Market Trends in Lateral Flow Immunoassays
Since i’m evaluating a point- of -care device based on lateral flow (LF) technology, it’s interesting to look at the market trends in this technology.
The LF format is so versatile that manufacturers of rapid immunoassay tests have developed LF tests for almost any situation where a rapid test is required.
The world market for LF- based tests is estimated at $3652 million in 2012. (This estimates includes LF tests used in human and veterinary medicine, food and beverage manufacturing, pharmaceutical, and water utilities.)
However, growth in LF testing is derived mainly from the clinical sectors. The clinical test segment is the biggest LF- test segment and generally seen as the most lucrative. Worldwide, there is a huge demand for decentralized availability of diagnostic tests. Therefore, clinical LF- tests are used primarily to replace lab- based immunoassays in decentralized testing locations, known as point -of- care testing (POC)
The US market accounts for 50 % and the European market for 40 % of the worldwide market for LF clinical tests. Japan and Asia represents only 5 % of the market. This seems quite surprising, but has a good explanation. The healthcare system in these countries is highly centralized, not leaving much room for POC testing in the physician office or at home.
The United States has an enormous impact on how rapid test industry develops. Managed care’s obsession with cost reductions is pushing the need for nearer the patient and decentralized testing (in the home, at the bedside and in the physician’s office). However, the European market for POC tests has been growing faster than that of the United States. The EU governments have begun placing greater emphasis on the prediction and prevention of disease through more proactive diagnostics. They want to control the cost of delivering healthcare to their aging populations.
Market opportunities are also evolving in other parts of the world. Emerging markets such as South America, Russia and parts of Africa are not longer ingnored. Companies are beginning to take advantage of them, more as a method of survival than for altruistic reasons.
Group T Thesis, Group 1316 
I found a paper where they discuss lateral flow technology and more particularly it’s commercialization. The conclude that a lot of research is being done but that it is done in small groups and not a lot of developments in the lab make it to an end product. While they also state that POC devices could really lower our health care cost it is still taking a long time. Do you think it is just to early for POC devices to be commercialized or do we need to have our governments to take some action here? They seem to give grants to development but a lot less to commercialization.
Is Belgium more specific KUL or UGent doing anything around POC devices? And is there any commercial initiative in our country?
source: http://orion.bme.columbia.edu/~sia/Chin_Linder_LOC_2012.pdf
Interesting article. Yes it’s true that POC and LF in particular have so far not lived up to expectation. I think the most important cause for POC limited market penetration is rather technological (performance limitations).
It’ s just too early and some drawbacks have to be solved. There is need for real quantification, by replacing visual detection with digital and instrument- based methods. (improvement of imaging and computational capabilities).
Other issues/challenges are:
-miniaturization of sample volume requirements below microliter level
-Simultaneous analysis of multiple markers (multiplexing)
-Sensitivity and reproducibility issues
-Unclear patent situations (see post ‘ Regulatory issues in the development and marketing of Lateral Flow Immunoassays’)
I also think that conservatism has fortified these limitations. More specific, the continuing use of traditional manufacturing practices and materials, labels and detection systems.
Despite all these issues, lateral flow immunoassays have achieved broad penetration in a variety of markets. But for a real breakthrough we still have to wait for another 5-15 years i think…
Because of the reasons mentioned in previous comment, i think it’s still to early for a big commercial initiative in our country.
Some previous/recent projects on KUL and UGent:
http://www.kuleuven.be/research/researchdatabase/project/3M08/3M080358.htm
://www.biw.kuleuven.be/biosyst/mebios/Thesissubjects12.html/thesis-subjects-2013-jeroen-lammertyn.html
https://biblio.ugent.be/publication/595882
Is the main problem of multiplexing not simply the small research groups? Or is it really hard to get several tests in 1 device? Is it not as easy as bringing everything together? What are the problems when combining different tests? Multiple markers means you can test for different substances, or am I mistaking?
What is hard about quantification? Could color intensity not be a measure for quantification? For a digital read out you will probably get more expensive devices since you need the electronics. Normally a POC device can only be used once, am I right? Are there also POC devices for multiple use? I saw in your source they tested glucometers. This could be a type of meter you would want to use more then once since patients hate to monitor this constantly.
Yes, with multiplexing you test for different analytes. For instance when you have to deal with a pathology that causes changes in different proteins, your diagnostic strategy requires multiplexing.
There are already handheld and portable lateral flow readers on the market that can be used for quantification. Scanning systems can measure the color intensity, but this is actualy only a semi quantification. When you apply a certain volume on a test strip, this volume moves through the membrane because of capilary force. The test result you get depends on this volume and capillary force and therefore you also need to measure these parameters in order to get a real quantification.
A lateral flow POC device can normally only be used once. Such a device is nothing more than a test strip with a cover cassette. Once the test strip is used (wetted with the sample), you can’t use it anymore.
A glucometer POC device is not based on the lateral flow test principle. These at- home blood sugar monitoring devices are ment for multiple use since you have to use them every day. Here you have a reader that measures the blood glucose level. (a small drop of blood is placed on a disposable test strip). These disposable test strips are very cheap. Documentation is important here, some devices can store the results in their memory and if not, you have to write down your results…
http://en.wikipedia.org/wiki/Glucose_meter
For a lateral flow test, you could of course just use another test every time and measure the color intensity with a portable reader. But lateral flow test strips are much more expensive than the test strips used for glucometers.
You can alo use fluorescent or magnetic detection instead of the color intensity.
These quantification techniques require different labels: colloidal gold, colored or fluorescent latex, paramagnetic latex particles…
Some techniques are better for multiplexing than others.
The problem with multiplexing is that the set-up of the membrane is more complex. spatial differentiation on the membrane is needed sometimes. How to make a good difference between the different analytes…You also have to be aware of cross- reactivity problems for instance.
But I think lateral flow tests are not the best way for multiplexing. For these applications, multiplexed systems such as microarrays are more likely to be utilized.
As a conclusion:
The problem is that the LF market is highly diversified, so it’s hard to keep track of everything that’s on the market yet. (at least 25 companies are active in the pregnancy test segment for instance)
Another thing that is remarkable: LF test strips are established for more than 30 years, but readers are only commercially available in recent years. There is some catching up to do…
You say that the world market was estimated at $3652 million in 2012, where did you obtain this statistic / reference from?