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市場調査レポート
商品コード
1801208
免疫血液学的検査の世界市場 - 市場規模、シェア、動向、予測:製品別、技術別、用途別、エンドユーザー別、地域別、2025年~2033年Immunohematology Market Size, Share, Trends and Forecast by Product, Technology, Application, End-User, and Region, 2025-2033 |
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免疫血液学的検査の世界市場 - 市場規模、シェア、動向、予測:製品別、技術別、用途別、エンドユーザー別、地域別、2025年~2033年 |
出版日: 2025年08月01日
発行: IMARC
ページ情報: 英文 115 Pages
納期: 2~3営業日
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免疫血液学的検査の世界市場規模は2024年に20億米ドルとなりました。今後、IMARC Groupは、同市場が2033年までに29億米ドルに達し、2025年から2033年にかけて4%のCAGRを示すと予測しています。現在、北米が市場を独占しており、2024年には40.2%以上の大きな市場シェアを占めています。この地域の優位性は、高度な医療インフラ、強力な産業プレゼンス、革新的技術の高い採用率、研究開発への多額の投資によってもたらされています。
免疫血液学的検査市場の主な促進要因は、慢性疾患の有病率の上昇と外科手術件数の増加により、高度な血液検査と適合ソリューションに対する需要が高まっていることです。これらの要因により、輸血や移植の際に患者の安全を確保するために、信頼性の高い血液型判定、クロスマッチング、抗体検出の必要性が高まっています。さらに、自動分析装置や分子診断などの免疫血液学的検査技術の進歩により、検査の精度と効率が向上し、医療現場での採用がさらに加速しています。例えば、2024年にはThermo Fisher Scientific社が疾患および薬理ゲノミクス研究用のAxiom PangenomiX Arrayを発売しました。これはSNPジェノタイピング、全ゲノムコピー数検出、血液、HLAタイピングを統合したものです。疾患リスク、家系、ウェルネス、医薬品開発のために設計され、PGxマーカーと病原性バリアントを含みます。このアレイは、強化された全ゲノムインピュテーションと、様々な民族を検査するための高い多様性を提供し、多様な遺伝子研究に適しています。新興市場における医療インフラの拡大や、安全な輸血に対する意識の高まりも、この市場の持続的成長に寄与しています。
米国は、先進的な医療インフラ、強力な研究開発イニシアティブ、精密診断に対する高い需要に牽引され、免疫血液学的検査市場の主要プレーヤーとなっています。同国には免疫血液学的検査機器や試薬の大手メーカーやサプライヤーが存在し、自動分析装置や分子診断などの革新的技術の急速な普及を可能にしています。例えば、2024年にはBeckman CoulterがDxC 500i Clinical Analyzerを発売し、化学と免疫測定機能を統合し、病院やラボに効率的で利用しやすい結果を提供し、患者ケア、業務モデル、在庫管理を強化しています。さらに、厳格な規制基準と確立された血液バンクシステムにより、信頼性が高く効率的な血液適合検査が可能です。慢性疾患の増加と高齢化により、免疫血液学的検査ソリューションの需要はさらに高まっており、米国はこの分野の進歩にとって極めて重要な市場となっています。
血液疾患の有病率の増加
白血病をはじめとする血液疾患の世界の増加に伴い、同市場は大きな成長を遂げています。新興諸国における医療インフラの開発、血液バンクや外傷センターの設立も、この成長を後押ししています。世界銀行によると、2023年には、169カ国にわたる約13,300の血液センターが、合計1億600万件の献血を集めたと報告されています。これらのセンターで集められた献血の数は、所得層によって異なります。低所得国では、センターあたりの年間献血件数の中央値は1,300件、低中所得国では4,400件、高中所得国では9,300件でした。一方、高所得国では、1センターあたりの年間寄付額の中央値は2万5,700件でした。血液の収集、処理、検査、保存に関わる活動に対する大衆の意識がこのように高まるにつれて、免疫血液学的検査機器の需要がさらに高まっています。
高度な診断技術の採用増加
免疫血液学的検査市場は、分子アッセイや自動血液型判定システムなどの高度な診断技術の統合によって大きな成長を遂げています。これらの次世代免疫血液学的検査機器は、診断の有効性を高め、分析にかかる時間やヒューマンエラーのリスク要因を減らし、患者への即時ケアサービスを拡大するのに役立ちます。自動化システムは、輸血の安全性に不可欠なクロスマッチングや抗体スクリーニングなどのプロセスを合理化します。例えば、2024年にQuidelOrthoのVITROS梅毒アッセイがFDAの認可を受け、VITROSシステム(3600、5600、XT 7600)でTreponema pallidum抗体の自動検出が可能になり、現在世界的に利用できるようになり、感染症診断が強化されています。さらに、分子診断学は正確な遺伝子型判定を可能にし、従来の方法では見落とされがちな希少な血液型や抗体の同定に役立っています。医療プロバイダーは、高品質かつ迅速な診断ソリューションに対する需要の高まりに対応するため、特に医療インフラが高度な機器をサポートしている新興国市場において、こうした技術の採用を増やしています。
