| REPORT ATTRIBUTE |
DETAILS |
| Historical Period |
2019-2022 |
| Base Year |
2023 |
| Forecast Period |
2024-2032 |
| North America Cancer Biopsy Market 2023 |
USD 10.34 billion |
| North America Cancer Biopsy Market, CAGR |
9.65% |
| North America Cancer Biopsy Market Size 2032 |
USD 27.55 billion |
Market Overview:
The North American Cancer Biopsy Market is projected to surge from USD 10,337.68 million in 2023 to USD 27,554.65 million by 2032, experiencing a remarkable growth rate of 9.65% over the forecast period. The North American Cancer Biopsy Market stands as a critical component within the region’s healthcare landscape, driven by evolving diagnostic technologies, increasing cancer incidence rates, and growing awareness regarding early disease detection. Characterized by a dynamic blend of technological advancements, regulatory frameworks, and healthcare infrastructure, this market represents a pivotal segment in the continuum of cancer care. The market dynamics are shaped by several key factors, primarily the rising incidence of cancer across the region. Technological innovations play a pivotal role in driving the evolution of cancer biopsy procedures. From traditional tissue biopsies to liquid biopsies and minimally invasive techniques, advancements in imaging modalities, molecular diagnostics, and biomarker identification have revolutionized the landscape. These innovations not only enhance diagnostic accuracy but also contribute to reducing patient discomfort and procedural complexities. The North American Cancer Biopsy Market can be segmented based on biopsy type, indication, end-user, and geography. Biopsy types may include tissue biopsy, liquid biopsy, and needle biopsy, among others. Indications encompass various cancer types, such as breast cancer, lung cancer, prostate cancer, and colorectal cancer. End-users of biopsy services range from hospitals and diagnostic laboratories to academic research institutions and ambulatory surgical centers.
The regulatory frameworks governing cancer biopsy procedures play a pivotal role in shaping market dynamics. Stringent oversight ensures the safety, efficacy, and quality of diagnostic devices and procedures. Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and Health Canada establish standards for product approval and post-market surveillance, fostering innovation while safeguarding patient interests. The North American Cancer Biopsy Market is characterized by intense competition, with key players vying for market share through product innovation, strategic collaborations, and mergers and acquisitions. Leading companies such as Roche Diagnostics, Becton, Dickinson & Company, Hologic Inc., Danaher Corporation, and Thermo Fisher Scientific Inc. invest significantly in research and development to introduce novel biopsy technologies and expand their geographical footprint.
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Segmentation Analysis
By Type:
The North American cancer biopsy market can be segmented into two primary categories: liquid biopsy and tissue biopsy. Liquid biopsy has emerged as a revolutionary approach for cancer diagnosis, offering non-invasive methods for detecting tumor-derived biomarkers in bodily fluids such as blood or urine. On the other hand, tissue biopsy remains a cornerstone in cancer diagnosis, offering histological insights essential for treatment planning and prognosis. While tissue biopsy procedures are more invasive, they continue to be widely used, particularly for the diagnosis of solid tumors.
By Product Type:
Within the North American Cancer Biopsy Market, products can be categorized into instruments, kits, consumables, and others. Instruments encompass a wide array of devices used for biopsy procedures, including biopsy needles, imaging equipment, and tissue processing systems. Kits and consumables consist of biopsy kits, reagents, and ancillary supplies necessary for sample collection, processing, and analysis. The others category may include software solutions, accessories, and supportive equipment integral to biopsy procedures without falling explicitly under the aforementioned segments.
By Application:
The application segment of the North American Cancer Biopsy Market focuses on specific cancer types for which biopsy procedures are routinely performed. Breast cancer and lung cancer represent two prominent applications within this segment. Breast cancer biopsy plays a crucial role in confirming malignancy, determining tumor subtype, and guiding treatment decisions, encompassing procedures such as core needle biopsy and surgical biopsy. Similarly, lung cancer biopsy aids in the diagnosis of pulmonary malignancies, enabling histopathological evaluation of lung tissue for accurate staging and treatment planning.
