Genetic Testing Market To Reach US$ 39.2 Billion By 2032

Introduction

Global Genetic Testing Market size is expected to be worth around US$ 39.2 Billion by 2032 from US$ 17.4 Billion in 2023, growing at a CAGR of 9.7% during the forecast period from 2024 to 2032. In 2023, North America held over 42.6% market share, reaching a revenue total of US$ 6.7 Billion.

This growth is primarily attributed to the increasing prevalence of genetic disorders, rising demand for personalized medicine, and advancements in genetic testing technologies. The adoption of next-generation sequencing (NGS), anticipated to grow at a CAGR of 22.8%, is playing a crucial role in driving innovation within the sector.

Key factors contributing to market expansion include the growing incidence of genetic diseases and cancer, emphasizing the need for early diagnosis and intervention. Increased awareness and the importance of detecting genetic anomalies early have bolstered the adoption of genetic testing in prenatal and newborn screening. In fact, the prenatal and newborn testing segment dominated the market in 2022, underscoring the focus on early genetic diagnoses.

However, the market faces notable challenges. The high cost of genetic tests, which can range from less than USD 100 to over USD 2,000 depending on the complexity, remains a significant barrier to widespread adoption. Furthermore, regulatory hurdles and concerns over data privacy, including fears of genetic discrimination and unauthorized access, limit market growth.

Recent industry developments highlight the dynamic nature of the market. Labcorp’s strategic acquisitions include the USD 239 million purchase of Invitae’s assets, expanding its oncology and rare diseases portfolio. Additionally, Labcorp acquired BioReference Health’s clinical diagnostics and women’s health business for USD 237 million, expected to generate USD 100 million in annual revenue.

Veracyte enhanced its cancer diagnostics capabilities by acquiring C2i Genomics for up to USD 95 million. Meanwhile, Gilead Sciences secured USD 210 million in funding from Abingworth to advance its antibody-drug conjugate, Trodelvy, for non-small cell lung cancer.

Key Takeaways

• The Global Genetic Testing Market was valued at USD 15.9 Billion in 2022.
• It is projected to reach USD 39.2 Billion by 2032, indicating a Compound Annual Growth Rate (CAGR) of 9.7% from 2023 to 2032.
• Consumables, comprising 59.6% of the market, generate the highest revenue among product segments.
• Next-generation sequencing is expected to exhibit the highest growth rate among technologies, with a projected CAGR of 22.8%.
• Health and wellness predisposition holds the largest share (46.8%) in the application segment.
• Hospitals and clinics are the primary end-users, representing 45.8% of the market share.
• North America leads the market with a revenue share of 42.6%, followed by Asia Pacific.
• The genetic testing market is fragmented, with key players including Abbott Molecular, Circle DNA, and 24 Genetics.

Genetic Testing Statistics

• Global Development: From 2012 to 2022, a total of 197,779 genetic tests were developed worldwide, reflecting rapid growth in genetic testing technologies.
• United States Contribution: Within the same period, the United States developed and submitted 129,624 genetic tests to the Genetic Testing Registry (GTR).
• Annual Growth: In 2012, 1,081 new genetic tests were introduced globally. By 2022, this number surged to 6,214, indicating significant market expansion.
• US Growth Trajectory: The United States saw a sharp increase in new genetic tests, rising from 607 in 2012 to 3,097 in 2022.
• Record-Breaking Year: The year 2016 marked the highest surge, with 21,952 new genetic tests introduced globally, showcasing a peak in innovation.
• Clinical Purpose Dominance: Over 90% of genetic tests submitted to the GTR are intended for clinical purposes, emphasizing their importance in diagnosis and treatment.
• Concentrated Innovation: 10 laboratories, out of over 250 in the United States, account for 81% of new genetic tests submitted to the GTR, highlighting concentrated industry efforts.
• Quality Assurance: About 93% of new genetic tests introduced between 2012 and 2022 were developed by CLIA-certified laboratories, ensuring high-quality standards.
• Diagnostic Test Dominance: Diagnostic tests lead the genetic testing sector, constituting 62% of all new tests during the study period.
• Secondary Applications: Risk assessment, pre-symptomatic testing, and screening together make up 32% of new genetic tests introduced from 2012 to 2022.
• Personalized Healthcare: The increasing availability of genetic tests underscores the rising demand for personalized healthcare solutions and the role of genetic insights in disease prevention and management.
• Cancer and Genetics: According to the National Cancer Institute, 5% to 10% of all cancers result from inherited genetic changes passed down from parents.
• Sample Testing: Genetic testing typically uses blood, saliva, or skin cell samples, with results returned within 2 to 3 weeks.
• Cancer-Specific Guidelines: Clinical guidelines recommend genetic testing for individuals with specific cancers, including triple-negative breast cancer, ovarian cancer, pancreatic cancer, colorectal cancer (before 50), metastatic prostate cancer, or male breast cancer.

Use Cases

• Cancer Risk Assessment: Genetic testing is pivotal in evaluating hereditary cancer risks. For instance, BRCA1 and BRCA2 mutation tests identify individuals at elevated risk for breast and ovarian cancers, enabling preventive strategies and timely interventions.
• Prenatal and Newborn Screening: Prenatal tests detect genetic abnormalities such as Down syndrome and chromosomal disorders, while newborn screening identifies metabolic and genetic disorders early, allowing treatments that prevent severe health complications.
• Pharmacogenomics: Genetic testing facilitates a personalized approach to medication, optimizing drug effectiveness and minimizing side effects. For example, CYP2C19 gene testing informs the use of antiplatelet drugs in cardiovascular patients, enhancing treatment outcomes.
• Rare Disease Diagnosis: It plays a crucial role in diagnosing rare genetic disorders. Techniques like whole-exome sequencing detect mutations linked to diseases such as cystic fibrosis and Huntington’s disease, guiding management and treatment.
• Carrier Testing: Carrier testing evaluates the likelihood of passing genetic disorders, such as sickle cell anemia or Tay-Sachs disease, to offspring. This aids individuals in making informed family planning decisions.
• Forensic Applications: Genetic testing is integral to forensic science, matching DNA from crime scenes to genetic databases for solving crimes. It is also used in tracing genealogical ancestry and discovering biological relatives.
• Personalized Health and Wellness: Direct-to-consumer tests provide insights into personal health traits, including condition susceptibility, nutritional needs, and exercise responses, empowering individuals to make data-driven lifestyle choices.

Recent Developments

• Labcorp Expands Oncology and Rare Disease Services (April 2024): Labcorp acquired assets from Invitae for USD 239 million during a bankruptcy auction, aiming to enhance its oncology and rare disease services. Earlier, Labcorp purchased BioReference Health’s clinical diagnostics and women’s health business for USD 237 million.
• Veracyte Strengthens Cancer Diagnostics (2024): Veracyte acquired C2i Genomics for up to USD 95 million to bolster its capabilities in cancer diagnostics, expanding its presence in the genomic diagnostics market.
• Gilead Sciences Advances Trodelvy (2024): Gilead Sciences secured USD 210 million from Abingworth to fund clinical trials and regulatory expansion of Trodelvy, an antibody-drug conjugate for treating non-small cell lung cancer.
• Apogee Therapeutics Raises Funds for Development (2024): Apogee Therapeutics generated USD 420 million through a public offering to support its development projects and operational growth.
• Prenetics Group Launches ColoClear (June 2022): Prenetics introduced ColoClear by Circle, an at-home colorectal cancer screening test, to improve early diagnosis and preventive healthcare for colorectal cancer.
• Illumina Launches Comprehensive Cancer Test (March 2022): Illumina launched a test in Europe that analyzes a broad spectrum of tumor genes from a single tissue sample, enhancing diagnostic precision and personalized cancer treatments.
• Pyxis Oncology Raises Research Funds (2024): Pyxis Oncology secured USD 50 million through a private investment, which will fund its oncology research and development programs.

Conclusion

The global genetic testing market is poised for significant growth, driven by rising demand for personalized medicine, early diagnosis, and advancements in genetic testing technologies such as next-generation sequencing (CAGR 22.8%). Valued at USD 15.9 billion in 2022, it is projected to reach USD 39.2 billion by 2032 (CAGR 9.7%).

Key drivers include increased awareness of genetic disorders, cancer diagnosis needs, and prenatal screening. Challenges such as high costs and regulatory concerns persist. Industry innovations, strategic acquisitions, and expanded testing applications in oncology, rare diseases, and pharmacogenomics underscore the sector’s dynamic nature and its pivotal role in modern healthcare.

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