グローバルIVD試薬市場規模、シェア、トレンド分析レポート – 業界概要と2032年までの予測

体外診断用試薬市場規模

• 世界の体外診断用試薬市場は2024年に548億9000万米ドルと評価され、 2032年までに998億5000万米ドルに達すると予想されています。
• 2025年から2032年の予測期間中、市場は主に病気の早期発見と個別化医療の需要増加により、4.60%のCAGRで成長すると予想されます。
• この成長は、慢性疾患の増加、技術の進歩、予防医療への関心の高まりなどの要因によって推進されている。

IVD試薬市場分析

• 体外診断（IVD）試薬は、患者から採取したサンプル（血液、尿、組織など）中の病気や症状を検出し診断するために臨床検査で使用される物質または化合物です。
• 医療施設における診断検査の需要の増加に伴い、体外診断用試薬市場は拡大しています。
• 例えば、COVID-19パンデミックはPCR検査キットや抗原検査キットの急増に見られるように、診断試薬の需要を大幅に押し上げました。
• 診断技術の進歩は、診断ラボにおける人工知能と自動化の統合など、市場を押し上げている。
• 例えば、ロシュ社のコバスやアボット社のアリニティなどの自動検査システムは、診断の効率と精度を向上させた。
• 個別化医療への関心が高まるにつれ、より正確で標的を絞った診断に対する需要が高まっています。イルミナやサーモフィッシャーサイエンティフィックなどの企業は、個別化医療に不可欠な次世代シーケンシング技術をリードしています。
• 特に糖尿病などの慢性疾患における定期的なスクリーニングと疾患モニタリングでは、診断試薬の使用が拡大し続けています。リアルタイムでは、何百万人もの人々がアボットのFreeStyle Libreなどの家庭用検査キットを使用して糖尿病を管理しています。
• 主要企業は、新しい試薬や診断検査を開発するために研究開発に多額の投資を行っている。
• 例えば、シーメンス・ヘルシニアーズによる免疫測定用試薬の継続的な開発は、市場イノベーションの好例である。

レポートの範囲とIVD試薬市場のセグメンテーション        

IVD Reagents Market Trends

“Increasing Use of Molecular Diagnostics”

• The increasing use of molecular diagnostics is transforming the healthcare landscape, as it enables accurate and early detection of diseases at the genetic level. PCR-based tests became vital for detecting COVID-19 infections globally
• Technologies such as polymerase chain reaction and next-generation sequencing are being adopted more widely for disease diagnosis. In cancer, molecular diagnostics are used to identify specific mutations, guiding treatment decisions, as seen with tests such as FoundationOne for identifying genetic mutations in tumors
• Molecular diagnostics are crucial in personalized medicine, allowing treatments to be tailored to the individual's genetic makeup
• For instance, Genetic tests such as BRCA1 and BRCA2 are used to assess breast cancer risk, which can influence decisions on preventive care and treatment plans
• The demand for molecular diagnostics is expanding in infectious disease detection. Real-time PCR tests have become a standard for diagnosing diseases such as tuberculosis and HIV, allowing for rapid and accurate results that improve patient outcomes
• Advances in molecular diagnostics are also accelerating the development of multiplex testing, enabling the simultaneous detection of multiple pathogens.
• For instance, The BioFire FilmArray system can identify a wide range of pathogens in a single test, streamlining diagnostic processes

IVD Reagents Market Dynamics

Driver

“Increasing Demand for Early Disease Detection and Personalized Medicine”

• The demand for early disease detection is increasing, especially in critical areas such as oncology, cardiology, and infectious diseases, where early diagnosis can drastically improve patient survival.
• For instance, Early-stage detection of breast cancer through mammography or genetic testing for BRCA mutations has led to better treatment outcomes and survival rates
• Molecular diagnostics and genetic testing are transforming personalized medicine, helping healthcare providers tailor treatment plans based on individual genetic profiles.
• For instance, Genetic testing in oncology, such as FoundationOne, helps doctors identify the most effective therapies based on a tumor’s genetic mutations, leading to more precise and successful treatments
• The growing trend of preventive healthcare has spurred an increase in routine screenings, enhancing early detection and proactive disease management. Blood glucose tests and cholesterol screenings are now part of regular check-ups, helping identify risks for chronic conditions such as diabetes and heart disease before they become critical
• The shift towards personalized medicine has led to advancements in diagnostic reagents that offer a more tailored approach to treatment
• For instance, Pharmacogenomic testing helps doctors determine how patients will respond to certain drugs, reducing adverse drug reactions and optimizing treatment strategies

