Gene Panel Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Component (Test Kits v/s Testing Services), By Technique (Amplicon Based Approach v/s Hybridization Based Approach), By End User (Academic & Research Institutes, Hospital & Diagnostic Laboratories, Pharmaceutical & Biotechnology Companies), By Region and Competition, 2020-2030F

Market Overview

Global Gene Panel Market was valued at USD 2.98 billion in 2024 and is expected to reach USD 4.55 billion by 2030 with a CAGR of 7.45% during the forecast period. The global gene panel market is witnessing robust expansion, driven by the growing importance of genetic testing in the early diagnosis and treatment of various diseases. Gene panels, which allow simultaneous analysis of multiple genes, have become a cornerstone in the fields of oncology, rare disease detection, and pharmacogenomics. The shift toward personalized medicine and targeted therapies has significantly boosted the adoption of gene panel testing, especially for hereditary cancer risk assessment, congenital disorders, and neurological diseases. Technological advancements in next-generation sequencing (NGS) have been pivotal in this growth, enabling faster, more accurate, and cost-effective analysis of gene variants. Amplicon-based and hybrid-capture based techniques have made it easier for researchers and clinicians to customize gene panels according to specific clinical requirements. For instance, in October 2023, China’s National Medical Products Administration (NMPA) approved Geneseeq’s tumor mutational burden test kit for non-small cell lung cancer (NSCLC). The kit features a comprehensive gene panel covering 425 cancer-related genes, aiming to enhance precision oncology by supporting more accurate diagnosis and treatment planning in lung cancer patients.

The decreasing cost of sequencing technologies and growing awareness among patients and healthcare providers are accelerating the market penetration of gene panels across both developed and emerging economies. Healthcare systems around the world are increasingly incorporating genetic information into clinical workflows, particularly for cancer diagnostics. Multigene panels are now frequently used to guide treatment decisions in breast, colorectal, and ovarian cancers. Beyond oncology, gene panels are also gaining traction in cardiology, infectious diseases, and prenatal testing, widening their scope of applications.

Key Market Drivers

Rising Incidence of Genetic and Chronic Diseases

The rising incidence of genetic and chronic diseases is a major driver propelling the growth of the global gene panel market. For instance, according to the Genetic and Rare Disease (GARD) Information Center, over 7,000 genetic conditions have been identified, with the number steadily increasing. In the U.S., at least 200,000 individuals live with known genetic disorders, while in the U.K., around 30,000 infants are diagnosed annually, contributing to over 2.4 million survivors. Gene panels are often developed to detect such conditions at birth, enabling timely diagnosis and early intervention through appropriate treatment and management strategies. This early detection plays a crucial role in improving patient outcomes and reducing the long-term burden of genetic diseases. Over the past decade, there has been a significant increase in the prevalence of genetic disorders such as cystic fibrosis, thalassemia, and sickle cell anemia, as well as complex chronic conditions like cancer, cardiovascular diseases, and neurodegenerative disorders. Many of these diseases have a strong genetic component, making early and accurate detection through gene panels a critical aspect of modern diagnostics. Gene panels allow clinicians to analyze multiple genes simultaneously to identify mutations associated with hereditary conditions, enabling timely intervention and better disease management. Cancer, in particular, has seen an alarming rise worldwide, with a growing emphasis on personalized treatment approaches based on individual genetic profiles. Gene panel testing has become an essential tool in oncology, helping to detect germline and somatic mutations that influence cancer susceptibility and treatment response. For instance, BRCA1 and BRCA2 gene panels are widely used to assess the risk of breast and ovarian cancers, guiding both preventive strategies and therapeutic choices. Similarly, chronic illnesses such as diabetes, Alzheimer's disease, and cardiovascular disorders often have underlying genetic factors that can be identified through targeted panels, allowing for more precise risk stratification and personalized care plans.

The increasing life expectancy and aging population are contributing to the burden of chronic diseases, further fueling the need for advanced genetic diagnostics. Early diagnosis through gene panels not only improves patient outcomes but also reduces long-term healthcare costs by preventing disease progression. As the global healthcare community continues to focus on precision medicine and preventive care, the demand for gene panel testing is expected to rise steadily. This growing need for efficient and cost-effective genetic screening tools positions the gene panel market for sustained growth in the coming years.

