Keywords : Diagnostics, diagnostic, molecular diagnostic, diagnostic test, clinical diagnostic, diagnostic device, clinical chemistry
While ‘personalised medicine’ (or theranostics) is not new it is only relatively recently that diagnostics companies and pharma have converged to explore and exploit its potential benefits. By using companion diagnostics, companies can identify those patients who will benefit most from, or suffer fewer side effects from targeted therapies, and thereby present a more compelling approval and prescribing case to regulators and clinicians. ...
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While ‘personalised medicine’ (or theranostics) is not new it is only relatively recently that diagnostics companies and pharma have converged to explore and exploit its potential benefits. By using companion diagnostics, companies can identify those patients who will benefit most from, or suffer fewer side effects from targeted therapies, and thereby present a more compelling approval and prescribing case to regulators and clinicians.
It could prove to be a lifesaver for a company. For the last few years, the leading players have had some success with line extensions through launches or improved formulations or combinations. However, the lack of new novel products coming through their pipelines means that even these are no longer guaranteed to provide sufficient income in the medium term, let alone the long term.
The first fact for the pharma industry to acknowledge is that the genie is out of the bottle: having seen the therapeutic and cost saving benefits of using companion diagnostics, regulators, clinicians and health payers will want to use the technology as a practice standard. Interestingly, at the end of 2011 two new molecularly-targeted cancer drugs, Pfizer's Xalkori (crizotinib) and Roche's Zelboraf (vemurafenib) were both launched alongside companion diagnostic tests.
And here is the trade off. Companion diagnostics will ensure closer scrutiny of efficacy and cost benefit by regulators, users and health payers but also will end any revenue generating speculative prescribing. With the days of blockbuster drugs such as Lipitor (atorvastatin) and Avastin (bevacizumab) becoming fewer and farther between, companies have been forced to look to other revenue sources and security, and having prescribing assurance may well prove to be of great benefit. Only time will tell.
All you need to know in this comprehensive and concise report
This compelling new market study from Espicom provides a complete appraisal of the competitive, regulatory and product issues shaping the fast-growing companion diagnostics sector. Essential reading for pharma and diagnostic company executives!
Companion diagnostics are here to stay. It is unthinkable that, in time, biologic drugs will be approved without them.
Impact on stakeholders in companion diagnostics
There are numerous stakeholders in the companion diagnostic market from technology developers to the clinicians using them. How are they affecting these groups?
Benefits for clinicians:
Clinician confidence is also crucial when it comes to prescribing a product. Why pay for costly diagnostic tests when there are cheaper, established products available which do not require genetic testing? However, if a specific subset of patients that will benefit from the therapy can be readily and accurately identified, companies will be better able to convince prescribers that these benefits are worth the extra expense. The use of companion diagnostics should, therefore, increase both physician and patient confidence in the products, as well as satisfying the requirements of regulatory bodies and smoothing the path to market.
Benefits for pharma: improving clinical trial results and supporting new applications
Limiting the patient population based on genomic analysis with companion diagnostics can improve clinical trial data for a new drug and strengthen the case for regulatory approvals for use in targeted patient populations. This use of biomarkers to enhance trial results is expected to become the norm rather than the exception and may expand the use of the product by seeking a higher level of regulatory approval.
Furthermore, the use of companion diagnostics may reinvigorate interest in the back file of products that failed to jump regulatory hurdles related to efficacy in larger patient populations if it can be proven that specific patient subsets would benefit.
Benefits for payers: more assurance that money will be well spent
With a couple of notable exceptions, the rise of targeted therapies has been hampered by their relatively poor improvements in real-world therapeutic benefits relative to their sometimes eye-watering expense. The role played by pharmacoeconomics cannot be understated: health payers do not want to pay for expensive medicines unless there is confidence that the therapeutic benefit will be achieved. Companion diagnostics go a long way to providing that confidence by determining the appropriateness of a drug to a given disease state.
The challenge for regulators
The companion diagnostics market has grown very rapidly, and regulators have been running to catch up. Drug developers need clear guidance which sets out the regulatory bodies’ expectations and standards for approval. So far, there has been little attempt by regulatory agencies to impose too many restrictions or enforce a parallel approval process. While this policy looks set to continue, however, we are already seeing an increase in companion diagnostic tests being stipulated as a requirement within the approval process and it may be inevitable that some standardisation of the guidelines is necessary.
An example of the regulatory muddle can be seen in drug labels. From an analysis of labels of previously-approved products it is possible to identify drugs that require companion diagnostics, although the lack of clear regulatory guidance means that there is considerable variation in how this information is presented in the drug label.
This is a developing area. The FDA is currently in Phase III of its programme to provide guidance for personalised medicine. Final guidance for in vitro companion diagnostic devices was anticipated for the end of June 2012. However, at the time of publication of this report, this had not materialised.
Diagnostics Industry in the United States
Contents
FOREWORD 1
EXECUTIVE SUMMARY 3
COMPANION DIAGNOSTICS 5
Towards Personalised Medicine 5
Pharmacogenomics and Targeted Therapies 5
What Are Biomarkers? 8
Biomarkers in Clinical Diagnostics 9
Genomic Biomarkers for Clinical Diagnostics 10
What Are In Vitro Diagnostics? 12
Clinical Chemistry 12
Immunochemistry 12
Haematology 12
Haemostasis 12
Microbiology 13
Molecular Diagnostics 13
What Are Companion Diagnostics? 13
Advantages of Companion Diagnostics 14
Narrowing the Patient Population 14
Reducing Development Costs 15
Increased Sales 15
A Cautionary Tale 16
Drug Labels 16
REGULATORY FRAMEWORK 22
Pharmaceutical Products 22
United States 22
European Union 23
Companion Diagnostics 23
United States 23
What is a Premarket Approval (PMA)? 23
What is a 510(k) Premarketing Notification? 24
European Union 24
Proposed Changes to the Regulatory Framework 24
PRODUCTS 27
Pharmaceuticals 27
Erbitux (cetuximab) 29
Faslodex (fulvestrant) 31
Glivec/Gleevec (imatinib) 31
Herceptin (trastuzumab) 32
Iressa (gefitinib) 35
Kalydeco (ivakaftor) 35
Perjeta (pertuzumab) 36
Poteligeo (mogamulizumab) 36
Selzentry (maraviroc) 37
Sprycel (dasatinib) 38
Tarceva (erlotinib) 38
Tasigna (nilotinib) 38
Tykerb/Tyverb (lapatinib) 39
Tysabri (natalizumab) 39
Vectibix (panitumumab) 40
Xalkori (crizotinib) 41
Xeloda (capecitabine) 41
Zelboraf (vemurafenib) 42
In Vitro Companion Diagnostics 43
Inform HER2 Dual ISH 45
My5-FU 45
OncoCEE-BR 45
OncoDefender 46
Therascreen KRAS RGQ PCR Kit 46
Vysis ALK Break Apart FISH Probe Kit 46
What’s in the Pipeline? 47
COMPANIES 50
Agreements 50
Pharmaceutical/Biotechnology Companies 54
AEterna Zentaris 54
Amgen 54
ARIAD Pharmaceuticals 54
Astellas Pharma 55
Agreement with Cell Signaling Technologies 55
Agreement with Roche 55
Agreement with Dako (Agilent) 55
AstraZeneca 55
Agreement with Roche Diagnostics 55
Agreement with Dako 56
Agreement with QIAGEN 56
Bayer Healthcare 56
Agreement with QIAGEN 56
Agreement with Ventana Medical Systems 56
Biogen Idec & Elan 57
Tysabri and STRATIFY JCV Antibody ELISA Test 57
Biogen Idec’s Agreement with Regulus Therapeutics 57
Boehringer Ingelheim 57
Agreement with QIAGEN 57
Bristol-Myers Squibb 58
Agreement with Life Technologies 58
Agreement with Saladax Biomedical 58
Agreement with Dako 58
Agreement with QIAGEN 58
Celldex Therapeutics 58
Clovis Oncology 59
Agreement with Array BioPharma 59
Agreement with Roche 59
Agreement with MDxHealth 60
Eisai 60
Morphotek Agreement with Biocare 60
Eli Lilly 60
Agreement with PrimeraDx 60
Agreement with QIAGEN 60
GlaxoSmithKline 61
Agreements with Abbott 61
Agreements with bioMérieux 61
Agreement with Life Technologies 62
Ipsen 62
Johnson & Johnson 62
Merck & Co 62
Agreement with Abbott 62
Agreement with BGI 62
Agreements with Roche 62
Merck KGaA 63
Agreement with MDxHealth 63
Novartis 63
Agreement with InVivoScribe Technologies 63
Pfizer 63
Xalkori (crizotinib) and the Vysis ALK Break Apart FISH Probe Kit 63
Agreement with Ventana Medical Systems (Roche) and Cell Signaling Technology 64
Agreement with QIAGEN 64
Agreement with Oxford BioMedica 64
Roche 65
Agreements with Dako (Agilent) 65
Agreement with Psynova Neurotech 65
SuppreMol 66
Syndax Pharmaceuticals 66
Tocagen 66
Transgene 67
UCB 67
ViiV Healthcare 67
Diagnostic Companies 68
Abbott 68
Agreements 68
BioGenex Laboratories 68
Clarient Diagnostic Services (a GE Company) 69
CompanDX Ltd 69
Dako (Agilent Technologies) 69
Agreements 70
Everist Genomics 70
Genomic Health 70
HTG Molecular Diagnostics 71
Life Technologies 71
MDxHealth 71
Myriad Genetics 72
Prometheus Laboratories 72
QIAGEN 73
Agreements 73
Roche Diagnostics 74
Roche Tissue Diagnostics (Ventana Medical Systems) 75
Roche Molecular Diagnostics 75
Roche Professional Diagnostics 76
Siemens Healthcare Diagnostics 76
SOURCES 77
List of Tables
Approved Targeted Cancer Drugs; Pharmacogenomic Data (US labels) 6
Biomarkers in Drug Labels 17
Selected Approved Therapeutic Products with Identified Biomarkers 28
FDA-Approved HER2 Tests 33
FDA Approved In Vitro Companion Diagnostics 44
Products in Clinical Development with Associated Companion Diagnostics 47
Roche Diagnostics’ Key Approved Companion Diagnostic Tests 74
Ventana Medical Systems’ Diagnostic Agreements 75
Roche Molecular Diagnostics Agreements 75
Roche Professional Diagnostics Agreements 76
List of Figures
Pharmacogenomic Data for Approved Targeted Cancer Drugs (US Labels) 8
US Drug Labels with Pharmacogenomic Information, Number by Therapeutic Area 10
Pharmacogenomic Biomarkers in US Drug Labels 11
US Drug Labels with Pharmacogenomic Test Requirements by Therapeutic Area 11
Sales of Major Therapeutic Products (2011) 29
Companion Diagnostics Agreement Activity, 2009- Q3 2012 50
Agreement Activity by Year, 2009-Q3 2012 51
Agreement Activity by Therapeutic Area, 2009-Q3 2012 51
Pharmaceutical/Biotechnology Company Agreement Activity, 2009-Q3 2012 52
Diagnostic Company Agreement Activity, 2009-Q3 2012 53
