In my last blog, I discussed Life Technologies’ acquisition of Matrix MicroScience. A new collaboration between SDIX and BD Diagnostics, a segment of BD (Becton, Dickinson and Company), also is intriguing.

BD has been relatively quiet in the food space over the past decade. Many people rely on BD media for food microbiology analysis, but BD hasn’t really built on this foundation.

SDIX continues to expand and build upon its easy to use lateral flow devices (LFD). Also, the company has developed some clever and effective enrichment medias that when combined with the LFDs make the overall detection that much stronger and better.

Now these two companies are partnering to enable BD to offer new detection capabilities. SDIX will provide the antibodies and the enrichment media while BD will develop the detection system and market the product.

SDIX will provide the antibodies and the enrichment media while BD will develop the detection system and market the product.

What niche is BD targeting and why are they utilizing an antibody-based approach? In 2009, BD acquired HandyLab and its molecular technology for $275M. While principally targeted to enhancing their competitive position in HAI (healthcare associated infections), the HandyLabs box also could offer a competitive advantage in food microbiology given its automation and ease of use (EOU).

The U.S. food market seems to increasingly be using molecular methods, and BD has an excellent molecular solution. So why is BD now investing in an antibody-based approach?

The question that comes to mind for me is how this new BD/SDIX product—which is probably one to two years away from commercialization—might be better than new product announcements from Roka, 3M, and most recently Neogen’s ANSR?

BD better have some good market success for this new detection platform. The upfront payment of $1.25M alone, combined with up to $2.5M in performance payouts and royalties, means BD will have to sell 250,000 tests just to cover this upfront signing fee (based on the assumption that the test selling price would be $8, and the margin would be in the 60-65% range). This doesn’t include R&D, sales, marketing, and support expenses associated with this project.

Strategic Consulting has just completed a market research and publication cycle for its most recent report, Food Micro, Sixth Edition: Food Microbiology Testing in Europe. One thing is clear, the food microbiology market will see more and more partnering of companies, products and technologies to come up with solutions that meet customer requirements. It’s not always possible to get to that “best solution” based on the technologies resident at one company. Why not go out and combine strengths with others if it will result in a better solution?

A couple of new diagnostic company pairings have created synergies with the potential to deliver real innovation in food safety testing: Life Technologies’ acquisition in January of Matrix MicroScience, and a new collaboration announced in February between SDIX and BD Diagnostics, a segment of BD (Becton, Dickinson and Company).

Life Technologies Acquires Matrix MicroScience

Matrix MicroScience first introduced its unique, patented sample concentration/cleanup technology over five years ago. It immediately captured the food industry’s imagination and interest because of its potential to both reduce enrichment time and help clean up the sample to enable better analysis. Because there is only so much that detection technologies can do to improve test performance, the logical progression is to enhance the sample prep phase of the analysis. Matrix clearly leads in this effort.

After a couple of product design improvements, it seems Matrix is now ready to offer a viable solution that the market will embrace.

In the meantime, Life Technologies seems to have gained some market traction over the past year or so. Their range of approved assays has increased, as has interest in their open platform instrument. However, Life is in a tough battle with other more entrenched competitors, and the market now has more than a dozen molecular platforms to choose from along with several antibody-based options.

The new STEC detection requirements are well suited to an antibody capture approach before the detection step. This approach is at the heart of BioControl’s GDS, which has significant share of the existing O157 market. Using Matrix’s technology as the front end could shorten the enrichment time as well as capture all of the possible O-types in the sample for subsequent virulence detection by Life’s molecular technology.

To date, detection companies have been hesitant to seek approvals for an approach that combines the Matrix front end with their detection method. With this acquisition, Life Technologies will certainly do so, and be able to demonstrate good sensitivity/specificity combined with reduced time-to-results.

Details of Matrix’s purchase price have not been made public so it’s difficult to comment on the performance expectations required to make this a profitable transaction.

As has been the case over the past number of years, the number of players in the food microbiology diagnostics market is shrinking. This acquisition is another example of a single-product company (Matrix) joining with a company with strong channel access (Life).

Up next, a look at the BD Diagnostics/SDIX collaboration.

Woodstock, VT February 9, 2012 — Europe is a substantial market for food microbiology testing. With a population of over 500 million, the 27 countries of the European Union (EU) conducted an estimated 275 million food safety microbiology tests in 2011, according to Food Micro, Sixth Edition: Food Microbiology Testing in Europe (Food Micro—6), a new market report from Strategic Consulting, Inc. In comparison, there were 213 million such tests conducted in the US in 2010.

EU Food Safety Test Volume 2005 - 2011

Food Micro—6 is the first definitive report to focus exclusively on the European food microbiology testing market, and reviews the methods, technologies, companies, regulations and trends shaping food safety testing in Europe.

According to Tom Weschler, president of Strategic Consulting and lead author of Food Micro-6, “Food safety microbiology testing in the EU will approach 350 million total tests in 2016, at which point the market should top $1 billion in value.” Given these numbers and other factors, the European food safety testing market must be examined and understood, Weschler says. “A resurgence in public awareness in the wake of the 2011 E. coli outbreak in Germany, and the continued focus of the European Food Safety Authority on EU-wide systems, could drive test volumes even higher.”

A resurgence in public awareness in the wake of the 2011 E. coli outbreak in Germany, and the continued focus of the European Food Safety Authority on EU-wide systems, could drive test volumes even higher.

In preparing this new and comprehensive review of the European food microbiology testing market, Strategic Consulting (SCI) conducted more than 175 detailed interviews in 11 European countries accounting for 77% of all agricultural/food value-added in the European Union. Because of this primary research with food-processing plants throughout Europe, Food Micro—6 is able to offer new, detailed data on European food safety testing such as test volumes, methods used for routine and pathogen testing, and costs per test performed. Differences in testing practices are analyzed for the meat, dairy, fruits/vegetables, and processed food segments. Variations within countries are outlined, and expected changes in future testing practices are discussed.

“Routine” microbiology tests used in the food processing industry in Europe to indicate the presence of microorganisms in the plant or food product include total bacteria, E. coli, Staphylococcus, yeast and molds. In 2011, these routine tests numbered 225.4 million. The balance of food microbiology tests in Europe were 49.9 million “pathogen” tests, which look for specific microbes such as Salmonella, Listeria, L. mono, Campylobacter, and E. coli O157.

Food Micro—6 also profiles the leading diagnostic companies competing in the food safety testing market including a discussion of new technologies and market strategies. Food Micro—6 includes company profiles for Becton-Dickinson, BioControl, bioMérieux, Bio-Rad, BIOTECON, DuPont Qualicon, Foss A/S, Idaho Technology, Life Technologies (ABI), Merck Millipore, 3M, Neogen, Pall Corporation, QIAGEN, Roka Bioscience, R-Biopharm, SDIX and Thermo Fisher.

Food Micro—6 is a companion report to Food Micro, Fifth Edition: Microbiology Testing in the U.S. Food Industry (Food Micro—5), published by SCI in 2011, which reviews the current practices and changes impacting food safety testing at 9,350 U.S. food processing plants.

Strategic Consulting has published six reports to date reviewing quality and safety testing in the food industry. The food sector represents almost 50% of the total industrial microbiology testing market, and is more than double the size of any other industrial segment including pharmaceutical, personal care products, beverage, environmental, and industrial processes. SCI market research reports are widely accepted by leading diagnostic manufacturers and investors as highly credible analyses of the industry.

For more information about Food Micro, Sixth Edition: Food Microbiology Testing in Europe, call Strategic Consulting’s U.S. office at 802-457-9933.

