乳房生検の世界市場の評価：製品タイプ・用途・エンドユーザー・地域別の機会および予測 (2017～2031年)

世界の乳房生検の市場規模は、2024年から2031年の予測期間中にCAGR 6.58％を記録し、2023年の21億1,000万米ドルから、2031年には35億1,000万米ドルの規模に成長すると予測されています。

この市場は、女性の癌罹患率の増加、低侵襲手術への嗜好の高まり、癌とそのスクリーニング法に関する意識の高まり、真空支援生検法、コアニードル生検法、定位ガイド下生検法などの生検技術や装置の技術進歩などの要因の影響を受けると予想されています。

さらに、政府やその他の組織によって実施されるさまざまなプログラムは、癌の早期発見に関する認識を広め、その診断薬需要にプラスの影響を与えると予想されます。近年、癌治療薬や診断ソリューションを開発するための投資が大幅に増加しており、市場規模はさらに拡大しています。WHOは、世界でもっとも多く診断されている癌の種類は乳癌であり、女性の癌関連死亡の主な原因であることを確認しています。50歳以上の女性は乳癌に罹患しやすいため、老年女性人口の増加が有病率に拍車をかけています。

一方で、高度な生検手技や機器に伴う高コスト性が、中低所得国の市場にとって大きな課題となっています。乳房生検は低侵襲の手技であるにもかかわらず、感染症や組織損傷のリスクがあります。加えて、患者の不快感も乳房生検の採用の障壁となる要因です。生検器具の製造に関する厳しい規制ガイドラインも市場拡大の大きな課題です。

癌の高い有病率

乳癌は、女性でもっとも多く診断される癌であり、世界的に見てももっとも多い癌タイプです。ライフスタイルの変化や日常生活における放射線や発癌性化学物質への曝露の増加に伴い、癌の有病率はさらに上昇すると予想されています。遺伝や家族歴が癌の主な要因である一方、望まない妊娠を避けるためにホルモンベースの避妊薬の使用が増加していることも、癌の有病率上昇に寄与している主な要因です。

乳房生検法の進歩

以前は外科的切除生検が唯一の選択肢であったが、現在では癌の診断に利用できる低侵襲の方法があります。超音波ガイド下生検、マンモグラフィ定位生検、磁気共鳴画像ガイド下生検、トモシンセシスガイド下生検、真空補助下生検などの画像ガイド下乳房生検法へのパラダイムシフトは、精密診断のさらなる可能性を開いています。リキッドバイオプシーは、血液サンプルを分析して循環腫瘍細胞や無細胞DNAを検出する新しい技術であり、癌の診断や予後の個別化に役立つ可能性があります。真空支援生検は、患者への外傷が少ないため、一般的な選択肢になりつつあります。メーカー各社は革新的なソリューションを開発することで市場機会を得ています。

当レポートでは、世界の乳房生検の市場を調査し、市場の定義と概要、市場規模の推移・予測、各種区分・地域別の詳細分析、産業構造、市場成長への影響因子の分析、ケーススタディ、競合情勢、主要企業のプロファイルなどをまとめています。

目次

第1章 調査手法

第2章 プロジェクトの範囲と定義

第3章 エグゼクティブサマリー

第4章 世界の乳房生検市場の展望

• 市場規模・予測
• 製品タイプ別
  • 生検針
  • MRIガイド付き生検システム
  • 超音波ガイド下乳房生検システム
  • 真空補助装置（VAD）
  • ガイドワイヤー
  • 乳房生検マーカー
• 用途別
  • 浸潤性癌
  • 上皮内乳管癌
• エンドユーザー別
  • 病院
  • 専門クリニック
  • 外来手術センター
  • 癌研究
• 地域別
  • 北米
  • 欧州
  • アジア太平洋
  • 南米
  • 中東・アフリカ
• 企業別市場シェア

