HPAPI and Cytotoxic Drugs Manufacturing Market (3rd Edition), 2020-2030

Overview

Highly potent active pharmaceutical ingredients (HPAPIs), which include cytotoxic APIs, are drug substances that can exhibit biological activity at approximately 150 μg per kilogram of body weight, with a therapeutic dose of or below 10 mg. Owing to the widespread applications associated with these compounds, HPAPIs have emerged as one of the key areas of interest to researchers and manufacturers across the globe. As compared to conventional therapeutic products, highly potent compounds offer multiple advantages, such as high target specificity and low dosage requirements. With over 25% of the total drugs worldwide being classified as highly potent, the HPAPI market is currently cited as one of the most important segments of the pharmaceutical industry.

The increasing focus on HPAPIs in development pipelines and the rising demand for cytotoxic drugs has led to a growing need for safe manufacturing and containment technologies. Though some pharmaceutical companies have invested in building in-house capabilities, the capital-intensive nature and specialized containment requirements make the role of contract manufacturers crucial. In fact, since 2000, several contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs), offering HPAPI and cytotoxic drug manufacturing services have been established. Amidst growing competition, the availability of cutting-edge tools and technologies has emerged as a differentiating factor. This has caused many service providers to actively expand their service portfolios, either through strategic acquisitions or facility/capability expansions. Over time, many CMOs / CDMOs claim to have developed end-to-end service capabilities, ranging from drug development (including preliminary R&D, preclinical studies and clinical trials), to regulatory filings, and commercial scale production.

Scope of the Report

The ‘HPAPI and Cytotoxic Drugs Manufacturing Market, 2020-2030 (3rd Edition)’ report features an extensive study of the current market landscape and future opportunities associated with the contract manufacturing of HPAPIs and cytotoxic drugs. The study also features a detailed analysis of the key drivers and trends related to this evolving domain.

Amongst other elements, the report includes:

A detailed review of the overall landscape of companies offering contract services for the manufacturing of HPAPIs and cytotoxic drugs, along with information on 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 and 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).
A competitiveness analysis of HPAPI and cytotoxic drugs contract manufacturers, taking into consideration supplier strength (based on company size and its experience in this field) and service strength (based on scale of operation, type of service(s) offered, type of product(s) manufactured, number and location of manufacturing facilities, type of highly potent finished dosage forms manufactured and type of primary packaging used).
Elaborate profiles of the key players (shortlisted based on a proprietary criterion) that offer a diverse range of capabilities for the development, manufacturing and packaging of HPAPIs and cytotoxic drugs, across North America, Europe and Asia Pacific. Each profile includes a brief overview of the company, its year of establishment, location of headquarters, number of employees and financial information (if available). In addition to this, the profile includes information on the various HPAPIs / cytotoxic dugs manufacturing services offered by the company, along with the location of their manufacturing facilities. Further, we have provided the recent developments of the company and an informed future outlook.
An analysis of the various partnerships pertaining to the contract manufacturing of HPAPIs and cytotoxic drugs, which have been established since 2014, based on several parameters, such as the year of partnership, type of partnership, type of product, scale of operation, company size, amount invested in acquisitions, most active player and geographical analysis.
An analysis of the various expansion initiatives undertaken by service providers, in order to augment their respective HPAPI and cytotoxic drug manufacturing capabilities, over the period 2014-2019, taking into consideration several relevant parameters, such as year of expansion, type of expansion (capacity expansion, facility expansion and new facility), scale of operation (preclinical, clinical and commercial), type of product manufactured (HPAPIs and highly potent finished dosage forms), and location of manufacturing facility.
An estimate of the overall, installed capacity for manufacturing HPAPIs and cytotoxic drugs based on data reported by industry stakeholders in the public domain; it highlights the distribution of available HPAPIs and cytotoxic drugs production capacity on the basis of company size (small-sized, mid-sized, large and very large companies), scale of operation (preclinical, clinical and commercial), and across key geographical regions (North America, Europe, Asia Pacific and rest of the world).
A qualitative analysis, highlighting the various factors that need to be taken into consideration by highly potent drug developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
A discussion on affiliated trends, key drivers and challenges which are likely to impact the industry’s evolution, under a comprehensive SWOT framework; it includes a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall industry.
A case study on the antibody drug conjugates (ADCs) manufacturing market, highlighting a list of contract service providers and in-house manufacturers that are currently active in this space. Additionally, it includes a detailed set of analyses of these companies based on several parameters, such as year of establishment, company size, scale of operation (preclinical, clinical and commercial), location of headquarters, number and location of manufacturing facilities, and type of service(s) offered.

