세계 생화학 자동 진단 시장 규모는 2023년 50억 1,000만 달러에서 2031년 78억 1,000만 달러에 달할 것으로 예상되며, 예측 기간인 2024-2031년 동안 5.7%의 CAGR로 성장할 것으로 예상됩니다. 신속하고 정확한 진단 검사에 대한 수요 증가가 시장을 주도하고 있습니다. 검사 절차의 자동화, 질병의 조기 진단에 대한 중요성, 생화학 진단에 사용되는 기술의 발전은 다른 성장 촉진요인으로 작용하고 있습니다. 만성 질환과 감염성 질환으로 인한 질병 부담의 급증은 자동화된 진단 절차에 대한 수요를 크게 증가시켜 이 시장의 범위를 더욱 확장하고 있습니다. 질병에 취약한 노령 인구의 증가도 진단에 대한 수요를 증가시키고 있습니다. 진단 기술 확대에 대한 관련 당국의 규제 지원은 시장 성장을 더욱 촉진할 것입니다.
그러나 생화학 자동 분석기의 구매 및 운영 비용이 높기 때문에 검사실의 보유 용이성이 문제가 되고 있으며, 이는 제조업체의 큰 과제 중 하나입니다. 또한, 새로운 기술 도입에 대한 거부감과 적절한 교육 모듈의 부족도 큰 문제이지만, 각 업체들은 현재 이를 해결하기 위해 노력하고 있습니다.
2023년 6월, Shenzhen Mindray Bio-Medical Electronics Co., Ltd.(Mindray)는 고처리량 M1000 Chemistry and Immunoassay Integrated Solution을 출시했습니다. 이 솔루션에는 BS-2800M Chemistry Analyzer, CL-8000i Chemiluminescence Immunoassay Analyzer, 지능형 샘플 전달 모듈이 포함됩니다.
신속하고 정확한 진단 검사에 대한 수요 증가
신속하고 정확한 진단 검사에 대한 수요 증가는 비감염성 질환의 유행, 고령화, 즉각적인 의료 진단, 검진 및 조사에 대한 요구와 같은 요인에 의해 발생합니다. 만성 질환의 유병률 증가와 고령화로 인해 진단 검사에 대한 수요는 계속 증가하고 있습니다. 즉각적인 의료 진단 및 조사에 대한 필요성이 증가함에 따라 고급 분석 장비와 혁신적인 기술에 대한 수요가 증가합니다. 이에 따라 임상 화학 분석 장비의 기술 혁신이 진행되어 질병의 조기 발견과 더 큰 규모의 검사를 가능하게 하고 있습니다. 진단에 대한 수요 증가는 자동 진단 생화학 분석기 및 소모품으로 쉽게 대응할 수 있어 시장이 더욱 확대되고 있습니다. 각 제조업체들은 신속하고 정밀한 생화학 분석기를 위한 솔루션 생산에 적극 나서고 있습니다.
예를 들어, 2023년 5월 Beckman Coulter는 DxI 9000 Access Immunoassay Analyzer를 출시했으며, DxI 9000 Analyzer는 평방미터당 시간당 최대 215건의 검사를 처리할 수 있는 가장 생산성이 뛰어난 Beckman Coulter는 전 세계에 첨단 진단 솔루션을 제공하는 선도적인 기업입니다.
검사 절차의 신속한 자동화
검사 절차의 급속한 자동화로 인해 생화학 자동 분석기에 대한 수요가 증가하고 있습니다. 진단 검사실의 자동화가 진행됨에 따라 정교한 장비는 수백에서 수천 개의 검사를 처리할 수 있게 되었습니다. 따라서 자동화된 분석 장비에 대한 수요가 증가하고 있습니다. 자동화는 신속하고 비용 효율적인 고품질 검사를 제공하며, 이는 임상 실험실의 검체량 증가와 운영 우수성에 대한 요구를 충족시키는 데 필수적입니다. 또한 자동화는 수십 년 동안 대부분의 임상화학 워크플로우에 필수적인 요소로 작용하여 실험실에서 많은 검사 의뢰를 처리하고 비용을 절감할 수 있게 해주었습니다.