第5章 世界の乳房生検市場の展望：地域別

• 北米
• 欧州
• アジア太平洋
• 南米
• 中東・アフリカ

第6章 市場マッピング

• 製品タイプ別
• 用途別
• エンドユーザー別
• 地域別

第7章 マクロ環境と産業構造

• 需要供給分析
• 輸出入分析
• バリューチェーン分析
• PESTEL分析
• ポーターのファイブフォース分析

第8章 市場力学

• 成長促進要因
• 成長抑制要因（課題、抑制要因）

第9章 規制の枠組みとイノベーション

• 臨床試験
• 特許の情勢
• 規制当局の承認
• イノベーション/新興技術

第10章 主要企業の情勢

• 市場リーダー上位5社の競合マトリックス
• 市場リーダー上位5社の市場収益分析
• M&A・ジョイントベンチャー (該当する場合)
• SWOT分析 (参入5社)

第11章 ケーススタディ

第12章 主要企業の見通し

• Becton, Dickinson and Company
• Hologic Inc.
• Danaher Corporation
• Argon Medical Devices Inc.
• Devicor Medical Products, Inc. (Mammotome)
• Merit Medical Systems, Inc.
• Qiagen NV
• Cook Medical Inc.
• OncoCyte Corporation
• INRAD, Inc.

第13章 戦略的提言

第14章 当社について・免責事項

List of Tables

• Table 1. Pricing Analysis of Products from Key Players
• Table 2. Competition Matrix of Top 5 Market Leaders
• Table 3. Mergers & Acquisitions/ Joint Ventures (If Applicable)
• Table 4. About Us - Regions and Countries Where We Have Executed Client Projects

List of Figures

• Figure 1. Global Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 2. Global Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 3. Global Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 4. Global Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 5. Global Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 6. Global Breast Biopsy Market Share (%), By Region, 2017-2031F
• Figure 7. North America Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 8. North America Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 9. North America Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 10. North America Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 11. North America Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 12. North America Breast Biopsy Market Share (%), By Country, 2017-2031F
• Figure 13. United States Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 14. United States Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 15. United States Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 16. United States Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 17. United States Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 18. Canada Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 19. Canada Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 20. Canada Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 21. Canada Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 22. Canada Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 23. Mexico Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 24. Mexico Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 25. Mexico Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 26. Mexico Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 27. Mexico Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 28. Europe Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 29. Europe Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 30. Europe Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 31. Europe Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 32. Europe Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 33. Europe Breast Biopsy Market Share (%), By Country, 2017-2031F
• Figure 34. Germany Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 35. Germany Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 36. Germany Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 37. Germany Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 38. Germany Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 39. France Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 40. France Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 41. France Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 42. France Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 43. France Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 44. Italy Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 45. Italy Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 46. Italy Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 47. Italy Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 48. Italy Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 49. United Kingdom Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 50. United Kingdom Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 51. United Kingdom Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 52. United Kingdom Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 53. United Kingdom Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 54. Russia Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 55. Russia Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 56. Russia Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 57. Russia Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 58. Russia Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 59. Netherlands Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 60. Netherlands Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 61. Netherlands Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 62. Netherlands Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 63. Netherlands Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 64. Spain Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 65. Spain Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 66. Spain Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 67. Spain Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 68. Spain Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 69. Turkey Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 70. Turkey Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 71. Turkey Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 72. Turkey Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 73. Turkey Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 74. Poland Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 75. Poland Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 76. Poland Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 77. Poland Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 78. Poland Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 79. South America Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 80. South America Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 81. South America Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 82. South America Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 83. South America Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 84. South America Breast Biopsy Market Share (%), By Country, 2017-2031F
• Figure 85. Brazil Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 86. Brazil Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 87. Brazil Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 88. Brazil Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 89. Brazil Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 90. Argentina Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 91. Argentina Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 92. Argentina Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 93. Argentina Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 94. Argentina Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 95. Asia-Pacific Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 96. Asia-Pacific Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 97. Asia-Pacific Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 98. Asia-Pacific Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 99. Asia-Pacific Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 100. Asia-Pacific Breast Biopsy Market Share (%), By Country, 2017-2031F
• Figure 101. India Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 102. India Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 103. India Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 104. India Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 105. India Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 106. China Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 107. China Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 108. China Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 109. China Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 110. China Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 111. Japan Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 112. Japan Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 113. Japan Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 114. Japan Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 115. Japan Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 116. Australia Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 117. Australia Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 118. Australia Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 119. Australia Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 120. Australia Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 121. Vietnam Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 122. Vietnam Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 123. Vietnam Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 124. Vietnam Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 125. Vietnam Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 126. South Korea Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 127. South Korea Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 128. South Korea Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 129. South Korea Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 130. South Korea Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 131. Indonesia Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 132. Indonesia Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 133. Indonesia Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 134. Indonesia Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 135. Indonesia Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 136. Philippines Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 137. Philippines Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 138. Philippines Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 139. Philippines Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 140. Philippines Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 141. Middle East & Africa Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 142. Middle East & Africa Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 143. Middle East & Africa Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 144. Middle East & Africa Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 145. Middle East & Africa Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 146. Middle East & Africa Breast Biopsy Market Share (%), By Country, 2017-2031F
• Figure 147. Saudi Arabia Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 148. Saudi Arabia Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 149. Saudi Arabia Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 150. Saudi Arabia Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 151. Saudi Arabia Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 152. UAE Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 153. UAE Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 154. UAE Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 155. UAE Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 156. UAE Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 157. South Africa Breast Biopsy Market, By Value, in USD Billion, 2017-2031F
• Figure 158. South Africa Breast Biopsy Market, By Volume, in Million Units, 2017-2031F
• Figure 159. South Africa Breast Biopsy Market Share (%), By Product Type, 2017-2031F
• Figure 160. South Africa Breast Biopsy Market Share (%), By Application, 2017-2031F
• Figure 161. South Africa Breast Biopsy Market Share (%), By End-user, 2017-2031F
• Figure 162. By Product Type Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 163. By Application Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 164. By End-user Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 165. By Region Map-Market Size (USD Billion) & Growth Rate (%), 2023

