In Vitro Diagnostics Market Report and Analysis 2008-2023

In Vitro Diagnostics Market Report and Analysis 2008-2023

This brand new report examines the commercial prospects for in vitro diagnostics (IVD) in the global healthcare market. Technological solutions are playing an increasingly important role in both clinical practice and pharmaceutical R&D - increasing safety, speeding up clinical development and facilitating regulatory acceptance. Furthermore, current developments in diagnostics - especially molecular diagnostics - are paving the way towards the long-held goal of personalised medicine, to the benefit of patients, companies and healthcare providers. Developments in IVD also receive encouraging support from regulators such as the FDA. Visiongain believes that some of the greatest opportunities ever available for diagnostics companies are now there to be seized, with important sales, licensing and partnership developments from the present onwards.

Importantly, this report also covers theranostics, a fusion of drug therapy and diagnostics to optimise efficacy and safety, as well as streamlining drug development. Combining a drug with a diagnostic process or test is also known as companion diagnostics, integrated medicine, pharmacodiagnostics and Dx/Rx partnering. This emerging field is generating strong interest from the healthcare industry and regulatory bodies, with the associated market expanding as the importance of theranostics is recognised, especially in cancer.

Our new In Vitro Diagnostics Market Report & Analysis 2008-2023 report examines the market for in vitro diagnostic solutions critically, through comprehensive primary and secondary research. Importantly, visiongain discusses IVD in the context of the wider healthcare market, with a strong emphasis on theranostics and related molecular diagnostics/medicine. In addition to consultation with experts in industry - including full interview transcripts - this research involved a detailed study of relevant documents, industrial reports and current developments. Vitally, visiongain applied unique in-house forecasting techniques and analysis of drivers and restraints. The result is a totally independent in-depth market-based report with detailed analyses and informed opinion.

In particular, this report concentrates on the following essential aspects of the in vitro diagnostics sector:

• Technologies that drive the IVD sector, including those related to theranostics
  
  
• Key industrial players in IVD - both established and emerging - including partnerships
  
  
• Forecasts of the global IVD market from 2008-2023 - including those of principal market segments, both by disease area and technology
  
  
• Forecasts for IVD sales in leading national markets, including China and India
  
  
• Forecasts for theranostic applications - including therapeutic areas - from 2008-2023
  
  
• Drivers and opportunities in the IVD sector
  
  
• Restraints and threats in the IVD sector
  
  
• Assessments of relevant business models, technological solutions and associated issues
  
  
• Coverage of future trends in IVD and theranostics
  
  
• Insight from a comprehensive survey with relevant experts

Why you should buy this report:

• To receive a comprehensive analysis of the prospects for IVD from 2008-2023, including sales by disease area, technology and country
  
  
• To discover predicted revenues, growth rates and other key metrics for theranostic solutions from 2008-2023
  
  
• To receive the views of experts in the IVD sector regarding current and future trends

To determine the forces that influence the market for IVD:

• Competition
  
  
• Drivers
  
  
• Restraints
  
  
• Strengths, weaknesses, opportunities and threats
  
  
• To find out where the IVD market is heading - both technologically and commercially

Visiongain predicts that the markets for IVD and theranostics will exhibit strong growth in revenues from 2008-2023, with significant investments being made by far-sighted companies and healthcare providers. Although still in its early stages of commercial development, molecular diagnostics will increasingly gain acceptance from stakeholders in healthcare. You should be benefiting from this opportunity. You and your company can benefit as a result, gaining early market prominence from high-value products. You cannot afford to ignore current developments in diagnostics, especially as personalised medicine becomes an inevitable reality.

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1 Executive Summary: In Vitro Diagnostics Market 2008-2023

2 Introduction to In-Vitro Diagnostics

2.1 The Continuing Success of the Healthcare Industries is Dependent upon Important Drivers and Restraints

2.1.1 Drivers of Sales in Global Healthcare Markets from 2008-2023

2.1.2 The Global Healthcare Markets Will Also Face Considerable Restraints Throughout the Foreseeable Future

2.2 What are In Vitro Diagnostic (IVD) Tests?

2.2.1 In Vitro Diagnostics are Medical Assays

2.2.2 Diagnosis and Disease Management

2.2.3 Screening of Populations and Risk Factors

2.2.4 How are In Vitro Diagnostic Technologies Regulated by the FDA?

2.2.5 Point-of-Care Testing

2.3 Advanced Diagnostics and Personalised Medicine

2.3.1 Polymerase Chain Reaction (PCR)

2.3.2 Need for Better Targeted Medicine to Suit Patient Sub-Populations

2.3.3 The Dawn of Pharmacogenomic Medicine

2.3.4 Completion of the Human Genome Project Has Been a Major Driver of Molecular Diagnostics and Personalised Medicine

2.3.5 Personalised Medicine Will Rely Heavily Upon Theranostics - Cooperation Between Diagnostics and Pharmaceutical Sectors