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Strategic Consulting, Inc. (SCI) provides market reports and business consulting for industrial diagnostics companies delivering microbiology-based products for quality and safety testing in food, beverages, pharmaceuticals, personal care products, environmental water, and industrial-process water. With more than 75 combined years of international management in the industrial marketplace, SCI’s principals have proven success in working with venture capital backed start-ups, publicly traded companies, technology acquisitions, and transformation of underachieving companies. For more information on Strategic Consulting, Inc. and its current market reports, visit www.strategic-consult.com or call 802-457-9933. Follow SCI president and industry expert, Tom Weschler, on LinkedIn or Twitter @tomweschler.

Food Micro—6 is the first definitive report to focus exclusively on the European food microbiology testing market, and reviews the methods, technologies, companies, regulations and trends shaping food safety testing in Europe.

In preparing this new report, Strategic Consulting (SCI) conducted more than 175 detailed interviews in 11 European countries accounting for 77% of all agricultural/food value-added in the European Union. Because of this primary research with European food-processing plants, Food Micro—6 is able to offer new, detailed data on European food safety testing including:

• Test volumes
• Market value
• Methods used for routine and pathogen testing
• Costs per test performed
• Testing practices by segment for meat, dairy, fruits/vegetables, and processed food
• Variations by country
• Expected changes in future testing practices

Strategic Consulting has published six reports to date reviewing quality and safety testing in the food industry. The food sector represents almost 50% of the total industrial microbiology testing market, and is more than double the size of any other industrial segment including pharmaceutical, personal care products, beverage, environmental, and industrial processes.

For more information about Food Micro, Sixth Edition: Food Microbiology Testing in Europe, download a prospectus, email info@strategic-consult.com, or call Strategic Consulting’s U.S. office at 802-457-9933.

“Pathogen testing has now been made simple and affordable,” said Niki Montgomery, 3M Food Safety global marketing development manager. “…Numerous organisms can be tested in a single run and it was designed to help our customers perform fewer repeat tests and make critical decisions faster.”

Read the full press release.

After reviews of 3M’s investor presentations and IAFP meeting buzz, we mentioned rumors of this product/technology several months ago in this blog. Products like this will help food producers justify keeping pathogen analysis at their plant labs. Also, this technology platform should help companies migrate from traditional and other methods to molecular methods.

Woodstock, VT December 12, 2011 — Europe is a substantial market for food safety microbiology testing. The population of the 27 countries of the European Union is 500 million, nearly 60% greater than the US population. Altogether, EU countries performed an estimated 275 million food micro tests in 2011. In comparison, there were 213 million such tests conducted in the US in 2010.

Food Micro, Sixth Edition: Food Microbiology Testing in Europe from Strategic Consulting, Inc. (SCI) is the first definitive report focusing exclusively on the European food safety microbiology testing market. Food Micro—6 reviews the important markets, methods, technologies and trends shaping food safety testing in Europe.

In addition to size, the European food safety testing market differs from the US market in areas such as methods used, organisms tested, and current and pending regulations. As a result, says Thomas Weschler, president of SCI and lead author of Food Micro—6, “Europe must be examined and understood as a separate entity as it relates to food microbiology testing, and not simply thought of and treated as ‘like the US.’”

“Europe must be examined and understood as a separate entity as it relates to food microbiology testing, and not simply thought of and treated as ‘like the US.’”

A strong global link between the European and US food markets remains however, Weschler says. Key global food companies such as Nestle and Kraft have a significant presence in both geographies. European consumers, like their American counterparts, want access to all types of food year-round and as a result draw increasingly from a global food supply.

At the same time, there is a growing public awareness of food safety issues, with the recent E. coli outbreak in Germany only one of the incidents heightening concern about contaminants in the food supply. “Growing public concern about food safety could ramp up change in Europe, and increased regulations and testing volumes should follow suit,” Weschler says.

