Cancer is the uncontrolled growth of abnormal cells in the body. It can affect numerous organs and tissues of the body. When a patient is suspected of having a particular type of cancer, a biopsy procedure is performed to extract a target tissue sample for histological analysis. This intervention typically provides a definitive cancer diagnosis for the patient. Given that these procedures play such an important role in the diagnostic pathway for various cancers, medical device manufacturers have worked to develop biopsy devices that maximize the volume and quality of the tissue samples, as well as decrease their negative impact on the patient’s body. As seen with other medical device markets, less invasive biopsy techniques have entered the market and have established a new gold standard in many global regions.
For this market analysis, the biopsy devices market is segmented by cancer indication and by the type of biopsy procedure performed. Beyond providing a general analysis and forecast for each device segment in different global regions from 2010–2019, this report offers a more granular approach by assessing the adoption patterns of the different biopsy procedure types for specific cancer indications in specific geographies. This report and forecast focus on the adoption patterns of surgical biopsies, fine needle aspiration (FNA) devices, core needle biopsy (CNB) devices, and vacuum-assisted biopsy (VAB) devices in the diagnosis of breast, prostate, lung, liver, and thyroid cancers. Additionally, this report and forecast focus on these adoption patterns in the 10 major global markets, which include the United States, France, Germany, Italy, Spain, the United Kingdom, Japan, Brazil, China, and India. This segmentation provides better business intelligence, so that more effective actions can be taken.
While the biopsy devices market has matured quite significantly, there are still significant barriers to overcome and opportunities for growth. While the US has seen the rapid adoption of VAB devices in the diagnosis of breast cancer, this market segment will be subjected to immense pricing pressure during the forecast period covered in this report. Changes in the reimbursement rates for image-guided breast biopsy procedures will affect both the average selling prices (ASPs) of these devices and the adoption levels of alternative tissue-extraction devices and procedures, including CNBs and open surgical biopsies. Additionally, the emerging economies will provide opportunities for growth as access to healthcare improves, adoption of FNA decreases, and governments work towards implementing cancer screening programs. This report is intended to elaborate on these market opportunities and barriers to help current and future competitors navigate the market.
Questions Answered in this Report
At the start of 2014, the reimbursement scheme for imaged-guided breast biopsy procedures performed in the US underwent significant changes in coding structure and cost levels. How will this affect the adoption of VAB and CNB devices in the country? To what extent will the ASPs of VAB devices be affected?
The biopsy devices markets in the developing economies of the Asia-Pacific (APAC) region and Brazil have higher Compound Annual Growth Rates (CAGRs) than any other country included in this report. Which countries will have the highest CAGRs in the FNA market, the CNB market, and the VAB market?
The major players in the VAB and CNB markets are drastically different. What is the global company share in the VAB and CNB markets? How will their market share shift through 2019?
New technologies, such as liquid and optical biopsies, are being developed as less invasive techniques to obtain a cancer diagnosis. What is the likelihood that these technologies could replace the conventional biopsy devices? Which companies are the furthest along in the development of these technologies?
The benefits of mass screening programs on prostate cancer mortality are controversial. What are the results of the major randomized clinical trials assessing a prostate cancer screening program’s effectiveness? How will this impact the institution of a mass prostate cancer screening program in the countries covered in this report?
Regions Covered: US, France, Germany, Italy, Spain, UK, Japan, Brazil, China, and India
Market Model Features
An interactive Excel forecast model based on primary research interviews with KOLs, physicians, industry participants, and distributors is included with this report.* This patient-based model provides diagnosis rates, patient segmentation, treatment rates, procedure volumes, average selling prices, and market values over a 10-year period (2010–2019). The forecast model is robust, fully-transparent, and easy to navigate. Moreover, our models support the data presented in the reports, and the complete methodology is outlined in the report and the model.
The model offers several valuable perspectives on the biopsy devices market. It includes procedure volumes and market valuations for three types of biopsy devices in five cancer indications, including:
*Interactive Excel forecast model only available to clients purchasing a site license or higher.
What Physicians Think
“What Do Physicians Think?” quotes provide a unique insight into how healthcare professionals are reacting to events within the industry, and what their responses could mean for industry strategists. This information is essential for all strategic decision-makers in every organization, allowing them to act on high-quality information.
1 Table of Contents 1
1.1 List of Tables 6
1.2 List of Figures 9
2 Executive Summary 11
2.1 Overview 11
2.2 Future Growth 12
2.3 Future Outlook 12
2.4 What Do Physicians Think? 13
3 Introduction 15
3.1 Overview 15
3.2 Catalyst 16
3.3 Related Reports 16
4 Industry Overview 16
4.1 Types of Biopsies 16
4.1.1 Surgical Biopsy 16
4.1.2 Fine Needle Aspiration 17
4.1.3 Core Needle Biopsy 18
4.1.4 Vacuum-Assisted Biopsy 19
4.2 Biopsy Procedure Trends 19
4.2.1 Global 19
4.2.2 United States 20
4.2.3 EU 22
4.2.4 South America 28
4.2.5 Asia-Pacific Region 29
4.3 Market Access to Cancer Screening Programs 35
4.3.1 Regulation 35
4.3.2 Biopsy Device Adoption Patterns 38
4.3.3 Reimbursement Trends 42
4.4 Regulatory Issues/Recalls 43
4.5 Mergers & Acquisitions/Key Partnerships 44
4.5.1 Hologic Acquires Suros Surgical Systems 44
4.5.2 C. R. Bard Acquires SenoRx 44
4.5.3 Devicor Medical Products Acquires Breast Care Portfolio from Ethicon Endo-Surgery 44
4.6 Economic Impact of Cancer Screening and Treatment 45
4.7 Additional Indications for Biopsy Devices 46
5 Unmet Needs 46
5.1 Overview 46
5.2 More Efficient Screening Tests for Prostate Cancer 47
5.3 More Efficient Screening Tests for Breast Cancer 47
5.4 More Efficient Screening Guidelines for Thyroid Cancer 48
5.5 Screening Tests That Can Provide Histological Analysis In Situ 49
6 Market Opportunity Analysis 49
6.1 Increase Marketing for Vacuum-Assisted Biopsy Devices in European Countries 49
6.2 Bundling Solutions 50
6.3 Focus Efforts on China’s Increasing Adoption of VAB Devices 52
6.4 Market for Prostate Cancer Screening Coverage in Europe 52
7 Market Drivers and Barriers 53
7.1 Market Drivers 53
7.1.1 Inadequate Screening Tests for Particular Cancers 53
7.1.2 Demand for Minimally-Invasive Biopsy Techniques 54
7.1.3 Increased Adherence to Certain Cancer Screening Guidelines 54
7.1.4 Aging Patient Population 55
7.2 Market Barriers 56
7.2.1 Increased Competition from Other Cancer Diagnostic Tests 56
7.2.2 Breast Biopsy Reimbursement Bundling 59
7.2.3 Decreased Adherence to Certain Cancer Screening Guidelines 62
7.2.4 Benefits of Mass Prostate Cancer Screening Being Outweighed by Risks 62
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