Cytotoxic Drug and HPAPI Manufacturing Market Opportunity Expected to Grow at an Annualized Rate of Approximately 12%, Through 2035, According to Roots Analysis

Cytotoxic Drug and HPAPI Manufacturing Market Opportunity Expected to Grow at an Annualized Rate of Approximately 12%, Through 2035, According to Roots Analysis

Root analysis

Root analysis

Driven by the potential to treat the root cause of diseases, including rare clinical conditions and those previously considered incurable, the gene therapy pipeline is expanding and the market is expected to experience substantial growth through 2030

London, Nov. 21, 2022 (GLOBE NEWSWIRE) — Root analysis announced the addition of “Cytotoxic Drugs and HPAPI Manufacturing Market (4th edition), 2022 – 2035” report to its list of offers.

The manufacture of highly potent compounds is a laborious procedure, plagued with various challenges, including high capital investment, extensive operational expertise, as well as access to advanced infrastructure and technology. As a result, outsourcing has become a preferred business model in this area, providing increased flexibility, lower costs, and rapid drug launch. Additionally, to keep up with changing customer needs, several contract manufacturing organizations have upgraded their existing capabilities/facilities.

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Key market information

Over 140 companies claim to offer High Potency Active Pharmaceutical Ingredients (HPAPI) and cytotoxic drug contract manufacturing services, worldwide
The majority (44%) of industry players are based in Europe, followed by those headquartered in North America (35%). Additionally, more than 30% of service providers claim to have the capabilities required to manufacture both HPAPIs and high potency finished dosage forms. It is also worth mentioning that more than 50% of the players offer contract manufacturing services for HPAPIs and cytotoxic drugs at all three scales of operation.

About 35% of partnership agreements were signed after 2020
The majority of agreements related to the contract manufacturing of cytotoxic drugs were observed as examples of acquisitions, representing 21% of the total partnerships. Moreover, most intercontinental agreements, as well as intracontinental ones, have been signed by players based in Europe.

Over 95 expansion initiatives have been observed since 2018
Approximately 50% of initiatives focused on expanding existing high potency compound manufacturing facilities, followed by examples of capacity expansion (27%) and new facility additions (24%). Over 65% of reported expansions in this area were local initiatives, followed by international initiatives (33%).

Global installed HPAPI contract manufacturing capacity is currently estimated at over 2.5 million liters
The maximum share (83%) of the current installed capacity should be captured by very large players. Additionally, nearly 40% of installed global manufacturing capacity is available with facilities located in the Europe region.

North America and Europe are expected to capture more than 70% market share by 2035
The market in Asia-Pacific is expected to grow at a relatively faster rate (12.8%) in the long term. Currently, the majority share (62%) of the overall cytotoxics and HPAPI manufacturing market is captured by HPAPIs; this trend is also unlikely to change in the foreseeable future. Moreover, in 2035, more than 80% of the market share will probably be captured by very potent small molecules.

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Answers to key questions

  • Who are the major players engaged in offering contract manufacturing services for Cytotoxic Drugs and HPAPI manufacturing?

  • What are the current opportunities in the HPAPI and Cytotoxic Drugs market?

  • What is the relative competitiveness of HPAPI and cytotoxic drug contractors?

  • What types of partnership models are commonly adopted by players in this industry?

  • What are the different types of expansion initiatives undertaken by HPAPI and cytotoxic drug contract manufacturers?

  • What are the main challenges facing HPAPIs and cytotoxic drug contractors?

  • What are the key market trends and driving factors that are likely to impact this market?

  • How is the revenue generation potential associated with the cytotoxic drug and HPAPI manufacturing market likely to develop in the coming years?

The financial opportunity in the HPAPI and Cytotoxic Drugs Manufacturing Market has been analyzed in the following segments:

Type of product

size of the company

  • Little

  • Medium sized

  • Big

  • Very large

Scale of operation

  • Preclinical

  • Clinical

  • Commercial

Molecule type

High Potency Finished Dosage Form Type

  • Injectables

  • Oral solids

  • Creams

  • Others

Key geographic regions

  • North America (United States, Canada and Mexico)

  • Europe (UK, Italy, Germany, France, Spain and Rest of Europe)

  • Asia-Pacific (China, India and Rest of Asia-Pacific)

  • Rest of the world

The report also features contributions from eminent industry players, according to whom, continued growth of oncology therapy pipeline and growing preference for outsourcing is likely to drive the growth of the overall HPAPI manufacturing market and cytotoxic drugs, for the foreseeable future. The report includes detailed transcripts of discussions held with the following experts:

  • Justin Mason-Home (Owner and Director, HPAPI Project Service)

  • Antonella Mancuso and Maria Elena Guadagno (Vice President and Chief Operating Officer and Chief Commercial Officer, BSP Pharmaceuticals)

  • Scott Patterson (Vice President Pharma/Bio Technical Support, ILC Dover)

  • Stacy McDonald and Jennifer L. Mitcham (Ex-Group Product Manager and Ex-Director-Business Development); Abul Khair (Business Development Associate, Catalent)

  • Roberto Margarita (Business Development Manager, CordenPharma)

  • Klaus Hellerbrand (Managing Director, Project Pharmaceuticals)

  • Kevin Rosenthal (former Sales Manager, Formulations and Finished Products, Alphora Research (acquired by Eurofins))

  • Mark Wright (Former Site Manager, Grangemouth, Piramal)

  • Allison Vavala (Ex-Senior Manager, Business Development, Helsinn)

  • Valentino Mandelli (Marketing and Sales Manager, Pharma, Cerbios-Pharma)

  • Javier E. Aznarez Araiz (Ex-Business Development, Idifarma)

The search includes profiles of key players (listed below); each profile presents a brief overview of the company, details related to its financial performance (if available), recent developments and informed future prospects.

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CONTACT: Gaurav Chaudhary Roots Analysis A430, 4th Floor, Bestech Business Towers, Sector 66, Mohali, India +1 (415) 800 3415 +44 (122) 391 1091 Web: LinkedIn: Twitter:

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