Non-Invasive Liquid Biopsy Market

Market Overview

The global non-invasive liquid biopsy market was valued at USD 1,589.55 million in 2022. It is estimated to reach USD 8,440.84 million by 2031, growing at a CAGR of 20.38% during the forecast period (2023–2031).

In the past ten years, significant advancements in liquid biopsy technologies have made it possible to analyze and diagnose a variety of biological fluids with accuracy. Non-invasive liquid biopsy is a relatively new field compared to conventional blood-based liquid and tissue-based biopsies. Non-invasive liquid biopsy uses non-invasive samples, including stool, urine, and saliva samples, to analyze any genetic alterations in the circulating biomarkers, enabling a clinician to screen and diagnose cancer in earlier stages.

The non-invasive liquid biopsy products and services are used for the identification and analysis of circulating biomarkers, including circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), circulating microRNA (miRNA), DNA methylation-based biomarkers, exosomes, and extracellular vesicles (EVs) from non-invasive sample types. The most significant advantage of liquid biopsies is their ability to detect disease progression or treatment resistance well before it causes clinical symptoms or appears on imaging scans. The clinical utilization of non-invasive liquid biopsy offers optimum patient comfort and ease of use, which makes this new approach highly suitable for routine check-ups.

Highlights

• Services dominate the offering segment
• Oncology dominates the application segment
• Hospitals and diagnostic laboratories dominate the end-user segment
• North America is the highest shareholder in the global market

Market Dynamics

Market Drivers

Global Increase in Cancer Prevalence

Factors such as the growing geriatric population, sedentary lifestyle, and other risk factors are combinatorial in the global prevalence of cancer. While incidence rates continue to spike, primarily due to high-fidelity diagnostic and screening measures, cancer prevalence has also been a significant concern for the global healthcare industry. According to the World Health Organization, cancer is the second leading cause of death across the globe and accounted for an estimated 9.6 million patient deaths in 2018.

Asia and Africa have more cancer deaths than cancer incidences. These regions have a high prevalence of cancer types with poor prognoses and restricted access to timely detection and treatment in many countries. Non-invasive liquid biopsy testing for early cancer detection and diagnosis has recently gained popularity in Asia, despite significant clinical advances in cancer diagnosis. Additionally, non-invasive liquid biopsy testing has dramatically improved diagnostic rates in the U.S. and EU. With global research into non-blood cancer biomarkers, the non-invasive liquid biopsy industry has enormous growth potential.

Rise in Patient Preference for Non-Invasive Cancer Diagnosis

Liquid biopsy tests using urine and saliva samples allow clinicians to conduct routine liquid biopsy testing in patients to detect cancer in earlier stages, further guiding treatment. The extraction of urine and saliva samples is painless compared to the commercialized blood-based liquid biopsy tests. Moreover, non-invasive liquid biopsy tests allow patients to collect samples at home, eliminating the need to visit healthcare centers. The advantages associated with the utility of non-invasive liquid biopsy tests for early cancer diagnosis are expected to significantly increase the adoption of these tests by patients, which is anticipated to bolster the global non-invasive liquid biopsy market during the forecast period.

Market Restraint

Existing Diagnostic Confidence on Conventional Tissue-Based Biopsies

Tissue biopsy is a widely used conventional method for the identification of the nature of a tumor. Although non-invasive liquid biopsy offers optimum patient comfort and ease of use, tissue biopsy is still the most widely used gold-standard source for the clinical analysis of several cancers, particularly by clinicians in developing economies. Clinicians prefer tissue biopsy over non-invasive liquid biopsy due to established trust and accuracy factors, which are high. Therefore, clinicians in developing economies generally opt for the conventional method whenever they need more confidence in the non-invasive liquid biopsy tests, restricting the market growth.

Market Opportunities

Amalgamation of Artificial Intelligence (AI) with Non-Invasive Liquid Biopsy

The amalgamation of artificial intelligence (AI) in personalized cancer care is a potential opportunity in the global non-invasive liquid biopsy market. Since AI-based solutions can directly identify genomic alterations from the urine and saliva sample specimens, they have the potential to outpace conventional blood-based liquid biopsies and tissue-based biopsies in early cancer detection and monitoring.

