Non-alcoholic fatty liver disease (NAFLD) is emerging as an important cause of a wide spectrum of liver diseases including non-alcoholic steatohepatitis (NASH) in India. A proactive focus on NAFLD if translated into action can halt its prognosis to NASH, thereby reducing its prevalence in the country, says GlobalData, a leading data and analytics company.
In February 2021, India launched operational guidelines to integrate NAFLD with the National Programme for Prevention & Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS).
Ms. Sasmitha Sahu, Pharma Analyst at GlobalData, comments: “Identification of diseases with high prevalence but with limited or no pharmacotherapeutic options and working towards prevention and management is a rational strategy. Control of the risk factors for NAFLD like obesity, diabetes or prediabetes will naturally delay or evade the prognosis to more complicated liver conditions like NASH, cirrhosis, and cancer.
It is known that the national program already focusses on the prevention of obesity and diabetes through early detection and lifestyle changes, which can be optimized to achieve common goals for NAFLD as well. Moreover, the involvement of government will ensure proper dissemination of information.”
According to GlobalData Epidemiology and Market Size Database, the number of total prevalent cases of NAFLD in India is expected to grow at an annual growth rate (AGR) of 3.23% from nearly 409 million cases in 2020 to 512 million cases in 2029 while the same for NASH is expected to increase at an AGR of 3.05% from nearly 19 million in 2020 to 24 million in 2029.
Ms. Sahu adds: “India has the second highest incidence of NAFLD within the Asia-Pacific region after China. The wide gap between the total prevalent and diagnosed cases highlights the need for increased screening, physician awareness, and identification of advanced fibrosis, which is characteristic of NASH, from simple steatosis.”
According to GlobalData Pharma Intelligence Center, the diagnosis rate for NAFLD in India was 36.83% in 2020 while it was 41% among the 16 major pharmaceutical markets (16MM*).
Ms. Sahu adds: “Usually NAFLD/NASH are silent indications with a few or no symptoms. Imaging and biomarker screening can be used as primary tools for predicting predisposition to NASH from NAFLD and in ensuring that at-risk patients do not potentially miss out on disease management guidance. Physician and patient education about the relation between these indications can play a critical role in improving diagnosis rates.”
Moreover, India became the first country to approve an innovative therapy, saroglitazar Mg (Lipaglyn), a dual peroxisome proliferator activated receptor α/γ agonist for NAFLD in December 2020, following an approval for NASH in March 2020.
Ms. Sahu concludes: “Until now there was no approved therapy for NAFLD/NASH globally and patients had to rely only on generic off-label therapies. India’s promptness in approving an innovative therapy will further complement the way NAFLD is managed in the country at the diagnosis stage itself, thereby reducing overall prognosis and incidence rates for NASH.”
*16MM = The US, France, Germany, Italy, Spain, the UK, Japan, Australia, Brazil, Canada, China, India, Mexico, Russia, South Africa and South Korea.