Biomarkers Market by Product & Service (Consumable, Service, Software), Type (Safety, Efficacy, Validation), Disease (Cancer, Infectious, Neurological), Application (Diagnostics, Drug Discovery, Personalized Medicine), Region - Global Forecast to 2028
Updated on : March 28, 2023
The global biomarkers market in terms of revenue was estimated to be worth $59.1 billion in 2023 and is poised to grow at a CAGR of 12.0% from 2023 to 2028.
The current edition of the report consists of updated industry trends. The report also includes strategic benchmarking, Porter's Five Force Analysis, and the impact of the recession on the global biomarker market. The current edition of the report consists of an updated competitive landscape along with the addition of a competitive leadership map for start-ups. Factors responsible for the growth in the global market are mainly factors such as the growing importance of companion diagnostics, the increasing prevalence of cancer and cardiac problems, increasing funds and grants for biomarker research, continuous product innovations, and biomarker advancements.
Biomarkers Market Trend
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Biomarkers Market Dynamics
Drivers: Increasing prevalence of cancer worldwide
The future burden of cancer is expected to be even larger due to the increasing prevalence of smoking, unhealthy food habits, and physical inactivity, among others. Biomarkers can indicate a variety of health or disease characteristics. Cancer is a complex disease developed through a multi-stage carcinogenesis process involving multiple molecular pathway events creating a hurdle in diagnosis, prognosis, and therapy. Due to the complex nature of cancer, a single marker is not helpful. Moreover, each type of cancer differs from others in molecular profile. The discovery of new biomarkers provides new opportunities for deriving therapeutic strategies designed to reverse dysregulation in cancer. Thus, the increasing prevalence of cancer will drive biomarker research and, in turn, the growth of the global market.
Restraints: High capital investments and lengthy timelines for biomarker development
Huge capital investments are required for the discovery, development, and validation of biomarkers. This weighs down the growth of the global market and other related markets such as diagnostics (in vitro diagnostics or companion diagnostics) and personalized medicines. The discovery of candidate biomarkers far outpaces the current ability to validate them. This is a major challenge faced by the personalized medicines market. Also, due to the high drug attrition rate in clinical trials (with almost 30% of drugs failing in phase III), diagnostics manufacturers face enormous financial challenges. To pass an IVD from the regulators, manufacturers need successful phase III clinical trials, which are in turn dependent on well-validated biomarker tests. Huge investments are required to run clinical trials and address stringent regulatory requirements, which not only affect the ability of small companies to develop biomarkers but also severely affect innovation. Hence, along with high capital investments, the low cost-benefit ratio also hinders the market growth.
Opportunities: Emerging economies
Emerging markets such as India and China offer significant growth opportunities for diagnostics biomarkers. This is largely due to the growing patient population and the subsequent increase in diseases such as cardiovascular diseases and cancer in these countries. A research study published by the American Heart Association (AHA) found that with risk factors remaining constant, annual cardiovascular events in China were projected to increase by more than 50% from 2010 to 2030. According to The Lancet, cardiovascular diseases accounted for 28% of all deaths in India in 2016, and it is projected to increase to 36% by 2030. The increasing incidences & burden of cardiovascular diseases in emerging countries will drive the demand for early disease diagnostic procedures, which will offer various opportunities for players operating in the biomarker testing market.
Additionally, the leading players of this market are also adopting various strategies to expand their position and product offerings in these nations. For instance, in January 2020, Merck (Germany) opened a non-profit, high-tech skill development center in collaboration with the Council of Scientific and Industrial Research’s Institute of Microbial Technology (CSIR-IMTECH) in Chandigarh, India. The center is equipped with genome-editing, single-molecule biomarker detection, and other technologies to help local students build life science skills. Such strategies adopted by leading players are expected to drive the market for biomarker research in these counties.
Challenges: Technical issues related to sample collection &storage.
Many epidemiology studies use biomarkers to investigate different stages of diseases in humans. It requires careful handling and storage of precious biological samples to obtain a large amount of information from limited samples and minimize future research costs by using banked samples. Sample collection is thus one of the key issues faced by service providers, followed by access to these samples.
Similarly, stringent quality control is also required for these samples, and they need to be stored under the right conditions to avoid any loss. Different samples are required for risk detection, screening, diagnosis, and monitoring processes. The validity of results from biomarker studies using archived specimens depends on the integrity of specimens and how they were collected, processed, and stored. In addition to the consideration of maintenance of samples likely to yield valid results, specimen banks have to be structured so that all elements of patient rights, privacy, and confidentiality are maintained with informed consent that is thorough and addresses the potential use of samples. Furthermore, detailed tracking, specimen storage, and retrieval software are important for proper sample handling and management. Thus, both sample collection and storage may pose a challenge for the global market.
