市場調查報告書
商品編碼
1445531
全球乳房切片市場評估:按產品類型、應用、最終用戶和地區劃分的機會和預測(2017-2031)Breast Biopsy Market Assessment, By Product Type, By Application, By End-user, By Region, Opportunities and Forecast, 2017-2031F |
全球乳房切片市場規模將從2023年的21.1億美元成長到2031年的35.1億美元,2024-2031年預測期間複合年增長率為6.58%,預計規模也將持續成長。
該市場的推動因素包括女性癌症發病率的增加、對微創手術的日益偏好、對癌症及其篩檢方法、真空輔助活檢、空芯針活檢和立體定向活檢的認識不斷增強。預計這將受到活檢技術和設備進步等因素的影響。
此外,政府和其他組織實施的各種計劃預計將提高人們對癌症早期檢測的認識,並積極影響對其診斷的需求。 近年來,開發癌症治療藥物和診斷解決方案的投資大幅增加,進一步擴大了市場規模。 世界衛生組織已確定乳癌是全世界最常被診斷的癌症類型,也是女性癌症相關死亡的主要原因。 50歲以上的女性更容易罹患乳癌,老年女性數量的增加使得盛行率不斷上升。
另一方面,先進活檢技術和設備的高成本是中低收入國家市場面臨的主要挑戰。 雖然乳房切片檢查是一種微創手術,但存在感染和組織損傷的風險。 此外,患者的不適感也是採用乳房切片檢查的障礙。 活檢儀器製造的嚴格監管指南也是市場擴張的主要挑戰。
癌症盛行率高
乳癌是女性最常被診斷出的癌症,也是全世界最常見的癌症類型。 由於生活方式的改變以及日常生活中接觸輻射和致癌化學物質的增加,癌症的盛行率預計將進一步增加。 雖然遺傳和家族史是癌症的主要因素,但越來越多地使用荷爾蒙避孕藥來避免意外懷孕也是導致癌症盛行率上升的一個主要因素。
乳房切片檢查方法的進展
雖然手術切除切片檢查是以前唯一的選擇,但現在有微創方法可用於診斷癌症。 向影像引導乳房切片檢查方法的範式轉變,如超音波引導活檢、乳房X光攝影立體定位活檢、磁振造影影像引導活檢、斷層合成引導活檢和真空輔助活檢等,將為進一步提高精準診斷打開可能性。 液體活檢是一項透過分析血液樣本來檢測循環腫瘤細胞和遊離 DNA 的新技術,這可能有助於診斷癌症和個人化預後。 真空輔助活檢正在成為一種流行的選擇,因為它對患者的創傷較小。 製造商正在透過開發創新解決方案來抓住市場機會。
本報告調查了全球乳房切片市場,並提供了市場定義和概述、市場規模趨勢和預測、各個細分市場和地區的詳細分析、行業結構以及影響市場成長的因素。我們編制分析、案例研究、競爭格局、主要公司簡介等等。
Global breast biopsy market is projected to witness a CAGR of 6.58% during the forecast period, between 2024-2031, growing from USD 2.11 billion in 2023 to USD 3.51 billion in 2031F. The market is anticipated to be influenced by factors such as the growing prevalence of breast cancer among females, rising preference for minimally invasive procedures, growing awareness about breast cancer and its screening methods along with technical advancements in biopsy techniques and devices such as vacuum-assisted biopsy, core needle biopsy, and stereotactic-guided biopsy techniques.
Additionally, various programs run by governments and other organizations are expected to spread awareness about early detection of breast cancer, positively impacting the demand for its diagnostics. A significant rise in investments has been made in recent years to develop breast cancer therapeutics and diagnostics solutions, further expanding the market offerings. WHO confirms that most common type of cancer being diagnosed globally is breast cancer and it is also the leading cause of cancer related deaths among women. The increasing geriatric female population is adding more numbers to the prevalence, as women above the age of 50 years are highly prone to breast cancer.
