Biologics, generics and contract services will drive 10% annual growth, according to CPhI’s annual industry report
At the CPhI conference in Madrid this week, Vivek Sharma, CEO of Pharma Solutions, the contract development and manufacturing organization (CDMO) division of Piramal Enterprises, forecast trends for the global injectables market. His comments appeared in CPhI’s annual industry report, released at the event, and covered both sterile biopharmaceutical and small-molecule injectables.
There has been a great deal of consolidation in the market recently, evidenced by Piramal’s acquisition of Coldstream Laboratories, the Kentucky-based contract services company. Sharma expects to see more merger and acquisition activity over the next few years, as companies scramble to gain a foothold in the space. “Access to manufacturing infrastructure will be a key driver,” he says.
The United States remains the primary outsourcing destination, particularly for high-value and biological formulations. However, in the longer term, Sharma expects firms in India and China to enter the business with generic injectables. Over the next few years, CMOs focused on prefilled syringes and those with the capability of handling highly potent active pharmaceutical ingredient (HPAPIs) will see the highest growth.
After the US market, the European market is the second major geographic area for outsourcing injectables, and Sharma expects it to continue to grow at around 10% per year.
Small-molecule injectables are likely to grow at a faster rate than steriles, albeit from a smaller base, with oncology and anti-infectives representing just over 50% of the total market.
In biologics, monoclonal antibodies (mAbs) account for the largest market share, followed by vaccines and insulin. “Demand for cutting edge injectable capabilities should grow as antibody drug conjugates (ADCs) and other high-value products dominate the "potent compound" development space,"Sharma says. However, the generic market is the primary market driver, outpacing the innovator side. Sharma expects it to double by 2020 to nearly $70 billion.
Drug-delivery systems such as Liposomes, PEGlyation and Depot Injections will play an important role in the market, Sharma says, especially in therapeutic segment that require more efficient drug targeting.
Overall, market conditions remain positive, but smaller firms may be challenged by 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.
A major driver of injectable outsourcing will be Big Pharma’s need to reduce the level of risk in its supply chain by relying on secondary manufacturing sites. The winners, Sharma says, will be experienced companies with a track record of taking injectable products through commercialization, as clients focus on quality and on-time delivery.