Companion Diagnostics: New Worry for Pharma Execs
September 23, 2010
Pharma execs with blockbuster drugs on the market should be up staying at night strategizing in case someone comes up with a “companion diagnostic” that the FDA requires before the blockbuster can be prescribed.
So write Scientia Advisors authors Amit Agarwal and Jonathan Pan in “Theranostics and Already Approved Drugs: What You Don’t Know Can Hurt You,” published in the 2010-2011 Parexel Yearbook.
Disclosure: Scientia is my client.
In the article, Agarwal, partner, and Pan, senior associate, describe the situation that led the US Food and Drug Administration (FDA) to require warning labels and recommend diagnostic testing for the blockbuster drug Plavix more than 10 years after the anti-thrombotic hit the market. Plavix is marketed by Bristol-Myers Squibb and Sanofi-Aventis to prevent myocardiofaction (MI) or strokes.
As early as 2001, when Plavix had been on the market for four years, studies began to show that Plavix helped certain patients more than others, the authors write. By 2008, genetic testing by a competing pharmaceutical company showed that nearly one-third of Plavix users did not fully benefit from the drug. Based on these and other trial results, in 2010 the FDA required that the manufacturers include a “black box” warning label and a diagnostic testing recommendation for the product.
In 2009, Plavix had worldwide sales of $9.5B including $5.6 B in the US. As a result of the FDA diagnostic testing recommendation, the authors project that by 2012, BMS and Sanofi Aventis will lose $450M to $575M in sales in the US alone– and more if regulators in other nations add requirements. “Given the need to maximize revenue in the face of generic competition across their portfolios, it is a significant amount to offset.” Other drugs, prescribed in conjunction with Plavix, will also most likely be impacted.
Agarwal and Pan recommend a number of actions that pharmaceutical executives can take to mitigate such potential post-launch losses.
- Expand competitive landscape and threat assessment coverage to monitor the diagnostic environment for new research and clinical trials which could potentially impact the sales of marketed drugs
- Upgrade skills, capabilities, reporting relationships and the organizational clout of the theranostic function
- Develop organizational structures that allow knowledge of new biomarkers and clinical trials to reach commercial decision makers
Scientia Advisors’ article is available in the PAREXEL’s Bio/Pharma R&D Statistical Sourcebook 2010/2011 at Barnett Educational Services.
—Anita M. Harris, President, Harris Communications Group
Scientia Advisors, located in Boston and San Francisco, is a management consulting firm specializing in growth strategies for major and emerging companies in health care, life sciences, biotechnology and nutrition.
HarrisComBlog is a publication of the Harris Communications Group, an award-winning public relations and marketing communications firm in Cambridge, MA.
The New York Times doesn’t need me to provide free advertising (I hope!) –but I found today’s business section fabulous for anyone interested in social media and media relations and thought I’d share some of the wealth.
First–David Carr, in The Zeal of a Convert to Twitter writes about how long-form magazine journalist, Buzz Bissinger, the author of “Friday Night Lights,” got hooked on twitter…
Then, there are Noam Cohen’s piece on Wiki Leaks: A Renegade Site, Now Working With the News Media
and Claire Cain Miller and Ashlee Vance on Bing and Google in a Race for Features .
Robert Cyran opines on how the growing popularity of the Ipad could present problems for many tech industries in iPad shift may wreak havoc on parts of tech sector…
and Jenna Wortham describes “tumbler,” a blogging platform that sounds like a cross of Facebook, Twitter, and WordPress, and which, supposedly, many media companies are starting to use to promote themselves. Media Companies Try Getting Social With Tumblr .
There are also articles on the UAR’s attempt to block blackberry messaging unless BB allows government monitoring, there, and Clarie Miller’s piece, New Site Aims to Connect Reporters and Publicists , which describes NewsBasis, a site on which journalists can get queries to potential sources, which launched today.
Founded by Darryl Siry, a freelance writer for Wired and a marketing executive, the new site sounds much like Peter Shankman’s Help a Reporter Out, (AKA HARO) in that it allows journalists to post questions or search for sources– asking questions anonymously to avoid tipping off competitors.
Speaking as former journalist, I can’t imagine giving away ideas, even anonymously–tho fishing in public is certainly easier than digging for sources.
Evidently, on NewsBasis, sources can also add a footnote to articles across the Web, so when reporters are doing research using their Web browser, a tab will appear indicating that a NewsBasis source has offered a different point of view or corrected a fact.
I hope this wasn’t too much information for one shot…but, hey, it’s the information age, we’re talking about here. I’ll be interested in seeing how all of this works out.
Anita M. Harris
Anita M. Harris is president of the Harris Communications Group, a marketing communications, media relations and social media firm in Cambridge, MA.
My client, Scientia Advisors, has found that the market for certain advanced medical testing methods is poised for accelerated growth.
Scientia, a management consulting firm, recommends that many diagnostics companies reexamine their portfolios and business models to position themselves for growth.
Immunoassays are laboratory tests used to identify and quantify blood components associated with particular diseases. Immunoassays are a key growth area within in vitro diagnostics (tests conducted in laboratories, as opposed to those carried out in living organisms).
Based on a review released on June 28, 2010, Scientia Advisors Founding Partner Arshad Ahmed said: “Most current immunoassay technologies focus on detecting one or several proteins in a patient’s blood/serum or other samples.
“However, novel markers and new technologies that can detect and measure multiple markers simultaneously will become increasingly available in the next several years.”
