Author information

• ¹Department of Advanced Metabolic Hepatology, Osaka University Graduate School of Medicine, 1-7, Yamadaoka, Suita, Osaka, 565-0871, Japan.
• ²Medicine Division, Nippon Boehringer Ingelheim Co., Ltd., 2-1-1, Osaki, Shinagawa-Ku, Tokyo, 141-6017, Japan.
• ³FibroScan Division, Integral Corporation, 2-25-2, Kamiosaki, Shinagawa-Ku, Tokyo, 141-0021, Japan.
• ⁴Immunology, Hepatology & Dermatology Medical Franchise Dept., Medical Division, Novartis Pharma K.K., 1-23-1, Toranomon, Minato-Ku, Tokyo, 105-6333, Japan.
• ⁵Medical Information Services, Institute of Immunology Co., Ltd., 1-1-10, Koraku, Bunkyo-Ku, Tokyo, 112-0004, Japan.
• ⁶Product Development 1St Group, Product Development Dept., Fujirebio Inc., 2-1-1, Nishishinjuku, Shinjuku-Ku, Tokyo, 163-0410, Japan.
• ⁷Academic Department, GE Healthcare Japan, 4-7-127, Asahigaoka, Hino, Tokyo, 191-8503, Japan.
• ⁸Ultrasound Business Area, Siemens Healthcare KK, 1-11-1, Osaki, Shinagawa-Ku, Tokyo, 141-8644, Japan.
• ⁹Department of Medicine, Division of Gastroenterology, Jichi Medical University, 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan.
• ¹⁰Cardiovascular and Diabetes, Product Marketing Department, Kowa Company, Ltd., 3-4-10, Nihonbashi Honcho, Chuo-Ku, Tokyo, 103-0023, Japan.
• ¹¹Clinical Development & Operations Japan, Nippon Boehringer Ingelheim Co., Ltd., 2-1-1, Osaki, Shinagawa-Ku, Tokyo, 141-6017, Japan.
• ¹²Medical Affairs Department, Kowa Company, Ltd., 3-4-14, Nihonbashi Honcho, Chuo-Ku, Tokyo, 103-8433, Japan.
• ¹³R&D Planning Department, EA Pharma Co., Ltd., 2-1-1, Irifune, Chuo-Ku, Tokyo, 104-0042, Japan.
• ¹⁴Diagnostics Business Area, Siemens Healthcare Diagnostics KK, 1-11-1, Osaki, Shinagawa-Ku, Tokyo, 141-8673, Japan.
• ¹⁵Marketing Dep. H.U. Frontier, Inc., Shinjuku Mitsui Building, 2-1-1, Nishishinjuku, Shinjuku-Ku, Tokyo, 163-0408, Japan.
• ¹⁶Clinical Development Dept, EA Pharma Co., Ltd., 2-1-1, Irifune, Chuo-Ku, Tokyo, 104-0042, Japan.
• ¹⁷Global Drug Development Division, Novartis Pharma KK, 1-23-1, Toranomon, Minato-Ku, Tokyo, 105-6333, Japan.
• ¹⁸2Nd Product Planning Dept, 2Nd Product Planning Division, Fujirebio Inc, 2-1-1, Nishishinjuku, Shinjuku-Ku, Tokyo, 163-0410, Japan.
• ¹⁹Departments of Hepatology, Graduate School of Medicine, Osaka Metropolitan University, 1-4-3, Asahi-Machi, Abeno-Ku, Osaka, Osaka, 545-8585, Japan.
• ²⁰Department of Gastroenterology and Hepatology, Suita Municipal Hospital, 5-7, Kishibe Shinmachi, Suita, Osaka, 564-8567, Japan.
• ²¹Department of General Internal Medicine2, Kawasaki Medical School, Kawasaki Medical Center, 2-6-1, Nakasange, Kita-Ku, Okayama, Okayama, 700-8505, Japan.
• ²²Department of Gastroenterology, JA Hiroshima Kouseiren General Hospital, 1-3-3, Jigozen, Hatsukaichi, Hiroshima, 738-8503, Japan.
• ²³Hyogo Life Care Clinic Hiroshima, 6-34-1, Enkobashi-Cho, Minami-Ku, Hiroshima, Hiroshima, 732-0823, Japan.
• ²⁴Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University, 1750-1, Oaza Ikenobe, Miki-Cho, Kita-Gun, Kagawa, 761-0793, Japan.
• ²⁵Department of Gastroenterology and Hepatology, Gifu Municipal Hospital, 7-1, Kashima-Cho, Gifu, Gifu, 500-8513, Japan.
• ²⁶Division of Hepatology, Shimane University Hospital, 89-1, Enya-Cho, Izumo, Shimane, 693-8501, Japan.
• ²⁷Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Defense Medical College, 3-2, Namiki, Tokorozawa, Saitama, 359-8513, Japan.
• ²⁸Division of Gastroenterology and Hepatology, Tokyo Medical University Ibaraki Medical Center, 3-20-1, Chuo, Ami-Machi, Inashiki-Gun, Ibaraki, 300-0395, Japan.
• ²⁹Liver Center, Faculty of Medicine, Saga University Hospital, Saga University, 5-1-1, Nabeshima, Saga, Saga, 849-8501, Japan.
• ³⁰Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine Graduate School of Medicine, 3-9, Fukuura, Kanazawa-Ku, Yokohama, Kanagawa, 236-0004, Japan.
• ³¹Department of Internal Medicine, Hanyang University College of Medicine, Seoul, 04763, Korea.
• ³²Division of Hepatology and Pancreatology, Department of Internal Medicine, Aichi Medical University, 21 Yazako Karimata, Nagakute, Aichi, 480-1195, Japan. sumida19701106@yahoo.co.jp.
• ³³Department of Gastroenterology & Hepatology, Saiseikai Suita Hospital, Osaka, 1-2, Kawazono-Cho, Suita, Osaka, 564-0013, Japan.

Abstract

Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease. Nonalcoholic steatohepatitis (NASH) is an advanced form of NAFLD can progress to liver cirrhosis and hepatocellular carcinoma (HCC). Recently, the prognosis of NAFLD/NASH has been reported to be dependent on liver fibrosis degree. Liver biopsy remains the gold standard, but it has several issues that must be addressed, including its invasiveness, cost, and inter-observer diagnosis variability. To solve these issues, a variety of noninvasive tests (NITs) have been in development for the assessment of NAFLD progression, including blood biomarkers and imaging methods, although the use of NITs varies around the world. The aim of the Japan NASH NIT (JANIT) Forum organized in 2020 is to advance the development of various NITs to assess disease severity and/or response to treatment in NAFLD patients from a scientific perspective through multi-stakeholder dialogue with open innovation, including clinicians with expertise in NAFLD/NASH, companies that develop medical devices and biomarkers, and professionals in the pharmaceutical industry. In addition to conventional NITs, artificial intelligence will soon be deployed in many areas of the NAFLD landscape. To discuss the characteristics of each NIT, we conducted a SWOT (strengths, weaknesses, opportunities, and threats) analysis in this study with the 36 JANIT Forum members (16 physicians and 20 company representatives). Based on this SWOT analysis, the JANIT Forum identified currently available NITs able to accurately select NAFLD patients at high risk of NASH for HCC surveillance/therapeutic intervention and evaluate the effectiveness of therapeutic interventions.