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.

Table of Contents

1. Research Methodology

2. Project Scope & Definitions

3. Executive Summary

4. Global Breast Biopsy Market Outlook, 2017-2031F

• 4.1. Market Size & Forecast
  • 4.1.1. By Value
  • 4.1.2. By Volume
• 4.2. By Product Type
  • 4.2.1. Biopsy Needle
    • 4.2.1.1. Core Needles
    • 4.2.1.2. Fine Aspiration Needles
  • 4.2.2. MRI-Guided Biopsy Systems
  • 4.2.3. Ultrasound Guided Breast Biopsy Systems
  • 4.2.4. Vacuum-Assisted Device (VAD)
  • 4.2.5. Guide Wire
  • 4.2.6. Breast Biopsy Marker
• 4.3. By Application
  • 4.3.1. Invasive Breast Cancers
  • 4.3.2. Ductal Carcinoma In Situ
• 4.4. By End-user
  • 4.4.1. Hospitals
  • 4.4.2. Specialty Clinics
  • 4.4.3. Ambulatory Surgical Centers
  • 4.4.4. Cancer Research Institutes
• 4.5. By Region
  • 4.5.1. North America
  • 4.5.2. Europe
  • 4.5.3. Asia-Pacific
  • 4.5.4. South America
  • 4.5.5. Middle East and Africa
• 4.6. By Company Market Share (%), 2023

5. Global Breast Biopsy Market Outlook, By Region, 2017-2031F

• 5.1. North America*
  • 5.1.1. Market Size & Forecast
    • 5.1.1.1. By Value
    • 5.1.1.2. By Volume
  • 5.1.2. By Product Type
    • 5.1.2.1. Biopsy Needle
    • 5.1.2.1.1. Core Needles
    • 5.1.2.1.2. Fine Aspiration Needles
    • 5.1.2.2. MRI-Guided Biopsy Systems
    • 5.1.2.3. Ultrasound Guided Breast Biopsy Systems
    • 5.1.2.4. Vacuum-Assisted Device (VAD)
    • 5.1.2.5. Guide Wire
    • 5.1.2.6. Breast Biopsy Marker
  • 5.1.3. By Application
    • 5.1.3.1. Invasive Breast Cancers
    • 5.1.3.2. Ductal Carcinoma In Situ
  • 5.1.4. By End-user
    • 5.1.4.1. Hospitals
    • 5.1.4.2. Specialty Clinics
    • 5.1.4.3. Ambulatory Surgical Centers
    • 5.1.4.4. Cancer Research Institutes
  • 5.1.5. United States*
    • 5.1.5.1. Market Size & Forecast
    • 5.1.5.1.1. By Value
    • 5.1.5.1.2. By Volume
    • 5.1.5.2. By Product Type
    • 5.1.5.2.1. Biopsy Needle
    • 5.1.5.2.1.1. Core Needles
    • 5.1.5.2.1.2. Fine Aspiration Needles
    • 5.1.5.2.2. MRI-Guided Biopsy Systems
    • 5.1.5.2.3. Ultrasound Guided Breast Biopsy Systems
    • 5.1.5.2.4. Vacuum-Assisted Device (VAD)
    • 5.1.5.2.5. Guide Wire
    • 5.1.5.2.6. Breast Biopsy Marker
    • 5.1.5.3. By Application
    • 5.1.5.3.1. Invasive Breast Cancers
    • 5.1.5.3.2. Ductal Carcinoma In Situ
    • 5.1.5.4. By End-user
    • 5.1.5.4.1. Hospitals
    • 5.1.5.4.2. Specialty Clinics
    • 5.1.5.4.3. Ambulatory Surgical Centers
    • 5.1.5.4.4. Cancer Research Institutes
  • 5.1.6. Canada
  • 5.1.7. Mexico

