The high potency active pharmaceutical ingredient (HPAPI) market is expected to grow significantly over the next five years, from $17bn in 2018 to about $26bn in 2023, said Anil Kane, PhD, MBA, executive director, global head of technical and scientific affairs, pharma services, Patheon, part of Thermo Fisher Scientific.
“The growth of high potent pharmaceutical market is also reflected by the fact that the top two indications for global clinical research are in the area of oncology and immunotherapies,” said Kane, who will be speaking next week at CPhI North America in Chicago, IL.
“A large majority of drug candidates in the oncology and immune therapy space are potent compounds that require special handling during the manufacture of drug substance and drug products,” he added, and this requires a tight-knit supply chain.
Global oncology market to reach $200bn by 2022
The global cancer drug market is expected to reach $200bn by 2022 as the industry experiences rapid changes in treatment pathways and guidelines – including efforts to ease restrictive clinical trial eligibility criteria – according to a report from the Iqvia Institute for Human Data Science.
Per the report, the global oncology drug market is expected to average annual growth of 10-13% through 2022, while the US market is predicted to grow 12-15% annually during the same time period.
In 2017, the industry’s pipeline reached more than 700 molecules in late-stage development, which is up more than 60% from a decade ago.
The immunotherapy pipeline specifically includes nearly 300 molecules with 60 separate mechanisms being evaluated in Phase I or Phase II clinical trials against 27 different tumor types.
Speaking to the complexity of immuno-oncology clinical trials, Dr. Chris Learn, program manager, oncology and hematology at Icon, previously told us: “Close coordination and communication across all stakeholders is a requirement, as one misstep anywhere in the supply chain may result in delay or permanent loss of patient sample, along with opportunity to treat."
These trials involve numerous handoffs of the drug product and patient samples, Learn said, and for the purposes of cellular manufacture, blood product transport typically involves 10 or more steps. This includes collection and shipment of the unprocessed drug product to a cell therapy laboratory for processing, manipulation, production, quality control, and QP release.