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市場調查報告書
商品編碼
1503439
到 2030 年核准藥物測試 (LDT) 市場預測:按產品、測試類型、應用、最終用戶和地區進行的全球分析Laboratory-Developed Testing Market Forecasts to 2030 - Global Analysis By Product (Mass Spectrometry, Microarrays and Next-Generation Sequencing ), Test Type, Application, End User and By Geography |
根據 Stratistics MRC 的數據,2024 年全球核准藥物檢測 (LDT) 市場規模為 58.6 億美元,預計到 2030 年將達到 101.6 億美元,預測期內複合年成長率為 9.6%。
核准藥物測試 (LDT) 是在臨床或研究環境中的單一實驗室內創建、檢驗和執行的診斷測試。與商業化測試不同,LDT 通常旨在滿足特定實驗室或患者群體的特定需求。 LDT 的範圍從簡單的測定到複雜的分子測試,為疾病、遺傳傾向和治療方法提供了寶貴的見解。 LDT 在促進個人化醫療和縮小診斷能力差距方面發揮著重要作用。
根據世界衛生組織 (WHO) 的數據,癌症已成為 183 個國家中 112 個國家 70 歲以上人口的第一或第二大死因,並已成為其他 23 個國家的第三或第四大死因。
增加與遺傳健康風險相關的產品供應
隨著基因檢測變得越來越普遍,人們對全面了解健康風險的需求也越來越大。這正在推動非核准測試(LDT)市場產品陣容的擴大。公司正在擴大其產品組合,包括評估更廣泛的遺傳健康風險的測試,以滿足消費者的多樣化需求。這些產品包括各種疾病易感性、藥物基因組學、血統追蹤等測試。透過提供多樣化的產品,LDT 提供者旨在滿足醫療保健專業人員和消費者不斷變化的需求,同時滿足人們對個人化醫療和預防性醫療保健策略日益成長的興趣。
嚴格規定
嚴格的監管對 LDT 市場構成了重大限制,影響了創新和市場准入。這些法規通常由 FDA 等監管機構執行,要求對 LDT 進行嚴格的驗證和合規標準,從而增加了開發時間和成本。公司在複雜的監管途徑中面臨障礙,限制了他們快速引入新測試的能力。此外,不斷變化的法規需要不斷適應,進一步增加了合規性挑戰。
個人化醫療的持續研究
對個人化藥物的持續研究正在非核准測試(LDT)市場創造重大機會。隨著基因組學和分子生物學的進步加速,個人化治療越來越成為現實。這一趨勢推動了對準確診斷工具的需求,並促使實驗室在 LDT 方面進行創新,以實現個人化治療策略。透過持續研究,LDT 可以增強其分析基因突變和生物標記的能力,以幫助定製藥物治療方案。這一演變與精準醫療的轉變相吻合,並為 LDT 領域的成長和創新提供了一條充滿希望的途徑。
執行診斷測試時面臨的業務障礙
進行診斷測試時常會出現行政障礙。這些障礙包括法規遵循的複雜性、驗證和品管的資源有限以及不同實驗室標準化程序的挑戰。此外,試劑和設備的一致供應鏈管理也是一個問題。現有醫療保健系統和資料管理平台的互通性問題使營運環境更加複雜。
COVID-19 的疫情對核准藥物檢測(LDT)市場產生了重大影響。隨著對準確診斷測試的迫切需求,對LDT,特別是COVID-19檢測套組的需求正在迅速增加。這種不斷成長的需求導致了對 LDT 研發的投資增加,並加強了監管監督,以確保測試的準確性和可靠性。此外,疫情也刺激了 LDT 技術的創新,促進了更快、更靈敏、更擴充性的測試解決方案的開發。然而,供應鏈中斷和監管挑戰也阻礙了市場成長。
預計在預測期內重症加護行業將是最大的
由於多種因素,核准藥物檢測 (LDT) 市場的重症加護領域正在顯著成長。醫療技術的進步推動了需求的成長,推動了更複雜的測試的開發,這些測試可以快速評估急診患者的關鍵健康指標。慢性病的增加需要對重症患者進行頻繁監測,並增加了對專門檢測的需求。此外,COVID-19 大流行凸顯了快速、準確診斷的重要性,進一步加速了 LDT 在重症加護中的採用。 LDT 提供的可自訂性和靈活性使醫療保健專業人員能夠根據特定患者的需求量身定做測試,從而增強臨床決策。
預計遺傳學在預測期內的複合年成長率最高
在核准藥物檢測(LDT)市場中,遺傳學領域正在經歷顯著的成長。基因組研究的進展揭示了有關疾病機制和個人化醫療的新知識,增加了對基因檢測的需求。此外,基因定序技術成本的下降使得醫療保健專業人員和患者更容易獲得這些測試。此外,遺傳疾病的日益普及以及人們對早期檢測和預防重要性的認知不斷增強,正在推動基因檢測服務的採用。這些測試為疾病風險評估、診斷、治療選擇和監測提供了有價值的資訊,使其對現代醫療保健至關重要。
最近的趨勢表明,歐洲的核准藥物檢測(LDT)市場正在經歷顯著成長。這種成長是由多種因素推動的,包括對個人化醫療和診斷的需求增加、實現更複雜測試的技術進步以及對醫療保健品質和效率的日益關注。此外,歐洲的支持性法規環境和強大的醫療保健基礎設施促進了 LDT 的創新和投資。因此,該地區檢測設施激增,為各種臨床需求提供專門的檢測服務。
由於多種因素,北美核准藥物檢測(LDT)市場正在經歷顯著成長。對個人化醫療和精準診斷的需求不斷成長正在推動 LDT 服務的擴展。此外,次世代定序和分子診斷等技術的進步正在擴大 LDT 產品的範圍。該地區的監管靈活性也促進了創新並加速了 LDT 的採用。此外,COVID-19 的爆發凸顯了非核准檢測的重要性,進一步提振了市場。
According to Stratistics MRC, the Global Laboratory-Developed Testing Market is accounted for $5.86 billion in 2024 and is expected to reach $10.16 billion by 2030 growing at a CAGR of 9.6% during the forecast period. Laboratory-developed testing (LDT) refers to diagnostic tests created, validated, and performed within a single laboratory, often in clinical or research settings. Unlike commercially available tests, LDTs are typically designed to meet the specific needs of a particular laboratory or patient population. They can range from simple assays to complex molecular tests, providing valuable insights into diseases, genetic predispositions, and treatment options. LDTs play a crucial role in advancing personalized medicine and filling gaps in diagnostic capabilities.
