Growing at an annualized rate of 12%, the HPAPI is projected to reach USD 25 billion by 2030, By Roots Analysis

Roots Analysis has done a detailed study on “HPAPI and Cytotoxic Drugs Manufacturing (3rd Edition) 2020-2030.” covering key aspects of the industry’s evolution and identifying potential future growth opportunities.

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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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Table of Contents

1.         PREFACE
1.1.       Scope of the Report
1.2.       Research Methodology
1.3.       Chapter Outlines

2.         EXECUTIVE SUMMARY

3.         INTRODUCTION
3.1.       Chapter Overview
3.2.       Overview of Highly Potent Active Pharmaceutical Ingredients (HPAPIs)
3.2.1.    Classification based on Potency of Pharmacological Ingredients
3.2.2.    Types of HPAPIs
3.2.3.    Challenges Associated with Handling HPAPIs
3.2.4.    Considerations for Handling HPAPIs
3.2.5.    Contract Manufacturing of HPAPIs and Cytotoxic Drugs
3.2.5.1. Selection of a Suitable CMO Partner for HPAPI Manufacturing
3.2.6.    Regulatory Considerations for HPAPI Manufacturing
3.2.7.    Concluding Remarks

4.         MARKET LANDSCAPE
4.1.       Chapter Overview
4.2.       HPAPI and Cytotoxic Drugs 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 Scale of Operation
4.2.4.    Analysis by Type of Service(s) Offered
4.2.5.    Analysis by Type of Product
4.2.6.    Analysis by Type of Pharmacological Molecule
4.2.7.    Analysis by Location of Headquarters
4.2.8.    Analysis by Location of Manufacturing Facilities
4.2.9.    Analysis by Facility Size
4.2.10. Analysis by Type of Highly Potent Finished Dosage Forms (FDFs)
4.2.11. Analysis by Type of Primary Packaging

5.         COMPANY COMPETITIVE ANALYSIS

5.1.       Chapter Overview

5.2.       Methodology

5.3.       Assumptions and Key Parameters

5.4.       Company Competitiveness Analysis: HPAPI and Cytotoxic Drugs Contract Manufacturers based     in North America

5.5.       Company Competitiveness Analysis: HPAPI and Cytotoxic Drugs Contract Manufacturers based in Europe

5.6.       Company Competitiveness Analysis: HPAPI and Cytotoxic Drugs Contract Manufacturers based in Asia Pacific and Rest of the World