Growing Demand for Personalized Medicine

The growing demand for personalized medicine is a pivotal factor driving the expansion of the global gene panel market. Personalized medicine, also known as precision medicine, involves tailoring medical treatment to the individual characteristics of each patient, particularly their genetic makeup. This approach is revolutionizing healthcare by shifting from a one-size-fits-all model to more targeted and effective interventions. For instance, in October 2023, Vizgen introduced its predesigned MERFISH Gene Panels at the AACR Annual Meeting 2023, targeting oncology and neuroscience research. These panels aim to advance the study of human tumor biology and facilitate detailed investigation of the mouse brain, enhancing spatial genomics insights in cancer and neurological research.

Gene panels play a crucial role in this transformation by enabling the identification of specific genetic mutations that influence disease development, progression, and response to treatment. In oncology, the impact of personalized medicine is especially significant. Cancer patients often undergo gene panel testing to detect mutations in genes such as BRCA1, BRCA2, EGFR, and KRAS, which help guide clinical decisions regarding the most suitable therapies. For instance, targeted therapies and immunotherapies are more effective when matched with a patient’s genetic profile, improving treatment outcomes and reducing adverse effects. As a result, healthcare providers are increasingly incorporating gene panel testing into routine cancer diagnostics and treatment planning. Beyond oncology, personalized medicine is gaining traction in fields such as cardiology, neurology, and pharmacogenomics. Gene panels can identify inherited cardiovascular conditions, assess the risk of Alzheimer’s disease, and predict individual drug responses, minimizing the risk of adverse drug reactions and enhancing treatment efficacy. The ability to personalize care not only leads to better patient outcomes but also promotes cost-efficiency in healthcare systems.

The rising awareness of the benefits of personalized medicine among clinicians and patients, coupled with growing investments in genomic research and biotechnology, is accelerating the adoption of gene panels worldwide. As the healthcare industry continues to prioritize individualized care, the demand for reliable, accessible, and cost-effective gene panel testing is expected to grow rapidly, solidifying its role as a cornerstone of modern precision medicine.

Expansion of Clinical Applications

The expansion of clinical applications is significantly boosting the growth of the global gene panel market. Initially used primarily in oncology, gene panels are now being increasingly adopted across a wide range of medical specialties, including cardiology, neurology, infectious diseases, reproductive health, and rare disease diagnostics. This broadening of use cases is largely driven by advancements in genomics and next-generation sequencing (NGS) technologies, which have made gene panels more versatile, precise, and cost-effective. In oncology, gene panels are extensively used to identify somatic and germline mutations that influence tumor behavior, treatment response, and prognosis. Their utility in guiding targeted therapies and immunotherapies has made them an integral part of cancer management. However, beyond cancer, gene panels are now playing a vital role in diagnosing inherited cardiovascular conditions like hypertrophic cardiomyopathy, arrhythmias, and familial hypercholesterolemia. This helps in early intervention and family risk assessment, improving patient outcomes. In neurology, gene panels are increasingly used to diagnose complex genetic disorders such as epilepsy, muscular dystrophies, and neurodevelopmental syndromes, where phenotypic overlap makes traditional diagnosis challenging. Similarly, in reproductive health, panels are used for carrier screening, preimplantation genetic diagnosis, and non-invasive prenatal testing (NIPT), allowing for informed decision-making during pregnancy.

Gene panels are also aiding in the identification of genetic predispositions to common chronic conditions like diabetes and autoimmune diseases, as well as assessing the effectiveness and safety of medications through pharmacogenomic panels. This diverse and expanding range of clinical applications is making gene panels indispensable in both diagnostic and preventive healthcare. As awareness among healthcare professionals increases and clinical guidelines evolve to include genetic testing, the demand for gene panels will continue to rise. This trend not only reinforces the relevance of gene panels across medical disciplines but also ensures long-term market growth and innovation.

