The report features an extensive study of the current market landscape and future potential of the HPAPI and cytotoxic drug manufacturing market, over the next decade.

Key Market Insights

• Presently, more than 140 players claim to have the required expertise to offer contract manufacturing services for highly potent compounds, across different scales of operation
• The current market landscape is highly fragmented, featuring the presence of both new entrants and established players across key geographical regions
• Leveraging their expertise, stakeholders are offering contract manufacturing services for a myriad of highly potent compounds; around 70% of the service providers possess analytical testing capability for HPAPIs
• In pursuit of building a competitive edge, stakeholders are actively upgrading their existing capabilities to enhance their respective service offerings and comply with the evolving industry benchmarks
• The growing interest in this domain is evident from the rise in partnership activity; in fact, the maximum number of collaborations related to HPAPI and cytotoxic drug manufacturing were inked in 2021 and 2019
• In order to meet the rising demand for high potency compounds, CMOs have made elaborate investments to expand their facilities and capacities; this trend is most pronounced in the US, Switzerland and UK
• The installed global contract manufacturing capacity for HPAPIs is well distributed across different geographies; 80% of the present capacity is installed in facilities owned by very large players
• Case Study: Antibody Drug Conjugates are one of the most popular classes of highly potent compounds; more than 30 players currently claim to offer contract manufacturing / conjugation services for such biopharmaceuticals
• We expect the highly potent drug developers to continue to outsource their manufacturing operations, enabling the service based revenues to grow at an annualized rate of 11.6%
• The projected opportunity for contract manufacturing of HPAPIs and cytotoxic drugs is likely to be well distributed across various types of molecules, finished dosage forms and key geographies

