Genetic Testing Market Growth & Trends | Forecast to 2035

The global genetic testing market is projected to experience significant growth, with estimates varying across different analyses. According to Vantage Market Research, the market size was valued at USD 22.60 billion in 2024 and is expected to reach USD 65.91 billion by 2034, growing at a compound annual growth rate (CAGR) of 11.3% from 2025 to 2034. This robust growth is primarily driven by the increasing prevalence of genetic conditions, advancements in research and development, and initiatives led by key market players. Additionally, the rising emphasis on personalized medicine is expected to impact the direct-to-consumer genetic testing industry positively.

Government initiatives play a crucial role in promoting genetic research. National programs aim to enhance data collection to develop personalized treatment plans and medicines suitable for diverse populations. Awareness and acceptance of genetic testing are vital components of these initiatives.

Genetic testing is essential for diagnosing and monitoring chronic illnesses, particularly various forms of cancer. The increasing incidence of cancers and higher remission rates associated with testing methodologies are expected to drive growth in this segment throughout the forecast period. Collaborations among companies to integrate advanced informatics tools for efficient cancer diagnosis further contribute to this growth. For instance, in February 2021, Tempus collaborated with Precision Health Informatics to advance precision medicine in oncology. This partnership utilized Tempus' genomic sequencing capabilities and AI-enabled platform to create compelling, personalized patient care and clinical research programs.

Moreover, governments in emerging countries are establishing infrastructure to support genetic testing. In 2021, the Mohammed Bin Rashid University of Medicine and Health Sciences and A.J. Children's Specialty Hospital collaborated to establish the Al Jalila Genomics Center. This center aims to promote genomics and gene discovery as part of a comprehensive academic health system.

Despite these advancements, challenges remain regarding analyzing the vast amounts of data produced in genetic studies. While technical improvements have enhanced equipment capabilities, the process still heavily relies on the expertise of professionals. The need for skilled professionals may hinder market growth in developing countries.

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Regions and Countries

North America is a leader in the genetic testing market, driven by a shift toward personalized care, favorable reimbursement policies, and a high prevalence of genetic disorders. Leading companies such as 23andMe and AncestryDNA are at the forefront of this technological advancement, driving innovation in the field. The rise of direct-to-consumer genetic testing has also expanded the market by allowing individuals to access services directly without the need for medical intermediaries.

In December 2023, Progenesis, a prominent genetic testing brand, entered the Indian market by inaugurating its first genetic laboratory in New Delhi and an AI & Bioinformatics Data Centre in Chennai. This strategic move solidifies Progenesis's foothold in North America and signals a significant expansion into the dynamic Asia-Pacific market.

The Asia-Pacific region is expected to experience the fastest growth in the genetic testing industry, driven by a growing population, increasing chronic conditions, and heightened awareness of genetic testing.

Professor Dennis Lo Yuk-ming of the Chinese University of Hong Kong, in collaboration with Prenetics, launched Insights, a venture valued at US$200 million. This initiative focuses on blood tests designed to detect cancer cells by identifying the genetic material of cancerous cells.

Genetic Testing Regional Outlook (Revenue, USD Million, 2017 - 2034)

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa

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Market Dynamics

Recent technological advancements have significantly reshaped the genetic testing market trends. The introduction of polymerase Chain Reaction (PCR), a technology that amplifies DNA, and DNA sequencing, which determines the order of bases in DNA, have revolutionized the field. These tools are frequently used to detect genetic variants linked to hereditary disorders or diseases like cancer, thereby enhancing the precision and speed of diagnosis.

Conventionally, Sanger sequencing has served as the gold standard for clinical DNA sequencing, but it is constrained in its ability to analyze a single, short DNA segment from a single patient at a time. Next-generation sequencing (NGS) technologies are rapidly transforming this process by enabling faster analysis and the ability to examine the entire exome or genome as they analyze millions of small DNA fragments simultaneously. Microarray testing, which uses synthetic DNA sequences to detect DNA changes, is often recommended for individuals with developmental delays, intellectual disabilities, autism spectrum disorders, or multiple congenital disabilities, as it can analyze chromosomes and single nucleotide polymorphisms (SNPs).

Researchers at MGH, BWH, MIT, and Harvard have developed a noninvasive genetic test to screen pregnant individuals' blood for fetal DNA sequence variants. These continuous technological advancements are positively contributing to the growth of the genetic testing market size.

