表紙:HER2検査市場:癌タイプ・技術・エンドユーザー・地域別、機会、予測、2017年~2031年
市場調査レポート
商品コード
1422074

HER2検査市場:癌タイプ・技術・エンドユーザー・地域別、機会、予測、2017年~2031年

HER2 Testing Market Assessment, By Cancer Type, By Technique, By End-user, By Region, Opportunities and Forecast, 2017-2031F

出版日: | 発行: Market Xcel - Markets and Data | ページ情報: 英文 231 Pages | 納期: 3~5営業日

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価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=157.89円
HER2検査市場:癌タイプ・技術・エンドユーザー・地域別、機会、予測、2017年~2031年
出版日: 2024年02月07日
発行: Market Xcel - Markets and Data
ページ情報: 英文 231 Pages
納期: 3~5営業日
  • 全表示
  • 概要
  • 図表
  • 目次
概要

世界のHER2検査の市場規模は、2023年の2億240万米ドルから、予測期間中は7.23%のCAGRで推移し、2031年には3億5,365万米ドルに成長すると予測されます。

乳癌や胃癌の有病率の上昇、技術の進歩、AIの利用、ヘルスケア支出の増加、政府のイニシアチブ、政策、プログラムなど、いくつかの要因が世界のHER2検査市場の成長を後押ししています。診断市場への官民からの投資の増加、複数の主要企業の存在、M&A、提携、新製品の発売などの開発戦略も、世界のHER2検査市場の成長を加速させる見通しです。

乳癌の有病率の上昇

乳癌の発生率の増加は、世界のHER2検査市場の主要な促進要因です。乳癌は、先進国だけでなく発展途上国でも有病率が増加しているため、世界レベルで公衆衛生上の問題となっています。乳癌は男女ともに罹患するが、高齢の女性が罹患するのが一般的です。WHOによれば、2020年には世界で230万人の女性が乳癌と診断され、685万人が死亡しています。乳癌は世界でもっとも多い癌であると推定されています。乳癌の家族歴、加齢、タバコやアルコールの過剰摂取、放射線被曝歴が主な危険因子です。乳癌は早期診断が最良の治療法であり、HER2検査などの診断ツールが重要な役割を果たします。HER2検査は、HER2陽性乳癌およびHER2陰性乳癌を検出するための非常に効率的な検査技術であり、そのためヘルスケアプロバイダーの間で需要が増加しています。さまざまなスクリーニングや診断ツール、技術に関する乳癌の意識向上プログラムの増加に伴い、HER2検査の人気は高まっており、世界のHER2検査市場の成長を加速させています。

HER2検査の技術的進歩

今日の世界では、デジタル化とAIがヘルスケア産業の進歩に革命をもたらしました。AIは、HER2検査などの医療ツールや医療機器において大きな可能性を秘めています。近年、より質の高い分析のために従来の検査技術の限界を克服することを目的とした革新的な技術が急増しています。こうした技術的進歩は、多数の集団における癌検出の精度と適時性を効率的に高めます。多くの主要参入企業は、製品ポートフォリオを改善し、患者により良い健康結果を提供するために、AIベースのHER2検査オプションを発表しています。

当レポートでは、世界のHER2検査の市場を調査し、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HER2検査市場の展望

  • 市場規模・予測
  • 癌別
    • 乳癌
    • 胃癌
    • その他
  • 技術別
    • 免疫組織化学 (IHC)
    • in situハイブリダイゼーション (ISH)
    • 特異的ポリメラーゼ連鎖反応 (dPCR)
    • その他
  • エンドユーザー別
    • 病院
    • 診断ラボ
    • その他
  • 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HER2検査市場の見通し:地域別

  • 北米
  • 欧州
  • 南米
  • アジア太平
  • 中東・アフリカ

第6章 市場マッピング

  • 癌別
  • 技術別
  • 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

  • 成長推進因子
  • 成長抑制因子 (課題・障壁)

第9章 規制の枠組み・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/最新技術

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)
  • 特許分析 (該当する場合)

第11章 ケーススタディ

第12章 主要企業の見通し

  • Thermo Fisher Scientific Inc.
  • Illumina, Inc.
  • Abbott Laboratories
  • Pfizer Inc.
  • Agilent Technologies, Inc.
  • Biocare Medical, LLC.
  • F. Hoffmann-La Roche Ltd.
  • QIAGEN GmbH
  • Sysmex Inostics, Inc.
  • Merck Group
  • Leica Biosystems
  • Abnova Corporation

