2018’s Leading Industry Challenges: Tomorrow’s Biggest Opportunities?

By Meg Snyder, Attendee Acquisition Manager – INTERPHEX, Reed Exhibitions

Whether you work in pharma, biopharma, biotech, or any other sector of the industry, one trend is clear—change. The industry continues to learn and grow, pursuing better, improved, and more sustainable solutions.

Consolidation Reigns Supreme

In 2018, consolidation continues to maintain prominence in the outsourcing space, according to Mark Quick, Executive Vice President – Corporate Development, Recipharm. “The largest CDMOs hold just 2-4 percent of the market and the top ten CMOs represent less than 30 percent,” he added. “With many consolidation opportunities still available, buying expertise remains an attractive prospect for a CDMO with sufficient financial resources.”

Although consolidation as a trend isn’t new to the industry, it’s seeing continued growth as companies are “realizing the time, cost, and efficiency benefits of reducing the number of outsourcing partners they engage with and accessing a full-service offering,” Quick explained.

“Weak players will slowly leave the market, creating supply issues for their customers who will need to find a reliable CDMO partner to ensure continuous business,” Quick continued. “We also expect demand for contract manufacturing to increase as drugs become more complex and pharma businesses look to reduce their in-house costs and resources.”

As a CDMO with a global presence, Recipharm has also experienced the rippling waves of serialization initiatives on multiple shores.

“Clearly, serialization is also a major industry development that is set to shape the sector over the coming months,” Quick said. “Contract manufacturers are facing the introduction of the European Falsified Medicines Directive (FMD) in February 2019 and are at different stages of their preparations. Those that fail to prepare risk loss of business, as they will no longer be able to supply products to this important market. We anticipate that pharmaceutical companies will increasingly make their outsourcing decisions based on whether their CMO has the necessary capabilities to comply with the FMD.”

According to Quick, Recipharm expects that more than 80 percent of the company’s production will require serialization. As a result, they are implementing new systems and processes across around 75 production lines. However, with the CDMO’s proactive approach to implementing a solution, including a dedicated taskforce and a serialization program in place, they are well on their way to being in compliance on a global scale.

Meanwhile, the next deadline for the Drug Supply Chain Security Act (DSCSA) in the US is November 27, 2018, where repackagers must have serialized product. In addition, due to the FDA’s extended deadline, manufacturers will also have to have serialized product by November of this year.

Rise in Manufacturing Demands

In addition to consolidation, the demand for the manufacture of highly-potent active pharmaceutical ingredients (HPAPIs) has seen an influx, said Chris Rombach, President, ChargePoint Technology Inc., which has been fueled by the growth of the biotech and oncology markets.

“As these markets flourish, huge implications have been felt throughout the supply chain, particularly by manufacturers,” Rombach continued. “In addition, we continue to see the diversification of the companies we serve.  Companies are increasingly operating on a global scale and are wanting to coordinate across different sites.”

With so many companies operating across multiple sites and outsourcing services, standardizing and organizing internal processes has become even more important.

“[T]here is a rise in ‘virtual’ companies that rely on outsourcing, collaborations, and contract manufacturing for their production,” said Rombach. “The result of this is there are increasing numbers of stakeholders and decision-makers involved in the projects and therefore being able to bring everything together is more complex today than in the past.”

Although the boom in biotech has been an ongoing industry trend, the containment sector is “expected to continue this rapid growth alongside it,” Rombach said, adding that 2018 appears to be a turning point.

“Finding the best containment strategy has always been important for high potency manufacturers, with operator safety and product quality at the forefront of their priorities,” said Rombach. “However, the growing need for advanced control strategies to improve efficiencies and handle ever-more complex products has led to the adoption of more innovative solutions.”

Increasing Output

According to Parrish Galliher, Chief Technology Officer – Upstream, Bioprocess, GE Healthcare Life Sciences, there have been a number of continued trends in 2018:

  1. Single-use, upstream continuous perfusion systems and continuous DSP
  2. High speed, at-line, on-the-floor QC assays for real-time release
  3. Commercial licensure of additional SU facilities (now at four worldwide)
  4. High productivity/output biomanufacturing

“[N]othing happens rapidly in this industry. It gets tested in the lab first and then takes years to be used in clinical manufacturing and eventually validated for commercial manufacturing,” Galliher said. “The exception is upstream continuous perfusion—this is an old technique used by 19 commercial biologics on the market.”

There have, however, been new trends developing over the past three years, Galliher added. There has been a rapid growth of SU manufacturing in non-US and non-EU territories. In addition, optimizing brioprocess, process understanding, and digital information support has also taken a turn due to digital technology and IoT (the Internet of Things).

Biologics & Biosimilars See a Global Boom

HighTech Business Decisions – Biopharmaceutical Contract Manufacturing states that “the biologics market is expected to grow by 7-9 percent by 2022 and is projected to reach $3.8bn,” Quick said.

Biosimilars entered the US market for the first time in 2015 with US FDA’s approval of Sandoz’s Zarxio (the biosimilar to Amgen’s Neupogen [filgrastim]).

In 2015, the US FDA approved one biosimilar. That number increased to three in 2016 and then to five approved biosimilars in 2017.

More biosimilars have been approved each year in not just the US, but around the world, Galliher added.

“The technically-challenging nature of biologic drug development and manufacturing will certainly help to fuel the outsourcing sector,” said Quick. “Demand for outsourced services is growing in areas, including lyophilization and sterile liquid fill and finish operations, as each requires significant investments and expertise.”

Addressing Industry Challenges

“Rising prices across the globe will always add an element of pressure to our industry,” said Rombach.

But price tags on treatments aren’t the only challenge facing the industry today.

According to Galliher, “hiring enough talent to keep up with growth rates” continues to be a challenge for the industry as a whole, along with “developing technology and expertise to support the development and manufacturing of new drug modalities” and “expanding and enhancing our supply chain to enable digital and IoT capabilities for biopharma.”

For 39 years, INTERPHEX has been the premier pharmaceutical, biotechnology, and medical device development and manufacturing event, taking place in New York and bringing more than 10,500 global industry professionals and 650+ suppliers from across the industry.

By bringing together thousands of industry professionals, assisting in the facilitation of the launches of new technologies, products, and services at the show, and providing opportunities for industry experts to share knowledge, INTERPHEX has assisted the industry in tackling these challenges head-on for nearly four decades.

“As always, we are very much looking forward to meeting with our industry peers to talk about the current industry trends and focus,” said Rombach. “The Technical Conference sessions are always a highlight for us and we are looking forward to seeing advancements being made across the industry.”

Register today and join thousands of industry professionals at the Javits Center in New York City on April 17-19, 2018!

About INTERPHEX

Official blog of: INTERPHEX New York - www.interphex.com
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