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The liquid biopsy market size was valued at USD 6.70 billion in 2022 and is projected to grow from USD 8.01 billion in 2023 to USD 34.71 billion by 2030, exhibiting a CAGR of 23.3% during the forecast period.
Cancer is a major contributor to disease burden across the globe, with its increasing incidence among the population. Certain environmental risk factors, such as air pollution and biological risk factors, including tobacco use, smoking, and physical inactivity, lead to cancer and other infectious diseases.
Thus, with rising cancer prevalence, the demand for early screening and therapeutics has increased globally. Furthermore, the rising incidence of genetic abnormalities among neonates and fetuses of pregnant women has led to the need for prenatal testing among the population. Also, a surge in government initiatives for public screening tests to reduce the surge of infectious diseases and chronic disorders such as cancer has led to the high adoption of non-invasive screening tests conducted by biological fluids such as blood, amniotic fluid, and Cerebrospinal Fluid (CSF).
The tests detect signs of cancerous tumors, including circulating biomarkers, cell free DNAs, and circulating tumor DNAs (ctDNAs), in all cancer patients at screening or recurrent stages. The regulatory agencies such as the Food and Drug Administration (FDA) have approved tests that can detect advanced cancers in a patient, predict prognosis and assist healthcare providers in ruling further treatment decisions. The rising introduction of advanced tests over various indications and extensive clinical studies on developing new products will boost the liquid biopsy market growth during the forecast period.
Decline in Cancer Screening amid Pandemic Affected Market Growth
The impact of the COVID-19 pandemic resulted in a decline in market growth in 2020. Several countries across the globe faced challenges in accessing prognostic tests owing to government imposed lockdowns. Moreover, the pandemic led to the postponement and de-prioritization of non-essential diagnostic tests such as cancer screening by various healthcare agencies among the population. Similarly, the disruption caused by the COVID-19 pandemic to international supply chains led to high-profile shortages of cancer diagnostic kits and assays across the globe.
Furthermore, major players in the market reported a decline in their product revenues during the fiscal year 2020. The decline was due to lower testing volume and decrease in product sales due to the pandemic.
However, the lifting of lockdown restrictions post-pandemic and the resumption of screening programs led to increased cancer prognostic tests. The rise in adoption of at-home tests and the high demand for oncology testing among patients further propelled the market growth.
Moreover, government organizations and key players have undertaken several initiatives to increase the access to cancer testing using liquid biopsy tests post the pandemic to eliminate the need for painful tissue biopsies. This propelled the number of cancer screening tests performed at home, further benefiting the market.
Thus, the rebound in cancer screening cases post-pandemic and the high demand for these products at home settings augmented the market growth.
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Increasing Product Deployment for Oncology Diagnosis
Tissue biopsy for cancer screening is associated with inherent limitations such as high test turnaround time, extensive time consumption, and its invasive nature. Liquid biopsy is emerging as a novel, non-invasive approach for detecting and monitoring cancer in several body fluids instead of tumor tissue. These tests pose an alternative for patients unable to undergo an invasive biopsy for screening, which additionally offers other clinical applications to patients, including disease prognosis, drug resistance, and drug response.
Therefore, the product demand is high owing to several advantages over traditional methods. These include early results, high sensitivity, and extensive presence across healthcare settings with the potential to offer insights across multiple metastatic sites, among others.
Thus, owing to high demand, manufacturers are focused on developing screening tests for the early detection of diseases with advanced technologies and extensive applications. Moreover, increasing product approvals by regulatory authorities for cancer screening coupled with high awareness of liquid biopsies among patients aid the growth of the market.
Rising Investments for Clinical Trials by Industry Players to Propel the Market Growth
Recent advancements in liquid biopsies are enabling the use of new technologies in cancer screening, therapeutic selection, drug trial optimization, and recurrence monitoring. Several major companies are focusing on investing in R&D for conducting clinical studies on liquid biopsy to offer precision medicine for patients. This is due to rising cancer prevalence and the high adoption of liquid biopsies among patients.
