Entecavir API Technology Transfer
Basic Information
Name: Entecavir
English Name: Entecavir
Molecular Formula: C12H15N5O3·H2O
Molecular Weight: 295.30
Chemical Structure: (Not provided in text)
Indication: Entecavir is indicated for the treatment of chronic hepatitis B in adults with active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels, or histological evidence of active liver disease.
Market Prospects
Entecavir is a novel antiviral nucleoside analog, recognized as the most potent and least likely to cause resistance among antiviral drugs. Approved by the U.S. FDA in 2005 and entering the Chinese market in 2006, entecavir has shown rapid sales growth, surpassing older drugs like lamivudine and adefovir dipivoxil, with a promising market outlook.
According to the World Health Organization, approximately 2 billion people worldwide are infected with the hepatitis B virus (HBV), with over 350 million suffering from chronic (long-term) hepatitis B. In China, there are about 90 million HBV carriers, including 28 million chronic hepatitis B patients, with around 7 million requiring urgent treatment. The annual cost of hepatitis B treatment in China exceeds 100 billion CNY. Globally, hepatitis B treatments are primarily divided into two categories: immune modulators (e.g., interferon) and nucleoside/nucleotide analogs (e.g., entecavir, tenofovir disoproxil, lamivudine, adefovir, and telbivudine). Entecavir is currently the most effective anti-HBV drug on the market, with strong clinical demand.
Since its launch, entecavir has maintained rapid growth. From 2006 to 2012, its global market achieved a compound annual growth rate (CAGR) of 62.5%, with sales rising from $83 million in 2006 to $1.526 billion in 2012, an 18-fold increase. By 2014, global sales reached $1.74 billion, accounting for 54.2% of the global nucleoside antiviral drug market, making it the fastest-growing drug in this category, while drugs like lamivudine and adefovir saw declining growth.
In China, sample hospital sales trends from 2006 to 2015 show entecavir sales growing from 36.15 million CNY in 2006 to 300 million CNY in 2010, and reaching 1.47 billion CNY in 2015—a 40.6-fold increase over nine years, with a CAGR of 50.9%. In Shanghai’s sample hospitals, entecavir sales were 160 million CNY in 2013, 190 million CNY in 2014, and 220 million CNY in 2015, with a CAGR of 17%. In 2015, nucleoside antiviral drug sales in Chinese sample hospitals totaled 2.32 billion CNY, with entecavir accounting for 1.47 billion CNY (63.4%), followed by adefovir (310 million CNY, 13.2%), telbivudine (280 million CNY, 12.3%), and lamivudine (230 million CNY, 10.1%). Entecavir holds over 60% of the market share.
In 2015, entecavir ranked seventh among the top 10 drugs by sales in Chinese sample hospitals, with 1.47 billion CNY in sales and a growth rate of 21.6%—the highest among the top 10, which included human serum albumin, sodium chloride, ganglioside, clopidogrel, creatine phosphate, paclitaxel, entecavir, alprostadil, atorvastatin, and lansoprazole.
According to data from 22 Chinese city sample hospitals, Bristol-Myers Squibb’s Baraclude (entecavir) generated 646 million CNY in sales in 2013, capturing a 70.1% market share with a year-on-year growth of 23.0%. From 2006 to 2013, Baraclude’s sales grew from 36.15 million CNY to 646 million CNY, an 18-fold increase with a CAGR of 51.0%. In 2015, Baraclude held a 57.4% market share with sales of 840 million CNY, maintaining a dominant position in China.
Chinese companies have accelerated their market penetration. In 2015, the top five entecavir market players were Bristol-Myers Squibb (840 million CNY, 57.4%), Chia Tai Tianqing (460 million CNY, 31.5%), Suzhou Dongrui (68.44 million CNY, 4.7%), Jiangxi Qingfeng (43.11 million CNY), and Fujian Cosunter (42.93 million CNY). While Baraclude led with 57.4% market share, its growth rate was only 8.0%, compared to Chia Tai Tianqing’s 48.1% growth, indicating rapid progress by domestic manufacturers. Baraclude dominates in large city hospitals with about 50% market share, while Chia Tai Tianqing leads in county-level hospitals with approximately 60% share.
China has a significant hepatitis B patient population, with around 130 million chronic HBV infections, including 30 million chronic hepatitis B cases. Entecavir is indicated for chronic hepatitis B with active viral replication, persistently elevated ALT, or histological evidence of active liver disease. Among available drugs, entecavir exhibits the strongest antiviral activity, reducing viral load by an average of 7 log units within a year—nearly 100 times more potent than lamivudine—and can suppress viral levels to undetectable in most high-viral-load patients within a year. With expanding national healthcare coverage, the hepatitis B treatment market is poised for continued growth, and entecavir’s market potential in China is substantial.
Collaboration Intent
Pilot-scale API technology transfer
