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市場調查報告書

商品編碼

1528888

實驗室開發的測試市場- 按測試類型（臨床生物化學、免疫學、血液學、微生物學、分子診斷、流式細胞儀、組織學/細胞學）、應用（腫瘤學、遺傳學、神經學）、最終用途和預測，2024 - 2032

Laboratory Developed Tests Market - By Test Type (Clinical Biochemistry, Immunology, Hematology, Microbiology, Molecular Diagnostics, Flow cytometry, Histology/Cytology), Application (Oncology, Genetics, Neurology), End Use & Forecast, 2024 - 2032

出版日期: 2024年05月03日 | 出版商:

Global Market Insights Inc. | 英文 100 Pages | 商品交期: 2-3個工作天內

價格

簡介目錄

由於診斷技術的進步以及不斷變化的監管變化和指南，全球實驗室開發的測試市場從 2024 年到 2032 年的複合年成長率將達到 6.4%。這些發展使實驗室能夠快速創建和部署高度專業化的測試，以更高的準確性和效率滿足不同的臨床需求。法規更新確保嚴格的品質保證，增強人們對 LDT 可靠性和安全性的信心。隨著醫療保健轉向個人化醫療，對根據患者個體情況量身定做的 LDT 的需求將會成長，從而推動診斷創新這一關鍵領域的顯著擴張。

例如，2024 年 4 月，FDA 發布了一項最終規則，將實驗室開發的測試 (LDT) 定義為體外診斷，並根據 FD&C 法案接受 FDA 的監督，這標誌著美國對 LDT 的監管發生重大轉變。這項發展意味著 LDT 的開發、驗證和行銷方式可能會發生變化，從而影響合規要求、創新時間表和市場進入策略。在全球範圍內，這種監管轉變可能會影響 LDT 的國際標準，進而影響市場動態，包括競爭力、創新步伐以及患者獲得先進診斷技術的機會。

實驗室開發的測試行業根據測試類型、應用、最終用途和地區進行分類。

由於其在診斷代謝紊亂、荷爾蒙失衡和其他健康狀況方面的關鍵作用，臨床生化領域將在 2024 年至 2032 年間顯著成長。隨著醫療保健提供者越來越依賴生化檢測來進行精確的患者評估和治療監測，對先進 LDT 的需求不斷成長。這部分的重點是分析生物標記和生化參數，為個人化醫療計劃提供至關重要的支持，確保準確的診斷和治療干預。隨著分析技術的不斷進步，臨床生物化學仍然處於最前沿，塑造著診斷測試的未來。

憑藉其提供綜合診斷解決方案的專業能力的推動，診斷中心部門到 2032 年將取得顯著收益。這些中心提供根據患者個別需求量身定做的各種 LDT，包括基因檢測和個人化醫療。隨著醫療保健需求的增加和對早期疾病檢測的關注，診斷中心在擴大先進診斷的覆蓋範圍方面發揮關鍵作用。他們與醫療保健提供者的策略合作以及對品質保證的承諾使他們在實驗室開發的測試市場前景中佔據顯著地位。

在醫療保健基礎設施快速發展和個人化醫療需求不斷成長的推動下，亞太地區將在 2024 年至 2032 年間獲得大量市場佔有率。該地區龐大的人口、不斷增加的醫療保健支出以及先進診斷技術的採用促成了其主導地位。隨著慢性病和傳染病負擔的日益加重，亞太地區對全球實驗室開發的檢測行業成長的貢獻是巨大的，強調了其作為醫療保健診斷和患者護理進步的關鍵貢獻者的作用。

產業生態系統分析
產業影響力
- 成長動力
  - 癌症和遺傳性疾病發生率增加
  - 傳染病和慢性病盛行率上升
  - 提高對早期疾病檢測的認知與關注
- 產業陷阱與挑戰
  - 替代測試方法的可用性
成長潛力分析
監管環境
報銷場景
技術進步
波特的分析
PESTEL分析
未來市場趨勢