In preparing this new and comprehensive review of the European food microbiology testing market, Strategic Consulting (SCI) conducted more than 175 detailed interviews in 11 European countries representing more than 75% of all food production in the EU. Through this primary research at food-processing plants throughout Europe, Food Micro—6 offers new data on European food safety testing practices including overall test volume, cost per test, and methods used for routine and pathogen testing. Differences in testing practices within food segments and countries also are detailed, and expected changes in future testing practices are discussed.

Like all SCI publications, Food Micro—6 is based on new, primary research and industry-specific expertise and analysis. Food Micro—6 incorporates:

• Lengthy interviews with food processing plants in the meat, dairy, fruit/vegetable, and processed food segments in 11 European countries representing more than 75% of the total food production in the EU.

• A discussion of key drivers for food microbiology testing, and a country-by-country comparison of total testing, organisms tested, and methods used.

• Test volumes, methods, and products used for routine, environmental and pathogen tests for TVO, Coliform, Yeast/Mold, ATP, Staphylococcus, Salmonella, Listeria, L. mono, E. coli O157, and Campylobacter.

• Forecasts for the state of the market in 2016 including routine, pathogen and overall test volumes and market values.

• Insights from Strategic Consulting’s principals honed over more than 75 combined years in the worldwide industrial diagnostics marketplace.

Strategic Consulting’s long tenure in the industrial diagnostics industry includes the publication of 14 research reports addressing critical market topics over the last 15 years. Strategic Consulting market research reports are widely accepted by leading diagnostic manufacturers and investors as highly credible analyses of the industry.

Food Micro—6 will publish in January 2012 but orders placed before January 16, 2012 can receive a pre-publication savings of $500 off the report price.

For more information on Food Micro—6, request a prospectus, email info@strategic-consult.com, or call (802) 457-9933.

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Strategic Consulting, Inc. (SCI) provides market reports and business consulting for industrial diagnostics companies delivering microbiology-based products for quality and safety testing in food, beverages, pharmaceuticals, personal care products, environmental water, and industrial-process water. For more information on Strategic Consulting, Inc. and its current market reports, visit www.strategic-consult.com or call 802-457-9933. Follow SCI president and industry expert, Thomas R. Weschler, on LinkedIn or Twitter @tomweschler.

It’s exciting, and I feel lucky, to be working in a field that continues to innovate and improve the quality and safety of our food, water and other products important to our health and well-being.

That said, I am far too often guilty of getting so busy day-to-day that I can take for granted how fortunate I am. I am blessed in so many ways. With a wonderful family and good friends. Health. Work that I love. The freedom and prosperity—even in these tough times—of life in the U.S.

It’s one of the reasons Thanksgiving is my favorite holiday. It’s simple: A time to pause, be with those we love, and be grateful. Okay, and maybe watch some football!

This year, Thanksgiving was made even more special by the birth of my second grandson, Nate, who arrived two days before Thanksgiving. Just in time to join the Weschler clan at a Thanksgiving gathering that included Nate’s three-month old cousin, Jackson.

Becoming a grandfather—twice in just four months—with everybody healthy and thriving… Now that’s something for which I am truly thankful.

I followed with interest Dr. Michael Miller’s blog from the PDA’s 6th Annual Global Conference on Pharmaceutical Microbiology last week. Dr. Miller consults on regulatory, quality and compliance solutions for rapid microbiological methods (RMM) in the pharmaceutical, biotech, and medical device industries, and was blogging on the meeting’s presentations related to rapid and alternative microbiological methods.

The meeting’s opening keynote was presented by Dr. Daniel Y. C. Fung, who is an expert in rapid methods for the food industry and an Industry Professor of Food and Science at Kansas State University. Dr. Fung’s presentation reviewed the last thirty years of global developments of rapid methods. Dr. Fung incorporated market data from SCI’s Industrial Microbiology Market Review, Third Edition (IMMR—3), on total micro tests conducted and total market size for food microbiology testing.