One of the key objectives of the report was to estimate the existing market size and the future growth potential within the HPAPI and cytotoxic drugs contract manufacturing market. Based on multiple parameters, such as projected growth of the overall highly potent drug products market, cost of goods sold and direct manufacturing costs, we have developed informed estimates on the financial evolution of the market, over the period 2020-2030. The report also provides details on the likely distribution of the current and forecasted opportunity across [A] type of product (HPAPIs and highly potent finished dosage forms), [B] company size (small-sized, mid-sized and large / very large), [C] scale of operation (preclinical, clinical and commercial), [D] type of pharmacological molecule (small molecules and biologics), [E] type of highly potent finished dosage form (injectables, oral solids, creams and others), and [F] key geographical regions, covering North America (the US, Canada and Mexico), Europe (the UK, Germany, France, Spain, Italy and rest of Europe), Asia Pacific (India, China, and rest of Asia-Pacific), and rest of the world. In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals:

Antonella Mancuso and Maria Elena Guadagno, Vice President and Chief Operating Officer and Business Director, BSP Pharmaceuticals
Stacy McDonald and Jennifer L Mitcham, Group Product Manager and Director-Business Development, Catalent Pharma Solutions
Roberto Margarita, Business Development Director, CordenPharma
Allison Vavala, Senior Manager, Business Development, Helsinn
Javier E. Aznárez Araiz, Business Development, Idifarma
Dr. Mark Wright, Site Head, Grangemouth, Piramal Healthcare
Klaus Hellerbrand, Managing Director, ProJect Pharmaceutics
Kevin Rosenthal, Business Head, Formulations and Finished Products, Alphora research