Moreover, government organizations in various developed economies are investing and partnering with industry players to conduct clinical test studies to meet the growing demand for such tests in the market. Also, research institutes are now providing funds to manufacturing companies to support R&D for the early detection and screening of various genetic and infectious disorders.
Furthermore, the increasing attention of key industry players in collaborating with other companies and research institutions to offer evidence-based treatment options with liquid biopsies for patients further augmented the market growth.
Therefore, such high investments by industry players and a wide range of potential applications are anticipated to fuel the introduction of advanced products across developed nations, further propelling the market growth.
High Costs of Tests and its Reimbursement Challenges to Limit the Product Adoption
Liquid biopsy is emerging as a complementary approach to tissue biopsy for screening and therapy of several indications such as cancer, prenatal testing, and others. However, despite potential advantages over traditional approaches in early disease detection and monitoring, the cost associated with screening and the test assay kits is comparatively high.
Moreover, the Next-Generation Sequencing (NGS) or Polymerized Chain Reaction (PCR) based assays are widely accepted and provide better clinical utility. However, the costs associated with developing those technologies are very high. These factors, along with high investment costs in conducting various clinical studies for screening, are restraining the market growth.
Besides, the use of these tests for early screening is constrained by reimbursement issues caused by test accuracy and uncertain clinical outcomes. The lack of insurance coverage for specific clinical outcomes, such as relapse monitoring, recurrence, advanced stage III and IV cancers, and others, limits the adoption of these tests for screening. This resulted in fewer incentives for companies to develop tests for cancer screening.
Moreover, the lack of awareness and unavailability of insurance coverage in developing countries such as India, China, along with South Africa for such tests further restricts the market growth in these countries.
The factors mentioned above and the lack of clinical utility of these tests are limiting their adoption. This is anticipated to hamper the market growth during the forecast period.
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Increasing Launch of Technologically Advanced Assay Kits to Augment Segment Share
By product, the market is segmented into kits & reagents and instruments. The kits & reagents segment accounted for the largest market share in 2022. The dominance was attributed to the rising focus of key players to expand their footprint and bolster their market presence through new product launches.
Furthermore, rise in the approval of assay & kits and increase in commercial reimbursement policies by regulatory authorities across developed economies further boosted the segment growth.
On the other hand, the instruments segment is expected to register a moderate CAGR during the forecast period. The segment growth is attributed to increasing investments in production and launch of new instruments and equipment by key players.
Increasing Preference of Non Invasive Prenatal Tests among Pregnant Women to Augment the Segment Growth
Based on application, the market is classified into Non-Invasive Prenatal Testing (NIPT), oncology, and others.
The non-invasive prenatal testing (NIPT) segment accounted for the highest market share in 2022. The share was attributed to the rising genetic and congenital abnormalities such as Down syndrome in the fetus of pregnant women across the globe. Similarly, the high demand for non-invasive screening tests among women and rising product approvals of advanced prenatal tests launched by key players further propelled the segmental share.
The oncology segment is projected to register a comparatively higher CAGR over the forecast period. This is due to the increasing focus of industry players to offer advanced tests to meet the growing demand for early diagnosis and monitoring of various non-communicable diseases such as cancer. Moreover, rising partnerships among key players to market their product portfolio and boost their global presence further propelled the segment share.
Surge in Demand for Tests in Hospital Settings to Propel Segment Growth
Based on end user, the market is divided into hospitals, clinical laboratories, and others.
The hospitals segment held the highest market share in 2022. The dominant share can be attributed to the rising number of cancer diagnostic tests and prenatal tests at hospitals across the globe. Additional factor favoring segment growth is the rising awareness regarding cancer screening among the population, especially in emerging countries.
The clinical laboratories segment is expected to grow at a considerable CAGR during the forecast period. The growth of the segment is owing to increasing number of clinical laboratories providing liquid biopsies across developing countries.