2023년 7월, 지멘스 헬시니어스는 미국 FDA 승인을 받은 면역 측정 진단용 Atellica CI Analyser를 출시했습니다. Atellica CI Analyser는 독립형 실험실 및 위성 실험실에서 Atellica Solution과 동일한 시약, 소모품 및 지능형 소프트웨어에 액세스할 수 있도록 지원합니다. 이 기술은 1.9평방미터의 작은 공간에 들어갈 수 있도록 설계되어 공간이 제한된 실험실에 적합합니다. 무작위 액세스 샘플링, 미량 흡입, 유지보수 및 품질 관리의 자동 스케줄링을 통해 실험실에서 보다 신뢰할 수 있고 시기적절한 결과를 제공할 수 있습니다.
이 보고서는 세계 생화학 자동 진단 시장에 대해 조사 분석했으며, 시장 규모와 예측, 시장 역학, 주요 기업 현황 및 전망 등을 제공합니다.
Global biochemical auto-diagnostics market is projected to witness a CAGR of 5.7% during the forecast period 2024-2031, growing from USD 5.01 billion in 2023 to USD 7.81 billion in 2031. The growing demand for rapid and accurate diagnostic tests primarily drives the biochemical auto-diagnostics market. Automation of laboratory procedures, emphasis on early diagnosis of diseases, and advancements in technologies used for biochemistry diagnostics are acting as other growth-inducing factors. The rapidly growing disease burden of chronic and infectious diseases significantly raises the demand for automated diagnostics procedures, further expanding the scope of this market. The growing geriatric population, which is most prone to catching diseases, increases the demand for diagnostics. Regulatory support from concerned authorities for technology expansion in diagnostics further boosts the market growth.
However, the high cost of purchasing and operating the automated biochemistry analyzer raises affordability issues for laboratories, which is one of the major challenges for the manufacturers. A significant challenge also comes from resistance to adopting new technology and a lack of suitable training modules, although companies are working on this now.
In June 2023, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Mindray) launched the high-throughput M1000 Chemistry and Immunoassay Integrated Solution. The solution includes the BS-2800M Chemistry Analyzer, CL-8000i Chemiluminescence Immunoassay Analyzer, and an intelligent sample delivery module.
Growing Demand for Rapid and Accurate Diagnostic Tests
The growing demand for rapid and accurate diagnostic tests is driven by factors such as the rising prevalence of noncommunicable diseases, an aging population, and the need for immediate medical diagnosis, screening, and surveillance. The demand for diagnostic testing continues to rise due to the increasing prevalence of chronic conditions and the aging population. As the need for immediate medical diagnosis and surveillance increases, the demand for advanced analyzers and innovative technologies rises. This has led to technological innovations in clinical chemistry analyzers, enabling early disease detection and testing on a larger scale. The growing demand for diagnostics can be easily catered to through auto-diagnostics biochemistry analyzers and consumables, further expanding the market. Manufacturers are actively involved in producing solutions for rapid and precise biochemistry analyzers.
For instance, in May 2023, Beckman Coulter unveiled the DxI 9000 Access Immunoassay Analyzer. The DxI 9000 Analyzer can perform up to 215 tests per hour per square meter, making it the most productive immunoassay analyzer in terms of footprint. Beckman Coulter is a leading provider of advanced diagnostics solutions across the globe.
Rapid Automation of Laboratory Procedures
The rapid automation of laboratory procedures has increased the demand for automated biochemistry analyzers. As diagnostic laboratories become more automated, sophisticated instruments can complete hundreds to thousands of tests. This has led to an increased demand for automated analyzers. Automation allows for fast, cost-efficient, and high-quality testing, essential to meet the growing sample load and the need for operational excellence in clinical laboratories. Additionally, automation has been an integral part of most clinical chemistry workflows for decades, allowing labs to handle many test requests and reduce costs.
In July 2023, Siemens Healthineers launched a US-FDA-approved Atellica CI Analyser for immunoassay diagnostics. The Atellica CI Analyzer allows standalone and satellite labs to access the same reagents, consumables, and intelligent software as Atellica Solution. This technology has been designed to fit into a small 1.9m2 space, perfect for laboratories with limited space. It allows labs to provide more reliable and timely results by allowing random access sampling, micro-volume aspiration, and automatic scheduling of maintenance and quality control.
