The global HPAPI market, currently valued at around $16 billion, shows tremendous growth potential—forecasted to grow at 15-18% CAGR through 2022.1 The primary driver behind this is the application of highly potent compounds to fight cancer, a leading cause of death worldwide. Many of the novel anti-cancer therapies in the pipeline are now extremely precise, conferring a selective potency against targeted diseased cells only, unlike traditional, systemic treatments. Examples of such targeted HPAPIs include small molecule cytotoxic compounds combined with a monoclonal antibody, or antibody-drug conjugates (ADCs), which can have occupational exposure levels (OELs) as low as 0.01μg/m3. ADCs are estimated to expand at nearly 20% CAGR until 2030.2 Thanks to the rapid growth of these oncology targets, the percentage of HPAPI candidates in the global drug pipeline is rising steadily. At WuXi STA, for example, we work with HPAPIs in the form of ADC payloads/linkers and small molecule HPAPI oncology therapies—some of which are in late-stage development and may go commercial shortly. Other drivers of the HPAPI pipeline are indications for diabetes and autoimmune diseases, with both areas accounting for around 20% each of the circa 1,000 HPAPIs currently in development. Initially, the growth of HPAPIs in the global pipeline stemmed from the U.S. and Europe, but China’s presence in the field has blossomed in recent years due to the growing importance of its oncology market and the streamlining of the drug approval process through the Marketing Authorization Holder (MAH) program. Again, we can report firsthand that we have seen a dramatic acceleration of products for the China market in our HP pipeline in recent years. Due to the specialized facilities and equipment, as well as extensive training required, the HPAPI manufacturing process is more resource-intensive than the manufacturing of conventional APIs. It is worth pointing out that a company is unlikely to invest in increasing its HPAPI manufacturing capacity if they only have a small number of HPAPI drugs in their pipeline. Nowadays, the market is no longer just big pharma—in the last several years we have seen a considerable number of start-ups and virtual innovators developing novel compounds within the highly potent space. However, these new market entrants often lack the specialized facilities to develop and manufacture their innovations in-house, and therefore their only option is to outsource the projects. In response to the growing demand…

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• Contamination Control

• Contract Manufacturing

• Manufacturing

• Contract Pharma

• 6/4/2020

• Article