世界のバイオマーカー市場規模、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

バイオマーカー市場規模

• 世界のバイオマーカー市場規模は2024年に569.4億米ドルと評価され、予測期間中に14.90%のCAGRで成長し、2032年までに1729.7億米ドル に達すると予想されています。 
• 市場の成長は主に、早期診断、疾患モニタリング、治療の最適化にバイオマーカーを大きく依存する精密医療と個別化医療の導入の増加によって推進されている。
• さらに、バイオテクノロジーと医薬品研究への投資の増加と、ゲノミクス、プロテオミクス、メタボロミクスの進歩が相まって、バイオマーカーに基づくソリューションの開発と応用を加速させています。これらの複合的な要因が、世界のバイオマーカー市場の成長を大きく後押しし、医療分野全体において、患者の転帰の改善、より標的を絞った治療、そして臨床意思決定の強化を可能にしています。

バイオマーカー市場分析

• 生物学的プロセス、疾患の進行、または治療反応の測定可能な指標として使用されるバイオマーカーは、腫瘍学、心血管疾患、神経疾患の診断、医薬品開発、個別化医療においてますます重要になっています。
• バイオマーカーの需要増加は、主に慢性疾患の罹患率の増加、精密医療への注目の高まり、ハイスループットスクリーニング技術の進歩、そして早期かつ正確な疾患検出の必要性によって推進されている。
• 北米は、高度な医療インフラ、高い患者意識、そして大手バイオテクノロジー企業や診断企業の存在に支えられ、2024年にはバイオマーカー市場において41.55%という最大の収益シェアを獲得し、市場を席巻しました。特に米国では、研究開発への多額の投資、規制当局による支援、そしてAIを活用したバイオマーカー分析プラットフォームの導入に支えられ、バイオマーカーの発見、検証、そして臨床応用が急速に成長しています。
• アジア太平洋地域は、予測期間中にバイオマーカー市場で最も急速に成長する地域になると予想されており、2025年から2032年にかけて23％のCAGRが予測されています。成長は、医療へのアクセスの拡大、精密医療を促進する政府の取り組み、慢性疾患の負担の増加、中国、インド、日本などの国における診断ラボの拡大によって促進されています。
• Cancer segment dominated the biomarkers market a revenue share of 46% in 2024, owing to its high prevalence and the critical role of biomarkers in early detection, prognosis, treatment monitoring, and precision oncology

Report Scope and Biomarkers Market Segmentation

Biomarkers Market Trends

Enhanced Convenience Through Technological Advancements

• A significant and accelerating trend in the global biomarkers market is the rapid adoption of advanced technologies in diagnostics, personalized medicine, and disease monitoring. These innovations are enhancing the accuracy, speed, and reliability of biomarker detection, enabling more precise and timely clinical decision-making
  • For instance, recent developments in high-throughput sequencing, proteomics, and metabolomics have allowed researchers and clinicians to identify novel biomarkers for early disease detection, prognosis, and therapeutic response monitoring. Similarly, multi-omics integration platforms are providing comprehensive insights into disease mechanisms and patient stratification, offering a discreet and targeted approach in biomarker research
• Advanced data analytics and bioinformatics tools are increasingly being employed to analyze complex biological datasets, improving the predictive power of biomarkers and supporting the development of personalized treatment plans. Furthermore, integration with electronic health records and cloud-based platforms allows for seamless sharing and interpretation of biomarker data, enhancing collaboration across healthcare institutions
• The convergence of cutting-edge laboratory techniques, computational methods, and clinical research is fundamentally reshaping expectations for biomarker discovery and utilization. Consequently, companies and research institutions are focusing on developing high-sensitivity assays, multiplex detection methods, and non-invasive testing solutions to accelerate biomarker adoption in routine clinical practice
• The demand for innovative biomarker solutions is growing rapidly across both diagnostic and therapeutic sectors, as healthcare providers and pharmaceutical companies increasingly prioritize early detection, precision medicine, and real-time patient monitoring

