DNA Diagnostics Market Size to Climb USD 17.44 Billion by 2034

DNA Diagnostics Market Companies, Advancements and Growth Opportunities

The DNA diagnostics market size was estimated at US$ 10.69 billion in 2023 and is projected to grow to US$ 17.44 billion by 2034, rising at a compound annual growth rate (CAGR) of 4.55% from 2024 to 2034. The rising prevalence of genetic disorders, growing genomics research, and increasing investments drive the market.

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DNA Diagnostics Market: Genomic Insights

DNA diagnostics or DNA testing involves testing genes or chromosomes to identify changes or mutations. It indicates the presence of a genetic condition or predicts the risk of developing a certain condition or passing on a genetic disorder. DNA diagnostics can also give ideas for developing medical treatments based on an individual’s genetic makeup. It is also used to test paternity or to predict an individual’s ancestry. Hence, DNA diagnostics have broad applications in healthcare, research, biotechnology, and forensics. The other uses of DNA diagnostics include newborn screening, carrier testing, preimplantation genetic diagnosis, prenatal diagnosis, and pharmacogenomics.

The rising incidences and prevalence of genetic and other chronic disorders and the demand for personalized medicines boost the market. DNA diagnostics can help to tailor treatment regimens by obtaining an individual’s genetic information. The market is also driven by favorable government policies for genetic testing to prevent genetic disorders and increasing investments in genomics and proteomics research.

DNA Diagnostics Market Trends

• In June 2024, BillionToOne, a diagnostic developer, raised $130 billion in venture capital funding and reached a billion-dollar valuation. The funding was made to help scale up its DNA testing businesses in non-invasive pre-natal screening and cancer.
• In May 2024, iMeUsWe announced the launch of their DNA testing services in collaboration with MapMyGenome to provide insights into vital aspects of health, wellness, and ancestry, along with expert genetic counseling.
• In March 2024, Oxford Nanopore Technologies announced a collaboration with SeqOne, an AI developer, to support its next-generation sequencing approach in clinical diagnostic testing.

Decoding DNA with AI: A New Era in DNA Diagnostics

Artificial intelligence (AI) is a boon to the healthcare sector, owing to its widespread applications and better outcomes. Implementing AI in DNA diagnostics creates numerous opportunities by significantly improving the process of genomics. AI and machine learning (ML) approaches can enhance the speed and efficiency of testing. They can also drastically reduce costs and improve precision without compromising testing accuracy. Several companies are leveraging AI to improve efficiency and stay competitive in the market. AI can accurately predict genetic variations related to diseases or traits and aid in the development of precision medicines. Hence, AI-based large datasets can address unmet clinical needs in genetics and uncover novel mechanistic insights.

Ethical Issues Hinder the DNA Diagnostics Market

The major challenge of the market is the ethical issues associated with DNA testing. Ethical issues include informed consent, privacy and confidentiality, and discrimination. Genetic testing carries a potential risk of securing the privacy of the patient’s genetic information. There are also chances of discrimination among patients, resulting in biased outcomes.

Regional Insights

Increasing Investments Dominated North America

North America held the largest share of the DNA diagnostics market in 2023. The rising incidences of chronic disorders, technological advancements, increasing awareness, and favorable government policies drive the market. In 2022, a total of 129,624 genetic tests were performed in the US. Newborn screening is one of the most valued public health programs in the US. In the US, 12,500 babies with serious, treatable conditions grow up healthy through newborn screening annually. The National Institute of Health plans to grant $5.4 million in first-year funding out of the total $27 million to establish genomics research. The Canadian government also invested $400 million over six years (2021-2027) to support the creation of the Canadian Genomics Strategy.

Favorable Government Policies Drive Asia-Pacific

Asia-Pacific is anticipated to grow at the fastest rate during the forecast period. The rapidly rising population, increasing incidences of chronic disorders, growing demand for personalized medicines, and increasing investments & collaborations drive the DNA diagnostics market. China's government announced plans to become the world’s leader in biotechnology by 2035, and it regards genetic information as a crucial ingredient in a scientific revolution. In Japan, 239,844 infants were screened from 2018 to 2023. The Japanese government put forth a law, “The Genome Medicine Promotion Act,” to achieve the world’s highest level of genome medicine. In India, more than 33,000 newborns have undergone screening for various genetic and rare disorders under the DBT-UMMID initiative from as of July 2024.

Segmental Insights

By technology, the PCR-based diagnostics segment held a dominant presence in the DNA diagnostics market in 2023. Polymerase chain reaction (PCR) is the most widely preferred technique for DNA diagnostics due to faster results, high sensitivity, and simplicity. The segment’s growth is attributed to the latest innovations in the PCR process, which augment the segment’s growth.

By technology, the NGS-based diagnostics segment is expected to grow fastest in the market during the forecast period. Next-generation sequencing (NGS) is an advanced technique that assesses multiple genes in a single assay, eliminating the need for multiple assays to identify causative mutations. The demand for NGS-based diagnostics is increasing due to the ability to screen more samples, cost-effectiveness, and scalability.

By application, the cancer genetics test segment registered its dominance over the global DNA diagnostics market in 2023. DNA diagnostics can analyze several mutations in a person’s genes, having a higher risk of getting cancer. The rising incidences of cancer, favorable government initiatives, increasing healthcare expenditures, and increasing awareness potentiate the segment’s growth.

By application, the newborn genetic screening segment is predicted to witness significant growth in the market over the forecast period. Newborn screening tests are laboratory tests to identify serious and rare disorders, including blood, hearing, and heart, in newborn babies. The increasing population and rising need to prevent severe disorders promote the segment’s growth.

Top Companies in the DNA Diagnostics Market

• Agilent Technologies, Inc.
• Beckman Coulter, Inc.
• Bio-Rad Laboratories
• F. Hoffmann-La-Roche
• Fisher Scientific
• GE Healthcare
• Illumina, Inc.
• Myriad Genetics
• Oxford Nanopore Technologies
• Siemens Healthineers
• Qiagen

Latest Announcements by Industry Leaders

Dr. Kevin Haas, Chief Technology Officer of Myriad Genetics, commented that genetic testing represents more than just scientific advancement; it’s a fundamental shift in the health and wellness approach. By fostering collaboration and seamless data integration, the industry is laying the groundwork for the future involving personalized medicine.

Recent Developments in the DNA Diagnostics Market

• In June 2024, researchers from the Case Western Reserve University School of Medicine developed a novel method, AMPLON (Amplifying DNA with Multiarm Priming and Looping Optimization of Nucleic Acid), to target DNA amplification, testing, and analysis.
• In November 2024, ProPhase Labs, Inc. announced the launch of DNA Complete, Inc., a wholly-owned subsidiary offering direct-to-consumer DNA tests that sequence virtually 100% of a customer’s genome.

Segments Covered in the Report

By Technology

• PCR-Based Diagnostics
• NGS-Based Diagnostics
• In-Situ Hybridization
• Microarrays-Based Diagnostics

By Application

• Cancer Genetics Tests
• Newborn Genetic Screening
• Infectious Diseases DNA Testing
  • HBV Diagnostic
  • TB Diagnostic
  • CT/NG Diagnostic
  • HPV Diagnostic
  • MRSA Diagnostic
  • Others
• Preimplantation & Reproductive Diagnosis
• Non-Infectious Diseases DNA Testing
  • Cardiovascular Diseases
  • CNS & PNS Related
  • Skeletal, Connective, Ectodermal & Dermal DNA Testing
  • Lung, Kidney, Liver & GT Related
  • Sensory Diseases
• Prenatal DNA Carrier Screening
• Pharmacogenomics/Drug Metabolism
• Hematology & Immunology/Identity Diagnostics & Forensics
• Others

By Region

• North America
  • US
  • Canada
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Thailand
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Sweden
  • Denmark
  • Norway
• Latin America
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa (MEA)
  • South Africa
  • UAE
  • Saudi Arabia
  • Kuwait