According to the World Health Organization, cancer is the leading or second-leading cause of death for those over the age of 70 in 112 of 183 nations, and third or fourth in the other 23 countries.
Increasing product offerings related to genetic health risks
As genetic testing becomes more prevalent, there's a growing demand for comprehensive insights into health risks. This driver fuels the expansion of product offerings within the Laboratory-Developed Testing (LDT) market. Companies are broadening their portfolios to include tests that assess a wider range of genetic health risks, catering to diverse consumer needs. These offerings may encompass tests for predispositions to various diseases, pharmacogenomics, and ancestry tracing, among others. By diversifying their products, LDT providers aim to meet the evolving demands of healthcare professionals and consumers while also capitalizing on the increasing interest in personalized medicine and preventive healthcare strategies.
Stringent regulations
Stringent regulations pose significant restraints in the Laboratory Developed Testing (LDT) market, impacting innovation and market entry. These regulations, often enforced by regulatory bodies like the FDA, require rigorous validation and compliance standards for LDTs, increasing the time and cost of development. Companies face hurdles in navigating complex regulatory pathways, limiting their ability to introduce new tests swiftly. Moreover, the evolving nature of regulations necessitates continuous adaptation, further adding to compliance challenges.
Continuous research on personalized medicines
Continuous research on personalized medicines presents a significant opportunity within the Laboratory Developed Testing (LDT) market. As advancements in genomics and molecular biology accelerate, tailored therapies become increasingly viable. This trend drives the demand for precise diagnostic tools, prompting laboratories to innovate LDTs for individualized treatment strategies. With ongoing research, LDTs can enhance their capabilities to analyze genetic variations and biomarkers, aiding in the customization of medication regimens. This evolution aligns with the shift towards precision medicine, offering a promising avenue for growth and innovation in the LDT sector.
Operational barriers faced in conducting diagnostic tests
Operational barriers often arise when conducting diagnostic tests. These hurdles may include regulatory compliance complexities, limited resources for validation and quality control, and challenges in standardizing procedures across different laboratories. Additionally, ensuring consistent supply chain management for reagents and equipment can be problematic. Interoperability issues with existing healthcare systems and data management platforms further complicate the operational landscape.