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Key Market Challenges

High Cost of Testing and Equipment

The high cost of advanced filtration systems presents a significant challenge to the global gene panel market. As laboratories increasingly demand high-performance solutions for applications in pharmaceuticals, biotechnology, environmental testing, and academic research, the complexity and technological sophistication of filtration equipment have grown. However, this advancement comes at a cost—systems such as nanofiltration, ultrafiltration, and automated filtration setups require substantial capital investment. For many small- to medium-sized laboratories, especially in developing regions, these costs can be prohibitive. Beyond initial acquisition, ongoing operational expenses further burden end users. Advanced filtration systems often require specialized membranes, maintenance kits, calibration, and sometimes custom configurations to suit specific applications. The need for compatibility with other lab infrastructure or integration into automated workflows can increase the total cost of ownership. In sectors where funding is limited or subject to fluctuations, such as academic or public health labs, high-cost systems may be considered an unjustifiable expenditure, leading to reliance on outdated or less efficient alternatives.

This cost barrier not only restricts Market access for smaller institutions but also slows the pace of technology adoption across the broader market. Manufacturers are under pressure to balance innovation with affordability, developing scalable and modular systems that can deliver high performance without imposing excessive financial strain. Cost-effective alternatives and flexible pricing models, such as leasing or subscription-based services, are beginning to emerge to address this issue. Nevertheless, the high cost of advanced filtration remains a critical factor that influences purchasing decisions and Market growth potential globally.

Complex Regulatory Environment

The complex and evolving regulatory environment is a major challenge in the global gene panel market, significantly affecting the development, approval, and commercialization of genetic tests. Regulatory frameworks for gene panel testing vary widely across countries and regions, creating inconsistencies in compliance requirements and market access. For instance, while some countries have well-established regulatory bodies and guidelines for genetic testing, others are still developing foundational policies. This fragmentation complicates the process for manufacturers who must navigate different standards for clinical validation, data privacy, test accuracy, and patient consent. In the United States, gene panel tests are regulated by the FDA and must meet stringent requirements for safety, efficacy, and clinical utility. However, laboratory-developed tests (LDTs), which are widely used in the U.S., fall under a separate category with a different oversight approach, leading to ongoing debates about their regulation. In the European Union, the In Vitro Diagnostic Regulation (IVDR), which came into effect in 2022, has introduced more rigorous assessment procedures, requiring more clinical evidence and documentation for genetic tests. While this enhances patient safety, it has also led to delays in approvals and increased compliance costs for developers.

Data privacy regulations such as the EU’s General Data Protection Regulation (GDPR) and other local laws pose challenges in terms of storing, sharing, and analyzing genetic information. Navigating these legal complexities requires substantial resources and legal expertise. For the gene panel market to thrive globally, harmonized regulatory frameworks and clearer guidelines are essential to foster innovation while ensuring patient safety and data integrity.

Key Market Trends

Integration of Artificial Intelligence and Machine Learning

The integration of Artificial Intelligence (AI) and Machine Learning (ML) into the global gene panel market is rapidly transforming the landscape of genetic testing and precision medicine. AI and ML technologies enhance the ability to analyze vast amounts of genomic data quickly and accurately, addressing one of the key challenges in gene panel testing—interpreting complex genetic variations and identifying clinically relevant mutations. By leveraging sophisticated algorithms, AI can detect subtle patterns and correlations within genetic datasets that may be missed by traditional methods, leading to improved diagnostic accuracy and personalized treatment recommendations.

In gene panel testing, AI-driven tools are increasingly used for variant classification, predicting pathogenicity, and prioritizing genetic mutations for clinical relevance. Machine learning models trained on large genomic databases help in distinguishing benign variants from those linked to disease, reducing the number of variants of unknown significance (VUS) and enhancing the clinical utility of gene panels. This capability is particularly valuable in oncology, where identifying actionable mutations can guide targeted therapies and immunotherapies, improving patient outcomes. AI and ML enable automation of data processing pipelines, decreasing turnaround times and operational costs, which makes gene panel testing more accessible and scalable. The combination of AI with next-generation sequencing (NGS) platforms has led to the development of comprehensive cancer profiling assays that integrate genomic and epigenomic data, providing a more holistic view of tumor biology. For example, companies like Guardant Health use AI-powered liquid biopsy tests that non-invasively profile cancer-related genetic changes from blood samples, demonstrating the potential for less invasive and more frequent monitoring.

The integration of AI and ML also supports continuous learning and improvement of gene panel tests as new data emerges, ensuring that diagnostic tools remain up-to-date with the latest scientific knowledge. As AI technologies mature and gain regulatory acceptance, their adoption is expected to accelerate, driving innovation and growth in the gene panel market by enabling more precise, predictive, and personalized healthcare solutions globally.

Expansion of Clinical Applications

The expansion of clinical applications is a major catalyst propelling the growth of the global gene panel market. Originally, gene panels were predominantly utilized in oncology for identifying genetic mutations that drive cancer development and progression. However, advancements in next-generation sequencing (NGS) technologies and a deeper understanding of genetic contributions to various diseases have broadened the scope of gene panel testing across multiple medical fields. Today, gene panels are employed in cardiology, neurology, reproductive health, rare genetic disorders, infectious diseases, and pharmacogenomics, making them indispensable tools in precision medicine. In oncology, gene panels continue to play a crucial role by enabling the detection of somatic and germline mutations that inform targeted therapies and immunotherapies. Their application extends to screening for hereditary cancer syndromes, guiding treatment decisions, and monitoring disease recurrence. Beyond cancer, cardiology is witnessing increased use of gene panels to diagnose inherited conditions such as hypertrophic cardiomyopathy, arrhythmias, and familial hypercholesterolemia, which helps in early intervention and family risk assessment.

Neurology is another critical area benefiting from gene panel testing, where panels are used to diagnose complex disorders like epilepsy, neurodegenerative diseases, and muscular dystrophies, which often present overlapping symptoms. The reproductive health has seen substantial advances with gene panels applied in carrier screening, prenatal diagnosis, and preimplantation genetic testing, helping prospective parents assess genetic risks and make informed decisions. Pharmacogenomics is emerging as a key clinical application, where gene panels help predict individual drug response and adverse reactions, leading to safer and more effective medication use. Infectious disease applications, including identifying pathogen resistance genes, further demonstrate the versatility of gene panels. The continual expansion into diverse clinical areas, combined with growing awareness among healthcare providers and patients, is driving the adoption of gene panel testing. This trend ensures a sustained increase in demand and fosters innovation, solidifying gene panels as vital components of modern healthcare worldwide.

Segmental Insights

Component Insights

Based on component, testing services currently hold a dominant position over test kits, driven by several factors related to accessibility, expertise, and cost-effectiveness. Testing services are typically offered by specialized laboratories equipped with advanced sequencing technologies and bioinformatics capabilities necessary for accurately analyzing complex gene panels. These laboratories provide end-to-end solutions, including sample processing, sequencing, data interpretation, and comprehensive reporting, which many healthcare providers and patients prefer due to the complexity involved in genetic testing. One of the key advantages of testing services is the access to expert genetic counselors and bioinformaticians who help interpret the results, especially in cases involving variants of unknown significance. This level of expertise is often unavailable with standalone test kits, which require in-house sequencing equipment and skilled personnel, making them less feasible for many clinical settings, especially smaller hospitals and clinics.  The capital investment and operational costs associated with purchasing and maintaining gene panel test kits and sequencing platforms are substantial. Testing services eliminate these barriers by offering scalable, pay-per-use models that reduce upfront costs and make genetic testing more accessible. However, test kits are gaining traction as sequencing technologies become more affordable and portable, allowing certain institutions to conduct in-house testing with faster turnaround times. Still, given the current infrastructure and expertise demands, testing services remain the preferred choice globally, especially in developed markets where centralized laboratories offer reliable, comprehensive genetic testing solutions.