個別化医療と希少血液疾患への注目の拡大
免疫血液学的検査市場におけるもう一つの新たな動向は、個別化医療、特に希少血液疾患の患者に対する個別化医療の重視の高まりです。ゲノム研究の進歩により、オーダーメイドの治療や正確な輸血の実践への道が開かれつつあります。ユニークな抗原プロファイルや希少な表現型の同定は、特に多様な人口集団を抱える地域において、ますます重要になってきています。例えば2024年、臨床段階の放射性医薬品会社であるCU6は、SARテクノロジープラットフォームを用いた次世代の予後診断製品を開発中です。同社はCOBRA試験の有望な第I/II相試験データを発表しました。この試験では、銅ベースのイメージング薬剤であるI64Cu-SAR-bisPSMAが安全であり、生化学的再発患者の前立腺がん病変を検出するのに非常に有効であることが確認されました。ターゲットイメージングと治療機能を統合することにより、この技術は診断精度を高め、免疫血液学的検査における個別化治療戦略を可能にします。希少な血液疾患に対する認識が高まるにつれて、専門的な免疫血液学的検査製品やサービスに対する需要は拡大すると予想され、精密医療における市場の役割が拡大していることを浮き彫りにしています。
The global immunohematology market size was valued at USD 2.0 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 2.9 Billion by 2033, exhibiting a CAGR of 4% during 2025-2033. North America currently dominates the market, holding a significant market share of over 40.2% in 2024. This region's dominance is driven by advanced healthcare infrastructure, strong industry presence, high adoption of innovative technologies, and significant investments in research and development.
A major driver of the immunohematology market is the increasing demand for advanced blood testing and compatibility solutions driven by the rising prevalence of chronic diseases and the growing volume of surgical procedures. These factors have heightened the need for reliable blood typing, cross-matching, and antibody detection to ensure patient safety during transfusions and transplants. Additionally, advancements in immunohematology technologies, such as automated analyzers and molecular diagnostics, have improved testing accuracy and efficiency, further accelerating adoption in healthcare settings. For instance, in 2024, Thermo Fisher Scientific launched the Axiom PangenomiX Array for disease and pharmacogenomics research. It integrates SNP genotyping, whole-genome copy number detection, blood, and HLA typing. Designed for disease risk, ancestry, wellness, and drug development, it includes PGx markers and pathogenic variants. The array offers enhanced whole-genome imputation and high diversity for testing various ethnicities, making it suitable for diverse genetic research. Expanding healthcare infrastructure in emerging markets and growing awareness of safe blood transfusion practices also contribute to the sustained growth of this market.