The COVID-19 pandemic has significantly impacted the laboratory-developed testing (LDT) market. With the urgent need for accurate diagnostic testing, there has been a surge in demand for LDTs, particularly for COVID-19 testing kits. This heightened demand has led to increased investment in LDT research and development, as well as regulatory scrutiny to ensure test accuracy and reliability. Furthermore, the pandemic has spurred innovation in LDT technologies, driving the development of faster, more sensitive, and more scalable testing solutions. However, supply chain disruptions and regulatory challenges have also posed obstacles to market growth.
The critical care segment is expected to be the largest during the forecast period
The Critical Care segment within the Laboratory Developed Testing (LDT) market is experiencing notable growth due to several factors. Advancements in medical technology have enabled the development of more sophisticated tests that can rapidly assess critical health indicators in acutely ill patients, driving demand. The rising prevalence of chronic diseases necessitates frequent monitoring of patients in critical care settings, fueling the need for specialized tests. Additionally, the COVID-19 pandemic has underscored the importance of rapid and accurate diagnostics, further boosting the adoption of LDTs in critical care. The customization and flexibility offered by LDTs allow healthcare providers to tailor tests to specific patient needs, enhancing clinical decision-making.
The Genetics segment is expected to have the highest CAGR during the forecast period
In the Laboratory Developed Testing (LDT) market, the genetics segment is experiencing notable growth. Advances in genomic research have unveiled new insights into disease mechanisms and personalized medicine, driving demand for genetic testing. Moreover, the declining cost of genetic sequencing technologies has made such tests more accessible to healthcare providers and patients. Additionally, the increasing prevalence of genetic disorders and the growing awareness of the importance of early detection and prevention are fuelling the adoption of genetic testing services. These tests offer valuable information for disease risk assessment, diagnosis, treatment selection, and monitoring, making them integral to modern healthcare practices.
In recent years, Europe has experienced significant growth in the Laboratory-Developed Testing (LDT) market. This growth can be attributed to several factors, including increasing demand for personalized medicine and diagnostics, advancements in technology enabling more sophisticated testing methods, and a rising emphasis on healthcare quality and efficiency. Additionally, Europe's supportive regulatory environment and robust healthcare infrastructure have fostered innovation and investment in LDT. As a result, the region has witnessed a proliferation of laboratories offering specialized testing services, catering to diverse clinical needs.
The Laboratory-Developed Testing (LDT) market in North America has witnessed substantial growth driven by several factors. Increased demand for personalized medicine and precision diagnostics has propelled the expansion of LDT services. Additionally, advancements in technology, such as next-generation sequencing and molecular diagnostics, have widened the scope of LDT offerings. Regulatory flexibility in the region has also fostered innovation and accelerated the adoption of LDTs. Moreover, the COVID-19 pandemic has highlighted the importance of diagnostic testing, further boosting the market.
Key players in the market
Some of the key players in Laboratory-Developed Testing market include Abbott Laboratories, Adaptive Biotechnologies, Bio-Rad Laboratories, Inc., Bruker Corporation, Epic Sciences, Inc., Eurofins Scientific, F. Hoffmann-La Roche Ltd, Genoptix, Inc., Guardant Health, Illumina, Inc., OPKO Health Inc., Qiagen, Quidel Corporation, Rosetta Genomics Ltd., Siemens Healthcare Private Limited, Sonic Healthcare Ltd. and Thermo Fisher Scientific Inc.
In June 2024, Bruker Corporation launches the new top-of-the-line timsTOF Ultra 2 system with significantly further enhanced sensitivity for deep profiling of small cells, subcellular organelles, as well as increased sample loading flexibility. Together with new Spectronaut 19 software and the novel PreOmics ENRICHplus kit, Bruker is setting new 4D-Proteomics standards from highest sensitivity to large-scale, deep plasma proteomics.
In March 2024, Global healthcare leader Abbott has announced the launch of its innovative automation solutions, GLP systems Track, to support laboratories' high-volume needs. With this launch, Abbott aims to strike a balance between quality of care and efficient use of resources. Across different care settings, depending on laboratory size and patient pool, this automation solution can handle bulk test tubes per day.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.