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Biopsy Devices - Global Analysis and Market Forecasts
Publication Date Feb 2014
Publisher GlobalData
Product Type Report
Pages 144
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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:
Breast cancer
Prostate cancer
Lung cancer
Liver cancer
Thyroid cancer
*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

8    Competitive Assessment    63

8.1    Overview    63

8.2    Classification Based on System    63

8.2.1    Vacuum-Assisted Biopsy Devices    63

8.2.2    Core Needle Biopsy Devices    66

8.2.3    Fine Needle Aspiration Devices    67

9    Pipeline Assessment    68

9.1    Overview    68

9.1.1    Optical Biopsy    70

9.1.2    Liquid Biopsy    71

10    Clinical Trial Analysis    71

11    Current and Future Players    73

11.1    Trends in Corporate Strategy    73

11.2    Company Profiles    73

11.2.1    Argon Medical Devices    74

11.2.2    Boston Scientific    76

11.2.3    Cardinal Health    79

11.2.4    CareFusion Corporation    80

11.2.5    Cook Medical    82

11.2.6    C. R. Bard    85

11.2.7    Devicor Medical Products    91

11.2.8    DTR Medical    95

11.2.9    Gallini Medical Devices    97

11.2.10    Hologic    99

11.2.11    INRAD    102

11.2.12    Intact Medical Corporation    104

11.2.13    TSK Laboratory    106

12    Market Outlook    107

12.1    Company Market Share    107

12.1.1    Vacuum-Assisted Biopsy Market Share    108

12.1.2    Core Needle Biopsy/Fine Needle Aspiration Market Share    110

12.2    By Segment    111

12.2.1    Fine Needle Aspiration    111

12.2.2    Core Needle Biopsy    112

12.2.3    Vacuum-Assisted Biopsy    113

12.3    By Geography    114

12.3.1    Global    114

12.3.2    United States    115

12.3.3    France    117

12.3.4    Germany    118

12.3.5    Italy    119

12.3.6    Spain    120

12.3.7    United Kingdom    121

12.3.8    Japan    122

12.3.9    Brazil    123

12.3.10    China    124

12.3.11    India    125

13    Appendix    126

13.1    Bibliography    126

13.2    Abbreviations    135

13.3    Report Methodology    138

13.3.1    Overview    138

13.3.2    Coverage    138

13.3.3    Primary Research    138

13.3.4    Secondary Research    139

13.3.5    Forecasting Methodology    140

13.4    Key Opinion Leaders Included in This Study    141

13.5    About the Authors    142

13.5.1    Joseph A. Gregory, Analyst, Surgical Devices    142

13.5.2    Derek Archila, MBA, Director of Research and Analysis, Medical Devices    142

13.6    Global Head of Healthcare    143

13.6.1    Bonnie Bain, Ph.D., Global Head of Healthcare    143

13.7    About MediPoint    144

13.8    About GlobalData    144

13.9    Contact Us    144

13.10    Disclaimer    144

List Of Tables
Table 1: Overview of Global Biopsy Devices Market*    10

Table 2: Breast Cancer Incidence Rates, 5EU, 2010–2019    24

Table 3: Biopsy Device Adoption Patterns in Diagnosing Prostate Cancer, Global, 2013 and 2019    38

Table 4: Biopsy Device Adoption Patterns in Diagnosing Breast Cancer, Global, 2013 and 2019    39

Table 5: Biopsy Device Adoption Patterns in Diagnosing Lung Cancer, Global, 2013 and 2019    40

Table 6: Biopsy Device Adoption Patterns in Diagnosing Liver Cancer, Global, 2013 and 2019    41

Table 7: Biopsy Device Adoption Patterns in Diagnosing Thyroid Cancer, Global, 2013 and 2019    42

Table 8: Age Demographics, Age >65 Years, Global, 2013    55

Table 9: Stereotactic Breast Biopsy Ambulatory Surgery Center Billing, 2011    60