Biomarkers Market Dynamics

Driver

Growing Need Due to Rising Healthcare Awareness and Personalized Medicine

• The increasing prevalence of chronic diseases, cancer, and genetic disorders, coupled with rising healthcare awareness and the push toward personalized medicine, is a significant driver for the heightened demand for biomarkers
  • For instance, in April 2024, several leading biotech companies announced advancements in multi-omics-based biomarker discovery, focusing on early disease detection and precision therapeutics. Such initiatives are expected to drive the Biomarkers market growth in the forecast period
• As healthcare providers and pharmaceutical companies emphasize early diagnosis and targeted treatment strategies, biomarkers are playing a critical role in patient stratification, therapy monitoring, and prognostic evaluation, offering significant improvements over traditional diagnostic methods
• Furthermore, the expanding integration of biomarkers into clinical trials, drug development, and companion diagnostic tools is making them an essential component of modern healthcare systems, supporting more effective and personalized treatment plans
• The growing focus on non-invasive diagnostic techniques, high-throughput screening methods, and advanced laboratory technologies, along with increasing government and private funding for biomarker research, is propelling market adoption. The trend toward data-driven healthcare solutions and the rising availability of validated biomarker panels further contribute to sustained market growth

Restraint/Challenge

Challenges in Standardization, High Costs, and Regulatory Compliance

• One of the primary challenges restraining the biomarkers market is the lack of universally accepted standards for biomarker validation, testing, and interpretation. This variability across laboratories and institutions can lead to inconsistent results, making healthcare providers cautious about widespread adoption
• The high costs associated with advanced biomarker assays, multi-omics platforms, and specialized laboratory equipment also limit accessibility, particularly in developing regions and smaller healthcare facilities. These financial barriers can delay implementation despite the clinical benefits offered by biomarkers
• Regulatory complexities further challenge market growth, as introducing new biomarkers into clinical practice requires rigorous approval processes. Adherence to evolving guidelines and compliance with local and international regulatory standards can be time-consuming and resource-intensive for both diagnostic and pharmaceutical companies
• In addition, the need for highly skilled personnel to perform and interpret biomarker tests adds another layer of difficulty for adoption, especially in regions with limited trained workforce in genomics and molecular diagnostics
• While technological advancements are gradually improving accuracy and reducing costs, the perception of high expense and procedural complexity continues to limit broader utilization. Addressing these hurdles through standardized protocols, cost-effective solutions, enhanced training, and streamlined regulatory pathways is essential to ensure sustained growth in the Biomarkers market

Biomarkers Market Scope

The market is segmented on the basis of type, application, product type, technology, and indication.

• By Type

On the basis of type, the biomarkers market is segmented into safety, efficacy, and validation. The safety segment dominated the market with the largest revenue share of 42% in 2024, as safety biomarkers are crucial for detecting potential adverse reactions, monitoring patient safety, and ensuring the tolerability of drugs and therapeutic interventions across preclinical and clinical stages. These biomarkers are integral to regulatory submissions, toxicity studies, and post-market surveillance programs, helping reduce clinical risks and support safer drug development. They provide actionable insights that guide dosage adjustments, minimize adverse events, and facilitate compliance with global safety standards.

The Validation segment is expected to witness the fastest CAGR of 20% from 2025 to 2032, propelled by the increasing need for standardized, reproducible, and reliable biomarkers to support diagnostics, drug development, and translational research. Rising regulatory requirements, heightened emphasis on reproducibility in scientific studies, and increased investment in validation initiatives are further driving the growth of this segment, positioning it as a key focus area in the biomarkers market.

• By Application

On the basis of application, the biomarkers market is segmented into diagnostics development, drug discovery and development, personalized medicine, disease-risk assessment, and others. Diagnostics development dominated with a revenue share of 40% in 2024, as biomarkers are extensively employed for early disease detection, clinical diagnostics, and population-wide screening programs. Their ability to track disease onset, progression, and patient responses has made them indispensable in diagnostic research and clinical practice.

Personalized Medicine is expected to witness the fastest CAGR of 22% from 2025 to 2032, driven by the growing emphasis on precision medicine and targeted therapies that rely on predictive and prognostic biomarkers. The integration of biomarkers into companion diagnostics, individualized treatment planning, and patient-specific therapy decisions is fueling demand in this segment, enabling more accurate, effective, and personalized healthcare solutions while supporting long-term market expansion.

• By Product Type

On the basis of product type, the Biomarkers market is segmented into Consumables, Services, and Software. Consumables dominated the market with a revenue share of 45% in 2024, due to the continuous need for reagents, assay kits, sample preparation tools, and platforms used in biomarker research, clinical testing, and high-throughput screening applications. These consumables form the backbone of laboratory workflows, ensuring reliable experimental results and consistent performance in both research and clinical environments.

