The state of pharma in 2019

European Pharmaceutical Manufacturer examines some of the biggest trends that have taken place throughout 2019.

Mergers & Acquisitions 

The beginning of 2019 was marked with by a string of large-scale acquisitions which would be indicative of the state of pharma and where the industry was headed. In January, both Bristol-Myers Squibb and Eli Lilly’s expanded their treatment portfolios with acquisitions that were worth $74 billion and $8 billion respectively.

Soon after, in February and April, the industry saw Catalent and Roche move into the gene therapy market with their acquisitions of Paragon Bioservices and Spark Therapeutics.

Though mergers and acquisitions (M&As) highlighted an active pharmaceutical industry, this didn’t necessarily result in the adoption of new innovations.

Sascha Sonnenberg, global head of business development at Sharp Clinical Services explains: “The industry continued to move slowly in 2019, hiding behind the excuse of heavy regulatory controls hamstringing innovation.

“A constant stream of new technologies, innovative therapies and regulatory “constraints” will see the industry continue to be confronted with new challenges. To succeed, large pharma will need to fill their pipelines with small biotech and cell & gene therapy (CGT) innovators and solve the supply chain challenges that those new therapies will bring.”

Contract Manufacturing 

The trend of M&As continued into the contract development and manufacturing organisation (CDMO) sector, as Mark Quick, executive VP, corporate development at Recipharm, points out.

“As the industry looks to diversify capabilities and expand geographical reach, 2019 saw a rise in consolidation amongst CDMOs and smaller pharmaceutical companies. M&A strategies have been vital to the success of CDMOs and their service offerings. 

“Through M&A activity, CDMOs have gained access to new technologies and specialised equipment which has enabled them to facilitate the delivery of offerings outside their core capabilities. This, in turn, bolsters their capacity to meet customer demand. To this end, consolidation has played a major role in CDMO activity and an increase in outsourcing of development and manufacture services.”

Indeed, Recipharm’s own launch of an integrated offering for end-to-end inhalation products was one example of companies attempting to offer more to customers.

Andrew Henderson, sales and marketing director at Sterling, believes examples such as this will continue into next year.

“Companies that can offer multiple services are now at a greater logistical advantage in a highly competitive sector, as sponsors often try to avoid having multiple companies in their product supply chains. Reducing layers of complexity helps to reduce project management requirements and can lessen a product’s time to market while lowering costs for the sponsor company. Naturally, we’ve seen a rise in global M&A activity in the CDMO sector over the past year in response to these requirements, which will likely continue throughout 2020,” Henderson said.

Falsified Medicines Directive 

Of course, one of the biggest events of 2019 was the implementation of the Falsified Medicines Directive (FMD), which came into effect in February in an attempt to stop counterfeit medicines getting into the supply chain.

In August this year, Oliver Pittock, managing director at Valley Northern wrote in EPM that ‘while pharmacists on the public front lines may have struggled with the implementation of the FMD with technology delays and minor technical issues, as highlighted in the EMVO newsletter, integration of the FMD into day-to-day pharmacy life has been welcomed, if somewhat delayed.’

And as Marcelo Cruz, head of marketing and business development, Tjoapack explains, FMD has “led to many companies refining their operations in response to the results of the implementation process, which highlighted a number of inefficiencies. And, now that the directive is in force, many firms that were well-prepared in advance of the FMD are looking towards aggregation as an obvious next step, which is likely to bring additional benefits to supply chain operations.”

However, while the regulation might be an overall positive step for the industry, its implementation certainly wasn’t without issue.

“Data integrity issues have thrown out some notable challenges in various ways throughout the year. When solutions first went live, handling falsified medicine alerts was a significant concern for manufacturers and dispensers, with users saying they had not anticipated having to deal with so many alerts so soon. Fortunately, most of these were caused by data entry problems rather than intentional wrongdoing - this has been somewhat resolved over time, but these alert causes are still much higher than expected,” said Allan Bowyer, director of industry marketing at TraceLink.

“There has also been a notable increase in the number of false alerts occurring due to errors made by dispensers, mostly caused by misconfigured scanners and double scanning/decommissioning. These are still false alerts and the EMVO has tasked manufacturers with identifying the root causes of alerts and working to reduce the alert rate from its current rate (latest according to EMVO is 2.87%) to less than 0.05%. This will be an ongoing effort likely to carry on for months to come.”

Innovation 

In recent years the life sciences industry has seen the rise of digital technologies beginning to make their mark and this year was no exception.

Things such as artificial intelligence being used to asses drug-tumour interactions; wearables being used collect real-world evidence; and partnerships designed to improve the adoption of mHealth technologies, are just some examples of an industry beginning to experience change.

Indeed, for Christian Hebenstreit, general manager and senior vice president, Medidata EMEA, 2019 was the year ‘digitalisation went mainstream’.

“Techniques like machine learning and AI are now an essential part of clinical research. Last year, the European Medicines Agency approved 84 new drugs and 42 drugs with new active substances - that's a substantial number. This is because, as an industry, we are running more and more studies every year and we are looking into different and rarer disease areas more than ever before. And this has only been made possible due to all these new technological innovations,” Hebenstreit said.