Cancer Biopsy Market

Market Overview

The global cancer biopsy market size was valued at USD 26.02 billion in 2022. It is estimated to reach USD 66.11 billion by 2031, growing at a CAGR of 10.9% during the forecast period (2023–2031). The growing global geriatric population and resulting surge in cancer incidences, particularly breast cancer, are fueling the demand for biopsy devices.

A biopsy involves removing a small amount of tissue for observation under the microscope, whereas, in a core biopsy, radiologists use a needle to remove a sample from the lung tumor for diagnosis. The healthcare provider often uses a chest CT scan or a special X-ray machine to guide the needle in this technique. Research studies have concluded that CT-guided core needle biopsies are a relatively safer and well-established technique for procuring tumor samples with a better yield than conventional biopsies, especially for screening EGFR mutation.

A biopsy is the process of removing tissue to examine it for disease. Tissue samples can be taken from any part of the body. Numerous techniques can be used to perform biopsies. Some biopsies include surgically removing a nodule or lump, while others involve removing a tiny sample of tissue using a needle. Despite their usefulness in detecting abnormalities, imaging tests like MRI and CT scans cannot tell the difference between cancerous and non-cancerous cells. The majority of cancers can only be identified by performing a biopsy and collecting cells for further analysis.

Market Dynamics

Global Cancer Biopsy Market Drivers:

Advent of Liquid Biopsy

In the upcoming years, the liquid biopsy market is predicted to grow rapidly, with a major contribution coming from companies that manufacture biopharmaceuticals and analyze genomic data. These companies are anticipated to make increasing investments and take strategic initiatives. For instance, in early 2018, Seven Bridges Genomics—a company engaged in biomedical data analysis—announced its plan to enter the liquid biopsy market. Such emerging companies are inclined toward collaborating with well-established liquid biopsy industry participants, including SOPHiA Genetics, QIAGEN Bioinformatics, Agilent Technologies, and Fabric Genomics. This trend is further expected to favor the overall growth of the cancer biopsy market.

Furthermore, the field of liquid biopsies is rapidly growing, involving noninvasive tests for patients with or at risk of developing cancer. Liquid biopsies can facilitate early cancer detection and real-time evaluation of potential treatments' efficacy. The emergence of biomarker-based diagnostics is anticipated to improve the liquid biopsy field. Diagnostic developers are collaborating with research institutes to develop liquid biopsies and deliver insights into cancer patients' progression, detection, and treatment options.

Moreover, manufacturers are also engaged in the development of associated tests and supportive tools designed to conduct blood sample analysis. Manufacturers such as Biocept, Inc. and Guardant Health also invest in developing noninvasive cancer diagnostic tests, propelling the need to introduce novel liquid biopsy tests. Therefore, cancer diagnostic developers, upcoming start-up companies, and innovative market players are keen on exploring the potential opportunities the liquid biopsy market poses in cancer diagnostics.

Transition of Novel Oncology Diagnostics from Bench to Clinics

Novel diagnostic and therapeutic oncology technologies are penetrating both benchtop settings and gaining significant demand in clinics. Several novel diagnostic technologies developed recently can transform oncology treatment and diagnosis. This has caught the attention of several care providers, regulators, and manufacturers, further increasing investments in this area. Approximately 8 million cancer patients die annually, which has strained the healthcare systems across the globe. Moreover, global oncology spending is anticipated to reach nearly USD 240 billion by 2023. This offers a huge opportunity for cancer biopsy manufacturers to establish their market presence as the need to effectively manage the cancer burden becomes imperative.

Additionally, current models adopted for cancer management in clinical settings include routine employment of needle biopsy or surgical excision to ensure accurate tissue diagnosis of samples extracted from cancer patients. This will drive the growth of the cancer biopsy market in the coming years. The rapidly increasing geriatric population worldwide and subsequent rise in cancer cases such as breast cancer drive the use of biopsy devices, thereby driving market revenue.

