The global biomarker discovery outsourcing services market was valued at USD 10.66 billion in 2022 and is expected to grow at a CAGR of 20.8% during the forecast period.
Advancements are influencing the market in personalized medicine, the integration of Omics techniques, and the increasing adoption of state-of-the-art technologies. Revolutionary technologies such as CRISPR-based approaches and single-cell analysis are shaping the landscape of discovery services. The COVID-19 pandemic has had a profound impact on the market, highlighting the critical need to identify biomarkers for infectious diseases and public health. The urgent nature of the situation has led to increased funding and interest in biomarker research related to COVID-19.
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Biomarkers of protein in bodily fluids play a crucial role in healthcare and clinical research, as they help with diagnosis and patient monitoring. In dementia research, new biomarkers could help tackle challenges related to early diagnosis and participant selection for clinical trials. Despite their potential, fluid biomarkers have yet to be integrated into standard clinical practice due to the difficulty of translating biomarker candidates from advanced high-throughput methods to precise antibody-based immunoassays. Fortunately, the field of bioinformatics has made significant progress, resulting in numerous user-friendly tools and data resources that aid researchers in selecting appropriate biomarker candidates and suitable commercial affinity reagents.
The market is experiencing significant growth due to the rising prevalence of chronic diseases such as cardiovascular diseases, cancer, diabetes, and neurodegenerative conditions. For instance, in 2022, the American Cancer Society reported approximately 1.9 million new cancer cases and 609,360 cancer-related deaths in the U.S. Biomarkers are instrumental in the early diagnosis, prognosis, and monitoring of these diseases. They provide valuable information about the disease's progression, helping clinicians make informed decisions about treatment strategies. As the demand for accurate and timely diagnosis continues to surge, the need for biomarker discovery services has increased substantially, driving the growth of the biomarker discovery outsourcing services market.
The sector of outsourcing biomarker discovery services is experiencing growth due to the expanding drug development pipeline. Recent data from NSF indicates a significant milestone, with over 20,000 products currently in development within the pharmaceutical industry. Biomarkers play a crucial role in this process by helping to identify and validate drug targets, as well as stratify patients in clinical trials. Biomarkers provide critical insights into how a drug interacts with the body and can help predict a patient's response to a particular treatment. Consequently, biomarker discovery services have become indispensable for pharmaceutical companies, ensuring the efficiency and effectiveness of their drug development endeavors.
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Growth Drivers
The market for Biomarker Discovery Outsourcing Services is poised for significant growth in the future, mainly due to the increasing focus on personalized medicine. In 2022, the U.S. Food and Drug Administration (FDA) played a crucial role in this trend. They approved 12 new personalized medicines and expanded the applications for existing personalized treatments. Additionally, the FDA authorized the use of five gene and cell-based therapies, provided guidelines for the advancement of such therapies, and approved two innovative siRNA therapies. The identification and validation of biomarkers is the key factor that is expected to drive the market's growth in the forecast period.
The growing emphasis on personalized medicine and targeted therapies is driving the demand for Biomarker Discovery Outsourcing Services. Traditional "one-size-fits-all" approaches to treatment have limitations in terms of efficacy and safety. This limitation has spurred a growing interest in customizing medical treatments to suit individual patients. Biomarker discovery plays a central role in this transformative shift, enabling healthcare providers and pharmaceutical companies to pinpoint specific biomarkers and genetic markers linked to various diseases. This, in turn, facilitates the development of tailored treatment strategies. Not only does this personalized approach enhance treatment effectiveness, but it also reduces adverse effects, leading to improved patient outcomes and satisfaction.
Furthermore, the increasing prominence of targeted therapies, which are designed to target molecules or pathways associated with diseases specifically, further amplifies the demand for biomarker discovery services. Biomarkers are instrumental in identifying the appropriate patient populations for these targeted therapies, ensuring that the right patients receive the most suitable treatment, ultimately increasing the chances of treatment success. As the pharmaceutical industry continues to invest in the development of more precise and effective drugs, the necessity for biomarker discovery outsourcing services is projected to grow.
The market is primarily segmented based on type, therapeutic area, discovery phase, end use, and region.
By Type |
By Therapeutic Area |
By Discovery Phase |
By End Use |
By Region |
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The surrogate endpoints segment had the largest revenue share in clinical trials. Clinical trials that aim to achieve critical outcomes like patient survival or disease progression often require a lot of time and resources. Surrogate biomarkers offer a solution by providing early insights into treatment effectiveness, allowing for shorter and more efficient trials. This advantage is expected to drive the growth of this segment.
