Piramal sees global sterile sales growing 10 percent annually

MUMBAI, India—Piramal Enterprises’ Pharma Solutions division, a global player in the contract development and manufacturing (CDMO) market, recently delivered its comprehensive review of the injectables market—both sterile and small-molecule—for the next five years during its annual report piece at the CPhI Worldwide conference held in Madrid, Spain, in October.

The review indicates that the near-term growth prospects are highest across generics, small-molecule injectables and in contract services. Vivek Sharma, CEO of Pharma Solutions, commented: “We recently acquired Coldstream in Kentucky, USA, to enhance our sterile injectables service offering. We expect that over the next few years there will be further acquisitions by both generic and big pharma players as companies look to gain a foothold in the growing sterile injectables space. In particular, we see this access to manufacturing infrastructure as a key driver for future consolidations.”

The United States remains the primary outsourcing destination, particularly for high-value and biological formulations. However, in the longer term, it is predicted that lower cost firms in India and China may try to enter with generic injectables. Over the next few years, CDMOs focused on prefilled syringes and those with high potent handling capabilities are expected to be the biggest beneficiaries of market growth.

“Outsourcing in the sterile injectable segment is still focused on the U.S., followed by the European Union,” added Sharma. “We anticipate this market to continue growing at around 10 percent annually for the next five years, with the U.S. remaining the most preferred outsourcing destination.”

Small-molecule injectables are likely to expand at a faster rate than steriles—albeit from a lower base—with oncology and anti-infectives representing just over half of the total market. In biologics, monoclonal antibodies account for the largest market share, followed by vaccines and insulin.

“Demand for cutting-edge injectable capabilities should grow as antibody-drug conjugates and other high-value products dominate the ‘potent’ development space,” Sharma said. “Nevertheless, the primary driver behind the growth in injectables is the generic market. Growth in the generic injectables is outpacing growth on the innovator side. By the year 2020, we expect this market to double to circa $70 billion.”

Technology is also a key component in companies’ prospects, and drug delivery systems such as liposomes, PEGlyation and depot injections will play an important role. The use of these technologies should see a spurt in growth, especially in therapeutic segments that require efficient targeting of drugs.

Overall, conditions remain positive, according to Piramal, but there could be challenges for some smaller firms due to high capital and operational costs, along with the complex compliance requirements for approval. This potential reduction in competition may also be augmented by consolidation. Finally, Piramal suggests that there may be more collaborative partnerships between larger and newer players to overcome any in-house technology gaps.

Sharma concluded: “The drivers for growth in outsourcing are primarily a need for Big Pharma to de-risk its supply chain, using secondary manufacturing sites. Firms that have experience and an attractive track record of taking injectable products through commercialization will become partners of choice, as clients focus on quality and on-time deliveries.”