U.S. Cancer Biopsy Market Size, Share & Growth Analysis Report 2033
The U.S. cancer biopsy market size was estimated at USD 10.21 billion in 2023 and is expected to be worth around USD 29.34 billion by 2033, poised to grow at a compound annual growth rate (CAGR) of 11.13% during the forecast period 2024 to 2033.
The U.S. cancer biopsy market is witnessing growth due to the factors such as advancements in quality & payment pertaining to genetic cancer diseases and the advent of liquid biopsies and their growing clinical implementation. Moreover, the increasing prevalence of cancer and the growing geriatric population is also likely to fuel the market growth. The COVID-19 outbreak has negatively impacted cancer treatment tourism across the globe. Due to the travel restrictions imposed by several countries, the treatment of many patients was interrupted abruptly. This may hinder the market growth of medical tourism for cancer treatment.
Cancer remains the leading cause of death across the globe. Thus, there is a growing need for advanced diagnostic tools designed for early detection. In recent years, precision oncology has emerged as a promising approach to management. With the evolution of the precision oncology field, companion diagnostic tools are increasingly being utilized to guide treatment decisions and select therapies based on a patient’s unique genomic profile. These tools facilitate the effective & safe use of corresponding therapeutic products. Till June 2021, more than 40 FDA-approved companion diagnostic assays for oncology indications are available in the market.
Advancements in diagnostic methods have created scope for their widespread clinical applications as well as translational research applications. Several initiatives have been undertaken to accelerate the utilization of various methods in translational research across academia and research industry. The Cancer Moonshot Blood Profiling Atlas is one such initiative that aims to accelerate the development of liquid biopsy tests for the management of cancer. This initiative focuses on collaborations between academia, government, and industries to boost test development.
Accurate detection of the progression of cancer is very important for the selection of an appropriate treatment regimen. Currently, available tests show false-positive results in some cases. Thus, supportive confirmatory tests are required to be performed, which increases the monetary burden on patients. Tests using tumor markers and specific biomarkers give results that are relatively more accurate. However, they are not available abundantly. As a result, the lack of highly sensitive tests is impeding market growth.
| Report Attribute | Details |
| Market Size in 2024 | USD 11.35 Billion |
| Market Size by 2033 | USD 29.34 Billion |
| Growth Rate From 2024 to 2033 | CAGR of 11.13% |
| Base Year | 2023 |
| Forecast Period | 2024 to 2033 |
| Segments Covered | Type, application, site(organ) |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Key Companies Profiled | BD (Becton, Dickinson and Company); IZI Medical Products; Johnson & Johnson Services, Inc.; Argon Medical; Spectra Medical Devices, Inc.; Medtronic; Boston Scientific Corporation; CONMED Corporation; INRAD, Inc.; Thermo Fisher Scientific, Inc. |
Fine-needle aspiration segment dominated the U.S. cancer biopsy market in 2023 with a revenue share of 34.7%. Fine-needle aspiration (FNA) biopsy is a well-established approach for the initial diagnosis of most body lesions, including benign and malignant. It is an effective and quick test for determining the status of uncertain tissue. Moreover, the simplicity offered by the noninvasive approach that demands a skilled aspirator aided with the routine use of needles, stains, and syringes is further propelling the growth of the market.
This has prompted several companies to invest in the development of FNA systems. For instance, in October 2022, Micro-Tech Endoscopy, launched endoscopic ultrasound-guided needles: Areus FNA and Trident FNB. Areus FNA and Trident FNB are available in 22ga and 25ga.
Skin /punch biopsy segment is expected to show lucrative growth during the forecast period. Skin biopsy is one of the most significant diagnostic tests for skin disorders. Punch biopsy is recognized as the most important technique for finding diagnostic full-thickness skin samples. This segment is inclusive of the revenue generated by biopsies performed on patients with skin lesions.
Awareness about the use of shave and punch biopsy, among others, has increased. The launch of new technologically advanced products will further drive the growth of the segment in the review period. For instance, in December 2021, Innovia Medical announced the expansion of its single-use instrument product line into the U.S. The product leading the growth is a gynecology product called the Cervical Rotating Biopsy Punch.
