Of the many vital changes the industry has undergone these past 20 years, the growth in biologics has been momentus. As part of the shift to biologics, a greater understanding of the science and technology that goes into developing and manufacturing these drugs became essential to their success. For example, with many bioloigcs and targeted therapies injectibles have become increasgly prevalent, placing increased demand for CDMOs with aspetic filling and packaging capabilities.

Oskar Gold, Senior Vice President Key Account Management and Marketing/ Corporate Communications, Vetter Pharma International GmbH, shares with Contract Pharma some of the major pharma/biopharma industry changes in the past 20 years that have impacted contract service providers and some of the changes he anticipates for the future of the industry and outsourcing.  –KB
 
Contract Pharma: What were some of the major pharma/biopharma industry changes in the past 20 years that have greatly impacted contract service providers? 
 
Oskar Gold: Vetter has been an active part of the industry for several decades now and for more than 35 years has offered vast experience in the fill and finish business. Of course, over that time we have experienced some strong developments in our industry. The major one that we see is the ever-increasing quality and regulatory requirements of both customers and authorities alike. This is not surprising, but actually a part of the overall evolution taking place throughout the world. Pairing state-of-the-art technology with experienced personnel enable to fulfill those increasing requests.
 
In the past decades, our customer portfolio has also changed and evolved. Until the early 2000’s, we had a business presence consisting of primarily large pharma customers. When biotechnology became more prolific around the turn of the millennium, we also started to conduct business with smaller biotech companies. Today, we serve biotechnology and pharmaceutical customers both large and small. And, as they are acting more and more in an international way, we also often serve them in the supply of global markets.

CP: What are some changes you anticipate for the future of the industry and outsourcing?
 
OG: In the coming years we expect even more emerging biotech companies to launch new medicines due to shifts in their business strategy, which includes maximizing financial returns to investors. This is supported by the fact that as a result of today’s currently low interest rates, they are well-funded with venture capital investments.
 
A further significant change is taking place within the industry. While identifying a positive development in the number of new drug approvals — 59 this year vs. 46 in 2018, particularly injectables, it must be stated that the market size for many drug products is getting smaller. Nowadays, a number of medicines  being developed are ever-more targeted, and consequently designed for smaller patient groups, representing a greater understanding and knowledge of precision medicine. Also, the business of data and intelligence is receiving a great deal of attention and is a topic that will continue to evolve. This is primarily due to new methods in the area of digital health.
 
Based on the oftentimes total cost of ownership calculation of our customers, we also expect the role of strategic partnerships to further increase. Our customers are looking for long-term partners to fulfill their manufacturing needs with a skill set that involves speed, flexibility, innovative approaches and a high level of expertise for complex compounds.
 
CP: How have service offerings and operations for CDMOs evolved over the years? 
 
OG: Overall, you can say that complex operations are in good hands when operated by teams with significant experience and a comprehensive service offering. At Vetter, we started the aseptic filling business as a Contract Manufacturing Organization (CMO), and were known for manufacturing large quantities of aseptic drug products that already have or are close to market approval. Over time, we enhanced our offering in order to support our customers from early-on in the drug development process in a comprehensive manner. Today, we provide injectable services from early clinical development through commercial manufacturing, including secondary packaging services and lifecycle management support. Consider, if you will, the metaphor of remodeling a house. Would you use several contractors, each with their own level of expertise or skill set such as plumbing, electricity or carpentry? If there were one contractor who could complete multiple jobs to your satisfaction, you would gladly make that choice, eliminating the need for multiple contracts and relationships.
 
Regarding the level of operations, drug product manufacturing continues to be more complex, as are the drug substances themselves. As a CDMO serving large and small pharma and biotech companies, you need to offer state-of-the-art technologies that are paired with deep experience in a variety of substance classes, all aimed to meet customers’ expectations.
 
CP: What global market changes have had the greatest impact on the industry and CDMO services?
 
OG: Still today, the US market is the leading pharmaceutical market and we expect it to continue to be so. However, looking to the Asian-Pacific (APAC) region, the opening of some markets there has provided new and significant opportunities for pharma and biotech customers as well as their strategic partners. As such, we have noticed a distinct shift taking place both in the nature and manner of the manufacturing in these markets, as well as where these manufactured products are distributed. For example, in prior years the medicines produced within the region were primarily intended for use within the APAC countries. In recent years, we have seen a significant increase in activities that are designed to enlarge the customer base for medicines manufactured within APAC by distributing to countries outside of the APAC region. We expect this activity to further evolve – more proof of the global character for today’s world.

 Oskar Gold