Contract Manufacturing Organizations (CMO)

The Blockbuster days are over, and not just for the obsolete movie rental business. “Blockbuster” drugs, like Cymbalta, Abilify, Lunesta and Nexium, which dominated commercial airwaves just a few years ago, were once the lifeblood of big pharma. They have since fallen off the patent cliff; revenue streams have decreased significantly as a result. This has dealt a major blow to many pharmaceutical companies, but contract manufacturing organizations (CMOs) are one of the beneficiaries of this decline, and they are seeing significant growth and playing a larger role in the delivery of drug products to market. Many pharma companies have refocused their efforts on drug discovery and turned to CMOs for manufacturing and supply chain capabilities to help them maintain profitability and meet growing demand.

Demand for CMO Services is on the Rise

The increase in demand for CMO services and capabilities has led to a flurry of M&A activity among contract service providers. Visiongain expects M&A activity to continue over the next five years and this trend will lead to further consolidation of the contract services market. There have been 18 acquisitions in the CMO space in the last three years alone.

Regulatory demands have also put pressure on the industry. The Drug Quality and Security Act (DQSA) and Falsified Medicines Directive are increasing the monitoring, and oversight of drug supply chain activities. The regulations include requirements for serialization down to the unit level and implementing solutions involves massive complexity at the systems, data and operational levels.  In addition to the serialization regulations, most sponsor organizations now require quality agreements with CMOs to ensure Good Manufacturing Practice (GMP) requirements are being adequately met.

Opportunity on the Horizon for CMOs

Sponsor expectations and competitive pressures are forcing CMOs to raise capabilities and performance levels. With client and regulatory expectations increasing, continued consolidation in the industry is likely and this presents many CMOs with the opportunity to create novel service offerings, tailored to specific customer needs. Nimble CMOs, who can react quickly to customer demands and provide unique and differentiated offerings can transform the industry much the way Netflix redefined the movie business.  

In the shakeout of CMO players, will your company be the hunter or the hunted? Will your valuation and cash position be stable? Or will operational flaws and inefficiencies leave you a sitting duck for acquisition or going the way of Blockbuster? To learn more about the challenges faced by CMO’s, download our white paper.