Screening & monitoring segment held the largest share of 54.31% in 2023. This can be attributed to the increasing adoption of different techniques in screening & monitoring applications. Biopsy has gained significant attention among professionals for the early detection of cancer, particularly when it is difficult to make a direct screening recommendation.
The screening process involves a negative biopsy report alongside other detection techniques. Previous negative biopsy lowers the risk of cancer onset, which relies heavily on race, family history, and increasing age. In addition, a number of risk-stratification or decision-making algorithms are developed that helps to minimize adverse effects associated with biopsy, which, in turn, is expected to impel the segment growth.
Pharma & Biopharma Discovery & Development segment is expected to show the fastest growth during the forecast period. The use of various types of biopsies in pharma drug discovery & development is currently at a nascent stage; however, it is expected to increase in the coming years. The U.S. is, thus, expected to become the fastest-growing market.
The construction of a bio bank of organoids requires a large pool of biopsy specimens so that gene expression profiling can be performed before drug screening, which is a complex process. The end goal of utilizing biopsy in gene expression profiling is to establish protocols for developing a Patient-derived Organoid (PDO) tumor model to study novel drug candidates.
For instance, in November 2021, FoundationOne Liquid CDx test manufactured by Foundation Medicine, Inc., which is a liquid biopsy, next-generation sequencing device, received approval from the U.S. FDA.
Breast cancer segment accounted for the largest revenue share of 22% in the U.S. cancer biopsy market in 2023. The dominance of the segment is attributed to the increasing prevalence of breast cancer aided by the growing recommendation for suspected cancer patients to undergo microscope-based analysis of breast tissue, which helps doctors conclude on a definitive diagnosis along with detecting stage and characterization of the disease.
.webp "U.S. Cancer Biopsy Market Share, By Site (Organ), 2023 (%)")
This has propelled the demand for a needle biopsy or surgical biopsy to obtain tissue for microscopic analysis. Image-guided needle biopsy has emerged as a safe and accurate nonsurgical approach for diagnosing suspicious tissues in the breast. These diagnostic approaches yield findings that are integral for designing apt therapeutic methods.
Thyroid segment is expected to show the fastest growth during the forecast period. Thyroid cancer is a comparatively infrequent malignancy that accounts for about 2.0% of cancer cases in men and less than 1.0% to 5.0% in women. Fine-needle aspiration (FNA) biopsy is the most accurate test for detecting malignancy in thyroid patients; it can be pivotal in the effective evaluation of thyroid nodules.
Several studies suggested that results obtained through FNA are superior when combined with Ultrasound Guidance (USFNA). Techniques such as palpation-directed FNA and Ultrasound-directed (US) FNA are set to gain traction in this segment. High demand for FNA is also a result of routine usage of US FNA across follow-up surveillance of thyroid cancer patients.
U.S. cancer biopsy market is the leading market in terms of revenue generation owing to high cancer prevalence, rapid technological advancements, and growing government initiatives. Moreover, investments and the presence of several biotechnology companies developing the tests will further propel the market growth during the forecast period.
Various organizations, such as the American Society of Clinical Oncology, are engaged in supporting the implementation of cancer biopsy, which is likely to boost revenue in this market. In addition, the US Preventive Services Task Force (USPSTF) also recommends population-based screening for cervical, breast, colorectal, and cancers.
In addition, strong government organizations and private cancer foundations have made significant contributions to the rising demand for cancer biopsy products in the U.S. This robust network has helped both patients and healthcare professionals to gain a better understanding of biopsy requirements in the diagnosis of cancer. Moreover, strong recommendations for biopsies for early diagnosis of breast cancer by the American Cancer Society are expected to positively impact the market growth during the forecast period.
In addition, doctors and physicians in the U.S. use Breast Imaging Reporting and Data Systems (BI-RADS), which is a numbered system for the assessment of mammogram reports. As per the BI-RADS, a breast biopsy is strongly recommended for the majority of the categories. Moreover, in vitro diagnostics companies are continuously investing and advancing through innovative automation strategies to introduce platforms that have gained CLIA-waived status.
These strategies aid the companies to effectively offset the regulatory challenges. For instance, in June 2021, Grail launched its liquid biopsy test in the U.S. and is sold under a CLIA waiver and can be used to test people aged over 50 at elevated risk of cancer.
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. Cancer Biopsy market.
By Type
By Application
By Site (Organ)
Chapter 1 Methodology and Scope
1.1 Research Methodology
1.2 Research Assumptions
1.2.1 Estimates And Forecast Timeline
1.3 Research Methodology
1.4 Information Procurement
1.4.1 Purchased Database
1.4.2 nova one advisor Internal Database
1.4.3 Secondary Sources
1.4.3.1 Primary Research
1.4.4 Details Of Primary Research
1.5 Information Or Data Analysis
1.5.1 Data Analysis Models
1.5.1.1 End-Use Landscape Assessment
1.5.1.2 Market Origin Assessment
1.5.1.3 Oncology Diagnosis: Market Competition Analysis
1.6 Market Formulation And Validation
1.7 Model Details
1.7.1 Commodity Flow Analysis
1.7.1.1 Approach 1: Commodity Flow Approach
1.7.1.2 Approach 2: Country-wise market estimation using bottom-up approach
1.8 U.S. Market: CAGR Calculation
1.9 List of Secondary Sources
1.10 List of Primary Sources
1.11 Objectives
1.11.1 Objective 1
1.11.2 Objective 2
1.11.3 Objective 3
1.11.4 Objective 4
Chapter 2 Executive Summary
2.1 Market Outlook
Chapter 3 Market Variables, Trends, and Scope
3.1 Cancer Medical Tourism Within & Outside the U.S.
3.2 Market Driver Analysis
3.2.1 Advent Of Liquid Biopsy
3.2.2 Transition Of Novel Oncology Diagnostics From Bench To Clinics
3.2.3 Advancements In Quality And Payment Pertaining To Genetic Cancer Tests
3.3 Market Restraint Analysis
3.3.1 Risks Associated With Biopsy Procedures
3.3.2 Technical And Clinical Challenges
3.4 Market Opportunity Analysis
3.4.1 Integral Role Of Biopsies In Oncology Companion Diagnostics
3.4.2 Increase In The Demand For Biopsies In Translational Research
3.5 Market Threat Analysis
3.5.1 Risk Associated With Repeat Biopsy Procedures
Chapter 4 Business Environment Analysis
4.1 SWOT Analysis; By Factor (Political & Legal, Economic, and Technological)
4.2 Porter’s Five Forces Analysis
Chapter 5 Supply Chain Analysis
5.1 Sample Collection (List of Biobanks/Center)
5.2 Sample Processing (List of Vendors)
Chapter 6 Cost/Pricing Analysis
6.1 Biopsy Cost
6.1.1 By Indication
6.1.1.1 Typical Biopsy Costs For Patients Not Covered By Health Insurance In The U.S.
6.1.2 By Type/Method
6.2 Key Factors Influencing The Cost
6.3 Costs Of Cancer Management
6.3.1 Pharma Versus Diagnostics Price Analysis For Cancer Care
6.3.2 U.S. Expenditures For Cancer By Source Of Payment
6.3.2.1 Expenditures For Cancer Care By Year & Cancer Site, USD Million, 2010 - 2018
Chapter 7 Reimbursement And Regulatory Analysis
7.1 Regulatory Framework: U.S. Cancer Biopsy Market
7.2 Reimbursement Framework: U.S. Cancer Biopsy Market
Chapter 8 Challenges/Restraints/Complications Analysis
8.1 Challenges/Restraints/Complications Analysis
8.1.1 By Site (Organ)
8.1.2 By Method
Chapter 9 Cancer Biopsy Product Manufacturers
Chapter 10 Type Business Analysis
10.1 U.S. Cancer Biopsy Market: Type Movement Analysis
10.2 U.S. Cancer Biopsy Market: Comparative Analysis of Biopsy Type
10.3 Fine Needle Aspiration
10.4 Core Needle Biopsy (CNB)
10.4.1 U.S. Cancer Core Needle Biopsy Market Estimates And Forecasts, 2021 - 2033
10.4.1.1 U.S. Cancer Core Needle Biopsy Market Estimates And Forecasts For Pharma Use, 2021 - 2033
10.4.1.2 U.S. Cancer Core Needle Biopsy Market Estimates And Forecasts For Clinical-Use, 2021 - 2033
10.5 Cancer Surgical Biopsy
10.5.1 U.S. Cancer Surgical Biopsy Market Estimates And Forecasts, 2021 - 2033
10.5.1.1 U.S. Cancer Surgical Biopsy Market Estimates And Forecasts For Pharma Use, 2021 - 2033
10.5.1.2 U.S. Cancer Surgical Biopsy Market Estimates And Forecasts For Clinical-Use, 2021 - 2033
10.6 Skin Biopsy/Punch Biopsy
10.6.1 U.S. Cancer Fine Needle Aspiration (Fna) Biopsy Market Estimates And Forecasts, 2021 - 2033
10.6.1.1 U.S. Cancer Fine Needle Aspiration (Fna) Biopsy Market Estimates And Forecasts For Pharma Use, 2021 - 2033
10.6.1.2 U.S. Cancer Fine Needle Aspiration (Fna) Biopsy Market Estimates And Forecasts For Clinical-Use, 2021 - 2033
10.6.1.3 U.S. Skin Biopsy/Punch Cancer Biopsy Market Estimates And Forecasts, 2021 - 2033
10.6.1.4 U.S. Skin Biopsy/Punch Cancer Biopsy Market Estimates And Forecasts For Pharma Use, 2021 - 2033
10.6.1.5 U.S. Skin Biopsy/Punch Cancer Biopsy Market Estimates And Forecasts For Clinical-Use, 2021 - 2033
10.7 Others
10.7.1 U.S. Cancer Biopsy Market Estimates And Forecasts For Other Types, 2021 - 2033
10.7.1.1 U.S. other types cancer biopsy market estimates and forecasts for pharma use, 2021 - 2033
10.7.1.2 U.S. other types cancer biopsy market estimates and forecasts for clinical-use, 2021 - 2033
Chapter 11 Site (Organ) Business Analysis
11.1 Cancer Biopsy Market: Site (Organ) Movement Analysis
11.2 Breast
11.2.1 U.S. Cancer Biopsy Market Estimates And Forecasts For Breast, 2021 - 2033
11.3 Thyroid
11.3.1 U.S. Cancer Biopsy Market Estimates And Forecasts For Thyroid, 2021 - 2033
11.4 Uterus & Cervix
11.4.1 U.S. Cancer Biopsy Market Estimates And Forecasts For Uterus & Cervix, 2021 - 2033
11.5 Lung
11.5.1 U.S. Cancer Biopsy Market Estimates And Forecasts For Lung, 2021 - 2033
11.6 Prostate
11.6.1 U.S. Cancer Biopsy Market Estimates And Forecasts For Prostate, 2021 - 2033
11.7 Bladder
11.7.1 U.S. Cancer Biopsy Market Estimates And Forecasts For Bladder, 2021 - 2033
11.8 Kidney
11.8.1 U.S. Cancer Biopsy Market Estimates And Forecasts For Kidney, 2021 - 2033
11.9 Liver
11.9.1 U.S. Cancer Biopsy Market Estimates And Forecasts For Liver, 2021 - 2033
11.10 Pancreas
11.10.1 U.S. Cancer Biopsy Market Estimates And Forecasts For Pancreas, 2021 - 2033
11.11 Other Sites
11.11.1 U.S. Cancer Biopsy Market Estimates And Forecasts For Other Sites, 2021 - 2033
Chapter 12 Application (Cause) Business Analysis
12.1 U.S. Cancer Biopsy Market: Application (Cause) Movement Analysis
12.2 Screening & Monitoring
12.2.1 U.S. Cancer Biopsy Market Estimates And Forecasts For Screening & Monitoring, 2021 - 2033
