Introduction and Background of the Project

Introduction

Limited availability of reliable data on diagnostic tests has been a major barrier to advancing global health, particularly for neglected tropical diseases (NTDs). The lack of a comprehensive overview of existing diagnostic tools makes it difficult to identify gaps and prioritize product development, ultimately slowing progress toward universal health coverage.

Both a global approach and a 360° view of the Japanese IVD/medical devices expertise and capabilities, will help to identify developers that are the most likely to respond to an unmet need with innovative and reliable tests.

Overall, this project aims to collect a body of IVD intelligence that will deliver actionable information to accelerate the development, availability and access of urgently needed diagnostic solutions for NTDs and beyond.

Project objective

The aim of the project is to identify and characterize existing gaps or unmet needs in the diagnostic test portfolio for the selected NTDs (the need side) as well as to identify and assess Japanese firms that are best equipped to provide a solution and fill the diagnostic gap (the feed side). The specific objectives are:

  (i)  Technology-based landscape analysis of Japanese IVD and medical device developers, including technical, commercial, and partnership assessments of the most promising partners. 

  (ii) Disease-based landscape, looking at available diagnostics tools at the global scale.

Specifically, we are planning to conduct disease-specific landscapes that will focus on uncovering diagnostic gaps and shedding light on the type of products that are needed for five neglected tropical diseases: Onchocerciasis, Lymphatic filariasis, Schistosomiasis, Mycetoma, and Leprosy. Furthermore, we will map the Japanese diagnostic and medical device national ecosystem to quickly identify partners that have the expertise and capacity to develop and manufacture innovative and reliable testing solutions.

Project design

This project is centered around technology scouting, market research and landscaping efforts. It will leverage FIND’s leadership in the collection of intelligence on diagnostics products for infectious diseases and will benefit from Fuji Keizai’s detailed understanding of the Japanese healthcare market. We propose three work packages (WPs) to meet the two objectives laid out above.

  WP1: A national landscaping of Japanese IVD and medical devices developers/manufacturers

  WP2: A global landscaping of existing diagnostic tools for a suite of neglected tropical diseases

  WP3: A partnership and technical assessment for the most promising developers

How can your partnership (project) address global health challenges?

Lack of funding, data and coordination is particularly striking for the diagnosis of NTDs, where less than 5% of the limited research and development funding made available to NTDs has been invested in diagnostics. The WHO 2021–2030 NTD roadmap identifies diagnostics as central to accelerating progress and making up lost ground during the COVID-19 pandemic. To accelerate the development, availability and access of urgently needed diagnostic solutions for NTDs, this project contributes to global health by: 1) Providing evidence-based insights, 2) Supporting data-driven prioritization as well as published on an open-access online portal for NTD diagnostics. Furthermore, finding and selecting the most suitable technology and qualified manufacturer can be complex in the fragmented ecosystem of IVD and medical devices. Many Japanese companies have entered the field of infectious disease testing using novel immunoassay or molecular technologies among other innovations, making it a field where Japanese companies can expect to quickly deliver their technology to populations in needs. Mapping and understanding this national ecosystem are critical for the rapid development of quality diagnostic products as it will help identify and select the Japanese firms that are the most suitable to respond to global health needs and partner on future product development efforts.

What sort of innovation are you bringing in your project?

The innovation lies in a structured data-driven approach as well as an in-depth investigation through mobilization of local expertise. FIND will not only build on the experience and network of a local partner in Japan such as Fuji Keizai but will also leverage its network in other regions through its country offices and local partnerships all over the world. This will provide a more realistic view of diagnostic gaps and opportunities in the NTD field across the globe. The open-access online portal for NTD diagnostics (NTD test directory) designed by FIND is also a unique and interactive platform to inform and support decision-making by global and regional stakeholders on funding strategy for IVD product development and access.

Role and Responsibility of Each Partner

FIND will be the coordinator of the project and will conduct the global landscaping activities of existing diagnostic tools for a suite of neglected tropical diseases with tabulated lists and test directory as outputs. FIND will also lead the technical and partnership assessment of Japanese companies identified throughout the project.

Fuji Keizai will be responsible for the national landscaping of Japanese IVD and medical devices developers/manufacturers (market/technology research focused on Japan). Fuji Keizai has great expertise in market and technology research with a large network in the Japanese healthcare industry. This will be of great value to support outreach to IVD industry players and conduct interviews and surveys.

Final Report

1. Project objective

The overall aim of the project is to identify and characterize existing gaps or unmet needs in the diagnostic test portfolio for the selected NTD as well as to identify and assess Japanese firms that are best equipped to provide a solution and fill the diagnostic gaps.

The specific objectives are: (i) Technology-base landscape focusing on Japanese IVD and medical devices developers and manufacturers, including a technical, commercial and partnership assessment of the most promising partners (ii) Disease-based landscape, looking at available diagnostic tools at the global scale.

2. Project design

Three work packages were decided to achieve this goal:

WP1: A national landscaping of Japanese IVD and medical devices developers/manufacturers (led by Fuji Keizai). They were divided  in 3 groups, (i) related to molecular, immunoassays, portable X-ray, ultrasound, skin imaging and smart auscultation tools, (ii) blood culture, BGM and HbA1c, (iii) sequencing, point-of-care blood test

WP2: A global landscaping of existing diagnostic tools for a suite of neglected tropical diseases (led by FIND)

WP3: A partnership and technical assessment for the most promising developers (led by FIND) 

3. Results, lessons learned

WP1:

Fuji Keizai selected 184 Japanese companies as potential partners for NTD diagnostics, narrowed the list down to 91 companies through communication with GHIT, and finally interviewed 27 companies regarding their technology platforms and partnership evaluations. Through these interviews, we identified issues and made recommendations for future partnerships.

WP2:

FIND completed the commercial diagnostic landscape analysis for the 5 selected NTDs and the results were published on FIND DxConnect Test Directory

(https://www.finddx.org/tools-and-resources/dxconnect/test-directory/)

A simple draft report was compiled summarizing findings across the diseases. This report was not finalized  as of today. In total, 102 commercial diagnostic tests were identified: 43 for lymphatic filariasis, 42 for schistosomiasis, 12 for leprosy, 5 for onchocerciasis and none for mycetoma. Notably, at least one point-of-care test with regulatory approval was identified for schistosomiasis, lymphatic filariasis and leprosy. These findings highlight significant disparities on test availability and information across the 5 NTDs. Key lessons learned include the need to broaden future landscape to include diagnostics in development, not only commercialized products.  Additionally, conducting a literature review of independent performance evaluations is essential to validate existing tests. This approach would provide a more accurate view of the pipeline and support R&D and investment priorities for the most neglected diseases.

WP3:

Report on partnership and technology conducted by Fuji Keizai as part of WP1 has been prepared.

Please see the full report here.