Biomarkers Market Report By Application (Risk Assessment, Development of Molecular Diagnostic, Disease Diagnosis, Drug Discovery and Development, Drug Formulation, Forensic Application, DNA Fingerprinting), By Indication (Oncology, Cardiology, Neurology, and Others), By End User, By Region And Companies - Industry Segment Outlook, Market Assessment, Competition Scenario, Trends, And Forecast 2023-2032

Report Overview

The Biomarkers Market was valued at USD 58.6 billion in 2022 and is expected to register a CAGR of 14.3% during the forecast period for 2023 to 2032. It is expected to reach USD 215.7 billion by 2032.

The demands in the diagnostic market have shifted towards early and precise detection, especially crucial in early-stage diseases like cancer. Diagnostic biomarkers, which are minimally invasive or non-invasive tools, have emerged to meet these expectations, though not without challenges. They integrate with advanced imaging and data management technologies, offering clear imaging of oncology tumours while minimizing radiation exposure in procedures like CT scans and MRI scans.

For instance, in October 2022, Boston University researchers secured a USD 4.6 million grant from the National Institutes of Health for pioneering lung cancer biomarkers. Additionally, technological advancements in biomarker-based diagnostics have greatly contributed to industry expansion, leveraging omics, proteomics, and metabolomics technologies for discovery. This encompasses risk assessment, molecular diagnostics, DNA fingerprinting, among others. Moreover, biomarkers play a vital role in drug validation, testing, sample preparation, and assay development, streamlining the intricate process of discovering and developing novel drugs.

Recent progress in the field now enables non-invasive testing, expediting drug development, and early diagnosis. For instance, in March 2022, Altoida partnered with the Digital Medicine Society (DiMe) to advance its next-generation precision neuro-biomarkers platform. Furthermore, leading industry players are instituting initiatives to boost the commercialization of biomarker-based products. A case in point is Amgen, Inc.'s introduction of the Biomarker Assist program in April 2021. This program offers financial aid to metastatic NSCLC patients seeking access to biomarker testing, including the KRAS Single Gene Test (SGT) and the NGS Affordability Programs.

At present, despite notable progress in data sharing and analytical infrastructure, particularly in the field of bioinformatics, its full potential remains underutilized. Additionally, a universally standardized regulatory framework is yet to be established globally. Notably, different regions, including countries within the European Union, uphold their unique sets of regulations. This presents a substantial hurdle for conducting transnational research and facilitating data exchange.

Nevertheless, the importance of biomarkers is steadily escalating, especially in the diagnosis of critical ailments like cancer and cardiovascular diseases. Biomarkers assume a pivotal role in early diagnosis, significantly influencing the development of efficacious treatments and overall medical advancements. Reimbursement hurdles are progressively being alleviated through regulatory interventions, a catalyst anticipated to propel growth in the commercial-level diagnostic market.

Driving Factors

A Rise in Cancer Cases, The Spread of CROs, And The Rising Incidence of Chronic Illnesses Globally Are All Driving Growth in The Global Biomarkers Market.

The global biomarkers market is experiencing notable growth driven by several key factors. These include an increasing incidence of cancer, a rise in Contract Research Organizations (CROs), and a higher prevalence of chronic diseases worldwide. Urban areas, in particular, witness a greater adoption of sedentary lifestyles, heightening the susceptibility to various chronic conditions. This upsurge in chronic diseases, notably cancer, cardiovascular diseases (CVDs), and diabetes, fuels the demand for more research initiatives, thereby fostering market expansion.

Furthermore, the growth of the global biomarkers market is propelled by various essential drivers. These include escalating research and development investments, an increase in healthcare expenditure, and a growing demand for biomarkers in diagnostic applications. Additionally, the availability of cost-effective clinical trial options in emerging economies, along with initiatives promoting biomarker research and the expanding role of information technology, contribute to the market's upward trajectory.

Government organizations worldwide are taking proactive measures to reduce the cost of treatment procedures, while also emphasizing personalized medicine. This has further heightened the demand for biomarkers in the market. The increasing prevalence of biomarkers amplifies the efficacy of drugs in pharmaceutical companies. Additionally, there is a growing public call for early disease detection to prevent its progression, which is a driving force for market expansion.