12.3 Diagnostics
12.3.1 U.S. Cancer Biopsy Market Estimates And Forecasts For Diagnostics, 2021 - 2033
12.4 Investigational & Translational Research
12.4.1 U.S. Cancer Biopsy Market Estimates And Forecasts For Investigational & Translational Research, 2021 - 2033
12.5 Pharma & Biopharma Discovery & Development
12.5.1 U.S. Cancer Biopsy Market Estimates And Forecasts For Pharma & Biopharma Discovery & Development, 2021 - 2033
Chapter 13 Regional Business Analysis
13.1 U.S. Cancer Biopsy Market: Regional Movement Analysis
13.2 U.S.
13.2.1 U.S. Cancer Biopsy Market, 2021 - 2033
Chapter 14 Competitive Landscape
14.1 Market Participation Categorization
14.2 Strategy Framework
14.3 Vendor Landscape
14.3.1 List Of Key Distributors And Channel Partners
14.3.2 Key Customers
14.3.2.1 List Of Key Customers
14.3.3 Public Companies
14.3.3.1 List Of Public Companies
14.3.4 Private Companies
14.3.4.1 List Of Key Private Companies
14.3.5 Emerging Players
14.3.5.1 List Of Key Emerging Companies
14.4 Major Deals And Strategic Alliances Analysis
14.4.1 Mergers And Acquisitions
14.4.2 Collaborations And Partnerships
14.4.3 New Product Launch
14.5 Market Impact Analysis By Key Participants
14.5.1 Ansoff Matrix
14.5.2 Company/Competition Categorization (Primary & Secondary Market Participants)
Chapter 15 Company Profiles
15.1 Company Profiles
15.1.1 Bd (Becton, Dickinson And Company)
15.1.1.1 Company Overview
15.1.1.2 Financial Performance
15.1.1.3 Product Benchmarking
15.1.1.4 Strategic Initiatives
15.1.2 Izi Medical Products
15.1.2.1 Company Overview
15.1.2.2 Product Benchmarking
15.1.2.3 Strategic Initiatives
15.1.3 Johnson & Johnson Services, Inc.
15.1.3.1 Company Overview
15.1.3.2 Depuy Synthes
15.1.3.2.1 Company Overview
15.1.3.3 Ethicon, Inc.
15.1.3.3.1 Company Overview
15.1.3.4 Financial Performance
15.1.3.5 Product Benchmarking
15.1.4 Argon Medical
15.1.4.1 Company Overview
15.1.4.2 Product Benchmarking
15.1.4.3 Cook
15.1.4.4 Company Overview
15.1.4.5 Product Benchmarking
15.1.5 Spectra Medical Devices, Inc.
15.1.5.1 Company Overview
15.1.5.2 Product Benchmarking
15.1.6 Medtronic
15.1.6.1 Company Overview
15.1.6.2 Financial Performance
15.1.6.3 Product Benchmarking
15.1.6.4 Strategic Initiatives
15.1.7 Boston Scientific Corporation
15.1.7.1 Company Overview
15.1.7.2 Financial Performance
15.1.7.3 Product Benchmarking
15.1.7.4 Strategic Initiatives
15.1.8 Conmed Corporation
15.1.8.1 Company Overview
15.1.8.2 Financial Performance
15.1.8.3 Product Benchmarking
15.1.9 Inrad, Inc.
15.1.9.1 Company Overview
15.1.9.2 Product Benchmarking
15.1.10 Thermo Fisher Scientific, Inc.
15.1.10.1 Company Overview
15.1.10.2 Financial Performance
15.1.10.3 Product Benchmarking
15.1.10.4 Strategic Initiatives
Cross-segment Market Size and Analysis for Mentioned Segments
Additional Company Profiles
(Upto 5 With No Cost)
Additional Countries (Apart
From Mentioned Countries)
Country/Region-specific Report
Go To Market Strategy
Region Specific Market DynamicsRegion Level Market Share Import Export AnalysisProduction AnalysisOthers