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市场调查报告书
商品编码
1663326
免疫诊断:市场洞察·竞争情形·市场预测 (~2032年)Immunodiagnostics - Market Insights, Competitive Landscape, and Market Forecast - 2032 |
免疫诊断市场规模预计将从 2024 年的 198.362 亿美元增长到 2032 年的 321.5936 亿美元,预测期内的复合年增长率为 6.28%。
免疫诊断的需求主要由慢性病和传染病的日益普及所驱动。此外,对即时诊断测试的需求不断增长以及免疫诊断领域产品发布的不断增加是预测期内推动市场成长的一些主要因素。
市场动态:
根据美国疾病管制与预防中心(CDC)2023年发布的报告,预计2021年美国将有120万人感染爱滋病毒,其中约13%的人并未意识到自己感染了爱滋病毒,这表明早期诊断解决方案的紧迫性。同样,美国癌症协会(ACS)2023年版预测,2023年美国将有约238,340例肺癌新病例,凸显了癌症负担日益加重以及及时诊断的重要性。
此外,根据世界卫生组织(WHO)2023年的报告,类风湿关节炎(RA)患者人数约为1800万人,其中70%为女性,55%的患者年龄在55岁以上。全球慢性病和传染病的流行凸显了对准确、早期和易获得的诊断工具的迫切需求,从而推动了预测期内免疫诊断市场的成长。
市场成长的另一个关键驱动力是对即时诊断(POC)测试的需求不断增加。 POC 测试可以在患者床边、远端或门诊环境中提供快速结果。这种分散化减少了对中央实验室的依赖,能够更快地做出临床决策,特别是对于传染病(如COVID-19、流感和结核病)和慢性疾病(如糖尿病和心血管疾病)。
免疫诊断测试以其检测各种生物标记(例如激素、传染性病原体、自体免疫标记)的准确性和可靠性而闻名,正越来越多地被整合到 POC 平台中。先进的免疫诊断技术与可存取的 POC 解决方案之间的协同作用正在刺激微流体设备、生物感测器和基于 AI 的诊断等技术创新,预计将进一步扩大免疫诊断市场。
本报告提供全球免疫诊断的市场调查,彙整市场概要,市场影响因素及市场机会分析,法律制度,市场规模的转变·预测,各种区分·地区/各主要国家的详细分析,竞争情形,主要企业简介等资讯。
Immunodiagnostics Market by Product (Instruments and Kits & Reagents), Type (Enzyme-Linked Immunosorbent Assay (ELISA), Radioimmunoassay, Chemiluminescent Immunoassay (CLIA), and Others), Disease (Infectious Diseases, Autoimmune Disorders, Oncological Disorders, and Others), End-User (Hospitals and Clinics, Diagnostics Centres, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the increasing prevalence of chronic and infectious diseases and rising demand for point of care testing.
The immunodiagnostics market was valued at USD 19,836.2 million in 2024, growing at a CAGR of 6.28% during the forecast period from 2025 to 2032 to reach USD 32,159.36 million by 2032. The demand for immunodiagnostics is primarily being boosted by the increasing prevalence of chronic and infectious diseases. Additionally, rising demand for point-of-care testing and increasing product launches in the domain of immunodiagnostics are some of the key factors, which are contributing to the growth of the immunodiagnostics market during the forecast period from 2025 to 2032.
Immunodiagnostics Market Dynamics:
According to the Centers for Disease Control and Prevention (CDC) 2023, an estimated 1.2 million people in the United States were living with HIV in 2021, with approximately 13% unaware of their infection, highlighting the urgent need for early diagnostic solutions. Similarly, the American Cancer Society (ACS) 2023 projected approximately 238,340 new cases of lung cancer in the U.S. in 2023, emphasizing the rising burden of cancer and the importance of timely diagnosis.
Globally, the World Health Organization (WHO) 2023 reported that around 18 million people were living with rheumatoid arthritis (RA), with 70% of those affected being women of whom 55% were aged over 55 years. The growing prevalence of chronic and infectious diseases globally underscores the critical need for accurate, early, and accessible diagnostic tools, thereby driving the positive growth of the immunodiagnostics market during the forecast period.
Another significant factor contributing to market growth is the rising demand for point-of-care (POC) testing. Healthcare systems worldwide are increasingly prioritizing faster and more efficient diagnostic solutions, with POC testing offering rapid results at the patient's bedside, in remote locations, or in outpatient settings. This decentralization reduces reliance on centralized laboratories, enabling quicker clinical decision-making, particularly for infectious diseases (e.g., COVID-19, influenza, tuberculosis), chronic conditions (e.g., diabetes, cardiovascular diseases), and acute medical emergencies.
Immunodiagnostic tests, renowned for their accuracy and reliability in detecting a variety of biomarkers (such as hormones, infectious agents, and autoimmune markers), are increasingly integrated into POC platforms. This synergy between advanced immunodiagnostic technologies and accessible POC solutions is spurring technological innovations such as microfluidic devices, biosensors, and AI-based diagnostics which are expected to further expand the immunodiagnostics market.
Despite these growth drivers, certain market restraints persist. Stringent regulatory approval processes especially in the U.S. (FDA) and Europe (CE marking) can delay product launches. Additionally, limited availability and awareness of immunodiagnostic solutions in low- and middle-income countries (LMICs), coupled with high costs of advanced diagnostics, and may hinder widespread adoption. Addressing these barriers through regulatory harmonization, public-private partnerships, and cost-effective innovations will be crucial to unlocking the full potential of the immunodiagnostics market.