2.4 The Human Genome Project Has Provided Important Scope for Pharmaceutical and Diagnostics Industries

2.4.1 Human Genome Project Marked Start of Genomic Era

2.4.2 Harnessing the Genomic Data is a Major Challenge for Science and Healthcare Industries for Many Years to Come

2.5 Biomarkers and Theranostics

2.5.1 Greater Understanding of Molecular Basis of Disease is Vital

2.5.2 Biomarkers Are Important for Determining Efficacy and Safety

2.5.3 The Scope of Biomarkers is Vast - The Search Will Intensify in the Years Ahead

2.6 Pharmacogenomics is Increasingly Relevant to Pharmaceutical Development

2.6.1 Genetic Variation and Response to Therapy

2.6.2 Molecular Technologies in Medical Science will Strongly Influence the Pharmaceutical and Molecular Diagnostics Sectors

2.6.3 The Number of Companies and Strategic Alliances is Increasing

2.7 Proteomics Constitutes the ``Next Step`` After Genomics

2.7.1 Applied Study of Protein Structure and Form is Important to Medical Developments

2.7.2 Elucidating the Relationship Between Genes and Proteins

2.8 Personalised Medicine Supported By Theranostics Could Supersede the Existing Blockbuster Model, With Sustainable Revenue Flows Continuing

2.8.1 Personalised Medicine Could Bring Significant Financial Gains for Diagnostics and Pharmaceutical Industries

2.8.2 Far-Sighted Pharma Companies are Looking Beyond the Present Technological and Commercial Challenges

2.9 Companies Are Gradually Changing Their Strategic Focus to Overcome Challenges in the Worldwide Healthcare Market

2.9.1 Product Life Cycle Management (PLM)

2.9.2 R&D Strategy is Crucial to Success

2.9.3 The Blockbuster “Model” Will Yield to More Segmented Product Development

2.10 Healthcare Stakeholders Can Benefit from Changes to Regulatory Processes

2.10.1 “Live” Licensing and “In-Life” Testing - The Way Forward?

2.10.2 Limited Approval Leading to Testing for Expanded License

2.10.3 Proposed Framework Could Bring Benefits to Patients While Aiding Drug Developers

2.11 There is an Expanding Market for In Vitro Diagnostics - Especially Molecular Diagnostics

2.11.1 Sales Potential for Increasingly Effective Diagnostic Agents is High

2.11.2 Personalised Medicine Will Not Necessarily Mark the End of High Revenues

2.11.3 The Demands of Treating Patient Sub-Populations Now a Prime Commercial Driver in Diagnostics and Pharmaceutical Industries

3 The World In Vitro Diagnostics Market 2013-2023

3.1 Significant Sales Growth Predicted for the Overall Global In Vitro Diagnostics Market from 2007 to 2023

3.1.1 IVD Market Led by Metabolism, Oncology and Infection Market Segments

3.1.2 Sales in Oncology Will Be Driven by Need for Early Detection and Determination of Efficacy

3.1.3 Metabolism and Oncology to Increase Market Shares in Overall IVD Market

3.2 Global IVD Market Breakdown by Principal Technology

3.2.1 High Growth for Nucleic Acid Testing

3.2.2 Nucleic Acid Testing is The Fastest Growing Segment of the Global Diagnostics Market

3.2.3 The Developing Role of Molecular Technologies in Clinical Diagnostics

3.2.4 Shift to Molecular Diagnostics with Drive for Personalised Medicine

3.2.5 Limitations to Revenue Growth in the IVD Market

3.2.6 Rise in Market for Diabetes Testing Products

3.2.7 Emerging Technologies Growing in Prominence from 2007 to 2023

3.2.8 Increasingly Important Role of IVD Technologies in Drug Discovery

3.2.9 Genetic Screening Sector has Great Potential as Emerging Technology and Market

3.2.10 Growth Restrained by Pricing Ceilings and Downward Pressures on Healthcare Spending

3.3 Fast-Growing Technologies in the Nucleic Acid Market Segment

3.3.1 The Nucleic Acid Segment Contains Some of the Brightest Hopes for the IVD Market

3.3.2 DNA Probes Segment Will Show High Growth from 2007-2023

3.3.3 Nucleic Acid Testing in a Point-of-Care (POC) Setting

3.3.4 Impact of Molecular Medicine Provides a Significant Boost for Molecular Diagnostics

3.3.5 Importance of PCR-Based Technology

3.3.6 Clinical Genetic Testing Still Emergent

3.4 Personalised Medicine Will Become More Prominent in Healthcare With Theranostics Benefiting as a Result

3.4.1 Personalised Medicine in its Infancy but Still a Great Hope for Advancement of IVD Sector

3.4.2 Theranostics Aids Matching of Patients with Treatments - Helping to Optimise Efficacy and Safety

3.4.3 Greater Use of IVD Tests Could Significantly Reduce Adverse Drug Reactions and Cut Mortality Rates Associated With Drug Treatment