第13章 戦略的提言

第14章 当社について・免責事項

図表

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 HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 2. Global HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 3. Global HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 4. Global HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 5. Global HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 6. Global HER2 Testing Market Share (%), By Region, 2017-2031F
  • Figure 7. North America HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 8. North America HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 9. North America HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 10. North America HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 11. North America HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 12. North America HER2 Testing Market Share (%), By Country, 2017-2031F
  • Figure 13. United States HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 14. United States HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 15. United States HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 16. United States HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 17. United States HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 18. Canada HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 19. Canada HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 20. Canada HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 21. Canada HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 22. Canada HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 23. Mexico HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 24. Mexico HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 25. Mexico HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 26. Mexico HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 27. Mexico HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 28. Europe HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 29. Europe HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 30. Europe HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 31. Europe HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 32. Europe HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 33. Europe HER2 Testing Market Share (%), By Country, 2017-2031F
  • Figure 34. Germany HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 35. Germany HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 36. Germany HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 37. Germany HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 38. Germany HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 39. France HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 40. France HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 41. France HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 42. France HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 43. France HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 44. Italy HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 45. Italy HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 46. Italy HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 47. Italy HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 48. Italy HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 49. United Kingdom HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 50. United Kingdom HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 51. United Kingdom HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 52. United Kingdom HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 53. United Kingdom HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 54. Russia HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 55. Russia HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 56. Russia HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 57. Russia HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 58. Russia HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 59. Netherlands HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 60. Netherlands HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 61. Netherlands HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 62. Netherlands HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 63. Netherlands HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 64. Spain HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 65. Spain HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 66. Spain HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 67. Spain HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 68. Spain HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 69. Turkey HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 70. Turkey HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 71. Turkey HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 72. Turkey HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 73. Turkey HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 74. Poland HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 75. Poland HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 76. Poland HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 77. Poland HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 78. Poland HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 79. South America HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 80. South America HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 81. South America HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 82. South America HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 83. South America HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 84. South America HER2 Testing Market Share (%), By Country, 2017-2031F
  • Figure 85. Brazil HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 86. Brazil HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 87. Brazil HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 88. Brazil HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 89. Brazil HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 90. Argentina HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 91. Argentina HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 92. Argentina HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 93. Argentina HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 94. Argentina HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 95. Asia-Pacific HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 96. Asia-Pacific HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 97. Asia-Pacific HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 98. Asia-Pacific HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 99. Asia-Pacific HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 100. Asia-Pacific HER2 Testing Market Share (%), By Country, 2017-2031F
  • Figure 101. India HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 102. India HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 103. India HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 104. India HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 105. India HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 106. China HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 107. China HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 108. China HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 109. China HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 110. China HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 111. Japan HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 112. Japan HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 113. Japan HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 114. Japan HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 115. Japan HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 116. Australia HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 117. Australia HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 118. Australia HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 119. Australia HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 120. Australia HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 121. Vietnam HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 122. Vietnam HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 123. Vietnam HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 124. Vietnam HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 125. Vietnam HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 126. South Korea HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 127. South Korea HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 128. South Korea HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 129. South Korea HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 130. South Korea HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 131. Indonesia HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 132. Indonesia HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 133. Indonesia HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 134. Indonesia HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 135. Indonesia HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 136. Philippines HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 137. Philippines HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 138. Philippines HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 139. Philippines HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 140. Philippines HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 141. Middle East & Africa HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 142. Middle East & Africa HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 143. Middle East & Africa HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 144. Middle East & Africa HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 145. Middle East & Africa HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 146. Middle East & Africa HER2 Testing Market Share (%), By Country, 2017-2031F
  • Figure 147. Saudi Arabia HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 148. Saudi Arabia HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 149. Saudi Arabia HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 150. Saudi Arabia HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 151. Saudi Arabia HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 152. UAE HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 153. UAE HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 154. UAE HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 155. UAE HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 156. UAE HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 157. South Africa HER2 Testing Market, By Value, in USD Million, 2017-2031F
  • Figure 158. South Africa HER2 Testing Market, By Volume, in Million Units, 2017-2031F
  • Figure 159. South Africa HER2 Testing Market Share (%), By Cancer, 2017-2031F
  • Figure 160. South Africa HER2 Testing Market Share (%), By Technique, 2017-2031F
  • Figure 161. South Africa HER2 Testing Market Share (%), By End-user, 2017-2031F
  • Figure 162. By Cancer Map-Market Size (USD Million) & Growth Rate (%), 2023
  • Figure 163. By Technique Map-Market Size (USD Million) & Growth Rate (%), 2023
  • Figure 164. By End-user Map-Market Size (USD Million) & Growth Rate (%), 2023
  • Figure 165. By Region Map-Market Size (USD Million) & Growth Rate (%), 2023
目次
Product Code: MX10939

