Genetic Testing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Genetic Testing Market is projected to expand from USD 9.31 Billion in 2025 to USD 18.58 Billion by 2031, achieving a compound annual growth rate of 12.21%. This sector involves the laboratory analysis of human DNA, RNA, chromosomes, proteins, or metabolites to detect genotypes, mutations, or phenotypes associated with somatic or heritable conditions. Key growth drivers include the rising global prevalence of chronic disorders and the increasing demand for personalized medicine, which requires precise biomarker identification for tailored treatments. According to the American Cancer Society, projections for 2025 estimated over 2 million new cancer diagnoses in the United States, indicating a vast patient pool necessitating genomic profiling for effective treatment planning.

Despite this potential, the market contends with a challenging and shifting regulatory environment. Inconsistent reimbursement policies and ambiguous oversight frameworks for Laboratory Developed Tests can hinder the creation and commercialization of new diagnostic assays. These regulatory barriers often lead to prolonged approval times and higher compliance costs, restricting patient access to advanced testing solutions and limiting revenue growth for both established and emerging market players.

Market Drivers

The growing use of genetic testing in oncology is a major market force, driven by the shift toward precision medicine and the necessity for companion diagnostics. As pharmaceutical companies introduce targeted therapies, the need for genomic profiling to identify eligible patients has surged, directly increasing test volumes for diagnostic providers. This trend is reinforced by the approval of new treatments; PharmaBoardroom noted in May 2025 that the FDA approved seven new cell and gene therapies in 2024, creating significant demand for precise genetic assays. Companies in liquid biopsy and molecular diagnostics are seeing utilization spikes; for example, Guardant Health’s October 2025 financial results reported a 40% year-over-year increase in clinical oncology test volumes, reaching approximately 74,000 tests.

Simultaneously, the rising adoption of Non-Invasive Prenatal Testing (NIPT) is extending market reach beyond oncology into reproductive health. The broad acceptance of cell-free DNA screening for chromosomal abnormalities has revolutionized prenatal care, prompting providers to make these safe, high-throughput solutions a routine part of practice. This adoption is reflected in the scale of operations at leading laboratories, which are handling record sample numbers. Natera reported in November 2025 that it processed roughly 893,600 tests during the third quarter, a 15.2% increase from the prior year, highlighting the strong and increasing reliance on genetic screening for clinical and reproductive needs.

Market Challenges

A complex and evolving regulatory landscape, along with inconsistent reimbursement policies, creates a significant barrier to the Global Genetic Testing Market's expansion. This environment generates uncertainty for laboratories, especially regarding Laboratory Developed Tests, by enforcing strict compliance requirements that lengthen approval timelines. When oversight is unclear or payers apply rigid coverage restrictions, the administrative burden on diagnostic providers grows substantially. These obstacles stifle innovation and deter the commercialization of new assays, as companies face increased operational costs and delayed revenue, causing the market to struggle in converting the demand for personalized medicine into actual testing volumes due to bureaucratic impediments.

Recent data confirms the operational impact of these coverage barriers. In 2024, the American Medical Association reported that 94% of surveyed physicians experienced delays in patient access to care due to prior authorization processes. Such administrative friction prolongs diagnosis times and often results in test abandonment, directly lowering the number of genomic profiles conducted and restricting the revenue potential for both established and emerging participants in the market.

Market Trends

The integration of Artificial Intelligence and Machine Learning into genomic data interpretation is fundamentally changing market operations. As sequencing throughput grows, the resulting data volume surpasses manual analysis capacities, requiring automated solutions for variant classification and interpretation. This technology enables laboratories to scale bioinformatic pipelines, shortening turnaround times for complex reports while improving accuracy. The commercial value of this adoption is clear; in a July 2025 survey by NVIDIA titled 'State of AI in Healthcare and Life Sciences: 2025 Trends', over 80% of healthcare and life sciences professionals indicated that AI contributed to revenue growth at their organizations, emphasizing the importance of computational tools for financial performance.

At the same time, a shift toward preventive genomic screening in healthy populations is widening the market beyond symptomatic patients. Health systems are moving from reactive diagnostics to proactive population health management, using large-scale sequencing to detect risk factors for conditions like hereditary cancer and cardiovascular disease before symptoms appear. Major institutional partnerships are supporting this transition to integrate genomic insights into primary care. For example, TriHealth announced in February 2025 a partnership with Helix to launch a precision population health initiative aiming to enroll 100,000 participants over five years, demonstrating the growing scale of preventive genetic data utilization.

Key Players Profiled in the Genetic Testing Market

• 24Genetics SL
• Prenetics Global Limited
• Circle DNA
• TellmeGen
• 23andMe, Inc.
• AncestryDNA
• myDNA Life Australia Pty Ltd.
• Myriad Genetics, Inc.
• MapmyGenome
• MyHeritage Ltd.

Report Scope

In this report, the Global Genetic Testing Market has been segmented into the following categories:

Genetic Testing Market, by Technology:

• Next Generation Sequencing
• Array Technology
• PCR-based Testing

Genetic Testing Market, by Application:

• Ancestry & Ethnicity
• Traits Screening
• Genetic Disease Carrier Status
• New Baby Screening
• Health & Wellness-Predisposition/Risk/Tendency

Genetic Testing Market, by Product:

• Consumables
• Equipment
• Software & Services

Genetic Testing Market, by Channel:

• Online
• Offline

Genetic Testing Market, by End User:

• Hospitals & Clinics
• Diagnostic Laboratories
• Others

Genetic Testing Market, by Region:

• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Genetic Testing Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

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

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