The United States is a key player in the immunohematology market, driven by its advanced healthcare infrastructure, robust research and development initiatives, and a high demand for precision diagnostics. The country is home to leading manufacturers and suppliers of immunohematology equipment and reagents, enabling rapid adoption of innovative technologies such as automated analyzers and molecular diagnostics. For instance, in 2024, Beckman Coulter launched DxC 500i Clinical Analyzer, combining chemistry and immunoassay capabilities, delivering efficient, commutable results for hospitals and labs, enhancing patient care, operational models, and inventory management. Additionally, stringent regulatory standards and well-established blood banking systems ensure reliable and efficient blood compatibility testing. The growing prevalence of chronic diseases and an aging population further enhance the demand for immunohematology solutions, positioning the US as a pivotal market for advancements in this sector.
Increasing Prevalence of Hematological Disorders
With the increasing instances of leukemia and other hematological disorders across the world, the market is witnessing immense growth. Developments in the healthcare infrastructure and the establishment of blood banks and trauma centers in developing countries are also motivating this growth. According to the World Bank, in 2023, approximately 13,300 blood centers across 169 countries reported collecting a total of 106 Million donations. The number of donations collected at these centers varies by income group. In low-income countries, the median annual donations per center was 1,300, while in lower-middle-income countries it was 4,400, and in upper-middle-income countries, it was 9,300. In comparison, high-income countries reported a median of 25,700 donations per center annually. With this increase in mass awareness concerning the activities involved in blood collection, processing, testing, and storage, it further enhances the demand for immunohematology devices.
Rising Adoption of Advanced Diagnostic Technologies
The immunohematology market is experiencing significant growth driven by the integration of advanced diagnostic technologies, including molecular assays and automated blood typing systems. These next-generation immunohematology devices help enhance the effectiveness of the diagnosis, reduce the time taken for analysis and the human error risk factors, and extend immediate care services to patients. Automated systems streamline processes such as cross-matching and antibody screening, which are critical for transfusion safety. For instance, in 2024, QuidelOrtho's VITROS syphilis assay received FDA-clearance, offering automated detection of Treponema pallidum antibodies on VITROS systems (3600, 5600, XT 7600), now globally available, enhancing infectious disease diagnostics. Additionally, molecular diagnostics allow for precise genotyping, aiding in the identification of rare blood groups and antibodies that traditional methods might overlook. Healthcare providers are increasingly adopting these technologies to meet the growing demand for high-quality and rapid diagnostic solutions, particularly in developed markets where healthcare infrastructure supports sophisticated equipment.
Expanding Focus on Personalized Medicine and Rare Blood Disorders
Another emerging trend in the immunohematology market is the growing emphasis on personalized medicine, particularly for individuals with rare blood disorders. Advances in genomic research have paved the way for tailored therapies and precise blood transfusion practices. The identification of unique antigen profiles and rare phenotypes is becoming increasingly important, especially in regions with diverse populations. For instance, in 2024, clinical-stage radiopharmaceutical company CU6 is advancing next-generation theragnostic products using its SAR Technology platform. The company announced promising Phase I/II trial data from the COBRA study. The trial confirmed that its copper-based imaging agent, I64Cu-SAR-bisPSMA, is safe and also highly effective in detecting prostate cancer lesions in patients with biochemical recurrence. By integrating targeted imaging with therapeutic capabilities, this technology could enhance diagnostic accuracy and enable personalized treatment strategies in immunohematology. As awareness of rare blood conditions rises, demand for specialized immunohematology products and services is anticipated to grow, highlighting the market's expanding role in precision healthcare.
Reagents and consumables stand as the largest product in 2024, holding around 65.5% of the market. This large share underlines their critical role in blood typing, antibody screening, and crossmatching procedures that are necessary for transfusion safety and compatibility testing. These products are essential for achieving accurate results in diagnostic laboratories, blood banks, and hospitals. The increasing incidence of chronic and infectious diseases, together with a rise in blood donation activities, adds to the market demand for reagents and consumables. Moreover, the advancement in diagnostic technologies and introduction of high-performance reagents enhance their adoption. This segment's dominance positions it to meet a rising global need for reliable and efficient immunohematology testing solutions.