All segments will be provided for all regions and countries covered

• 5.2. Europe
  • 5.2.1. Germany
  • 5.2.2. France
  • 5.2.3. Italy
  • 5.2.4. United Kingdom
  • 5.2.5. Russia
  • 5.2.6. Netherlands
  • 5.2.7. Spain
  • 5.2.8. Turkey
  • 5.2.9. Poland
• 5.3. Asia-Pacific
  • 5.3.1. India
  • 5.3.2. China
  • 5.3.3. Japan
  • 5.3.4. Australia
  • 5.3.5. Vietnam
  • 5.3.6. South Korea
  • 5.3.7. Indonesia
  • 5.3.8. Philippines
• 5.4. South America
  • 5.4.1. Brazil
  • 5.4.2. Argentina
• 5.5. Middle East & Africa
  • 5.5.1. Saudi Arabia
  • 5.5.2. UAE
  • 5.5.3. South Africa

6. Market Mapping, 2023

• 6.1. By Product Type
• 6.2. By Application
• 6.3. By End-user
• 6.4. By Region

7. Macro Environment and Industry Structure

• 7.1. Demand Supply Analysis
• 7.2. Import Export Analysis
• 7.3. Value Chain Analysis
• 7.4. PESTEL Analysis
  • 7.4.1. Political Factors
  • 7.4.2. Economic System
  • 7.4.3. Social Implications
  • 7.4.4. Technological Advancements
  • 7.4.5. Environmental Impacts
  • 7.4.6. Legal Compliances and Regulatory Policies (Statutory Bodies Included)
• 7.5. Porter's Five Forces Analysis
  • 7.4.7. Supplier Power
  • 7.4.8. Buyer Power
  • 7.4.9. Substitution Threat
  • 7.4.10. Threat from New Entrant
  • 7.4.11. Competitive Rivalry

8. Market Dynamics

• 8.1. Growth Drivers
• 8.2. Growth Inhibitors (Challenges and Restraints)

9. Regulatory Framework and Innovation

• 9.1. Clinical Trials
• 9.2. Patent Landscape
• 9.3. Regulatory Approvals
• 9.4. Innovations/Emerging Technologies

10. Key Players Landscape

• 10.1. Competition Matrix of Top Five Market Leaders
• 10.2. Market Revenue Analysis of Top Five Market Leaders (in %, 2023)
• 10.3. Mergers and Acquisitions/Joint Ventures (If Applicable)
• 10.4. SWOT Analysis (For Five Market Players)

11. Case Studies

12. Key Players Outlook

• 12.1. Becton, Dickinson and Company
  • 12.1.1. Company Details
  • 12.1.2. Key Management Personnel
  • 12.1.3. Products & Services
  • 12.1.4. Financials (As reported)
  • 12.1.5. Key Market Focus & Geographical Presence
  • 12.1.6. Recent Developments
• 12.2. Hologic Inc.
• 12.3. Danaher Corporation
• 12.4. Argon Medical Devices Inc.
• 12.5. Devicor Medical Products, Inc. (Mammotome)
• 12.6. Merit Medical Systems, Inc.
• 12.7. Qiagen NV
• 12.8. Cook Medical Inc.
• 12.9. OncoCyte Corporation
• 12.10. INRAD, Inc.

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

13. Strategic Recommendations

14. About Us & Disclaimer