Breast Recurrence Score Test Market Size, Share, and Growth Forecast for 2025 - 2032

Breast Recurrence Score Test Market Outlook (2025 to 2032)

The Global Breast Recurrence Score Test market is projected to rise from US$ 281.1 million in 2025 to US$ 529.5 million in 2032. The market is anticipated to exhibit a promising CAGR of 9.5% during the forecast period from 2025 to 2032.

Global Market Attributes	Key Insights
Breast Recurrence Score Test Market Size (2025)	US$ 281.1 Mn
Market Value Forecast (2032F)	US$ 529.5 Mn
Projected Growth (CAGR 2025-2032)	9.5%
Historical Market Growth (CAGR 2019 to 2024)	8.9%

In early-stage breast cancer patients, adjuvant tamoxifen combined chemotherapy is linked with a considerable decrease in recurrence and breast cancer-specific mortality (BCSM). However, not all patients benefit in the same way, making predicting distant recurrence (DR) risk and adjuvant treatment a critical therapeutic choice. Standard clinicopathological parameters are insufficient to assess chemotherapy efficacy, resulting in over- or under-treatment. To overcome this restriction, multigene assays such as the 21-gene recurrence score test have been created.

• Test kits for the breast recurrence score test occupied a market share of 71.1% in 2024.
• As per Molecular Diagnosis & Therapy 2020, in patients with hormone receptor-positive/HER2-negative, lymph node-negative, or LN-positive early-stage invasive breast cancer, the 21-gene recurrence score test estimates 9-year DR risk and treatment benefit probability. The article covers various aspects related to the assay, including its creation, technology, analytical validation, prognostic and predictive value, impact on treatment decisions, and cost-effectiveness.
• Furthermore, a comprehensive meta-analysis published in NEJM Evidence in July 2024 evaluated the 21-gene RS assay’s prognostic value for late distant recurrence, integrating it with clinical factors to improve risk stratification. In an independent cohort of 1,098 women, the enhanced RSClin model was validated which demonstrated superior long-term prognostic accuracy.
• The 21-gene recurrence score test is expected to be cost-effective in many countries throughout the world, owing to improved clinical outcomes and less adjuvant chemotherapy use.

The recurrence score, which consists of 21 genes, is a predictive test for 9-year distant recurrence and predicts adjuvant treatment effectiveness in patients with early-stage breast cancer. It has been found to be cost-effective in many countries due to improved clinical outcomes and reduced chemotherapy use.

• According to the New England Journal of Medicine 2018, the TAILORx trial discovered that lymph node-negative patients with a recurrence score of 0 to 25 profited greatly from endocrine treatment alone, but those with a recurrence score of 26 to 100 benefited from adjuvant chemotherapy.

Historical Growth and Course Ahead

The global market for breast recurrence score test recorded a historic CAGR of 8.9% from 2019 to 2024.

The Breast Recurrence Score Test has witnessed significant growth over the years, driven by advancements in genomic testing and increasing emphasis on personalized cancer treatment. Historically, traditional risk assessment tools were widely used, but they had limitations such as inconsistent interpretation and overtreatment risks.

The introduction of genomic tests like the 21-gene recurrence score test revolutionized breast cancer management by providing precise recurrence risk predictions and guiding chemotherapy decisions. Large-scale clinical trials, such as TAILORx and RxPONDER, validated its effectiveness, leading to its inclusion in major guidelines from ASCO, NCCN, and ESMO.

As genomic testing gained credibility, evolving insurance and reimbursement policies in developed markets improved financial accessibility, driving wider adoption. Integrating digital health and telemedicine has further enhanced availability, making recurrence score testing more accessible to diverse patient populations. Looking ahead, ongoing AI-driven research and next-generation genomic assays promise even greater accuracy in risk assessment. Expanding applications in emerging markets and younger patient groups will further solidify the test’s role in modern breast cancer care.

What’s Fueling the Growth of the Breast Recurrence Score Test Market?

“Rising Adoption of Non-Invasive Prognostic Tests for Enhanced Breast Cancer Management and Treatment”

The shift toward non-invasive prognostic diagnostics is gaining momentum. Traditional methods like tissue biopsies can be invasive, costly, and uncomfortable. In contrast, genomic-based recurrence score testing offers a risk-free way to guide treatment decisions.

A New England Journal of Medicine study found that early-stage HR+ breast cancer patients with a low recurrence score could safely avoid chemotherapy without affecting survival rates. This has boosted physician confidence and global adoption.

Advancements in liquid biopsy, analyzing ctDNA in blood, further enhance recurrence risk prediction. A JAMA Oncology study showed ctDNA assessments could detect relapse months before imaging, improving early intervention.

Regulatory support, including NCCN endorsement, is accelerating market growth. As demand for personalized diagnostics rises, non-invasive prognostic tests will play a crucial role in breast cancer management.

• In February 2025, Researchers at Vanderbilt University developed an ultrafast power doppler ultrasound technique to monitor tumor vasculature in real-time. This method helps track how tumors respond to radiation and immunotherapy, offering a non-invasive way to personalize cancer treatment strategies.
• In June 2024, Researchers from The Institute of Cancer Research, London, presented a new ultra-sensitive blood test at the ASCO 2024 meeting. This test can predict the recurrence of breast cancer in high-risk patient’s months or even years before relapse by detecting tiny amounts of cancer DNA left in the body after treatment.

What are the Primary Obstacles to the Demand Growth for Breast Recurrence Score Tests?

“Complex Impact of Patient Age and Hormone Receptor Expression on 21-Gene Recurrence Score Test”

Patient age significantly impacts the 21-gene recurrence score methodology, emphasizing the importance of considering patient age, especially for women under 50, in genomic-based algorithms for breast cancer care. This complexity increases the likelihood of misinterpretation, as physicians are required to evaluate multiple factors before analyzing results.

• When compared to other multigene assays, the 21-gene recurrence score test exhibits a large disparity (40% to 60%) in risk categorization as exhibited in the International Journal of Cancer 2019.

Hormone receptor protein expression changes during the menstrual cycle due to estrogen and progesterone concentrations, impacting recurrence score test signature genes like PGR, MKI67, CCNB1, BIRC5, and MYBL2. In vitro research suggests co-treatment with estrogen and progesterone increases recurrence scores, further complicating interpretation and treatment decisions.

• TAILORx Trial: National Comprehensive Cancer Network (NCCN) publication (July 2024), Involving 8,916 patients with hormone receptor-positive, HER2-negative, node-negative breast cancer, the trial found that patients with a low RS (0-10) had a 1.7% event rate for breast cancer-specific survival (BCSS) over 11.6 years of follow-up.

Region-wise Insights

Why is there an Increasing Demand for Breast Recurrence Score Testing in the North America?

“Rising Prevalence of Invasive Breast Cancer in the Country”

North America held a significant share of 30.6% in the global breast recurrence score test market in 2024. Breast cancer is the most commonly diagnosed cancer among women in the U.S. and is the second leading cause of death. However, advances in hormone therapy and other adjuvant therapies have significantly reduced the risk of breast cancer recurrence.

• According to National Breast Cancer Foundation, Inc., an estimated 56,500 new instances of non-invasive (in situ) breast cancer and 310,720 new cases of invasive breast cancer were detected in women in the United States in 2024.
• In the U.S., breast cancer is still the second most prevalent cause of cancer-related deaths among women and the most often diagnosed cancer overall.

What is the Demand Outlook for Breast Recurrence Score Tests in Europe?

“Large Cancer Patient Pool and Favorable Reimbursement Policies”

Europe accounted for a substantial 25.4% share of the global breast recurrence score test market in 2024. The presence of a large patient pool, favorable reimbursement policies, and increasing awareness initiatives by public entities are the key factors behind market growth in Europe.

• As of 2024, there are approximately 74,500 new cases of breast cancer annually in Germany. The 5-year prevalence has increased to around 315,000 cases. The number of deaths due to breast cancer is still high, with about 18,527 deaths reported in 2023.
• The Federal Joint Committee (G-BA) on June 2019 decided to provide Oncotype DX® testing (the first biomarker-based recurrence score test assay) as a statutory health insurance (SHI) benefit. Later, G-BA made three more biomarker-based tests covered by the statutory health insurance on Oct 2020 (Prosigna®, MammaPrint®, and EndoPredict®).
• On Sep 2021, the Evaluation Committee, Europe introduced a new code (19506) for Oncotype DX® testing in the EBM (German Uniform Evaluation Standard), at a procedure cost of US$ 2,938.58. The biomarker-based testing procedures covered by EBM are now established in Germany, which were available only in the United States previously.

What Makes South Asia a Lucrative Market for Breast Recurrence Score Test Providers?

“Aggressive Breast Cancer Patterns in South Asia Population Necessitating Early Cancer Recurrence Screening”

South Asia contributed a significant 17% share to the global breast recurrence score test market in 2024. Breast cancer in the Indian population is generally more aggressive than in the West, with a mean age of around 47 years, a decade younger than in the West. The biology of breast cancer in the Asian population is different compared to the West, with significant cases of triple-negative breast cancers.

• As per a 2022 article by the National Institutes of Health, 1 in every 9 people in India is expected to develop cancer in their lifetime with lung and breast cancer leading among both males and females.

Social factors such as lack of awareness, lack of screening programs, and limited access to quality healthcare contribute to this disparity. However, the growing cancer burden and rising need for cancer screening are likely to provide players with lucrative growth opportunities in India.