Dominance of Fully Automatic Biochemistry Analyzers Segment
Fully automatic biochemistry analyzers are preferred over semi-automatic ones for several reasons. One of the primary advantages is that fully automatic analyzers require little or no manual intervention, reducing the potential for human error. They can also handle a higher throughput of samples, making them more suitable for larger laboratories with high testing volumes. Additionally, fully automatic analyzers offer more automation, from sample addition to result reporting, leading to improved efficiency and streamlined testing processes. Furthermore, the test results of fully automatic analyzers are generally more accurate and convenient than semi-automatic analyzers. Fully automatic analyzers are ideal for high sample volumes and efficient processing, semi-automatic analyzers may be sufficient for smaller laboratories or point-of-care settings with lower sample volumes and can accommodate a slightly longer turnaround time.
In July 2023, Anbio launched a fully automated CLIA analyzer. The Anbio ADL i1910 is an affordable and compact chemiluminescence immunoassay analyzer that provides a comprehensive range of testing options for analytes in human serum, plasma, whole blood, and urine samples. It uses the direct chemiluminescence method to ensure accurate and reliable hormone detection, disease screening, and antigen analysis results.
Hospitals to Lead the End-user Segment
Hospitals use biochemical analyzers for various purposes, including routine check-ups, disease screening, confirmation tests, and diagnosis of different ailments. These analyzers are critical for assessing chemicals in biological samples, analyzing analytes such as proteins, electrolytes, enzymes, and metabolites, and evaluating the performance of organs like the liver, heart, and kidneys. They are also helpful in drug monitoring, detecting drug misuse, and diagnosing infectious diseases. The growing demand for diagnostic testing has led to an increase in the usage of biochemical analyzers, making hospitals one of the primary consumers of these devices. Market players are designing products to cater to the specific requirements of hospitals.
In May 2023, Wondfo launched the Ucare-6000 Automatic Blood Gas Biochemical Analyzer at the 20th China Association of Clinical Laboratory Practice Expo (CACLP). The Ucare-6000 automatic blood gas biochemical analyzer offers accuracy, efficiency, flexibility, and simplified operation. It uses electrochemistry sensing technology, microfluidic technology, and thin-film microelectrode technology. With its sound QC system, it can perform automatic calibration and internal QC to ensure accurate results.
North America to be the Dominating Region
North America is the leading consumer of biochemistry analyzers due to the rising prevalence of chronic diseases, such as diabetes and cardiovascular disorders, which require efficient diagnostic tools to manage and monitor these conditions. The need for rapid and on-site diagnostic solutions is also driving the demand for biochemistry analyzers, and the trend toward miniaturization is contributing to cost-effectiveness. The United States is a significant market for biochemistry analyzers, with high investments in research and development initiatives. The presence of key market players like Beckman Coulter Inc., and Abbott Diagnostics Inc. in the region also contributed to the region's dominance in this market.
Future Market Scenario (2024 - 2031F)
The major drivers of the market include digital transformation for labs, increasing research and development activities across the healthcare industry, and growing expenditure on the diagnostics industry.
The growing affinity of healthcare providers for adopting technology-based solutions for diagnostics is anticipated to increase the demand for the biochemical auto-diagnostics market.
Fully automated biochemical analyzers are preferred over semi-automated biochemical analyzers due to enhanced efficacy and efficiency and are expected to be the dominating segment throughout the assessment period.
Hospitals are anticipated to be the leading end-users for this market due to the growing requirement for rapid diagnostic tests, owing to the high disease burden and growing geriatric population.
Key Players Landscape and Outlook
The key players in the landscape of the biochemical auto-diagnostics market include companies involved in the manufacturing and distribution of biochemistry analyzers and biochemical diagnostic instruments. Some prominent companies in this market are Roche Diagnostics GmbH, Siemens AG, Beckman Coulter Inc., and Abbott Diagnostics. These companies are known for their advanced healthcare technologies and have a significant market presence. The market is expected to witness healthy competition with the integration of new technologies.
In December 2023, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. announced the acquisition of a 75% stake in Germany-based DiaSys Diagnostic Systems GmbH, this acquisition makes DiaSys, a subsidiary of Mindray. The acquisition will expand the IVD offerings of Mindray including the biochemical analyzers.
All segments will be provided for all regions and countries covered
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.