Global Cancer Biopsy Market Restraint:

Risks Associated with Biopsy Procedures

The selection of an appropriate treatment regimen depends critically on the accurate detection of cancer progression. Presently, available tests show false-positive results in some cases. Therefore, supportive confirmatory tests must be performed, increasing patients' monetary burden. Tests using specific biomarkers and tumor markers give comparatively more accurate results. However, specific biomarkers and tumor biomarkers are not abundantly available. Therefore, the lack of highly sensitive tests is impeding market growth.

Moreover, diagnostic cancer tests are very expensive and increase the financial burden on patients' families. The government insurance framework is not as well-defined in developing countries as in developed countries. Thus, these tests are not affordable for a middle-class patient population that is not covered under any insurance (private or government). In these nations, many private insurance providers do not cover the costs related to a cancer diagnosis. As a result, the high cost of diagnosis is being constrained to the adoption of cancer screening methods, particularly in developing nations. Due to the rising medical tourism in these nations, such as Malaysia and India, where medical procedures and diagnostic tools are getting more affordable, the situation is anticipated to change in the upcoming years.

Global Cancer Biopsy Market Opportunities:

Advancements in Quality and Payment About Genetic Cancer Tests

The quality of cancer diagnostic tests holds crucial importance among healthcare professionals, doctors, and physicians to design patient-specific therapeutic approaches. Payments associated with cancer tests are pivotal to patients with cancer or showing susceptibility toward cancer conditions. This has led to an increasing focus of commercial manufacturers and emerging market entrants on developing high-quality cancer testing solutions, further presenting a lucrative opportunity to expand the cancer biopsy business. Moreover, the growing need for liquid biopsy-based diagnostics has been largely attributed to an increased emphasis on the cost and quality of cancer diagnostic testing.

Furthermore, liquid biopsy tests are gaining increasing relevance to everyday prescriptions of cancer therapeutics and clinical decisions; laboratories are getting accredited as per the latest standards for molecular testing, which is expected to fuel market growth in the coming years. An increase in the penetration of biopsies across the workflow of genetic cancer tests can be attributed to the robust reproducibility and reliability of the same. Initiatives toward resolving the payment issues associated with genetic cancer testing are expected to enhance the uptake of cancer biopsy in this market.

For instance, the Centers for Medicare & Medicaid Services (CMS) is analyzing whether Medicaid and Medicare should reimburse payments associated with Next-generation Sequencing (NGS) tests incorporated to diagnose advanced cancer patients. However, in January 2020, CMS announced its extension of coverage concerning NGS-based diagnostic solutions developed for patients suffering from ovarian and breast cancer. CMS is actively tracking the rapid innovation of NGS diagnostic solutions and their potential applications in oncology management. This can be attributed to the wide acceptance of the same, as these solutions offer a more comprehensive analysis concerning the genetics of cancer patients. Novel liquid biopsy solutions introduced lately can detect tumor-derived components such as circulating cancer cells (CTCs), ctRNA, and circulating tumor DNA (ctDNA) shed in the circulation.

Regional Analysis

North America Dominates the Global Market

Region-wise, the global cancer biopsy market is segmented into North America, Europe, Asia-Pacific, and LAMEA.

North America is the most significant global cancer biopsy market shareholder and is expected to expand substantially during the forecast period. Due to the substantial contribution of the U.S., the region is anticipated to sustain its dominant position throughout the forecast period. The primary objectives of companies in this region are to distribute and develop novel kits with applications for rapid diagnostics. Moreover, the lucrative strategies specified by the pertinent government authorities have significantly supported the increasing adoption of liquid biopsies across the United States. The framework, created recently by the U.S. Food and Drug Administration (FDA), is the foundation for liquid biopsy-based oncology diagnostics regulatory initiatives. This framework comprises the rules governing enrichment biomarkers, companion diagnostics, and approval precedents. The FDA's approval of tests created under the Clinical Laboratory Improvement Amendment has added value to the regulatory paths for liquid biopsy.

