Genetic testing market to record USD 7.10B growth from 2023-27

The global genetic testing market size is estimated to grow by USD 7.10 billion from 2023 to 2027, according to Technavio. This growth is expected to occur at a Compound Annual Growth Rate (CAGR) of about 12.78% during the forecast period.

Major challenges:

• Varying regulations on genetic testing and research globally
  • Regulatory standards vary globally for genetic testing, posing challenges for market vendors. Accurate test results are crucial in healthcare decisions. Compliance with regulations from US FDA, EMEA, ATGA, WHO, ISO, and CFDA ensures product quality and safety. However, differing regulations, like acceptable DNA limits in qPCR studies, complicate compliance.
  • Genetic test definitions lack global consensus, affecting policymaking. Regulations also differ for predictive and diagnostic tests, and for PCR kits—US FDA regulates under 21 CFR, while Europe uses IVD Directive.
  • Clinical labs must adhere to validation requirements, and test results must meet CMS, CLIA, and EMA standards. These variations hinder compliance, potentially impacting market growth.

Market overview
The genetic testing market encompasses various segments, including healthcare expenditure, cancer types, gene sequences, and ancestral DNA. Businesses in this market cater to carrier disease genetic testing, toxicology research, and direct-to-customer companies through OTC channels. Costs involve equipment expenses, consumables like reagents and accessories, and services.

Genetic testing facilitates identifying inherited conditions, predicting disease risks, and understanding ancestry. Healthcare expenditure in this field covers a range of services from testing to interpretation. Cancer types are investigated through gene sequences, aiding in diagnosis and treatment planning. Genetic research contributes to advancements in understanding diseases and developing tailored treatments.

Direct-to-customer companies provide accessible testing options, while toxicology research focuses on identifying genetic factors in drug response. Overall, the genetic testing market serves diverse needs, from medical diagnostics to consumer interests in ancestry and health. Technavio