第 4 章：競爭格局

介紹
公司矩陣分析
公司市佔率分析
競爭定位矩陣
戰略儀表板

第 5 章：市場估計與預測：按測試類型，2021 - 2032 年

主要趨勢
臨床生化
免疫學
血液學
微生物學
分子診斷
流式細胞儀
組織學/細胞學
其他測試類型

第 6 章：市場估計與預測：按應用分類，2021 - 2032

主要趨勢
腫瘤學
遺傳學
傳染病
自體免疫疾病
神經病學
精神/行為障礙
營養與代謝疾病
其他應用

第 7 章：市場估計與預測：按最終用途，2021 - 2032 年

主要趨勢
醫院實驗室
診斷中心
臨床研究機構
學術及研究機構
其他最終用戶

第 8 章：市場估計與預測：按地區分類，2021 - 2032 年

主要趨勢
北美洲
- 美國
- 加拿大
歐洲
- 德國
- 英國
- 法國
- 義大利
- 西班牙
- 荷蘭
- 歐洲其他地區
亞太地區
- 中國
- 日本
- 印度
- 澳洲
- 韓國
- 亞太地區其他地區
拉丁美洲
- 巴西
- 墨西哥
- 阿根廷
- 拉丁美洲其他地區
中東和非洲
- 沙烏地阿拉伯
- 南非
- 阿拉伯聯合大公國
- 中東和非洲其他地區

第 9 章：公司簡介

23andMe, Inc.
Abbott
Bio-Rad Laboratories, Inc.
Eurofins Scientific
F. Hoffmann-La Roche Ltd.
Illumina, Inc.
NeoGenomics Laboratories
OPKO Health, Inc.
QIAGEN
Quest Diagnostics Incorporated

簡介目錄

Product Code: 9340

Global Laboratory Developed Tests Market will reach a 6.4% CAGR from 2024 to 2032, attributed to advancements in diagnostic technologies along with evolving regulatory changes and guidelines. These developments enable labs to create and deploy highly specialized tests swiftly, catering to diverse clinical needs with greater accuracy and efficiency. Regulatory updates ensure rigorous quality assurance, boosting confidence in LDTs' reliability and safety. As healthcare shifts towards personalized medicine, the demand for LDTs tailored to individual patient profiles will grow, driving noteworthy expansion in this pivotal segment of diagnostic innovation.

For instance, in April 2024, the FDA issued a final rule defining laboratory-developed tests (LDTs) as in vitro diagnostics, subjecting them to FDA oversight under the FD&C Act, marking a significant regulatory shift for LDTs in the US. This development implies potential shifts in how LDTs are developed, validated, and marketed, impacting compliance requirements, innovation timelines, and market entry strategies. Globally, this regulatory shift may influence international standards for LDTs, affecting market dynamics, including competitiveness, innovation pace, and patient access to advanced diagnostic technologies.

The laboratory-developed tests industry is classified based on test type, application, end-use, and region.

The clinical biochemistry segment will see a notable surge between 2024 and 2032, owing to its pivotal role in diagnosing metabolic disorders, hormonal imbalances, and other health conditions. As healthcare providers increasingly rely on biochemical assays for precise patient assessment and treatment monitoring, the demand for advanced LDTs grows. This segment's focus on analyzing biomarkers and biochemical parameters crucially supports personalized medicine initiatives, ensuring accurate diagnostics and therapeutic interventions. With ongoing advancements in analytical techniques, clinical biochemistry remains at the forefront, shaping the future of diagnostic testing.

The diagnostic centers segment will amass remarkable gains through 2032, propelled by its specialized capabilities in providing comprehensive diagnostic solutions. These centers offer a wide array of LDTs tailored to individual patient needs, including genetic testing and personalized medicine. With increasing healthcare demands and a focus on early disease detection, diagnostic centers play a critical role in expanding access to advanced diagnostics. Their strategic collaborations with healthcare providers and commitment to quality assurance position them prominently in the laboratory developed tests market outlook.

Asia Pacific will secure a substantial market presence from 2024 to 2032, driven by rapid healthcare infrastructure development and rising demand for personalized medicine. The region's expansive population, increasing healthcare expenditure, and adoption of advanced diagnostic technologies contribute to its dominance. With a growing burden of chronic diseases and infectious ailments, Asia Pacific's contribution to the global laboratory developed tests industry growth is significant, emphasizing its role as a key contributor to advancements in healthcare diagnostics and patient care.

Chapter 1 Methodology & Scope

1.1 Market scope & definitions
1.2 Research design
- 1.2.1 Research approach
- 1.2.2 Data collection methods
1.3 Base estimates & calculations
- 1.3.1 Base year calculation
- 1.3.2 Key trends for market estimation
1.4 Forecast model
1.5 Primary research and validation
- 1.5.1 Primary sources
- 1.5.2 Data mining sources

Chapter 2 Executive Summary

2.1 Industry 360° synopsis

Chapter 3 Industry Insights

3.1 Industry ecosystem analysis
3.2 Industry impact forces
- 3.2.1 Growth drivers
  - 3.2.1.1 Increasing incidence of cancer and genetic disorders
  - 3.2.1.2 Rising prevalence of infectious and chronic diseases
  - 3.2.1.3 Growing awareness and focus on early disease detection
- 3.2.2 Industry pitfalls & challenges
  - 3.2.2.1 Availability of alternative testing methods
3.3 Growth potential analysis
3.4 Regulatory landscape
3.5 Reimbursement scenario
3.6 Technological advancements
3.7 Porter's analysis
3.8 PESTEL analysis
3.9 Future market trends

Chapter 4 Competitive Landscape, 2023

4.1 Introduction
4.2 Company matrix analysis
4.3 Company market share analysis
4.4 Competitive positioning matrix
4.5 Strategy dashboard

Chapter 5 Market Estimates and Forecast, By Test Type, 2021 - 2032 ($ Mn)

5.1 Key trends
5.2 Clinical biochemistry
5.3 Immunology
5.4 Haematology
5.5 Microbiology
5.6 Molecular diagnostics
5.7 Flow cytometry
5.8 Histology/Cytology
5.9 Other test types

Chapter 6 Market Estimates and Forecast, By Application, 2021 - 2032 ($ Mn)

6.1 Key trends
6.2 Oncology
6.3 Genetics
6.4 Infectious diseases
6.5 Autoimmune disorders
6.6 Neurology
6.7 Mental/behavioral disorder
6.8 Nutritional & metabolic diseases
6.9 Other applications

Chapter 7 Market Estimates and Forecast, By End-use, 2021 - 2032 ($ Mn)

7.1 Key trends
7.2 Hospital laboratories
7.3 Diagnostic centers
7.4 Clinical research organizations
7.5 Academic and research institutes
7.6 Other end-users

Chapter 8 Market Estimates and Forecast, By Region, 2021 - 2032 ($ Mn)

8.1 Key trends
8.2 North America
- 8.2.1 U.S.
- 8.2.2 Canada
8.3 Europe
- 8.3.1 Germany
- 8.3.2 UK
- 8.3.3 France
- 8.3.4 Italy
- 8.3.5 Spain
- 8.3.6 Netherlands
- 8.3.7 Rest of Europe
8.4 Asia Pacific
- 8.4.1 China
- 8.4.2 Japan
- 8.4.3 India
- 8.4.4 Australia
- 8.4.5 South Korea
- 8.4.6 Rest of Asia Pacific
8.5 Latin America
- 8.5.1 Brazil
- 8.5.2 Mexico
- 8.5.3 Argentina
- 8.5.4 Rest of Latin America
8.6 Middle East and Africa
- 8.6.1 Saudi Arabia
- 8.6.2 South Africa
- 8.6.3 UAE
- 8.6.4 Rest of Middle East and Africa