However, the high cost associated with advanced biopsy procedures, and equipment poses a significant challenge for the market in low and middle-income countries. Despite being a minimally invasive procedure, breast biopsy procedures have the risk of infections and tissue damage. Alongside, patient discomfort is another factor posing limitations for the adoption of breast biopsies. Stringent regulatory guidelines for manufacturing biopsy instruments are another major challenge for market expansion.
In August 2023, Mammotome released a new breast biopsy site marker called HydroMARK Plus, which is designed to improve ultrasound visibility, ease of locating, and prevent displacement during surgical procedures. The HydroMARK Plus Breast Biopsy Site Marker is anticipated to be be available to healthcare professionals in the United States by the end of 2023, and company haveplans to expand the market to Canada and some other selected countries worldwide.
High Prevalence of Breast Cancer
Breast cancer is the most commonly diagnosed cancer type in women and the most common cancer type among all types of cancers globally. With changing lifestyles and increasing exposure to radiation and carcinogenic chemicals in day-to-day life, the prevalence of breast cancer is anticipated to increase further. Genetics and family history of breast cancer is a dominating factor while increasing use of hormone-based contraceptives in females to avoid unwanted pregnancies is another major factor contributing to the rising prevalence of breast cancer.
Although breast cancer mainly occurs in females, around 0.5-1% of breast cancer cases are diagnosed in men, which may occur due to hormonal imbalance or other reasons. Physical examination of breasts is a preliminary diagnostic method, but confirmation is done by biopsy method with high precision. The high prevalence is anticipated to significantly increase the demand for breast biopsy equipment and procedures in the assessment period.
As per the American Cancer Society, incidence rates of breast cancer in the United States have increased by 0.6% per year. The rise in incidence rates is steeper in women younger than 50 years (1.0%). WHO estimates around 685,000 annual death cases due to breast cancer globally.
Advancements in Breast Biopsy Methods
Previously, surgical excisional biopsy was the single alternative, but presently there are minimally invasive procedures available for diagnosis of breast cancer. The paradigm shift towards image-guided breast biopsy methods, such as ultrasound-guided biopsy mammographic stereotactic biopsy, magnetic resonance imaging-guided biopsy, tomosynthesis-guided biopsy, and vacuum-assisted biopsy have opened further opportunities for precision diagnostics. Liquid biopsy is a newer technique that involves analyzing blood samples to detect circulating tumor cells or cell-free DNA, which may help personalize breast cancer diagnosis and prognosis. Vacuum-assisted biopsy is becoming a popular choice due to lesser trauma to patients. Manufacturers are encashing market opportunities by producing innovative solutions.
For instance, in December 2023, Exai Bio announced new data that its AI-driven liquid biopsy test can detect breast cancer at early stages and small tumor sizes, including DCIS, using a standard blood sample. In a recent study, the test showed 87% sensitivity for stage I breast cancer and 81% for tumors =10mm at 90% specificity. Overall sensitivity was 88% for invasive breast cancer stages, outperforming any DNA-based liquid biopsy. The sensitivity for DCIS was 78%. These findings are being presented at the San Antonio Breast Cancer Symposium (SABCS), 2023.
Dominance of Biopsy Needle Segment
The biopsy needle segment is anticipated to dominate the breast biopsy market with the highest share. The dominance of biopsy needles in breast biopsy procedures can be attributed to their cost efficiency and research-based efficacy. A study comparing image-guided and palpation-guided core needle biopsies of palpable breast masses. It found that image-guided biopsies were considered more accurate than palpation-guided biopsies, with image-guided biopsies being preferred for sampling breast masses, even if they are palpable. The research suggests that core needle biopsy, especially when guided by imaging, is preferred for its accuracy and safety in diagnosing breast lesions. Biopsy needles are hollow needle instruments used to collect tissues from the breast and analyze them. These instruments are easy to handle and are thus preferred by professionals.
For instance, in February 2024, NeoDynamics received clearance (US plate_number_1(k)) for their innovative breast biopsy system, NeoNavia. This groundbreaking technology utilizes a patented pulse system to provide accurate and controlled needle insertion, based on research carried out at Karolinska Institutet. The system comprises of a base unit, a handheld driver, and three distinct biopsy needles. The pulse technology delivers precise needle placement within the tumor, allowing for high-quality tissue samples from both breasts and lymph nodes.