As reported in Miller’s blog: “Within the food processing sector, it was projected that more than 740 million micro tests were performed in 2008 by more than 40,000 food processing plants, and it is estimated that the worldwide market for micro testing is more than $2 billion. And the market for food microbiology testing continues to grow, year over year. For example, the rate of growth of micro testing from 2008 to 2010 was more than 6%.”

Miller goes on to report that, “The take home message from Dr. Fung’s keynote is that the number of microbiology assays associated with the monitoring of food will continue to increase, especially in light of recent contamination events, and that rapid technologies will play a very important role in protecting the world’s food supplies.

What is interesting to me in all of this is the comparison of rapid microbiological method use in the food versus pharmaceutical sectors. Millers says that, “When asked what the pharmaceutical industry can learn from the food industry (in terms of the adoption of rapid methods), Dr. Fung stated that the expectations for microbiological safety is much higher in the pharmaceutical industry than in the food industry, and that we can benefit greatly from the implementation of rapid methods. Interestingly, the food industry looks up to the pharma industry for guidance on excellence in microbiology testing.”

Dr. Miller goes on to say that in his view, the pharmaceutical industry “has been extremely slow to adopt rapid methods for a number of reasons, and that the food industry is actually well ahead of where we are today.”

Strategic Consulting has been conducting market research and developing business strategies for industrial diagnostics companies for more than 15 years. In that time, we have followed the growth—or lack thereof—of rapid microbial methods in the six key segments in the industrial microbiology testing market: food, beverage, pharmaceutical, personal care products, environmental, and industrial process water.

Without question, the usage of rapid microbiological methods is not uniform across all segments. As would be expected, the needs/drivers of each segment vary greatly, which in turn influence testing requirements. Sample matrices and organisms to be tested also come into play.

Rapid Microbiological Methods Usage by Sector

What’s surprising is that the pharmaceutical industry actually uses the least amount of RMMs (measured as a percentage of total tests) of all the industrial segments. As seen in this chart from IMMR—3, currently less than 2.5% of all pharma tests utilize a RMM. Given Dr. Fung’s comments that all hold pharma in the highest regard, one would think that more use of RMMs would be the case. Certainly progress is being made, with more RMM approvals happening monthly, but the segment has much to do to catch up to some other areas.

In SCI’s report, Pharma/PCP Micro, Second Edition, we summarize the thoughts and experiences with RMMs of 20 key opinion leaders in the pharmaceutical and personal care products industries. These interviews give real insight into the successes and issues regarding adoption and usage of newer methods, such as the difficulty and expense in validating RMMs, concerns about FDA support and acceptance, and of course, return on investment.

As the number of illnesses and deaths from listeria-tainted cantaloupes grows, the safety of the U.S. food supply is again in the spotlight. So too, are the roles and responsibilities of government, food producers, food retailers and restaurants, and ultimately consumers themselves, in ensuring that food is healthy and safe.

Given the increased attention—and food recalls—consumers’ fears are growing. The 2011 Consumer Food and Product Insights Survey produced by Deloitte says that 73% of respondents are more concerned now than five years ago about the food they eat—and that number is up from 65% just last year.

Judging by the amount of food safety testing, the U.S. food industry is paying attention. Strategic Consulting (SCI) has been tracking changes to microbiology testing practices in the U.S. food industry for more than 15 years. Our latest market report, Food Micro—5, shows an increase in microbiology testing in the U.S. food industry of 14.4% since 2008. In 2010, 213.2 million microbiology tests were collected in U.S. food plants with more than 25 employees. Even more important, during the same two-year period, testing for specific pathogens like Listeria and Salmonella increased by more than 30%.

According to a report from CDC’s FoodNet, which monitors infections caused by key food pathogens, some progress is being made in reducing foodborne outbreaks. As a group, infections caused by six critical pathogens were 23% lower in 2010, including a 27% decrease in Campylobacter infections, 38% decrease in Listeria, and 44% decrease in E. coli O157. The rate of Salmonella infection, however, has not declined in 15 years.