Global HER2 testing market is projected to witness a CAGR of 7.23% during the forecast period 2024-2031F, growing from USD 202.4 million in 2023 to USD 353.65 million in 2031. Several factor drive the growth of global HER2 testing market, such as the rising prevalence of breast cancer and gastric cancer, technological advancements, the use of AI, increased healthcare expenditure, government initiatives, policies, and programs. An increase in private and public sector investments in the diagnostics market, the presence of several top players, and developmental strategies like mergers, acquisitions, collaborations, and new product launches accelerate the global HER2 testing market growth.

The global HER2 testing market is further undergoing robust growth due to the rise in the prevalence of breast cancer at the global level. Women are more prone to get affected by this deadly disease. Genetic mutations, family history of breast cancer, and obesity are some of the risk factors for breast cancer. To combat the disease, HER2 tests play a crucial role as a prognostic and predictive marker in breast cancer specimens. HER2 testing is a highly reliable tool to detect whether a breast cancer is HER2-positive or HER2-negative, through which a clinician can choose an appropriate treatment strategy for the patient. Other factors, such as improvement in healthcare facilities by adopting HER2 testing in the healthcare sector and technological advancements in the market, such as integrating AI in HER2 testing for quick and accurate analysis, are further accelerating growth in the global HER2 testing market.

Governmental support to combat breast cancer worldwide, by initiating policies and programs at national and international level, to increase awareness regarding screening, early diagnosis, and proper management of the disease, further encourage increased use of cancer detecting techniques such as HER2 testing among the population. These governmental initiatives attract public and private companies to join and invest in further innovations, new launches, research, and development of more efficient and effective HER2 testing techniques to provide quality medical treatment and improve healthcare facilities in the market. Moreover, continuous mergers and acquisitions, partnerships and collaborations between the healthcare industries and increased FDA approvals for HER2 testing further propel the global HER2 testing market.

For instance, in January 2023, Guardant Health announced that it has received FDA approval for Guardant360 CDx, which is a blood diagnostic test, that detects ESR1 mutations and HER2-positive and HER2-negative breast cancer.

Rise in Prevalence of Breast Cancer

The increasing occurrence of breast cancer is a major driving factor for the global HER2 testing market. Breast cancer has become a public health problem at a global level due to its increasing prevalence in developing as well as developed countries. It affects both men and women; however, most commonly affecting women of older age. WHO states that, in 2020, worldwide, 2.3 million women were diagnosed with breast cancer leading to 6,85,000 deaths globally. It is estimated that breast cancer is the most common cancer worldwide. Family history of breast cancer, increasing age, excessive tobacco and alcohol consumption, and history of radiation exposure are the leading risk factors for the rising prevalence of breast cancer around the world. Early diagnosis is the best treatment for breast cancer, and diagnostic tools such as HER2 tests play a crucial role in it. HER2 test is a highly efficient testing technique in detecting HER2-positive and HER2-negative breast cancer, due to which its demand among the healthcare providers is increasing. With growing breast cancer awareness programs regarding various screening and diagnostic tools and techniques, popularity of HER2 testing is increasing, escalating growth of the global HER2 testing market.

Technological Advancement in HER2 Testing

In today's world, digitalization and AI have revolutionized advancement in the healthcare industry. AI has a huge potential in medical tools and appliances such as HER2 testing. In recent years, there has been a surge in innovative technologies aimed at overcoming the limitations of traditional testing techniques for more quality analysis. These technological advancements efficiently increase the accuracy and timeliness of cancer detection in a large population. Many key market players are launching AI-based HER2 testing options to improve their product portfolio and provide better health outcomes to the patients.

For instance, in July 2023, PathAI, a pioneer in providing AI-integrated pathology tools and appliances to advance precision medicine, announced the availability of AIM-HER2 Breast Cancer for research use by biopharma researchers and clinical research lab pathologists. In addition to providing automatic digital HER2 scoring, AIM-HER2 Breast Cancer is the first algorithm in the market to show the slide features that influence the system's predicted score using additive multiple instance learning (aMIL) heatmaps. Integrating AI in the HER2 testing can further provide a boost to the global HER2 testing market.

