- Close to 120 companies across the globe claim to possess the required expertise and infrastructure to offer contract manufacturing services for HPAPIs and cytotoxicdrugs
- 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
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- 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
- 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 - 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
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- 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
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