Furthermore, companies in the non-invasive liquid biopsy landscape are incorporating synergies with other companies to explore and incorporate AI for novel biomarker development, which could be used for conducting non-invasive liquid biopsy testing. For instance, in September 2018, Predicine, Inc. partnered with Flagship Biosciences to support global biomarker development. Additionally, extensive research is being conducted to understand better AI's utility in non-invasive liquid biopsy along with novel biomarker discovery. Such initiatives by the market players and researchers are expected to revolutionize the entire landscape of non-invasive liquid biopsy in the forthcoming years.

Regional Analysis

Based on region, the global non-invasive liquid biopsy market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Rest-of-the-World (RoW).

North America Dominates the Global Market

North America is the most significant global non-invasive liquid biopsy market shareholder and is estimated to grow at a CAGR of 19.77% over the forecast period. North America is home to many legacy companies in the non-invasive liquid biopsy industry updating their portfolios to offer advanced products and services. The legacy companies operating in the North American non-invasive liquid biopsy market include Exact Sciences Corporation, Predicine, Inc., Bio-Techne Corporation, OraSure Technologies, Inc., Thermo Fisher Scientific Inc. Additionally, the growing prevalence and incidence of various cancers have escalated the need for conducting non-invasive liquid biopsy to detect genomic alterations in circulating biomarkers present in non-invasive sample types. Moreover, the rising adoption of next-generation sequencing (NGS)-based non-invasive liquid biopsy services significantly supports the market growth. These factors are cumulatively bolstering the development of North America's non-invasive liquid biopsy market.

Europe is anticipated to exhibit a CAGR of 23.83% over the forecast period. The Europe non-invasive liquid biopsy market has been growing since its inception. The region has always been at the forefront when establishing research to advance high-fidelity cancer diagnosis globally due to high fund infusions. Europe was expected to launch a new "Cancer Diagnostic and Treatment for All" by the end of 2021, which will help clinicians and researchers to improve access to innovative cancer diagnosis and treatment solutions. Furthermore, Europe was also expected to launch another cancer initiative in 2021, the European Initiative to Understand Cancer, which aims to identify individuals at high risk from common cancers. Launching these initiatives is expected to ensure scientific excellence in cancer diagnostics, which will likely offer lucrative opportunities in the Europe non-invasive liquid biopsy market in the forthcoming years.

Asia-Pacific is at the forefront of a global effort to learn about non-invasive liquid biopsy and its potential applications in fields like oncology. With a large geographic area and substantial ethnic and cultural diversity, the region has become a focus area for many cancer-related studies. Although the market is expected to remain in a strong growth phase due to the growing prevalence of Cancer, increasing health consciousness, and rising purchasing power for people in the emerging economies of Asia-Pacific, a significant barrier to the increasing adoption is an uneven economic balance among the countries within the region. However, growth is expected to be tremendous in the regional market due to substantial commercial growth of new start-ups, high-profile publications, and the establishment of multidisciplinary consortiums aiming to accelerate standardization and harmonization of regulatory consensus for an emerging field.

In light of the rapid global expansion, the Latin American regional market is still in its infancy. However, several Latin American countries, including Brazil, Mexico, and Argentina, are working rigorously to enhance the adoption of non-invasive liquid biopsy tests across emerging economies in the Latin America region. Although sluggish growth has been observed in the region, economically developing regions in Latin America is likely to grow in non-invasive liquid biopsy.

The Rest-of-the-World (RoW) consists of several other promising regions, like the Middle East and Africa. The regulatory environment in this region is very different from the other regions. The requirements for achieving marketing authorization for in vitro diagnostics (IVDs), including non-invasive liquid biopsy products, vary from country to country in the region. In addition, different nations' focus on developing standard guidelines for commercializing these tests, coupled with the uptake of research collaborations between the countries, is slowly increasing the acceptance of non-invasive liquid biopsy products in routine clinical settings.

Segmental Analysis

The global non-invasive liquid biopsy market is bifurcated into the offering, sample, technology, application, and end-user.

Based on the offering, the global market is divided into products and services.