North America Liquid Biopsy Market Size, 2022 (USD Billion)
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Rise in Introduction of Technologically Advanced Products to Augment North America Market Share
Based on region, the market is segmented into North America, Asia Pacific, Europe, Latin America, and the Middle East & Africa.
The North America market was valued at USD 3.64 billion in 2022 and is predicted to dominate the global market share over the forecast period. The market expansion is driven by rising R&D and introduction of new technologies by key players to help aid in patient screening for chronic disorders or abnormalities. Moreover, increasing collaborations among manufacturing players and growing approvals of new products with extensive regional presence further enhanced the North America market.
Europe is the second dominant region in terms of market share and revenue. The Europe market held a significant share owing to the rising awareness regarding cancer and prenatal screening among the population. Also, increasing strategic initiatives by the European government to boost cancer screening along with other pathology tests will further strengthen the regional growth during the forecast timeframe.
The rising prevalence of genetic abnormalities, such as Down syndrome and chromosomal aneuploidies, among the population drives the market growth in Asia Pacific. The region is anticipated to exhibit the highest CAGR over the study period. This is due to the increasing demand for predictive screening owing to high disease prevalence.
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The Latin America market is anticipated to grow at a slower pace over the forecast period. The growth is due to the rising cancer prevalence amongst the population and the high demand for cancer screening across hospitals and pathology laboratories. The Middle East & Africa is expected to grow at a moderate CAGR owing to the rising NIPT testing among pregnant women, creating demand for non-invasive liquid biopsies during the forecast period.
Strategic Collaborations among Key Players to Offer Growth Opportunities for the Market
The industry is majorly dominated by manufacturers such as Guardant Health, Inc., Foundation Medicine, Personalis, Inc., and other prominent players. The key players are aiming at accelerating test production and receiving product approvals from various regulatory bodies, which is responsible for their higher liquid biopsy market share.
Other major players operating in the market, such as F. Hoffmann-La Roche Ltd, are focusing on key developments such as strategic partnerships with other research institutions across the globe to develop effective screening and monitoring tests for patients. Such initiatives by significant players are expected to boost the global market during the forecast period.
Furthermore, other players operating in the global market include Menarini Silicon Biosystems, Inc., Thermo Fisher Scientific Inc., QIAGEN, Bio-Rad Laboratories, Inc., BioChain Institute Inc., Stilla, BIOCEPT, INC., and GRAIL, LLC. The robust focus on conducting various clinical studies to offer highly accurate assays for disease diagnosis and therapy selection is responsible for other players' high market growth rate.
Such continuous engagement in the launch of diagnostic tests by several market players and a rising focus on collaborations with other organizations to establish their footprints in screening tests will further propel the market expansion.
An Infographic Representation of Liquid Biopsy Market
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The report provides a detailed market analysis and focuses on crucial aspects such as leading players, product types, and major applications of the product. Additionally, it offers insights into market trends, key industry developments, such as mergers, partnerships, and acquisitions, and the impact of COVID-19 on the market. In addition to the factors mentioned above, the report includes the factors that have contributed to the market growth in recent years with a regional analysis of different segments.
Value (USD Billion)
CAGR of 23.3% from 2023-2030
By Product, By Application, By End User, and Region
By End User
Fortune Business Insights says that the global market size was USD 6.70 billion in 2022 and is projected to reach USD 34.71 billion by 2030.
Registering a CAGR of 23.3%, the market will exhibit steady growth over the forecast period (2023-2030).
By product, the kits & reagents segment is expected to lead this market during the forecast period.
The rising prevalence of cancer and the increasing R&D for technologically advanced products across the globe are the key factors driving the market growth.
Guardant Health, Inc., Foundation Medicine, and Natera, Inc. are the major players in the global market. Guardant Health, Inc., Foundation Medicine, and Natera, Inc. are the major players in the global market.
The growing prevalence of genetic disorders in the fetuses of pregnant women and an upsurge in the number of cancer screening tests across the globe are expected to drive the adoption of these tests.
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