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

List Of Figures

Figure 3.1 Types of HPAPIs
Figure 4.1 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Year of Establishment
Figure 4.2 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Company Size
Figure 4.3 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Scale of Operation
Figure 4.4 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type Service(s) Offered
Figure 4.5 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Product
Figure 4.6 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Pharmacological Molecule
Figure 4.7 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Headquarters (Region and Country-Wise)
Figure 4.8 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Manufacturing Facilities
Figure 4.9 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Facility Size
Figure 4.10 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Highly Potent Finished Dosage Forms
Figure 4.11 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type Primary Packaging
Figure 5.1 Company Competitiveness Analysis: HPAPI and Cytotoxic Drugs Contract Manufacturers based in North America
Figure 5.2 Company Competitiveness Analysis: HPAPI and Cytotoxic Drugs Contract Manufacturers based in Europe
Figure 5.3 Company Competitiveness Analysis: HPAPI and Cytotoxic Drugs Contract Manufacturers based in Asia Pacific and Rest of the World
Figure 9.1 Partnerships and Collaborations: Distribution by Year of Partnership
Figure 9.2 Partnerships and Collaborations: Distribution by Type of Partnership
Figure 9.3 Partnerships and Collaborations: Distribution by Year and Type of Partnership
Figure 9.4 Partnerships and Collaborations: Distribution by Type of Product
Figure 9.5 Partnerships and Collaborations: Distribution by Type of Product and Type of Partnership
Figure 9.6 Partnerships and Collaborations: Distribution by Scale of Operation
Figure 9.7 Partnerships and Collaborations: Distribution by Scale of Operation and Type of Partnership
Figure 9.8 Partnerships and Collaborations: Distribution by Company Size
Figure 9.9 Partnerships and Collaborations: Distribution of Acquisitions by Amount Invested (USD Million)
Figure 9.10 Most Active Players: Distribution by Number of Partnerships
Figure 9.11 Partnerships and Collaborations: Continent-wise Distribution
Figure 9.12 Partnerships and Collaborations: Country-wise Distribution
Figure 10.1 Recent Expansions: Distribution by Year of Expansion
Figure 10.2 Recent Expansions: Distribution by Type of Expansion
Figure 10.3 Recent Expansions: Distribution by Scale of Operation and Type of Expansion
Figure 10.4 Recent Expansions: Distribution by Type of Product and Type of Expansion
Figure 10.5 Recent Expansions: Distribution by Expanded Facility Area (sq ft)
Figure 10.6 Recent Expansions: Distribution by Amount Invested (USD Million)
Figure 10.7 Recent Expansions: Distribution by Company Headquarters and Company Size
Figure 10.8 Recent Expansions: Distribution by Location of Facility and Type of Expansion
Figure 10.9 Most Active Players: Distribution by Number of Expansions
Figure 10.10 Recent Expansions: Distribution by Geography and Year
Figure 10.11 Recent Expansions: Country-wise Distribution
Figure 11.1. HPAPI and Cytotoxic Drugs Contract Manufacturing Capacity: Distribution by Company Size
Figure 11.2. HPAPI and Cytotoxic Drugs Contract Manufacturing Capacity: Distribution by Scale of Operation
Figure 11.3. HPAPI and Cytotoxic Drugs Contract Manufacturing Capacity: Distribution by Location of Manufacturing Facility
Figure 12.1. Parameters to Assess Complexity of Outsourcing Manufacturing Operations
Figure 12.2. HPAPI and Cytotoxic Drugs Contract Manufacturing: Make versus Buy Decision Making
Figure 13.1 Overall HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2020-2030 (USD Billion)
Figure 13.2 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Type of Product (USD Billion)
Figure 13.3 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Company Size (USD Billion)
Figure 13.4 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Scale of Operation (USD Billion)
Figure 13.5 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Type of Pharmacological Molecule (USD Billion)
Figure 13.6 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Type of Highly Potent Finished Dosage Forms (USD Billion)
Figure 13.7 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Key Geographical Regions (USD Billion)
Figure 13.8. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in North America, 2020-2030 (USD Billion)
Figure 13.9 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the US, 2020-2030 (USD Billion)
Figure 13.10 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Canada, 2020-2030 (USD Billion)
Figure 13.11 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Mexico, 2020-2030 (USD Billion)
Figure 13.12 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Europe, 2020-2030 (USD Billion)
Figure 13.13 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the UK, 2020-2030 (USD Billion)
Figure 13.14 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Italy, 2020-2030 (USD Billion)
Figure 13.15 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Germany, 2020-2030 (USD Billion)
Figure 13.16 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in France, 2020-2030 (USD Billion)
Figure 13.17 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Spain, 2020-2030 (USD Billion)
Figure 13.18 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of Europe, 2020-2030 (USD Billion)
Figure 13.19 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Asia Pacific, 2020-2030 (USD Billion)
Figure 13.20 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in China, 2020-2030 (USD Billion)
Figure 13.21 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in India, 2020-2030 (USD Billion)
Figure 13.22 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of Asia Pacific, 2020-2030 (USD Billion)
Figure 13.23 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the Rest of the World, 2020-2030 (USD Billion)
Figure 14.1 HPAPI and Cytotoxic Drugs Contract Manufacturing: SWOT Analysis
Figure 14.2 Comparison of SWOT Factors: Harvey Ball Analysis
Figure 15.1 Key Components of an ADCs
Figure 15.2 ADC Manufacturing: Key Process Steps
Figure 15.3 ADC Contract Manufacturers: Distribution by Location of Headquarters
Figure 15.4 ADC Contract Manufacturers: Distribution by Year of Establishment
Figure 15.5 ADC Contract Manufacturers: Distribution by Company Size
Figure 15.6 ADC Contract Manufacturers: Distribution by Service(s) Offered
Figure 15.7 ADC Contract Manufacturers: Distribution by Location of Headquarters and Services Offered
Figure 15.8 ADC Contract Manufacturers: Distribution by Location of Manufacturing Facilities
Figure 15.9 ADC Contract Manufacturers: Distribution by Scale of Operation