Software is expected to witness the fastest CAGR of 21% from 2025 to 2032, driven by the increasing adoption of bioinformatics, AI-driven analytics, and cloud-based platforms that facilitate comprehensive integration, interpretation, and visualization of biomarker data. The combination of advanced software solutions with consumables and services is enhancing research efficiency, improving data accuracy, and streamlining workflows, ultimately contributing to more informed decision-making and accelerated development in the Biomarkers sector.

• By Technology

On the basis of technology, the Biomarkers market is segmented into Safety Biomarkers, Efficacy Biomarkers, and Validation Biomarkers. Safety Biomarkers dominated with a revenue share of 43% in 2024, as they are extensively utilized to monitor toxicological effects, assess patient tolerability, and ensure overall safety during drug development and clinical trials. These biomarkers are critical for preclinical studies, helping researchers identify potential adverse effects before human testing, and they support continuous monitoring during clinical trials to maintain regulatory compliance. Safety biomarkers also play a pivotal role in post-market surveillance, minimizing risks associated with therapy administration and guiding dose adjustments.

Efficacy Biomarkers are expected to witness the fastest CAGR of 23% from 2025 to 2032. This rapid growth is driven by the increasing need to evaluate treatment response, measure therapeutic effectiveness, and perform outcome-based research, particularly in targeted therapies and personalized medicine. The integration of efficacy biomarkers in clinical trials, drug development programs, and regulatory frameworks is further enhancing their adoption and reinforcing their significance across the healthcare ecosystem.

• By Indication

On the basis of indication, the biomarkers market is segmented into cancer, cardiovascular disorders, neurological disorders, immunological disorders, and others. Cancer dominated with a revenue share of 46% in 2024, owing to its high prevalence and the critical role of biomarkers in early detection, prognosis, treatment monitoring, and precision oncology. Biomarkers help identify specific molecular targets, predict disease progression, and guide personalized therapy decisions, making them indispensable in oncology research and clinical practice.

Neurological disorders are expected to witness the fastest CAGR of 24% from 2025 to 2032. The rapid growth in this segment is driven by the rising incidence of neurodegenerative diseases such as Alzheimer’s, Parkinson’s, and other cognitive impairments. Increased focus on early diagnostic markers, advancements in understanding disease pathophysiology, and the development of targeted therapeutic strategies are supporting strong adoption of biomarkers in this area, fueling robust market expansion over the forecast period.

Biomarkers Market Regional Analysis

• North America dominated the biomarkers market with the largest revenue share of 41.55% in 2024, primarily supported by a well-established healthcare infrastructure, high patient awareness, and the presence of leading biotech and diagnostic companies
• The region benefits from extensive R&D investments, advanced laboratory facilities, and regulatory support that enable rapid adoption of novel biomarker technologies
• The increasing focus on personalized medicine, early disease detection, and treatment monitoring has significantly driven demand across hospitals, diagnostic centers, and research institutions

U.S. Biomarkers Market Insight

The U.S. biomarkers market captured the largest revenue share in North America in 2024, fueled by substantial growth in biomarker discovery, validation, and clinical applications. The market is supported by high adoption of AI-enabled biomarker analysis platforms, growing prevalence of chronic and oncologic diseases, and rising participation in clinical trials. Collaboration between biotech firms, research institutions, and hospitals is enhancing innovation, while increasing awareness among healthcare professionals and patients is driving utilization. These factors collectively contribute to the U.S. market’s robust expansion.

Europe Biomarkers Market Insight

The Europe biomarkers market is expected to witness steady growth throughout the forecast period, driven by strong healthcare systems, government initiatives promoting personalized medicine, and increasing investment in AI-powered biomarker technologies. Countries such as Germany, France, and the U.K. are adopting advanced diagnostic infrastructure to facilitate early detection, disease monitoring, and precision treatment. Emphasis on clinical accuracy, regulatory compliance, and integration of biomarkers into routine diagnostics is encouraging growth across hospitals, research centers, and specialized clinics.

