Int'l : +1-503-894-6022 | Toll Free : +1-800-792-5285 | help@alliedmarketresearch.com
A00021 | Pages: 347 | Charts: 82 | Tables: 148 |
The global biomarkers market size was valued at $46.4 billion in 2023, and is projected to reach $134.2 billion by 2033, growing at a CAGR of 11.2% from 2024 to 2033. The growth of the biomarkers market size is driven by an increase in adoption of biomarkers for drug discovery and development. For instance, according to a 2020 report by the National Library of Medicine, it was reported that in the U.S., biomarkers are qualified using the Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program (BQP) that is described within the ˜Drug Development Tools (DDTs) Program.
In addition, the rise in prevalence of chronic diseases is expected to contribute significantly to the growth of the biomarkers industry. According to a 2023 report by the National Library of Medicine, it was reported that biomarkers exploration is essential in detecting diseases as it helps predict, diagnose, identify, treat diseases, and understand disease processes.
Biomarkers are measurable indicators that signal the presence or progression of a biological process, disease, or pharmacological effect of a drug. Biomarkers serve as valuable tools in medical research, diagnostics, and personalized medicine, providing insights into an individual's health status, response to treatment, or disease risk. Biomarkers play a crucial role in early detection and diagnosis, enabling healthcare professionals to identify diseases at their onset when treatments are often most effective. In addition, biomarkers aid in monitoring disease progression, assessing the effectiveness of therapies, and predicting patient outcomes.
High adoption of biomarkers for drug development procedures, rise in prevalence of chronic diseases and increased adoption of biomarkers in cancer, cardiac diseases, & neurological diseases, and collaborative efforts of major key players to develop biomarkers technology are the key factors that drive the growth of the biomarkers market.
The high adoption of biomarkers for drug development procedures stands as a significant driver that propels biomarkers market growth. Biomarkers, which are measurable indicators of biological processes or responses to therapeutic interventions, have gained substantial traction within the pharmaceutical industry due to their multifaceted utility. One of the primary reasons behind their widespread adoption is their ability to streamline and expedite drug development processes. By offering insights into drug efficacy, safety, and mechanisms of action, biomarkers allow more informed decision-making at various stages of drug development, from preclinical research to clinical trials. According to a 2020 report by the National Library of Medicine, it was reported that immunosuppressants, immunostimulants, drugs used in diabetes, antithrombotic drugs, antineoplastic agents, and antivirals are some of the pharmacotherapeutic class of drugs which majorly include biomarkers study in drug development process. Moreover, biomarkers play a crucial role in personalized medicine, facilitating the identification of patient subpopulations most likely to benefit from specific treatments. This targeted approach enhances patient outcomes and contributes to the optimization of healthcare resources. Thus, the high adoption of the biomarkers in drug development procedures is expected to contribute significantly to the growth of the biomarker industry.
In addition, according to biomarkers market trends analysis, the rise in prevalence of chronic diseases, such as cancer, cardiac diseases, and neurological diseases, is expected to drive the growth of the market. According to a 2023 report by the National Library of Medicine, it was reported that neurological disorders are the leading cause of physical and cognitive disability across the globe, currently affecting approximately 15% of the worldwide population. As these diseases often require long-term management and care, there is a surge in need for effective diagnostic and prognostic tools to facilitate early detection, monitoring, and personalized treatment approaches. Biomarkers, which are measurable indicators of biological processes or responses to therapies, play a crucial role in disease diagnosis. Biomarkers offer valuable insights into disease progression, therapeutic efficacy, and patient stratification, thereby enabling healthcare professionals to make informed clinical decisions.
According to a 2020 report by the National Library of Medicine, it was reported that Apolipoprotein E (APOE) gene variations are used as susceptibility/risk biomarkers to identify individuals with a predisposition to develop Alzheimer‐™s disease. Thus, a rise in the prevalence of chronic diseases is expected to drive the growth of the market.
Furthermore, according to the biomarkers market forecast analysis, the collaborative efforts by the major players and other government and private organization for advancement of biomarkers technology has significantly contributed in the growth of the market. Pharmaceutical companies, research institutions, and biotechnology firms have increasingly recognized the potential of biomarkers in revolutionizing diagnostics, drug development, and personalized medicine. Collaborations between these entities have led to the pooling of resources, expertise, and data to accelerate the discovery and validation of novel biomarkers.