Polymerase chain reaction leads the market with around 38.5% of the market share in 2024. Its dominance underscores its critical role in diagnostics, research, and therapeutic applications. PCR's precision in amplifying DNA and RNA sequences makes it a cornerstone technology for detecting infectious diseases, genetic mutations, and cancer markers. The increasing rate of chronic disease and an emphasis on earlier diagnosis make its widespread use popular among laboratories, clinics, and research institutions. Technological innovation such as the development of real-time PCR and digital PCR enhances its sensitivity and efficiency, creating further success in the marketplace. Finally, its emerging application fields such as in personalized medicine and pharmacogenomics has cemented its position as one of the more dominant technologies in the space of molecular diagnostics and research.
HIV lead the market in 2024. HIV stands as the leading application in the market, reflecting its critical importance in diagnostics, treatment monitoring, and research. The overall interest in the management of HIV/AIDS around the world increases the adoption of advanced diagnostic technologies to enable early detection, viral load monitoring, and antiretroviral therapy efficacy. The rise in the incidence of HIV in underserved areas further escalates the demand for effective testing solutions. Innovations such as point-of-care diagnostics and molecular technologies further facilitate efficient and accurate results. Moreover, the government's initiatives and funds for eradicating HIV enhance market growth. The application leadership has indicated its importance in public health endeavors, improved patient outcomes, and facilitating research toward efficient prevention and cure strategies.
Hospitals lead the market with around 23.8% of the market share in 2024. Hospitals are leading centers for diagnostic procedures, interventions for therapeutic management, and treatment and care. These institutions thus account for the highest number of the market share. A higher need for proper and timely diagnostics of chronic as well as acute diseases promotes the acceptance of advanced technology within the hospitals. Moreover, the increasing incidence of complex diseases and the requirement for state-of-the-art facilities for the comprehensive management of patients contribute to this segment's dominance. Hospitals have the advantage of a high volume of patients, infrastructure, and multidisciplinary expertise, which allows them to provide consistent and efficient services, thereby making them a strong market segment.
In 2024, North America accounted for the largest market share of over 40.2%. The dominance of this region is attributed to advanced healthcare infrastructure, strong research and development activities, and high adoption of novel diagnostic and therapeutic technologies. Leadership in the region is also boosted by increased government funding for healthcare initiatives, strong presence of key industry players, and increased demand for advanced medical devices and diagnostics. High level of awareness and access to advanced treatment is a major contributor toward the region's pre-eminent market position. Furthermore, chronic and infectious disease prevalence, coupled with a well-developed regulatory system, encourages the use of advanced health care delivery solutions. It, therefore, points out that North America is an innovation, investment, and development hub in the health and life sciences industries.
United States Immunohematology Market Analysis
US accounts for 73.5% share of the market in North America. The United States market is largely driven by advances in healthcare infrastructure and an increase in demand for blood transfusion services. According to the CDC, 1 in 76 Americans is affected by a blood disorder, creating demand for immunohematology testing. Sickle cell anemia, thalassemia, and hemophilia are some of those that have received diagnostic monitoring and blood management for a prolonged period. The aging population and increasing prevalence of chronic diseases are additional factors increasing the demand for blood transfusions. Cutting-edge immunohematology technologies, especially automated blood-typing and crossmatching systems, increase accuracy of diagnosis and help the growth of the market. Government initiatives directed toward building blood safety standards and regulations provide an essential impetus for the growth of the market. Further, the rise of personalized medicine and genetic testing boosts the adoption of advanced immunohematology products. The increasing demand for high-quality blood products and greater emphasis on donor screening augment market growth. A healthy presence of major companies together with ongoing efforts to enhance blood-testing techniques signifies that the U.S. market is ready for great development, confronting healthcare problems and ensuring transfusion safety.
