Leading HPAPI Manufacturing Companies

Published: March 2024


High potency active pharmaceutical ingredients act as a driving force behind the innovative therapeutics, delivering potency in treating health challenges and navigating healthcare domain to new heights. We analyzed more than 140 companies that are actively engaged in engaged in offering contract manufacturing services for HPAPI and cytotoxic drugs. In this article, discover the top 5 HPAPI manufacturing companies.


High potency APIs represent a class of substances that elicit therapeutic effects at low doses; these compounds play a significant role in the development of drugs that address complex indications, such as autoimmune disorders, oncological disorders and some infectious diseases. Further, they selectively interact with specific targets involved in disease mechanism (offering an effective pharmacological response) and reduce the occurrence of side effects (enhancing patient safety).

However, the high potency manufacturing process is associated with certain challenges; some of which include requirement of specialized facilities (for containment and preventing cross contamination), advanced equipment (for purification of the final product) and stringent safety measures (for protecting both workers and environment). Therefore, outsourcing of HPAPI manufacturing to contract service providers emerged as a lucrative option for stakeholders in this domain in order to overcome the existing concerns; further, it enables access to experienced teams and sophisticated production units, thereby streamlining the manufacturing operations and reduce capital expenditures.

It is worth mentioning that the HPAPI manufacturing market is anticipated to witness substantial growth in the coming years, owing to the increasing prevalence of chronic conditions (demanding need for precision medicines, oncology drugs and targeted therapeutics), rising investments in drug development (enhancing therapeutic efficacy) and ongoing technological advancements (developing innovative containment strategy and containment solutions).

Roots Analysis has conducted an exhaustive study on Cytotoxic Drugs and HPAPI Manufacturing Market featuring the current market landscape of companies engaged in offering high potency manufacturing and cytotoxic drug manufacturing, and future opportunity associated with the cytotoxic drugs and HPAPI manufacturing market, till 2035.

Table of Contents

Below, we have listed (in alphabetical order), the top 5 (shortlisted based on the number of manufacturing facilities):

  1. Catalent
  2. Cambrex
  3. Piramal Pharma Solutions
  4. AbbVie
  5. STA Pharmaceutical (a WuXi AppTec company)

Interested in exploring all 140+ HPAPI manufacturers across various regions?

In this Article, Discover the Details on Top 5 HPAPI Manufacturing Companies

This article highlights the top 5 players to watch out for in this industry. These companies were chosen based on the number of manufacturing facilities. It is essential to note that the selection of top players can differ substantially according to the defined criteria.

With More than 20 Years of Experience in the High Potency Drugs Market, Catalent Claims to Possess the Capability to Handle Over 300 Potent Molecules Belonging to Category 3 and 4

Catalent - Leading HPAPI Manufacturing Companies


Catalent is engaged in offering development solutions and advanced delivery technologies for drugs and biologics. It is worth mentioning that the company was founded in April 2007, post the acquisition of Pharmaceutical Technologies and Services segment of Cardinal Health by The Blackstone Group. As per the firm’s website, at any given time, over 1,000 products are being developed. Further, the company has enabled the acceleration of more than 1,000 partner programs and launched over 150 innovative products, annually. By leveraging its extensive scientific expertise, the firm further provides integrated development, manufacturing, analytical, clinical supply and packaging solutions for highly potent molecules, including hormones and cytotoxic drugs.  In addition, with a focus on operational and quality excellence, the company intends to make investments in growth-enabling capacity and capabilities.

HPAPI and Cytotoxic Drug Manufacturing Service Offerings:

Parameter Description 
Overview of HPAPI and Cytotoxic Drug Offerings
  • HPAPIs / Cytotoxic Drugs Production: The firm has set up a Center of Excellence for highly potent active pharmaceutical ingredients in Somerset, US.
    Additionally, it claims to have well trained personnel, special protocols and detailed risk assessment processes for safe handling and containment of
    high potency drugs.
  • Conjugation Services: The company utilizes its SMARTag  technology platform (initially developed by Redwood Bioscience) in order
    to produce optimized antibody drug conjugates and bioconjugates, having better stability and safety profiles. The technology offers
    site-specific, controlled drug-protein conjugation and employs naturally occurring modifications to proteins, which require minimal cell-line engineering.
    The company also produces stable conjugates by using its proprietary conjugation chemistry, which involves the incorporation of covalent carbon-carbon
    bonding. The firm claims to have a conjugation yield of more than 95%.
Type of Product Manufactured
  • Highly Potent Active Pharmaceutical Ingredient
  • Highly Potent Drug Formulation
Type of Highly Potent Finished Dosage Form
  • Capsules
  • Tablets
  • Liquids / Injectables
Type of Molecule Manufactured
  • Biologics
  • Small Molecules
Additional Services Offered In addition to manufacturing the HPAPIs and cytotoxic drugs, the company offers various other services, including:
  • Process Development
  • Formulation Development
  • Stability Studies
  • Analytical Testing
  • Regulatory Support
  • Packaging


Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities:

Parameter Details
Facility Locations The company has nine facilities that offer HPAPI and cytotoxic drug manufacturing services:
  • Beinheim, Alsace, France
  • Dartford, Kent, UK 
  • Eberbach, Baden-Wurttemberg, Germany
  • Kansas City, Missouri, US
  • Malvern, Pennsylvania, US
  • Nottingham, East Midlands, UK
  • San Diego, California, US
  • Somerset, New Jersey, US
  • St. Petersburg, Florida, US
Facility Size
  • 78,100 sq. ft. (Beinheim facility)
  • 20,250 sq. ft. (Dartford facility)
  • 370,580 sq. ft. (Eberbach facility)
  • 421,655 sq. ft. (Kansas City facility)
  • 84,000 sq. ft. (Malvern facility)
  • 46,900 sq. ft. (Nottingham facility)
  • 68,000 sq. ft. (San Diego facility)
  • 265,000 sq. ft. (Somerset facility)
  • 453,000 sq. ft. (St. Petersburg facility)
Scale of Operation
  • Preclinical 
  • Clinical
  • Commercial
Regulatory Certification / Accreditation   ANVISA, EMA, FDA, ISO, MHLW


Key Developments:

  • In February 2024, the company announced the expansion of its potent capsule filling capabilities for inhaled dry powders in its facilities in the US.
  • In May 2022, the company announced the expansion of its manufacturing facility in Kentucky, US, through an investment of USD 175 million. Through this expansion, the firm intends to enhance its high potency material safe handling capabilities. 
  • In January 2022, the firm announced the expansion of its high potency micronization capabilities through an investment of USD 10 million, in Dartford, UK and Pennsylvania, US.

Further information related to this company and other HPAPI manufacturing companies is available in the full report.

Cambrex Claims to have HPAPI Production Capacity of up to 20L (lab scale), 150 L (kilo lab scale) and 16,000L (commercial scale)

Cambrex - Leading HPAPI Manufacturing Companies


Cambrex is engaged in providing research, development and manufacturing services for small molecule therapeutics. The company claims to have a team of more than 2,200 experts and serves its clients across the world, through its sites located in North America and Europe. Additionally, the firm provides different drug substance technologies and capabilities, including biocatalysis, controlled substances, highly potent APIs, material assessment and solid-state science. Further, the company manufactures finished dosage forms, such as tablets (bi-layer, fixed-dose combination and modified-release), granules, liquids, powders, suspensions and ointments. In December 2019, Cambrex was acquired by Permira Funds in order to support the former company’s capabilities and growth.

HPAPI and Cytotoxic Drug Manufacturing Service Offerings:

Parameter                      Description 
Overview of HPAPI and Cytotoxic Drug Offerings HPAPIs / Cytotoxic Drugs Production: The firm provides contract manufacturing services for highly potent APIs, including
(arranged in alphabetical order) cytostatics / protein kinase inhibitors, drug linkers, drug product intermediates, immunosuppressants,
polyethyleneglycol (PEG) and cyclodextrin polymeric conjugations, ultra-potent cytotoxic drug substance, and warheads / toxins for
antibody drug conjugates. Additionally, the company has the ability to handle HPAPIs with OEL < 0.01 μg/m3.
Type of Product Manufactured
  • Highly Potent Active Pharmaceutical Ingredient
  • Highly Potent Drug Formulation
Type of Highly Potent Finished Dosage Form
  • Capsules
  • Granules
  • Liquids / Injectables
  • Tablets
Type of Primary Packaging Blisters
Type of Molecule Manufactured Small Molecules
Additional Service Offered In addition to manufacturing the HPAPIs and cytotoxic drugs, the company offers various other services, including:
  • Process Development
  • Formulation Development
  • Stability Studies
  • Analytical Testing
  • Scale-Up
  • Packaging


Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities:

Parameter Details
Facility Locations The company has four facilities that offer HPAPI and cytotoxic drug manufacturing services:
  • Charles City, Iowa, US
  • Edinburgh, Scotland, UK
  • Longmont, Colorado, US
  • Mirabel, Quebec, Canada
  • Paullo, Milan, Italy
  • Whippany, New Jersey, US
Facility Size
  • 15,000 sq. ft. (Edinburgh facility)
  • 1,800 sq. ft. (Longmont facility)
  • 14,500 sq. ft. (Paullo facility)
Scale of Operation
  • Preclinical 
  • Clinical
  • Commercial
Regulatory Certification / Accreditation   GMP


Key Developments:

  • In March 2023, the company was recognized with 2023 CDMO Leadership Awards in the categories of Quality, Service, Expertise, and Compatibility.
  • In October 2022, the company launched a 9,000 square-foot expansion and 21,000-square-foot renovation project in Charles City, Iowa; the expansion focuses on enhancing the existing quality control, and research and development capabilities of the firm.
  • In April 2022, the company announced the expansion of its API manufacturing facility in Iowa, US, through an investment of USD 50 million; the expansion allows the company to develop and manufacture highly potent compounds and controlled substances within a single facility.

Further information related to this company and other HPAPI manufacturing companies is available in the full report.

Piramal Pharma Solutions Handles Derivatives or Analogs of Highly Potent Cytotoxic Agents Including Auristatin, Maytansinoids and Duocarmycins

Pirmal Pharma Solutions - Leading HPAPI Manufacturing Companies


Piramal Pharma Solutions is a contract development and manufacturing segment of the Piramal Group. The company specializes in the discovery, clinical development and commercial manufacturing of drug substances and drug products, including APIs, HPAPIs and antibody drug conjugates. The firm has been involved in the manufacturing of antibody drug conjugates for over 15 years and has developed an unparalleled track record in such operations. It is worth mentioning that the Grangemouth facility of the company has worked with more than 180 unique bioconjugate platforms. Additionally, the company claims to have been successfully inspected by various regulatory bodies including Federal Commission for the Protection against Sanitary Risk, Health Canada (COFEPRIS), Ministry of Food and Drug Safety (MFDS), Pharmaceuticals and Medical Devices Agency (PMDA), Therapeutic Goods Administration (TGA) and the US Food and Drug Administration.

HPAPI and Cytotoxic Drug Manufacturing Service Offerings:

Parameter Description 
Overview of HPAPI and Cytotoxic Drug Offerings
  • HPAPIs / Cytotoxic Drugs Production: The company’s HPAPI manufacturing facilities have airlocks and barrier isolation systems,
    that are capable of safe handling compounds with OEL ≤ 0.02 µg/m3. Further, the Quality by Design (QbD) services of the company
    are aligned with the ICH Guidelines. In June 2019, the company expanded its HPAPI capabilities in its Riverview, US facility, through
    an investment of USD 10 million.
  • Conjugation Services: The firm offers antibody drug conjugates contract development and manufacturing services through its facilities
    located in the UK and US. Further, it claims to have a batch success rate of 98%. All the suites of the company possess chromatographic
    purification capabilities and can handle volumes up to 1000L.
Type of Product Manufactured
  • Highly Potent Active Pharmaceutical Ingredient
  • Highly Potent Drug Formulation
Type of Primary Packaging System
  • Blisters
  • Vials
Type of Highly Potent Finished Dosage Form
  • Capsules
  • Liquids / Injectables
  • Tablets
  • Nanoparticles
  • Liposomes
Type of Molecule Manufactured
  • Biologics
  • Small Molecules
Additional Service Offered In addition to manufacturing the HPAPIs and cytotoxic drugs, the company offers various other services, including:
  • Process Development
  • Formulation Development
  • Stability Studies
  • Analytical Testing
  • Scale-Up
  • Regulatory Support
  • Fill / Finish
  • Packaging


Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities:

Parameter Details
Facility Locations The company has six facilities that offer HPAPI and cytotoxic drug manufacturing services:
  • Ahmedabad, Gujarat, India
  • Aurora, Ontario, Canada
  • Grangemouth, Scotland, UK
  • Lexington, Kentucky, US
  • Riverview, Michigan, US
  • Sellersville, Pennsylvania, US
Scale of Operation
  • Preclinical 
  • Clinical
  • Commercial
Regulatory Certification / Accreditation   EMA, FDA, PMDA, Taiwan GMP


Key Developments:

  • In December 2023, the company announced the opening of its expanded antibody drug conjugates manufacturing facility in Grangemouth, Scotland, UK.
  • In February 2023, the company initiated production of initial batches of high potency APIs in its new reactor suites in Riverview, US facility.
  • In July 2022, the company announced the opening of a new manufacturing facility in Aurora, Canada, through an investment of USD 24 million. Through this expansion, the firm intends to expand the production of clinical to commercial scale HPAPIs. 
  • In February 2022, the company announced the expansion of its antibody drug conjugates manufacturing facility in Grangemouth, Scotland, through an investment of GPB 45 million.

Further information related to this company and other HPAPI manufacturing companies is available in the full report.

Abbvie has the Ability to Handle and Advance Highly Potent Drugs from Lab Scale (1 to 100 kg) Through Clinical Trials to Commercial Manufacturing

Abbvie - Leading HPAPI Manufacturing Companies


Abbott Laboratories provides a wide range of services and has 30 years of experience as a pharmaceutical developer and manufacturer. In 2011, the company announced its plans to split into two separate companies; one focused on medical products and the other to deal with research-based pharmaceuticals. In January 2013, the two separate entities of the company were formed, namely Abbott (medicinal products) and AbbVie (research-based pharmaceuticals). Further, the firm possesses capabilities in various fields, including antibody drug conjugate, biologics, drug products, fermentation, fill-finish, hot melt extrusion, highly potent drugs and prefilled syringes.

HPAPI and Cytotoxic Drug Manufacturing Service Offerings:

Parameter Description 
Overview of HPAPI and Cytotoxic Drug Offerings
  • HPAPIs / Cytotoxic Drugs Production: The company claims to have the ability to handle highly potent drugs (OEL less than 1 µg/m3).
    In addition, the company develops optimal processes, clinical trial designs and drug delivery methods, depending upon the product’s OEB classification.
  • Conjugation Services: The company’s state-of-the-art facility in Massachusetts, US is engaged in streamlining the production process and
    supply chain for antibody drug conjugates. Further, it provides ADC-related services, including process development, analytical development,
    release studies and stability testing. The firm has the capability to handle compounds with OEL < 0.01 μg/m3.
Type of Product Manufactured
  • Highly Potent Active Pharmaceutical Ingredient
  • Highly Potent Drug Formulation
Type of Highly Potent Finished Dosage Form
  • Capsules
  • Granules
  • Liquids / Injectables
  • Tablets
Type of Primary Packaging
Type of Molecule Manufactured
  • Biologics
  • Small Molecules
Additional Service Offered In addition to manufacturing the HPAPIs and cytotoxic drugs, the company offers various other services, including:
  • Process Development
  • Formulation Development
  • Stability Studies
  • Analytical Testing
  • Scale-Up
  • Regulatory Support
  • Fill / Finish
  • Packaging


Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities:

Parameter Details
Facility Locations The company has five facilities that offer HPAPI and cytotoxic drug manufacturing services:
  • Barceloneta, Puerto Rico, US
  • Lake County, Illinois, US
  • Sligo, Connacht, Ireland
  • Worcester, Massachusetts, US
  • Wyandotte, Michigan, US
Facility Size
  • 110,000 sq. ft. (Sligo facility)
  • 400,000 sq. ft. (Worcester facility)
Scale of Operation  
  • Preclinical 
  • Clinical
  • Commercial
Regulatory Certification / Accreditation   EU, FDA, IMB


Key Developments:

  • In February 2024, the company acquired Immunogen and added flagship antibody drug conjugate, namely ELAHERE® (useful in treatment of platinum-resistant ovarian cancer) to its portfolio
  • In 2023, the company won two awards at the 2023 Clinical Trials Arena Excellence Awards.
  • In 2023, the company was presented with the ‘Green Pharmaceutical Award’ at the 2023 Green Awards.

Further information related to this company and other HPAPI manufacturing companies is available in the full report.

STA Pharmaceutical Provides One-Stop-Shop Solutions from Process R&D to Commercial Manufacturing of HPAPIs

STA Pharmaceutical - Leading HPAPI Manufacturing Companies


STA Pharmaceutical, a WuXi AppTec company, is engaged in the research, development and manufacturing of small molecule APIs and finished dosage forms. Additionally, it offers efficient, flexible and superior quality solutions for integrated Chemical, Manufacturing and Controls (CMC) solutions, from preclinical to commercial uses. Further, the company operates through eight sites, spread across California, Delaware, Jiangsu, Neuchatel and Shanghai, and has more than 1,000 research scientists for process development, optimization, scale-up and process validation. The firm strives to develop innovative medications, lower the cost of new drug development and shorten the drug development time in order to reach the market.

HPAPI and Cytotoxic Drug Manufacturing Service Offerings:

Parameter Description 
Overview of HPAPI and Cytotoxic Drug Offerings 
  • HPAPIs / Cytotoxic Drugs Production: STA Pharmaceutical’ HPAPI facilities have an OEL of 0.01 μg/m³. Its capabilities include high potency
    milling through hammer mill, jet mill and pin mill. The highly potent manufacturing facilities of the company are equipped with reactors (size up to 3,000L),
    large scale preparative high performance liquid chromatography and lyophilizers (up to 10m2) to support large scale HPAPI manufacturing. 
  • Conjugation Services: The company develops and manufactures payloads for antibody drug conjugates. The firm is collaborating with the other
    WuXi AppTec sister companies in order to streamline the supply chain and all preclinical activities, thereby, simplifying the ADC development process.
Type of Product Manufactured
  • Highly Potent Active Pharmaceutical Ingredient
  • Highly Potent Drug Formulation
Type of Highly Potent Finished Dosage Form
  • Capsules
  • Granules
  • Tablets
Type of Molecule Manufactured
  • Small Molecules
  • Biologics
Additional Service Offered In addition to manufacturing the HPAPIs and cytotoxic drugs, the company offers various other services, including:
  • Process Development
  • Analytical Testing
  • Fill / Finish


Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities:

Parameter Details
Facility Locations The company has five facilities that offer HPAPI and cytotoxic drug manufacturing services:
  • Changzhou, Jiangsu, China
  • Jinshan, Shanghai, China
  • Taixing, Jiangsu, China
  • Waigaoqiao, Shanghai, China
  • WuXi, Jiangsu, China
Facility Size
  • 3,223,440 sq. ft. (Changzhou facility)
  • 161,459 sq. ft. (Jinshan facility)
  • 7,405,200 sq. ft. (Taixing facility)
Scale of Operation    
  • Preclinical 
  • Clinical
  • Commercial


Key Developments:

  • In July 2023, the company launched its first fully automated, high potency sterile injectable manufacturing line at its drug product site located in Wuxi City, China.
  • In 2023, the company received 2023 CDMO leadership award in recognition of capabilities and reliabilities.
  • In June 2022, the company announced the establishment of a new HPAPI manufacturing facility in Changzhou, China. The new plant has advanced technologies in order to handle potent compounds with OEL as low as 10 ng/m3.

Further information related to this company and other HPAPI manufacturing companies is available in the full report.

What About the Other HPAPI Manufacturing Companies?

The above presentation features the top 5 HPAPI manufacturing companies selected from a pool of over 140 firms that we have compiled. If you're interested, you can download the Sample Report on this topic by Roots Analysis. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don't hesitate to reach out to us at sales@rootsanalysis.com.

About Author

Simran Kaur

Simran, a Senior Business Analysis, has been an integral part of the Roots Analysis team since 2020. Holding a Master’s and Bachelor’s in pharmacy from a prestigious institution, she embarked on her professional journey with a strong academic foundation and an interest in life sciences domain. Her keenness to learn more about the emerging trends, regulatory dynamics and technological advancements enables her to provide comprehensive analyses. Till date, she has diligently contributed to over 15 comprehensive research reports on trending topics, ranging from anti-aging therapeutics, allogeneic cell therapies, lipid nanoparticles, pre-sterilized pharmaceutical packaging to next generation sequencing kits.

Sources:

  1. “Catalent Announces Addition of Potent Capsule Filling Capabilities for Inhaled Dry Powders at its Boston, MA USA Facility”
    https://www.catalent.com/catalent-news/catalent-announces-addition-of-potent-capsule-filling-capabilities-for-inhaled-dry-powders-at-its-boston-ma-usa-facility/
  2. “Piramal Pharma Solutions Announces Production of First Batches at New API Facility in Riverview, Michigan”
    https://www.prnewswire.com/news-releases/piramal-pharma-solutions-announces-production-of-first-batches-at-new-api-facility-in-riverview-michigan-301747713.html
  3. “WuXi STA Debuts Its First High Potency Sterile Injectable Manufacturing Line at Wuxi City Site”
    https://stapharma.com/en/news/newsroom/wuxi-sta-debuts-its-first-high-potency-sterile-injectable-manufacturing-line-at-wuxi-city-site/

MEDIA CITATIONS

  • We are your partners with no equity

  • We fit in your budget

  • We love what we do

  • Chance to prove ourselves

  • Best in class quality of work

  • Most trusted consulting partner in the industry