3.5 The Completion of the Human Genome Project Has Been a Major Driver of Molecular Diagnostics

3.5.1 Human Genome Sequencing has Made Matching of Therapy to Genetics and Phenotype a Possibility

3.5.2 High Gains for Developers and Marketers of Targeted Therapies and Supporting IVD Tests

3.6 Biomarker Technology is Still Emerging - But the Technological and Commercial Potential Remains Very Significant

3.6.1 Biomarker Use Increasingly Prevalent - but Long Way to Go Still

3.6.2 Biomarkers Key to Growth of IVD Market from Present Onwards

3.7 Protein Chip Technologies Gaining in Importance

3.7.1 Protein Chip Technologies in Molecular Diagnostics

3.7.2 What are the Advantages and Limitations of Protein Chip Technologies in Clinical Diagnostics?

3.7.3 Diagnostic Applications of Protein Chip Technologies

3.7.4 Which System Will Lead the Way for Diagnostic Protein Chip Technologies?

3.7.5 Cancer Diagnostics - The Key Field in the Future of Protein Chip Assays

4 Issues Affecting the Molecular Diagnostics Market

4.1 A SWOT Analysis for In Vitro Diagnostics

4.2 Diagnostics Companies Will Continue To Expand Their Presence in the Global Healthcare Industry

4.3 IVD Applications Face Some Commercial Obstacles

4.4 IVD is the Cornerstone of Personalised Medicine

4.4.1 Personalised Drugs are More Likely to Work Safely and Efficaciously

4.4.2 Advanced Screening for Disease Leading to Quicker Diagnoses

4.4.3 Improved Vaccines

4.4.4 Improvements in Drug Discovery and Reduced Cost of Clinical Trials

4.4.5 European Union IVD Directive (98/79/EC)

4.4.6 Medical Errors Cost the US Billions of Dollars

4.5 Theranostics will Benefit from FDA’s Guidance on Pharmacogenomic Data Submission

4.5.1 Guidance On Pharmacogenomic Data Submission Will Accelerate The Development of Theranostics

4.5.2 Distinguishing Patients at a Greater Risk is Vital

4.5.3 In Future Parallel Use of Markers and Drugs Will Become Prevalent

4.6 Personalised Medicine is a Strong Driver of the IVD Sector

4.6.1 EDMA Cites Theranostics as a Medium-to-Long-Term Driver for Healthcare

4.6.2 Personalised Medicine Constitutes a New Chapter In Diagnostics

4.6.3 The Technology for Personalised Medicine Already Exists

4.7 Identifying Suitable Biomarkers Remains a Significant Challenge

4.8 Theranostics Bill Introduced in the US Senate During 2006

4.9 Development of Novel IVD Products May Be Limited by Low Reimbursement - Will Systems Change Advantageously?

4.10 Cancer Diagnostics is an Important Growth Area With Relevance to In Vitro Diagnostics - Especially Theranostics

4.10.1 Cancer is the Main Developmental Area for Greater Use of In Vitro Diagnostics

4.10.2 Drivers of the Market for IVD and Therapeutics in Oncology

4.10.3 The Oncology Market also has some Restraints

4.11 Collaboration Among Stakeholders is Essential

4.12 Nucleic Acid Testing Technologies Will Be Decisive in the Development of the Theranostics Market

4.12.1 Nucleic Acid Amplification Techniques

4.12.2 Techniques are Presently Complicated

4.12.3 Biochips are Promising

4.12.4 Key Players Large and Small Making Gains in Nucleic Acid Testing

4.12.5 Prospects from Now Looking Forward

4.13 Primary Care and Personal Use of IVD

4.13.1 There is Definitely Scope for Greater Use

4.13.2 What Hurdles Must be Overcome for Point-of-Care IVD Technologies to Become Fully Established in Primary Care?

4.13.3 Personal Use of In Vitro Diagnostic Technologies

4.13.4 While Medical Stakeholders Will Benefit from Molecular Diagnostic and Other Applications of Genomics, Concerns Over Privacy Likely to Impede Progress

4.14 Barriers to the Growth of Pharmacogenomics

4.14.1 Pharmacogenomics Still an Emerging Field

4.14.2 The Complexity of Finding SNP Gene Variations that Affect Drug Responses

4.14.3 Limited Therapeutic Alternatives

4.14.4 Disincentives for Drug Companies to Develop and Produce Multiple Treatments for a Disease

4.14.5 Educating Healthcare Providers

4.15 Potential Changes to Pharma Regulatory and Developmental Processes Dependent upon IVD

4.15.1 Leading Industry Figures Call for More Flexible Approach to Drug Approval

4.15.2 Regulators Acknowledge the Need for Stratification of Treatment Populations

4.15.3 Visiongain Predicts Stratification of Patient Populations Leading to Live-Licensing/In-Life Testing

4.15.4 Stratification of Patients is Key to More Personalised Medicine Sought by Developers and Increasingly Required by Regulators

4.15.5 Traditional Clinical Development has a Significant Disadvantage - Better-Targeted Studies will Take Precedence

4.15.6 Evidence-Based Medicine will Become Increasingly Demanded by Pharma Stakeholders

4.16 Adaptive Clinical Trial Design Will Facilitate Interaction with Regulators and Provide Increased Rationalisation of Drug Development

4.16.1 Adaptive Clinical Trial Design Uses Accumulating Data

4.16.2 Regulators Should be Involved in the Process

4.16.3 Adaptive Trial Design will Gain Acceptance by Early Next Decade

4.17 Personalised Medicine Driven by Theranostics and Live Licensing/In-Life Testing Will Become Established by 2020

4.17.1 Drivers for Better-Targeted Medicine

4.17.2 The Prospects for More-Personalised Medicine and Related Diagnostics are Good

4.17.3 FDA Critical Path Initiative is a Progressive Move in the Right Direction

4.18 Personalised Medicine Aided by Regulatory Reform will also Face Significant Obstacles

4.18.1 The Complex, Disparate Pharma Industry Will Prove Difficult to Reform, Especially in a Revolutionary Manner

4.18.2 It is Unclear How Extensively New Clinical Testing Models and Supporting Regulation will be Applied

4.19 While Personalised Medicine and Better Targeted Clinical Trials are Emerging, Such Developments are Welcomed by the FDA and EMEA

4.19.1 Emerging Developments are Welcomed by Pharma Stakeholders

4.19.2 Cancer Drug Development Leads the Way in its Merging of Drug Development and Treatment of the Disease

4.19.3 FDA's Critical Path Initiative and Personalised Medicine

4.20 Pricing of Personalised Medicine

4.20.1 Personalised Medicine will Lead to Changes in Pricing and Reimbursement

4.20.2 Onus is on Companies to Prove Benefits of their Drugs Including Comparative Cost-Benefits

4.20.3 Biomarkers Can Create Value

4.20.4 The Developments are Complex and Systemic, Posing both Opportunities and Challenges for Healthcare Stakeholders

4.21 The Outlook for In Vitro Diagnostics is Exciting

5 Leading Players and Developments in the IVD Sector

5.1 Profiles of Some Important In Vitro Diagnostics Companies

5.1.1 Roche Diagnostics Division

5.1.2 Abbott Diagnostics

5.1.3 Gen-Probe Inc.

5.1.4 LifeScan Inc.

5.1.5 Axis-Shield

5.1.6 Clinical Data Inc and PGxHealth

5.1.7 Visible Genetics

5.1.8 NGI

5.2 Spotlight on Emerging Companies with High Promise in IVD Technologies

5.2.1 Proteome Sciences - Harnessing Proteomics

5.2.2 Investigen - Novel DNA Testing Applications

5.2.3 DxS Ltd - Facilitating Personalised Medicine

5.2.4 HBV Theranostica - IVD Solutions for Hepatitis B

5.2.5 Enigma Diagnostics - Exciting Developments in Rapid Detection

5.2.6 Itsi-Biosciences - Technology for Proteomics and Biomarker Discovery

5.2.7 Amorfix Life Sciences and Biogen Idec - an Important Partnership

5.2.8 MLT Research Ltd - Technologies Important to IVD

5.2.9 Innogenetics - Ambitious Programme in Theranostics

5.2.10 A&G Pharmaceutical - Solutions for Cancer Theranostics

5.3 Landmark Developments in Theranostics

5.3.1 Genentech’s Herceptin and Novartis’ Gleevec are Probably the Best Known

5.3.2 PharmaNetics’ Thrombolytic Assessment System - Pioneers in the Field

5.3.3 Genentech and DakoCytomation: Herceptin and HercepTest

5.3.4 ImClone Systems and DakoCytomation: Erbitux and EGFR pharmDx Test

5.3.5 Abbott Laboratories’ PathVysion HER-2 DNA Probe Kit

5.3.6 Bayer Diagnostics and Oncogene Science

5.3.7 Novartis and Ventana Medical Systems: Gleevec and VentanaDx c-Kit

5.4 Protein Chip Technologies for Clinical Diagnosis

5.4.1 ProteinChip by Ciphergen

5.4.2 Trinectin Proteome Chip by Phylos

5.4.3 Triage by Biosite

5.4.4 Tissue Microarray Technology

5.4.5 Molecular Diagnostics and Antigen-Antibody Interactions

6 In Vitro Diagnostic Sales in the Leading Developed and Developing Nations, 2007-2023

6.1 Expansion of the World Market Boosted by Increasing Sales in the Developing Healthcare Markets

6.1.1 High Sales in Developed Markets but India and China Catching Up

6.1.2 US to Lead World Market but Leading Developing Markets Exhibiting Highest Growth

6.2 Market Shares of Leading Nations for IVD Sales

6.2.1 US to Lose Market Share to India and China in Particular

6.3 There Will be High Sales Growth in Both Developed and Developing Markets for Diagnostics in the Years Ahead

6.3.1 US is Largest IVD Market

6.3.2 Potential for Sales Growth in Developing Countries is Significant

6.3.3 Improving Access to Modern Healthcare is a Principal Driver of Growth in Developing Nations

6.4 China and India are the Most Exciting New Prospects for the IVD Industry

6.4.1 China and India Both Have the Potential to be Leading Economic Nations

6.4.2 Strategies for Market Entry and Consolidation are Vital for Diagnostics Companies

6.5 WTO Agreements Affect Developments in Emerging Markets

6.5.1 The Principal Diagnostics Markets Remain the Leading Developed Nations But Developing Nations Are Increasingly Important

6.5.2 Expansion into Developing National Markets Will Help to Bring the IVD Industry to a New Level of Commercial Success

7 Theranostics Market Analysis, 2007-2023

7.1 Theranostic Products Will Constitute a Major Driver of the Global IVD Market

7.1.1 IVD Theranostics Market to Expand to Multi-Billion Dollar Sales by 2013

7.1.2 Drive for Personalised Medicine to Boost Theranostic Revenues

7.1.3 Fastest Growth in Cardiovascular & Respiratory and Oncology Segments

7.2 Market Share Gains in Prominent Market Segments

7.2.1 Cardiovascular & Respiratory and Oncology Segments to Gain Market Share from Present Onwards

7.2.2 CNS Segment to Lose Market Share from 2007 Onwards

7.3 Theranostics is Essentially a Fusion of Drug Therapy and Diagnostics

7.3.1 Diagnosis and Treatment Brought Closer Together

7.3.2 Reduction of ADRs

7.3.3 Narrowing of Gap Between Diagnostics and Pharmaceuticals

7.3.4 Recent Advances in Biomedical Sciences Have Made Theranostics Possible

7.3.5 Genentech’s Herceptin is a Prominent Example of the Theranostics Approach

7.3.6 Recent FDA Publication Places Increasing Importance on Theranostics

7.4 Industry Has Been Relatively Slow to Adopt Theranostics - But That Situation Is Changing

7.4.1 Trends in Healthcare are Increasingly Favouring Theranostics

7.4.2 Will The Success of Theranostics Lead To a Shift in Spending From Drugs to Diagnostics?

7.5 Theranostics Will Take Off In a Few Important Therapy Areas First

7.5.1 There are Exciting Possibilities for Theranostics

7.5.2 Cancer Diagnostic Technologies Constitute a Particularly Important Application

7.6 The Improvement in Clinical Performance from Theranostics Will Make It Easier To Justify Costs to Payers

7.6.1 Theranostics Can be a Win-Win for Diagnostics and Pharma Industries

7.6.2 A Theranostic Combination Can Provide an Important Competitive Advantage

7.7 Personalised Medicine Supported By Theranostics Could Supersede the Existing Blockbuster Model, With Sustainable Revenue Flows Continuing

7.7.1 Market is Expanding with Technology Flourishing

7.7.2 The Market for Theranostic Products Is Creating Significant Opportunities for Many Companies in the Pharmaceutical, Diagnostics and Biotechnological Sectors

7.7.3 Rising Health Insurance Coverage Will Benefit the Market

7.7.4 Inter-Industry Links Will Continue to Drive the Theranostics Market

7.7.5 Key Factors Required for Success in the Theranostics Market

8 Interviews with Industry Experts: In Vitro Diagnostics - Current and Future Trends

8.1 Interview 1: Director of a Diagnostics Company

8.1.1 Most Promising Therapeutic areas for IVD

8.1.2 Un-Met Medical Needs in IVD

8.1.3 Greatest Obstacles to Market Growth

8.1.4 Prospects for IVD Market Growth in the Developing Nations

8.1.5 Prospects for Theranostics

8.2 Interview 2: CEO of a Diagnostics Company

8.2.1 Most Promising Therapeutic areas for IVD

8.2.2 Un-Met Medical Needs in IVD

8.2.3 Greatest Obstacles to Market Growth

8.2.4 Prospects for IVD Market Growth in the Developing Nations

8.2.5 Prospects for Theranostics

8.3 Interview 3: Director of a Diagnostics Company

8.3.1 Most Promising Therapeutic areas for IVD

8.3.2 Un-Met Medical Needs in IVD

8.3.3 Greatest Obstacles to Market Growth

8.3.4 Prospects for IVD Market Growth in the Developing Nations

8.3.5 Prospects for Theranostics

8.4 Interview 4: Business Development Director of a Diagnostics Company

8.4.1 Most Promising Therapeutic areas for IVD

8.4.2 Un-Met Medical Needs in IVD

8.4.3 Greatest Obstacles to Market Growth

8.4.4 Prospects for IVD Market Growth in the Developing Nations

8.4.5 Prospects for Theranostics

8.5 Responses from a KOL Survey on Theranostics

8.5.1 How Influential Will Theranostics Be In Coming Years?

8.5.2 Comment on Responses

8.5.3 Are Pharmaceutical and Diagnostic Companies Ready for Closer Links?

8.5.4 Comment on Responses

8.5.5 Will Theranostics Contribute Significantly to Clinical Trials?

8.5.6 Visiongain Comment on Responses

8.5.7 In What Areas Will Theranostics Be Most Prominent?

8.5.8 Visiongain Comment on Responses

9 Conclusions

9.1 In Vitro Diagnostics are Vital to Clinical Decision Making

9.2 Significant Growth of In Vitro Diagnostics Market from 2007 to 2023

9.3 Personalised Medicine Will Rely Heavily Upon Theranostics - Cooperation Between Diagnostics and Pharmaceutical Sectors

9.4 Expansion of the World Market Boosted by Increasing Sales in the Developing Healthcare Markets

9.5 Expansion into Developing National Markets and Lifestyle Diseases Will Drive Market

Appendices

Appendix A: Glossary

Appendix B: Notes on FDA Classification and Regulation of IVD Applications

Appendix C: EC Classification of In Vitro Diagnostic Medical Devices

Appendix D: In Vitro Diagnostics: Prominent Companies

Appendix E: About visiongain

Appendix F: Visiongain report evaluation form

List of Tables

Table 3.1 Sales ($bn) for the World In Vitro Diagnostic Market by Disease Area, 2007-2013

Table 3.2 Sales ($bn) for the World In Vitro Diagnostic Market by Disease Area, 2014-2020

Table 3.3 CAGR (%) for the World In Vitro Diagnostic Market by Disease Area, 2007-2020

Table 3.4 World IVD Market by Disease Area: Long Range Sales Forecasts ($bn) with CAGR (%), 2007-2023

Table 3.5 Market Share (%) for the World In Vitro Diagnostic Market by Disease Area, 2007, 2014, 2018 and 2023

Table 3.6 Sales ($bn) for the World In Vitro Diagnostic Market by Principal Technology, 2007-2013

Table 3.7 Sales ($bn) for the World In Vitro Diagnostic Market by Principal Technology, 2014-2020

Table 3.8 CAGR (%) for the World In Vitro Diagnostic Market by Principal Technology, 2007-2020

Table 3.9 World In Vitro Diagnostic Market by Principal Technology: Long Range Sales Forecasts ($bn) with CAGR (%), 2007-2023

Table 3.10 Market Share (%) for the World In Vitro Diagnostic Market by Principal Technology, 2007, 2014, 2018 and 2023

Table 3.11 Sales ($bn) for the Nucleic Acids Segment of the World IVD Market by Sub Technology, 2007-2013

Table 3.12 Sales ($bn) for the Nucleic Acids Segment of the World IVD Market by Sub Technology, 2014-2020

Table 3.13 CAGR (%) for the Nucleic Acids Segment of the World IVD Market by Sub Technology, 2007-2020

Table 3.14 Nucleic Acids Segment of the World IVD Market by Sub Technology: Long Range Sales Forecasts ($bn) with CAGR (%), 2007-2023

Table 3.15 Market Share (%) for the Nucleic Acids Segment of the World IVD Market by Sub Technology, 2007, 2014, 2018 and 2023

Table 4.1 A SWOT Chart for In Vitro Diagnostic Applications, 2008-2023

Table 4.2 Greater Use of Disease Knowledge and Biomarkers Will Benefit Pharmaceutical Development

Table 6.1 Sales ($bn) for the World In Vitro Diagnostic Market by Leading Nation, 2007-2013

Table 6.2 Sales ($bn) for the World In Vitro Diagnostic Market by Leading Nation, 2014-2020

