Biomarkers Market - Global Forecast to 2026

August, 2021

Biomarkers Market by Product, Type, Application, Disease Indication, Region), Region, Trends, Competitive Analysis, and Growth Opportunities, Key Insights.

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Executive Summary

The global biomarkers market size is expected to grow from USD 43.94 billion in 2020 to USD 92.35 billion by 2026 at a CAGR of 13.2%.

The growth in the biomarkers market is largely driven by factors such as the growing importance of their associated diagnoses, the global cancer epidemic, increased funding and biomarker research grants, and new and ongoing products.

COVID-19 is an infectious disease caused by a recent coronavirus. Little known before the outbreak in Wuhan (China) in December 2019, COVID-19 has moved from a regional crisis to a global epidemic. The World Health Organization (WHO) has officially announced the outbreak of the COVID-19 epidemic.

A study by Diaceutics PLC (UK) in tracking the levels of diagnostic and biomarker tests for certain types of cancer has suggested that in the US market, the number of non-small cell cancer patients recently diagnosed has dropped by more than 30% from February 2020 to March. 2020. This dramatic decline in just one month has contributed to the KRAS, BRAF and EGFR screening levels, which are key indicators that support the right choice of treatment options that benefit certain patients. Specifically, about 4,000 fewer EGFR tests are conducted per month when most of the country initiates strict "stay at home" orders, representing a 13% decline in the previous month. Decreases were also observed in a wide range of cancers (14% lower), acute myeloid leukemia (also 14% lower), breast cancer (8.4% lower), and cervical cancer (8.6% lower).

On the other hand, many biomarkers also play a key role in securing COVID-19. Biomarkers such as C-reactive protein, serum amyloid A, interleukin-6, lactate dehydrogenase, neutrophil-to-lymphocyte balance, D-dimer, cardiac troponin, renal biomarkers, lymphocytes, and platelet count. These marks showed significantly higher rates in patients with severe COVID-19 infection compared to their non-severe counterparts. Lymphocytes and platelet counts showed significantly lower levels in severe patients compared to non-severe patients.

Partner diagnoses and biomarkers are becoming increasingly relevant to drug development, which has led to the diagnosis, treatment, and monitoring in many areas of disease. It can be used to identify patients who may respond well to specific drugs or treatment options. These trumpets are often used in conjunction with a particular medicine. For example, the Oncomine Dx Target Test (Thermo Fisher Scientific, Inc.) assists in biomarker testing of non-small lung cancer patients (NSCLC) suitable for ROZLYTREK.

Confirmation of biomarkers is a long process due to inconsistencies in its effectiveness in diagnosing diseases. Because of this, the verification process is time-consuming (about 15 years and the time required for FDA approval) and is expensive. Different phases of biomarker tend to divide the stages of the development and validation process, so the process and timeline for growing and validating biomarkers are the same for all biomarker categories, with few exceptions. One difference is the length of time required for clinical validation and the phase of use of predictive biomarkers and endpoints, compared with predictive and safety biomarkers. Development and validation are very expensive for end-of-life tests, especially in clinical trials, due to the extensive clinical validation required.

Biomarkers play a major role in customized medicine, with applications that include diagnostics, prognosis, and selection of targeted drugs. Over the years, personalized medicine has received recognition for its wide range of standard diagnostic and therapeutic procedures. Many areas of medicine, from cancer to allergies, go to treatments designed for individual patients based on their genetic signature and clinical signs. Personalized medicine is used to identify the most effective treatment for each patient. The use of biomarkers plays a very important role in certain aspects of the drug made for you. The materials used for biomarker testing enable the identification of these diseases. Biomarker diagnostic products are also used as a test component of several investigative treatments.

In addition, advances in genomics have promoted a better understanding of certain types of cancer, allowing for the development of specific therapies based on genetic mutations or cellular immunization, which can give patients better ways to treat their cancer. Biopharmaceutical researchers focus on identifying biomarkers, for example, positive HER2-positive genetic mutations in women with breast cancer. These changes can be passed from one generation to the next and can help predict a patient's risk of developing specific cancer. By providing medical care using biomarkers, health care providers can bring personalized benefits to each patient.

