Hot topics in pharmaBy the Editorial team - 05/07/2018
We take a look at some of the hot topics and trends influencing the pharmaceutical industry today.
Success in today’s pharmaceutical marketplace requires the continual reassessment of strategic direction, and the ability to anticipate and respond to any changes. Key to this is understanding the trends that impact the industry, and how to capitalize on arising opportunities. Chemicals Knowledge has identified five hot topics that could influence your business.
1. Cost control measures
Pharmaceutical companies have faced price pressures from governments for some time, but the past 18 months has seen the US, in particular, placing a great deal of focus on drug prices. The restructuring of the US healthcare system, the regulatory environment, and the competitive landscape are all challenging the marketplace. Manufacturers and others in the supply chain must work effectively within these cost control measures. Methods such as lean manufacturing, along with better procurement management, are just two ways that companies are rising to the challenge.
Furthermore, as the evaluation and approval of biosimilars and generic drugs become faster, to increase competition in the market, that competition will create greater motivation for the development of new drugs, for which ever-increasing efficiencies will be demanded to hasten evaluations, authorizations and commercial launches.
Regulatory requirements are constantly evolving, but the top regulatory issue right now appears to be serialization. Although the US Food and Drug Administration (FDA) has issued a one-year delay for the first-phase of Drug Supply Chain Security Act (DSCSA) requirements, many companies may still not be ready when the regulations take effect on 27th November.
Smaller and mid-sized players with limited resources are turning to third-party partners to manage their serialization programmes. Perhaps the biggest hurdle here is supply chain connectivity — as well as enabling serialization, there needs to be an exchange of data between partners. Only then can companies achieve the end-to-end visibility that is needed to comply with regulations. This leads us neatly into our third topic – digitization.
The level of data generated as a result of serialization, and from chemicals manufacturing in general, is driving companies to look for more effective ways to store and manage huge amounts of data. All current systems may collect data, but companies that don’t focus on the integrity of those data, and make use of what is collected, will be left out in the cold. Manufacturing analytics can be a first step in realizing the promise of digitization. It delivers data and statistics to users in real-time, allowing proactive decision-making by technology teams and engineers. Big Data is ‘big’ in every sense, and any company not prepared for this next era in manufacturing will be at a disadvantage.
Blockchain is another buzzword for today’s pharmaceutical professionals. Offering decentralization, security and transparency, blockchain can alleviate frictions in procurement, transportation management, customs collaboration and trade finance. It can track chemicals through the supply chain, and combat the counterfeiting of drugs and false medication via sophisticated track-and-trace capabilities. It is likely that we will see more pharmaceutical companies exploring the benefits of blockchain to create a more efficient and connected supply chain.
4. Personalized preventative medicine
The old paternalistic model of medicine has been transforming into an equal partnership between patients and healthcare professionals in recent years. This has been augmented by technology that offers patients the ability to take control of their own healthcare in a way that was unimaginable to previous generations. The concepts of self-diagnosis and self-management, using personalized approaches, offer tremendous opportunities.
Artificial intelligence, machine learning, nanotechnology, cloud-based data, 3D printing, wearable personal devices and personalized genomics are at the tip of a rapidly growing iceberg that the pharmaceutical industry is starting to embrace. Companies will benefit from planning the applicability of new (and existing) products to this new model of patient care, if they intend to be part of the personalized preventative medicine era.
5. New players
Perhaps not the biggest topic, but one that has the Chemicals Knowledge team watching in fascination, is Amazon’s bold entry into the pharmaceutical space this year. Following the launch of its own line of over-the-counter drugs (produced by US-based Perrigo) in February, we saw the industry shudder from a move that could have a greater impact on cost than any government control measures might ever hope.
Then, in June, Amazon shook up the prescription drug sector though the acquisition of online pharmacy PillPack. The market perceived a rapidly accelerated threat to other retailers and distributors. According to Bloomberg, insurance companies and drug-benefit managers had been striking a series of deals to thwart a big splash in the health world from Amazon. But this online retail giant isn’t for thwarting. The smart strategy must be to prepare for a market that includes Amazon.
We have touched on just five topics that we see affecting the pharmaceutical industry. There are of course many more advances and changes taking place that influence this marketplace. As we enter the second half of 2018, now could be a good time to start rethinking basic assumptions and forcing debate around conventional approaches to your commercial success.