Breast Cancer Diagnostics Market Size, Share & Trends Analysis Report By Product (Platform-based, Instrument-based), By Type (Imaging, Biopsy, Genomic Tests, Blood Tests), By Application, By End-use, By Region, And Segment Forecasts, 2021 - 2028

Report Overview

The global breast cancer diagnostics market size was valued at USD 3.9 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 7.0% from 2021 to 2028. The growth can be attributed to the increasing prevalence of cancer and rising government initiatives to increase the screening and diagnostic rate. The increasing incidence of breast cancer is expected to drive the market for breast cancer diagnostics. According to the American Cancer Society, in 2021, 281,550 new cases of breast cancer are estimated to be diagnosed, and around 49,290 related deaths are expected to occur in the U.S. alone. As per the WHO, in 2021, breast cancer is the most common type of cancer at a global level, with new cases surpassing 2.3 million.

Growing demand for technologically advanced products that can enable better accuracy, speed, and cost-effectiveness is likely to be the dominant growth factor over the forecast period. For instance, the introduction of Direct-To-Consumer (DTC) testing in the field of cancer diagnostics. The first DTC test, introduced in 2018 by 23andMe, received the U.S. FDA approval for BRCA testing. It is one of the first DTC tests for the BRCA gene mutations that increase the risk of breast and ovarian cancers.

Besides, the increasing reimbursement and insurance coverage are expected to increase the adoption of testing. Different tests are being approved by government agencies for nationwide reimbursement. Medicaid, Medicare, and third-party payer benefit plans in the U.S. cover the cost of genetic testing. Genetic tests, such as BRCA1 and BRCA2, are reimbursed by most health plans for individuals with a family history of cancer, which has led to an increase in the number of tests being carried out.

Early detection is a key to the effective management of the disease. It can result in improved quality of life, provide several treatment options, and increase survival rates. According to a 2018 article published in Research Fast Facts, regular screening and early detection with mammography can decrease the breast cancer rate by 30%. Furthermore, research conducted to develop tests that can detect breast cancer as early as possible is expected to boost the growth of the market for breast cancer diagnostics.

However, there are specific risk factors associated with the imaging procedures. Imaging tests involve administering high doses of fluorescent and barium contrast agents, as well as radiation exposure in imaging and endoscopic procedures, which can cause several adverse effects such as nausea or diarrhea. The risks of ionizing radiation associated with the use of CT, MRI, and X-rays, and the use of radioactive tracer injections in PET can limit the adoption of such screening procedures.

Product Insights

The instrument-based testing segment dominated the market for breast cancer diagnostics and accounted for the largest revenue share of 72.7% in 2020. Imaging is the first choice for general population-based screening of breast cancer patients. A biopsy is performed for a confirmed diagnosis in all breast cancer patients. Many organizations such as the National Breast Cancer Foundation, Inc. are undertaking initiatives to spread awareness regarding breast cancer, the benefits of early detection, and available treatment options.

The platform-based products segment is anticipated to witness the fastest growth over the forecast period, owing to the novelty of products and the higher preference of such products for the targeted therapy. The market for breast cancer diagnostics is segmented into Next Generation Sequencing (NGS), microarrays, PCR, and others. The presence of commercialized products such as GeneReader NGS system, Ion GeneStudio S5 next-generation sequencing systems, and Ion AmpliSeq HD panels for targeted NGS and QIAseq Panel assays are responsible for market growth.

Application Insights

The diagnostics and predictive application segment dominated the market for breast cancer diagnostics and accounted for the largest revenue share of around 47.6% in 2020. The increasing trends of genetic testing may further contribute to the growth of the segment. An article suggests that around 25% of the women had genetic testing for cancer in 2019. Moreover, advancements in this field such as the development of biomarkers may support the growth of the market for breast cancer diagnostics.

The prognostic segment is expected to witness a significant CAGR over the forecast period. These tests are becoming increasingly important as they are being used to match patients with therapies. This, in turn, increases the survival rate of the patients substantially. This includes products like companion diagnostics. For instance, BRACAnalysis CDx by Myriad Genetic Laboratories, Inc. for Lynparza and Talzenna; PD-L1 IHC 22C3 pharmDx by Dako North America, Inc. (a part of Agilent Technologies, Inc.), and FoundationOne CDx by Foundation Medicine, Inc. (a part of F.Hoffmann La-Roche Ltd.)

End-use Insights

The hospitals and clinics segment dominated the market for breast cancer diagnostics and accounted for the largest revenue share of around 50.2% in 2020. The increasing hospitalization of patients and the growing burden of the disease are expected to propel the growth of the segment. After the screening test, patients undergo biopsy for confirmatory testing in hospitals. Moreover, PET, CT, and MRI are used for checking disease progression and for the assessment of the effectiveness of cancer treatment.

The diagnostic centers and medical laboratories segment is expected to witness a significant growth rate over the forecast period due to an increase in the number of initiatives undertaken by governments to provide various services, such as reimbursement for diagnostic tests. Many healthcare institutions are working with laboratories to integrate different tests, such as mammography, ultrasound, and MRI.

Type Insights

The imaging segment dominated the market for breast cancer diagnostics and accounted for the largest revenue share of 73.6% in 2020. The factors such as the large volume of procedures, easy accessibility, and enhanced effectiveness are anticipated to drive the market. The most common imaging procedures carried out for screening and diagnosis are mammogram, ultrasound, and MRI. Furthermore, quite a few advanced emerging imaging techniques such as breast tomosynthesis, Molecular Breast Imaging (MBI), CT, and PET, among others for breast cancer diagnosis, are expected to change the landscape of breast imaging.

The blood tests segment is projected to be the fastest-growing segment during the forecast period due to several research studies being carried out globally by the research organizations and major players. The high efficacy of liquid biopsy tests is expected to drive the growth of the blood tests segment. As per a research published by the American Association for Cancer Research in April 2020, DNA blood tests are effective in the early diagnosis of breast cancer.

The blood test analyzes very small amounts of tumor DNA, called circulating tumor DNA, floating in the bloodstream. Researchers at MSK have found mutations in two extra genes PTEN and ESR1, that foster resistance to estrogen-blocking drugs using the liquid biopsy.

Regional Insights

North America dominated the breast cancer diagnostics market and accounted for the largest revenue share of 45.9%, in 2020. The major factors contributing to the dominance of this region are the presence of major players, well-established diagnostic and screening infrastructure, technological advancements, high patient awareness, and favorable reimbursement policies.

In Asia Pacific, the market for breast cancer diagnostics is expected to witness the highest CAGR during the forecast period owing to the increasing incidence of breast cancer and the adoption of advanced diagnostic techniques. Additionally, the improving reimbursement guidelines and rising healthcare infrastructure are also expected to support market growth.

Key Companies & Market Share Insights

The key companies are adopting strategies such as mergers and acquisitions and partnerships, to acquire a larger market share, globally. In January 2021, Hologic Inc. acquired Biotheranostics and SOMATEX Medical Technologies GmbH. The acquisition of these companies has helped the company to expand its breast health product portfolio and strengthen its position in the market for breast cancer diagnostics.

In September 2020, Thermo Fisher Scientific, Inc. entered into an agreement with AstraZeneca and the University of Nebraska Medical Center for the development of innovative clinical biomarkers. Furthermore, In October 2018, the company entered into an agreement with Pfizer, Inc. for BRACAnalysis CDx to be used as a companion diagnostic with Pfizer’s proprietary talazoparib. Some of the prominent players in the breast cancer diagnostics market include:

• Hologic Inc.

• Genomic Health (Exact Sciences Corporation)

• BD

• Danaher

• Koninklijke Philips N.V.

• QIAGEN

• Thermo Fisher Scientific Inc.

• Myriad Genetics

• Argon Medical Devices, Inc.

• F. Hoffmann-La Roche Ltd.

Breast Cancer Diagnostics Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2028. For the purpose of this study, Grand View Research has segmented the global breast cancer diagnostics market report on the basis of type, product, application, end-use, and region:

• Type Outlook (Revenue, USD Million, 2017 - 2028)

  • Imaging

  • Biopsy

  • Genomic Tests

  • Blood Tests

  • Others

• Product Outlook (Revenue, USD Million, 2017 - 2028)

  • Platform-based Products

    • Next-generation Sequencing

    • Microarrays

    • PCR

    • Others

  • Instrument-based Products

    • Imaging

    • Biopsy

• Application Outlook (Revenue, USD Million, 2017 - 2028)

  • Screening

  • Diagnostic and Predictive

  • Prognostic

  • Research

• End-use Outlook (Revenue, USD Million, 2017 - 2028)

  • Hospitals & Clinics

  • Diagnostic Centers and Medical Laboratories

  • Others

• Regional Outlook (Revenue, USD Million, 2017 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Spain

    • Italy

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

  • Latin America

    • Brazil

    • Mexico

  • Middle East & Africa

    • South Africa

    • Saudi Arabia