Biomarkers Market

Global Biomarkers Market Size (2024 to 2029)

As per our research report, the global biomarkers market size is predicted to grow to USD 102.81 billion by 2029 from USD 57.64 billion in 2024. This market is showcasing an increasing pace of 12.27% CAGR from 2024 to 2029.

Current Scenario of the Global Biomarkers Market

Biomarkers play a crucial role in diagnosing and treating various diseases such as cancer, CVDs and others. Combining biomarkers with novel drugs evaluates effective treatment procedures for different conditions. With the help of technological advancements, biomarkers are designed to treat neurological diseases by measuring biomolecules that track the brain's health. Launching biomarker signatures makes treating neurological disease easier by diagnosing it through non-invasive testing methods. Biomarkers are expected to be safe and give valid results with high precision. A biomarker is used to know how well the body responds to a treatment for a disease condition. 

MARKET DRIVERS

The rising incidence of cancer, growing CROs, and increasing prevalence of chronic diseases worldwide are primarily expanding the global biomarkers market.

In urban areas, people are more likely to adopt sedentary lifestyles, causing a high possibility of being prone to various chronic diseases. Growing chronic disease incidence, majorly cancer, CVDs, and diabetes, are demanding more research initiatives to favour market growth. According to the American Cancer Society, in 2022, an estimated 1.9 million new cancer cases are expected to register in the U.S., accounting for 609,360 deaths. The rising cancer prevalence is demanding innovations in research activities for the diagnosis and treatment of cancer. The growing innovative product launches where the innovative treatments combine biomarkers with new or existing medicine propel the biomarkers market growth.

Increasing investments in research and development, rising healthcare expenditure, and growing demand for biomarkers in the diagnostic field are crucial factors augmenting the growth of the global biomarkers market. Besides, an increasing number of low-cost clinical trials in emerging countries, growth initiatives in biomarkers research, increasing growth of information technology, and growing demand for drug discovery are further propelling the growth of the global biomarkers market. Increasing initiative steps by government organizations worldwide to reduce the cost of treatment procedures and growing focus on personalized medicine are also lavishing the demand of the biomarkers market. The rising prevalence increases the productivity of drugs in pharmaceutical companies, and people's demand for disease prevention by diagnosing as early as possible further escalates the market growth. Growing investments in healthcare centers by both public and private organizations and the rise in the priority for minimally invasive and non-invasive treatment procedures also prompt the demand of this market.

The emergence of digital biomarkers, which assist pharmaceutical companies with information to conclude clinical trial decisions, is expected to increase the market growth opportunities during the forecast period. The growing innovations in developing novel biomarkers are anticipated to record significant CAGR to the global market expansion. According to an article published by PubMed in 2022, new electroencephalogram-based non-invasive techniques with bodily fluid biomarkers are being developed, which offer an accurate prediction of Alzheimer's disease status in a patient. The rising prevalence of various chronic diseases and improving usage of biomarkers in diagnosis and treatment procedures fuel market growth opportunities. The increasing prevalence of chronic disease conditions demands innovative advancements in diagnosis and treatment methods during procedures like biomarkers, which enhance the expansion of the global biomarkers market. 

MARKET RESTRAINTS

Huge investment needs and unfavorable reimbursement policies are major restraints to the growth of the global biomarkers market.

High costs are associated with the testing processes, which is estimated to limit market expansion. Biomarker validation is a highly time-consuming and expensive procedure for launching the biomarker for administration and use in diagnostic procedures, which hampers market expansion. Healthcare settings and physicians need to evaluate the clinical trial validity of a biomarker before investing in the product. The validity may take up to 15 years, and significant investments can be very taxing, especially for smaller organizations. All these factors are estimated to limit the growth of the market size. FDA approvals for biomarkers take a lot of time and have multiple steps, making it a tiring process and restraining the market's growth. A biomarker is tested based on multiple approval points like sensitivity, reproducibility, and specificity, where meeting all these criteria can be challenging for the market players. The presence of a stringent regulatory framework for the approval, development, and marketing of the biomarkers is hindering the global market growth. 

Impact Of COVID-19 On the Global Biomarkers Market

The increase in the number of covid-19 positive cases has led to the massive development of the biomarkers market. The molecular markers in the blood are used to prevent the virus and the diseases it causes. Amplified studies have been launched into study results about understanding the pathophysiology and clinical progress of COVID-19. Biomarkers categorize early infection and individuals in danger of increasing critical conditions and requiring hospital care. Biomarkers have played an essential role in clinical decision-making and the number of infectious diseases and treatment procedures. Accessing biomarkers to determine the severity of illness and suitable resource allocation has become mandatory.

REPORT COVERAGE

SEGMENTAL ANALYSIS

Global Biomarkers Market Analysis By Product

The consumables product type segment held 56.08% of the global market share in 2023 and is expected to hold a significant market share in the global biomarkers market during the forecast period. Increasing awareness of using various devices to improve therapeutic procedures elevates the demand for this segment. The rising healthcare expenditure is expected to boost the growth rate of the global biomarkers market. The growing prevalence of chronic diseases such as cardiovascular diseases, cancer, and neurodegenerative disorders is increasing the consumption of consumables, which is expected to drive the market in the coming years further. 

The services segment is projected to grow prominently and register a CAGR of 8.84% during the forecast period as these are used in clinical trials for patient stratification and monitoring treatment responses. Biomarker services support the design, implementation, and analysis of clinical trials, where biomarkers are used extensively for decision-making in drug development, which enhances market growth. 

Global Biomarkers Market Analysis By Type

The safety biomarkers segment is predicted to register the largest share at 38.3% in the global market in 2023. The safety biomarkers are used to customize the therapies for patients due to the risk of adverse reactions, a crucial driver for segment growth. The safety biomarkers can detect the patient's adverse effects, and the growing use of safety biomarkers in drug discovery and development is expected to boost the global market expansion in the forecast period. 

The efficacy biomarkers segment is projected to have the fastest growth with a prominent CAGR during the forecast period. Efficacy biomarkers are used to predict patient responses to specific drug moieties. The increasing collaborations among companies and institutes are enhancing drug discovery and development procedures, which is escalating the market revenue.  

Global Biomarkers Market Analysis By Application

The drug discovery and development segment dominated the global market, holding 40.7% of the worldwide market share, and is anticipated to showcase a healthy CAGR during the forecast period. Biomarkers are highly beneficial in accelerating the development of drugs for various diseases as they predict efficacy more efficiently than conventional clinical methods. Biomarkers help detect the drug candidates' efficacy, reducing drug development costs as they state the drug failure chances, fueling the segmental growth in the coming years. These applications allow market players to invest in these biomarkers for drug development, leading to global market expansion. 

The diagnostics development segment is another major segment and is projected to grow fastest, with a significant CAGR during the forecast period. The growing focus of research studies on diagnostic biomarkers for certain diseases is expected to drive segment growth and expand the global market. For Instance, in February 2022, Japanese scientists discovered two diagnostic biomarkers indicated for malignant pleural mesothelioma and other cancers. 

Global Biomarkers Market Analysis By Disease Indications

The cancer segment is the most dominant and is predicted to grow with a significant CAGR during the forecast period. The increasing geriatric population and rising incidences of cancer diseases are escalating the demand for the biomarkers market. Increasing new cancer patients and the rising number of deaths due to cancer expand the scope of the cancer disease indication segment. Rapid and accurate diagnostic tools are necessary for the biomarkers, and the growing research activities for drug discovery and development for novel cancer biomarkers are expanding the global market size. 

The immunological diseases segment is anticipated to register lucrative growth during the forecast period with prominent CAGR—the rising prevalence of immunological diseases—leading to widening research activities and segment growth. For Instance, in May 2023, according to an article published by Boston Children's Hospital, researchers developed immune biomarkers to predict COVID-19 severity, which is expected to be beneficial in future pandemic conditions. 

REGIONAL ANALYSIS

North America held a significant market share of 43.21% of the global biomarkers market in 2023 and is expected to have a significant revenue share during the forecast period. The high incidence of cancer, proactive government initiatives, technical advancements, advanced healthcare infrastructure, and increased use of biomarkers in customized treatment drive the market growth in the North American region. The rising disease burden, investments from essential market participants, and growing consumer awareness in countries like the U.S. and Canada are boosting regional market expansion. The presence of significant market players, advanced research institutes, and government support initiatives in the United States are fueling the market expansion in the region. 

The market in Europe is also expected to have sizable growth during the forecast period due to the presence of several renowned research institutions and industry representatives. The growing partnerships and collaborations, access to biomarker testing, and rising interest from European universities and biomarker solution providers drive the market's growth in countries like the U.K., France, Germany, and Italy. European countries have advanced healthcare infrastructure, and the adoption of technological advancements in the healthcare industry boosts the European market expansion.

Asia-Pacific is estimated to have the fastest growth, with a significant CAGR of 14.90% during the forecast period. The market is expected to grow due to increasing cases of CVDs in countries like China and India and rising government research and development investments. The escalation of aging populations and biopharmaceutical advancements are anticipated to drive market growth. The low cost of clinical trials in developing nations and the surge in funding for discovery and development are fueling regional growth. 

KEY PLAYERS IN THE GLOBAL BIOMARKERS MARKET

Some of the noteworthy companies operating in the global biomarkers market profiled in this report are Bio-Rad Laboratories (U.S.), Qiagen N.V. (Netherlands), Enzo Biochem (U.S.), PerkinElmer, Inc. (U.S.), Merck & Co, Inc. (U.S.), EKF Diagnostics Holdings plc. (U.S.), Meso Scale Diagnostics, LLC (U.S.), Singulex, Inc. (U.S.), BioSims Technologies (France), Cisbio Bioassays (France), and Signosis, Inc. (U.S.)

RECENT MARKET DEVELOPMENTS

• In November 2023, QIAGEN launched three new kits for use on its QIAcuity systems and a new software update designed to expand the portfolio of applications for using digital PCR technology in cell and gene therapies and DNA and RNA quantification. 
• In October, LabCorp announced the launch of a tri-biomarkers blood test to diagnose Alzheimer's disease. 
• In October 2023, Mindray announced the launch of high-sensitivity NT-proBNP and troponin I cardiac biomarkers, which are used to manage and diagnose cardiovascular diseases. This launch is expected to increase the company's product portfolio. 
• In August 2023, Quest Diagnostics entered into a partnership with Envision Sciences to commercially launch a novel prostate cancer biomarker test for the identification of severe and aggressive forms of the disease. 
• In February 2023, Cardio Diagnostics Holdings Inc. announced the launch of PrecisionCHD, an epigenetic-genetic blood test for early diagnosis of coronary heart disease. 
• In March 2020, Meso Scale Discovery, a division of Meso Scale Diagnostics, announced its Biomarkers services at the AAPS National Biotechnology Conference. 
• In February 2020, Enzo Biochem announced that its subsidiary, Enzo Clinical Labs, Inc., had received New York State Approval for its CT/NG/TV tests using liquid-based cytology sample collection on its proprietary Gen-Flex platform. 
• In February 2020, QGEnN announced the receipt of the CE Mark for its therascreen PIK3CA Rotor-Gene Q PCR Kit and its subsequent Europe Launch. 
• In July 2019, Enzo Biochem Inc. announced several vital transformative initiatives in its lab business unit designed to propel and accelerate its growth. 
• In August 2018, Enzo Biochem, an integrated diagnostic and therapeutic company, announced the implementation of its growth strategy. It has agreed to purchase a commercial facility. 
• In December 2018, Singulex announced granting a significant European patent covering methods for determining myocardial. 
• In April 2016, DiagnoCure Inc. announced that its board of directors had decided to proceed with the voluntary liquidation and dissolution of Quebec's Business Corporations Act, subject to shareholder approval. 

DETAILED SEGMENTATION OF THE GLOBAL BIOMARKERS MARKET INCLUDED IN THIS REPORT

This research report on the global biomarkers market has been segmented by product, type, application, disease indications, and region.

By Product

• Consumables
• Software
• Services

By Type

• Safety Biomarkers
• Efficacy Biomarkers
• Validation Biomarkers

By Application

• Diagnostics Developments
• Drug Discovery & Development
• Personalized Medicine
• Disease Risk Assessment

By Disease Indications

• Cancer
• Cardiovascular
• Neurological
• Immunological Disorders

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• The Middle East and Africa