Simultaneously, substantial investments in healthcare facilities by both public and private entities, coupled with a heightened focus on minimally invasive and non-invasive treatment approaches, are further stimulating the market's growth.

Global Cancer Incidence Is Rising

The escalating global cancer rates, influenced by factors like increased smoking, unhealthy dietary patterns, and sedentary lifestyles, are anticipated to lead to a greater cancer burden. Biomarkers, which reveal various health and disease characteristics, play a vital role in understanding cancer's complex development involving multiple molecular pathway events. Given the intricate nature of cancer, a single marker is insufficient, and each type of cancer exhibits a distinct molecular profile.

The discovery of novel biomarkers offers fresh avenues for developing therapeutic approaches aimed at rectifying cancer dysregulation. Consequently, the growing prevalence of cancer is poised to propel biomarker research and foster the expansion of the global market.

Expanding Diagnostic Uses of Biomarkers to Drive Industry Growth

The rise in investment for biomarker research and development, along with strategic collaborations and product launches, is anticipated to fuel biomarker demand in the coming years. Significant partnerships, such as the one between Personalis, Inc. and Merck KGaA, are dedicated to uncovering novel biomarkers related to cancer immunotherapy response and resistance mechanisms, employing Personalis' advanced cancer immunogenomics platform, ImmunoID NeXT.

Similar collaborations are poised to introduce cutting-edge products. Additionally, innovations like Owlstone Medical Ltd.'s ReCIVA Breath Sampler and CASPER Portable Air Supply, alongside Olink Proteomics' ONCOLOGY III panel, are advancing biomarker exploration. The FDA's approval of Keytruda for specific genetic biomarkers underscores the increasing importance of biomarkers in cancer treatment. With a surge in cancer and cardiovascular diseases and heightened investment from major market players, the demand for biomarkers is on track for substantial growth.

Restraining Factors

Challenges Posed by Biomarker Complexity and Variability

The intricacy and diversity of biomarkers present significant obstacles in their development, validation, and therapeutic application. Biomarkers encompass a broad spectrum, including proteins, nucleic acids (DNA, RNA), metabolites, and other substances, each introducing its own unique complexities. This ranges from the requirement for specialized detection techniques to challenges in sample collection and processing. Dealing with different biomarker types further amplifies the complexity of research and analysis.

Stringent Regulatory Procedures

The integration of biomarker-based diagnostics into clinical practice often necessitates regulatory clearance or permission. This regulatory pathway is contingent on the intended use of the biomarker, whether it's for diagnostic, prognostic, or predictive purposes. While various countries have their respective regulatory bodies, in the United States, the Food and Drug Administration (FDA) is responsible for overseeing the approval process.

Growth Opportunities

Surging Adoption of Biomarkers in Clinical Trials

The swift integration of biomarkers into clinical trials is reshaping the landscape of clinical research. Biomarkers serve as invaluable tools in the development of new drugs, providing crucial insights into disease biology, treatment responsiveness, and patient categorization. Pharmaceutical companies are increasingly relying on biomarkers to expedite drug development, reduce costs, and enhance the likelihood of successful clinical trials. Anticipated is a growing demand for biomarkers aiding in drug development, clinical trial strategizing, and discovery, presenting a significant opportunity for market expansion.

Escalating Need for Point-of-Care Testing (POCT)

Biomarkers play a pivotal role in enabling swift and convenient diagnostic testing at the point of care, closely intertwining with Point-of-Care Testing (POCT). In point-of-care diagnostics, biomarkers are harnessed to detect and quantify specific biological indicators associated with diseases or other health conditions. These biomarkers can be identified using portable devices or rapid diagnostic kits, furnishing healthcare professionals and patients with immediate and practical outcomes. This dynamic sets the stage for market growth.

Progress in Personalized Medicine

Biomarkers are pivotal in tailoring treatments to an individual's distinct genetic profile and disease traits. With ongoing advancements in genomics and proteomics research, the discovery of precise biomarkers for targeted therapies is projected to expand. This not only enhances treatment effectiveness but also minimizes side effects, leading to an increased demand for biomarker-driven diagnostics.

By Application Type

Due to substantial investments in research and development, leading to the creation of tailored treatments, along with improved predictability of drug effectiveness and streamlined approval processes, the drug discovery and development sector took the forefront in the biomarkers market and accounting for over 32.6% of the revenue share. A notable example is Halozyme, Inc.'s introduction of a personalized therapy for individuals with EGFR mutations in non-small cell lung cancer (NSCLC).

The diagnostics segment, on the other hand, is projected to experience the swiftest growth in the coming years due to its advantages in early-stage disease detection. This presents an opportunity for the diagnostic segment to champion early diagnosis and elevate diagnostic rates, thereby simplifying the identification and treatment of COVID-19. The increasing disposable income in both developed and developing nations is further driving market demand. Additionally, the expansion of hospital capacities is contributing to the accelerated growth rate of the market.

By Disease Type

The cancer segment claimed the largest portion of the global market, driven by factors such as early management and detection facilitated by cancer biomarkers. Forecasts suggest that the cancer biomarkers sector will receive an additional boost from a robust product pipeline courtesy of major manufacturers in the field. The growing elderly population and a surge in cancer cases further fuel the demand for biomarkers in the market. With an increasing number of new cancer patients and higher mortality rates due to the disease, the cancer disease segment's potential continues to expand.

By End User Type

The market is categorized into pharmaceutical and biotechnology companies, diagnostics and research facilities, specialty clinics, hospitals, and other entities. Significantly, substantial financial commitments by prominent market players in spearheading biomarker development for both diagnostic and therapeutic purposes, combined with considerable support from governmental and private sectors for advancing drug discovery and development, are expected to play a crucial role in driving the growth of the diagnostics and research laboratories sector. As an illustration, Empire Genomics, LLC, provides grants amounting to USD 250,000 to aid researchers and clinicians in creating and validating novel biomarkers in the realm of oncology.

Key Market Segment

By Application

• Risk Assessment
• Development of Molecular Diagnostic
• Disease Diagnosis
• Drug Discovery and Development
• Drug Formulation
• Forensic Application
• Others (DNA Fingerprinting and Others)

By Disease

• Cancer
• Infectious Diseases
• Immune Disorders
• Neurological Disorders
• Cardiovascular Disorders
• Other Disease Indications

By End User

• Pharmaceutical & Biotechnology Companies
• Diagnostics & Research Laboratories
• Hospitals
• Specialty Clinics
• Others

Latest Trends

More Emphasis Towards Personalized Medicine

This approach customizes medical care based on an individual's unique genetic profile, lifestyle, and environmental influences. Biomarkers serve as vital indicators of a patient's physical condition or how they respond to a specific treatment. For instance, genetic biomarkers can pinpoint particular genetic variations that might affect how a patient reacts to a specific medication. This trend holds significant importance as it enables more accurate and efficient treatments, minimizing the chances of adverse effects and enhancing overall patient well-being.

The Rising Popularity of Liquid Biopsy Biomarkers

This technique involves examining various biomarkers, such as circulating tumour DNA (ctDNA) or specific proteins, from a patient's blood sample. This non-invasive method has gained traction in oncology for offering a less intrusive alternative to conventional tissue biopsies. Liquid biopsies furnish valuable insights into the presence, status, and genetic composition of tumours, enabling oncologists to make more informed decisions about treatment. Additionally, they facilitate real-time tracking of disease progression and how a patient respond to treatment, a critical aspect in tailoring patient care.

Incorporation of Advanced Technologies Like Artificial Intelligence (AI) And Machine Learning

These technologies enhance the processing and interpretation of complex biomarker data, allowing researchers to uncover subtle patterns and correlations that might elude traditional methods. AI-driven algorithms can sift through extensive datasets to unearth novel biomarkers, forecast disease advancement, and even offer guidance on treatment strategies. This trend is reshaping how biomarkers are identified and confirmed, hastening the development of cutting-edge diagnostics and therapeutic interventions.