Such advanced technologies—already used in diagnosing and treating infectious diseases, cancer, and kidney injury—are faster, more accurate and more cost-effective than many “traditional” tests. As a result, they may command higher prices and are driving growth in the overall immunoassay market.
What is more, for diagnostics players, marketing and business models are changing, according to Ahmed. Pharmaceutical companies are beginning to incorporate diagnostic tests into their sales processes. And certain diagnostics companies are adopting a “sole service provider” model—in which tests are marketed directly to physicians and performed in company-run laboratories.
In light of these changes, “it is crucial that companies in the diagnostics space re-examine their business strategies in order to compete successfully in the coming years,” Ahmed said.
Review highlights:
- The $7.7B immunoassay market, which comprises one fifth of the $37B in vitro diagnostics (IVD) market, grew approximately 6% a year between 2005 and 2007. The immunoassay market has since shown 9% compound annual growth — a rate that is expected to continue through 2012, largely due to technology advancements.
- Growth in the immunoassay market will be driven by the emergence of (1) ultra-sensitive platforms, which enable detection of analytes at minute concentrations; (2) multiplex technologies, which allow simultaneous analysis of multiple compounds and (3) novel biomarkers that increase the accuracy and efficiency of diagnosis or treatment.
- Emerging economies, such as China’s, are experiencing robust immunoassay market growth.
- Personalized medicine and new business models such as the bundling of immunoassays with marketed drugs and the sole service provider areare changing industry paradigms.
*
Scientia’s study, Strategic Review of Immunoassays: Seeing Beyond the Market Inflection Point”. is available for download at no cost at www.scientiaadv.com.
—Anita M. Harris
Harriscom Blog is a publication of the Harris Communications Group of Cambridge, MA.
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A new review by my client, Scientia Advisors, finds that, with the market for biologic drugs growing much faster than that of drugs based on chemical compounds, many biopharma companies are repositioning and forming new alliances in order to succeed in a rapidly changing pharmaceutical landscape.
In the review, released today, Scientia reports that revenue growth for the small molecule (chemically-based) drug segment has slowed and will begin to decline within three years as numerous blockbuster drugs go off patent and are replaced by less expensive generic substitutes.
In contrast, the market for biologics (based on living matter) which comprises approximately one-third of the overall pharmaceutical market, increased at a 21% compound annual growth rate (CAGR) between 2003 and 2008, to $110B.
While the CAGR for biologics has since slowed to 8%, Scientia projects 2013 revenues of $165B, due largely to rapid growth in monoclonal antibodies. Scientia also projects growth opportunities in the vaccine and cell therapy segments.
Many biologics command relatively high prices and require complex and expensive manufacturing processes. To keep costs down, biopharmaceutical companies are increasingly seeking to outsource their manufacturing to contract manufacturing organizations (CMOs).
In addition, “numerous biologic therapies with total revenues of $37B will have lost patent protection by 2017, promising considerable opportunity in biosimilars (government-approved new versions of branded biopharmaceutical products following patent expiration),” Glorikian said. “As a result, pharmaceutical, generic drug, and contract manufacturing companies are joining forces to enter the biosimilars space. To be successful, they must take into account the considerable technical, competitive, and regulatory hurdles that will be involved.”
Scientia Advisors’ review, entitled “Assessing the Biopharmaceutical Market: Promises and Challenges,” is available for download at no charge from www.scientiaadv.com.
–Anita M. Harris
HarriscomBlog is a publication of the Harris Communications Group–a public relations, content and thought leadership firm in Cambridge, MA. We also publish New Cambridge Observer.
Molecular Diagnostics, Personalized Medicine, Changing Health Care Landscape, Scientia Advisors Finds
April 26, 2010
A new global review from my client, Scientia Advisors , predicts rapid growth in molecular diagnostics and that, with traditional pharma companies slow to innovate, a myriad of new entrants vying for market share will change the healthcare landscape.
(Molecular diagnostics are genetic tests used to judge the effectiveness of particular treatments for individual patients–key to the burgeoning new field of personalized medicine).
Released earlier this month (and available for download at no charge at www scientiaadv.com) the review projects that MDx will grow at an annually compounded rate 15% to approximately $7.5B in 2013.
Currently, molecular tests used for oncology and critical care infectious diseases are experiencing the fastest growth among MDx segments.
“Ultimately, MDx will enhance care, cut health care costs and make personalized medicine a worldwide reality,” said Scientia Advisors Managing Partner Harry Glorikian.
Among other major findings:
- The industry is transitioning away from low-cost, low-margin tests. New, “high-value” MDx tests are changing the health care paradigm by providing critical information to physicians more quickly and accurately than was previously possible.
- While most MDx revenue is currently generated in the US and Europe, future growth will be most pronounced in the developing world.
- New, easy-to-use, random access and fast-turnaround-time MDx platforms are enabling widespread adoption of MDx in small and mid-sized hospitals, worldwide.
- Companies seeking to enter the MDx field must be cognizant that, with the growing impact of MDx, government oversight and regulation will likely increase and reimbursement policies will evolve to reflect added value.
Scientia Advisors is a global management consulting firm specializing in growth strategies for companies in health care, life sciences, biotechnology and nutrition, world wide. The firm is based in Boston and San Francisco.
—Anita M. Harris
HarrisCom Blog is a publication of the Harris Communications Group of Cambridge, MA.