The projected growth rate of injectable contract manufacturing is 12.2%, according to a Frost & Sullivan report on the ‘Global Pharmaceutical Contract Manufacturing Market,’ published last month, which concluded that between 2012 and 2017, contract manufacturing organisations' (CMOs) growth would be led by biomanufacturing.
“Cytotoxics will be the key driver” - Frost & Sullivan Senior Research Analyst Aiswariya Chidambaram told Biopharma-Reporter.com - “because of the robust demand for oncology and other high-potency drugs such as antibody conjugates, steroids, and IV fluids that require quick onset of action.”
Furthermore, the growth in demand for outsourcing will be fuelled by the “highly sterile and aseptic conditions and skilled personnel” required for such manufacturing “as it appears to be a viable alternative to add additional manufacturing capacities for pharmaceutical and biotech companies,” she added.
As the pharma industry moves away from small molecules to biopharmaceuticals, the use of CMOs is set to increase, Chidambaram said, for the “outsourcing of both crucial operations such as upstream and downstream activities as well as fill-finish, toxicity testing and product characterisation activities in the interest of time, cost and efficiency,”
The report also said cytotoxics contract manufacturing is set to grow as “they are anticipated to be the most significant sources of revenue,” whilst liquid and semi-solid dose formulation manufacturers are set to suffer due to price competition and poor profit margins.
CMOs Rise to Demand
One CMO the report highlighted as a key company to watch was Baxter Biopharma Solutions who produces more than one billion sterile units per year.
The firm has invested in a string of expansions in its cytotoxics manufacturing plant in Halle, Germany, the most recent being the planned €58m ($77m) addition of new commercial and clinical filling lines, plus three freeze dryers, set to be completed in 2015.
Robert Felicelli, General Manager of Baxter’s BioPharma Business told us: “Cancer incidence is on the rise, and cytotoxic therapies continue to be at the center of oncology treatment program.
“[Our] expansion in Halle reinforces our ongoing commitment to the cytotoxic market, and the additional capacity will help to provide critical drugs to patients worldwide.”
Other recent developments in the CMO sector include Catalent’s entry into the antibody-drug conjugate (ADC) market in April, and Fujifilm Diosynth Biotechnologies’ expansion of its mammalian cell banking facility in the same month.
East vs West
Chidambaram also spoke to us regarding the choice of CMO and its location. Whilst the industry has seen a move towards low cost markets such as India and China for small molecule active pharmaceutical ingredients (APIs), intermediates and generics, bio-contract manufacturing is yet to have shifted East due to quality concerns and high shipping costs.
"As far as injectables and biologics are concerned, the Asian markets are still at an infancy stage as there is still a wide gap with regard to technology advancements, infrastructure and regulatory compliance.”