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市場調查報告書
商品編碼
1494911
體外診斷 (IVD) 市場至2030年的預測:按產品、檢體、技術、應用、最終用戶和地區的全球分析In Vitro Diagnostics (IVD) Market Forecasts to 2030 - Global Analysis By Product (Instruments, Reagents & Kits and Software), Specimen (Blood, Urine, Stool, Saliva, Tissue Biopsies and Other Specimens), Technology, Application, End User and By Geography |
根據Stratistics MRC的資料,2024年全球體外診斷(IVD)市場規模為1,041億美元,預計到2030年將達到1,485億美元,預測期內年複合成長率為6.1%。
體外診斷(IVD)是對從人體採集的樣本(例如血液、尿液或組織)進行的醫學測試,以檢測疾病、狀況或感染疾病。這些測試在體外、受控的實驗室環境中進行,在現代醫療保健和個人化醫療中發揮重要作用,為診斷、治療監測和疾病預防提供關鍵資訊。
根據美國生物技術資訊中心(NCBI)的報告,體外診斷(IVD)測試在臨床實踐中很有價值,88%的患者用於初步診斷,77%用於治療監測,72%的患者用於治療用於治療後續觀察。這凸顯了 IVD 在病患管理和醫療保健中的重要角色。
慢性病增加
糖尿病、心血管疾病和癌症等慢性疾病的上升趨勢是體外診斷(IVD)市場的關鍵促進因素。這些疾病需要定期監測和早期診斷,體外診斷(IVD)測試有助於實現這一目標。隨著世界人口老化以及與生活方式相關的健康問題的增加,對準確、高效的診斷工具的需求不斷增加,推動了市場的擴張。
診斷平台高成本
先進診斷平台的高成本是體外診斷市場的主要限制因素。這些平台通常需要大量投資,包括初始設置、維護和熟練人員。較小的醫療機構和新興市場可能會發現難以承擔實施這些技術的成本,限制了採用並可能減緩市場成長。此外,成本因素可能會阻礙新技術的頻繁升級和整合。
新興市場的成長
新興市場代表了 IVD 市場的主要成長機會。亞太、拉丁美洲和非洲部分地區等地區經濟快速發展,衛生基礎建設不斷改善,衛生支出不斷增加。這些因素,加上人們對早期疾病檢測和預防保健意識的增強,為體外診斷(IVD)產品和服務的擴展提供了肥沃的土壤。在這些地區投資的公司可以開拓到許多服務不足的患者。
嚴格的法律規範
管理體外診斷的核准和商業化的嚴格法律規範是市場成長的主要威脅。 FDA 和 EMA 等監管機構制定了嚴格的標準,以確保診斷測試的安全性和有效性。這些法規雖然保護病人安全,但也延長了核准流程並增加了製造商的成本。違規可能導致產品召回、法律問題和市場信心喪失。
COVID-19 大流行大幅推動了 IVD 市場的發展,對 PCR、NGS 和基於血清學的快速檢測等診斷檢測的需求激增。這次疫情加速了就地檢驗和遠距離診斷的採用,凸顯了快速、準確的診斷解決方案的重要性。需求激增導致對 IVD 技術和基礎設施的投資增加,為未來的成長開創了先例。
試劑和套件細分市場預計將成為預測期內最大的細分市場
試劑和套件領域預計將主導 IVD 市場,因為它在診斷測試中發揮重要作用。試劑是各種體外診斷測試中用於檢測和測量患者樣本中特定分析物的關鍵組件。常規診斷程序對這些消耗品的持續需求,加上試劑配方的進步和新檢測套組的推出,推動該領域的成長。
免疫測量領域預計在預測期內年複合成長率最高
免疫測量領域由於其廣泛的應用,包括感染疾病、癌症生物標記和荷爾蒙濃度的檢測,預計將出現最高的年複合成長率。免疫檢測具有較高的敏感性和特異性,對於臨床診斷非常重要。自動免疫檢測系統等技術進步和多重分析的市場開拓進一步提高了其效率和採用率,促進了市場的快速成長。
北美由於其先進的醫療基礎設施、高昂的醫療成本以及主要 IVD 公司的存在,在 IVD 市場佔據主導地位。該地區對早期疾病檢測、個人化醫療和先進診斷技術引進的關注推動市場成長。此外,政府的支持政策和慢性病的高盛行率也促進了北美的主要市場佔有率。
由於醫療保健投資增加、醫療保健基礎設施改善以及預防醫學意識不斷增強,預計亞太地區 IVD 市場將快速成長。慢性病和感染疾病患者的上升,經濟的發展和中產階級的壯大推動對先進診斷解決方案的需求。政府為改善醫療保健的可近性和可負擔性所做的努力進一步支持了該地區的高年複合成長率。
According to Stratistics MRC, the Global In Vitro Diagnostics (IVD) Market is accounted for $104.1 billion in 2024 and is expected to reach $148.5 billion by 2030 growing at a CAGR of 6.1% during the forecast period. In Vitro Diagnostics (IVD) refers to medical tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are conducted outside the body, in a controlled laboratory environment, to provide crucial information for diagnosis, treatment monitoring, and disease prevention, playing a vital role in modern healthcare and personalized medicine.
According to a report by the National Center for Biotechnology Information (NCBI), IVD testing is valuable in clinical practice, with 88% of patients using it for initial diagnosis, 77% for treatment monitoring, and 72% for follow-up. This highlights the indispensable role of IVDs in patient management and healthcare outcomes.