Segmentations:
By Type:
- Liquid Biopsy
- Tissue Biopsy
By Product Type:
- Instruments
- Kits and consumables
- Others
By Application:
- Breast Cancer
- Lung Cancer
Market Drivers
Rising Cancer Prevalence and Aging Population:
North America faces a concerning rise in cancer diagnoses, attributed in part to an aging population where cancer risk escalates with age. For instance, in the United States in 2020, 1,603,844 new cancer cases were reported, and 602,347 people died of cancer. For every 100,000 people, 403 new cancer cases were reported, and 144 people died of cancer. In the United States alone, the American Cancer Society estimates over 1.9 million new cancer cases in 2024, an increase of 5% from 2023. Similarly, in Canada, the Canadian Cancer Society forecasts over 232,000 new cases for 2023, a 3% rise from the previous year.
As life expectancy increases and medical advancements allow individuals to live longer, the incidence of cancer inevitably rises. With the baby boomer generation aging, there’s a significant demographic shift towards older adults, thereby contributing to the uptick in cancer cases. Additionally, increased screenings and heightened awareness campaigns have led to more frequent cancer detection, further amplifying the demand for diagnostic procedures like biopsies.
Technological Advancements in Biopsy Techniques:
The North American Cancer Biopsy Market is witnessing a surge in innovative biopsy technologies, offering minimally invasive, image-guided procedures. These advancements represent a paradigm shift in cancer diagnosis, enhancing accuracy, reducing patient discomfort, and enabling earlier detection. Needle biopsies, liquid biopsies, and endoscopic biopsies are among the notable examples of technological breakthroughs driving this market evolution. By leveraging cutting-edge imaging modalities and molecular diagnostic techniques, healthcare providers can obtain precise tissue samples and biomarker analysis, facilitating more targeted treatment strategies. For instance, image-guided biopsies, utilizing technologies such as ultrasound, X-ray, or CT scans, have improved needle placement accuracy by up to 90%, minimizing patient discomfort.
Continuous advancements in biopsy techniques are driving market growth by enhancing precision and reducing invasiveness. For instance, image-guided biopsies, utilizing technologies such as ultrasound, X-ray, or CT scans, have improved needle placement accuracy by up to 90%, minimizing patient discomfort. Furthermore, molecular diagnostics are revolutionizing biopsy analysis. These advanced techniques can identify over 300 genetic mutations in tumor samples, providing deeper insights into tumor characteristics and potential treatment avenues. This has led to a 15% improvement in personalized treatment plans for patients.
Growing Demand for Early Cancer Detection:
Early diagnosis is paramount for successful cancer treatment, and the North American market reflects a growing emphasis on early detection methods, with biopsies playing a central role. Detecting cancer at an early stage not only improves treatment outcomes but also allows for less aggressive therapeutic approaches, potentially reducing treatment-related side effects and improving the overall quality of life for patients. As such, there’s a burgeoning demand for biopsy procedures that enable timely and accurate detection of cancerous lesions, driving market growth in this segment.
Government Funding and Insurance Coverage:
Governments across North America are increasingly allocating funds for cancer research and development, including advancements in biopsy techniques. Recognizing the critical role of early cancer detection in improving patient outcomes and reducing healthcare costs, policymakers are prioritizing investments in innovative diagnostic technologies. Furthermore, insurance coverage for cancer diagnostics, including biopsies, is expanding in many regions, making these procedures more accessible to patients. This broader insurance coverage not only improves patient access to essential diagnostic services but also alleviates the financial burdens associated with cancer diagnosis and treatment.
Focus on personalized medicine:
The rise of personalized medicine has underscored the importance of accurate tissue or liquid biopsy analysis to determine the specific type and genetic makeup of a cancer. This molecular profiling enables oncologists to tailor treatment plans to individual patients, maximizing therapeutic efficacy while minimizing adverse effects. As such, there’s a growing demand for biopsy techniques that provide comprehensive molecular and genomic information, facilitating precision medicine approaches. The convergence of technological innovations and personalized medicine principles is reshaping the landscape of cancer diagnostics, driving the adoption of advanced biopsy techniques across North America.
Market Trends
The landscape of cancer biopsy procedures is witnessing a significant shift towards minimally invasive techniques, marking a departure from traditional surgical approaches. For instance, image-guided percutaneous biopsy techniques provide an accurate histologic diagnosis without the need for a surgical biopsy. Up to 80%–90% of women with nonpalpable breast lesions turn out to have benign disease and, in retrospect, undergo unnecessary surgery.
Rise of Liquid Biopsies:
A notable trend in the North American cancer biopsy market is the rising prominence of liquid biopsies as a promising alternative to conventional tissue biopsies. Liquid biopsies analyze circulating tumor cells or DNA in a patient’s blood, offering a non-invasive means of cancer detection and monitoring. For instance, liquid biopsies consist of isolating tumor-derived entities like circulating tumor cells, circulating tumor DNA, tumor extracellular vesicles, etc., present in the body fluids of patients with cancer, followed by an analysis of genomic and proteomic data contained within them. Around 200 liquid biopsy trials in oncology started in 2021 and 2022, continuing the growth trend over the past 15 years. While still in the developmental stages, liquid biopsies hold significant potential for facilitating earlier cancer detection, monitoring treatment response, and advancing the frontier of personalized medicine, positioning them as a key focus area for future research and development efforts.
Integration of Advanced Imaging Technologies:
The integration of advanced imaging technologies is revolutionizing cancer biopsy procedures, enhancing accuracy and precision while minimizing procedural risks. Techniques such as ultrasound, CT scans, and MRI scans are increasingly utilized to visualize tumors and precisely target biopsy needles, allowing for real-time guidance during the procedure. This technological synergy between imaging modalities and biopsy techniques not only improves diagnostic accuracy but also enhances patient safety and overall procedural outcomes, reflecting a commitment to delivering state-of-the-art care within the North American healthcare landscape.
Focus on Automation and Robotics:
Automation and robotics are gaining traction in the realm of cancer biopsy procedures, offering the potential to augment surgical precision and efficiency. Robotic arms, for instance, are being employed to assist surgeons during biopsy procedures, enhancing procedural accuracy and reducing the likelihood of human error. This focus on automation and robotics underscores a broader trend towards leveraging cutting-edge technologies to optimize clinical workflows, improve patient outcomes, and advance the standard of care in cancer diagnosis and treatment across North America.
Growing Point-of-Care Testing:
Point-of-care testing is emerging as a pivotal trend in the North American cancer biopsy market, facilitating rapid diagnostic evaluation and timely treatment decisions. By enabling biopsy samples to be analyzed quickly at the doctor’s office or bedside, point-of-care testing streamlines the diagnostic process, reduces patient anxiety, and minimizes delays in care. This emphasis on rapid diagnostic capabilities underscores a commitment to enhancing patient-centered care delivery, fostering greater accessibility, and improving clinical outcomes within the North American healthcare ecosystem.
Market Restraints and Challenges
High Cost of Procedures and Technologies:
Advanced biopsy techniques often come with a hefty price tag, involving expensive equipment and specialized personnel, which collectively contribute to driving up the overall cost of the procedure. This financial burden can pose challenges for both patients and healthcare systems, potentially limiting access to these advanced diagnostic tools for some individuals. The affordability of biopsy procedures remains a critical consideration in ensuring equitable access to quality healthcare across North America.
Limitations of Biopsy Techniques:
While minimally invasive techniques are gaining ground in the North American Cancer Biopsy Market, traditional surgical biopsies may still be necessary for certain cancers or when a larger tissue sample is required. However, surgical biopsies can be more complex and carry higher risks for patients, including surgical complications and prolonged recovery times. Balancing the advantages and limitations of different biopsy techniques is essential for healthcare providers to optimize patient outcomes while minimizing procedural risks.
Accuracy Concerns:
Biopsy procedures, particularly minimally invasive ones, carry inherent risks of sampling errors, which can compromise the accuracy of the diagnosis. Sampling errors may result in misdiagnosis or the need for repeat biopsies, leading to increased patient anxiety and treatment delays. Addressing concerns surrounding biopsy accuracy through quality assurance measures and ongoing professional development is paramount to maintaining patient trust and confidence in the diagnostic process.
Skilled labor shortage:
Proper diagnosis and interpretation of biopsy results necessitate highly trained pathologists and radiologists. However, a shortage of such skilled professionals in certain regions of North America can create bottlenecks, leading to delays in diagnosis and treatment. Efforts to address this skilled labor shortage through targeted recruitment strategies, professional training programs, and technology-enabled diagnostic support systems are essential for ensuring timely and accurate cancer care delivery.
Patient anxiety and discomfort:
Despite advancements in minimally invasive biopsy techniques, patients may still experience anxiety and discomfort during the procedure. Addressing these psychosocial aspects of patient care through empathetic communication, patient education, and the provision of adequate pain management and emotional support services remains crucial. By prioritizing patient-centered care approaches, healthcare providers can minimize patient distress and enhance the overall biopsy experience, ultimately improving patient satisfaction and treatment outcomes.
Key Players
- BD (Becton, Dickinson And Company)
- INRAD, Inc.
- Thermo Fisher Scientific, Inc.
- IZI Medical Products
- CONMED Corporation
- Johnson & Johnson Services, Inc.
- Argon Medical
- Spectra Medical Devices, Inc.
- Medtronic
- Boston Scientific Corporation
Recent Developments
- In January 2023, Agilent Technologies, Inc. announced an agreement with Quest Diagnostics. The agreement will make the Agilent Resolution ctDx FIRST liquid biopsy next-generation sequencing (NGS) test available to providers and patients across the U.S. Quest and Agilent’s collaboration will make it possible for ctDx FIRST, a single-site premarket approval (ssPMA) test run at the Resolution Bioscience CLIA laboratory in Kirkland, Washington, to be widely used. The U.S. Food and Drug Administration (FDA) has approved the first liquid biopsy test, known as ctDx FIRST, as a companion diagnostic (CDx) to help diagnose patients with advanced non-small cell lung cancer (NSCLC) who may benefit from KRAZATI treatment.
- In August 2022, Guardant Health obtained approval from the US Food and Drug Administration (FDA) for its Guardant360 CDx liquid biopsy test. This approval designated Guardant360 CDx as a companion diagnostic (CDx) to aid in the selection of patients with unresectable or metastatic HER2-mutant non-small cell lung cancer (NSCLC) whose tumors possess activating HER2 (ERBB2) mutations. The approval allows for the identification of patients suitable for treatment with ENHERTU (fam-trastuzumab deruxtecan-nxki), providing healthcare professionals with a valuable tool for personalized treatment decision-making in this patient population.
- In May 2022, Delfi Diagnostics, a pioneer in developing a new class of high-performance, cost-effective liquid biopsy tests for early cancer detection, showcased several applications for its next-generation liquid biopsy platform. During this presentation, Delfi Diagnostics provided an update on the trial-in-progress for DELFI-L101, a prospective, case-control study aimed at training and testing classifiers for the detection of lung cancer. By leveraging innovative liquid biopsy technology, Delfi Diagnostics aims to advance early cancer detection capabilities, potentially revolutionizing the diagnostic landscape and improving patient outcomes through earlier diagnosis and intervention.
