체외진단(IVD) 품질 관리 세계 시장 규모는 2024년 11억 4,000만 달러로 평가되었고, 예측기간 동안 1.55%의 연평균 복합 성장률(CAGR)로 2030년에는 12억 5,000만 달러에 달할 것으로 예상됩니다.
세계 체외진단(IVD) 품질 관리 시장은 광범위한 헬스케어 산업에서 인체 외부에서 수행되는 진단 검사의 정확성과 신뢰성을 보장하는 데 초점을 맞춘 역동적이고 필수적인 분야입니다. 체외진단제(IVD)의 품질 관리는 임상 검사 결과의 정확성을 보장하는 데 있어 매우 중요한 역할을 하며, 이는 환자의 진단 및 치료 방침 결정에 영향을 미칩니다. 이 시장은 진단 기기, 시약, 검사 시스템의 성능을 모니터링하고 궁극적으로 환자의 안전과 의료 결과를 개선하기 위해 설계된 다양한 제품과 서비스가 특징입니다. 세계 체외진단(IVD) 품질 관리 시장 성장의 주요 촉진요인으로는 만성질환의 확산, 노인 인구 증가, 첨단 진단 기술에 대한 수요 증가 등이 있습니다. 검사 기관과 의료 기관은 엄격한 규제 요건을 충족하고 최고 수준의 정확도를 유지해야 한다는 압박을 받고 있으며, 이는 품질 관리 솔루션에 대한 투자를 촉진하고 있습니다.
| 시장 개요 | |
|---|---|
| 예측 기간 | 2026-2030년 |
| 시장 규모 : 2024년 | 11억 4,000만 달러 |
| 시장 규모 : 2030년 | 12억 5,000만 달러 |
| CAGR : 2025-2030년 | 1.55% |
| 급성장 부문 | 품질 관리 |
| 최대 시장 | 북미 |
시장 진출기업에는 기존 IVD 품질 관리 제공업체뿐만 아니라 혁신적인 기술 및 방법을 활용하는 신생 기업도 포함됩니다. 품질 관리 제품에는 품질 관리 재료, 소프트웨어 솔루션, 데이터 관리 시스템 등 다양한 제품이 포함됩니다. 이러한 도구는 실험실에서 오류를 감지하고, 절차를 표준화하고, 실시간으로 문제를 해결하여 진단 결과의 품질을 향상시킬 수 있도록 도와줍니다.
미국 임상검사협회(American Clinical Laboratory Association)에 따르면 미국에서는 연간 70억 건 이상의 임상검사가 실시되며, 임상적 판단의 80%가 임상검사 후 내려진다고 합니다. 국제당뇨병연맹(IDF)이 발표한 정보에 따르면 2021년에는 전 세계적으로 약 5억 3,700만 명이 당뇨병을 앓고 있으며, 이 숫자는 2030년에는 약 6억 4,300만 명, 2045년에는 7억 8,300만 명에 달할 것으로 예상되고 있습니다. 서비스 제공업체 증가와 임상 진단 검사에 대한 수요 증가는 IVD QC 제품의 사용량 증가로 이어지고 있습니다.
만성질환 유병률 증가
규제의 복잡성과 엄격함
현장 진료(POC) 검사의 부상
Global In Vitro Diagnostics Quality Control Market was valued at USD 1.14 billion in 2024 and is expected to reach USD 1.25 billion by 2030 with a CAGR of 1.55% during the forecast period. The Global In Vitro Diagnostics Quality Control Market represents a dynamic and essential sector within the broader healthcare industry, focused on ensuring the accuracy and reliability of diagnostic tests conducted outside the human body. In vitro diagnostics (IVD) quality control plays a pivotal role in guaranteeing the precision of clinical laboratory results, which, in turn, influences patient diagnoses and treatment decisions. This market is characterized by a diverse range of products and services designed to monitor the performance of diagnostic instruments, reagents, and test systems, ultimately enhancing patient safety and healthcare outcomes. Key drivers behind the growth of the Global In Vitro Diagnostics Quality Control Market include the increasing prevalence of chronic diseases, a rising geriatric population, and the growing demand for advanced diagnostic technologies. Laboratories and healthcare institutions are under constant pressure to meet stringent regulatory requirements and maintain the highest standards of accuracy, prompting them to invest in quality control solutions.
| Market Overview | |
|---|---|
| Forecast Period | 2026-2030 |
| Market Size 2024 | USD 1.14 Billion |
| Market Size 2030 | USD 1.25 Billion |
| CAGR 2025-2030 | 1.55% |
| Fastest Growing Segment | Quality Controls |
| Largest Market | North America |
Market participants include established IVD quality control providers, as well as emerging companies leveraging innovative technologies and methodologies. Quality control products encompass a wide array of offerings, including quality control materials, software solutions, and data management systems. These tools enable laboratories to detect errors, standardize procedures, and troubleshoot issues in real-time, thereby improving the quality of diagnostic results.
