Monthly Archives: November 2019

Review of Current Worldwide Microbiology Testing Methods and Markets in Pharmaceutical Manufacturing

Presented in 2019 at the 14th Annual PDA Global Conference on Pharmaceutical Microbiology, Bethesda MD

PDA Bethesda 2019

Strategic Consulting, Inc. was pleased to have had a poster presentation at the 14th Annual PDA Conference on Pharmaceutical Microbiology.  The poster presented the results of our work in studying and measuring the volume and market value of worldwide microbiological testing in the pharmaceutical sector.

Strategic Consulting, Inc. collected primary data on the number and types of tests conducted worldwide, using interviews and electronic surveys with key knowledgeable individuals at more than 300 pharmaceutical facilities in North America, Europe, Latin America and Asia (incl. India and China).  The market at the end of 2018 was validated as consisting of a worldwide test volume of 415 million tests and a market value for test materials of $1.64 billion.

It is important to recognize that Strategic Consulting defines the worldwide pharma sector as including approximately 5,400 plants with 25 or more employees. Our research project focused only on these facilities and did not attempt to collect data from smaller facilities.  These facilities were found to conduct an average of approx. 77,000 tests per year, with a very wide range in test volumes with smaller facilities that may collect “thousands” of tests per year to the largest pharma plants that collect more than 1 million tests per year.

Due to the crucial nature of this testing, and the steady growth of the pharmaceutical manufacturing sector, the growth of this market has continued steadily since we first started tracking this market in 1993.  The worldwide Pharma Sector has shown steady growth in test volume from 105 million tests in 1993, 206 million tests in 2003, 348 million tests in 2014 to our estimated volume of 415 million tests in 2018.  This growth is expected to continue at a slightly faster growth rate and reach 526 million tests in 2023.

The market value of Industrial Microbiology testing in the Pharma Sector has gained steadily from US$ 365 million in 1993, US$ 995 million in 2008, and now reaching over US$1.640 billion in 2018.  With a slightly decreasing rate of market value growth expected, due to developing competition that will add to pricing pressure, the Pharma Sector is projected to reach an estimated US $2.1 billion in market value by 2023.

What are Processors doing to combat Food Fraud?

What are Processors doing to combat Food Fraud?

Economically Motivated Adulteration (EMA) – otherwise known as Food Fraud – can be committed in many ways, including mislabeling, product substitutions, or product adulteration. There are no shortages of reports of this type of fraud with stories of sugar being added to honey, lower quality vegetable oil being misrepresented as extra virgin olive oil or horse meat being sold as beef being common in the popular press.

It may be tempting to think that because our food supply chain is so large and complex that some of these incidents occur simply through errors. If this were the case, we would often find a more expensive ingredient substituted for a lower quality one – and yet this is rarely found to happen.

In our article in the Oct/Nov issue of Food Safety Magazine, we asked processors what they were doing to combat food fraud.

 

As you can see in the full article, there were varying levels of concern about food fraud throughout different processor types and processors in the US and Canada seemed to be less concerned (or perhaps had better control) than those suppliers and processors outside of the US/Canada.

The processor vertical that reported a different response was Spices and Ingredients where we saw a much higher level of concern than in other food areas. It has been known that this market has had a history with EMA with many cases of substitutions and alterations. And “spices” are not a food type but a broad category with a far larger and more global supply chain than what most other processors deal with. This complexity provides many more “touch points” that are very difficult to track providing ample opportunities for someone tamper with a product.

When we asked about the testing that processors are doing, most reported that they are not testing or doing limited testing with the most common control being to deal only with known and trusted suppliers and make sure that they have Certificates of Analysis (CoA) from each of those suppliers.

Consistent to what we heard from Spices and Ingredient processors about risk, these processors are doing far more testing than other verticals and using more varied types of analytical tests.

Food fraud is not new, and it is not going to be eliminated any time soon. As supply chains get longer, more global and more complex there will be ever more opportunities for food fraud to occur and food companies will have to remain vigilant.

Find out more in the full article – Economically Motivated Adulteration: What Are Processors Doing to Combat Food Fraud? http://bit.ly/34raGxm