Quick “Point-of-Care” (POC) Medical Testing Is On the Rise
September 15, 2010
Ever wait anxiously for days to get the results of medical tests? Such periods may eventually become passe as new methods for analyzing blood and other tests increasingly allow quick turnaround times in doctors offices, “rapid clinics,” and even in patients’ homes.
According to a new review of the global “point of care” testing industry released today by Scientia Advisors, a Cambridge, San Francisco strategy consulting firm (yes, my client!)–the market for point-of -care medical tests (those analyzed in close proximity to patients)–is growing at 8 per cent–and even faster for certain types of tests and in the developing world.
Harry Glorikian, Scientia’s managing partner, points out that this growth is fueled in part by a trend toward decentralization of health care—in which testing and treatment are migrating from hospital labs to settings such as emergency rooms, outpatient, doctor’s offices, rapid and urgent care clinics, and homes.
But, he points out, “companies bringing point-of-care (POC) tests to market must consider not only accuracy, reliability and ease of use, but also the challenges of gaining clinical acceptance and meeting sometimes-onerous regulatory and reimbursement requirements.”
Based on primary and secondary research and proprietary analysis, Scientia projects that the POC testing market, which includes professional and over-the-counter segments, will experience compound annual growth of 8%, from $11.6B in 2008 to $18.4B through 2013 —with additional potential for growth in emerging economies.
While diabetes is the largest segment of the POC testing market, infectious disease testing, a smaller segment, has high growth potential due to (1) increasing awareness of public health problems such as flu, chlamydia and hospital-acquired infections (2) potential availability of disruptive, point-of-care molecular diagnostics and (3) increased adoption of POC testing in emerging markets.
Scientia also found that:
- While the US is a major influencer in the global POC testing market, the developing world will experience the fastest growth—especially in China and India, where the governments plan to open thousands of rural clinics.
- In the current economic slowdown, US retail giants such as CVS and Wal-Mart have closed many rapid clinics. As a result, rapid clinics may need new strategies, such as partnering with hospitals, to remain viable.
- Next-generation, portable, easy-to-use technologies, which promise greater accuracy, convenience and clinical impact, will fuel the growth of many POC segments.
- Stringent regulatory and reimbursement requirements and a need for pharmaco-economic studies remain barriers to widespread POC adoption in the US and abroad.
Scientia’s review, “The Point-of-Care Diagnostics Market: Growth Drivers and Challenges to Widespread Adoption”, is available for download at no cost at www.scientiaadv.com.
—Anita M. Harris
Harriscom blog is a publication of the Harris Communications Group is a marketing communications and public relations firm located in Boston, MA.
###
Instrumentation Labs’ New Test for Neonates
July 29, 2010
I’ve been working with Instrumentation Laboratory, a Bedford, MA company, to spread the word about its new diagnostic test that helps prevent brain injury in newborns. Newly cleared by the FDA, it’s first-ever, rapid point-of-care, lab-quality blood test for measuring total bilirubin (tBili) in neonates.
Bilirubin, a toxin, can, in high amounts, lead to irreversible brain injury in neonates. The new tBili assay is performed on IL’s GEM Premier 4000 critical care analyzer. It allows clinicians to receive lab-quality test results in 90 seconds fromwhole blood in the Neonatal Intensive Care Unit (NICU), rather than wait up to an hour for results from the lab, using traditional chemistry methods.
During the first few days of life, the body breaks down fetal red blood cells, producing bilirubin. More bilirubin is produced than the liver can remove, and it remains circulating in the blood.
This results in jaundice, the most common condition requiring medical attention in newborns, present in approximately 70%. However, in 8-10% of newborns, jaundice progresses to severe hyperbilirubinemia. Left untreated, hyperbilirubinemia can quickly evolve into kernicterus, a devastating, irreversible neonatal brain injury.
IL announced that it had received the FDA clearance for the test on Tuesday, at the annual meeting of the American Association for Clinical Chemistry. For more information, check out the Instrumentation Laboratory (US) Web site-http://www.instrumentationlaboratory.com/ilus.aspx .
—Anita Harris
HarrisCom Blog is a publication of the Harris Communications Group of Cambridge, MA. We also publish New Cambridge Observer and Ithaca Diaries Blogs.
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.
###
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.
I’m very
pleased to announce that the Harris Communications Group is now located at 1 Broadway, on the 14th floor of the esteemed Cambridge Innovation Center.
The CIC, founded in 1999, offers shared or dedicated space to some 250 startups and emerging companies–in an atmosphere of co-operation and positive energy. (Those are my words, not the CIC’s!)
My first day at the CIC, I met at least 10 people; now two weeks in, I’ve attended three “VC Cafes,” which are social events, open to CIC members and the public, at which venture capitalists are available, by appointment, to discuss funding opportunities. 
I’ve also met Internet entrepreneur Costas Boussios; clinical trial designer Candida Fratazzi, MD , president of Boston Biotech Clinical Research; CIC founder Tim Rowe , and a gentleman from another CIC floor whose name I did not catch but who advised me, in the 14th floor snack area, to stay away from the yogurt because it has high sugar content–then indulged in some, himself.
On Thursday, I was invited to speak about blogging at a May meeting sponsored by the CIC Women Innovators Network (WIN), which will be open to everyone at the CIC.
I’m about to head over now; can’t wait to see what the new week will bring!
—–Anita M. Harris
HarrisCom blog is a publication of the Harris Communications Group of Cambridge, MA. We also publish the New Cambridge Observer and Ithaca Diaries blogs.
Scientia Advisors of Cambridge, MA, and Palo Alto, CA, has found that while HIT’s share of the $1 trillion healthcare products market by will grow by 25% through 2013, some segments will do better than others as a result of government incentives and regulations and a changing healthcare marketplace, worldwide.
Based on an industry review released today, Scientia, which is my client, says that in order to remain competitive, companies must factor in government incentives, new clinical decision-making and electronic health record requirements, as well as emerging competitors and markets in Asia and elsewhere in the developing world.
“Historically, therapeutics and medical devices have captured more than 90 per cent of worldwide healthcare product sales,” said Harry Glorikian, Scientia Advisors’ managing partner.
“But with declining marginal benefits from new interventional products and greater emphasis on appropriate use of existing interventions, we project accelerating HIT-related sales.” By 2013, indications are that HIT sales will grow from four per cent of the worldwide health care products market to five per cent—representing a 25% increase in HIT’s market share.
The review assessed HIT’s likely impact on “front” and “back office systems,” clinical testing, diagnostics , and pharmacies; how government mandates in North American, Germany, Norway, the UK, China and Australia will affect worldwide HIT opportunity– including a 25% CAGR in China; how the US stimulus bill will impact electronic health records, clinical decision support systems and the adoption of HIT by hospitals of various sizes; and the consequences of CDSS for healthcare market participants.
The review, funded by Scientia itself, was based on extensive primary and secondary research and proprietary analytic methods. It’s available for download from Scientia’s Web site at www.scientiaadv.com.
HarrisComBlog is a publication of the Harris Communications Group of Cambridge, MA. We also publish New Cambridge Observer.
###



