Sarah HardingDecember 24, 2020
China has been viewed in recent years as a ‘rising star’ of the pharma industry. Notwithstanding political pressures – primarily from the US – founded on concerns over China’s growing dominance in the field, and the West’s increasing dependence on China for raw ingredients, the relatively lower manufacturing costs, availability of cheap and skilled labour, and regulatory developments supporting the strength of the industry, have all combined to help China realise its potential in becoming a leading supplier for API and FDF manufacturing projects. It has been estimated that up to 80% of APIs used by pharma manufacturers in the US are now imported from China or India.
Of course, changes to supply chains caused by the COVID-19 pandemic are having an impact, as many Western manufacturers were forced to seek out more local suppliers during the downturn in China’s productivity at the beginning of this year. However, as companies resume full-scale operations after the outbreak, demand for ingredients and large-scale contract manufacturing is expected to rebound. China’s pharma companies have also taken centre stage in discovering and developing treatments and potential vaccines for the virus, which in itself could change the global pharma landscape if one of those candidates is successful in ongoing trials.
The COVID pandemic has had such a massive impact on the shape of the pharma industry in China, that it is sometimes easy to overlook other trends that are continuing to influence the sector’s relentless progress in the region. An increased uptake of digital medicine, progress with serialization and aggregation, and significant growth in biologicals and gene therapies, are just a few examples of developments that have been bubbling away in the hot melting pot of pharma in China throughout 2020. The pandemic has also somewhat overshadowed the so-called "phase one" deal signed by the US and China in January this year, which was widely heralded as the possible beginning of the end of the bitter trade battle that has engaged the world's two largest economies since 2018.
Underlying many of these trends is a necessary revolution in the way that manufacturing plants in China are run. As much of China shut down for over a month in efforts to control the spread of the virus, many manufacturing plants simply had to close. China made the brave decision to pause its economy, but the virtual shutdown of the world’s second largest financial system led to marked disruptions in the manufacture and supply of drug products, active ingredients and excipients. In order to maintain its position and reputation as a reliable provider to the world market, Chinese suppliers cannot afford another prolonged period of enforced shut down.
The key to addressing this challenge lies in smart manufacturing. The digitalization of manufacturing was already picking up speed before the COVID pandemic, as companies across numerous industries realised the benefits of consistently higher quality products, produced more efficiently, more ‘in-spec’ and more economically, with better process safety. The pharma industry, in particular, had embraced the utility and application of manufacturing analytics, as the technology provides a way of satisfying regulatory demands for greater consistency and better traceability.
Now, in a post-COVID world of lock-down and personal distancing, manufacturing analytics provide another important advantage. During the pandemic, manufacturing analytics-based monitoring tools enabled manufacturers with the technology to supervise their plants remotely. The tools allowed engineers and operators to monitor their equipment and infrastructures remotely, from their homes, while only skeleton crews were needed on-site.
“Over the past few months, we have seen most of our customers change the way they operate but output has tended to remain steady,” said Peter Guilfoyle, CEO of Northwest Analytics, in a recent article.
Companies that already had these systems in place were able to quickly reduce their physical presence at the plant, while still observing their processes and equipment. They were able to continue production throughout the pandemic, and their output was minimally – if at all – affected.
As the world realizes the unfortunate truth that SARS, Ebola and COVID-19 probably mark the first of many outbreaks, suppliers and manufacturers wishing to maintain their reliability feel added pressure to keep their factories running, whatever the future may bring. Digitalization offers a path to achieving this goal, allowing managers and engineers to work effectively from home, while a skeleton crew of operators keeps the plant running safely and productively.
The widespread adoption of these manufacturing analytics tools in China’s factories is the underlying revolution that will enable other trends and influences – big and small – to progress and continue to shape the region’s pharma industry. As with many of the technologies discussed in this column, companies missing the chance to digitalize their operations in this way are likely to find themselves at a significant disadvantage in the future. When it comes to pharma manufacturing, the only smart way forward is digital.
Author biography
Sarah Harding, PhD
Sarah Harding worked as a medical writer and consultant in the pharmaceutical industry for 15 years, for the last 10 years of which she owned and ran her own medical communications agency that provided a range of services to blue-chip Pharma companies. She subsequently began a new career in publishing as Editor of Speciality Chemicals Magazine, and then Editorial Director at Chemicals Knowledge. She now focusses on providing independent writing and consultancy services to the pharmaceutical and speciality chemicals industry.
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