The global Breast Cancer Diagnostics Market size was worth $ XX billion in 2018 and is forecasted to reach $ XX billion by 2026, at a CAGR of XX% during the forecast period. Breast cancer is characterized by malignant tumor formed in breast cells. It is the most common invasive cancer in women, and the second main cause of cancer death in women, after lung cancer.
The Breast Cancer Diagnostics market growth is driven several factors such as rising incidence of breast cancer globally, technological advancement in diagnosis, and increasing government initiatives towards awareness about the breast cancer.
According to WHO, breast cancer is the most frequent cancer among women, impacting 2.1 million women each year, and also causes the greatest number of cancer-related deaths among women. In 2018, it is estimated that 627,000 women died from breast cancer, i.e. approx. 15% of all cancer deaths among women. While breast cancer rates are higher among women in more developed regions, rates are increasing in nearly every region globally. In order to improve breast cancer outcomes and survival, early detection by diagnosis and screening is crucial. Hence, the demand for diagnosis of the breast cancer is rising globally.
In addition, rise in the emergence of new technologies in early screening and diagnosis for breast cancer is also driving the growth of the breast cancer diagnostics market globally. For instance, on July 10th 2019, Arizona-based SimonMed Imaging announced their implementation of the first U.S. Food and Drug Administration (FDA)-cleared artificial intelligence (AI) program for significantly enhancing early breast cancer detection for 3-D mammography. The AI program, called ProFound AI for digital breast tomosynthesis (DBT), is a technology developed by iCAD Inc.
In addition, rising government initiatives to create awareness towards breast cancer is also boosting the growth of the market. Increased funding from various government and nongovernment organizations in both developed and developing countries and the development of innovative technologies to reduce healthcare expenditures are also driving the breast cancer diagnostic market. For instance, in November 2016, the Indian government has published an operational framework for the country’s first national cancer screening programme. Also, in January 2017, Narayana Multispeciality Hospital Mysore, India launched the state-of-theart Digital Mammography Unit for timely and accurate diagnosis of breast cancer. This initiative was taken to make high-end medical facilities accessible to more number of people. With the new digital mammography unit located within the hospital premises, more people will be screened for breast cancer and they will be educated on early detection and self-breast examination. Under the 2010 Affordable Care Act, most insurance companies must now cover breast cancer screening at no cost to women over 40.
However, costly follow ups for diagnosis, limited availability and stringent regulatory framework, are some of the factors hindering the growth of the breast cancer diagnostics market globally. For instance, mammography costs around $200 and approx. 50% of women are poorly diagnosed. There is also limited access to current cancer screening methods in Eastern Europe, Asia and Africa due to the high cost of diagnostic imaging equipment outlays. High false positive cancer diagnosis rate and indeterminate mammograms that require follow-up with MRI, 3D mammography and biopsies are challenges to the breast diagnostics market.
According to the ClinicalTrials.gov, there are about 9181 studies based on breast cancer diagnosis. Among these, there are 132 studies in Early Phase 1, 1536 in Phase 1, 2912 in Phase 2, 1064 in Phase 3, and 213 in Phase 4.
On the basis of type of diagnostic, the global breast cancer diagnostics market is segmented into imaging test (Mammogram, Ultrasound, MRI) Biopsy, and Blood Test. The imaging test market held a significant market share in 2018 and expected to grow at a high CAGR during the forecast period (2019-2026). Growth in the global mammography market is driven by rising cases of breast cancer globally. A mammogram is an x-ray that allows a qualified specialist to examine the breast tissue for any suspicious areas. In a diagnostic mammogram, more x-rays are taken, providing views of the breast from multiple vantage points. Mammography is less likely to reveal breast tumors in women younger than 50 years than in older women because younger women have denser breast tissue that appears white on a mammogram. Mammography facilities in the United States and its territories (including military bases) are subject to the Mammography Quality Standards Act (MQSA). The act requires annual inspections and accreditation every 3 years through an FDA-approved body. Key players are collaborating to innovate new technological test to diagnose the breast cancer. For instance, on July 25th 2019, Hologic partnered with mammography information solutions provider MagView to develop Unifi EQUIP, an automated solution that will facilitate compliance with the U.S. Food and Drug Administration’s (FDA) Enhancing Quality Using the Inspection Program (EQUIP) guidance.
On July 24th 2019, Fujifilm Medical Systems U.S.A. Inc. expanded its breast imaging solutions with the launch of its Tomosynthesis Biopsy option for the Aspire Cristalle mammography system.
North America is dominating the breast cancer diagnostics market in 2018 and estimated to hold largest market size over the forecast period (2019-2026) owing to rising breast cancer cases and increasing technological advancements for diagnosis of cancer. For instance, about 1 in 8 U.S. women (about 12%) will develop invasive breast cancer over the course of her lifetime. In 2019, an estimated 268,600 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S., along with 62,930 new cases of non-invasive (in situ) breast cancer. About 2,670 new cases of invasive breast cancer are expected to be diagnosed in men in 2019. A man’s lifetime risk of breast cancer is about 1 in 883.
In addition, increasing initiatives taken by the manufacturers to create awareness about breast cancer is driving the growth of the market in this region. For instance, in July 2019, Fujifilm Medical Systems USA has launched a nationwide effort to enhance access to breast cancer screening and raise awareness about the importance of early disease detection. Called “Aspire to Be Fearless,” the 18-month, 48-state campaign features a mobile mammography bus that will travel around the country to educate local communities and offer mammograms.
The Breast Cancer Diagnostics market is highly fragmented, with the presence of a large number of local and international players. Some of the major players in the Breast Cancer Diagnostics market are: Abbott Laboratories, Roche Holding AG, Thermo Fischer Scientific, Inc., Siemens AG, Bio-Rad Laboratories, Inc., Illumina, Inc., Biocept, Inc., Epigenomics AG, AstraZeneca plc, Myriad Genetics, Inc, Quest Diagnostics Incorporated, Hologic Inc., Koninklijke Philips N.V., FUJIFILM Holdings Corporation, and Toshiba Corporation.
The key players are adopting various growth strategies such as product launches, mergers & acquisitions, partnerships, and collaborations which are contributing to the growth of the Breast Cancer Diagnostics market globally. For instance,
- In July 2019, Paragon Biosciences LLC launched its seventh portfolio company, Qlarity Imaging LLC, which was founded to harness the value of artificial intelligence (AI) to improve medical outcomes. Qlarity Imaging will further develop QuantX, the U.S. Food and Drug Administration (FDA)-cleared computer-aided breast cancer diagnosis system.
- In May 2019, QIAGEN launched its first FDA-approved companion diagnostic for PIK3CA biomarkers to enhance precision medicine in breast cancer.
- In April 2019, Hologic, Inc. launched the Trident® HD specimen radiography system, a next-generation solution that delivers enhanced image quality, improved workflow and instant sample verification during breast-conserving surgeries and stereotactic breast biopsies.
- In March 2019, NeoGenomics, a leading provider of cancer-focused genetic testing services, launched the Ventana PD-L1 (SP142) Assay for tumor tissue from patients with the triple negative subtype of breast cancer.
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