Biomarkers Market

Biomarkers Market (Distribution by Product (Consumables, Services and Software), by Type of Biomarker (Safety Biomarkers, Efficacy Biomarkers, Predictive Biomarkers, Surrogate Biomarkers, Pharmacodynamics Biomarkers, Prognostic Biomarkers, Validation Biomarkers and Other Type of Biomarkers), by Applications (Diagnostics, Drug Discovery and Development, Personalized Medicine, Disease Risk Assessment and Other Applications), by Therapeutic Areas (Oncological Disorder, Infectious Diseases, Immune Disorders, Neurological Disorders, Cardiovascular Disorders and Other Therapeutic Areas) and Key Geographical Regions (North America, Europe, Asia-Pacific, Middle East and North Africa and Latin America): Industry Trends and Global Forecasts, 2023-2035

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Biomarkers Market Overview 2023-2035

The global biomarkers market is a growing field with several pharmaceutical companies taking full advantage of these tools to improve healthcare delivery to patients. Biomarkers play a crucial role in the diagnosis, management, and treatment of various diseases. It involves the use of biological markers to identify and monitor the progress of medical conditions, enabling early detection and tailored treatment strategies.

Biomarkers are molecular, cellular, or biochemical changes that can be accurately and repeatably measured, and they can be used to identify and monitor physiological and pathogenic processes or responses to pharmacological interventions. They play a crucial role in various aspects of clinical research and practice, including prognosis, prediction of response to therapy, risk assessment, screening, diagnosis, pharmacogenetics, and patient monitoring during and after treatment. Biomarkers can be derived from various sources, such as DNA, RNA, proteins, lipids, cells, or processes, and they can describe a normal or abnormal biological state in an organism.

Biomarkers are essential in the rational development of medical diagnostics and therapeutics, as they help identify potential therapeutic targets, aid in understanding the mechanisms of candidate therapeutics, and assess the validity of potential therapeutics. Biomarkers are the backbone of companion diagnostics, which are an essential tool to drive the personalized medicine trend. However, there is significant confusion regarding the fundamental definitions and concepts involved in their use in research and clinical practice, which could hinder the full benefits of biomarkers. Clarification of the definitions of different biomarker classes and a better understanding of their appropriate application could yield substantial benefits in this field.

Technological developments have also been noted in biomarkers market, with the development of digital biomarkers. Digital biomarkers are analyzed in silico, using advanced analytical algorithms and artificial intelligence (AI) enabled tools, and therefore, can be used to rapidly generate actionable insights and identify previously undetected biological events (obscured by the shortcomings of manual processes).

Biomarkers Market Size 2023 - 2035 Biomarkers Market Report by Segmentation Biomarkers Market Trends by Region 2023-2035


Market Drivers: Increasing Adoption of Biomarkers to Continue to Drive the Market Growth

The biomarkers market is witnessing substantial growth driven by various factors. These include the increasing global prevalence of cancer and cardiac disorders, as well as advancements in biomarker technology. The technological advancements and innovations in biomarker testing are contributing to market expansion. Other influential factors include regulatory and reimbursement systems, the high cost of biomarkers, and investments in research and development. Additionally, the increasing focus on personalized medicine will continue to support the growth of the biomarkers market size during the forecast period.

The companies evaluating and exploring new biomarkers, especially digital biomarkers are catching the interest of venture capital firms. In February 2022, New York based Koneska raised $ 45 million in Series C funding for development of digital biomarkers. More recently in March 2023, Genialis which is working on the development of clinical biomarkers based on machine learning, raised $13 million in Series A financing.

Market Restraints: Accessibility and Affordability Challenges

Market restraints in the market include accessibility to the tests and affordability of the tests for the uninsured population. According to a recent research article, the median payer lifetime costs of all biomarker testing per patient were $394 for lung cancer and $148 for thyroid cancer in the US. Further challenges are related to high product costs and data security concerns. These factors limit the market's potential for growth despite the increasing prevalence of diseases and the surge in demand for biomarkers owing to ongoing clinical trials.

In recent times though, a number of pharmaceutical companies are collaborating with research organizations to collate evidence on biomarker testing. As such the pharmaceutical companies are also bearing the costs for the biomarker testing for the patients.

Market Opportunities: Technological Advancements Will Allow Cost Reduction and Emerging Economies Present an Untapped Market

The biomarkers market presents significant opportunities for growth and innovation, driven by various factors such as technological advancements, increasing prevalence of chronic diseases, and the growing need for early detection and personalized medicine. The global biomarkers market, including both traditional and digital biomarkers, is expected to experience substantial expansion. The rise of digital biomarkers offers unique insights into patient health through continuous and passive data collection, using wearable, sensor, and remote technology, and is expected to witness considerable growth over the coming years. Additionally, the increasing usage of wearables and ongoing clinical trials are contributing to the surge in demand for digital biomarkers, despite challenges such as high product costs and data security concerns. Overall, the biomarkers market presents lucrative opportunities for stakeholders, including healthcare companies, hospitals, pharmaceutical companies, and other industry players, to capitalize on the growing demand for biomarker-based diagnostics and personalized medicine.

The emerging economies of APAC, including India and China are amongst the most populous countries and are facing increasing burden of diseases such as cancer. It will become imperative for the healthcare systems in these economies to adopt biomarker testing to manage the healthcare costs.

Biomarkers Market Segments Overview

The biomarkers market forecast on the basis of product (consumables, services and software). On the basis of type of biomarker (safety biomarkers, efficacy biomarkers, predictive biomarkers, surrogate biomarkers, pharmacodynamics biomarkers, prognostic biomarkers, validation biomarkers and other type of biomarkers). On the basis of applications (diagnostics, drug discovery and development, personalized medicine, disease risk assessment and other applications). On the basis of therapeutic areas (oncological disorder, infectious diseases, immune disorders, neurological disorders, cardiovascular disorders and other therapeutic areas). By geographical regions, the market is analyzed across North America, Europe, Asia-Pacific, Middle East and North Africa and Latin America.

Application Analysis Section: Drug Discovery and Development to Increased Usage of Biomarkers

Based on applications, the biomarkers market is analyzed across diagnostics, drug discovery and development, personalized medicine, disease risk assessment and other applications. The drug discovery and development segment is expected to have a significant impact on the biomarkers industry. This is attributed to several factors, including the extensive research and development being carried out by prominent players, the increasing use of biomarkers in drug discovery, and the ongoing collaborative efforts in biomarker discovery. Additionally, the rising adoption of personalized medicine for chronic diseases, the widespread use of pharmacogenomics, and the growing awareness among healthcare professionals about personalized medicine are all contributing to the biomarkers market growth. However, at present the diagnostic application of biomarkers hold the largest market share.

Therapeutics Area Analysis Section: Cancer Biomarkers to Hold the Largest Market Share of Biomarkers Market

The market is segmented into different disease indications, with cancer biomarkers expected to hold the largest market share. Key drivers of market growth encompass the focus on early disease detection and management through biomarkers, escalating research and development projects funded by biotechnology and pharmaceutical firms, and the rising incidence of cancer and other diseases. Researchers are actively working on developing biomarkers that allow early detection of cancer. Many such biomarkers are being developed into liquid biopsy tests.

Regional Analysis Section: North America to Hold the Largest Share of the Global Biomarkers Market

Based on region, the biomarkers market is analyzed across North America, Europe, Asia-Pacific, and LAMEA. North America is expected to lead the biomarkers industry attributing to several factors, including a high disease burden, increased consumer awareness, supportive government initiatives, technological advancements, and improvements in healthcare infrastructure. The region is also home to key players in the industry, and various organic and inorganic developments undertaken by them are major factors expected to drive the region’s growth. Additionally, the presence of a large population suffering from chronic diseases, increasing use of biomarkers in personalized medicine, and various growth strategies adopted by key players with established pharmaceutical companies contribute to North America's dominance in the biomarkers market. On the other hand, Asia Pacific is anticipated to register the fastest growth rate in the projected period. This growth is attributed to factors such as a surge in funding for biomarkers discovery, high prevalence of cancer, rising research initiatives, and low cost of clinical trials in developing nations. Furthermore, an increase in funding for biotech and pharma companies, a rise in the number of CROs, and an increasing application scope of biomarkers are expected to facilitate regional market growth during the projected period.

Top Companies Engaged in Biomarkers Market

Key market players that are engaged in the biomarkers market are (in alphabetical order) Abbott, Axon Medchem, Bio-Rad Laboratories, BioVision, CENTOGENE, Myriad, R&D System, Roche, Sino Biological and Thermo Fisher Scientific. This market report includes an easily searchable excel database of all the biomarkers companies worldwide.

Biomarkers Market Report Highlights

Aspects Details
by Product
  • Consumables
  • Services 
  • Software
by Type of Biomarker  
  • Safety Biomarkers
  • Efficacy Biomarkers
  • Predictive Biomarkers
  • Surrogate Biomarkers
  • Pharmacodynamics Biomarkers
  • Prognostic Biomarkers 
  • Validation Biomarkers 
  • Other Type of Biomarkers
by Applications
  • Diagnostics
  • Drug Discovery and Development
  • Personalized Medicine
  • Disease Risk Assessment 
  • Other Applications
by Therapeutic Areas
  • Oncological Disorder
  • Infectious Diseases
  • Immune Disorders
  • Neurological Disorders
  • Cardiovascular Disorders 
  • Other Therapeutic Areas
Key Geographical Regions 
  • North America (U.S., Canada, Mexico)
  • Europe (France, Germany, Italy, Spain, UK, Russia, Rest of Europe)
  • Asia-Pacific (China, Japan, India, South Korea, Australia, Thailand, Malaysia, Indonesia, Rest of Asia-Pacific)
  • LAMEA (Brazil, South Africa, Saudi Arabia, UAE, Argentina, Rest of LAMEA)
Key Market Players
  • Abbott
  • Axon Medchem
  • Bio-Rad Laboratories
  • BioVision
  • CENTOGENE
  • Myriad
  • R&D System
  • Roche
  • Sino Biological
  • Thermo Fisher Scientific


Recent Developments in Biomarkers Market

There has been recent activity in the biomarkers industry and some of the key developments have been mentioned below:

  • In March 2023, Koneksa announced a partnership with SSI Strategy to accelerate and scale the adoption of evidence-based digital biomarkers in clinical trials.
  • In February 2023, Roche and Janssen broadened their partnership to enhance personalized healthcare by incorporating various companion diagnostics, such as those based on tissue and blood biomarkers, sequencing, and digital pathology.

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