6.         HPAPI AND CYTOTOXIC DRUGS CONTRACT MANUFACTURERS BASED IN NORTH AMERICA: COMPANY PROFILES

6.1.       Chapter Overview

6.2.       AbbVie Contract Manufacturing

6.2.1.    Company Overview

6.2.1.1. HPAPI and Cytotoxic Drugs Manufacturing Service Offerings

6.2.1.2. Manufacturing Facilities

6.2.1.3. Recent Developments

6.2.1.4. Future Outlook

6.3.       Catalent

6.3.1.    Company Overview

6.3.1.1. HPAPI and Cytotoxic Drugs Manufacturing Service Offerings

6.3.1.2. Manufacturing Facilities

6.3.1.3. Recent Developments

6.3.1.4. Future Outlook

6.4.       Pfizer CentreOne

6.4.1.    Company Overview

6.4.1.1. HPAPI and Cytotoxic Drugs Manufacturing Service Offerings

6.4.1.2. Manufacturing Facilities

6.4.1.3. Recent Developments

6.4.1.4. Future Outlook

6.5.       Piramal Pharma Solutions

6.5.1.    Company Overview

6.5.1.1. HPAPI and Cytotoxic Drugs Manufacturing Service Offerings

6.5.1.2. Manufacturing Facilities

6.5.1.3. Recent Developments

6.5.1.4. Future Outlook

6.6.       SAFC (a business division of Sigma-Aldrich)

6.6.1.    Company Overview

6.6.1.1. HPAPI and Cytotoxic Drugs Manufacturing Service Offerings

6.6.1.2. Manufacturing Facilities

6.6.1.3. Recent Developments

6.6.1.4. Future Outlook

7.         HPAPI AND CYTOTOXIC DRUGS CONTRACT MANUFACTURERS BASED IN EUROPE: COMPANY PROFILES

7.1.       Chapter Overview

7.2.       Carbogen Amics

7.2.1.    Company Overview

7.2.1.1. HPAPI and Cytotoxic Drugs Manufacturing Service Offerings

7.2.1.2. Manufacturing Facilities

7.2.1.3. Recent Developments

7.2.1.4. Future Outlook

7.3.       Evonik

7.3.1.    Company Overview

7.3.1.1. HPAPI and Cytotoxic Drugs Manufacturing Service Offerings

7.3.1.2. Manufacturing Facilities

7.3.1.3. Recent Developments

7.3.1.4. Future Outlook

7.4.       Lonza

7.4.1.    Company Overview

7.4.1.1. HPAPI and Cytotoxic Drugs Manufacturing Service Offerings

7.4.1.2. Manufacturing Facilities

7.4.1.3. Recent Developments

7.4.1.4. Future Outlook

7.5.       Siegfried

7.5.1.    Company Overview

7.5.1.1. HPAPI and Cytotoxic Drugs Manufacturing Service Offerings

7.5.1.2. Manufacturing Facilities

7.5.1.3. Recent Developments

7.5.1.4. Future Outlook

7.6.       Teva API

7.6.1.    Company Overview

7.6.1.1. HPAPI and Cytotoxic Drugs Manufacturing Service Offerings

7.6.1.2. Manufacturing Facilities

7.6.1.3. Recent Developments

7.6.1.4. Future Outlook

8.         HPAPI AND CYTOTOXIC DRUGS CONTRACT MANUFACTURERS BASED IN ASIA PACIFIC: COMPANY PROFILES

8.1.       Chapter Overview

8.2.       Formosa Laboratories

8.2.1.    Company Overview

8.2.1.1. HPAPI and Cytotoxic Drugs Manufacturing Service Offerings

8.2.1.2. Manufacturing Facilities

8.2.1.3. Recent Developments

8.2.1.4. Future Outlook

8.3.       Intas Pharmaceuticals

8.3.1.    Company Overview

8.3.1.1. HPAPI and Cytotoxic Drugs Manufacturing Service Offerings

8.3.1.2. Manufacturing Facilities

8.3.1.3. Future Outlook

8.4.       MabPlex

8.4.1.    Company Overview

8.4.1.1. HPAPI and Cytotoxic Drugs Manufacturing Service Offerings

8.4.1.2. Manufacturing Facilities

8.4.1.3. Future Outlook

8.5.       ScinoPharm

8.5.1.    Company Overview

8.5.1.1. HPAPIs and Cytotoxic Drugs Manufacturing Service Offerings

8.5.1.2. Manufacturing Facilities

8.5.1.3. Future Outlook

8.6.       STA Pharmaceutical (a WuXi AppTec company)

8.6.1.    Company Overview

8.6.1.1. HPAPI and Cytotoxic Drugs Manufacturing Service Offerings

8.6.1.2. Manufacturing Facilities

8.6.1.3. Recent Developments

8.6.1.4. Future Outlook

9.         PARTNERSHIPS AND COLLABORATIONS

9.1.       Chapter Overview

9.2.       Partnership Models

9.3.       HPAPI and Cytotoxic Drugs Contract Manufacturers: 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 Type of Product

