Decline in medical technologies created to diagnose deadly diseases

Research by Marks & Clerk and CPA Global shows downward trend in novel testing technologies for antimicrobial resistance

New research has pointed to a decline in the number of new point-of-care technologies being created to diagnose infectious disease and identify pathogens and antimicrobial resistance (AMR), amid a concerning lack of innovation and investment.

Ahead of the World Health Summit in Berlin, a comprehensive study of patent filings was undertaken by IP firm, Marks & Clerk, and CPA Global for Nesta’s Longitude Prize.

Patent filing figures are often seen as a gauge of the health of any market, and it’s crucial that AMR remains a focus for businesses and regulators

The study reveals a year-on-year decline in patent filings for point-of-care diagnostics to tackle infectious disease and detect pathogens and AMR through 2014 and 2015.

Following a dip in innovation as a possible result of the financial crisis of 2008; patent filings reached their highest levels for the past decade in 2014, with 118 patents for point-of-care diagnostics for infectious disease filed globally.

But, by 2015, this figure had dropped significantly to 94 patents.

The global market for point-of-care diagnostics for infectious disease, and particularly those looking to tackle AMR, remains in its infancy.

Most diagnostics are routinely done in a laboratory setting so that the introduction of a new point-of-care diagnostic requires the creation of new markets.

Much of the recent new funding in AMR has been allocated for early research into new antibiotics and so far funds to support diagnostics have been limited.

Paul Chapman, a partner at Marks & Clerk and a member of Longitude Prize advisory panel, said: “The role of medtech in delivering quicker and more-reliable diagnoses, and the impact this can have in tackling AMR, is often underestimated.

“It’s encouraging, therefore, to see that there is a great deal of innovation in this space.

“Nevertheless, that we have seen a dip in filings over the past two years in which data is available, after seeing steady growth in the years prior, is surprising.

“Patent filing figures are often seen as a gauge of the health of any market, and it’s crucial that AMR remains a focus for businesses and regulators.”

The fact that patents on AMR diagnostics are slowing is concerning, but another equally-important challenge for test makers is the dearth of available grants and venture capital funding for tests that will reduce and improve the use of antibiotics

In 2017 the World Health Organization (WHO) published a list of 12 ‘priority pathogens’, which will be central to the fight against AMR.

Patents filed subsequent to the publication of this list will not yet appear in the data, but the report shows there is already a good deal of activity directed at these pathogens.

The Longitude Prize has been designed to incentivise innovation in rapid tests to reduce antibiotic resistance using Nesta’s challenge prize methodology.

Currently 75 diagnostic developers from 14 countries are competing to win an £8m prize.

Launched in 2014, the prize aims to foster innovation in globally accessible, affordable, rapid and accurate point-of-care diagnostic devices to help reduce the inappropriate prescribing of antimicrobial drugs.

Daniel Berman, leader of the glbal health team at the Challenge Prize Centre, said: “The fact that patents on AMR diagnostics are slowing is concerning, but another equally-important challenge for test makers is the dearth of available grants and venture capital funding for tests that will reduce and improve the use of antibiotics.

“The report also speaks about the need to create a market for these products. It recommends that governments and aid funders ring-fence funds for purchase rapid diagnostic tests.

“Without reducing the unnecessary use of antibiotics through better testing, experts say it will be impossible to slow resistance and ensure the availability of antibiotics that work.”

The study showed that industry leads the way, with almost two thirds of patent filings.

The role of medtech in delivering quicker and more-reliable diagnoses, and the impact this can have in tackling AMR, is often underestimated

A number of academic institutions are particularly active, nine of the top 10 of which are in the US - led by the University of California, Harvard University and John Hopkins University. The other institution in the top 10 is the University of Edinburgh in the UK.

The US continues to lead the way with 60% of patent families with inventions in this area. The UK is the second-largest source for developments in this field with 8%, followed by the rest of Europe (6%), Japan (4%), Korea (3%) and China (2%).

The research uncovered a general downward trend in filings in the UK, Korea, Japan and via the European Patent Convention; whereas there was an upward trend in South Africa, China and Australia.

Unsurprisingly, there has been a recent increase in filings for mobile phone-led technology and hand-held devices, 44% of which have been filed within the past five years.

Mobile technology is crucial for the advent of in-field and at-home testing, as it promises diagnostics that can reach remote areas, without the need for laboratory testing or complex and expensive equipment.

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