The percentage of HPAPI drug candidates in the clinical development is rising steadily, owing to the rapid growth in small molecule cytotoxic compounds and antibody drug conjugates (ADCs) targeted therapies for oncology indications. Overall, cancer drugs as a class account for the greatest share of the global HPAPI market. The oncology-focus R&D pipeline growth is driving the CDMO industry to invest into small- and large-volume HPAPI facilities to gear up its ability to support current and future pharma outsourcing demands.
With more than 20 new oncology therapies launched in the past two years, and over 250 small molecule cancertargeted therapies in late-stage clinical development, the HPAPI market is estimated to grow up to $28.0 billion at a healthy CAGR of 8–10% through 2025.
WHY USE A CDMO
Increasing number of drug oncology candidates is pressuring the CDMO industry to invest and/or acquire new HPAPI facilities to support current and future pharmaceutical outsourcing needs.
HPAPIs manufacturing requires specialized facilities, equipment, operating procedures and operator skills and training, because of the limited doses required for HPAPIs, generally only relatively small volumes of these drug substances and formulated products are needed.
Consequently investment by branded pharmaceutical industries, and particularly small virtual/start-up companies, in the high level of specialized equipment and expertise often is not economically practical. While some large pharmaceutical companies have invested in in-house capabilities, most have elected to outsource the development and manufacture of HPAPIs and formulated potent drugs to CDMOs / CMOs to remain competitive in the industry.
Being the number of discovery pharmaceutical companies involved in the HPAPI R&D continuesly growing HPAPI outsourcing penetration expected to soar from 30% in 2018 to over 50% in 2023 benefiting the CDMO industry.
With demand outstripping current HPAPI CDMO capacity, selecting the right long-term partner is critical for brand pharmaceutical industries to mitigate development costs and expedites their R&D development-to-market timeline.
Being many HPAPIs oncology candidates with accelerated approval designations (Fast Track, Breakthrough
Therapy, Orphan Drug), they often reach the commercial stage more rapidly than conventional drugs. Working with a CDMO that can take a project from early phases to commercial launch becomes even more important for these projects when considering the compressed timelines associated with positive clinical trials. As a result, the “D” from the CDMO is bringing the “dimension” of development in-house as the key metric to ensure a successful partnership for this product category.
Partnering from the outset with a CDMO capable of supporting HPAPI projects across the drug development lifecycle can eliminate the need for technology transfer to multi manufacturers sites, which can be costly and lead to product market launch delays.
ANGELINI PHARMA AS YOUR PREFERRED PARTNER
Facing the rising number of custom HPAPIs demand, Angelini Fine Chemicals decided to expand its HPAPI capacity at its Aprilia,Italy plant site.
The investment is complementing Angelini’s existing range of HPAPI R&D and manufacturing capacities to provide a full HPAPI CDMO solution. The recently completed HPAPI capacity expansion covers the addition of two new cGMP kilo-lab suites fully dedicated to development and smalland mid-scale cGMP manufacturing of custom HPAPIs (OEL 0,1 μg/m3 – OEB5).
The new platform offers all scales of HPAPI manufacture across the full OEL / OEB band spectrum to meet a wide range of pharmaceutical outsourcing services, from route selection / proof of concept runs to scale-up up to small- and large-volume HPAPI cGMP manufacturing. Equipped with cutting-edge lab-, pilot- and industrial-scale facility, Angelini Fine Chemicals boasts a wide reaction technology portfolio and scale-up capabilities assuring a smooth, safe and optimized process technology transfer – from 1-100+ kg up to tons-scale.
The investment adds batch- and flowchemistry capabilities on kilogram-scale to Angelini’s HPAPI platform, that already houses over 5000 L of total reaction volume. The new cGMP kilo-labs target to running small-volume HPAPI production campaigns with batch size 0,25 - 5+ kg. The chemical synthesis capacity will be backed-up by a cGMP compliant suite for HPAPI finishing operations to offer full-integrated solution and tailormade HPAPI particle size reduction and micronization services for customer formulation batch needs.
Based on its long experience and tradition now in HPAPI development and manufacturing as well as its continued investments in other high-barrier-to- entry chemical technologies, pharmaceutical customers see Angelini Fine Chemicals an attractive and trustworthy CDMO partner to accelerate the path of their high potent compounds from pipeline to the market.