9.3.4.    Analysis by Scale of Operation

9.3.5.    Analysis by Company Size

9.3.6.    Analysis of Acquisitions by Amount Invested

9.3.7.    Most Active Players: Analysis by Number of Partnerships

9.3.8.    Geographical Analysis

9.3.8.1. Continent-wise Distribution

9.3.8.2. Country-wise Distribution

10.        RECENT EXPANSIONS

10.1.     Chapter Overview

10.2.     HPAPI and Cytotoxic Drugs Contract Manufacturers: Recent Expansions

10.2.1.  Analysis by Year of Expansion

10.2.2.  Analysis by Type of Expansion

10.2.3.  Analysis by Scale of Operation and Type of Expansion

10.2.4.  Analysis by Type of Product and Type of Expansion

10.2.5.  Analysis by Expanded Facility Area

10.2.6.  Analysis by Amount Invested

10.2.7.  Analysis by Company Headquarters and Company Size

10.2.8.  Analysis by Location of Facility and Type of Expansion

10.2.9.  Most Active Players: Analysis by Number of Expansions

10.2.10. Geographical Analysis

10.2.10.1. Continent-wise Distribution

10.2.10.2. Country-wise Distribution

11.        CAPACITY ANALYSIS

11.1.     Chapter Overview

11.2.     Key Assumptions and Methodology

11.3.     HPAPI and Cytotoxic Drugs Contract Manufacturers: Global, Installed Capacity

11.3.1. Analysis by Company Size

11.3.2. Analysis by Scale of Operation

11.3.3. Analysis by Location of Manufacturing Facility

11.4.     Concluding Remarks

12.        MAKE VERSUS BUY DECISION MAKING FRAMEWORK

12.1.     Chapter Overview

12.2.     HPAPI and Cytotoxic Drugs Contract Manufacturing: Make versus Buy Decision Making

13.        MARKET SIZING AND OPPORTUNITY ANALYSIS

13.1.     Chapter Overview

13.2.     Forecast Methodology and Key Assumptions

13.3.     Overall HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2020-2030

13.4.     HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2020-2030:  Distribution by Type of Product

13.5.     HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Company Size

13.6.     HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Scale of Operation

13.7.     HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Type of Pharmacological Molecule

13.8.     HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Type of Highly Potent Finished Dosage Forms

13.9.     HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2020-2030: Distribution across Key Geographical Regions

13.9.1.  HPAPI and Cytotoxic Drugs Contract Manufacturing Market in North America, 2020-2030

13.9.1.1. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the US, 2020-2030

13.9.1.2. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Canada, 2020-2030

13.9.1.3. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Mexico, 2020-2030

13.9.2.  HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Europe, 2020-2030

13.9.2.1. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the UK, 2020-2030

13.9.2.2. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Italy, 2020-2030

13.9.2.3. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Germany, 2020-2030

13.9.2.4. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in France, 2020-2030

13.8.2.5. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Spain, 2020-2030

13.9.2.6. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of Europe, 2020-2030

13.9.3.    HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Asia Pacific, 2020-2030 (USD Billion)

13.9.3.1. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in China, 2020-2030

13.9.3.2. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in India, 2020-2030

13.9.3.3. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of Asia Pacific, 2020-2030

13.9.4.  HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the Rest of the World, 2020-2030

14.        SWOT ANALYSIS

14.1.     Chapter Overview

14.2.     Strengths

14.3.     Weaknesses

14.4.     Opportunities

14.5.     Threats

14.6.     Concluding Remarks

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

15.1.     Chapter Overview

15.2.     Key Components of ADCs

15.2.1.  Antibody

15.2.2.  Cytotoxin

15.2.3.  Linker

15.3.     Overview of ADC Manufacturing

15.3.1.  Key Process Steps

15.3.2.  Challenges Associated with ADC Manufacturing

15.3.3.  Growing Trend of Outsourcing in ADC Manufacturing

15.4.     Challenges Associated with Supply Chain and Method Transfer

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

15.6.     Key Considerations for Selecting a CMO Partner

15.7.     ADC Contract Manufacturers: Overall Market Landscape

15.7.1.  Analysis by Location of Headquarters

15.7.2.  Analysis by Year of Establishment

15.7.3.  Analysis by Company Size

15.7.4.  Analysis by Service(s) Offered

15.7.5.  Analysis by Location of Headquarters

15.7.5.  Analysis by Location of Manufacturing Facility

15.7.6.  Analysis by Scale of Operation

16.        CONCLUDING REMARKS

17.        EXECUTIVE INSIGHTS

17.1.     Chapter Overview

17.2.     BSP Pharmaceuticals

17.2.1.  Company Snapshot

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

17.3.     Catalent

17.3.1.  Company Snapshot

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

17.4.     CordenPharma

17.4.1.  Company Snapshot

17.4.2.  Interview Transcript: Roberto Margarita, Business Development Director

17.5.     Helsinn

17.5.1.  Company Snapshot

17.5.2.  Interview Transcript: Allison Vavala, Senior Manager, Business Development

17.6.     Idifarma

17.6.1.  Company Snapshot

17.6.2.  Interview Transcript: Javier E. Aznárez Araiz, Business Development

17.7.     Piramal Healthcare

17.7.1.  Company Snapshot

17.7.2.  Interview Transcript: Dr. Mark Wright, Site Head, Grangemouth

17.8      ProJect Pharmaceutics

17.8.1.  Company Snapshot

17.8.2.  Interview Transcript: Klaus Hellerbrand, Managing Director

17.9.     Alphora Research

17.9.1.  Company Snapshot

17.9.2.  Interview Transcript: Kevin Rosenthal, Business Head, Formulations and Finished Products

18.        APPENDIX 1: TABULATED DATA

19.        APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com