Regional Analysis

North America leads the global biomarkers market with a substantial 39.0% share, driven by factors like high cancer rates, proactive government initiatives, advanced healthcare infrastructure, and increased use of biomarkers in personalized treatment. This dominance is expected to continue due to ongoing investments and heightened awareness, particularly in the U.S. and Canada.

Europe is poised for substantial market growth, ascribed to esteemed research institutions, collaborations, improved access to biomarker testing, and growing interest from universities and solution providers in countries like the U.K., France, Germany, and Italy.

In the Asia-Pacific region, a remarkable compound annual growth rate (CAGR) of 16.20% is projected, fueled by rising cardiovascular disease cases in China and India, increased government R&D investments, and advances in biopharmaceuticals. Aging populations also contribute to this growth, with substantial expansion anticipated from 2023 to 2032 due to heightened global cancer concerns and a surge in research activities.

The country-specific report section offers detailed insights into individual markets, including domestic regulatory changes, influencing current and future trends. Various analytical tools like value chain analysis, technical trends assessment, Porter's five forces, and case studies are utilized to project market scenarios. Additionally, global brand presence and accessibility, competition from local players, considerations of domestic tariffs, and trade routes are all factored into the comprehensive forecast analysis of country-specific data.

Key Regions and Countries

North America

• US
• Canada

Europe

• Germany
• France
• UK
• Spain
• Italy
• Russia
• Netherland
• Rest of Europe

Asia Pacific

• China
• Japan
• South Korea
• India
• New Zealand
• Singapore
• Thailand
• Vietnam
• Rest of APAC

Latin America

• Brazil
• Mexico
• Rest of Latin America

Middle East & Africa

• South Africa
• Saudi Arabia
• UAE
• Rest of MEA

Key Players Analysis

In the competitive landscape of the biomarkers market, key competitors are assessed based on various factors including company overview, financial performance, revenue generation, market potential, R&D investments, global presence, production capabilities, strengths and weaknesses, product portfolio, and application dominance.

Leading players in this space include Abbott Laboratories Inc., Johnson & Johnson, Roche Diagnostics, Bio-Rad Laboratories, Epigenomics AG, and Qiagen, collectively holding the majority of the market share. The growth trajectory of this market is closely tied to technological advancements and R&D investments. Presently, a significant portion of resources in pharmaceutical companies is directed towards research and development, with governments also allocating substantial funding to drive technological progress. This collaborative effort between private and public sectors is instrumental in shaping the future of the biomarkers market.

Key Players in Biomakers Market

• Abbott
• Qiagen
• Hoffmann-La Roche Ltd
• Thermo Fisher Scientific, Inc
• Siemens Healthcare Private Limited
• Agilent Technologies, Inc
• Bio-Rad Laboratories, Inc
• Johnson & Johnson Services, Inc
• Epigenomics AG
• Bruker
• Quest Diagnostics Incorporated
• General Electric Company
• Becton, Dickinson and Company
• Cisbio Bioassays

Recent Developments

• In October 2023, the Indian Institute of Technology (IIT), Madras unveiled a pioneering Centre of Excellence on Cancer Genomics and Molecular Therapeutics centred on growing biomarkers for early pancreatic most cancers detection.
• In October 2023, PDS Biotech disclosed promising preliminary findings from a biomarker study involving a specific group of advanced HPV-positive head and neck cancer patients, suggesting potential positive effects.
• In October 2023, Pfizer's combination therapy of encorafenib (BRAFTOVI) and binimetinib (MEKTOVI) received FDA approval for treating adult patients with metastatic non-small cell lung cancer (NSCLC) bearing a BRAF V600E mutation. This milestone was supported by promising data from the Phase 2 PHAROS clinical trial (NCT03915951), covering both treatment-naïve and previously treated patients with this mutation.
• In March 2023, Abbott made a significant announcement regarding the FDA clearance for their pioneering laboratory blood test for traumatic brain injuries (TBIs). This milestone ensures widespread accessibility for hospitals across the United States.

Report Scope