Asia Pacific Immunohematology Market Analysis
The Asia-Pacific immunohematology market mainly benefited from the growing healthcare needs of an aging population and increasing prevalence of chronic diseases. According to the WHO, noncommunicable diseases (NCDs), especially those of cardiovascular, cancer, diabetes, and chronic respiratory diseases, account for 62% of all deaths in the South-East Asia Region, affecting 9 Million people. The premature mortality from NCDs is a matter of grave concern, with a very notable portion of these deaths occurring before the age of 70. This rising burden of NCDs leads to a growing demand for blood transfusions or immunohematology services. Rapid advancements in medical technology, together with enhanced healthcare investments in the emerging economies of China and India, will further aid market expansion. Moreover, advanced immunohematology technologies, including automation in blood typing and compatibility testing, immensely accelerate their adoption in the region.
Europe Immunohematology Market Analysis
The immunohematology market in Europe is influenced by factors such as a growing need for blood transfusions, improving of tests for diagnosis, and increased patient population base with chronic blood disorders. As per the European Commission on January 1, 2023, the population of the EU was approximately estimated to be 448.8 Million, with 21.3% above 65 years, representing an increase of 0.2% points from the last year and 3.0% points over the last one decade. Changes in demographics point toward higher healthcare needs when it comes to managing age-related blood issues. The high prevalence of cardiovascular diseases and other chronic conditions in older populations further strengthens the need for immunohematology services. Europe's emphasis on blood safety standards because of stringent regulatory frameworks encourages the adoption of innovative immunohematology products. The availability of advanced technologies such as molecular blood group typing and automated crossmatching systems increases the present market opportunity. Government efforts to improve healthcare services and ensure safe blood transfusions also aid in market growth. The presence of key industry players and ongoing research to improve the accuracy of testing and safety during transfusion ensure continued growth for the immunohematology market in Europe.
Latin America Immunohematology Market Analysis
In Latin America, the immunohematology market is driven by increased healthcare access and blood safety awareness. A PubMed Central study states that 100,000 - 150,000 Latin Americans are afflicted with sickle cell disease (SCD), leading to an increase in blood transfusions and immunohematology services. The prevalence of SCD and thalassemia calls for advanced diagnostic solutions. Improvements in healthcare standards, driven by government initiatives and blood donation programs, also support market growth. Moreover, there is a rising demand for accurate blood screening and testing solutions, as healthcare providers are focusing on better blood transfusion safety and reliability.
Middle East and Africa Immunohematology Market Analysis
The immunohematology market, driven by infrastructural improvements in healthcare, increased investment in biotechnology, and increasing awareness of blood-related safety issues, will grow in the Middle East and Africa area. According to PubMed Central, 30% of the people in the Middle East who suffer from anemia are primarily women, mostly due to iron deficiency or other causes. The high prevalence of blood disabilities such as SCD and thalassemia enables the need for blood transfusions and immunohematology services. Government initiatives to develop the healthcare systems in the region and to ensure that blood products are safe and accurate contribute to regional market growth.
The immunohematology market is characterized by intense competition among key players focused on innovation, collaborations with key partners, and expansion into new regions to enhance their market footprint. Prominent companies lead the market by offering a broad range of products, including blood typing reagents, analyzers, and software solutions. These players heavily invest in research and development to introduce advanced technologies, such as fully automated systems and molecular diagnostic tools, that enhance testing accuracy and efficiency. Strategic mergers, acquisitions, and collaborations are common, enabling companies to expand their product portfolios and gain access to new markets. Additionally, the presence of regional and local players contributes to market competitiveness, particularly in emerging economies. The growing emphasis on cost-effective and high-quality diagnostics drives innovation, while regulatory compliance and certifications remain key differentiators. For instance, in 2024, Abbott and Big Ten's "We Give Blood Drive" inspired nearly 20,000 donations, saving 60,000 lives, alleviating blood shortages, and contributing to the collection of blood essential for life-saving transfusions and immunohematology research. The competitive landscape is further shaped by increasing demand for personalized healthcare and enhanced transfusion safety.