Personalized Medicine Biomarkers Market Size, Share & Trends Analysis Report By Application (Early Detection, Diagnostics), By Indication (Oncology, Neurology), By Test Location, By Region, And Segment Forecasts, 2022 - 2030

Report Overview

The global personalized medicine biomarkers market size was estimated at USD 11.76 billion in 2021. It is expected to expand at a compound annual growth rate (CAGR) of 15.51% from 2022 to 2030. The growth can be attributed to the increasing demand for personalized medicine, the increasing prevalence of chronic diseases, and technological advancements in the diagnosis and detection of chronic diseases. The growth is further propelled by lifesaving benefits offered by biomarkers, which include the ability to detect health conditions in their early stages, improve patient survival, and reduce treatment costs.

Increased screening is a top priority for the majority of hospitals and community health centers. The pandemic-related screening rates have significantly decreased as a result of the COVID-19 outbreak. The number of screenings for other diseases significantly reduced in 2020 as the coronavirus epidemic grew. Out of fear of contracting COVID-19, people were also hesitant to seek non-emergency medical care in hospitals and other healthcare facilities. However, as the situation normalized the testing rates bounced back to normal.

Moreover, modern diagnostic techniques are accelerating the shift toward personalized, or precision care for many ailments. With the aid of this technique, physicians can identify and measure a variety of biomarkers (molecules that indicate the presence of a disorder) to categorize patients into subgroups that differ in their tendency. This include patient’s vulnerability to develop a disease, their personalized mutation to develop a disease even after successful treatment, and their likelihood of responding to a particular treatment.

Use of diagnostics to determine biomarker impact in relation to its direct drug use is a crucial factor in personalized medicine. A variety of applications for in vitro diagnostic testing that support personalized treatment methods were approved by the FDA's Center for Devices and Radiological Health (CDRH) in 2021. The tests guide focused on treatment decisions to increase drug safety and efficacy through new approvals and expanded indications. For instance, in May 2020, FoundationOne CDx, was approved for diagnosis of MET exon 14 skipping mutations to make decisions regarding the use of Tabrecta (capmatinib) for non-small cell lung cancer. Moreover, in September 2021, Therascreen KRAS RGQ PCR Kit, was approved to make decisions regarding Lumakras for non-small cell lung cancer treatment.

However, technological advancements in the development of biomarkers witnesses a rapid rise as the demand for personalized medicine grows substantially. Thus, to ensure patient access to these new technologies, a reimbursement framework needs to be put in place to reflect the changing healthcare landscape. This will potentially encourage manufacturers to invest in new products as reimbursement policies which have a direct impact on the development and growth of diagnostic and prognostic tools.

Cancer screening and care are expected to undergo a significant transformation as a result of the innovative multi cancer early detection (MCED) screening technology, which is currently in the advanced phases of development. The detection of tumors utilizing biomarkers circulating in human fluids (such as blood), such as circulating tumor cells and circulating cell-free tumor DNA, is known as molecularly guided excision biopsy (MCED), and it may be the most advanced use of the liquid biopsy approach to date (ctDNA). The goal of MCED screening is to significantly increase the number of cancers for which screening methods are available and to enlarge the pool of people who are asymptomatic & can be diagnosed for cancer.

Application Insights

Treatment selection segment held the largest share in 2021. Based on the molecular characteristics of the tumor, personalized medicine biomarkers help choose the most suitable patients for early-phase clinical trials. They also provide information regarding action mechanism of a particular medicine. The focus of oncology drug development programs has shifted from the creation of non-specific cytotoxic chemotherapies to the creation of molecularly targeted therapeutics as a result of the identification of particular mutations that efficiently perform the prediction for a given drug in a molecularly defined patient group. Moreover, with an enhanced selection of treatment, the probability to tackle the condition increases.

Early detection/screening segment is expected to show lucrative growth over the forecast period. The growth of the segment can be attributed to the need to provide early treatment. For patients who display the biomarker linked to a therapy's response, the probability of survival is dependent on the course of treatment. For instance, the expression of the HER2/neu protein is a prognostic biomarker of breast cancer. Moreover,KRAS is a frequently mutated oncogene in colorectal cancer and a biomarker for anti-EGFR monoclonal antibody therapy resistance. Moreover, the development of novel technologies to help in the early detection of various conditions further propels the growth of the market.

