Biomarkers Market Highlights

The global biomarkers market was estimated at USD 58.78 billion in 2023, which is expected to reach USD 183.6 billion at a CAGR of 12.06% during 2023-2033.

Biomarkers are distinct descriptors of the functional, qualitative, and safety-/toxicity-related characteristics of a product forming part of the translational regenerative medicine industry. They aid identification of patients most probable to gain from regenerative medicine, apart from efficacious monitoring of patients who have already been identified.

The global biomarkers market size is notably significant, and clinically critical indicators signal promise. At the same time, their perceived and practical applicability is dependent on the extent of sustainability of the global biomarkers market concerning its deployment and clinical efficacy. The global biomarkers market is particularly relevant for the development of drugs sans approval, in terms of charting the development pipeline promptly, as well as, informing appropriate calling-off of the pursuance of less promising drugs. Moreover, meticulous clinical trial design is a tool of value that assists with the validation and deployment of biomarkers, accelerating cost-efficient drug development, particularly in the realm of regenerative medicine.

Biomarkers Market CAGR

2023-2033

CAGR OF

12.06%

Biomarkers Market

The market is driven due to multiple factors. An uptick in the cases of cancer, demand for companion diagnostics, investments in research and development, and innovative practices, positively affect prospects of growth of the biomarkers market. For example, a study conducted as part of the Precision Medicine in Diabetes Initiative (a joint initiative of the American Diabetes Association and the European Association for the Study of Diabetes), published on 22 January 2024 in Communications Medicine, concluded with the identification of 13 biomarkers that considerably enhance the accuracy of the prediction of CVD risk in patients of type-2 diabetes. This analysis was notably performed by a global team of experts spearheaded by The John Hopkins University in the U.S., the Chinese University of Hong Kong in Hong Kong, and Sweden’s Lund University. Such advances are proof of the investments funneled into research and development practices generating potent outcomes that the biomarkers market is sure to be served by and gain from.

However, constraints exist for the biomarkers industry. As previously hinted at, application of biomarkers in relevant settings highly depends on the sustainability of their clinical efficacy deployment strategies. Additionally, the discovery-to-validation pipeline within the biomarkers market demands substantial capital investments countering the global market’s growth potential. Also, candidate-discovery overwhelms candidate-validation in terms of speed and present abilities. The financial issues facing the biomarkers market are exacerbated by fact of about 70% of drugs passing through phase III, while the rest fail to do so (disallowing manufacturers to clear In Vitro Diagnostics tests). Such clinical trials and strict regulations necessitate hefty investment figures, which constrain the relatively smaller companies from developing biomarkers.

Opportunities for the global biomarkers market arise from the continual spread of fatal diseases as noted previously, the use of biomarkers in the diagnosis of infectious diseases (expected to be commonplace in the coming years), active launches of innovation-driven combination-based treatments employing biomarkers and novel or already available medicines, the advent of digital biomarker which aids pharmaceutical companies in concluding clinical trials, and the increased focus on the commercial potential of biomarkers and related products.

Several investments in the biomarkers market have been directed in recent years, which would boost the overall biomarkers market. Some of them are:

•    On 30 January 2024, ‘Inoviv’, a developer of tailored biomarker tests, was entrusted with a huge investment from venture capital firm ‘Hoxton Ventures’ and investment manager ‘Foresight Group’ to further build up the “delivery of highly accurate, fully quantitative targeted biomarker workflows and panels.”  
•    On 16 February 2023, ‘Accenture’ announced its investment in ‘Ocean Genomics’, intended to serve as a strategic acceleration of artificial intelligence-driven drug discovery and development pipeline of personalized medicine products. The investment was channeled via ‘Accenture Ventures’. 
•    On 17 May 2023, ‘Fujitsu’ announced a collaborative undertaking with Kyoto University and ‘Chordia Therapeutics, Inc.’ to conduct artificial intelligence-based field trials building upon Fujitsu’s artificial intelligence-based causal discovery technology to enable discoveries of novel cancer drugs and better understand such biomarkers that enhance chances of breakthroughs/truncate timelines of clinical trials in the development of said drugs.

Biomarkers Market Segments’ Analysis

The biomarkers market is segmented based on type, product & service, application, disease, and region.

Based on type, the market is classified into safety biomarkers, efficacy biomarkers, and validation biomarkers. 
The safety biomarkers segment claimed the largest revenue share in 2023, which is anticipated to continue its position by 2033. Safety biomarkers allow for the customization of treatments, as well as the prediction and detection of exposure-caused effects. An uptick in the employment of safety biomarkers in drug discovery and development is expected to induce expansive biomarkers market growth. 
Efficacy biomarkers assist with the prediction of patient response to a given drug, as well as the detection of certain cancer(s) such as ovarian cancer.  

Based on product & service, the market is segmented into consumable biomarkers, service biomarkers, and software biomarkers. 
The consumable biomarkers segment spearheaded the market in 2023. Demand for consumable biomarkers employed in biomarker discovery and validation processes is pushed forward by the related demand for biomarkers to specialize in the identification of particular diseases and customize appropriate treatments, in turn, fed by the increasing attention directed toward personalized medicine. The exacerbation of the extent of cardiovascular diseases, cancer, and such, has further driven the demand for consumable biomarkers. 
The service biomarkers help in designing, implementing, and analyzing clinical trials.

Biomarkers Market

By Type

Safety Biomarkers

Efficacy Biomarkers

Validation Biomarkers

The Market will Grow

At the CAGR of:

12.06%

The Forecast Market

Size for 2033 in USD:

$183.6B

The application-based segments are diagnostics biomarkers, drug discovery & development biomarkers, personalized medicine biomarkers, and others.
Diagnostics biomarkers have attracted accelerated research efforts driving growth of the diagnostics biomarkers segment. For example, in a ‘Deccan Herald’ article dated 21 October 2023, it is announced that the ‘Centre of Excellence on Cancer Genomics and Molecular Therapeutics’ at ‘IIT Madras’ is set to start the identification and development of biomarkers to detect and understand the drug response to pancreatic cancer. Such a research initiative acts as a potent precedent for the proliferation of related research efforts at scale in India.   
The drug discovery and development biomarkers segment was dominant over the rest in 2023. Biomarkers allow for expeditious drug development in some cases by conducting predictions of drug efficacy in an easier manner than made possible by traditional clinical methodologies. This also helps in the identification of candidates that are probable to fail, consequently cutting costs.

Biomarkers Market

By Application

XX%

Diagnostics

Drug Discovery & Development

Personalized Medicine

Others

58.78

Total Market Size

USD (Billion), 2023

12.06%

CAGR

2023 - 2033

Based on disease, the market is split into cancer biomarkers, cardiovascular disease biomarkers, immunological diseases biomarkers, and others.
The cancer biomarkers segment spearheaded the market in 2023. This has been due to the increasing demand for efficient diagnostic tools and an uptick in the spread of cancer. Also, a blooming research culture invested in discovering and developing new cancer biomarkers is further pushing the biomarker market’s potential growth. For example, a research article in ‘Scientific Reports’ published on 19 January 2024, elaborates on the study undertaken which concluded with the identification of a new biomarker “based on microbiome profiling of bronchoalveolar lavage fluid” for detecting lung cancer. 
The immunological diseases biomarkers segment is driven by the increasing research characterizing the segment paired with the increasing spread of immunological diseases. For example, a report in ‘News Medical’ dated 30 January 2024, shares details of a research paper published in ‘Aging’, which claims that X-Ray repair cross-complementation group 1 (XRCC1) could potentially be utilized as a “prognostic and immunological pan-cancer biomarker”. This advance is noted to present a new target for tumor immunotherapy.

Biomarkers Market Regional Analysis

Biomarkers Market

By Region

The Market will Grow

At the CAGR of:

12.06%

The Forecast Market

Size for 2033 in USD:

$183.6B

Geographically, the market is present across regions such as North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa.  
The North American biomarkers segment spearheaded the global market in 2023. This was driven by the acute incidence of diseases, the evolution of technology, advances in consumer awareness, government-sponsored support, and advances in the infrastructural capability of the healthcare industry. Moreover, this region is advantaged by the regional set-ups of key market players based in North America. Further, key market players enter collaborative set-ups with academic research groups and such to push forward the development of biomarkers for many diseases’ diagnoses and monitoring. Additionally, the funneling of resources into developing digital biomarkers is also expected to induce further growth.

However, the Asia-Pacific region is anticipated to witness a maximum growth rate in the upcoming years, due to an acute incidence of cancer, increasing investments in the discovery of biomarkers, characteristically reduced costs of clinical trials in the region, and an uptick in research efforts, are all factors that engender and sustain regional growth.

Biomarkers Market Key Players

The market is characterized by a small number of dominant, established global market players. Such market players invest strongly in technological and infrastructural improvements, aiding in the efficient processing and analyzing of sizeable samples. Strategies such as partnerships and collaborations also characterize measures taken to consolidate increasing market shares.

In recent years, the market has witnessed several developments as companies strive to expand their product portfolios, geographical reach, and market share. For instance:
•    On 1 April 2024, it was announced that ‘Lunit’ (a leader in artificial intelligence-driven solutions concerning cancer diagnostics and therapeutics), will present seven studies at the ‘American Association for Cancer Research (AACR)’ 2024 Annual Meeting from 5-10 April 2024. The studies will showcase artificial intelligence-driven innovations in biomarker identification and their role in immunotherapy. Such advances will in turn benefit personalized treatment and medicine. 
•    On 13 February 2024, it was announced that ‘Biofourmis’ (a leading provider of digital health and decentralized clinical trial solutions) secured four new agreements with the top-20 pharmaceutical companies. The report notes former’s specialization in digital biomarker development. Said agreements are focused on oncology therapies/programs, which are in turn focused “on developing digital biomarkers and safety monitoring algorithms”. 
•    On 24 January 2024, it was announced that ‘Gate Neurosciences’ (a biotechnology company) has entered a tactical collaboration with ‘Beacon Biosignals’ to pursue advancement of the role played by “electroencephalogram (EEG) biomarkers across the company’s clinical pipeline in neuropsychiatry and cognition”.

The prominent players in this market are F. Hoffmann-La Roche AG, Epigenomics AG, Abbott, Thermo Fisher Scientific, Inc., General Electric, Merck KGaA, PerkinElmer, Inc., Agilent Technologies, Inc., Bio-Rad Laboratories, Inc., Qiagen, and Epigenomics AG.

Biomarkers Market Scope: