Prior to the COVID-19 outbreak, our dataset comprised some 700 firms, primarily in North America, Europe and Asia Pacific. Over the last month, we have combined our dataset with lists of COVID-19 test manufacturers produced by other organisations, such as the Foundation for Innovative Diagnostics (FIND) and the UK National Institutes for Health Research (NIHR) Innovation Lab, and trawled media coverage for additional data. We now have 303 firms in our dataset of COVID-19 molecular diagnostics firms and our main database has increased to 830 firms.

Our list of molecular diagnostics firms may be the most comprehensive

FIND and NIHR have the definitive lists because they have data on immunoassays, as well as molecular diagnostics, but we believe our list of molecular diagnostics firms may be the most comprehensive, thanks to our prior work on the sector. Also, we have data on the firms, such as their location. We are now developing a collaboration with FIND and hope to establish links with the NIHR Innovation Lab for future work.

Trends in the development and commercialisation of COVID-19 tests

With our broader dataset of all molecular diagnostics firms, we have been able to compare the global industry of molecular diagnostics manufacturers with those firms that have COVID-19 tests. Asia Pacific has more molecular diagnostics firms (40 % of all firms) than either USA (29 %) or Europe (28 %), but the region is even more dominant in the COVID-19 market, with 55% of all firms.

The Asia Pacific lead is also clear if one looks at the number of firms with a test in development versus the number of firms with a test on the market. In Asia Pacific 90 % of firms have a test on the market, in Europe 78 % and in the USA 67 %.

In Germany and South Korea domestic firms are more likely to have commercialised their testsThe lag is striking, because it mirrors the global spread of the pandemic, starting in Asia Pacific and then moving to Europe and then North America. It suggests that perhaps firms could have responded more quickly when the pandemic began, which might have helped with ramping up capacity.

The differences in firm responsiveness are also striking at the national level. In Germany and South Korea – the two countries seen as having the most comprehensive testing strategies – domestic firms are more likely to have commercialised their tests compared with countries like the USA and UK, which are seen as failing in their testing strategies. In South Korea and Germany 88 % and 80 % of firms have commercialised tests, but in the UK the figure is 54 % and in the USA it is 67 %.

Link between state activism and the responsiveness of domestic firms

There may be multiple reasons for the gap, and the pattern is not consistent across all nations, but our data does suggest that strong leadership by the national government may play a role in industry responsiveness, at least at the extremes of leaders and laggards.

If the EU is to address the danger of poor quality tests, then further action must be taken

The rate of regulatory approvals is another significant difference between regions/countries. Although most countries have put in place fast-track emergency approval mechanisms, the EU already had a very low barrier-to-market entry. The ‘CE mark’ indicates that a test complies with the EU regulations, but for nearly all types of diagnostic tests manufacturers self-certify – the firm awards itself a CE mark. Given that lack of regulatory scrutiny, the EU is an attractive market for firms, thus it is unsurprising that 62 firms across China, USA, South Korea and Singapore are exporting CE-marked COVID-19 tests to the EU. In China, USA and South Korea the position is reversed – most firms with approved tests are domestic. There are 50 % more Chinese firms with a CE mark for the EU market than have approval in China, and the pattern is almost identical in South Korea. Conversely, only South Korean firms have approval in South Korea, very few firms that are not Chinese have approval in China, and that trend is replicated in the USA.

If the EU is to address the danger of poor quality tests, then further action must be taken. That is already happening at national level, as individual Member States are forced to undertake post-market evaluation to assess the quality of tests to inform their procurement decisions.

More analysis from CancerScreen

Stuart Hogarth has been awarded ERC Starting Grant in 2016.