Medical Devices US

US Hereditary Cancer Testing Market Analysis, 2024–2034

Updated Reviewed by Vidhi Upadhyay

US Hereditary Cancer Testing Market Industry Trends and Forecast to 2034: Segmented by (Cancer, Test, End User, Region) - Growth, Market Size, Future Prospects & Competitive Analysis, 2024-2034

Overview

Market Dashboard

US · 2024–2034 · placeholder estimates

Values shown here are placeholder estimates, not researched figures. Researched 2024 historical, 2025 base-year and 2026–2034 forecast values are prepared with the full report.

Estimate 2024 $1.97 Bn Placeholder estimate
Estimate 2025 $2.13 Bn 39.1% of the global market
Projected 2034 $4.30 Bn 101.6% Adds $2.16 Bn over 9 forecast years
CAGR 2025–2034 8.1% Faster than 61% of 173 Medical Devices markets here
Key players 5
  • US is 39.13% of the global market.
  • In North America, the largest is US (this report) at $2.13 Bn.
  • Fastest growing: Canada at 9.9% a year.
  • US ranks 1st of 2 by size in North America.

Market size projection

US

Source: Acuitas Health Analytics. Full methods, sources and usage terms come with report purchase.

Value added each year

$2.16 Bn total, 2026–2034

Year-by-year market size, 2024–2034
Hereditary Cancer Testing Market market size by year, US
YearMarket sizeChange that yearSince 2025
2024 (estimate) $1.97 Bn — —
2025 (base) $2.13 Bn +$159.7 Mn —
2026 (forecast) $2.30 Bn +$172.6 Mn +8.1%
2027 (forecast) $2.49 Bn +$186.6 Mn +16.9%
2028 (forecast) $2.69 Bn +$201.7 Mn +26.3%
2029 (forecast) $2.91 Bn +$218.0 Mn +36.6%
2030 (forecast) $3.15 Bn +$235.7 Mn +47.6%
2031 (forecast) $3.40 Bn +$254.8 Mn +59.6%
2032 (forecast) $3.68 Bn +$275.4 Mn +72.5%
2033 (forecast) $3.97 Bn +$297.7 Mn +86.5%
2034 (forecast) $4.30 Bn +$321.8 Mn +101.6%

Placeholder estimates. Each year is projected from our earlier market estimate and its CAGR. Researched values come with the full report.

Report snapshot

US Hereditary Cancer Testing Market Analysis at a glance
Market size, 2025$2.13 Bn placeholder estimate
Forecast, 2034$4.30 Bn placeholder estimate
Growth (CAGR), 2025–20348.1% placeholder estimate
Years2024 historical · 2025 base year · 2026–2034 forecast
SegmentsCancer, test and end user (see all)
Key playersMyriad Genetics, Inc., Ambry Genetics, Invitae, Natera, Quest Diagnostics (see all)
Regulator in the USFDASource: US Food and Drug Administration. Checked 14 Nov 2026.
FormatsPDF, PPTX, XLSX

Sizes and growth here are placeholder estimates, not researched figures. Researched figures come with the full report.

The US Hereditary Cancer Testing Market Analysis Executive Summary

Hereditary cancer testing looks for inherited gene changes, such as BRCA1 and BRCA2, that raise the risk of cancer.

Key segments of the hereditary Cancer Testing market include cancer (Breast and Ovarian, Colorectal (Lynch Syndrome) and Prostate) and test (Multi-Gene Panels, BRCA Tests and Whole Exome).

Bar chart: US Hereditary Cancer Testing market size, 2024–2034, placeholder estimates. $1.97 Bn in 2024, $2.13 Bn in 2025 and $4.30 Bn in 2034, 8.1% CAGR.
US Hereditary Cancer Testing market size, 2024–2034. Placeholder estimates; researched figures come with the full report. Source: Acuitas Health Analytics.

US Hereditary Cancer Testing Market Dynamics

Market Growth Drivers

The falling cost of DNA sequencing, more targeted medicines, large national genome programmes and growing use of genetic results in everyday care are driving the hereditary Cancer Testing market.

Opportunity

Routine use of genomics in screening, pharmacy and primary care gives the hereditary Cancer Testing market large room to grow.

Market Restraints

Data privacy concerns, limited reimbursement for some tests, shortages of genetic counsellors and complex data analysis hold back the hereditary Cancer Testing market.

Competitive Landscape for Hereditary Cancer Testing Market in US

The hereditary Cancer Testing market is moderately concentrated. Leading companies compete on product innovation, clinical evidence, pricing and geographic reach, and use partnerships and acquisitions to expand their portfolios.

Key Players

Healthcare Policies and Regulatory Landscape for Hereditary Cancer Testing Market in US

Hereditary Cancer Testing in the US: rules and payment

The FDA clears or approves medical devices by risk class, through 510(k) clearance, De Novo classification or premarket approval (PMA).⁠[1] Medicare covers people aged 65 and over and some younger people with disabilities, and Medicaid covers many people on low incomes; both are run with the Centers for Medicare & Medicaid Services (CMS).⁠[2]

[1] US Food and Drug Administration. Checked 14 Nov 2026.

[2] Centers for Medicare & Medicaid Services. Checked 14 Nov 2026.

Policy changes and Reimbursement scenario

Medical device rules, such as the US FDA 510(k) and PMA pathways and the EU Medical Device Regulation, govern how hereditary Cancer Testing products are approved and monitored. Reimbursement codes and hospital purchasing policies decide how widely they are used in US.

Beyond the market numbers

Research, trials and patients

What doctors and scientists are doing in Hereditary Cancer Testing right now, from free public sources.

Latest research 45 papers since 2021 (worldwide)

  1. MAP of molecular analyses in real-worlD oncology centers - MAPpaMoNDO: a study of the translational research Young GOIM group. Journal of translational medicine, 2026
  2. The Economic Value of Hereditary Cancer Testing: A Systematic Review. Genetics in medicine : official journal of the American College of Medical Genetics, 2026
  3. Universal Germline Genetic Testing after a Diagnosis of Cancer. Cancer discovery, 2026
  4. Yield of actionable variants from high-risk cancer gene panel testing in guideline-eligible and ineligible individuals. Frontiers in genetics, 2026
  5. Point-of-care models for genetic testing among patients at risk of hereditary cancer: A systematic review. Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 2026
Search all of them on PubMed (opens in a new tab)

Sources: PubMed (US National Library of Medicine), ClinicalTrials.gov, World Bank. Fetched 12 Nov 2026. Papers and trials are found by search words, so the counts are a guide. Titles only; read each paper at its source.

Public data, with sources

Hereditary Cancer Testing in context

The US compared

  • Health spending per person: 13,473 US$ per person (2023). World: 1,317 US$ per person (2023).[1]
  • Doctors: 3.68 per 1,000 people (2022). World: 1.86 per 1,000 people (2022).[2]
  • People aged 65 and over: 18.4% of people (2025). World: 10.4% of people (2025).[3]

[1] World Bank Open Data, Health spending per person (US$ per person). Retrieved 14 Nov 2026.

[2] World Bank Open Data, Doctors (per 1,000 people). Retrieved 14 Nov 2026.

[3] World Bank Open Data, People aged 65 and over (% of people). Retrieved 15 Nov 2026.

Free data on this topic

Quick answers

Frequently asked questions

How big is the Hereditary Cancer Testing market in the US?
Placeholder estimate: about $2.13 Bn in 2025, rising to about $4.30 Bn by 2034. These are early estimates, not researched figures; the researched values come with the full report.
How fast is the Hereditary Cancer Testing market in the US growing?
Placeholder estimate: about 8.1% a year (CAGR, 2025–2034). The researched growth rate comes with the full report.
What segments does the Hereditary Cancer Testing market report cover?
The report splits the market by cancer (Breast and Ovarian, Colorectal (Lynch Syndrome), Prostate, Pancreatic), test (Multi-Gene Panels, BRCA Tests, Whole Exome) and end user (Hospitals, Ambulatory Surgical Centers, Diagnostic Centers, Home Care Settings).
Who are the key players in the Hereditary Cancer Testing market?
Key players include Myriad Genetics, Inc., Ambry Genetics, Invitae, Natera and Quest Diagnostics.
What is driving the Hereditary Cancer Testing market?
The falling cost of DNA sequencing, more targeted medicines, large national genome programmes and growing use of genetic results in everyday care are driving the hereditary Cancer Testing market.
Who regulates Hereditary Cancer Testing in the US?
The FDA clears or approves medical devices by risk class, through 510(k) clearance, De Novo classification or premarket approval (PMA). Source: US Food and Drug Administration. Checked 14 Nov 2026.
How is healthcare paid for in the US?
Medicare covers people aged 65 and over and some younger people with disabilities, and Medicaid covers many people on low incomes; both are run with the Centers for Medicare & Medicaid Services (CMS). Source: Centers for Medicare & Medicaid Services. Checked 14 Nov 2026.
How much research is published on Hereditary Cancer Testing?
PubMed lists 45 papers on Hereditary Cancer Testing added since January 2021, worldwide. Source: PubMed, Papers added since 1 January 2021 matching this market. Retrieved 12 Nov 2026.
Back to Catalogue

Related Medical Devices reports in US

See all

Related on genomics and oncology

See the topic