Increased Demand for In Situ Hybridization (ISH)

Among the technique segment, in situ hybridization is expected to show the fastest growth in the global HER2 testing market. Extensive research and development activities and increased investments by key market players in the segment have led to huge demand in the HER2 testing market. Moreover, its potential to provide information about the location of the target nucleic acids within cells or complex tissues is the main reason behind its increasing demand in the industry. Due to this, many key market players are launching the technique in their product portfolio.

For instance, in December 2023, Cytelabs, which is a leader in providing diagnostics products and services for cancer treatment and management, announced that it has launched Dual in situ hybridization (DISH) test for breast cancer detection. The launch is expected to improve accuracy in HER2 testing and will assist in providing the right and best treatment plan for breast cancer patients. A supportive regulatory system is enabling pharmaceutical companies to invest and launch drugs for these growing heart diseases, which further propels the global HER2 testing market.

Hospitals Hold Dominant Share in Global HER2 Testing Market

Among the end-user segment, hospitals hold a significant market share in the global HER2 testing market. The increasing global population and rising number of hospitals are the main reasons for the segment's dominance in the market. With growing healthcare expenditure, increased healthcare infrastructure, and increased prevalence of chronic diseases, the market is growing with increasing hospital facilities providing proper diagnosis and treatment facilities. For instance, according to the American Hospital Association, in 2023, there were 6,129 hospitals in the United States, and more hospitals are under construction. Increased availability of various types of diagnostic tools and appliances, along with increased trust among the population regarding the reliability and quality of healthcare facilities provided in the hospitals, further propelled the growth of this segment. Hospitals offer a broader range of services compared to diagnostic laboratories, such as inpatient care, surgeries, and specialized testing such as HER2 tests for cancer detection and quality treatment, leading to better growth opportunities in the segment.

North America Holds the Largest Share in HER2 Testing Market

North America holds the maximum share of the global HER2 testing market. The robust healthcare infrastructure of the region, along with increased healthcare expenditure and investments in providing improved healthcare facilities to the population involving drug discoveries and manufacturing, research, and development in manufacturing innovative, efficient diagnostics such as HER2 testing, leads to an enhanced HER2 testing market in the region. Moreover, the growing prevalence of breast cancer in the United States has been a prominent factor in the huge demand for HER2 testing in the region.

Breast cancer is the most common cancer among women in the United States, as per the American Cancer Society. It states that in the year 2023, about 297,790 new cases of invasive breast cancer and approximately 55,720 new cases of ductal carcinoma in situ (DCIS) were diagnosed among women in the United States. It states that breast cancer will lead to about 43,700 women deaths in the country. The increasing number of breast cancer cases in the United States has led to an increased demand for potential diagnostic measures such as HER2 testing in healthcare facilities. Due to this, the HER2 testing market holds a significant regional share. Moreover, increased investments, constant governmental support, and research and development further accelerate growth in the market.

Future Market Scenario (2024 - 2031F)

The global HER2 testing market is expected to grow in the future due to multiple factors. Primarily, the increasing prevalence of breast cancer and gastric cancer worldwide has increased the adoption of HER2 testing in the healthcare industry. Increase in healthcare expenditure, governmental support, policies, and programs, reimbursement policies, increased research and development, and innovative launches by the public and private companies along with technological advancements such as AI-based HER2 testing techniques are further accelerating the growth of global HER2 testing market. Moreover, collaborative ventures involving diagnostics industry, biomedical companies, and other pharmaceutical companies have spurred innovation and growth in global HER2 testing market.

Key Players Landscape and Outlook

In HER2 testing market, public and private companies are progressively establishing initiatives, strategic partnerships, and distribution agreements, which are pivotal in propelling the global HER2 testing market's expansion. These alliances empower firms to adapt to each other's strengths, gain access to new markets and technologies, and pool resources for research and development endeavors. Distribution agreements enable companies to broaden their market presence at an international level. These collaborative initiatives promote innovation, expedite product development, and improve disease treatment and, in the end, contribute to the enduring and robust growth of the healthcare industry.