The American Clinical Laboratory Association stated that more than 7 billion lab tests are performed in the U.S. annually, and 80% of clinical decisions are taken after laboratory testing. As per the information published by the International Diabetes Federation (IDF), in 2021, approximately 537 million people worldwide had diabetes, and this number is expected to reach around 643 million by 2030 and 783 million by 2045. The increasing number of service providers and rising demand for clinical diagnostic tests are leading to an increase in the usage of IVD QC products.
Key Market Drivers
Rising Prevalence of Chronic Diseases
The rising prevalence of chronic diseases is a compelling driver behind the growing prominence of the Global In Vitro Diagnostics Quality Control Market. Chronic diseases, such as diabetes, cardiovascular conditions, cancer, and respiratory ailments, are becoming increasingly prevalent worldwide. These conditions necessitate frequent diagnostic testing, which is fundamental to disease management, early detection, and treatment evaluation. In this context, the demand for quality control solutions has surged, driven by the imperative need to maintain the integrity of diagnostic tests.
As the global population continues to age and lifestyles become increasingly sedentary, the incidence of chronic diseases has skyrocketed. The elderly population, in particular, faces a higher risk of chronic ailments, and they require routine diagnostic tests to monitor their health status and manage their conditions effectively. Reliable and accurate diagnostic results are non-negotiable for the elderly, who often have complex healthcare needs, further underscoring the significance of quality control in ensuring consistent and dependable diagnostic outcomes.
Key Market Challenges
Regulatory Complexity and Stringency
The Global In Vitro Diagnostics Quality Control Market plays a vital role in ensuring the accuracy and reliability of diagnostic tests, serving as a linchpin in the healthcare system. However, a significant challenge that hampers its growth and effectiveness is the regulatory complexity and stringency that surrounds the in vitro diagnostics (IVD) industry.
Regulations governing IVD quality control are multifaceted, intricate, and subject to continual evolution. This complexity is primarily rooted in the need to safeguard patient safety by ensuring that diagnostic tests meet rigorous standards of accuracy and reliability. While stringent regulations are undoubtedly essential, they can present a myriad of challenges for manufacturers and stakeholders in the IVD quality control market.
One of the primary issues is the extensive documentation and reporting requirements that regulatory bodies impose on IVD quality control providers. The approval process for new quality control products can be time-consuming and expensive, involving rigorous testing and validation procedures. The stringent compliance measures necessitate substantial resources and expertise, contributing to the overall high cost of quality control solutions.
Furthermore, regulatory variations exist not only between countries but also between different regions within countries. This lack of uniformity complicates the global landscape, making it challenging for manufacturers to develop and maintain quality control solutions that adhere to the specific requirements of various markets. These disparities can result in delays, additional costs, and increased complexities for quality control providers, which in turn impact their ability to serve a global clientele efficiently.
Key Market Trends
Rise of Point-of-Care (POC) Testing
The rise of Point-of-Care (POC) testing is a significant trend that is strongly boosting the Global In Vitro Diagnostics Quality Control Market. POC testing has gained momentum in recent years as it enables rapid, on-site diagnostic assessments, delivering results in real time and often at the patient's bedside. This trend is reshaping the landscape of healthcare delivery, and with it, the demand for specialized quality control solutions that cater to the unique needs of decentralized testing environments.
POC testing offers several advantages, such as reduced turnaround times for results, increased accessibility, and the potential for immediate medical decision-making. However, these benefits come with the inherent challenge of maintaining the accuracy and reliability of diagnostic tests performed outside the controlled environment of a central laboratory.
Quality control is paramount in POC testing to ensure that test results are consistent, precise, and dependable. The stringent requirements for quality control in POC testing are driven by the need to guarantee the accuracy of medical decisions made at the point of care, whether for diagnosing infectious diseases, monitoring chronic conditions, or evaluating the effectiveness of treatments.
To meet these quality control demands, the In Vitro Diagnostics Quality Control Market has adapted by developing a range of products and services tailored to the unique aspects of POC testing. These include specialized quality control materials and software designed to validate the performance of POC devices and maintain the integrity of testing processes.
The global prevalence of POC testing is expected to continue its ascent, driven by the need for rapid diagnostics, especially in scenarios where immediate medical decisions are crucial, such as emergency departments, ambulances, and remote or resource-limited settings. This growth in POC testing will, in turn, fuel the demand for quality control solutions that can effectively ensure the reliability of these decentralized tests.
In this report, the Global In Vitro Diagnostics Quality Control Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Company Profiles: Detailed analysis of the major companies present in the Global In Vitro Diagnostics Quality Control Market.
Global In Vitro Diagnostics Quality Control Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report: