Breast Recurrence Score Test Market

Breast Recurrence Score Test Market Outlook (2023 to 2033)

Revenue generated by the global breast recurrence score test market reached US$ 216.8 million in 2022. The market is projected to expand at a CAGR of 9.2% and climb to a value of US$ 576.6 million by the end of 2033.

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 2022.
• Revenue from breast recurrence score testing accounted for 45.6% share of the global breast cancer genomic tests market in 2022.

• 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.
• 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.

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

“Rising Cases of Breast Cancer and Technological Advancements in Multigene Assays”

Growing burden of breast cancer globally has boosted the demand for screening and diagnostic procedures.

• As per the Susan G. Komen® Foundation—Cancer Treatment Centers of America (2022), even after treatment, 7% to 11% of patients experience a local cancer recurrence within the first five years of treatment. Females with inflammatory breast cancer (IBC) and triple-negative breast cancer (TNBC) are at significantly higher risk.
• As reported in Breast Cancer Research and Treatment in 2013, a systematic review of health economic analysis identified 18 cost-effectiveness evaluations of the 21-gene recurrence score assay. These evaluations were conducted in various countries, including Australia, Canada, Hungary, Ireland, Israel, Japan, Singapore, the United Kingdom, and the United States, spanning the period from 2002 to 2012.

Evaluations estimated that the assays would be cost-effective from a healthcare payer perspective, driven by improved clinical outcomes and reduced adjuvant chemotherapy use.

The 21-gene recurrence score test is a multigene assay that has been included in major breast cancer therapy guidelines such as the European Society for Medical Oncology (ESMO), American Society of Clinical Oncology (ASCO), San Antonio Breast Cancer Symposium (SABC), and International Society for Pharmacoeconomics and Outcomes Research (ISPOR), among others.

It is the only multigene test recommended by the NCCN (National Comprehensive Cancer Network) that has Category 1 evidence for predictive and prognostic usefulness in patients with estrogen receptor (ER)-positive lymph node (LN)-negative breast cancer. The only validated multigene test for chemotherapy benefit prediction and prognosis is the 21-gene recurrence score assay.

The breast recurrence score test assay is a predictive and prognostic multigene assay, a cost-effective alternative to adjuvant chemotherapy in early breast cancer patients. It is more effective and cost-effective than clinical risk tools alone. The results show that targeted treatment of a minority of women with RS 26-100 who benefit from chemotherapy can reduce cost and improve survival.

Continuous research efforts are being undertaken to develop novel product lines to predict the recurrence of early-stage breast cancer such as the development and validation of an AI-enabled digital breast cancer assay. Such research initiatives along with the abovementioned factors are likely to drive market growth going forward.

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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 approach complicates the test since the physician must examine all aspects impacting the test and then only analyze the results, making it more prone to misunderstanding and inaccuracy.

• 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.

The 21-gene test had the lowest number of individuals categorized as high risk, offering possible over- or under-treatment concerns in clinical practice. Diagnosis involving genetic material needs professional individuals for precise procedures, handling, measurements, and interpretation, all of which take time.

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 shows that co-treatment with estrogen and progesterone increases recurrence scores.

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Country-wise Insights

Why is There Increasing Demand for Breast Recurrence Score Testing in the United States?

“Rising Prevalence of Invasive Breast Cancer in the Country”

The United States accounted for 24.9% share of the global breast recurrence score test market in 2022.

Breast cancer is the most commonly diagnosed cancer among women in the United States 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.

• As per the American Cancer Society statistics for breast cancer (2022 to 2024), more than 4 million women in the United States were living with breast cancer as of Jan 2022. Estimated new diagnoses in 2022 were around 287,850 for invasive breast cancer and 51,400 for ductal carcinoma in situ (DCIS).

The 21-gene recurrence score assay has been found to be cost-effective in the United States, Germany, Japan, and Türkiye since 2013. However, it is only cost-effective in patients with intermediate or high clinical risk stratified by the PREDICT tool.

• Analyses by the National Comprehensive Cancer Network from 2019 suggest that the test is effective in community practice settings when realistic variations in input variables are considered.

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

“Large Cancer Patient Pool and Favorable Reimbursement Policies”

Germany accounted for 10% share of the global market in the year 2022.

Presence of a large patient pool, favorable reimbursement policies, and increasing awareness initiatives by public entities are the key factors behind market growth in Germany.

• As of 2020, breast cancer is the leading cause of death in Germany, with nearly 299,702 patients (5-year prevalent cases), 69,697 new cases, and 20,579 deaths reported (Globocan, 2020).
• 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 India a Lucrative Market for Breast Recurrence Score Test Providers?

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

India accounted for 6.7% share of the global market in the year 2022.

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 Indian 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.
• As per Globocan 2020, breast cancer accounted for 26.3% of all cancer cases in India.

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.

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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 2022.

Recurrence test kits have been created to 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.

Data supplied by recurrence test kits can help clinicians make educated judgments. The test results give further information on the tumor's aggressiveness and the chance of recurrence. This process facilitates the customization of the treatment approach, including the identification of the necessity for additional medications like chemotherapy or hormone therapy, while also providing guidance on the duration and intensity of the treatment regimen.

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

“Increased Recurrence Likelihood of Stage II Breast Cancer Due to Large Tumor Size and Lymph Node Involvement Necessitating Efficient Screening”

By indication, stage 2 breast cancer accounted for 41% share of the global market in 2022.

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. 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 40% share of the global market in 2022.

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 have the infrastructure, technology, and competence to perform these tests. The analysis requires a multidisciplinary team of healthcare specialists from many disciplines, including surgeons, medical oncologists, and radiation oncologists, to collaborate on patient treatment, assuring a holistic approach to breast cancer therapy that includes recurrence score testing.

Hospitals often have extensive laboratory facilities and technology needed to perform recurrence score examinations. These studies frequently entail molecular profiling and gene expression analysis, which necessitates the use of sophisticated laboratory equipment and trained experts. Because of these considerations, hospitals occupy a dominant share of the market.

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 July 2023, NanoString Technologies was granted permission to include counterclaims in a patent action against 10x Genomics and Harvard College, accelerating the production process.
• In June 2023, Exact Sciences joined forces with the MIT Broad Institute and Harvard University to work on the development of highly sensitive detection technologies for molecular residual disease.

Similarly, the team at Persistence Market Research has tracked recent developments related to companies operating in the breast recurrence score test market, which are available in the full report.

Breast Recurrence Score Test Industry Report Scope

Key Segments of Breast Recurrence Score Test Industry Research

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