Complete analysis of the growing manufacturing market of HPAPIs and cytotoxic drugs

Published on August 12, 2014 at 3:49 AM · No Comments has added a new market research report: HPAPIs and Cytotoxic Drugs Manufacturing Market, 2014 - 2024


With the rising demand for targeted therapies, high potency compounds such as high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become the key focus of researchers and manufacturers worldwide. HPAPIs, which include cytotoxic APIs, are drug substances that are formulated to manufacture high potency drug products. Cytotoxic drugs are a category of highly potent drug products and, due to their increased utility in the treatment of cancer indications, have gained wide attention in recent years.

Some of the key benefits of these compounds include low dosage requirement and lower side effects. With over 25% of the total drugs worldwide being classified as highly potent, the HPAPI market is currently cited as one of the most important segments of pharmaceutical industry. The market is currently dominated by contract manufacturers. Though some pharmaceutical companies have invested in building in-house capabilities, the capital intensive nature and specialized containment requirements make the role of contract manufacturers more crucial. SAFC, Lonza and Evonik are amongst the pioneers in the field of manufacturing highly potent compounds. In addition, new entrants such as Medichem and Wuxi Pharma have also recently sprung up.

The growing number of investments and partnerships in this field are evident of the current market intensity. Majority of the investments in recent years have been expansion programs which reflect that manufacturers are keen to expand their existing production facilities to meet the growing demand. Looking at the ongoing focus, we certainly believe that stakeholders will continue to invest in this area. The current market landscape will gradually evolve as manufacturers look to gain competitive advantage in the near future.


The 'HPAPIs and Cytotoxic Drugs Manufacturing Market, 2014-2024' report provides an extensive study of the rapidly growing manufacturing market of HPAPIs and cytotoxic drugs. Due to their numerous advantages and increased applications in treatment of cancer and other disorders, HPAPIs and cytotoxics have emerged as one of the key focus areas of researchers across the globe. When compared to conventional therapeutic products, these compounds offer multiple advantages. The focus of this report is primarily to understand the likely future evolution of contract manufacturing of HPAPIs and cytotoxics over the next decade.

The report covers various aspects such as analysis of CMOs involved in HPAPI/Cytotoxics manufacturing, pharmaceutical companies with in-house capabilities, regulatory guidelines, key drivers and upcoming opportunities for various stakeholders. Though a few pharmaceutical companies have in-house capabilities, a sizeable proportion of this market is covered by contract manufacturing. The future growth in the market will primarily be driven by the rapidly expanding market for oncology drugs; majority of the high potency and cytotoxic drugs are being developed for treatment of cancer. With evolving clinical research, use of HPAPIs and cytotoxics in other therapeutic areas such as glaucoma, hormonal imbalances and respiratory disorders have also been identified.

Despite some of these key benefits and a promising future, the study also highlights considerable challenges associated with production of these compounds. Due to their highly toxic nature, they can lead to occupational hazards, if not handled carefully. In addition, cross-contamination with other products can be highly detrimental for the patients. Thus, adequate containment strategies and proper classification of hazards is essential for the uptake of this market.

The base year for the report is 2013; actual sales data of respective companies has been presented for the latest year. The report provides short-mid term and long term market forecasts for the period 2014 - 2019 and 2019 - 2024, respectively. The research, analysis and insights presented in this report is backed by a deep understanding of key insights gathered both from secondary and primary research.


1. Oncology is the leading domain for HPAPIs and cytotoxic drugs. Around 60% of the HPAPIs are being developed for treatment of cancer. The trend is likely to continue and the anti-cancer market will drive the growth of HPAPIs and cytotoxics in the future.
2. A good proportion of HPAPI / cytotoxics manufacturing is currently outsourced. In fact, specifically for ADCs, the outsourcing proportion is as high as 75%-80%. During our research, we identified 76 CMOs (with over 100 production facilities worldwide) which are focused in this area. SAFC and Lonza are amongst some of the CMOs which are well-known.
3. Having said this, big pharma companies such as Merck, Roche, Pfizer and AbbVie have also established in-house capabilities.
4. Many CMOs offer commercial scale manufacturing of these compounds. A relatively less number of players, including Corden Pharma and Aptuit, provide one stop shop service ranging from manufacturing of APIs to formulation and fill/finish of the drug product.
5. North America and Europe are the predominant regions where HPAPI and cytotoxic drugs production facilities are located. The US accounts for 27% of the total HPAPI production facilities and 31% of the cytotoxic drugs production facilities. Companies have also recently moved their focus to developing countries in order to take advantage of relatively lower costs.
6. CMOs have regularly engaged in investment programs to expand their production set ups. Since 2006, there have been more than 60 investments to add new facilities and / or to expand existing capacities.
7. Stakeholders have also inked numerous partnerships to combine their manufacturing expertise. Of the 35 recent partnerships that we studied during our research, an overwhelming proportion was manufacturing collaborations and merger/acquisitions.



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