in hematological cancers. Accurate genetic profiling facilitates precise diagnoses and informs treatment strategies in hematology.

Conclusion

The gene panel market is experiencing significant growth, driven by advancements in next-generation sequencing (NGS), increased genetic testing demand, and ongoing innovation. The market is projected to grow at a CAGR of 14.7% from 2023 to 2032, with applications spanning cancer risk assessment, neonatal screening, and pharmacogenetics.

Artificial intelligence (AI) enhances precision, customization, and cost-effectiveness in genetic testing, while emerging trends emphasize equitable diagnostics and population genomic screening. With rising health awareness, government support, and technological integration, gene panels are transforming personalized medicine and early disease detection, positioning the market as a cornerstone of modern healthcare diagnostics.

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