The services segment is the most significant contributor to the market and is estimated to exhibit a CAGR of 19.51% over the forecast period. Services in the global non-invasive liquid biopsy market employ methods and technologies such as next-generation sequencing (NGS) and polymerase chain reaction (PCR). These service providers primarily enable the analysis of circulating cancer biomarkers from the urine and stool to identify and detect underlying molecular alterations, enabling clinicians to offer critical insights regarding cancer status. The high share of the services segment is majorly attributed to the growing prominence of early cancer detection, increasing awareness about non-invasive cancer testing, rising prevalence of cancer, and increasing emphasis on adopting precision medicine strategies, among others.

Based on the sample, the global market is divided into stool, urine, saliva, and others.

The stool segment contributes to the highest market share and is expected to exhibit a CAGR of 19.33% over the forecast period. Stool samples are only used to screen patients with colorectal cancer (CRC). Using the stool as a sample helps the clinician detect CRC and pre-malignant colorectal neoplasia by assessing the alterations in the DNA markers. The majority of the CRCs develop over time from precancerous polyps. The growth of the CRC polyps gradually changes with a series of mutations in the cellular DNA. The CRC tumors shed cells with abnormal DNA, which gets mixed with stool, further helping clinicians screen CRC by analyzing molecular modifications.

Based on technology, the global market is divided into polymerase chain reaction (PCR), sequencing, microarray, and others.

The polymerase chain reaction (PCR) segment accounts for the most extensive market share and is predicted to exhibit a CAGR of 19.93% over the forecast period. Polymerase chain reaction (PCR) enables clinicians and researchers to amplify small amounts of genetic material in the non-invasive sample types for conducting non-invasive liquid biopsy tests. PCR has been extensively applied in molecular cancer diagnosis, including non-invasive liquid biopsy testing, to identify genetic alterations and mutations from a meager sample. In addition, PCR is one of the most preferred technologies in the non-invasive liquid biopsy market due to its ease of use, better results, reduced turnaround time, and cost-effectiveness. PCR technology has undergone significant advancements, and as a result, related technologies like real-time PCR (RT-PCR) and digital PCR (dPCR) have emerged.

Based on application, the global market is bifurcated into oncology, reproductive health, metabolic disorders, and others.

The oncology segment owns the highest market share and is expected to exhibit a CAGR of 20.13% over the forecast period. The effective understanding of the intricacies related to cancer formation and progression, accompanied by the growth of interest in the field, has facilitated the emergence of a new era of precision cancer care, where anomalies are identified through the analysis and profiling of circulating cancer biomarkers in non-invasive sample types, further offering better clinical decisions. In the past few years, the analysis of tumors using circulating biomarkers in samples such as stool, urine, and saliva has received massive attention from caregivers and researchers. The ability to screen and detect cancer using such a non-invasive method has revolutionized how a cancer biopsy is perceived.

Based on the end-user, the global market is bifurcated into academic and research institutions, hospitals and diagnostic laboratories, and others.

The hospitals and diagnostic laboratories segment dominates the global market and is predicted to exhibit a CAGR of 19.85% during the forecast period. Hospitals and diagnostic laboratories are at the epicenter of end users in the global non-invasive liquid biopsy market. Hospitals and diagnostic laboratories offer a wide range of expertise in pathology and advanced laboratory diagnostics for conducting non-invasive liquid biopsy testing. These laboratories combine state-of-the-art testing services, which are required to assess genetic alterations in circulating biomarkers present in non-invasive sample types. Additionally, diagnostic laboratories often achieve a tight integration with local physicians, thus benefiting both specialties.

Recent Developments

• January 2023- Micronoma, the first biotech organization to offer early cancer diagnosis with a microbiome-driven liquid biopsy platform, announced that the FDA had granted its OncobiotaLUNG assay Breakthrough Device Designation.

• December 2022- Agilent Technologies Inc. (NYSE: A) confirmed that the U.S. Food and Drug Administration (FDA) approved Agilent Resolution ctDx FIRST as a companion diagnostic (CDx) to recognize patients with advanced non-small cell lung cancer (NSCLC) and KRAS G12C mutations who may benefit from treatment with KRAZATITM (adagrasib).