Technique Insights

Based on technique, the amplicon-based approach currently dominates over the hybridization-based approach due to its efficiency, cost-effectiveness, and suitability for targeted sequencing applications. Amplicon-based sequencing involves selectively amplifying specific genomic regions using PCR before sequencing, which makes it highly sensitive and efficient, especially when working with limited or degraded DNA samples. This approach is widely favored in clinical diagnostics because it enables rapid, high-throughput analysis of selected gene panels with relatively low input DNA, making it ideal for routine use in oncology, inherited disease testing, and pharmacogenomics. The amplicon-based method also offers faster turnaround times and simpler workflows compared to hybridization-based capture, which requires more complex probe design and longer processing times. The lower cost per sample with amplicon-based assays makes them attractive for laboratories and healthcare providers aiming to balance accuracy with affordability. On the other hand, the hybridization-based approach, which uses probes to capture target sequences, offers higher uniformity and better coverage of large or complex genomic regions. It is preferred for comprehensive genomic profiling and research applications but is less common in routine clinical testing due to its higher costs and longer processing times. While hybridization-based methods have specific advantages, the amplicon-based approach currently leads the market in clinical applications, driven by its practicality, cost-efficiency, and adaptability to a wide range of genetic testing needs.

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Regional Insights

North America dominated the global gene panel market due to a combination of advanced healthcare infrastructure, robust research and development activities, and strong regulatory support. The region, particularly the United States, benefits from well-established genomic research centers and leading biotechnology companies that drive innovation in gene panel technologies. Significant investments in next-generation sequencing (NGS) and bioinformatics have enabled the development of sophisticated gene panels used for a wide range of clinical applications, including oncology, rare genetic disorders, and pharmacogenomics. North America has a high prevalence of genetic and chronic diseases, which increases the demand for precise diagnostic tools like gene panels. The presence of comprehensive healthcare systems and higher healthcare spending facilitates greater patient access to genetic testing services. The favorable reimbursement policies and insurance coverage for genetic tests in many parts of the region encourage both healthcare providers and patients to adopt these technologies.

Regulatory agencies like the U.S. Food and Drug Administration (FDA) have established clear pathways for the approval and oversight of genetic tests, fostering trust and ensuring safety and efficacy. The growing awareness among clinicians and patients about the benefits of personalized medicine contributes to the widespread adoption of gene panel testing. The synergy of technological advancements, strong healthcare infrastructure, supportive policies, and high disease burden positions North America as the leading market for gene panel technologies worldwide.

Recent Developments

• In April 2023, Agilent Technologies, Inc. launched a new next-generation sequencing (NGS) assay designed for somatic variant profiling across a wide variety of solid tumors. This innovative assay aims to enhance precision oncology by providing comprehensive genomic profiling (CGP), enabling more accurate and personalized cancer diagnosis and treatment. By capturing a broad spectrum of genetic alterations, the test supports clinicians in making informed decisions tailored to individual patients' tumor profiles. Agilent’s latest NGS assay reflects the ongoing advancements in genomic technologies, reinforcing the role of comprehensive genomic profiling as a critical tool in the fight against cancer. This launch is expected to significantly contribute to the global effort to improve cancer care through precision medicine.
• In May 2023, India’s Unipath Specialty Laboratory launched the HRD Gene Panel using SOPHiA GENETICS technology, aiming to advance cancer genomics by enabling better detection and understanding of homologous recombination deficiency in tumors.
• In January 2023, Twist Bioscience and Centogene introduced new next-generation sequencing (NGS) panels designed to enhance the sensitive detection of specific genetic sequences. These panels are expected to support advanced research and diagnostics in hereditary cancer, enabling more precise identification of genetic mutations and improving personalized treatment strategies for patients with inherited cancer risks.

Key Market Players

• Illumina, Inc.
• Agilent Technologies, Inc.
• Thermo Fischer Scientific, Inc.
• QIAGEN NV
• Eurofins Scientific SE
• Foundation Medicine Inc.
• Guardant Health, Inc.
• Myriad Genetic Laboratories Inc.
• Bio-Rad Laboratories, Inc.
• F. Hoffmann-La Roche AG

Report Scope:

In this report, the Global Gene Panel Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Gene Panel Market, By Component:

o   Test Kits

o   Testing Services  

• Gene Panel Market, By Technique:

o   Amplicon Based Approach

o   Hybridization Based Approach

• Gene Panel Market, By End User:

o   Academic & Research Institute

o   Hospital & Diagnostic Laboratories

o   Pharmaceutical & Biotechnology Companies

• Gene Panel Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia-Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Gene Panel Market.

Available Customizations:

Global Gene Panel Market report with the given Market data, TechSci Research, offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional Market players (up to five).