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Table of Contents

1. PREFACE

1.1.         Scope of the Report

1.2.         Market Segmentation

1.3.         Research Methodology

1.4.         Key Questions Answered

1.5.         Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

3.1.         Chapter Overview

3.2.         High Potency Active Pharmaceutical Ingredients

3.2.1.      Classification by Potency

3.2.1.1.               Classification of HPAPIs

3.2.2.      Different Types of HPAPIs

3.2.2.1.               Antibody Drug Conjugates

3.2.2.2.               Cytotoxic Drugs

3.2.2.3.               Peptides

3.2.2.4.               Hormones

3.2.2.5.               Beta-Lactam Compounds

3.2.2.6.               Prostaglandins

3.2.2.7.               Cytostatics

3.2.2.8.               Steroids

3.2.3.      Considerations for Handling HPAPIs

3.2.4.      Contract Manufacturing of HPAPIs and Cytotoxic Drugs

3.2.4.1.               Key Considerations While Selecting a Contract Manufacturing Partner

3.2.5.      Regulatory Considerations for Manufacturing HPAPIs

3.2.6.      Concluding Remarks

4. MARKET LANDSCAPE

4.1.         Chapter Overview

4.2.         HPAPI and Cytotoxic Drug Contract Manufacturers: Overall Market Landscape

4.2.1.      Analysis by Year of Establishment

4.2.2.      Analysis by Company Size

4.2.3.      Analysis by Location of Headquarters

4.2.4.      Analysis by Company Size and Location of Headquarters

4.2.5.      Analysis by Location of Manufacturing Facility

4.2.6.      Analysis by Area of Manufacturing Facility

4.2.7.      Analysis by Scale of Operation

4.2.8.      Analysis by Type of Product Manufactured

4.2.9.      Analysis by Location of Manufacturing Facility and Type of Product Manufactured

4.2.10.    Analysis by Type of Finished Dosage Form

4.2.11.    Analysis by Occupational Exposure Limit (OEL)

4.2.12.    Analysis by Type of Molecule Manufactured

4.2.13.    Analysis by Type of Primary Packaging System

4.2.14.    Analysis by Regulatory Certification / Accreditation Received

4.2.15.    Analysis by Type of Service(s) Offered

5. COMPANY COMPETITIVENESS ANALYSIS

5.1.         Chapter Overview

5.2.         Assumptions and Key Parameters

5.3.         Methodology

5.4.         HPAPI Contract Manufacturers: Company Competitiveness Analysis

5.4.1.      HPAPI Contract Manufacturers based in North America  

5.4.2.      HPAPI Contract Manufacturers based in Europe

5.4.3.      HPAPI Contract Manufacturers based in Asia-Pacific and Rest of the World

5.5.         Highly Potent FDF Contract Manufacturers: Company Competitiveness Analysis

5.5.1.      Highly Potent FDF Contract Manufacturers based in North America

5.5.2.      Highly Potent FDF Contract Manufacturers based in Europe

5.5.3.      Highly Potent FDF Contract Manufacturers based in Asia-Pacific and Rest of the World

5.6.         HPAPI and Highly Potent FDF Contract Manufacturers: Company Competitiveness Analysis

5.6.1.     HPAPI and Highly Potent FDF Contract Manufacturers based in North America

5.6.2.      HPAPI and Highly Potent FDF Contract Manufacturers based in Europe

5.6.3.      HPAPI and Highly Potent FDF Contract Manufacturers based in Asia-Pacific and Rest of the World

6. COMPANY PROFILES: HPAPI AND CYTOTOXIC DRUG MANUFACTURERS IN NORTH AMERICA

6.1.         Chapter Overview

6.2.         AbbVie

6.2.1.      Company Overview

6.2.2.      HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings

6.2.3.      Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities

6.2.4.      Recent Developments and Future Outlook

6.3.         Cambrex

6.3.1.      Company Overview

6.3.2.      HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings

6.3.3.      Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities

6.3.4.      Recent Developments and Future Outlook

6.4.         Catalent

6.4.1.      Company Overview

6.4.2.      HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings

6.4.3.      Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities

6.4.4.      Recent Developments and Future Outlook

6.5.         Pfizer CentreOne

6.5.1.      Company Overview

6.5.2.      HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings

6.5.3.      Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities

6.5.4.      Recent Developments and Future Outlook

6.6.         Piramal Pharma Solutions

6.6.1.      Company Overview

6.6.2.      HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings

6.6.3.      Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities

6.6.4.      Recent Developments and Future Outlook

7. COMPANY PROFILES: HPAPI AND CYTOTOXIC DRUG MANUFACTURERS IN EUROPE

7.1.         Chapter Overview

7.2.         Abzena

7.2.1.      Company Overview

7.2.2.      HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings

7.2.3.      Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities

7.2.4.      Recent Developments and Future Outlook

7.3.         Aenova

7.3.1.      Company Overview

7.3.2.      HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings

7.3.3.      Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities

7.3.4.      Recent Developments and Future Outlook

7.4.         CARBOGEN AMCIS

7.4.1.      Company Overview

7.4.2.      HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings

7.4.3.      Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities

7.4.4.      Recent Developments and Future Outlook  

7.5.         Hovione

7.5.1.      Company Overview

7.5.2.      HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings

7.5.3.      Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities

7.5.4.      Recent Developments and Future Outlook

7.6.         Lonza

7.6.1.      Company Overview

7.6.2.      HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings

7.6.3.      Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities

7.6.4.      Recent Developments and Future Outlook

8. COMPANY PROFILES: HPAPI AND CYTOTOXIC DRUG MANUFACTURERS IN ASIA-PACIFIC AND REST OF THE WORLD

8.1.         Chapter Overview

8.2.         Intas Pharmaceuticals

8.2.1.      Company Overview

8.2.2.      HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings

8.2.3.      Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities

8.2.4.      Recent Developments and Future Outlook

8.3.         Scinopharm

8.3.1.      Company Overview

8.3.2.      HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings

8.3.3.      Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities

8.2.4.      Recent Developments and Future Outlook

8.4.         STA Pharmaceutical (a WuXi AppTec company)

8.4.1.      Company Overview

8.4.2.      HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings

8.4.3.      Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities

8.4.4.      Recent Developments and Future Outlook

8.5.         Syngene

8.5.1.      Company Overview

8.5.2.      HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings

8.5.3.     Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities

8.5.4.      Recent Developments and Future Outlook

8.6.         Teva API

8.6.1.      Company Overview

8.6.2.      HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings

8.6.3.      Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities

8.6.4.      Recent Developments and Future Outlook

9. PARTNERSHIPS AND COLLABORATIONS

9.1.         Chapter Overview

9.2.         Partnership Models

9.3.         HPAPI and Cytotoxic Drugs: List of Partnerships and Collaborations

9.3.1.      Analysis by Year of Partnership

9.3.2.      Analysis by Type of Partnership

9.3.3.      Analysis by Year and Type of Partnership

9.3.4.      Analysis by Scale of Operation

9.3.5.      Analysis by Type of Product

9.3.6.      Analysis by Type of Partnership and Type of Product

9.3.7.      Analysis of Amount Invested Via Acquisitions

9.3.8.      Analysis by Type of Partner

9.3.9.      Most Active Players: Analysis by Number of Partnerships

9.3.10.    Analysis by Geography

9.3.10.1.  Intracontinental and Intercontinental Deals

9.3.10.2.  International and Local Deals

10. RECENT EXPANSIONS

10.1.       Chapter Overview

10.2.       HPAPI and Cytotoxic Drugs: List of Recent Expansions

10.2.1.    Analysis by Year of Expansion

10.2.2.    Analysis by Type of Expansion

10.2.3.    Analysis by Year and Type of Expansion

10.2.4.    Analysis by Company Size and Location of Headquarters

10.2.5.    Analysis by Scale of Operation

10.2.6.    Analysis by Type of Expansion and Scale of Operation

10.2.7.    Analysis by Type of Product

10.2.8.    Analysis by Type of Expansion and Type of Product

10.2.9.    Analysis by Location of Expanded Facility

10.2.10.   Analysis by Type of Expansion and Location of Expanded Facility

10.2.11.   Analysis by Expanded Facility Area

10.2.12.   Analysis by Amount Invested on Expansions

10.2.13.   Most Active Players: Analysis by Number of Recent Expansions

10.2.14.   Geographical Analysis

10.2.14.1. Analysis by Continent

10.2.14.2. Analysis by Country

11. CAPACITY ANALYSIS

11.1.       Chapter Overview

11.2.       Key Assumptions and Methodology

11.3.       HPAPI Contract Manufacturers: Global Installed Capacity

11.3.1.    Analysis by Range of Installed Capacity

11.3.2.    Analysis by Company Size

11.3.3.    Analysis by Scale of Operation

11.3.4.    Analysis by Location of Manufacturing Facility

11.3.4.1.  Analysis of HPAPI Contract Manufacturing Capacity Installed in North America

11.3.4.2.  Analysis of HPAPI Contract Manufacturing Capacity Installed in Europe

11.3.4.3.  Analysis of HPAPI Contract Manufacturing Capacity Installed in Asia-Pacific

11.3.4.4.  Analysis of HPAPI Contract Manufacturing Capacity Installed in Rest of the World

11.3.5.    Concluding Remarks

12. REGIONAL CAPABILITY ASSESSMENT ANALYSIS

12.1.       Chapter Overview

12.2.       Assumptions and Key Parameters

12.3.       HPAPI and Cytotoxic Drug Manufacturing Capabilities in North America

12.4.       HPAPI and Cytotoxic Drug Manufacturing Capabilities in Europe

12.5.       HPAPI and Cytotoxic Drug Manufacturing Capabilities in Asia-Pacific

12.6.       HPAPI and Cytotoxic Drug Manufacturing Capabilities in Rest of the World

12.7.       Concluding Remarks

13. MAKE VERSUS BUY DECISION MAKING FRAMEWORK

13.1.       Chapter Overview

13.2.       Assumptions and Key Parameters

12.2.1.    Scenario 1

12.2.1.    Scenario 2

12.2.1.    Scenario 3

12.2.1.    Scenario 4

13.3.       Concluding Remarks

14. MARKET SIZING AND OPPORTUNITY ANALYSIS

14.1.       Chapter Overview

14.2.      Forecast Methodology and Key Assumptions

14.3.       Global HPAPI and Cytotoxic Drug Contract Manufacturing Market, 2022-2035

14.3.1.    HPAPI and Cytotoxic Drug Contract Manufacturing Market: Analysis by Type of Product, 2022-2035

14.3.2.    HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Analysis by Company Size, 2022- 2035

14.3.3.    HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Analysis by Scale of Operation,
   2022-2035

14.3.4.    HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Analysis by Type of Molecule, 2022- 2035

14.3.5.    HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Analysis by Type of Highly Potent Finished Dosage Forms, 2022-2035

14.3.6     HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Analysis by Geography, 2022-2035

14.3.7.    HPAPI and Cytotoxic Drugs Contract Manufacturing Market in North America, 2022-2035

14.3.7.1.  HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the US, 2022-2035

14.3.7.2.  HPAPI and Cytotoxic Drug Contract Manufacturing Market in Canada, 2022-2035

14.3.7.3.  HPAPI and Cytotoxic Drug Contract Manufacturing Market in Mexico, 2022-2035

14.3.8.    HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Europe, 2022-2035

14.3.8.1.  HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the UK, 2022-2035

14.3.8.2.  HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Italy, 2022-2035

14.3.8.3.  HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Germany, 2022-2035

14.3.8.4.  HPAPI and Cytotoxic Drugs Contract Manufacturing Market in France, 2022-2035

14.3.8.5.  HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Spain, 2022-2035

14.3.8.6.  HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of Europe, 2022-2035

14.3.9.    HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Asia-Pacific, 2022-2035

14.3.9.1.  HPAPI and Cytotoxic Drug Contract Manufacturing Market in China, 2022-2035

14.3.9.2.  HPAPI and Cytotoxic Drugs Contract Manufacturing Market in India, 2022-2035

14.3.9.3.  HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of Asia-Pacific, 2022-2035

14.3.10.   HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the Rest of the World, 2022-2035

15. SWOT ANALYSIS

15.1.       Chapter Overview

15.2.       Strengths

15.3.       Weaknesses

15.4.       Opportunities

15.5.       Threats

15.6.       Concluding Remarks

16. CASE-IN-POINT: CONTRACT MANUFACTURING OF ANTIBODY DRUG CONJUGATES

16.1.       Chapter Overview

16.2.       Key Components of Antibody Drug Conjugates

16.2.1.    Antibody

16.2.2.    Cytotoxin

16.2.3.    Linker

16.3.       Overview of ADC Manufacturing

16.3.1.    Key Process Steps

16.3.2.    Challenges Associated with ADC Manufacturing

16.3.3.    Growing Trend of Outsourcing in ADC Manufacturing

16.4.       Challenges Associated with Supply Chain and Method Transfer

16.4.1.    Growing Demand for One-Stop-Shops and Integrated Service Providers

16.5.       Key Considerations for Selecting a CMO Partner

16.6.       ADC Contract Manufacturing Service Providers: Overall Market Landscape

16.6.1.    Analysis by Year of Establishment

16.6.2.    Analysis by Company Size

16.6.3.    Analysis by Location of Headquarters

16.6.4.    Analysis by Service(s) Offered

16.7.       Concluding Remarks

17. CONCLUDING REMARKS

18. EXECUTIVE INSIGHTS

18.1.       Chapter Overview

18.2.       HPAPI Project Service

18.2.1.    Company Snapshot

18.2.2.    Interview Transcript: Justin Mason-Home, Owner and Director

18.3.       BSP Pharmaceuticals

18.3.1.    Company Snapshot

18.3.2.    Interview Transcript: Antonella Mancuso and Maria Elena Guadagno, Vice President and Chief Operating Officer and Business Director

18.4.       ILC Dover

18.4.1.    Company Snapshot

18.4.2.    Interview Transcript: Scott Patterson, Vice President Pharma/Bio Technical Support

18.5.       Catalent

18.5.1.    Company Snapshot

18.5.2.    Interview Transcript: Stacy McDonald and Jennifer L. Mitcham, Ex-Group Product Manager and Ex-Director-Business Development

18.5.3.    Interview Transcript: Abul Khair, Business Development Associate

18.6.       CordenPharma

18.6.1.    Company Snapshot

18.6.2.    Interview Transcript: Roberto Margarita, Business Development Director

18.7.       ProJect Pharmaceutics

18.7.1.    Company Snapshot

18.7.2.    Interview Transcript: Klaus Hellerbrand, Managing Director

18.8.       Alphora Research

18.8.1.    Company Snapshot

18.8.2.    Interview Transcript: Kevin Rosenthal, Ex-Business Head, Formulations and Finished Products

18.9.       Piramal Healthcare

18.9.1.    Company Snapshot

18.9.2.    Interview Transcript: Mark Wright, Ex-Site Head, Grangemouth

18.10.     Helsinn

18.10.1.   Company Snapshot

18.10.2.   Interview Transcript: Allison Vavala, Ex-Senior Manager, Business Development

18.11.     Cerbios-Pharma

18.11.1.   Company Snapshot

18.11.2.   Interview Transcript: Valentino Mandelli, Marketing and Sales Manager, Pharma

18.12.     Idifarma

18.12.1.  Company Snapshot

18.13.2.  Interview Transcript: Javier E. Aznárez Araiz, Ex-Business Development Technician

19. APPENDIX 1: TABULATED DATA

20. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

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