Immunodiagnostics Market Segment Analysis:
Immunodiagnostics Market by Product (Instruments and Kits & Reagents), Type (Enzyme-Linked Immunosorbent Assay (ELISA), Radioimmunoassay, Chemiluminescent Immunoassay (CLIA), and Others), Disease (Infectious Diseases, Autoimmune Disorders, Oncological Disorders, and Others), End-User (Hospitals and Clinics, Diagnostics Centres, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)
In the type segment of the immunodiagnostics market, the Enzyme-Linked Immunosorbent Assay (ELISA) category is projected to amass a significant revenue share in 2024. ELISA remains a cornerstone diagnostic technique due to its widespread application, high sensitivity, specificity, and versatility in detecting and quantifying antigens or antibodies. Its extensive use spans the diagnosis of infectious diseases (e.g., HIV, hepatitis, COVID-19), autoimmune disorders (e.g., rheumatoid arthritis, lupus), cancer biomarkers, and allergen detection, making it indispensable in both clinical and research settings.
One of the primary drivers of ELISA's market dominance is its ability to process large sample volumes with high throughput, enabling mass screening and epidemiological studies. Recent technological advancements including improved detection methods (e.g., chemiluminescent and fluorescent ELISA), automation, and microplate innovations have enhanced accuracy, processing speed, and user-friendliness. The cost-effectiveness of ELISA kits, along with the availability of a wide range of commercially available tests, further strengthens its market position, especially in resource-limited settings where affordability is crucial.
Moreover, the continuous introduction of innovative ELISA-based products is significantly fueling market growth. For instance, in February 2023, Charles River Laboratories International, Inc. launched its first ELISA kit for detecting and quantifying residual host cell proteins (HCP) in CHO-based biotherapeutics, addressing a critical need in biopharmaceutical manufacturing and ensuring product safety and compliance with regulatory standards. Such product developments underscore ELISA's expanding applications beyond traditional diagnostics into biopharma quality control and therapeutic monitoring.
Furthermore, the growing prevalence of chronic and infectious diseases, increased focus on early disease detection, and government initiatives promoting public health screening programs are expected to bolster the adoption of ELISA globally. The integration of digital platforms with ELISA systems for data management and remote diagnostics is another emerging trend driving market expansion.
Considering the broad applicability, continuous technological innovations, cost advantages, and new product launches, the ELISA category is anticipated to maintain its significant market share and continue its robust growth trajectory in the immunodiagnostics market during the forecast period.
North America is expected to dominate the overall immunodiagnostics market:
In 2023, North America is projected to hold the largest share of the immunodiagnostics market among all regions. This dominant position is primarily driven by the increasing prevalence of chronic and infectious diseases, growing patient awareness regarding early and accurate diagnosis, robust research and development (R&D) initiatives, and a rapidly aging population prone to various chronic conditions.
According to GLOBOCAN 2022, approximately 2.6 million individuals in North America were living with cancer in 2022, underscoring the region's significant oncological diagnostic needs. Furthermore, data from the Centers for Disease Control and Prevention (CDC) 2022 revealed that approximately 283,000 children and adolescents under 20 years in the United States had been diagnosed with diabetes, with 244,000 cases attributed to Type 1 Diabetes. Chronic infectious diseases also remain a pressing health concern, with the CDC 2023 estimating that around 880,000 people in the U.S. are living with long-term hepatitis B. The rising burden of such diseases necessitates the early detection and continuous monitoring of biomarkers, thus significantly increasing the demand for immunodiagnostic solutions across the region.
Additionally, North America's advanced healthcare infrastructure, combined with strong reimbursement frameworks and supportive government initiatives, further accelerates market growth. For example, public health programs emphasizing early disease detection and preventive care have fueled the adoption of point-of-care (POC) immunodiagnostics and automated laboratory-based testing platforms.
Another key growth driver in the region is the steady stream of product launches and regulatory approvals that enhance diagnostic capabilities. Notably, in June 2023, American Laboratory Products Company, Ltd. (ALPCO) a leading provider of specialty diagnostic solutions received FDA 510(k) clearance for its Calprotectin Immunoturbidimetric Assay, aimed at assisting in the diagnosis and management of inflammatory bowel diseases (IBD). Such regulatory milestones not only reflect the region's dynamic innovation landscape but also improve patient access to advanced diagnostic tools.
Furthermore, increasing investments by key industry players in research collaborations, technological advancements (e.g., AI-integrated immunodiagnostics and digital health platforms), and the expansion of clinical laboratories are expected to bolster market penetration in both urban and remote areas.
In summary, factors such as the rising prevalence of chronic and infectious diseases, heightened patient awareness, aging population, technological innovations, and favorable regulatory environment are collectively driving the positive growth trajectory of the immunodiagnostics market in North America. With continued product development, regulatory approvals, and healthcare infrastructure enhancements, the region is poised to maintain its market leadership throughout the forecast period.
Immunodiagnostics Market Key Players:
Some of the key market players operating in the immunodiagnostics market include Thermo Fisher Scientific, Abbott, F. Hoffmann-La Roche Ltd., Bio-Rad Laboratories, Beckman Coulter, Inc., Cytiva, ImmunoDX, DiaSorin S.p.A, Quest Diagnostics, Creative Diagnostics, Danaher Corporation, Merck KGaA, Siemens Healthineers, DiaSorin S.p.A, Werfen, Autobio, ZECEN Biotech Co., Ltd, PHC Corporation, BD, and Quidel Corporation.
Recent Developmental Activities in the Immunodiagnostics Market:
Key Takeaways from the Immunodiagnostics Market Report Study
Target Audience Who Can Be Benefited From This Immunodiagnostics Market Report Study
Frequently Asked Questions for the Immunodiagnostics Market: