NEW YORK, Dec. 12, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
The Complete Guide to Companion Diagnostics: Market Environment Products and Companies
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.
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