Indication Insights

Oncology segment dominated the market in 2021, attributable to increased adoption of personalized medicine biomarker-based tests for early detection and treatment selection. The selection of appropriate treatment alternatives regularly benefit patient health. For instance, the Oncotype DX test can evaluate the activity of 21 different genes to predict the applicability of chemotherapy for breast cancer cases. Hence, major opportunities exist for personalized medicine biomarkers in the personalized medicine segment owing to their significant role in helping physicians decide the appropriate treatment.

In March 2021, Oxford BioDynamics signed a resale and supply agreement with Agilent Technologies, Inc. for EpiSwitch Explorer, an array kit that can be used for biomarker discovery and acts as a critical component in personalized medicine development. Moreover, the non-invasive method provided by cfDNA for diagnosing recurrence or progression, streamlining prognosis, and finding emerging genomic anomalies remain a major promise. Furthermore, it can also find patients linked to drug resistance and provides ability to track tumors with molecular profiles in real-time at various time points.

Autoimmune diseases segment is anticipated to grow at a lucrative CAGR over the forecast period owing to the increased prevalence of autoimmune diseases among the global population. The growing awareness about benefits of early treatment among physicians also remains a promising driver of growth. According to the United States Autoimmune Association, in 2021, there is an existence of approximately 100 types of autoimmune diseases, affecting 4-5% of total world’s population.

Moreover, the inability to detect the onset of autoimmune disease in a patient is hampered by the lack of a single highly specific diagnostic test that can confirm the presence of a specific autoimmune disorder. This further increases the demand to provide diagnosis and monitoring of autoimmune diseases using minimally invasive methods that could be used to identify disease development and provide appropriate treatment.

Regional Insights

North America dominated the overall market in 2021 which can be attributed to increased funding for biomarkers. This is further aided by technological advancements, high disposable income, and the presence of key market players operating in the region. The U.S. held the largest share of personalized medicine in the region owing to increased private and public initiatives and high awareness among the population about chronic diseases and treatments.

Moreover, key players are focusing on developing novel products to maintain their dominance over the market. For instance, in February 2022, FoundationOne CDx was approved by the FDA approval as a companion diagnostic for Keytruda to categorize patients with microsatellite instability-high solid tumors.

Asia Pacific is estimated to showcase the fastest growth over the forecast period. The growth of the market in the region is due to the growing healthcare reforms in the region. This is further aided by improved healthcare infrastructure, a growing population, and an increase in the number of companies entering the market. The Asia Pacific region is home to a large population and a high cancer prevalence.

According to Global Cancer Statistics 2020, an estimated one-half of all cases and around 58.3% of cancer deaths occurred in Asia in 2020. Thus, the usage of screening tests for cancer has increased in the past few years owing to growing government initiatives, such as free screening for breast cancer and increased collaborations for the distribution and supply of these tests.

Moreover, the presence of government funding and initiatives in the region further fuels regional growth. For instance, The Chinese Personal Medicine Initiative which is expected to be funded with USD 9 billion by 2030, aims to provide better healthcare provisions mainly for oncology.

Key Companies & Market Share Insights

The key players operating in the field of personalized medicine remain focused on adapting and, launching new technologies that enhance patient outcomes. This remains key to significantly increasing the effectiveness and efficiency of healthcare outcomes. For instance, in June 2022, GRAIL and AstraZeneca formed a strategic partnership to create companion diagnostic tests that would enable the treatment of early-stage cancer. Some prominent players in the global personalized medicine biomarkers market include:

• Laboratory Corporation of America Holding

• Quest Diagnostics Incorporated

• Agilent Technologies, Inc.

• Genome Medical, Inc.

• Coriell Life Sciences.

• Thermo Fisher Scientific Inc.

• NeoGenomics Laboratories

• FOUNDATION MEDICINE, INC.

• Illumina, Inc.

• Guardant Health

Personalized Medicine Biomarkers Market Report Scope

Global Personalized Medicine Biomarkers Market Segmentation

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this report, Grand View Research has segmented the global personalized medicine biomarkers market report based on application, indication, and region:

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Early Detection/Screening

  • Diagnosis

  • Treatment Selection

  • Monitoring

• Indication Outlook (Revenue, USD Million, 2018 - 2030)

  • Oncology

    • By Type

      • Breast Cancer

      • Lung Cancer

      • Colon Cancer

      • Others

    • By Circulating Biomarkers

      • Circulating Tumor Cells (CTCs)

      • Circulating Cell-free DNA (cfDNA)

      • Extracellular Vesicles (EVs)

      • Other Circulating Biomarkers

  • Neurology

  • Diabetes

  • Autoimmune Diseases

  • Cardiology

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East and Africa

    • South Africa

    • Saudi Arabia

    • UAE