면역진단 시장 규모는 2024년 198억 3,620만 달러에서 예측 기간 동안 연평균 6.28%의 CAGR로 성장하여 2032년에는 321억 5,936만 달러 규모로 성장할 것으로 예상됩니다.
면역진단에 대한 수요는 주로 만성질환 및 감염성 질환의 증가로 인해 증가하고 있습니다. 또한, 현장 검사에 대한 수요 증가와 면역진단 분야의 제품 출시 증가는 예측 기간 동안 시장 성장에 기여하는 주요 요인 중 일부입니다.
시장 역학:
미국 질병예방통제센터(CDC)의 2023년 발표에 따르면 2021년 미국에서 약 120만 명이 HIV에 감염된 것으로 추정되며, 약 13%가 감염 사실을 모르고 있어 조기 진단 솔루션이 시급한 것으로 나타났습니다. 마찬가지로 American Cancer Society(ACS) 2023년판은 2023년 미국에서 새롭게 폐암에 걸릴 환자 수를 약 23만 8,340명으로 예측하며, 암 부담 증가와 적시 진단의 중요성을 강조하고 있습니다.
또한, 세계보건기구(WHO)의 2023년 보고서에 따르면, 류마티스 관절염(RA) 환자 수는 약 1,800만 명에 달하며, 그 중 70%가 여성이고, 55%는 55세 이상입니다. 만성질환과 감염성 질환의 전 세계적인 확산은 정확하고 조기에 쉽게 사용할 수 있는 진단 도구의 중요성을 강조하고 있으며, 예측 기간 동안 면역진단 시장의 성장을 촉진하고 있습니다.
시장 성장의 또 다른 중요한 요인은 환자의 침대 옆이나 원격지, 외래에서 빠른 결과를 얻을 수 있는 현장진단(POC) 검사에 대한 수요가 증가하고 있다는 점입니다. 특히 감염병(COVID-19, 독감, 결핵 등), 만성질환(당뇨, 심혈관질환 등) 등에서는 이러한 분산화를 통해 중앙 검사실에 대한 의존도를 낮추고 신속한 임상적 판단을 가능하게 합니다.
다양한 바이오마커(호르몬, 감염성 물질, 자가면역 마커 등)를 검출하는 정확성과 신뢰성으로 유명한 면역진단 검사는 점점 더 POC 플랫폼에 통합되고 있습니다. 첨단 면역진단 기술과 접근성 높은 POC 솔루션의 시너지 효과는 미세유체 디바이스, 바이오센서, AI 기반 진단 등의 기술 혁신에 박차를 가하고 있으며, 면역진단 시장의 추가 확대가 기대되고 있습니다.
세계의 면역진단 시장을 조사했으며, 시장 개요, 시장 영향요인 및 시장 기회 분석, 시장 규제 환경, 시장 규모 추정 및 예측, 각종 부문별·지역별·주요 국가별 상세 분석, 경쟁 구도, 주요 기업 개요 등의 정보를 정리하여 전해드립니다.
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: