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市場調査レポート
商品コード
1663326
免疫診断:市場洞察・競合情勢・市場予測 (~2032年)Immunodiagnostics - Market Insights, Competitive Landscape, and Market Forecast - 2032 |
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カスタマイズ可能
適宜更新あり
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免疫診断:市場洞察・競合情勢・市場予測 (~2032年) |
出版日: 2025年02月01日
発行: DelveInsight
ページ情報: 英文 150 Pages
納期: 2~10営業日
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免疫診断の市場規模は、2024年の198億3,620万米ドルから、予測期間中はCAGR 6.28%で推移し、2032年には321億5,936万米ドルの規模に成長すると予測されています。
免疫診断の需要は、主に慢性疾患や感染症の流行が増加していることが後押ししています。さらに、ポイントオブケア検査に対する需要の高まりや、免疫診断の領域における製品上市の増加が予測期間中の市場成長に寄与している主な要因の一部です。
市場力学:
米国疾病予防管理センター (CDC) の2023年の発表によると、米国では2021年に推定120万人がHIVに感染しており、約13%が感染に気づいていないことから、早期診断ソリューションの緊急性が示されています。同様に、American Cancer Society (ACS) 2023年版は、2023年に米国で新たに肺癌に罹患する患者数を約23万8,340人と予測し、癌の負担増と適時診断の重要性を強調しています。
また、世界保健機関 (WHO) の2023年の報告によると、関節リウマチ (RA) の患者数は約1,800万人であり、その70%が女性、そのうち55%が55歳以上です。慢性疾患や感染症の世界の蔓延は、正確で早期かつ利用しやすい診断ツールの重要な必要性を強調しており、予測期間中の免疫診断市場の成長を促進しています。
市場成長のもう一つの重要な要因は、ポイントオブケア (POC) 検査に対する需要の高まりです。POC検査は、患者のベッドサイドや遠隔地、外来で迅速な結果を得ることができます。特に感染症 (COVID-19、インフルエンザ、結核など) 、慢性疾患 (糖尿病、心血管疾患など) などでは、このような分散化によって中央検査室への依存度が下がり、迅速な臨床判断が可能になります。
様々なバイオマーカー (ホルモン、感染性物質、自己免疫マーカーなど) を検出する精度と信頼性で知られる免疫診断検査は、ますますPOCプラットフォームに統合されつつあります。高度な免疫診断技術と利用しやすいPOCソリューションの相乗効果は、マイクロ流体デバイス、バイオセンサー、AIベースの診断などの技術革新に拍車をかけており、免疫診断市場のさらなる拡大が期待されています。
当レポートでは、世界の免疫診断の市場を調査し、市場概要、市場影響因子および市場機会の分析、法規制環境、市場規模の推移・予測、各種区分・地域/主要国別の詳細分析、競合情勢、主要企業のプロファイルなどをまとめています。
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: