Known for its innovation and fast-paced developments, the pharmaceutical industry’s hot topics are constantly evolving. As continuous manufacturing, high potency active pharmaceutical ingredients (APIs), hot melt extrusion (HME) and injectable products are becoming more widely available, their novelty diminishes and new buzz words are taking to the floor. Today’s forward thinkers are looking at biologics, personalized medicine, and technologies for digitization and serialization. The other ‘elephant in the room’ that cannot be ignored is the issue of US re-shoring and trade negotiations between East and West.

Biologics
In a market conventionally driven by small molecules, the share of biologics is steadily increasing as most spending growth is expected to be fueled by innovations in oncology and autoimmune diseases. While new molecular entity (NME) approvals saw a 20-year low of 14 in 2016, the years 2015 and 2016 saw 12 and eight new approvals for biologics, respectively. Biologics represent nearly half of all pharmaceutical products currently in the global pipeline. Yet, as biologics take to the fore, there remain limited contract manufacturing offerings in this area, as few companies have the resources to invest sufficiently in this area. Those that have already passed this high entry barrier might find themselves with relatively unique selling opportunities.

Personalized medicine
Another major revolution taking place in healthcare is that of personalized medicine. In years gone by, drugs were designed on a ‘one size fits all’ basis – one drug could be destined to treat millions of patients, with little consideration for physiological or genetic variances. In contrast, the emerging model is one of ‘personalized medicine’, which is based on the customization of healthcare, with medical decisions, treatments, practices and products all being tailored to the individual patient. New tests and applications for personalized medicine are being developed all the time, making this one of the most fast-moving and innovative fields of medical technology. Artificial intelligence, machine learning, pharmacogenomics and wearable devices are all at the forefront of this revolution, which the pharmaceutical industry is eager to embrace. Companies already considering this evolving aspect of global healthcare could be one step ahead in the not too distant future.

Serialization
Within the next few months, serialization will be an essential offering for any companies dealing with Europe or the US, as new regulations demand a comprehensive system to track and trace the passage of prescription drugs through the entire supply chain. Pharmaceutical companies and governments believe that these measures may reduce counterfeiting. However, many companies are not ready, or unable, to implement serialization programmes themselves, leading third parties with resources and agility to move into place to address those needs. This is a novel, but necessary, service offering that will impact companies across the globe by the end of 2018.

Digitization
‘Big data’ is driving digitization of the pharmaceutical industry, supporting other trends in personalized medicine and serialization, not to mention providing more efficient and safer manufacturing practices. The potential for digitization to improve practices and procedures in the pharmaceutical industry is vast. Industry giants have already embraced this so-called fourth industrial revolution, which is being broadly referred to as Industrie 4.0. Smaller companies not embracing this trend are at risk of being left out in the cold.

East vs West
The past year has seen a series of exchanges relating to the imports and exports of products between the US and China, leading to an increasing number of tariffs intended to discourage trade between the two countries. The result is a clear trend for reshoring pharmaceutical manufacturing in the US, rather than having APIs, intermediates and finished products produced overseas and importing them. The impact of this movement is not limited to China, and is seen by many as being more simply rooted in the US president’s pre-election pledges of ‘America First’ when it comes to trade. However, there is no doubt that pharmaceutical manufacturing companies in China, due to the emergence of tariffs over the past year, may be particularly affected.

Conclusion
These and other factors are influencing the industry in which we work. It may be helpful to consider them when discussing strategies for 2019 and beyond. As the saying goes, you don’t need to pay attention to the changing landscape in your industry… nor do you need to stay in business…

Author biography

Sarah Harding, PhD, Independent Science Writer

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. In 2016, she began a new career in publishing as Editor of Speciality Chemicals Magazine, and is currently providing independent writing and consultancy services to the pharmaceutical and speciality chemicals industry.

-----------------------------------------------------------------------------
Editor's Note:

To apply for becoming a contributor of En-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.