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市場調査レポート
商品コード
1702218
IVD(体外診断)の市場規模、シェア、動向、予測:検査タイプ、製品、ユーザビリティ、用途、エンドユーザー、地域別、2025年~2033年In Vitro Diagnostics Market Size, Share, Trends and Forecast by Test Type, Product, Usability, Application, End User, and Region, 2025-2033 |
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IVD(体外診断)の市場規模、シェア、動向、予測:検査タイプ、製品、ユーザビリティ、用途、エンドユーザー、地域別、2025年~2033年 |
出版日: 2025年04月01日
発行: IMARC
ページ情報: 英文 142 Pages
納期: 2~3営業日
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IVD(体外診断)の世界市場規模は、2024年に1,167億米ドルとなりました。今後、IMARC Groupは、2033年には1,815億米ドルに達し、2025~2033年のCAGRは5.0%になると予測しています。現在、北米が市場を独占しており、2024年の市場シェアは42.7%を超えています。感染症の流行増加、継続的な技術の進歩、個別化医療への消費者の嗜好の変化、高齢者人口の増加などがIVD(体外診断)の市場のシェアを押し上げる主な要因となっています。
IVD(体外診断)(IVD)とは、血液、尿、組織、その他の体液などのサンプルを用いて、通常は実験室内で、生体外で実施される医療検査や処置を指します。これらの検査は、様々な病状や疾患の検出、診断、モニターを目的としています。生体内で行われるin vivo診断とは異なり、in vitro診断では、管理された実験室条件下で生物学的検体を検査します。IVD(体外診断)用医薬品(IVD)検査は現代のヘルスケアに不可欠なものであり、医療従事者が患者のケアについて十分な情報を得た上で意思決定を行うための重要な情報を提供します。これらの検査は、病気のスクリーニング、早期診断、治療法の選択、治療経過のモニタリングにおいて重要な役割を果たしています。これらの検査は、臨床化学、微生物学、血液学、免疫学、分子診断学など、さまざまな医療専門分野で使用されています。
同市場は、慢性疾患や感染症の有病率の増加に牽引され、大きな成長を遂げています。人口の高齢化とライフスタイルの変化に伴い、糖尿病、心血管疾患、がんなどの慢性疾患が蔓延しています。IVD(体外診断)は、これらの疾患の早期発見と効果的な管理に関する重要な洞察をヘルスケア専門家に提供し、患者の転帰の改善と医療費の削減につながります。さらに、技術の進歩と自動化の統合がIVD(体外診断)用医薬品市場に革命をもたらしました。ポイントオブケア検査装置や分子診断薬などの自動化システムは、診断プロセスを合理化し、より迅速で正確な結果を可能にしました。さらに、個別化医療と精密診断への注目の高まりが、特殊なIVD(体外診断)用検査の需要を押し上げています。これらの検査は、個々の患者の遺伝的・分子的特徴に合わせて治療計画を調整し、治療結果を最適化し、副作用を最小限に抑えるのに役立ちます。
さまざまな技術の進歩と自動化
技術革新の急速なペースはIVD(体外診断)(IVD)市場に革命をもたらしました。分子診断、次世代シーケンシング、マイクロ流体などの先端技術により、より正確で高感度な検査法が可能になりました。自動化によって診断プロセスが合理化され、人為的ミスが減り、効率が向上しています。ポイントオブケア検査装置のような自動化システムは、より迅速な結果をもたらし、患者ケアにおけるタイムリーな意思決定を可能にしています。こうした進歩は診断精度を高めるだけでなく、コスト削減や患者の転帰改善にも寄与しています。さらに、自動化によって遠隔地や資源に乏しい地域にも診断検査が行き届くようになり、ヘルスケア格差に対処し、必要不可欠な診断サービスへの患者のアクセスを改善しています。人工知能と機械学習アルゴリズムの統合により、診断システムの分析能力はさらに強化され、より正確でパーソナライズされた検査解釈が可能になりました。技術の進歩に伴い、IVD(体外診断)の市場は継続的な成長が期待され、診断検査とアプリケーションの範囲はますます拡大しています。
慢性疾患の増加
糖尿病、心血管疾患、がんなどの慢性疾患の有病率の増加は、IVD(体外診断)用医薬品(IVD)市場の成長を促す重要な要因となっています。人口の高齢化とライフスタイルの変化に伴い、慢性疾患は世界的に蔓延しています。IVD(体外診断)は、これらの疾患の早期発見、モニタリング、管理において重要な役割を果たしています。診断検査はヘルスケアの専門家が十分な情報を得た上で治療を決定するのを支援し、より良い疾病管理と患者のQOL向上につながります。さらに、慢性疾患の蔓延は予防医療へのパラダイムシフトを促しています。早期発見と早期介入は、慢性疾患の進行を防ぎ、ヘルスケアシステムの負担を軽減するために不可欠です。IVD(体外診断)は、早期スクリーニングと危険因子の特定を容易にし、タイムリーな予防措置を可能にします。このような予防医療の重視は、日常的な健康診断やウェルネス・プログラムにおけるIVD(体外診断)用医薬品の採用に拍車をかけています。
個別化医療の重視
個別化医療への注目の高まりはIVD(体外診断)用医薬品市場に大きな影響を与えています。個別化医療は、遺伝的体質、ライフスタイル、その他の要因に基づいて個々の患者に合わせた治療を行うことを目的としています。遺伝子検査やコンパニオン診断薬などのIVD(体外診断)は、患者固有の特性に関する重要な洞察を提供し、標的治療を可能にし、不必要な治療や副作用を回避します。次世代シーケンシング(NGS)やコンパニオン診断のような先端技術によって可能になる精密診断は、特定の疾患サブタイプや分子標的の同定を容易にします。精密医療が脚光を浴びるにつれ、特殊な診断検査に対する需要は増加の一途をたどっています。ヘルスケアプロバイダーや製薬会社は、新たなバイオマーカーを同定し、精密医療イニシアチブをサポートする革新的な診断ソリューションを創出するための研究開発への投資を増やしています。
The global in vitro diagnostics market size was valued at USD 116.7 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 181.5 Billion by 2033, exhibiting a CAGR of 5.0% from 2025-2033. North America currently dominates the market, holding a market share of over 42.7% in 2024. The rising prevalence of infectious diseases, the continuous technological advancements, shifting consumer preferences towards personalized medicine, and increasing geriatric population are among the primary factors driving the in vitro diagnostics market share.
In vitro diagnostics (IVD) refers to medical tests and procedures that are performed outside the living organism, typically in a laboratory setting, using samples such as blood, urine, tissue, or other body fluids. These tests are designed to detect, diagnose, and monitor various medical conditions and diseases. Unlike in vivo diagnostics, which are conducted within the living body, in vitro diagnostics involve the examination of biological specimens in controlled laboratory conditions. IVD tests are an integral part of modern healthcare, providing crucial information to healthcare professionals for making informed decisions about patient care. These tests play a vital role in disease screening, early diagnosis, treatment selection, and monitoring treatment progress. They are used across various medical specialties, including clinical chemistry, microbiology, hematology, immunology, molecular diagnostics, and more.
The market is experiencing significant growth, driven by the increasing prevalence of chronic diseases and infectious conditions. With the rise in aging populations and lifestyle changes, chronic diseases such as diabetes, cardiovascular disorders, and cancer have become more prevalent. In vitro diagnostics provide healthcare professionals with essential insights into the early detection and effective management of these conditions, leading to improved patient outcomes and reduced healthcare costs. Moreover, advancements in technology and the integration of automation have revolutionized the IVD market. Automated systems, such as point-of-care testing devices and molecular diagnostics, have streamlined the diagnostic process, enabling faster and more accurate results. Additionally, the growing focus on personalized medicine and precision diagnostics has boosted the demand for specialized in vitro diagnostic tests. These tests help tailor treatment plans to individual patients' specific genetic and molecular characteristics, optimizing therapeutic outcomes and minimizing adverse reactions.
Various technological advancements and automation
The rapid pace of technological innovation has revolutionized the In vitro diagnostics (IVD) market. Advanced technologies, such as molecular diagnostics, next-generation sequencing, and microfluidics, have enabled more accurate and sensitive testing methods. Automation has streamlined diagnostic processes, reducing human errors and increasing efficiency. Automated systems like point-of-care testing devices have facilitated faster results, enabling timely decision-making in patient care. These advancements not only enhance diagnostic accuracy but also contribute to cost savings and improved patient outcomes. Moreover, automation has extended the reach of diagnostic testing to remote or resource-limited areas, addressing healthcare disparities and improving patient access to essential diagnostic services. The integration of artificial intelligence and machine learning algorithms has further enhanced the analytical capabilities of diagnostic systems, allowing for more precise and personalized test interpretations. As technology continues to advance, the In vitro diagnostics market is expected to witness continued growth, with an ever-expanding range of diagnostic tests and applications.
The increasing prevalence of chronic diseases
The rising prevalence of chronic diseases, such as diabetes, cardiovascular disorders, and cancer, has been a key driver in the growth of the IVD market. With aging populations and lifestyle changes, chronic conditions have become more prevalent globally. In vitro diagnostics play a crucial role in the early detection, monitoring, and management of these diseases. Diagnostic tests assist healthcare professionals in making informed treatment decisions, leading to better disease management and improved quality of life for patients. Moreover, the prevalence of chronic diseases has prompted a paradigm shift towards preventive healthcare. Early detection and intervention are essential in preventing the progression of chronic conditions and reducing the burden on healthcare systems. In vitro diagnostics facilitate early screening and identification of risk factors, enabling timely preventive measures. This emphasis on preventive healthcare has spurred the adoption of IVD tests in routine health check-ups and wellness programs.
The growing emphasis on personalized medicine
The growing focus on personalized medicine has significantly impacted the IVD market. Personalized medicine aims to tailor medical treatment to individual patients based on their genetic makeup, lifestyle, and other factors. In vitro diagnostics, such as genetic testing and companion diagnostics, provide critical insights into patients' unique characteristics, enabling targeted therapies and avoiding unnecessary treatments or adverse reactions. Precision diagnostics, enabled by advanced technologies like Next-Generation Sequencing (NGS) and companion diagnostics, facilitate the identification of specific disease subtypes and molecular targets. As precision medicine gains prominence, the demand for specialized diagnostic tests continues to rise. Healthcare providers and pharmaceutical companies are increasingly investing in research and development to identify new biomarkers and create innovative diagnostic solutions to support precision medicine initiatives.
Molecular diagnostics represents the most popular test type
Molecular diagnostics offer high levels of accuracy and sensitivity in disease detection. They can identify even low concentrations of target molecules, enabling early diagnosis and precise monitoring of diseases. This level of sensitivity is particularly crucial in the detection of infectious diseases, genetic disorders, and certain types of cancer, where early intervention is vital for successful treatment. Moreover, molecular diagnostics play a key role in the advancement of personalized medicine. By analyzing an individual's genetic makeup or specific biomarkers, these tests can tailor treatment plans to each patient's unique characteristics. This approach optimizes therapeutic outcomes, minimizes adverse effects, and enhances overall patient care, contributing to the growing demand for personalized healthcare solutions.
Reagents and kits represent the leading segment
Reagents and kits are fundamental components of diagnostic tests. They contain the necessary substances and chemicals required to perform specific assays and analyze patient samples. Diagnostic laboratories and healthcare facilities rely heavily on reagents and kits to conduct a wide range of tests, from routine screenings to complex molecular diagnostics. Moreover, Reagents and kits are designed to be user-friendly and standardized, ensuring consistent and reliable results across different laboratories and testing sites. They simplify the testing process, reducing the need for extensive manual preparation and minimizing the risk of errors. Standardization also facilitates inter-laboratory comparability, making it easier for healthcare providers to interpret and act upon test results.
Disposable IVD devices are designed for single-use and are discarded after a single patient interaction or testing procedure. They are pre-sterilized and come in a ready-to-use format, which eliminates the need for cleaning, disinfection, or reprocessing after each use. Healthcare providers find disposable IVD devices convenient and time-saving, as they eliminate the need for complex and time-consuming reprocessing procedures. This is especially advantageous in high-volume testing environments.
Reusable IVD devices, as the name suggests, can be used multiple times after appropriate cleaning, sterilization, and maintenance. They are made of durable materials that can withstand repeated use without compromising their performance. They also offer greater flexibility in terms of test customization and parameter adjustments, making them suitable for research and specialized testing needs.
Infectious diseases currently dominate the market
Infectious diseases pose significant global health challenges, and outbreaks or pandemics can have severe consequences on public health and economies. The COVID-19 pandemic, for example, has highlighted the critical role of diagnostic testing in controlling the spread of infectious diseases. Besides, infectious diseases have a high incidence and prevalence rate, affecting millions of people worldwide. Common infectious diseases such as influenza, tuberculosis, hepatitis, and sexually transmitted infections continue to impact communities across the globe. Moreover, in vitro diagnostics offer a rapid and reliable way to identify infectious agents, allowing healthcare providers to initiate appropriate therapies, implement infection control measures, and prevent further transmission.
Hospital laboratories are an essential part of healthcare facilities, providing diagnostic testing services to inpatients and outpatients. These laboratories are equipped with a wide range of IVD instruments and reagents to perform various tests, including clinical chemistry, hematology, microbiology, and immunology. Hospitals rely on timely and accurate diagnostic results from their in-house laboratories to aid in patient diagnosis, treatment, and disease management.
Clinical laboratories, also known as independent or reference laboratories, are separate entities that offer diagnostic testing services to healthcare providers, hospitals, clinics, and other healthcare settings. They often handle high-volume and specialized tests that may not be available in all hospital laboratories. Clinical laboratories serve as centralized testing facilities, supporting multiple healthcare facilities with their comprehensive testing capabilities.
Point-of-care testing (POCT) centers represent a rapidly growing segment in the IVD market. These centers provide diagnostic tests at or near the location where patient care is delivered. POCT devices offer rapid results, allowing for immediate treatment decisions and interventions. Point-of-care testing centers are especially valuable in emergency rooms, ambulances, nursing homes, and remote or resource-limited settings where quick diagnosis is critical.
Academic institutes, including research universities and medical schools, contribute to the IVD market through research, development, and education. They play a pivotal role in advancing diagnostic technologies, discovering new biomarkers, and evaluating the effectiveness of diagnostic tests. Academic institutes often collaborate with diagnostic companies to conduct clinical trials and validate the performance of novel diagnostic assays.
Patients are becoming increasingly involved in their healthcare decisions, including diagnostic testing. The IVD market caters to the direct-to-consumer testing trend, where patients can access certain diagnostic tests without a healthcare provider's prescription. These tests allow individuals to monitor their health status, identify risk factors, and take proactive steps towards better health management.
North America accounts for the majority of market share
The report has also provided a comprehensive analysis of all the major regional markets, which includes North America (United States, Canada); Asia-Pacific (China, Japan, India, South Korea, Australia, Indonesia, Others); Europe (Germany, France, United Kingdom, Italy, Spain, Russia, Others); Latin America (Brazil, Mexico, Others); and the Middle East and Africa. According to the report, North America was the largest market for in vitro diagnostics.
North America boasts a well-developed and advanced healthcare infrastructure, including modern hospitals, clinical laboratories, and research institutions. The region's robust healthcare system supports a high volume of diagnostic testing, driving the demand for IVD products and services. Besides, North America is at the forefront of technological innovations in the IVD industry. The region is home to many leading diagnostic companies and research institutions that invest heavily in research and development, leading to the creation of cutting-edge diagnostic technologies and products. Moreover, the region has stringent regulatory standards for diagnostic products, ensuring safety and efficacy. Companies operating in the region must comply with rigorous quality control measures, which helps build trust in the reliability of IVD products.
The competitive landscape of the In vitro diagnostics (IVD) market is characterized by a diverse and highly competitive environment, with numerous companies vying for market share. They are developing advanced technologies, novel biomarkers, and point-of-care testing devices to meet the evolving needs of the healthcare industry. They are engaging in mergers and acquisitions (M&As) to expand their product portfolios, gain access to new markets, and enhance their technological capabilities. They are also expanding their market presence by establishing distribution networks in new regions or countries. Moreover, companies are embracing digitalization and investing in digital diagnostic solutions. This includes the development of digital pathology, remote monitoring, and telehealth solutions to enhance diagnostic efficiency and accessibility.