List Of Tables

Table 3.1 APIs and HPAPIs: OEL
Table 3.2 Classification of APIs: OEL and OEB System
Table 3.3 SafeBridge: Categorization System
Table 3.4 Merck: Categorization System
Table 3.5 Lonza: Categorization System
Table 3.6 Ampac Fine Chemicals: Categorization System
Table 3.7 Helsinn: Categorization System
Table 3.8 Alkermes: Categorization System
Table 4.1 List of HPAPI and Cytotoxic Drugs Contract Manufacturers
Table 4.2 HPAPI and Cytotoxic Drugs Contract Manufacturers: Details on Manufacturing Facilities
Table 4.3 HPAPI and Cytotoxic Drugs Contract Manufacturers: Services Offered
Table 6.1 Leading HPAPI and Cytotoxic Drugs Contract Manufacturers based in North America
Table 6.2 AbbVie Contract Manufacturing: Company Overview
Table 6.3 AbbVie Contract Manufacturing: HPAPI and Cytotoxic Drug-related Contract Service Offerings
Table 6.4 AbbVie Contract Manufacturing: Manufacturing Facilities
Table 6.5 AbbVie Contract Manufacturing: Recent Developments
Table 6.6 AbbVie Contract Manufacturing: Future Outlook
Table 6.7 Catalent: Company Overview
Table 6.8 Catalent: HPAPI and Cytotoxic Drug-related Service Offerings
Table 6.10 Catalent: Manufacturing Facilities
Table 6.11 Catalent: Recent Developments
Table 6.12 Catalent: Future Outlook
Table 6.13 Pfizer CentreOne: Company Overview
Table 6.14 Pfizer CentreOne: HPAPI and Cytotoxic Drug-related Service Offerings
Table 6.15 Pfizer CentreOne: Manufacturing Facilities
Table 6.16 Pfizer CentreOne: Recent Developments
Table 6.17 Pfizer CentreOne: Future Outlook
Table 6.18 Piramal Pharma Solutions: Company Overview
Table 6.19 Piramal Pharma Solutions: HPAPI and Cytotoxic Drug-related Service Offerings
Table 6.20 Piramal Pharma Solutions: Manufacturing Facilities
Table 6.21 Piramal Pharma Solutions: Recent Developments
Table 6.22 Piramal Pharma Solutions: Future Outlook
Table 6.23 SAFC: Company Overview
Table 6.24 SAFC: HPAPI and Cytotoxic Drug-related Service Offerings
Table 6.25 SAFC: Manufacturing Facilities
Table 6.26 SAFC: Future Outlook
Table 7.1 Leading HPAPIs and Cytotoxic Drugs Contract Manufacturers based in Europe
Table 7.2 Carbogen Amics: Company Overview
Table 7.3 Carbogen Amics: HPAPI and Cytotoxic Drug-related Service Offerings
Table 7.4 Carbogen Amics: Manufacturing Facilities
Table 7.5 Carbogen Amics: Recent Developments
Table 7.6 Carbogen Amics: Future Outlook
Table 7.7 Evonik: Company Overview
Table 7.8 Evonik: HPAPI and Cytotoxic Drug-related Service Offerings
Table 7.9 Evonik: Manufacturing Facilities
Table 7.10 Lonza: Company Overview
Table 7.11 Lonza: HPAPI and Cytotoxic Drug-related Service Offerings
Table 7.12 Lonza: Manufacturing Facilities
Table 7.13 Lonza: Recent Developments
Table 7.14 Lonza: Future Outlook
Table 7.15 Siegfried: Company Overview
Table 7.16 Siegfried: HPAPI and Cytotoxic Drug-related Service Offerings
Table 7.17 Siegfried: Manufacturing Facilities
Table 7.18 Siegfried: Recent Developments
Table 7.19 Siegfried: Future Outlook
Table 7.20 Teva API: Company Overview
Table 7.21 Teva API: HPAPI and Cytotoxic Drug-related Service Offerings
Table 7.22 Teva API: Manufacturing Facilities
Table 8.1 Leading HPAPIs and Cytotoxic Drugs Contract Manufacturers based in Asia Pacific
Table 8.2 Formosa Laboratories: Company Overview
Table 8.3 Formosa Laboratories: HPAPI and Cytotoxic Drug-related Service Offerings
Table 8.4 Formosa Laboratories: Manufacturing Facilities
Table 8.5 Formosa Laboratories: Recent Developments
Table 8.6 Formosa Laboratories: Future Outlook
Table 8.7 Intas Pharmaceuticals: Company Overview
Table 8.8 Intas Pharmaceuticals: HPAPI and Cytotoxic Drug-related Service Offerings
Table 8.9 Intas Pharmaceuticals: Manufacturing Facilities
Table 8.10 MabPlex: Company Overview
Table 8.11 MabPlex: HPAPI and Cytotoxic Drug-related Service Offerings
Table 8.12 MabPlex: Manufacturing Facilities
Table 8.13 Mabplex: Recent Developments
Table 8.14 Mabplex: Future Outlook
Table 8.15 Scinopharm: Company Overview
Table 8.16 Scinopharm: HPAPI and Cytotoxic Drug-related Service Offerings
Table 8.17 Scinopharm: Manufacturing Facilities
Table 8.18 STA Pharmaceutical (a WuXi AppTec company): Company Overview
Table 8.19 STA Pharmaceutical (a WuXi AppTec company): HPAPI and Cytotoxic Drug-related Service Offerings
Table 8.20 STA Pharmaceutical (a WuXi AppTec company): Manufacturing Facilities
Table 8.21 STA Pharmaceutical (a WuXi AppTec company): Recent Developments
Table 8.22 STA Pharmaceutical (a WuXi AppTec company): Future Outlook
Table 9.1 HPAPI and Cytotoxic Drugs Contract Manufacturing: List of Partnerships, 2014-2019
Table 10.1 HPAPI and Cytotoxic Drugs Contract Manufacturing: List of Expansions, 2014-2019
Table 15.1 Commonly Used Cytotoxins for ADCs
Table 15.2 List of ADC Contract Manufacturers
Table 15.3 ADC Contract Manufacturers: Services Offered
Table 15.4 ADC Contract Manufacturers: Details on Manufacturing Facilities
Table 15.5 ADC Manufacturers: Details on Scale of Operationand Capacity
Table 16.1 HPAPI and Cytotoxic Drugs Contract Manufacturing: Summary of the Report
Table 18.1 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Year of Establishment
Table 18.2 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Company Size
Table 18.3 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Scale of Operation
Table 18.4 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type Service(s) Offered
Table 18.5 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Product
Table 18.6 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Pharmacological Molecule
Table 18.7 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Headquarters (Region and Country-Wise)
Table 18.8 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Manufacturing Facilities
Table 18.9 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Facility Size
Table 18.10 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Highly Potent Finished Dosage Forms
Table 18.11 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type Primary Packaging
Table 18.12 Partnerships and Collaborations: Distribution by Year of Partnership
Table 18.13 Partnerships and Collaborations: Distribution by Type of Partnership
Table 18.14 Partnerships and Collaborations: Distribution by Year and Type of Partnership
Table 18.15 Partnerships and Collaborations: Distribution by Type of Product
Table 18.16 Partnerships and Collaborations: Distribution by Type of Product and Type of Partnership
Table 18.17 Partnerships and Collaborations: Distribution by Scale of Operation
Table 18.18 Partnerships and Collaborations: Distribution by Scale of Operation and Type of Partnership
Table 18.19 Partnerships and Collaborations: Distribution by Company Size
Table 18.20 Partnerships and Collaborations: Distribution of Acquisitions by Amount Invested (USD Million)
Table 18.21 Most Active Players: Distribution by Number of Partnerships
Table 18.22 Partnerships and Collaborations: Country-wise Distribution
Table 18.23 Recent Expansions: Distribution by Year of Expansion
Table 18.24 Recent Expansions: Distribution by Type of Expansion
Table 18.25 Recent Expansions: Distribution by Scale of Operation and Type of Expansion
Table 18.26 Recent Expansions: Distribution by Type of Product and Type of Expansion