Table 6.3 CAGR (%) for the World In Vitro Diagnostic Market by Leading Nation, 2007-2020

Table 6.4 World In Vitro Diagnostic Market by Leading Nation: Long Range Sales Forecasts ($bn) with CAGR (%), 2007-2023

Table 6.5 Market Share (%) for the World In Vitro Diagnostic Market by Leading Nation, 2007, 2014, 2018 and 2023

Table 7.1 Sales ($bn) for the World IVD Theranostics Market by Disease Area, 2007-2013

Table 7.2 Sales ($bn) for the World IVD Theranostics Market by Disease Area, 2014-2020

Table 7.3 CAGR (%) for the World IVD Theranostics Market by Disease Area, 2007-2020

Table 7.4 World IVD Theranostics Market by Disease Area: Long Range Sales Forecasts ($bn) with CAGR (%), 2007-2023

Table 7.5 World IVD Theranostics Market Sales Compared With Overall IVD Market ($bn), Market Share (%) and CAGR (%), 2007-2023

Table 7.6 Market Share (%) for the World IVD Theranostics Market by Disease Area, 2007, 2014, 2018 and 2023

List of Figures

Figure 1.1 Total Sales ($bn) for the World In Vitro Diagnostic Market, 2007-2020

Figure 2.1 The Drug Development Process is Long, Complex and Costly

Figure 3.1 Sales ($bn) for the World In Vitro Diagnostic Market by Disease Area, 2007-2013

Figure 3.2 Total Sales ($bn) for the World In Vitro Diagnostic Market, 2007-2013

Figure 3.3 Sales ($bn) for the World In Vitro Diagnostic Market by Disease Area, 2014-2020

Figure 3.4 Total Sales ($bn) for the World In Vitro Diagnostic Market, 2014-2020

Figure 3.5 Market Share (%) for the World In Vitro Diagnostic Market by Disease Area, 2007

Figure 3.6 Market Share (%) for the World In Vitro Diagnostic Market by Disease Area, 2014

Figure 3.7 Market Share (%) for the World In Vitro Diagnostic Market by Disease Area, 2018

Figure 3.8 Market Share (%) for the World In Vitro Diagnostic Market by Disease Area, 2023

Figure 3.9 Sales ($bn) for the World In Vitro Diagnostic Market by Principal Technology, 2007-2013

Figure 3.10 Sales ($bn) for the World In Vitro Diagnostic Market by Principal Technology, 2014-2020

Figure 3.11 Market Share (%) for the World In Vitro Diagnostic Market by Principal Technology, 2007

Figure 3.12 Market Share (%) for the World In Vitro Diagnostic Market by Principal Technology, 2014

Figure 3.13 Market Share (%) for the World In Vitro Diagnostic Market by Principal Technology, 2018

Figure 3.14 Market Share (%) for the World In Vitro Diagnostic Market by Principal Technology, 2023

Figure 3.15 Sales ($bn) for the Nucleic Acids Segment of the World IVD Market by Sub Technology, 2007-2013

Figure 3.16 Total Sales ($bn) for the Nucleic Acids Segment of the World IVD Market, 2007-2013

Figure 3.17 Sales ($bn) for the Nucleic Acids Segment of the World IVD Market by Sub Technology, 2014-2020

Figure 3.18 Sales ($bn) for the Nucleic Acids Segment of the World IVD Market, 2014-2020

Figure 3.19 Market Share (%) for the Nucleic Acids Segment of the World IVD Market by Sub Technology, 2007

Figure 3.20 Market Share (%) for the Nucleic Acids Segment of the World IVD Market by Sub Technology, 2014

Figure 3.21 Market Share (%) for the Nucleic Acids Segment of the World IVD Market by Sub Technology, 2018

Figure 3.22 Market Share (%) for the Nucleic Acids Segment of the World IVD Market by Sub Technology, 2023

Figure 4.1 How Pharmaceutical Development Will Evolve into a More Progressive System

Figure 4.2 The Dynamic Integrated Regulatory System of the Future

Figure 4.3 Systemic Changes to Pharmaceutical Regulation Involve all Healthcare Stakeholders

Figure 6.1 Sales ($bn) for the World In Vitro Diagnostic Market by Leading Nation, 2007-2020

Figure 6.2 Sales ($bn) for the World In Vitro Diagnostic Market by Leading Nation, 2007-2020 (Continued)

Figure 6.3 Market Share (%) for the World In Vitro Diagnostic Market by Leading Nation, 2007

Figure 6.4 Market Share (%) for the World In Vitro Diagnostic Market by Leading Nation, 2014

Figure 6.5 Market Share (%) for the World In Vitro Diagnostic Market by Leading Nation, 2018

Figure 6.6 Market Share (%) for the World In Vitro Diagnostic Market by Leading Nation, 2023

