3 min read
PART II: HPAPI Market Forecasts and Manufacturing Challenges
In this two-part blog series, Alcami Senior Director of Global Manufacturing Science and Technology, Adam Kujath, discusses the market forecasts and...
The highly potent active pharmaceutical ingredient (HPAPI) market is growing rapidly with no signs of slowing down. But what is it, how is the market changing, and what are the expected trends in this space?
What Is HPAPI?HPAPI is generally defined as:
The potency of HPAPIs is characterized by OELs in µg/m3. The lower the value, the more potent the compound and the greater the level of containment required. OELs and related criteria, such as toxicity and carcinogenicity, establish exposure control limits.
Critical Factors for Achieving Appropriate Levels of Containment in HPAPI Manufacturing
Shifting HPAPI Approaches
The industry continues to move away from compound classifications— such as beta-lactones,
Alcami relies on certified internal and third-party toxicologists who perform evaluations to establish not only an OEL but also an ADE. In cases of substantial uncertainty and limited information, this analysis also allows us to assign
HPAPI Market Trends
Currently, approximately 25 percent of drugs in development worldwide are classified as highly potent. This number continues to rise, driven in particular by growth in the oncology market.
The global oncology market was valued at $107 billion in 2015, an increase of 11.5 percent from 2014. The IMS Institute for Healthcare Informatics and Grand View Research estimate that the market for HPAPIs will be valued at $25.86 billion by 2022. The high investment necessary to establish and maintain cost-effective production sites has led many sponsor companies to turn to contract development and manufacturing organizations (CDMOs) like Alcami, with established track records in the successful development,
The market for HPAPIs continues to grow at approximately 10 percent per year, primarily due to the development of highly targeted drugs for the treatment of cancer and chronic diseases such as diabetes and heart disease.
Stay tuned for our next HPAPI post titled: Have a Highly Potent API? Here’s What to Consider.
3 min read
In this two-part blog series, Alcami Senior Director of Global Manufacturing Science and Technology, Adam Kujath, discusses the market forecasts and...
3 min read
In this two-part blog series, Alcami Senior Director of Global Manufacturing Science and Technology, Adam Kujath, discusses the market forecasts and...
3 min read
Given the risks highly potent active pharmaceutical ingredients (HPAPIs) present in cross-contamination and containment, it is important to consider...