For instance, in December 2023, AstraZeneca India signed a partnership with Roche Diagnostics India to improve diagnostic testing for breast cancer patients by streamlining HER2 diagnostic tests in its diagnostics segment's product portfolio. The strategic acquisition will enable the company to help in improving standards of care for breast cancer patients and improve its product portfolio for management of the disease. Along with improving medical treatment, the partnership aims to enhance in-depth knowledge, research and development activities, and innovative product launches that will further expand the company's global footprint in the market.

Table of Contents

1. Research Methodology

2. Project Scope & Definitions

3. Executive Summary

4. Global HER2 Testing Market Outlook, 2017-2031F

  • 4.1. Market Size & Forecast
    • 4.1.1. By Value
    • 4.1.2. By Volume
  • 4.2. By Cancer
    • 4.2.1. Breast Cancer
    • 4.2.2. Gastric Cancer
    • 4.2.3. Others
  • 4.3. By Technique
    • 4.3.1. Immunohistochemistry (IHC)
    • 4.3.2. In situ hybridization (ISH)
      • 4.3.2.1. Fluorescence in situ hybridization (FISH)
      • 4.3.2.2. Chromogenic in situ hybridization (CISH)
      • 4.3.2.3. Silver enhanced in situ hybridization (SISH)
      • 4.3.2.4. Dual in situ hybridization (DISH)
      • 4.3.2.5. Others
    • 4.3.3. Differential polymerase chain reaction (PCR)
    • 4.3.4. Others
  • 4.4. By End-user
    • 4.4.1. Hospitals
    • 4.4.2. Diagnostic Laboratory
    • 4.4.3. Others
  • 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 HER2 Testing 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 Cancer
      • 5.1.2.1. Breast Cancer
      • 5.1.2.2. Gastric Cancer
      • 5.1.2.3. Others
    • 5.1.3. By Technique
      • 5.1.3.1. Immunohistochemistry (IHC)
      • 5.1.3.2. In situ hybridization (ISH)
      • 5.1.3.2.1. Fluorescence in situ hybridization (FISH)
      • 5.1.3.2.2. Chromogenic in situ hybridization (CISH)
      • 5.1.3.2.3. Silver enhanced in situ hybridization (SISH)
      • 5.1.3.2.4. Dual in situ hybridization (DISH)
      • 5.1.3.2.5. Others
      • 5.1.3.3. Differential polymerase chain reaction (PCR)
      • 5.1.3.4. Others
    • 5.1.4. By End-user
      • 5.1.4.1. Hospitals
      • 5.1.4.2. Diagnostic Laboratory
      • 5.1.4.3. Others
    • 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 Cancer
      • 5.1.5.2.1. Breast Cancer
      • 5.1.5.2.2. Gastric Cancer
      • 5.1.5.2.3. Others
      • 5.1.5.3. By Technique
      • 5.1.5.3.1. Immunohistochemistry (IHC)
      • 5.1.5.3.2. In situ hybridization (ISH)
      • 5.1.5.3.2.1. Fluorescence in situ hybridization (FISH)
      • 5.1.5.3.2.2. Chromogenic in situ hybridization (CISH)
      • 5.1.5.3.2.3. Silver enhanced in situ hybridization (SISH)
      • 5.1.5.3.2.4. Dual in situ hybridization (DISH)
      • 5.1.5.3.2.5. Others
      • 5.1.5.3.3. Differential polymerase chain reaction (PCR)
      • 5.1.5.3.4. Others
      • 5.1.5.4. By End-user
      • 5.1.5.4.1. Hospitals
      • 5.1.5.4.2. Diagnostic Laboratory
      • 5.1.5.4.3. Others
    • 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 Cancer
  • 6.2. By Technique
  • 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
    • 7.5.1. Supplier Power
    • 7.5.2. Buyer Power
    • 7.5.3. Substitution Threat
    • 7.5.4. Threat from New Entrant
    • 7.5.5. 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)
  • 10.5. Patent Analysis (If Applicable)

11. Case Studies

12. Key Players Outlook

  • 12.1. Thermo Fisher Scientific Inc.
    • 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. Illumina, Inc.
  • 12.3. Abbott Laboratories
  • 12.4. Pfizer Inc.
  • 12.5. Agilent Technologies, Inc.
  • 12.6. Biocare Medical, LLC.
  • 12.7. F. Hoffmann-La Roche Ltd.
  • 12.8. QIAGEN GmbH
  • 12.9. Sysmex Inostics, Inc.
  • 12.10. Merck Group
  • 12.11. Leica Biosystems
  • 12.12. Abnova Corporation

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