Direct-to-consumer (DTC) genetic testing has become a popular method for obtaining genetic information due to its ease of use and accessibility. This type of testing allows individuals to access health information without the need for a medical professional. Available over the counter or online, DTC tests provide insights into genetic predispositions for health disorders and metabolism, helping individuals optimize their health and wellness. However, concerns regarding data security, privacy, and accuracy have been raised. Additionally, unexpected or alarming results can lead to psychological distress.

Restraints

Ethical and social considerations are not just important, but they play a crucial role in the genetic testing market. The complex nature of genetic testing raises several ethical concerns, including genetic discrimination, informed consent, privacy, confidentiality, family dynamics, psychological effects, equity, regulation, and education. Ensuring ethical supervision and regulation is paramount to safeguard individuals' rights, while fostering public awareness to facilitate informed decision-making among the public, legislators, and healthcare professionals is crucial to ensure the optimal growth of the genetic testing market.

Interoperability and data sharing present significant challenges due to a lack of standardization, concerns over data security, legal and regulatory hurdles, and fragmented data environments. Financial and resource constraints exist, and incentives for improving data integration are often insufficient. Patient consent and control over their data further complicate matters. While standardized procedures and formats can facilitate data integration, they also require robust safeguards to protect patient privacy. Addressing these concerns is vital for advancing data sharing and interoperability in the genetic testing market outlook.

Opportunity

Research collaboration stands as a beacon of potential in the field of genetic testing and personalized treatment. By fostering resource sharing, data harmonization, clinical trials, and international partnerships, research collaboration allows for a deeper understanding of the genetic basis of health and disease. This cross-disciplinary collaboration, spanning genetics, bioinformatics, medicine, and ethics, can lead to innovative solutions and pave the way for the future of genetic testing.

Recent Developments

On October 9, 2024, Illumina, Inc., a global leader in DNA sequencing and array-based technologies, announced the launch of its MiSeq i100 Series of sequencing systems. The new system, which includes two benchtop instruments, the MiSeq i100, and the MiSeq i100 Plus Systems, offers unparalleled benchtop speed and simplicity to advance next-generation sequencing for laboratories. The system is designed to provide customers with the ability to unlock powerful insights through an affordable, comprehensive solution that is straightforward to understand and use, even for those with limited NGS expertise.

February 7, 2024: Sysmex Corporation and Hitachi High-Tech Corporation have entered into a collaboration for the development of Genetic Testing systems using Capillary Electrophoresis sequencers. This collaboration builds on the previously signed Feasibility Study (FS) agreement in August 2023, with both companies conducting joint research focused on Genetic Testing systems. This collaboration aligns with the shared objectives of Sysmex and Hitachi High-Tech to produce Genetic Testing systems that are more efficient and cost-effective, thereby facilitating the broader clinical application of personalized Genetic Testing for various diseases.

On September 29, 2023, The U.S. Food and Drug Administration (FDA) granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in-vitro diagnostic test designed to help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers. The test is the first of its kind to receive FDA marketing authorization, and it can also help identify potentially cancer-associated hereditary variants in individuals with already-diagnosed cancer. It evaluates DNA extracted from a blood sample to identify variants in 47 genes known to be associated with an elevated risk of developing certain types of cancer.

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Genetic Testing Market Segmentation

Vantage Market Research has segmented the global genetic testing market report on the basis of technology, application, product, channel, end-use and region:

By Test Type:

• Diagnostic Testing
• Predictive and Presymptomatic Testing
• Carrier Testing
• Prenatal and Newborn Screening
• Pharmacogenomic Testing
• Other

By Technology:

• Next-Generation Sequencing (NGS)
• Polymerase Chain Reaction (PCR)
• Chromosomal Microarray
• Fluorescence In Situ Hybridization (FISH)
• Sanger Sequencing

By Application:

• Oncology
• Rare Diseases
• Neurological Disorders
• Cardiovascular Diseases
• Genetic Disease Risk Assessment
• Ancestry Testing
• Paternity Testing
• Other

By End-User:

• Hospitals and Clinics
• Diagnostic Laboratories
• Research Institutes
• Direct-to-Consumer (DTC) Testing Services
• Forensic Laboratories
• Other