- In July 2021, GE Healthcare announced that Serena Bright had been installed in five hospitals and radiology facilities across the country. The first contrast-guided biopsy product on the market, Serena Bright, supports patients and clinicians in their battle against breast cancer. Using the same mammography equipment, in the same room, and with the same staff as the screening or diagnostic mammogram, patients can now have their breast biopsy exams with contrast guidance. This technique received U.S. Food and Drug Administration 510(k) clearance in May 2020.
Regional Analysis
United States
The United States holds the largest market share of approximately 86% in the North American cancer biopsy market. This dominant position can be attributed to several key factors, including the country’s advanced healthcare infrastructure, robust research and development efforts, and the presence of major industry players.
The United States is at the forefront of cancer research and treatment, with numerous prestigious medical institutions and cancer centers actively engaged in the development and adoption of innovative biopsy techniques. These institutions, such as the Memorial Sloan Kettering Cancer Center, MD Anderson Cancer Center, and Dana-Farber Cancer Institute, have played a crucial role in driving the demand for advanced cancer biopsy procedures and technologies.
Additionally, the presence of leading medical device companies, such as Becton, Dickinson and Company (BD), Hologic, Inc., and C. R. Bard, Inc., has further fueled the growth of the cancer biopsy market in the United States.
Canada
Canada accounts for approximately 14% of the North American cancer biopsy market share. The country’s strong commitment to cancer research, universal healthcare system, and presence of renowned medical institutions have contributed to the growth of this market segment.
The Canadian healthcare system, which provides universal coverage for essential medical services, including cancer screening and treatment, has played a significant role in promoting early detection and timely access to cancer biopsy procedures. This, coupled with the country’s robust cancer research programs and the adoption of advanced biopsy techniques, has driven the demand for innovative cancer biopsy solutions.
Mexico
Mexico represents an important and growing segment of the North American cancer biopsy market. The country holds a market share of approximately 6–8% in the overall regional market. Mexico has witnessed an increasing incidence of cancer in recent years, partly attributable to lifestyle factors and an aging population. This has necessitated greater access to cancer screening, diagnosis, and treatment options, including biopsy procedures. Mexico has emerged as a destination for medical tourism, particularly for cancer treatment. Many healthcare providers are adopting the latest biopsy technologies to attract international patients seeking high-quality, cost-effective cancer care.
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Future Outlook
- Continued Technological Advancements: Expect ongoing innovation in biopsy techniques, driven by advances in imaging modalities, molecular diagnostics, and artificial intelligence.
- Expansion of Liquid Biopsy Applications: Anticipate broader adoption of liquid biopsy technologies for early cancer detection and treatment monitoring across various cancer types.
- Enhanced Personalized Medicine Approaches: Look for increased integration of biopsy results into personalized treatment plans, optimizing therapeutic strategies for individual patients.
- Rising Demand for Minimally Invasive Procedures: With a growing focus on patient comfort and safety, expect a continued shift towards minimally invasive biopsy techniques.
- Greater Emphasis on Accuracy and Precision: As precision medicine gains prominence, there will be heightened emphasis on improving the accuracy and reliability of biopsy procedures.
- Addressing Healthcare Disparities: Efforts to bridge gaps in access to biopsy services, particularly in underserved communities, will likely gain momentum.
- Collaboration Across Stakeholders: Anticipate increased collaboration between industry, academia, and regulatory bodies to drive innovation and address unmet needs in cancer diagnosis.
- Integration of Biomarker Discovery: Advancements in biomarker identification and validation will play a pivotal role in enhancing the diagnostic capabilities of biopsy procedures.
- Expansion of Point-of-Care Testing: Expect the proliferation of point-of-care biopsy testing solutions, enabling faster diagnosis and treatment decision-making at the bedside.
- Regulatory Adaptation to New Technologies: Regulatory agencies will likely continue to adapt to the evolving landscape of biopsy technologies, facilitating market access for innovative diagnostic products.