In 2022, by product and service segment, the consumables segment accounted for the largest share of the biomarkers market.
Based on product, the market is segmented into consumables, services, and software. In 2022, the consumables segment accounted for the largest share of the global global market. The large share of this segment can primarily be attributed to the increasing use of kit-based products for biomarker testing and the repeated purchase of consumables.
In 2022, by type, the safety biomarkers segment accounted for the largest share of the biomarkers market.
On the basis of type, the market is segmented into efficacy biomarkers, safety biomarkers, and validation biomarkers. In 2022, the safety biomarkers segment accounted for the largest share of the global market. Factors responsible for the large share of this segment are higher awareness of routine health checks in people, lower attrition rate for drugs and an increase in number of people with chronic diseases.
In 2022, by disease indication, the cancer segment accounted for the largest share of the biomarkers market.
On the basis of disease indication, the market is segmented into cancer, infectious diseases, neurological disorders, immunological disorders, cardiovascular disorders, and other disease indications. In 2022, cancer segment accounted for the largest share of the global market. Factors responsible for the high growth of the segment includes early management and early detection by cancer biomarkers. In the future, the cancer biomarkers is expected to be further boosted by a strong pipeline of products from major manufacturers related to cancer.
By application, the diagnostics application segment accounted for the largest share of the biomarkers market in 2022.
On the basis of application, the market is segmented into diagnostics, drug discovery & development, personalized medicine, disease risk assessment, and other applications. In 2022, the diagnostics segment accounted for the largest share of the application segment in the market. Factor responsible for the growth in this segment include, the segment will expand as chronic diseases will become more prevalent, and targeted treatment and diagnosis demand will increase. The growing applications of biomarkers is also driving the growth of the diagnostics segment of the global market.
In 2022, North America accounted for the largest share of the biomarkers market.
In 2022, North America accounted for the largest share of the market. Factors responsible for the growth of the region includes increasing population suffering from chronic diseases in the region, increasing use of biomarkers in personalized medicine, various organic & inorganic growth strategies adopted by key players with established pharmaceutical companies in this region, increasing applications and advancements in biomarkers.
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The biomarkers market is dominated by a few globally established players such as F. Hoffmann-La Roche Ltd. (Switzerland), Thermo Fisher Scientific Inc. (US), Abbott Laboratories (US), QIAGEN N.V. (Netherlands), PerkinElmer, Inc. (US), Merck KGaA (Germany), Bio-Rad Laboratories, Inc. (US), Enzo Biochem, Inc. (US), Charles River Laboratories International, Inc. (US), and Eurofins Scientific (Luxembourg).
Biomarkers Market Report Scope
Report Metric |
Details |
Market Revenue in 2023 |
$59.1 billion |
Estimated Value by 2028 |
$104.0 billion |
Growth Rate |
Poised to grow at a CAGR of 12.0% |
Segments Covered |
Product & Service, Type, Application, Disease Indication, and Region |
Geographies Covered |
North America, Europe, Asia Pacific, and Rest of World |
The study categorizes the biomarkers market into following segments & sub-segments:
By Product
- Consumables
- Services
- Software
By Type
- Safety Biomarkers
- Efficacy Biomarkers
- Predictive Biomarkers
- Surrogate Biomarkers
- Pharmacodynamics Biomarkers
- Prognostic Biomarkers
- Validation Biomarkers
By Application
- Diagnostics
- Drug Discovery & Development
- Personalized Medicine
- Disease Risk Assessment
- Other Applications
By Disease Indication
- Cancer
- Infectious Diseases
- Immune Disorders
- Neurological Disorders
- Cardiovascular Disorders
- Other Disease Indications
By Region
-
North America
- US
- Canada
-
Europe
- Germany
- Italy
- Spain
- UK
- France
- Rest of Europe
-
Asia Pacific
- China
- Japan
- India
- Rest of Asia Pacific
-
Rest of the World
- Latin America
- The Middle East and Africa
Recent Developments
- In December 2022, F. Hoffmann-La Roche Ltd. (Switzerland) announced that Elecsys beta-amyloid (1-42) CSF II (Abeta42) and Elecsys phospho-Tau (181P) CSF (pTau181) assays had received U.S. Food and Drug Administration (FDA) 510(k) clearance. The Elecsys AD CSF Abeta42 and pTau181 assays (used as a pTau181/Abeta42 ratio) measure two biomarkers that are hallmarks of Alzheimer's pathology, beta-amyloid and tau proteins, in adults ages 55 and older being evaluated for the disease.
- In September 2022, Enzo Biochem launched the AMPIVIEW Gene Expression Platform with products targeting the detection of HPV and SARS-CoV-2.