Salmonella is the pathogen most tested for across all food products in the US including meat and poultry, fruits and vegetables, dairy, and processed foods. What’s interesting in light of the most recent outbreak is that Listeria is the second most tested pathogen across all food products, and the most tested for pathogen by U.S. fruit and vegetable producers. Food Micro—5 found that more than 85% of the U.S. fruit and vegetable producers surveyed tested for Listeria.

Listeria is the second most tested pathogen across all food products, and the most tested for pathogen by U.S. fruit and vegetable producers.

“Lessons of the Listeria Outbreak,” a New York Times editorial published online on September 30th, suggests that “For its own good, the food industry needs to increase its cleansing and monitoring efforts. Big grocery chains and box stores ought to demand that their suppliers test their fruits and vegetables for pathogens before shipping them.” Clearly, constant efforts and diligence are required. Just as clear, however, is that increased end product testing alone will not solve this multifaceted problem. Every part of the food chain must control and test its raw materials, processing environment and end product before shipping, and that requires better tools and processes than are currently available.

Take the increasingly global nature of the food supply. According to an in-depth report on food safety by Carnegie-Knight News21.com, FDA inspectors physically examined 2.06% of food-related imports in 2010. This year, the agency expects to examine just over 1.5% of all food imports, and even less than that in 2012.

Ultimately, increased testing alone will not directly improve food safety because the time-to-results of current test methods makes proactive microbiology testing very difficult. Current technology requires one to three days to get a test result, depending on the pathogen. Without tests capable of producing point-of-sample, immediate results, it is impractical to test at the point of import or the farm, and as the food is received or being processed at the factory. As a result, food producers are reliant on end product testing alone. Continual recalls demonstrate that this is an insufficient and ineffective approach.

You can’t test in quality after the product has been produced. Better and faster microbiological detection tools will enable food producers to be proactive and to practice the true intentions of HACCP: to control the raw materials and control the factory so that the end product will be under control. So while more testing is necessary, what’s most important is better testing tools. Without the technology to efficiently and effectively test at multiple points along the food chain, even significant increases in end product testing won’t eliminate food recalls or restore consumer confidence in food producers.

As discussed in my last post, the increasing trend in food safety testing is to send samples to an outside food testing laboratory rather than conduct pathogen analysis in the food processing plant. In this post I want to quantify the implications of this concentration of analysis in contract testing labs, and to discuss the resulting impact on product requirements for pathogen detection systems.

In Food Micro—5, Strategic Consulting’s report on the U.S. food safety testing market, we show that approximately 40% of test samples are sent outside the food plant for analysis, either to a central, corporate testing lab or a contract testing laboratory like Silliker. We also show that the percentage of samples being sent outside the food plant for pathogen analysis is rising, and is expected to continue to do so in the coming years.

Food Micro—5 estimates an overall increase in the volume of food safety tests of 15% in the next 3-5 years. If the percentage of test samples outsourced were to reach 50%, we estimate that the daily test volume of corporate and contract labs would grow by over 40% when combined with the testing volume increases that are projected. This growth in sample testing at outsourced locations would mean that each lab location would be processing upwards of several hundred samples per day.

If the percentage of test samples outsourced were to reach 50%, we estimate that the daily test volume of corporate and contract labs would grow by over 40% when combined with the testing volume increases that are projected.

The increase in overall test volume combined with the concentration of testing in corporate and contract testing labs will dramatically change product requirements for pathogen detection systems. They must be able to process a much greater volume of samples in a faster and more efficient manner. This requirement clearly stretches the capabilities of current pathogen testing systems used during the last decade, which were targeted primarily to food plants with low to mid-range testing volumes.

Indications are that pathogen systems are changing, however. At IAFP this August, Roka Bioscience introduced its new pathogen platform, which is targeting higher volume labs with higher throughput capabilities. I am sure there will be additional companies moving into this new space, given the size and fast growth of the outsource testing lab market.