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市場調査レポート
商品コード
1634220
乳房生検装置の世界市場 - 2025年~2033年Global Breast Biopsy Devices Market - 2025 - 2033 |
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カスタマイズ可能
適宜更新あり
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乳房生検装置の世界市場 - 2025年~2033年 |
出版日: 2025年01月13日
発行: DataM Intelligence
ページ情報: 英文 176 Pages
納期: 即日から翌営業日
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乳房生検装置の世界市場は、2024年に22億5,000万米ドルに達し、2033年には37億7,000万米ドルに達すると予測され、予測期間2025年~2033年にはCAGR 6.1%で成長します。
乳房生検は、診断目的で乳房組織の極小サンプルを採取する医療処置です。この治療は、乳房で検出された懸念が悪性か良性かを判断するために必要です。病気を診断するための臨床検査を専門とする病理医が組織サンプルを分析します。乳房生検は、悪性細胞が存在するという決定的な証拠を提供するため、乳がんを診断するための最も確実な方法と考えられています。
乳房生検の手技はさまざまで、それぞれ異なる画像技術を使用して手技を誘導します。コアニードル生検(CNB)とバキュームアシスト生検(VAB)の2つが一般的な低侵襲手技です。コアニードル生検では中空の針を用いて乳房から小さな円柱状の組織を採取するのに対し、吸引補助下生検では1回の挿入で数個の組織サンプルを採取します。その他の方法としては、極細の針で液体や細胞を採取する細針吸引(FNA)や、切開して大きな組織片を採取する外科的生検があります。マンモグラフィ、超音波検査、MRIなどの画像検査で発見された異常の特徴が、使用する生検法の種類に影響することが多いです。
促進要因と抑制要因
乳房生検装置に対する需要の増加
乳房生検に対する需要の増加は、世界の乳房生検市場の成長における重要な要因になると予想されます。乳房生検の需要は、乳がんの有病率の上昇、技術の進歩、乳がんに関する意識の高まり、最近の発売や承認によって増加しています。
乳がんは世界的に最も罹患率の高いがんのひとつであり続けているため、正確でタイムリーな診断手技の必要性はかつてないほど高まっています。例えば、国際がん対策連合(UICC)によると、乳がんは世界157カ国の女性で最も多く診断されるがんで、がん患者の4人に1人を占める。男女ともに2番目に多い悪性腫瘍であり、女性のがんによる死亡の主な原因となっています。乳がんは、2022年には230万人が新たに罹患すると予想され、世界で男女ともに診断される悪性腫瘍のほぼ9件に1件を占める。2022年には66万9,418人が乳がんで死亡すると予想されており、こうした死亡事故は低所得者層で不釣り合いに多く発生しています。乳がんの有病率の上昇により、ヘルスケアシステムは、診断を確定し効果的な治療戦略を決定するために重要な乳房生検のような早期発見処置を優先するようになっています。
乳がんは依然として世界で最も多い悪性腫瘍のひとつであり、毎年数百万人が新たに乳がんと診断されているため、正確な診断ツールの必要性はかつてないほど高まっています。乳房生検装置は、技術の進歩により、より利用しやすく、効率的で、侵襲性が低くなっており、より多くの女性が必要不可欠な検査や生検を受けられるようになっています。最近では、斬新な技術や最新の製造技術を使用した製品の発売や承認が数多く行われています。例えば、2024年5月、BSC(バルセロナ・スーパーコンピューティング・センター)は、バル・デブロン大学病院において、放射線を使わない乳がん診断技術の臨床検証を開始しました。この新しい戦略は、最新の超音波技術とスーパーコンピューティングを組み合わせることで、乳がん検出のための画像品質を向上させ、電離放射線に依存するマンモグラムなどの標準的な処置に代わる実質的な選択肢を提供するものです。QUSTomイニシアチブの一環であるこの新技術は、検査中の患者の快適性を保ちながら診断精度を高めることを目的としています。
感染症のリスク
感染リスクなどの要因が世界の乳房生検市場を阻害すると予想されます。組織サンプルを採取するために切開したり針を刺したりする生検手技は、体内に病原体を持ち込む可能性があります。この危険性は、外科的生検やコアニードル生検のような侵襲的な方法において特に高く、より深く刺入することで患者が周囲の細菌やその他の感染性物質にさらされることになります。治療後の感染症は、回復の遅れやさらなる治療などの問題につながり、患者がこれらの必要な診断手技を受けられなくなる可能性があることが治療で指摘されています。
生検後の感染に対する恐怖は患者の不安や消極性を引き起こし、乳がんの診断や治療の遅れにつながる可能性があります。乳がん患者の生存率を高めるためには早期発見が重要であるため、このような遅れは特に懸念されます。ヘルスケア従事者はこのような懸念をますます認識するようになっており、より厳格な滅菌プロセスを導入したり、侵襲を最小限に抑える新しい生検技術を開発したりして、患者の安全性向上に努めています。
The global breast biopsy devices market reached US$ 2.25 billion in 2024 and is expected to reach US$ 3.77 billion by 2033, growing at a CAGR of 6.1% during the forecast period 2025-2033.
A breast biopsy is a medical procedure that includes removing a tiny sample of breast tissue for diagnostic purposes. This treatment is necessary to determine whether a concern detected in the breast is malignant or benign. Pathologists, who specialize in using laboratory tests to diagnose diseases, analyze the tissue sample. Breast biopsies are considered the most definitive procedure for diagnosing breast cancer since they provide conclusive evidence of the existence of malignant cells.
Breast biopsy techniques vary, with each using a distinct imaging technology to guide the procedure. Core needle biopsy (CNB) and vacuum-assisted biopsy (VAB) are two common minimally invasive procedures. A hollow needle is used in a core needle biopsy to take a small cylinder of tissue from the breast, whereas a suction-assisted biopsy collects several tissue samples in a single insertion. Other procedures include fine needle aspiration (FNA), which removes fluid or cells using a very thin needle, and surgical biopsies, which require removing bigger pieces of tissue through an incision. The characteristics of the abnormality found during imaging examinations such as mammograms, ultrasounds, or MRIs frequently influence the type of biopsy method used.
Market Dynamics: Drivers & Restraints
Increasing demand for breast biopsy devices
The increasing demand for breast biopsy procedures is expected to be a significant factor in the growth of the global breast biopsy market. The demand for breast biopsy procedures is increasing owing to the rising prevalence of breast cancer, technological advancements, growing awareness regarding breast cancer, and recent launches and approvals.
As breast cancer continues to be one of the most prevalent cancers worldwide, the need for accurate and timely diagnostic procedures has never been more critical. For instance, according to the Union for International Cancer Control (UICC), Breast cancer is the most commonly diagnosed cancer in women worldwide and in 157 countries, accounting for one in every four cancer cases. It is the second most common malignancy in both sexes and the major cause of mortality from cancer in women. Breast cancer is expected to cause 2.3 million new cases in 2022, accounting for nearly one out of every nine malignancies diagnosed in both sexes worldwide. Breast cancer is expected to kill 669,418 people in 2022, with a disproportionate amount of these fatal incidents taking place in low-income communities. The rising prevalence of breast cancer is driving healthcare systems to prioritize early detection procedures like breast biopsies, which are critical for confirming diagnoses and deciding effective treatment strategies.
As breast cancer remains one of the most common malignancies worldwide, with millions of new cases diagnosed each year, the need for accurate diagnostic tools has never been greater. Breast biopsy equipment has become more accessible, efficient, and less intrusive due to technological advancements, promoting more women to receive essential tests and biopsies. There are many recent launches and approvals that use novel technology and the latest manufacturing techniques. For instance, in May 2024, BSC (Barcelona Supercomputing Center) launched clinical validation of an establishing radiation-free breast cancer diagnosis technology at Vall d'Hebron University Hospital. This novel strategy combines modern ultrasound technology with supercomputing to improve imaging quality for breast cancer detection, providing a substantial alternative to standard procedures such as mammograms, which rely on ionizing radiation. The new technology, part of the QUSTom initiative, aims to increase diagnostic accuracy while keeping patients comfortable during the test.
Risk of infections
Factors such as the risk of infections are expected to hamper the global breast biopsy market. Biopsy techniques, which include incisions or needle insertions to collect tissue samples, have the potential to introduce pathogens into the body. This danger is especially high in invasive methods like surgical and core needle biopsies when deeper penetration exposes patients to ambient germs and other infectious agents. Studies have indicated that post-procedure infections can lead to problems, including delayed recovery times and further medical treatments, which may prevent patients from undergoing these required diagnostic procedures.
The fear of post-biopsy infections can cause anxiety and reluctance among patients, potentially leading to delayed breast cancer diagnosis and treatment. This delay is especially concerning because early identification is crucial for boosting survival rates in breast cancer patients. Healthcare practitioners are increasingly aware of these concerns and are working to improve patient safety by introducing stricter sterilizing processes and developing novel biopsy techniques that minimize invasiveness.
The global breast biopsy market is segmented based on product, technique type, guidance technology, end-user, and region.
Core needle biopsy segment is expected to dominate the global breast biopsy market share
The core needle biopsy segment is anticipated to dominate the global breast biopsy market owing to its growing importance in the diagnosis of breast cancer, technological advancements, recent launches and approvals, and increase in the number of breast cancer. Core needle biopsies use a stronger, hollow needle to take a cylindrical tissue sample from the breast, providing for a more thorough examination than fine needle aspiration biopsies (FNA) and other traditional methods, which typically obtain smaller samples. This capability not only improves diagnosis accuracy but also provides more detailed architectural information about the tissue, which is critical for assessing the possibility and severity of cancer.
Core needle biopsies are now much more precise due to technological integration with imaging modalities including ultrasonography, mammography, and MRI. Recently launched technologies such as PrecisionCore combine modern imaging technology with real-time guidance, allowing clinicians to precisely target lesions during the biopsy procedure. This breakthrough not only improves diagnostic accuracy but also increases patient safety by decreasing unwanted tissue removal. Moreover, in May 2024, Hologic introduced a new disposable 7-gauge breast biopsy needle as part of its Brevera breast biopsy system in Europe.
This advancement is significant as it allows radiologists to capture larger tissue samples, which can enhance diagnostic accuracy while potentially reducing patient discomfort and the duration of compression during the procedure. The Brevera system is notable for being the world's first vacuum-assisted breast biopsy solution that integrates tissue acquisition, real-time imaging, and post-biopsy handling. The newly launched 7-gauge needle complements the existing 9-gauge options, providing healthcare professionals with more flexibility to choose the most appropriate needle size for specific procedures. This adaptability is crucial for accommodating varying patient needs and enhancing overall procedural efficiency.
Recent advancements in molecular analysis techniques have significantly reinforced the importance of core needle biopsy in customized therapy. Core needle biopsies allow for the analysis of proteins and genetic mutations within tumor tissues, facilitating individualized therapy methods for patients. This skill is essential for monitoring individual responses to medicines and optimizing treatment programs based on specific tumor features.
North America is expected to hold a significant position in the global breast biopsy market share
North America will likely account for a significant share of the global breast biopsy market, owing to its advanced healthcare infrastructure, extensive research capabilities, proactive patient awareness initiatives a high prevalence of breast cancer, technological advancements, and recent launches and approvals. The increasing number of breast cancer cases is a primary driver of the breast biopsy market in North America.
For instance, according to breastcancer.org, approximately 13% (or one out of every eight) of women in the United States will develop invasive breast cancer over their lives. In recent years, incidence rates have grown somewhat, approximately 0.5% each year. Breast cancer is one of the leading causes of cancer-related deaths among women in the United States, trailing only lung cancer. Breast cancer is the most commonly diagnosed cancer in women in the United States, second only to skin cancer. Every year, breast cancer accounts for around 30% of all newly diagnosed cancers in women. In the United States, approximately four million women have been diagnosed with breast cancer. So, the increasing number of breast cancers increases the demand for cancer diagnostics which increases the demand for breast biopsy devices.
The region has established itself as a pioneer in the use of advanced medical technologies, particularly in oncology. The design and functionality of biopsy equipment have advanced significantly. The discovery of liquid biopsy techniques, which examine circulating tumor cells or cell-free DNA in blood samples, represents a significant advancement. For instance, in June 2023, Labcorp launched liquid biopsy to detect cancer biomarkers. This non-invasive method offers a viable alternative to standard tissue biopsies and is gaining popularity in the North American market due to its potential for early diagnosis and monitoring of breast cancer progression. Patients find these tests appealing because they can be performed with minimal discomfort.
Asia Pacific is growing at the fastest pace in the global breast biopsy market
The Asia Pacific region is emerging as the fastest-growing market for breast biopsy, owing to a combination of demographic trends, increased healthcare investment, recent launches, technological advancements, and a rising number of breast cancers. The Asia-Pacific (APAC) region is experiencing strong expansion in the breast biopsy market, owing mostly to the increased incidence of breast cancer. This concerning trend is highlighted by considerable increases in breast cancer cases in different countries, including China, India, and South Korea. According to the World Health Organization, breast cancer is currently the most frequent cancer in the world, affecting millions of women each year. In APAC, the expanding population and aging demographic exacerbate the situation, as older women are more likely to acquire breast cancer. For instance, according to the National Institute of Health, Female breast cancer (BC) is the major cause of cancer incidence and mortality in India, accounting for 13.5% of new cancer cases and 10% of all cancer-related deaths. So, the increasing number of breast cancers increases the demand for cancer diagnostics which increases the demand for breast biopsy devices.
The major global players in the global breast biopsy market include STERYLAB S.r.l., Argon Medical Devices, Danaher Corporation, Cigna, Siemens Healthcare Private Limited, BD, Hologic, Inc., Devicor Medical Products, Inc., F. Hoffmann-La Roche Ltd, Cook among others.
Emerging Players
AOA DX, Kheiron Medical, and Hera-MI among others
The global breast biopsy market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.
Target Audience 2024
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