Segmental Analysis

The global cancer biopsy market is segmented based on product, type, and application.

Based on product, the global cancer biopsy market is segmented into instruments, kits and consumables, and services. 

The kits and consumables segment dominates the global market and is estimated to grow at a CAGR of 10.6% during the forecast period. Rapid transition from tumor biopsies to liquid biopsies is anticipated to propel the adoption of consumables and kits in various cancer biopsy procedures. Several industry players recognize this trend and are investing in developing next-generation cancer biopsy kits to diversify their offerings. For instance, Biocept, Inc. recently introduced a liquid biopsy kit developed for research applications related to cancer gene mutations. This launch was targeted to make the company's proprietary Target Selector platform of circulating tumor DNA assays accessible to molecular laboratories worldwide; these assays are used for performing liquid biopsies.

Based on type, the global cancer biopsy market is categorized into tissue biopsies, needle biopsies {Fine Needle Aspiration [FNA] and Core Needle Biopsy [CNB]} and Surgical Biopsies), liquid biopsies, and others. 

The tissue biopsies segment owns the highest market share and is expected to exhibit a CAGR of 10.22% during the forecast period. Tissue biopsy is still considered the mainstay for cancer biopsies and is largely adopted in several cancer diagnostic applications. This can be attributed to robust research activities evaluating its safety and efficacy, which is anticipated to contribute to the segment's dominance in the global market over the forecast period. Liquid biopsies have the potential to completely transform the field of cancer diagnosis, but physicians and medical professionals in developing nations are only slowly embracing this innovative method.

Moreover, enhancements to tissue biopsy procedures would maintain their position as industry leaders in acceptance over the next few years. For instance, Cernostics is creating a tissue biopsy test ideal for identifying cancer patients with Barrett's esophagus. Digitally scanned biopsy images from this one-of-a-kind cancer diagnostic test are used to analyze and quantify changes emerging at the cellular or molecular levels within a tissue.

Based on application, the global cancer biopsy market is categorized into breast cancer, colorectal cancer, prostate cancer, skin cancer, kidney cancer, liver cancer, pancreatic cancer, ovarian cancer, and others. 

The breast cancer segment dominates the global market and is expected to grow at a CAGR of 12.6% during the forecast period. Open surgical biopsy has been a reference standard in evaluating patients who present abnormal breast lesions; this can be attributed to the proven accuracy in diagnosing breast lesions. A rising number of patients suspected to suffer from cancer are recommended to undergo microscope-based analysis of breast tissue, which helps doctors decide on a definitive diagnosis and detect the disease's stage and characterization. This has propelled the demand for a needle or surgical biopsy to gain tissue for microscopic examination.

Additionally, image-guided needle biopsy has emerged as an accurate and safe nonsurgical approach for detecting suspicious tissues in breast imaging; these yield findings integral for designing apt therapeutic methods. Percutaneous image-guided needle biopsy is gaining demand in effectively managing abnormal breast lesions, which is further expected to contribute to the segment's growth. Moreover, various manufacturers operate in this space, working toward introducing comprehensive biopsy systems designed specifically for breast cancer. For instance, Trivitron Healthcare offers Upright Stereotactic System and MultiCare Platinum breast biopsy prone table; the latter is designed to characterize lesions that are difficult to detect.

Recent Developments

• July 2023 - QIAGEN announced the launch of the QIAseq Normalizer Kits, giving researchers a fast, convenient, and cost-effective method to pool different DNA libraries for best-quality results from next-generation sequencing (NGS) runs. 
• June 2023 - QIAGEN announced that its variant interpretation and reporting software, QIAGEN Clinical Insight (QCI) Interpret, is being deployed as a part of a national initiative in Denmark to offer sequencing-based solutions for cancer patients.