In January 2024, Quibim, the global company transforming imaging data into actionable predictions of cancer progression and treatment response, announced that it has entered into a collaboration with leading science and technology company Merck KGaA. The two companies explore how to harness the potential of biomarkers and radiomics to predict a cancer patients response to immunotherapy and anticipate cancer patient outcomes. Through collaborative initiatives, major players implement technological advancements in biomarker discovery platforms and establish standards for biomarker validation and regulatory approval. Such concerted efforts are essential for overcoming the complex challenges associated with biomarker development, including variability in sample collection, assay standardization, and data interpretation. Thus, the collaborative efforts by the major players and other government & private organizations for advancement of biomarkers technology is expected to drive the growth of the market.
However, the high development cost of biomarkers stands as a significant restraint for the growth of the biomarkers market. The process of identifying, validating, and commercializing biomarkers is inherently complex and resource intensive. Researchers often encounter substantial challenges in discovering reliable biomarkers due to the intricacies of biological systems and the need for rigorous validation studies to ensure accuracy & reproducibility. In addition, regulatory requirements for biomarker validation and approval further escalate expenses, as extensive clinical trials are typically required to demonstrate their clinical utility and safety. Thus, the high development cost of biomarkers might restrain the growth of the market.
The biomarkers market growth is segmented on the basis of type, application, service, and region. By type, the market is divided into efficacy biomarkers, safety biomarkers, and validation biomarkers. By application, the market is classified into risk assessment, development of molecular diagnostic, disease diagnosis, drug discovery & development, drug formulation, forensic application, and others. By service, it is categorized into pharmaceutical & sample preparation, assay development, biomarker validation & testing, and other services. Region-wise, the market is analyzed across North America (U.S., Canada, and Mexico), Europe (France, Germany, Italy, Spain, UK, and rest of Europe), Asia-Pacific (China, Japan, India, South Korea, Australia, rest of Asia-Pacific), and LAMEA (Brazil, South Africa, Saudi Arabia, rest of LAMEA).
On the basis of type, the biomarkers market share is categorized into efficacy biomarkers, safety biomarkers, and validation biomarkers. The safety biomarkers segment dominated the global market in 2023 owing to high adoption of safety biomarkers for evaluation of safety of the drug candidate during the drug discovery and development process.
[TYPEGRAPH]
On the basis of application, the market is categorized into risk assessment, development of molecular diagnostic, disease diagnosis, drug discovery & development, drug formulation, forensic application, and others. The drug discovery and development segment dominated the global market in 2023. This is attributed to the fact that the biomarkers are used for the safety and efficiency evaluation of the drug candidate during the clinical trials. However, the disease diagnosis segment is expected to register highest growth during the forecast period, owing to high use of the biomarkers in cancer and lung cancer biomarkers.
[APPLICATIONGRAPH]
On the basis of service, the market is categorized into sample preparation, assay development, biomarker validation & biomarker testing, and other services. The sample preparation segment dominated the market in 2023. This is attributed to the fact that sample preparation encompasses a series of techniques aimed at extracting, isolating, and purifying biomolecules from complex biological matrices such as blood, urine, or tissue samples. These preparatory steps are crucial for enhancing the sensitivity, specificity, and reproducibility of biomarker assays, improving diagnostic accuracy and clinical utility. However, the assay development segment is expected to register the highest CAGR as assay development plays a pivotal role in the biomarker discovery process, serving as the foundation for accurately measuring and quantifying specific biomolecules indicative of various biological processes or disease states.
[SERVICESGRAPH]
The biomarkers market is analyzed across North America, Europe, Asia-Pacific, and LAMEA. North America dominated the market share in terms of revenue in 2023. The growth in this region is mainly attributed to the strong presence of key players and higher adoption of biomarkers for new drug development processes.
Asia-Pacific is expected to grow at the highest rate during the forecast period. This is attributed to the rise in prevalence of chronic diseases and high adoption of biomarkers for disease diagnosis such as in lung cancer biomarkers. Furthermore, the biomarkers market in Asia-Pacific is cost effective as compared to North America and some parts of Europe.
[REGIONGRAPH]
Competitive analysis and profiles of the major players in the biomarkers market, such as GE Healthcare, Abbott Laboratories, Inc., Bio-Rad Laboratories, Epistem Ltd., Eisai Co. Ltd., Roche Diagnostics Limited, Thermo Fisher Scientific Inc., Agilent Technologies Inc., Aushon Biosystem, and Siemens AG are provided in the report. Major players have adopted product launch, strategic alliance, partnership, new product development, and collaboration as key developmental strategies to improve the product portfolio and gain a strong foothold in the biomarkers market.
Key Market Segments
Key Market Players