Increasing prevalence of chronic diseases
The rising prevalence of chronic diseases such as diabetes, cardiovascular diseases, and cancer is a significant driver for the In Vitro Diagnostics (IVD) market. These conditions require regular monitoring and early diagnosis, which IVD tests facilitate. As the global population ages and lifestyle-related health issues increase, the demand for accurate and efficient diagnostic tools continues to grow, thereby driving market expansion.
High cost of diagnostic platforms
The high cost of advanced diagnostic platforms poses a significant restraint to the IVD market. These platforms often require substantial investment in terms of initial setup, maintenance, and skilled personnel. Smaller healthcare facilities and developing regions may find it challenging to afford these technologies, limiting their adoption and slowing market growth. Additionally, the cost factor can deter frequent upgrades and integration of new technologies.
Growth in emerging markets
Emerging markets present substantial growth opportunities for the IVD market. Regions such as Asia-Pacific, Latin America, and parts of Africa are experiencing rapid economic development, improved healthcare infrastructure, and increased healthcare spending. These factors, combined with a growing awareness of early disease detection and preventive healthcare, create a fertile ground for the expansion of IVD products and services. Companies investing in these regions can tap into a large, underserved patient population.
Stringent regulatory framework
The stringent regulatory framework governing the approval and commercialization of IVD products is a significant threat to market growth. Regulatory bodies like the FDA and EMA impose rigorous standards to ensure the safety and efficacy of diagnostic tests. While these regulations protect patient safety, they also lead to lengthy approval processes and increased costs for manufacturers. Non-compliance can result in product recalls, legal issues, and loss of market credibility.
The COVID-19 pandemic significantly boosted the IVD market, with a sharp rise in demand for diagnostic tests such as PCR, NGS, and serology-based rapid tests. The pandemic accelerated the adoption of point-of-care testing and remote diagnostics, highlighting the importance of rapid and accurate diagnostic solutions. This surge in demand led to increased investments in IVD technologies and infrastructure, setting a precedent for future growth.
The reagents & kits segment is expected to be the largest during the forecast period
The reagents and kits segment is anticipated to dominate the IVD market due to their essential role in diagnostic testing. Reagents are critical components used in various IVD tests to detect and measure specific analytes in patient samples. The continuous need for these consumables in routine diagnostic procedures, coupled with advancements in reagent formulations and the introduction of new test kits, drives the segment's growth.
The immunoassays segment is expected to have the highest CAGR during the forecast period
The immunoassays segment is projected to experience the highest CAGR due to its widespread application in detecting infectious diseases, cancer biomarkers, and hormone levels. Immunoassays offer high sensitivity and specificity, making them indispensable in clinical diagnostics. Technological advancements, such as the development of automated immunoassay systems and multiplex assays, further enhance their efficiency and adoption, contributing to rapid market growth.
North America is positioned to dominate the IVD market due to its advanced healthcare infrastructure, high healthcare expenditure, and the presence of major IVD companies. The region's focus on early disease detection, personalized medicine, and the adoption of advanced diagnostic technologies drives market growth. Additionally, supportive government policies and a high prevalence of chronic diseases contribute to North America's leading market share.
The Asia Pacific region anticipates rapid growth in the IVD market, driven by increasing healthcare investments, improving healthcare infrastructure, and a growing awareness of preventive healthcare. The rising prevalence of chronic and infectious diseases, coupled with economic development and expanding middle-class populations, fuels the demand for advanced diagnostic solutions. Government initiatives to enhance healthcare access and affordability further support the region's high CAGR.
Key players in the market
Some of the key players in In Vitro Diagnostics (IVD) market include Roche Diagnostics, Siemens Healthineers, Abbott Laboratories, Danaher Corporation (Beckman Coulter), Thermo Fisher Scientific, Becton, Dickinson and Company (BD), bioMerieux SA, Sysmex Corporation, Johnson & Johnson (Ortho Clinical Diagnostics), Bio-Rad Laboratories, Qiagen N.V., Hologic, Inc., Grifols, Illumina, Inc., and Agilent Technologies.
In December 2023, Thermo Fisher Scientific Inc., the world leader in serving science, announced the launch of the Thermo Scientific(TM) KingFisher(TM) Apex(TM) Dx, an automated nucleic acid purification instrument, and Applied Biosystems(TM) MagMAX(TM) Dx Viral/Pathogen NA Isolation Kit for the isolation and purification of viral and bacterial pathogens from respiratory biological specimens. Together these products provide laboratories with an in vitro diagnostic (IVD) and in vitro diagnostic regulation (IVD-R) approved automated sample preparation solutions for increased confidence in downstream results.
In November 2023, Roche announced the launch of the LightCycler(R) PRO System based on the proven gold standard technology of the LightCycler(R) Systems that came before it. This new system raises the bar for performance and usability while bridging the gap between translational research and in vitro diagnostics. The LightCycler PRO System further complements Roche's molecular PCR testing portfolio, which includes solutions for a variety of healthcare professionals - from those performing research, to those testing patients for cancer, infectious diseases, and other public health challenges.
In June 2023, Hologic announced FDA 510(k) clearance of its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. The news came months after the FDA granted an emergency use authorization for a COVID/flu/RSV test from BD.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.