Figure 7.1 Sales ($bn) for the World IVD Theranostics Market by Disease Area, 2007-2013

Figure 7.2 Sales ($bn) for the World IVD Theranostics Market by Disease Area, 2007-2013 (Continued)

Figure 7.3 Total Sales ($bn) for the World IVD Theranostics Market, 2007-2013

Figure 7.4 Sales ($bn) for the World IVD Theranostics Market by Disease Area, 2014-2020

Figure 7.5 Sales ($bn) for the World IVD Theranostics Market by Disease Area, 2014-2020 (Continued)

Figure 7.6 Total Sales ($bn) for the World IVD Theranostics Market, 2014-2020

Figure 7.7 World IVD Theranostics Market Sales Compared With Overall IVD Market ($bn), 2007, 2018 and 2023

Figure 7.8 Total IVD Theranostics Share (%) of World IVD Market, 2007, 2018 and 2023

Figure 7.9 Market Share (%) for the World IVD Theranostics Market by Disease Area, 2007

Figure 7.10 Market Share (%) for the World IVD Theranostics Market by Disease Area, 2014

Figure 7.11 Market Share (%) for the World IVD Theranostics Market by Disease Area, 2018

Figure 7.12 Market Share (%) for the World IVD Theranostics Market by Disease Area, 2023

 
 

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More Details

Companies Listed

3M

A&G Pharmaceutical

Abbott Diagnostics

Abbott Laboratories

Affymetrix

Agendia

Agilent Technologies Inc.

American Diagnostica

Amorfix Life Sciences

Applera Corporation

Applied Biosystems

Applied Imaging

Apria Healthcare

Arcturus

ARKRAY Incorporated

AstraZeneca

Athena Diagnostics

Axis-Shield

Baxter International Inc.

Bayer

Bayer Diagnostics

Beckman Coulter

Becton Dickinson

Binax Incorporated

Biogen Idec

BioMerieux

Bio-Rad Laboratories Incorporated

Biosite

Bristol-Myers Squibb

Cambridge Theranostics

CanAg Diagnostics

Celera Diagnostics, see Applera Corporation

Chiron

Ciphergen Biosystems

Clarient

Clinical Data Inc.

Competitive Technologies

CyGene

Cytyc

Dade Behring

DakoCytomation

Del Mar Reynolds Medical Ltd.

Diagnostic Products Corporation

Diagnostic Systems Laboratories

Digene Corporation

DNAPrint Genomics

DxS Ltd

Enigma Diagnostics Ltd

Epigenomics

EXACT Sciences

First Check Diagnostics

Fisher Scientific

Fornix Theranostics

Fresenius Medical Care

Fujirebio Diagnostics

Gambro AB

GE Healthcare

Gemini (Eurona)

Genaissance Pharmaceuticals

Genentech

GeneOhm Sciences

General Nutrition Centers Inc.

Genetic Vectors

Gen-Probe Inc.

Gentiva Health Services Inc.

Genzyme

Glaxo Wellcome

Graham-Field Health Products

HBV Theranostica

Health Discovery

HealthGrades

Hypoguard USA

Hyseq

IGEN International

ImClone Systems

Innogenetics

Intronn Inc.

Invacare Corporation

Inverness Medical Innovations

Investigen

Invitrogen Corporation

Itsi-Biosciences

Johnson & Johnson

Kingo Diagnostika

LabCorp

Lifescan Inc.

Lincare

Lpath Therapeutics

Lumigen

Matria Healthcare

MDY Healthcare plc

Medisys plc

Merck & Co.

Merck KGaA

Millennium Predictive Medicine

MLT Research Ltd

Monogram Biosciences

Myriad Genetics Inc.

Neighborhood Connections

NGI

Nova Biomedical Corporation

Novartis

Olympus Corporation

Oncogene Sciences

Oncomethylome Sciences

Organon Teknika

Orion Genomics

Ortho-Clinical Diagnostics

Pathwork Informatics

PeptiFarma

PerkinElmer Incorporated

PGxHealth

PharmaNetics

Phylos

Power3 Medical

Primagen

Primus Corporation

Pronto Diagnostics

Proteome Sciences

Provalis

QIAGEN NV

Quest Diagnostics

Quidel

Ranbaxy Laboratories

Respironics

Response Biomedical

Roche

Rubicon Genomics

Seapro Theranostics International B.V

Sequenom

Siemens Medical Solutions

Sunrise Medical

TheraNostics GmbH

Thermo Electron

Tibotec-Virco

Trinity Biotech plc

TriPath Imaging Inc.

Ventana Medical Systems

Veridex LLC

Veri-Q Inc.

Visible Genetics

Vysis Inc.

Wyeth