While the market has produced a large number of R&D scientists, manufacturing plants and patient data, it has also emerged as the world’s main supplier of low-cost generic drugs.
But this is beginning to change as we witness more local manufacturers shift their focus from non-differentiated generics to a more differentiated portfolio. Green Cross, a Korean Biopharmaceutical Company, for example, first produced “Hepavax B” in 1987 which is the world’s third Hepatitis B Vaccine that has vaccinated over 130 million people. Since then they have developed other drugs including “Hantavax”, the first epidemic hemorrhagic fever vaccine; the first diagnostic reagent for AIDS; and more recently, “Greengene”, the world’s 4th recombinant drug for hemophilia A and the world's second treatment of Hunter syndrome “Hunterase”.
Several companies in India have also been working on patenting their own drugs - Serum Institute is one of the world’s largest vaccine producers with over 1.3 billion doses produced and sold to over 140 countries; Zydus Cadilla developed Lipaglyn, an innovative new diabetes drug and the first chemical entity that was discovered and formulated in India to reach the market; Biocon’s oral insulin which is considered the “holy grail” of diabetes treatment aimed at replacing insulin injections; and Sun Pharma’s in-licensing of biologics from MSD, indicating its willingness to advance its pipeline towards the upper-value chain.
The transformation to original manufacturing marks a new era for Asia’s pharmaceutical industry...
Similarly in China, companies like Simcere Pharmaceuticals have partnered with global brands like Merck and BMS to concentrate on therapies for cardiovascular diseases. Endu, its innovative anti-angiogenic drug used in the treatment of lung cancer was introduced as the world's first listed recombinant human endostatin; and Bicun, an edaravone injection treatment for strokes is the world’s first synthetic free radical scavenger.
The transformation to original manufacturing marks a new era for Asia’s pharmaceutical industry, particularly in the supply of innovative new drugs to both domestic and global markets.
However, all this has come at a challenging time for local pharma companies as healthcare reform by drug regulators continue to take centre stage in the region. Tighter regulations and enforcements by the Chinese government to crack down on bribery and corruption have left many companies with substantial penalties or ongoing investigations. More stringent standards for drug approvals are impacting revenues as product launches are delayed, sometimes for up to two years.
India’s reputation as a safe and affordable drug producer suffered when the U.S. Food and Drug Administrator (FDA) placed import bans on several companies over concerns on manufacturing practices. As FDA staff increases audit on plants, production approvals are reduced, once again, impacting companys’ bottom lines.
Inadvertently, pressures from the authorities have led to a two-tier system of controls where some drug makers have dedicated plants to serve the American market. Because Asia supplies medication worldwide, one can’t help but wonder if FDA’s manufacturing requirements are too onerous or do quality standards need to be raised? Surely patients in other countries deserve medication of the same quality as America.
That is not always the case. Local pharmaceutical companies in Asia make low-cost drugs available to millions who cannot afford them. While many of the drugs are of high quality, there are some that are made with too little active ingredient or are tainted. Yet, some countrys’ drug administration caution against over-regulation. Clearly, this needs to change for Asia’s home-grown companies to continue to flourish.
Nevertheless, Asia is still the largest emerging market and there is evidence of companies moving up in the value chain while still leveraging their advantage in low-cost manufacturing, the region’s huge market and healthy government support.
Faithful+Gould continues to support this sector through our integrated solutions of development advisory, project management, program management, cost management, project controls and energy and sustainability advisory services. Our expertise is targeted at all stages of both R&D and manufacturing facility projects from the business planning phase, plant design, construction, commissioning, start up, operation and eventual disposal.