The biomarker verification process includes experimental testing or measurement of performance factors such as sensitivity, specificity, and reproduction. Verification is important in establishing biomarkers as a reliable tool to support development, medical care, and biopharma investment decisions. However, the high costs involved in biomarker certification are a major problem for companies, especially small organizations. In addition, factors such as natural variability in biomarker levels and cellular heterogeneity pose additional challenges to the biomarker validation process. Another challenge is the length of time required for the development of an assay because the ability to develop assays does not match the ability to produce biomarkers.

The use of biomarker-based testing in clinical settings requires proof of clinical validity of the biomarker. This is important not only to assist physicians in their decision-making process within the manufacture of evidence-based medicine but also to obtain regulatory approval and appropriate re-examination. However, collecting the necessary information to demonstrate the validity of the clinic and its use can be a time-consuming and expensive process, which continues to be complicated by the lack of standards. There are also questions about data sharing, protection, and analysis. All of these factors can pose a significant challenge to the biomarkers market.

By product, the market for biomarkers is divided into consumables, services, and software. In 2020, the consumables segment had the largest share in the global biomarkers market. A large proportion of this category can mainly be attributed to the increasing use of products based on biomarker testing kits and repeated sales.

By type, the market for biomarkers is divided into efficacy biomarkers, safety biomarkers, and validation biomarkers. In 2020, the efficacy biomarkers segment had the largest share in the global biomarkers market. A large proportion of this phase is due to the ability of these biomarkers to evaluate the therapeutic efficacy of drug products.

By disease indication, the market for biomarkers is divided into cancer, infectious diseases, neurological disorders, immunological disorders, cardiovascular disorders, and other disease indications. In 2020, the infectious diseases segment had the largest share in the biomarkers market. A large proportion of this phase is due to an increase in infectious diseases, which are associated with the outbreak of the COVID-19 epidemic.

By application, the market for biomarkers is divided into diagnostics, drug discovery & development, personalized medicine, disease risk assessment, and other applications. In 2020, the diagnostic segment had the largest share of the application component in the biomarkers market. The use of biomarkers in the diagnosis of many diseases, including cancer, infectious diseases, cardiovascular disorders is on the rise. The increasing use of biomarkers is a major factor contributing to the growth of the diagnostic component in the biomarkers market.

In 2020, North America had the largest market share. A large proportion of this region is due to the increasing use of biomarkers in personalized medicine, the various growth strategies available to key players with established pharmaceutical companies in the region, and the high level of acceptance of diagnostic biomarkers, especially in cancer testing.

The prominent players of the biomarkers market are Thermo Fisher Scientific Inc. (US), F. Hoffmann-La Roche Ltd. (Switzerland), Abbott Laboratories (US), QIAGEN N.V. (Netherlands), PerkinElmer, Inc. (US), Bio-Rad Laboratories, Inc. (US), Merck KGaA (Germany), Enzo Biochem, Inc. (US), Charles River Laboratories International, Inc. (US), and Eurofins Scientific (Luxembourg).

Global Biomarkers Market Size, 2017-2026 (USD Billion)
Global Biomarkers Market Size, By Region, 2017-2026 (USD Billion)
Global Biomarkers Market Revenue Share (%), By Product (2020)
Global Biomarkers Market Revenue Share (%), By Type (2020)
Global Biomarkers Market Revenue Share (%), By Application (2020)
Global Biomarkers Market Revenue Share (%), By Disease Indication (2020)
Global Biomarkers Market Revenue Share (%), By Region (2020)

Market Overview

Definition & Scope

A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition.

Currency, Year & Forecasts Overview

For companies reporting their revenues in other currencies, the average annual currency conversion rates were used for a particular year to convert the value to USD.
For companies reporting their revenues in USD, the revenues were taken from their respective annual reports/SEC filings.
The currency used in this report is USD, with the market size indicated in terms of USD million/billion.

Industry Analysis

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Market Analysis

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By Product

Global Biomarkers Market Size, By Product, 2017-2026 (USD Billion)
Consumables Market Size, 2017 vs 2020 vs 2026 (USD Billion)
Services Market Size, 2017 vs 2020 vs 2026 (USD Billion)
Software Market Size, 2017 vs 2020 vs 2026 (USD Billion)

By Type

Global Biomarkers Market Size, By Type, 2017-2026 (USD Billion)
Safety Biomarkers Market Size, 2017 vs 2020 vs 2026 (USD Billion)
Efficacy Biomarkers Market Size, 2017 vs 2020 vs 2026 (USD Billion)
Validation Biomarkers Market Size, 2017 vs 2020 vs 2026 (USD Billion)

By Application

Global Biomarkers Market Size, By Application, 2017-2026 (USD Billion)
Diagnostics Market Size, 2017 vs 2020 vs 2026 (USD Billion)
Drug Discovery and Development Market Size, 2017 vs 2020 vs 2026 (USD Billion)
Personalized Medicine Market Size, 2017 vs 2020 vs 2026 (USD Billion)
Disease Risk Assessment Market Size, 2017 vs 2020 vs 2026 (USD Billion)
Other Applications Market Size, 2017 vs 2020 vs 2026 (USD Billion)

By Disease Indication

Global Biomarkers Market Size, By Disease Indication, 2017-2026 (USD Billion)
Cancer Market Size, 2017 vs 2020 vs 2026 (USD Billion)
Cardiovascular Disorders Market Size, 2017 vs 2020 vs 2026 (USD Billion)
Neurological Disorders Market Size, 2017 vs 2020 vs 2026 (USD Billion)
Immunological Disorders Market Size, 2017 vs 2020 vs 2026 (USD Billion)
Other Diseases Market Size, 2017 vs 2020 vs 2026 (USD Billion)

North America

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Europe

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Asia Pacific

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Middle East & Africa

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Latin America

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Company Analysis

Thermo Fisher Scientific

Thermo Fisher Scientific was founded in 1956 and is headquartered in Massachusetts, US. Its employee strength is 80,000. The company has direct presence across the regions of North America, Europe, Asia Pacific, Middle East and Africa, and South America. It is a leading global supplier of life sciences technologies and solutions. Thermo Fisher Scientific enables its customers to make the world cleaner, safer, and healthier. Thermo Fisher Scientific serves over 400,000 customers from the fields of pharmaceuticals, biotech, hospitals, clinics, diagnostic labs, universities, research institutes, and government.

Biomarker: Cancer Biomarker

Competitive Analysis

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Analyst Insights For Success

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Research Methodology

This research study involved the usage of extensive secondary sources, directories, and databases such a Hoovers, Bloomberg Business, Factiva, and Avention, in order to identify and collect information useful for this technical, market-oriented, and commercial study of the global biomarker market. The primary sources were mainly industry experts from the core and related industries. These include service providers, technology developers, standards and certification organizations, and organizations related to all segments of the value chain.

In-depth interviews were conducted with various primary respondents, which include key industry participants, subject-matter experts (SMEs), C-level executives of key market players, and industry consultants, to obtain and verify critical qualitative and quantitative information as well as to assess future prospects.

Various secondary sources were referred to for the identification and collection of information for this study. Secondary sources include annual reports, press releases, and investor presentations of companies, white papers, medical journals, certified publications, articles from recognized authors, gold standard and silver standard websites, directories, and databases.

Secondary research was mainly used to obtain key information about the industry’s supply chain, market’s monetary chain, the total pool of key players, market classification and segmentation according to industry trends to the bottom-most level, geographical markets, and key developments from both market-and technology-oriented perspectives.

After the market engineering process (which includes calculations for market statistics, market breakdown, market size estimations, market forecasting, and data triangulation) was completed, extensive primary research was conducted to verify and validate the critical numbers arrived at. Primary research was also conducted to identify the segmentation types; industry trends; key players; the competitive landscape of global biomarker market; and key market dynamics such as drivers, restraints, opportunities, challenges, and key industry trends.

In the complete market engineering process, both top-down and bottom-up approaches were extensively used along with several data triangulation methods to perform market estimation and market forecasting for the overall market segments and sub segments listed in this report.

Appendix

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