AbbVie

Massimiliano Brescia

The last years during which pharmaceutical technology has served the bio and pharmaceutical industry have been years of momentous growth and change in the way drugs are discovered, developed, manufactured, and sold. Contract development and manufacturing organizations (CDMOs) have long played a part in the industry’s growth, but it is only in the past 20 years that they have become a critical element in bio and pharmaceutical company operations.

Early Stage

Phase one of the CDMO industry includes the years before the ‘90s. In those years, there were three primary participants in the CDMO industry: global bio and pharma companies that provided manufacturing services to each other; fine chemical companies providing intermediates; and a small number of dedicated service providers offering specialized capabilities.

The concept of outsourcing was coined at the beginning of the early blockbuster era of pharmaceuticals, at a time when volume demands outstripped pharmaceutical companies’ internal resources and capacity. After the end of the first wave of blockbusters, Big Pharma companies came under increasing pressure to reduce their costs. At the same time, the industry shifted from custom synthesis to toll manufacturing, and using a CMO for its skill or knowhow in a specialist technology or developing a process was no longer required.

Modern Age

The modern CDMO industry emerged in the late 1990s and three main factors contributed to the industry’s launch during that period. The first was the shedding of excess capacity by global bio and pharmaceutical companies as older products went off-patent.

A second factor was the explosion of early-stage bio and pharma companies, thanks to the maturity of biotechnology and the availability of external funding.

The third factor boosting the CDMO industry was the success of clinical research organizations (CROs). Their success validated outsourcing as an effective alternative to in-house capacity for critical development activities.

During the financial crisis, some CDMOs went out of business while others had to downsize and restructure their operations to survive. The financial crisis created an opening for an important group of players in the CDMO industry-- private equity firms. Low valuations and low-interest rates combined to provide savvy investors the opportunity to get into an industry whose long-term prospects looked very attractive. The private equity firms brought new capital and financial expertise to the industry. Most importantly, however, the private equity firms were able to recruit top-tier people to run those CMOs, former Senior executives from leading bio and pharmaceutical companies as well as experienced operating managers. Since 2010, CDMO development services revenues have grown by 10 to 15 percent annually.

The robust environment for contract drug development has fed a frenzy of merger and acquisition activity in the CMO industry creating big CDMOs players. CDMOs have had to be increasingly attentive to their customer’s requirements, investing accordingly inappropriate capabilities, technologies, and capacity. 

Establishing in-house market intelligence groups has also proved important to monitor and measure industry trends and adapt to fulfill the markets’ needs.

The shift in the customer base and reacting to customers with new and different needs is key. Typically, these companies have little or no captive manufacturing, are less resourced in managing single or multiple outsourced suppliers and are likely to have less experience in bringing a drug to market than Big Pharma. This means that those CDMOs in a position to offer integrated solutions over the lifecycle of a drug can benefit from strong, strategic partnerships with the growing number of smaller companies who are taking their products through the clinical pipeline and onto the market.

The ability to offer end-to-end solutions with multiple sites and technologies leads to some key advantages:

• Savings — Clients can partner with big “pure” CDMOs or big “embedded” CDMOs on a variety of products increasing their negotiation leverage.

• Speed to market — An integrated supplier eliminates the need to find separate development and manufacturing providers and qualify yet another site for fill and finish processes

• Long-term alliances — If CDMOs offer a one-stop solution and the relationship is good, more likely Clients will be in favor to have longterm alliances.

What the Customers are Looking For The CDMO industry is robust today and will remain a vital part of the bio and pharmaceutical industry. But significant challenges loom and individual companies will need strong leadership, vision, and operational discipline to succeed. The key factors to succeed in the CDMO industry can be summarized below. Clients are currently looking for CDMOs with:

• An excellent track record of quality performance metrics

• Capacity to meet their demand.

• Flexibility to respond to sudden changes in volumes that the customer has perhaps not forecast

• Reliable on-time deliveries

• Ability to smoothly scale up manufacturing and transfer technology.

• Scientific knowledge and high experience level of staff

As worldwide demand continues on its path of exponential growth, CDMOs will become an increasingly critical element of the bio and pharmaceutical supply infrastructure. It’s imperative that CDMOs continue to invest in the development of facilities capable of the throughput necessary to meet demand and equip those facilities with the latest and best technology, processes, and quality control measures to ensure the satisfaction of regulatory bodies and the safety of both patients and line workers, such as our organization is doing to deliver the best products to the patients.

The selection of the right CDMO is now more than ever important and fortunately, in recent years, several organizations provide insights and rankings of the best-in-class CDMOs which help bio and pharma companies to make the right decision when selecting their contract de