Biomarkers Market - Forecasts from 2021 to 2026

The global biomarkers market was valued at US$29.956 billion in 2019 and is expected to grow at a CAGR of 17.38% over the forecast period to reach a market size of US$91.969 billion by 2026. The diagnostic market is experiencing an increase in demand. Traditionally, diagnostic tools were geared toward producing accurate and consistent results, but the current market needs early diagnosis using accurate and consistent results. The difficulty of presenting accurate results during the early stage of diseases, especially cancer, is significant. Biomarkers are non-invasive diagnostic tools. A combination of biomarkers with modern imaging and data management techniques meets market expectations. In imaging technology, biomarkers are used to provide clear imaging of oncology tumors and other problems, reducing radiation exposure during CT scans and MRI scans.

The pharmaceutical industry is investing more than ever in this sector. For instance, RA Capital Management led a $220 million Series C investment round alongside BlackRock, Sands Capital, Avidity Partners, and Pura Vida Investments that will fund the new ultrasound device and software, which will enable the company to spread its own brand of health information.

The application of biomarkers includes risk assessment, molecular diagnostics, disease diagnosis, DNA fingerprinting, and other molecular applications. Increasing demands for safe and effective treatment doses make them essential to pharmaceutical companies. The use of biomarkers eliminates the need for complex data preparation, testing, and assay development in drug development. The growing prevalence of cancer and heart diseases, as well as increasing investment by major market players towards the biomarkers production, are projected to boost the biomarkers demand during the forecast period.

Growth Trends

Growth of companion diagnostics

Medical companion diagnostics and biomarkers have become increasingly important, allowing for better diagnosis, treatment, and monitoring of several diseases. This method is useful for identifying patients who would benefit from particular drugs or treatment options. Diagnostic tests are often used in conjunction with specific drugs. Oncomine Dx Target Test, for instance, assists in the biomarker testing of non-small cell lung cancer (NSCLC) patients eligible for ROZLYTREK (entrectinib). Biomarkers play an important role in the development of companion diagnostics by identifying the molecules that act as drug targets. As a result, companion diagnostics are expected to drive the biomarkers market in the future.

Companion diagnostics are frequently developed with the partnership of pharmaceutical companies. For instance:

• The Burning Rock Biotech Company has entered into a global strategic alliance with IMPACT Therapeutics to develop companion diagnostics (CDx) for a pipeline of synthesized lethality drugs. Senaparib, a targeted oncology drug, will be developed jointly by the two companies for the treatment of prostate cancer worldwide,
• In May 2021, Qiagen announced a partnership with Mirati Therapeutics to develop a KRAS-G12C companion diagnostic for Non-Small Cell Lung Cancer (NSCLC). QIAGEN's therascreen KRAS testing portfolio will be expanded with the new companion diagnostic.

Growth of diagnostic biomarker market

In recent years, diagnostic biomarker tests have become more prevalent as a result of the development of technologies in clinical laboratory tests, imaging exams, and clinical management of patients. As a result of technological advancements in the fields of genomics and proteomics, diagnostic biomarker technology is poised to revolutionize clinical research, medical practice, and drug development. In addition to helping in drug development and diagnosis of critical diseases, biomarkers also provide clinical trial information. Diagnostic biomarkers allow pathologists to identify diseases more quickly and accurately.

The Japanese start-up, AI Medical Service, which is developing artificial intelligence-driven technology to detect cancer from endoscopic footage, secured about USD $43 million US (about 4.6 billion yen). The MedTech industry is investing more than ever in this sector. The market for MedTech in Asia-Pacific reached $133 billion in 2020. This is undoubtedly a demanding region for business leaders, particularly compared with more developed and homogeneous markets, such as North America. (Source: apacmed.org)

Restraints

Validating biomarkers: a challenge

Biomarkers are validated by evaluating their performance characteristics, such as sensitivity, specificity, and reproducibility. In order to establish biomarkers as reliable tools to support biopharmaceutical investment decisions, validation is essential. Nonetheless, the cost of the process poses a major concern to businesses, especially small ones. Further challenges arise due to the inherent variability of biomarker levels and molecular heterogeneity. A biomarker's clinical validity and utility must be demonstrated before it can be used in clinical settings. In addition to aiding physicians in their decision-making process, this is imperative for gaining regulatory approvals. A lack of standards, however, makes collecting the data necessary to demonstrate clinical validity and utility a time-consuming and costly process. Biomarker market growth may be slowed by all these factors.

Impact Of COVID-19 On The Biomarkers Market

The research related to COVID-19 used innovative biomarker technologies and a wide range of products, including antibody tests and PCR tests, to help researchers understand the complex picture of coronaviruses. This has positively influenced the biomarkers market.

• Biomarkers during the COVID 19 pandemic have the potential to be useful in several areas:
• Early detection of disease
• Formulating hospital admission criteria
• Identification of cohorts with a high risk of infection
• Rationalizing treatments
• Assessing therapeutic effectiveness
• Predicting outcome

Competitive Insights

Growth in the biomarkers market is attributed to personalized medicine, technological advances in disease diagnosis, and a growing preference for biomarkers in drug discovery and development. The key factors anticipated to drive biomarker demand include the increasing investment made by market players in biomarkers along with the launch of multiple tests in the market. Additionally, several collaborations and partnerships are expected to fuel demand.

• Merck KGaA and Personalis Inc., two global leaders in advanced genomics for cancer, are working together to identify novel biomarkers that indicate a patient's response to clinical treatment. Immunold Next, Personali’s newest cancer immunogenomics platform, will be employed for the identification and development of clinical biomarkers by Merck KGaA.
• The introduction of new products is expected to be driven by similar collaborations and partnerships. Owlstone Medical Ltd. also introduced a new ReCIVA Breath Sampler and CASPER Portable Air Supply. Researchers use this device to identify disease biomarkers and to measure volatile organic compounds (VOCs) on a person's breath.
• Bio SB, Inc., has launched a system for testing IVD biomarkers. In addition, the U.S. FDA has approved a cancer biomarker-based treatment. Keytruda (Merck) has been approved for the treatment of adults and children with unresectable solid tumors who have certain genetic biomarkers, microsatellite instability-high (MSI-H), and the DNA mismatch repair gene (PMMR).

Segmentation:

By Type

• Safety Biomarkers
• Validation Biomarkers
• Efficacy Biomarkers

By Application

• Drug Discovery and Development
• Diagnostics
• Disease Risk Assessment
• Personalized Medicine
• Other

By Geography

• North America
• United States
• Canada
• Mexico
• South America
• Brazil
• Argentina
• Others
• Europe
• UK
• Germany
• Italy
• Spain
• Others
• Middle East and Africa
• Israel
• Saudi Arabia
• Others
• Asia Pacific
• China
• Japan
• India
• Australia
• South Korea
• Taiwan
• Thailand
• Indonesia
• Others