- In April 2021, F. Hoffmann-La Roche Ltd. (Switzerland) launched two cardiac biomarker tests: high-sensitivity cardiac troponin T (cTnT-hs) and N-terminal pro-brain natriuretic peptide (NT-proBNP). These gold standard biomarkers support cardiovascular disease management and can help clinicians diagnose heart attacks and manage heart failure better.
- In May 2021, QIAGEN N.V. (Netherlands) launched the first FDA-approved tissue companion diagnostic, therascreen KRAS RGQ PCR Kit, to identify the KRAS G12C mutation in NSCLC tumors and expand precision medicine options in lung cancer.
Frequently Asked Questions (FAQs):
What is the projected market value of the global biomarkers market?
The global market of biomarkers is projected to reach USD 104.0 billion.
What is the estimated growth rate (CAGR) of the global biomarkers market for the next five years?
The global biomarkers market is projected to grow at a Compound Annual Growth Rate (CAGR) of 12.0% from 2023 to 2028.
What are the major revenue pockets in the biomarkers market currently?
In 2022, North America accounted for the largest share of the market. Factors responsible for the growth of the region includes increasing population suffering from chronic diseases in the region, increasing use of biomarkers in personalized medicine, various organic & inorganic growth strategies adopted by key players with established pharmaceutical companies in this region, increasing applications and advancements in biomarkers.
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This market research study involved the extensive use of secondary sources, directories, and databases to identify and collect information useful for this technical, market-oriented, and financial study of the global biomarkers market. In-depth interviews were conducted with various primary respondents, including key industry participants, subject-matter experts (SMEs), C-level executives of key market players, and industry consultants, among other experts, to obtain and verify critical qualitative and quantitative information and assess market growth prospects. The global size of the biomarkers market (estimated through various secondary research approaches) was then triangulated with primary research inputs to arrive at the final market size.
Secondary Research
The secondary sources referred to for this research study include publications from organizations such as the World Bank, GLOBOCAN, World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), National Cancer Institute, Food and Drug Administration (FDA), European Medicines Agency, National Comprehensive Cancer Network (NCCN), The European Association for Cancer Research (EACR), Australian Cancer Research Foundation (ACRF), and National Institutes of Health (NIH).
Secondary sources also include corporate and regulatory filings (such as annual reports, SEC filings, investor presentations, and financial statements); business magazines and research journals; press releases; and trade, business, and professional associations. Secondary data was collected and analyzed to arrive at the overall size of the global biomarkers market, which was validated through primary research.
Primary Research
Extensive primary research was conducted after acquiring basic knowledge about the global biomarkers market scenario through secondary research. Several primary interviews were conducted with market experts from both the demand-side (such as personnel from pharmaceutical & biotechnology companies, academia, research, and CROs) and supply-side (such as C-level and D-level executives, product managers, and marketing and sales managers of key manufacturers, distributors, and channel partners from tier 1 and tier 2 companies offering biomarkers) across five major regions—North America, Europe, the Asia Pacific, and the Rest of the World (Latin America & the Middle East & Africa). Approximately 70% and 30% of primary interviews were conducted with supply-side and demand-side participants, respectively. This primary data was collected through questionnaires, e-mails, online surveys, personal interviews, and telephonic interviews.
To know about the assumptions considered for the study, download the pdf brochure
Data Triangulation
After arriving at the overall size of the biomarkers market through the methodology mentioned above, this market was split into several segments and subsegments. Market breakdown procedures were employed, wherever applicable, to arrive at the exact market value for the key segments and subsegments. The extrapolated market data was triangulated by studying various macroindicators and regional trends from both demand and supply-side participants.
Report Objectives
- To define, describe, and forecast the global biomarkers market on the basis of product & service, type, application, disease indication, and region
- To provide detailed information regarding the major factors influencing the growth of the market (drivers, restraints, opportunities, and challenges)
- To strategically analyze micromarkets and subsegments with respect to individual growth trends, future prospects, and contributions to the overall biomarkers market
- To analyze the opportunities in the market for stakeholders and provide details of the competitive landscape for market leaders
- To profile the key players in the global biomarkers market and comprehensively analyze their core competencies and market rankings
- To forecast the size of the market segments with respect to four main regions, namely, North America, Europe, Asia Pacific, and the Rest of the World (RoW)
- To track and analyze competitive developments such as acquisitions, new product developments & approvals, agreements, partnerships and collaborations in the biomarkers market
Available Customizations
With the given market data, MarketsandMarkets offers customizations as per the company’s specific needs. The following customization options are available for the report:
Geographic Analysis
- Further breakdown of the European biomarkers market into RoE countries
- Further breakdown of the Asia Pacific biomarkers market into RoAPAC countries
Company Information
- Detailed analysis and profiling of additional market players (up to 5)
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