Invasive Breast Cancer to Dominate the Market
Invasive breast cancer spreads into the surrounding breast tissues, it can be of two types, invasive ductal carcinoma and invasive lobular carcinoma. Due to the high prevalence of these types of breast cancer, the related segment is anticipated to dominate the breast biopsy market. Another reason can be the widespread application of biopsy in deeper tissue extraction in case of invasive types of cancer. As per the American Cancer Society, invasive (or infiltrating) breast cancer is the most common type and within it, Invasive ductal carcinoma makes up about 70-80% of all breast cancers.
The American Cancer Society estimates that about 310,720 new cases of invasive breast cancer will be diagnosed in women in 2024 in the United States and about 56,500 new cases of ductal carcinoma in situ (DCIS) are expected to be diagnosed. Another estimate states that approximately 13% (about one in eight) of women in the United States are going to develop invasive breast cancer during their lives.
North America to be the Dominating Region
North America, particularly the United States and Canada, exhibits a notable prevalence of breast cancer, which can be attributed to several factors. The region has well-established screening programs that detect breast cancer at early stages, leading to higher diagnosis rates. Also, changes in risk factors, such as increased obesity and physical inactivity, have contributed to higher breast cancer rates. Socioeconomic factors, including access to healthcare and lifestyle choices, play a role in breast cancer prevalence. Additionally, genetic factors, like the presence of BRCA1 and BRCA2 mutations, are more common in North America, contributing to higher breast cancer rates. Despite these factors, breast cancer mortality rates have been declining in North America, which may be due to improved detection and treatment. With such factors, North America is expected to lead in the demand for breast biopsy methods.
For example, as per the statistics by the Centers for Disease Control and Prevention, about 240,000 cases of breast cancer per year are diagnosed in women and about 2,100 cases of breast cancer in men in the United States only. About 42,000 women and 500 men die from breast cancer in the United States every year. Within these statistics, the number of black women is higher as they are genetically more prone to breast cancer as compared to other races..
Future Market Scenario
Advancements in imaging techniques have led to enhanced tissue visualization and improved efficacy of biopsy methods, promising a bright future for the breast biopsy market. Novel techniques such as multiparametric MRI, photoacoustic imaging, and virtual biopsy provide advanced diagnostic insights. Imaging-guided therapies and theragnostic promise targeted precision treatment, revolutionizing the future of breast radiology. Similar to other domains, the integration of artificial intelligence in biopsy methods is another promising advancement that is anticipated to contribute to the market expansion.
For instance, in November 2023, Syantra, a company that specializes in liquid biopsy platforms and innovation, announced the expansion of its Intellectual Property (IP) portfolio and a strategic partnership with Limmi which is a US-based technology company. Limmi focuses on AI-driven insights to facilitate the development of next-generation techniques for disease detection and management. These achievements are major milestones for Syantra and represent significant advancements in the understanding of human diseases, starting with Syantra DX Breast Cancer.
Key Players Landscape and Outlook
The key players in the breast biopsy market include a variety of players ranging from multi-billion dollar companies to small startups. Some of the major players in global breast biopsy market are Becton, Dickinson and Company, Hologic Inc., Danaher Corporation, Argon Medical Devices, and Devicor Medical Products, Inc. (Mammotome). These players are constantly involved in innovation and R&D to cater to the demand for breast biopsy products. Market tactics like mergers and acquisitions, and collaborations have been significant contributors to the market expansion.
In April 2023, Quest Diagnostics announced a definitive agreement to acquire Haystack Oncology in an all-cash equity transaction. Quest Diagnostics is the United States' leading provider of diagnostic information services, and Haystack Oncology is an early-stage oncology company dedicated for testing of minimal residual cancer cells which helps in the early andaccurate detection of residual or recurring cancers, such as in the case of breast cancer, to provide better-informed therapy decisions.
All segments will be provided for all regions and countries covered
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.