Predictive biomarkers are expected to grow rapidly. Pharmaceutical companies are increasingly relying on predictive biomarkers to identify patient groups that are likely to respond to experimental drugs. These biomarkers offer commercial appeal by streamlining drug development and regulatory approvals, resulting in cost savings and revenue generation.
The oncology segment has the largest market share, as cancer is a significant global health issue that causes extensive morbidity and mortality. The high incidence of various types of cancers, such as lung, breast, prostate, and colorectal cancer, has led to significant investment and research in oncology biomarkers. The identification of genomic biomarkers, which include gene mutations like EGFR, KRAS, and BRCA, has been critical in oncology. Advanced technologies like next-generation sequencing have facilitated the precise identification of these biomarkers.
Autoimmune disorders are expected to grow rapidly, and there is a need for improved diagnostic and prognostic biomarkers to address the increasing incidence of such disorders. Additionally, personalized medicine is gaining more prominence in the area of autoimmune diseases, where biomarkers play a vital role in identifying specific patient subgroups that may respond better to treatments or exhibit diverse disease progressions.
The biomarker identification segment holds the largest share of the market. Biomarkers are used in various applications, such as disease diagnosis, prognosis, drug development, and therapeutic regimen monitoring. Outsourcing biomarker identification proves to be cost-effective and time-efficient compared to in-house endeavors. Organizations can leverage advanced technologies and expert teams without requiring substantial capital investments.
The biomarker validation segment is expected to grow rapidly. Biomarker validation involves ensuring the accuracy, reliability, and clinical relevance of potential biomarkers. The high demand for biomarker validation services is driven by the emphasis on clinical translation. Regulatory bodies such as the FDA and the European Medicines Agency (EMA) mandate precise validation of biomarkers for their use in diagnostics, prognostics, or treatment selection. These further fuels market growth.
The biotechnology companies segment holds the largest share of biomarker discovery outsourcing. This is because outsourcing is a more cost-effective option as compared to maintaining in-house teams, infrastructure, and equipment. This approach enables biotechnology firms to allocate resources more efficiently, allowing them to concentrate on their core strengths, like drug development and therapeutic research.
The pharmaceutical companies segment is expected to grow rapidly. These companies play a crucial role in drug discovery and development, where biomarker identification holds significant importance. Biomarkers help in identifying drug targets, categorizing patients in clinical trials, and evaluating responses. As a result, pharmaceutical firms are highly motivated to invest in biomarker discovery, leveraging these findings to enhance their strategic intelligence.
North America has emerged as the largest region for biomarker research and validation. This dominance can be attributed to the region's access to state-of-the-art technologies, sophisticated healthcare infrastructure, regulatory proficiency, and a thriving biotechnology sector. The Canadian Food Inspection Agency (CFIA) and the U.S. Food and Drug Administration (FDA) have well-defined regulatory frameworks for biomarkers in drug and diagnostic development, which provide substantial support for biomarker research and validation initiatives.
The Asia Pacific region is expected to experience rapid growth in the biomarker market. Emerging markets for pharmaceuticals and biotechnology, particularly in China and India, make several Asia Pacific countries attractive for outsourcing biomarker discovery initiatives due to their cost-effectiveness. Furthermore, the introduction of new biomarkers into the market is anticipated to fuel growth in the upcoming years.
Prominent companies in this sector are implementing diverse strategic moves, including forming partnerships, collaborations, and introducing new services, to uphold their robust position in the market.
Some of the major players operating in the global market include:
Report Attributes |
Details |
Market size value in 2023 |
USD 12.85 billion |
Revenue forecast in 2032 |
USD 70.44 billion |
CAGR |
20.8% from 2023 – 2032 |
Base year |
2022 |
Historical data |
2019 – 2021 |
Forecast period |
2023 – 2032 |
Quantitative units |
Revenue in USD billion and CAGR from 2023 to 2032 |
Segments covered |
By Type, By Therapeutic Area, By Discovery Phase, By End Use, By Region |
Regional scope |
North America, Europe, Asia Pacific, Latin America; Middle East & Africa |
Customization |
Report customization as per your requirements with respect to countries, region and segmentation. |