Opportunity

“Growth in Point-of-Care Testing and Home Diagnostics”

• The growing trend of point-of-care testing is increasing demand for quick, accessible, and reliable diagnostic solutions.
• For instance, During the COVID-19 pandemic, companies such as Abbott and Roche developed rapid antigen and PCR tests that could be used in non-laboratory settings, such as at home or in community health centers, allowing for fast diagnosis and timely intervention
• Point-of-care testing reduces patient wait times and enables healthcare providers to make prompt clinical decisions, improving patient outcomes
• For instance, Portable devices such as Roche’s cobas Liat System allow clinicians to test for infectious diseases such as flu and strep throat in a matter of minutes, supporting faster treatment decisions
• The increasing demand for home diagnostics, especially for chronic disease management, is driving market growth
• For instance, Is the use of home glucose monitoring systems such as the FreeStyle Libre from Abbott, which enables patients with diabetes to monitor their blood sugar levels and make immediate adjustments to their treatment plans
• Point-of-care tests for infectious diseases are especially beneficial for remote areas or underserved populations
• For instance, Malaria diagnostic kits, such as those developed by SD Biosensor, allow healthcare workers in low-resource settings to quickly and accurately diagnose malaria without needing advanced laboratory infrastructure
• The development of innovative at-home diagnostic kits is expanding the market for self-testing
• For instance, The Everlywell platform offers a range of at-home testing options, including for food sensitivity, hormones, and sexually transmitted infections, making healthcare more accessible and personalized

Restraint/Challenge

“Regulatory and Quality Control Issues”

• Regulatory and quality control issues pose a significant challenge for the in vitro diagnostics reagents market, as diagnostic reagents must comply with stringent regulations from authorities such as the Food and Drug Administration in the U.S. or the European Medicines Agency in Europe.
• For instance, The regulatory approval process for new diagnostic tests often involves extensive clinical trials and documentation, which can delay product launches and increase costs
• The complexity of these regulations varies across different regions, making it difficult for companies to navigate international markets.
• For instance, Diagnostic reagents that are approved in one region may require additional testing or modifications to meet the regulatory requirements in another region, creating hurdles for companies seeking global distribution
• 小規模企業や新規参入企業は、規制要件を満たす際に、リソースを大量に消費する可能性があるため、さらなる課題に直面します。そのため、規制環境を効率的に乗り越えるリソースを持つ、より大規模で確立された企業との競争能力が制限されることがよくあります。
• 規制の更新や基準の変更が継続的に行われると、プロセスがさらに複雑になる可能性があります。
• 例えば、医療機器や試薬に対するより厳しい規制の実施により、企業は既存の製品や製造プロセスを変更する必要が生じ、追加費用が発生し、製品の市場投入が遅れる可能性があります。
• 品質管理は、診断試薬の性能と信頼性を維持するために不可欠です。バッチ間のばらつきや汚染などの不一致は、診断検査の精度を損なう可能性があり、製品リコール、消費者の信頼の失墜、そして多大な経済的損害につながる可能性があります。こうしたリスクを回避するには、厳格な品質保証プロセスを維持することが不可欠です。

IVD試薬市場の展望

市場は、試薬の種類、技術、用途、テストの種類、およびエンドユーザーに基づいてセグメント化されています。

IVD試薬市場の地域分析

「北米はIVD試薬市場における主要地域です」

• 北米は、確立された病院や診断研究所のおかげでIVD試薬市場を支配しており、この地域は大量の診断検査を実施する設備が整っており、試薬の需要を高めています。
• 特に米国には、アボット、ロシュ、サーモフィッシャーサイエンティフィックなどの大手企業が拠点を置いており、この地域の市場優位性に大きく貢献しています。
• 北米では、患者にとって診断検査がより利用しやすく手頃な価格になる有利な償還政策の恩恵を受けており、市場の成長がさらに促進されている。
• The high demand for early disease detection, personalized medicine, and point-of-care testing also boosts the adoption of in vitro diagnostic reagents in the region. Furthermore, the ongoing advancements in molecular diagnostics, genetic testing, and automation technologies continue to support the demand for these reagents in hospitals, clinics, and research labs
• Another key factor contributing to North America's dominance is the high prevalence of chronic diseases, including cardiovascular conditions, diabetes, and cancer. This growing disease burden has led to a greater focus on routine diagnostic testing, increasing the need for diagnostic reagents. As a result, North America remains the dominant region in the in vitro diagnostics reagents market, both in terms of market share and technological advancements

“Asia-Pacific is Projected to Register the Highest Growth Rate”

• The Asia-Pacific region is expected to witness the highest growth rate in the IVD Reagents market, driven by rapidly expanding healthcare infrastructure, increasing healthcare awareness, and the rising prevalence of chronic diseases such as diabetes, cardiovascular diseases, and infections
• Major cities in North India, such as Delhi, Noida, Chandigarh, and Jaipur, have become prominent healthcare hubs, driving demand for diagnostic reagents. These cities are home to numerous hospitals, diagnostic laboratories, and healthcare centers, which have significantly increased the demand for diagnostic testing
• The increasing adoption of point-of-care testing, home diagnostics, and advanced molecular diagnostic technologies in these cities is further contributing to the market’s growth. The growing middle-class population in North India, combined with an increasing focus on preventive healthcare, has led to a higher demand for routine diagnostic tests, including cholesterol screenings, blood glucose tests, and cancer markers
• The region’s population density and urbanization also play a key role in accelerating the demand for in vitro diagnostics, with more people seeking immediate and accessible healthcare solutions. As a result, North India has emerged as the fastest-growing region in the market, with continuous growth expected due to the expanding healthcare infrastructure and increasing disease awareness

IVD Reagents Market Share

The market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to market.

The Major Market Leaders Operating in the Market Are:

• Danaher Corporation (U.S.)
• Bio-Rad Laboratories, Inc. (U.S.)
• Chembio Diagnostics, Inc. (U.S.)
• F. Hoffmann-La Roche Ltd (Switzerland)
• Sysmex Corporation (Japan)
• Surmodics, Inc. (U.S.)
• Abbott (U.S.)
• QIAGEN N.V. (Netherlands)
• Merck KGaA (Germany)
• Agilent Technologies, Inc. (U.S.)
• MEDICAL & BIOLOGICAL LABORATORIES CO., LTD. (Tokyo)
• Siemens Healthineers AG (Germany)
• Revvity (U.S.)
• Thermo Fisher Scientific Inc. (U.S.)
• DiaSorin S.p.A (Italy)
• Canvax (Spain)
• Illumina, Inc. (U.S.)
• Grifols, S.A. (Spain)
• Prestige Diagnostics (Ireland)

Latest Developments in Global IVD Reagents Market

• In December 2023, Roche entered into a definitive agreement to acquire LumiraDx's Point of Care technology. This acquisition involves a platform that integrates multiple diagnostic modalities on a single instrument, enabling faster, more affordable, and accessible testing in decentralized healthcare settings. The technology will enhance Roche’s existing diagnostics portfolio, spanning across immunoassay, clinical chemistry, and molecular tests. By incorporating LumiraDx's innovations, Roche aims to improve patient access to timely and accurate diagnostics in various settings, such as home care, pharmacies, and general practices. This acquisition is expected to expand Roche’s point-of-care solutions and drive market growth in decentralized diagnostics
• In July 2022, Thermo Fisher Scientific showcased new clinical and research lab solutions at AACC 2022. The company introduced innovative platforms and technologies designed to improve diagnostic development and laboratory productivity. These solutions, including advanced testing kits and automation systems, aim to minimize hands-on time and accelerate time-to-results, enhancing efficiency in clinical diagnostics. The impact on the market includes a significant boost in the adoption of rapid, high-precision diagnostics, particularly in infectious diseases and autoimmune testing. This development positions Thermo Fisher as a leader in the evolving diagnostics sector, supporting improved patient outcomes globally
• In May 2022, Hologic received the European CE mark for two new molecular assays—the Panther Fusion EBV Quant Assay and Panther Fusion BKV Quant Assay—designed for transplant patients. These assays quantify the viral load of Epstein-Barr virus and BK virus in whole blood, plasma, and urine samples. By aiding in the diagnosis and management of solid organ and stem cell transplant patients, these assays provide critical tools for monitoring infections in immunocompromised individuals. The new assays will enhance diagnostic capabilities on the Panther Fusion system, improving patient outcomes and driving market growth in transplant diagnostics

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