Category-wise Insights

Which Product is Widely Adopted for Breast Recurrence Score Testing?

“Personalized Test Kits Providing Accurate Recurrence Prediction and Tumor Aggressiveness”

By product, test kits accounted for 71.1% of overall product sales in 2024.

Recurrence test kits predominantly estimate the likelihood of breast cancer recurrence. These tools evaluate the genetic composition of tumor cells using modern molecular profiling methods. When compared to traditional clinical and pathological criteria, these tests give a more accurate prediction of the chance of cancer recurrence by detecting the expression level of particular genes linked with cancer recurrence.

The test results give further information on the tumor's aggressiveness and the chance of recurrence. Thus, facilitating custom treatment approach, including identifying the necessity for additional medications like chemotherapy or hormone therapy, while guiding the duration and intensity of the treatment regimen.

Why Does Stage II Breast Cancer Account for a Prominent Market Share?

“Increased Stage II Breast Cancer Recurrence Risk, Demand for Early Detection, and Advanced Treatment Options”

By indication, stage 2 breast cancer accounted for 43.2% of the global breast recurrence score test market in 2024.

The likelihood of recurrence is higher for stage II cancer, characterized by a large tumor that has spread to nearby lymph nodes. Despite surgical excision and lymph node clearing, tiny cancer cells may continue to develop and cause recurrence. The presence of hormone receptors, such as HER-2, is critical for molecular-targeted therapy in breast cancer. HER-2 overexpression instances had a high response rate, according to studies. Hence, stage II is more prevalent and recurrent than other stages of cancer.

Which End User Dominates the Breast Recurrence Score Test Market?

“Specialized Infrastructure for Breast Recurrence Score Diagnostics in Hospitals”

By end user, hospital settings accounted for a 45.1% share of the global breast recurrence score test market in 2024.

Hospitals provide full medical services for breast cancer patients, including diagnosis, treatment, and follow-up care. Breast recurrence score testing is an essential component of the diagnostic procedure, and hospitals often have extensive laboratory facilities and technology needed to perform recurrence score examinations. The analysis requires a multidisciplinary team of healthcare specialists to collaborate on patient treatment, assuring a holistic approach to breast cancer therapy that includes recurrence score testing.

Competition Landscape

Several players are currently active within the breast recurrence score test market offering products and services at both local and global levels. These businesses are using strategies such as enhanced research and development and expansion to meet patients’ demands and grow their customer base.

• In January 2025, Exact Sciences shared clinical validation data for its Oncodetect MRD test at the ASCO Gastrointestinal Cancers Symposium. While this test is primarily for colorectal cancer, it builds on the foundation of the Oncotype DX test, demonstrating the company's commitment to advancing cancer diagnostics.
• In November 2024, Exact Sciences presented new data at the San Antonio Breast Cancer Symposium (SABCS) demonstrating the value of the Oncotype DX Breast Recurrence Score test in guiding treatment decisions and improving outcomes for breast cancer patients.
• In July 2023, NanoString Technologies was granted permission to include counterclaims in a patent action against 10x Genomics and Harvard College, accelerating the production process.

Breast Recurrence Score Test Industry Report Scope

Attribute	Details
Historical Data/Actuals	2019 - 2024
Forecast Period	2025 - 2032
Market Analysis Units	Value: US$ Bn/Mn Volume: As Applicable
Geographical Coverage	North America Europe East Asia South Asia and Oceania Middle East and Africa Latin America
Segmental Coverage	Product Indication End User Region
Key Companies Covered	Exact Sciences (Genome Health Inc.) NanoString Technologies, Inc. Foundation Medicine, Inc ThermoFisher Scientific  Illumina, Inc Hologic Inc (Biotheranostic) Biocartis Roche Diagnostics Epic Sciences Qiagen Abbott Myriad Genetics, Inc Guardant Health Agendia Genomic Health iCAD CancerIQ Siemens Healthineers General Electric Company Koninklijke Philips NV
Report Highlights	Market Forecast and Trends Competitive Intelligence & Share Analysis Growth Factors and Challenges Strategic Growth Initiatives Pricing Analysis & Technology Roadmap Future Opportunities and Revenue Pockets Industry Market Analysis Tools
Customization & Pricing	Available upon Request

Breast Recurrence Score Market Segmentation

Product:

• Test Kits
• Reagents & Consumables

Indication:

• Stage 1 Breast Cancer
• Stage 2 Breast Cancer
• Estrogen-Receptor-Positive Cancer
• Lymph-Node-Negative Cancer

End User:

• Hospitals
• Specialty Cancer Centers
• Diagnostic Centers
• Cancer Research Institutions

Region:

• North America
• Europe
• East Asia
• South Asia and Oceania
• Middle East and Africa
• Latin America

To know more about delivery timeline for this report Contact Sales

About Author