Rapid growth in injectables driven by pharm de-risking and biological pipeline, outlined in CPhI annual report
Piramal Enterprises' Pharma Solutions division, a leader in contract development and manufacturing (CDMO), delivered its review of the injectables market – both sterile and small molecule – for the next five years in its piece in the CPhI Annual Report.
The review indicated that the near-term growth prospects are highest across generics, small molecule injectables, and in contract services.
Vivek Sharma, CEO – Pharma Solutions, Piramal Enterprises, said: 'We recently acquired Coldstream in Kentucky, US, 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 US 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, CMOs focused on prefilled syringes and those with high potent handling capabilities are expected to be the biggest beneficiaries of market growth.
Sharma added: 'Outsourcing in the sterile injectable segment is still focused on the US, followed by the EU. We anticipate this market to continue growing at around 10% annually for the next five years, with the US remaining the most preferred outsourcing destination.'
Demand for cutting edge injectable capabilities should grow
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 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 ADCs and other high value products dominate the ‘potent’ development space. 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 US$70bn,' added Sharma.
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, 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.
Overall, Sharma remains bullish on global sterile sales and anticipates a significant expansion – around 10% per year – in this market over the next five years.
He 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 commercialisation, will become partners of choice, as clients focus on quality, and on time deliveries.'