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MediPoint: Biopsy Devices - US Analysis and Market Forecasts

LONDON, April 17, 2014 /PRNewswire/ -- has added a new market research report:

MediPoint: Biopsy Devices - US Analysis and Market Forecasts

MediPoint: Biopsy Devices - US Analysis and Market Forecasts


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.

While the global biopsy devices market is expected to see growth over the forecast period, there are several barriers that are dampening the intervention's potential adoption levels. Notably in the US, reimbursement for image guided breast biopsies has undergone some restructuring. The 2014 Medicare Fee Schedule Final Rule imposed drastic reimbursement cuts for these procedures which will have a significant effect on the adoption of more expensive vacuum assisted biopsy (VAB) devices.


- An overview of biopsy devices, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized the US biopsy devices market revenue and future forecasts from 2010 to 2012, forecast for 7 years to 2019.
- Investigation of current and future market competition for biopsy devices
- Insightful review of the key industry drivers, restraints and challenges as well as predicted impact of key events.
- Competitor assessment including device approval analysis and device sales forecasts.
- Marketed and pipeline product profiles covering efficiency, safety, clinical study details, device approvals, product positioning and device sales forecast.
- Analysis of unmet needs within the market and opportunities for future players.
- Technology trends evaluation to assess strength of pipeline.
- An overview of all devices in development including clinical study details, design and material selection considerations, efficacy reports, and device approval timelines.
- Company profiles including business description, financial overview and SWOT analysis.
- Coverage of key market players.
- Strategic assessment of the biopsy devices sector through market impact analysis, future market scenario and company analysis.
- Direct quotes from Key Opinion Leaders (KOL).

Reasons to buy

- Understand the trends shaping and driving the US biopsy devices Market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in the US biopsy devices market through 2019.
- Quantify candidate patient populations to better design product pricing & launch plans.
- Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape.
- Perform benchmarking analysis of growth opportunities against currently marketed products.
- Assess competitiveness of products in market by understanding the strengths and weaknesses of current competition.
- Take a comprehensive look at the market's device pipeline and identify promising, paradigm-shifting products.
- Create an effective counter-strategy to gain a competitive advantage against those currently in the market.
- Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for growth.
- What's the next big thing in the US biopsy devices market landscape? Identify, understand and capitalize.
1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 9
1.2 List of Figures 11
2 Introduction 12
2.1 Overview 12
2.2 Catalyst 13
2.3 Related Reports 13
3 Industry Overview 14
3.1 Types of Biopsies 14
3.1.1 Surgical Biopsy 14
3.1.2 Fine Needle Aspiration 14
3.1.3 Core Needle Biopsy 15
3.1.4 Vacuum-Assisted Biopsy 16
3.2 Biopsy Procedure Trends 16
3.2.1 United States 16
3.3 Market Access to Cancer Screening Programs 18
3.3.1 Regulation 18
3.3.2 Biopsy Device Adoption Patterns 21
3.3.3 Reimbursement Trends 25
3.4 Regulatory Issues/Recalls 27
3.5 Mergers & Acquisitions/Key Partnerships 28
3.5.1 Hologic Acquires Suros Surgical Systems 28
3.5.2 C. R. Bard Acquires SenoRx 28
3.5.3 Devicor Medical Products Acquires Breast Care Portfolio from Ethicon Endo-Surgery 28
3.6 Economic Impact of Cancer Screening and Treatment 29
3.7 Additional Indications for Biopsy Devices 30
4 Unmet Needs 31
4.1 Overview 31
4.2 More Efficient Screening Tests for Prostate Cancer 31
4.3 More Efficient Screening Tests for Breast Cancer 32
4.4 More Efficient Screening Guidelines for Thyroid Cancer 32
4.5 Screening Tests That Can Provide Histological Analysis In Situ 33
5 Market Opportunity Analysis 34
5.1 Increase Marketing for Vacuum-Assisted Biopsy Devices in European Countries 34
5.2 Bundling Solutions 35
5.3 Focus Efforts on China's Increasing Adoption of VAB Devices 36
5.4 Market for Prostate Cancer Screening Coverage in Europe 36
6 Market Drivers and Barriers 38
6.1 Market Drivers 38
6.1.1 Inadequate Screening Tests for Particular Cancers 38
6.1.2 Demand for Minimally-Invasive Biopsy Techniques 39
6.1.3 Increased Adherence to Certain Cancer Screening Guidelines 39
6.1.4 Aging Patient Population 40
6.2 Market Barriers 41
6.2.1 Increased Competition from Other Cancer Diagnostic Tests 41
6.2.2 Breast Biopsy Reimbursement Bundling 44
6.2.3 Decreased Adherence to Certain Cancer Screening Guidelines 46
6.2.4 Benefits of Mass Prostate Cancer Screening Being Outweighed by Risks 47
7 Competitive Assessment 49
7.1 Overview 49
7.2 Classification Based on System 49
7.2.1 Vacuum-Assisted Biopsy Devices 49
7.2.2 Core Needle Biopsy Devices 51
7.2.3 Fine Needle Aspiration Devices 52
8 Pipeline Assessment 54
8.1 Overview 54
8.1.1 Optical Biopsy 54
8.1.2 Liquid Biopsy 56
9 Clinical Trial Analysis 57
10 Current and Future Players 59
10.1 Trends in Corporate Strategy 59
10.2 Company Profiles 59
10.2.1 Argon Medical Devices 59
10.2.2 Boston Scientific 62
10.2.3 Cardinal Health 64
10.2.4 CareFusion Corporation 66
10.2.5 Cook Medical 69
10.2.6 C. R. Bard 71
10.2.7 Devicor Medical Products 77
10.2.8 DTR Medical 81
10.2.9 Gallini Medical Devices 82
10.2.10 Hologic 85
10.2.11 INRAD 88
10.2.12 Intact Medical Corporation 90
10.2.13 TSK Laboratory 91
11 Market Outlook 94
11.1 Company Market Share 94
11.1.1 Vacuum-Assisted Biopsy Market Share 94
11.1.2 Core Needle Biopsy/Fine Needle Aspiration Market Share 96
11.2 By Geography 97
11.2.1 United States 97
12 Appendix 99
12.1 Bibliography 99
12.2 Abbreviations 108
12.3 Report Methodology 110
12.3.1 Overview 110
12.3.2 Coverage 110
12.3.3 Primary Research 110
12.3.4 Secondary Research 111
12.3.5 Forecasting Methodology 112
12.4 Key Opinion Leaders Included in This Study 112
12.5 About the Authors 113
12.5.1 Joseph A. Gregory, Analyst, Surgical Devices 113
12.5.2 Derek Archila, MBA, Director of Research and Analysis, Medical Devices 113
12.6 Global Head of Healthcare 114
12.6.1 Bonnie Bain, Ph.D., Global Head of Healthcare 114
12.7 About MediPoint 115
12.8 About GlobalData 115
12.9 Disclaimer 115

List of Tables

Table 1: Biopsy Device Adoption Patterns in Diagnosing Prostate Cancer, Global, 2013 and 2019 22
Table 2: Biopsy Device Adoption Patterns in Diagnosing Breast Cancer, Global, 2013 and 2019 23
Table 3: Biopsy Device Adoption Patterns in Diagnosing Lung Cancer, Global, 2013 and 2019 24
Table 4: Biopsy Device Adoption Patterns in Diagnosing Liver Cancer, Global, 2013 and 2019 24
Table 5: Biopsy Device Adoption Patterns in Diagnosing Thyroid Cancer, Global, 2013 and 2019 25
Table 6: Age Demographics, Age >65 Years, Global, 2013 40
Table 7: Stereotactic Breast Biopsy Ambulatory Surgery Center Billing, 2011 45
Table 8: Stereotactic Breast Biopsy Physician Billing, 2011 45
Table 9: Company Profile - Argon Medical Devices 60
Table 10: Product Portfolio - Argon Medical Devices 61
Table 11: Argon Medical Devices, SWOT Analysis, 2013 61
Table 12: Company Profile - Boston Scientific 62
Table 13: Product Portfolio - Boston Scientific 63
Table 14: Boston Scientific SWOT Analysis, 2013 64
Table 15: Company Profile - Cardinal Health 65
Table 16: Product Portfolio - Cardinal Health 65
Table 17: Cardinal Health SWOT Analysis, 2013 66
Table 18: Company Profile - CareFusion Corporation 67
Table 19: Product Portfolio - CareFusion 68
Table 20: CareFusion, SWOT Analysis, 2013 68
Table 21: Company Profile - Cook Medical 69
Table 22: Product Portfolio - Cook Medical 70
Table 23: Cook Medical, SWOT Analysis, 2013 71
Table 24: Company Profile - C. R. Bard 72
Table 25: Product Portfolio - C. R. Bard 72
Table 26: C.R. Bard, SWOT Analysis, 2013 76
Table 27: Company Profile - Devicor Medical Products 77
Table 28: Product Portfolio - Devicor Medical Products 80
Table 29: Devicor Medical Products SWOT Analysis, 2013 80
Table 30: Company Profile - DTR Medical 81
Table 31: Product Portfolio - DTR Medical 81
Table 32: DTR Medical SWOT Analysis, 2013 82
Table 33: Company Profile - Gallini Medical Devices 83
Table 34: Product Portfolio - Gallini Medical Devices 84
Table 35: Gallini Medical Devices SWOT Analysis, 2013 84
Table 36: Company Profile - Hologic 85
Table 37: Product Portfolio - Hologic 87
Table 38: Hologic SWOT Analysis, 2013 87
Table 39: Company Profile - INRAD 88
Table 40: Product Portfolio - INRAD 89
Table 41: INRAD SWOT Analysis, 2013 89
Table 42: Company Profile - Intact Medical Corporation 90
Table 43: Product Portfolio - Intact Medical Corporation 91
Table 44: Intact Medical Corporation SWOT Analysis, 2013 91
Table 45: Company Profile - TSK Laboratory 92
Table 46: Product Portfolio - TSK Laboratory 92
Table 47: TSK Laboratory SWOT Analysis, 2013 93
Table 48: VAB, Global Market Share, 2013 95
Table 49: CNB/FNA, Global Market Share, 2013 96
Table 50: United States Biopsy Devices Sales ($m) Forecast, 2010-2019 97

List of Figures

Figure 1: Biopsy Procedure Volumes: All Indications, United States, 2010-2019 18
Figure 2: EnCor Breast Biopsy System 73
Figure 3: EnCor Enspire Breast Biopsy System 74
Figure 4: EnCor Ultra Breast Biopsy System 74
Figure 5: Finesse Ultra Breast Biopsy System 75
Figure 6: Vacora Breast Biopsy System 76
Figure 7: Original Mammotome System 78
Figure 8: Mammotome Elite 79
Figure 9: Mammotome Revolve 80
Figure 10: VAB, Global Market Share, 2013 95
Figure 11: CNB/FNA, Global Market Share, 2013 96
Figure 12: United States Biopsy Devices Sales ($) Forecast, 2010-2019 98

Read the full report:
MediPoint: Biopsy Devices - US Analysis and Market Forecasts

For more information:
Sarah Smith
Research Advisor at
Email: [email protected]
Tel: +44 208 816 85 48



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