Table 10: Stereotactic Breast Biopsy Physician Billing, 2011    60

Table 11: Company Profile – Argon Medical Devices    74

Table 12: Product Portfolio – Argon Medical Devices    75

Table 13: Argon Medical Devices, SWOT Analysis, 2013    76

Table 14: Company Profile – Boston Scientific    77

Table 15: Product Portfolio – Boston Scientific    78

Table 16: Boston Scientific SWOT Analysis, 2013    78

Table 17: Company Profile – Cardinal Health    79

Table 18: Product Portfolio – Cardinal Health    80

Table 19: Cardinal Health SWOT Analysis, 2013    80

Table 20: Company Profile – CareFusion Corporation    81

Table 21: Product Portfolio – CareFusion    82

Table 22: CareFusion, SWOT Analysis, 2013    82

Table 23: Company Profile – Cook Medical    83

Table 24: Product Portfolio – Cook Medical    84

Table 25: Cook Medical, SWOT Analysis, 2013    85

Table 26: Company Profile – C. R. Bard    86

Table 27: Product Portfolio – C. R. Bard    86

Table 28: C.R. Bard, SWOT Analysis, 2013    90

Table 29: Company Profile – Devicor Medical Products    91

Table 30: Product Portfolio – Devicor Medical Products    94

Table 31: Devicor Medical Products SWOT Analysis, 2013    95

Table 32: Company Profile – DTR Medical    95

Table 33: Product Portfolio – DTR Medical    96

Table 34: DTR Medical SWOT Analysis, 2013    96

Table 35: Company Profile – Gallini Medical Devices    97

Table 36: Product Portfolio – Gallini Medical Devices    98

Table 37: Gallini Medical Devices SWOT Analysis, 2013    99

Table 38: Company Profile – Hologic    100

Table 39: Product Portfolio – Hologic    101

Table 40: Hologic SWOT Analysis, 2013    101

Table 41: Company Profile – INRAD    102

Table 42: Product Portfolio – INRAD    103

Table 43: INRAD SWOT Analysis, 2013    103

Table 44: Company Profile – Intact Medical Corporation    104

Table 45: Product Portfolio – Intact Medical Corporation    105

Table 46: Intact Medical Corporation SWOT Analysis, 2013    105

Table 47: Company Profile – TSK Laboratory    106

Table 48: Product Portfolio – TSK Laboratory    107

Table 49: TSK Laboratory SWOT Analysis, 2013    107

Table 50: VAB, Global Market Share, 2013    108

Table 51: CNB/FNA, Global Market Share, 2013    110

Table 52: Global FNA Device Sales ($m) Forecast, 2010–2019    111

Table 53: Global CNB Device Sales ($m) Forecast, 2010–2019    112

Table 54: Global VAB Device Sales ($m) Forecast, 2010–2019    113

Table 55: Global Biopsy Devices Sales ($m) Forecast, 2010–2019    114

Table 56: United States Biopsy Devices Sales ($m) Forecast, 2010–2019    116

Table 57: France Biopsy Devices Sales ($m) Forecast, 2010–2019    117

Table 58: Germany Biopsy Devices Sales ($m) Forecast, 2010–2019    118

Table 59: Italy Biopsy Devices Sales ($m) Forecast, 2010–2019    119

Table 60: Spain Biopsy Devices Sales ($m) Forecast, 2010–2019    120

Table 61: United Kingdom Biopsy Devices Sales ($m) Forecast, 2010–2019    121

Table 62: Japan Biopsy Devices Sales ($m) Forecast, 2010–2019    122

Table 63: Brazil Biopsy Devices Sales ($m) Forecast, 2010–2019    123

Table 64: China Biopsy Devices Sales ($m) Forecast, 2010–2019    124

Table 65: India Biopsy Devices Sales ($m) Forecast, 2010–2019    125

List Of Figures
Figure 1: Composition of Global Biopsy Devices Procedures, 2012 and 2019    12

Figure 2: Biopsy Procedure Volumes: All Indications, United States, 2010–2019    21

Figure 3: Biopsy Procedure Volumes: Prostate, 5EU, 2010–2019    23

Figure 4: Biopsy Procedure Volumes: Breast, 5EU, 2010–2019    24

Figure 5: Biopsy Procedure Volumes: Lung, 5EU, 2010–2019    25

Figure 6: Biopsy Procedure Volumes: Liver, 5EU, 2010–2019    26

Figure 7: Biopsy Procedure Volumes: Thyroid, 5EU, 2010–2019    27

Figure 8: Biopsy Procedure Volumes: All Cancer Indications, Brazil, 2010–2019    28

Figure 9: Biopsy Procedure Volumes: Prostate, APAC Region, 2010–2019    30

Figure 10: Biopsy Procedure Volumes: Breast, APAC Region, 2010–2019    31

Figure 11: Biopsy Procedure Volumes: Lung, APAC Region, 2010–2019    32

Figure 12: Biopsy Procedure Volumes: Liver, APAC Region, 2010–2019    33

Figure 13: Biopsy Procedure Volumes: Thyroid, APAC Region, 2010–2019    34

Figure 14: VAB, Global Market Share, 2013    69

Figure 15: CNB/FNA, Global Market Share, 2013    69

Figure 16: CNB/FNA, Global Market Share, 2013    75

Figure 17: EnCor Breast Biopsy System    87

Figure 18: EnCor Enspire Breast Biopsy System    88

Figure 19: EnCor Ultra Breast Biopsy System    88

Figure 20: Finesse Ultra Breast Biopsy System    89

Figure 21: Vacora Breast Biopsy System    90

Figure 22: Original Mammotome System    92

Figure 23: Mammotome Elite    93

Figure 24: Mammotome Revolve    94

Figure 25: VAB, Global Market Share, 2013    109

Figure 26: CNB/FNA, Global Market Share, 2013    110

Figure 27: Global FNA Device Sales ($m) Forecast, 2010–2019    111

Figure 28: Global CNB Device Sales ($m) Forecast, 2010–2019    112

Figure 29: Global VAB Device Sales ($m) Forecast, 2010–2019    113

Figure 30: Global Biopsy Devices Sales ($) Forecast, 2010–2019    115

Figure 31: United States Biopsy Devices Sales ($) Forecast, 2010–2019    116

Figure 32: France Biopsy Devices Sales ($) Forecast, 2010–2019    117

Figure 33: Germany Biopsy Devices Sales ($) Forecast, 2010–2019    118

Figure 34: Italy Biopsy Devices Sales ($) Forecast, 2010–2019    119

Figure 35: Spain Biopsy Devices Sales ($) Forecast, 2010–2019    120

Figure 36: United Kingdom Biopsy Devices Sales ($) Forecast, 2010–2019    121

Figure 37: Japan Biopsy Devices Sales ($) Forecast, 2010–2019    122

Figure 38: Brazil Biopsy Devices Sales ($) Forecast, 2010–2019    123

Figure 39: China Biopsy Devices Sales ($) Forecast, 2010–2019    124

Figure 40: India Biopsy Devices Sales ($) Forecast, 2010–2019    125

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