U.K. Biomarkers Market Insight

The U.K. biomarkers market is anticipated to grow at a significant CAGR during the forecast period, fueled by increasing R&D activity, regulatory support for clinical trials, and growing adoption of biomarker-guided therapies. Rising awareness of personalized medicine, along with substantial investments by healthcare providers in advanced diagnostic solutions, is boosting market expansion. The integration of biomarkers in oncology, cardiovascular, and neurological diagnostics is creating new avenues for innovation and clinical application.

Germany Biomarkers Market Insight

The Germany biomarkers market is projected to expand steadily during the forecast period, driven by strong healthcare infrastructure, a robust biotechnology sector, and high patient awareness. Germany’s focus on innovation and the integration of AI-based diagnostic tools is enhancing biomarker applications in early detection, treatment planning, and monitoring of chronic and oncologic diseases. Increasing collaboration between research institutions and healthcare providers is further strengthening market growth.

Asia-Pacific Biomarkers Market Insight

The Asia-Pacific biomarkers market is expected to be the fastest-growing region during the forecast period, with a projected CAGR of 23% from 2025 to 2032. Growth is fueled by increasing access to healthcare services, rising prevalence of chronic diseases, government initiatives promoting precision medicine, and expansion of diagnostic laboratories in countries such as China, India, and Japan. Rising investments in biotechnology research, growing patient awareness, and the adoption of advanced biomarker platforms for disease diagnosis and treatment monitoring are key factors driving market expansion in the region.

Japan Biomarkers Market Insight

The Japan biomarkers market is gaining momentum due to the country’s advanced healthcare system, strong R&D capabilities, and growing demand for precision diagnostics. Clinical applications of biomarkers in oncology, cardiovascular, and neurological disorders are expanding rapidly, supported by government incentives, regulatory frameworks, and integration with AI-enabled diagnostic platforms. Increasing awareness among healthcare professionals and patients is further contributing to market growth.

China Biomarkers Market Insight

The China biomarkers market accounted for the largest revenue share in the Asia-Pacific region in 2024, driven by rapid urbanization, rising healthcare expenditures, expanding diagnostic infrastructure, and increasing patient awareness. The adoption of biomarkers is being fueled by government initiatives promoting biotechnology innovation, strong domestic manufacturers, and the growing focus on precision medicine and early disease detection. Increasing collaboration between hospitals, research institutions, and diagnostic companies is further accelerating market growth in China.

Biomarkers Market Share

The Biomarkers industry is primarily led by well-established companies, including:

• Enzo Biochem Inc. (U.S.)
• Bio-Rad Laboratories, Inc. (U.S.)
• Merck KGaA (Germany)
• PerkinElmer (U.S.)
• QIAGEN (Germany)
• Agilent Technologies, Inc. (U.S.)
• Bruker (U.S.)
• Epigenomics AG (Germany)
• MESO SCALE DIAGNOSTICS, LLC (U.S.)
• EKF Diagnostics Holdings plc (U.K.)
• General Electric Company (U.S.)
• Nexus-Dx (U.S.)
• LifeSign LLC (U.S.)
• F.Hoffman-La Roche Ltd (Switzerland)
• Thermo Fischer Scientific Inc. (U.S.)
• Eurofins Scientific (Luxembourg)
• Abbott (U.S.)
• Charles River Laboratories International Inc. (U.S.)
• Sino Biological, Inc. (China)
• CENTOGENE N.V. (Germany)

Latest Developments in Global Biomarkers Market

• In April 2023, the U.S. National Institutes of Health (NIH) announced a USD4 million funding initiative to Eastern Virginia Medical School (EVMS) for the research and development of biomarkers aimed at the early detection of aggressive prostate cancer. This investment underscores the growing emphasis on precision diagnostics and personalized medicine in oncology
• 2025年7月、レベレーション・バイオサイエンスは、ジェミニ候補薬の第1相臨床試験において、主要安全性評価項目を達成し、統計的に有意なバイオマーカー活性を示したと発表しました。このマイルストーンは、この治療薬が、疾患治療における有効性に極めて重要な生物学的マーカーを活性化させる可能性を示唆しています。
• 2025年8月、コネチカット州は、2026年1月1日から医療保険会社にバイオマーカー検査の適用を義務付ける法案を可決しました。この政策イニシアチブは、個人および団体保険プランの両方でバイオマーカー検査の適用を義務付けることで、アルツハイマー病、癌、パーキンソン病などのさまざまな慢性疾患の診断と治療を改善することを目的としています。

SKU-1389