Growing at an annualized rate of 12%, the HPAPI and cytotoxic drugs contract manufacturing market is projected to reach USD 25 billion by 2030, claims Roots Analysis

Published: May 2020

With over 1,000 highly potent drugs in the development pipeline, the demand for developing and manufacturing of such products is anticipated to increase beyond the capabilities of innovator companies alone

Roots Analysis has announced the addition of the Cytotoxic Drugs and HPAPI Manufacturing Market report to its list of offerings. 

Development initiatives of HPAPIs and cytotoxic drugs are generally very demanding, both in terms of experience and capital investment. Most companies generally lack the necessary resources to meet the aforementioned requirements and are unable to set up dedicated HPAPI and cytotoxic drug manufacturing facilities. This has led to an increased demand for contract manufacturing service providers in this field.

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Key Market Insights

Over 115 CMOs presently claim to offer manufacturing services for HPAPIs and cytotoxic drugs
The market is currently dominated by the presence of mid-sized and large companies, which represent 75% of the industry stakeholders. Further, more than 65% of CMOs claim to have the capabilities to manufacture HPAPIs and cytotoxic drugs across all scales of operation (preclinical, clinical and commercial). 

Europe emerged as a manufacturing hub for HPAPI and cytotoxic drugs 
More than 205 manufacturing facilities have been established by various players, worldwide; of these, 48% are in Europe, followed by those based in North America (35%). Other prominent regions, serving as bases of operations for such companies, include (in decreasing order of number of manufacturing facilities) China, India and Australia.

Partnership activity within this domain has grown at a CAGR of 6%, between 2014 and 2019
More than 100 agreements have been inked in the last 6 years; majority of which were acquisitions. Other popular types of partnership models adopted by players engaged in this domain include R&D agreements (11%), manufacturing agreements (11%) and technology licensing deals (9%).

115+ facility expansions were reported between 2014-2019
More than 55% of such initiatives were focused on expanding manufacturing facilities, followed those by those undertaken for building new facilities (24%). It is worth mentioning that most of expansion initiatives (90%) were carried out in Europe and North America.

Approximately 85% of the total installed capacity is dedicated to commercial scale manufacturing 
Whereas, rest (15%) of the capacity is being used for preclinical / clinical scale manufacturing of HPAPIs. In addition, over 50% of the total current global, installed HPAPI manufacturing capacity is installed in Europe.

North America and Europe are anticipated to capture over 80% of the market share by 2030
In addition, the market in the Asia Pacific is projected to grow at a relatively faster rate (~13%). Further, the majority share (85%) of contract service revenues is anticipated to be generated from commercial scale operations; this trend is unlikely to change in the foreseen future. 

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Key Questions Answered

  • Who are the key manufacturers of HPAPIs and cytotoxic drugs, across the world?
  • What kind of partnership models are commonly adopted by stakeholders in this domain? 
  • What is the current, installed contract manufacturing capacity for HPAPIs?
  • What are the key factors influencing the make (manufacture in-house) versus buy (outsource) decision related to HPAPIs and cytotoxic drugs?  
  • What are the key drivers and growth constraints in HPAPI and cytotoxic drugs manufacturing market?
  • How is the current and future market opportunity likely to be distributed across key market segments?

The USD 25 billion (by 2030) financial opportunity within the HPAPI and cytotoxic drugs contract manufacturing market has been analyzed across the following segments: 

  • Type of Product
    • HPAPIs
    • Highly Potent Finished Dosage Forms
  • Company Size
    • Small 
    • Mid-sized 
    • Large / Very Large 
  • Scale of Operation
    • Preclinical / Clinical
    • Commercial
  • Type of Pharmacological Molecule
    • Small Molecules
    • Biologics
  • Type of Highly Potent Finished Dosage Form
    • Injectables
    • Oral Solids
    • Creams
    • Others
  • Key geographical regions 
    • North America
    • Europe
    • Asia Pacific
    • Rest of the World

The report features inputs from eminent industry stakeholders, according to whom the manufacturing of HPAPIs and cytotoxic drugs is largely being outsourced owing to the exorbitant costs associated with setting-up of in-house expertise. The report includes detailed transcripts of discussions held with the following experts:

  • Vice President, and Chief Operating Officer and Business Director, Very Large Company, Italy
  • Former Group Product Manager and Former Director of Business Development, Very Large Company, US
  • Business Development Associate, Very Large Company, US
  • Business Development Director, Very Large Company, Germany
  • Managing Director, Small Company, Germany
  • Former Business Head, Formulations and Finished Products, Very Large Company, Luxembourg
  • Former Site Head, Grangemouth, Very Large Company, Luxembourg
  • Former Senior Manager, Business Development, Large Company, Switzerland
  • Marketing and Sales Manager, Pharma, Mid-sized Company, Switzerland
  • Former Business Development, Mid-sized Company, Spain

The research covers profiles of key players that offer manufacturing services for HPAPIs and cytotoxic drugs, featuring a company overview, information on their respective service portfolios, manufacturing facilities and capabilities, recent developments and an informed future outlook. 

  • AbbVie Contract Manufacturing
  • Catalent
  • Evonik
  • Formosa Laboratories
  • Intas
  • Lonza
  • MabPlex
  • Pfizer CentreOne
  • Piramal Pharma Solutions
  • SAFC (a business division of Sigma-Aldrich)
  • ScinoPharm
  • Siegfried
  • STA Pharmaceutical (a WuXi AppTec company)
  • Teva api

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