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HPAPI and cytotoxic drugs contract manufacturing market is projected to reach USD 25 billion by 2030

Stella Wilson

The “HPAPI and Cytotoxic Drugs Manufacturing Market 2021-2030” report features an extensive study of the current market landscape, offering an informed opinion on the manufacturing of HPAPIs and cytotoxic drugs over the next decade.

Close to 120 companies across the globe claim to possess the required expertise and infrastructure to offer contract manufacturing services for HPAPIs and cytotoxic drugs, claims Roots Analysis

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.

The USD 25 billion (by 2030) financial opportunity within the HPAPI and Cytotoxic Drugs Manufacturing Market Size 2021- 2030 has been analysed across the following segments:

Type of Product

  • HPAPIs
  • Highly Potent Finished Dosage Forms

Company Size

  • Small-sized
  • 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

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The “HPAPI and Cytotoxic Drugs Manufacturing (3rd Edition) 2020-2030” report features the following companies, which we identified to be key players in this domain:  

  • AbbVie Contract Manufacturing
  • Catalent
  • Evonik
  • Formosa Laboratories
  • Intas
  • Lonza
  • MabPlex
  • Pfizer CentreOne

Key Market Insights

  • Close to 120 companies across the globe claim to possess the required expertise and infrastructure to offer contract manufacturing services for HPAPIs and cytotoxic drugs
  • The market is fragmented, featuring the presence of both established players and new entrants based in different geographies that claim to be capable of manufacturing highly potent products, at varying scales of operation
  • In order to acquire competencies across the supply chain and cater to evolving needs of sponsors, companies offering services across different scales of operation have established presence in various geographical regions
  • In recent years, a steady increase in partnership activity has been observed in this domain; a variety of deals have been inked related to highly potent drug products
  • In order to enhance the core competencies in this domain, CMOs are actively investing in upgrading existing infrastructure and expanding their respective manufacturing capacities
  • Most of the installed, global HPAPI and cytotoxic drug manufacturing capacity belongs to established CMOs, accounting for close to 75% of the available capacity across various geographies
  • Case-in-point: ADCs represent a significant growth opportunity; over 30 CMOs currently extend their services to manufacture one or multiple components of an ADC molecule
  • We expect highly potent drug developers to continue to outsource their manufacturing operations in the mid to long term, causing service-based revenues to grow at an annualized rate of more than 10%
  • In the long-term, the projected opportunity for the contract manufacturing of HPAPIs and cytotoxic drugs is likely to be well distributed across various dosage forms, nature of molecules and sizes of contract service providers
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Chapter Outlines

Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the HPAPI and cytotoxic drugs contract manufacturing market and its likely evolution in the short-mid term and long term.

Chapter 3 provides a general introduction to HPAPIs and cytotoxic drugs, featuring information on the classification of APIs based on potency, types of HPAPIs, and challenges in associated with handling HPAPIs. Additionally, it includes a detailed description of specific containment requirements for handling HPAPIs and cytotoxic drugs, and provides details related to the growing need for outsourcing the manufacturing of such products.

Chapter 4 provides an overview of the HPAPI and cytotoxic drugs contract manufacturing landscape. It includes information on over 115 contract manufacturers that claim to offer HPAPI and cytotoxic drug manufacturing services. In addition, it features an in-depth analysis of the market, based on a number of parameters, such as year of establishment, company size, scale of operation (preclinical, clinical and commercial), location of headquarters, number and location of manufacturing facilities, facility size, type of service(s) offered (clinical manufacturing, commercial manufacturing, analytical testing, scale-up, process development / pre-formulation, formulation development, stability studies, regulatory support, fill / finish and packaging), type of product manufactured (HPAPIs and highly potent finished dosage forms), type of pharmacological molecule (biologics and small molecules), type of highly potent finished dosage form manufactured (capsules, granules, injectables, liquids and tablets), and type of primary packaging used (ampoules, blisters, prefilled syringes, conventional syringes, vials and others).

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About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at

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Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

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Stella Wilson

I am an Expertise in Business Development and Marketing Management with more than 5+ years in Healthcare and Pharmaceutical Industry.

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