Table 18.27 Recent Expansions: Distribution by Expanded Facility Area
Table 18.28 Recent Expansions: Distribution by Amount Invested (USD Million)
Table 18.29 Recent Expansions: Distribution by Company Headquarters and Company Size
Table 18.30 Recent Expansions: Distribution by Location of Facility and Type of Expansion
Table 18.31 Most Active Players: Distribution by Number of Expansions
Table 18.32 Recent Expansions: Distribution by Geography and Year
Table 18.33 Recent Expansions: Country-wise Distribution
Table 18.34 HPAPI and Cytotoxic Drugs Contract Manufacturing Capacity: Distribution by Company Size
Table 18.35 HPAPI and Cytotoxic Drugs Contract Manufacturing Capacity: Distribution by Scale of Operation
Table 18.36 HPAPI and Cytotoxic Drugs Contract Manufacturing Capacity: Distribution by Location of Manufacturing Facility
Table 18.37 Overall HPAPI and Cytotoxic Drugs Contract Manufacturing Market, Conservative, Base and Optimistic Scenarios, 2020-2030 (USD Billion)
Table 18.38 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Type of Product (USD Billion)
Table 18.39 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Company Size (USD Billion)
Table 18.40 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Scale of Operation (USD Billion)
Table 18.41 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Type of Pharmacological Molecule (USD Billion)
Table 18.42 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Type of Highly Potent Finished Dosage Forms (USD Billion)
Table 18.43 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Key Geographical Regions (USD Billion)
Table 18.44 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in North America, Conservative, Base and Optimistic Scenarios, 2020-2030 (USD Billion)
Table 18.45 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the US, Conservative, Base and Optimistic Scenarios, 2020-2030 (USD Billion)
Table 18.46 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Canada, Conservative, Base and Optimistic Scenarios, 2020-2030 (USD Billion)
Table 18.47 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Mexico, Conservative, Base and Optimistic Scenarios, 2020-2030 (USD Billion)
Table 18.48 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Europe, Conservative, Base and Optimistic Scenarios, 2020-2030 (USD Billion)
Table 18.49 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the UK, Conservative, Base and Optimistic Scenarios, 2020-2030 (USD Billion)
Table 18.50 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Italy, Conservative, Base and Optimistic Scenarios, 2020-2030 (USD Billion)
Table 18.51 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Germany, Conservative, Base and Optimistic Scenarios, 2020-2030 (USD Billion)
Table 18.52 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in France, Conservative, Base and Optimistic Scenarios, 2020-2030 (USD Billion)
Table 18.53 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Spain, Conservative, Base and Optimistic Scenarios, 2020-2030 (USD Billion)
Table 18.54 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of Europe, Conservative, Base and Optimistic Scenarios, 2020-2030 (USD Billion)
Table 18.55 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Asia Pacific, Conservative, Base and Optimistic Scenarios, 2020-2030 (USD Billion) (USD Billion)
Table 18.56 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in China, Conservative, Base and Optimistic Scenarios, 2020-2030 (USD Billion)
Table 18.57 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in India, Conservative, Base and Optimistic Scenarios, 2020-2030 (USD Billion)
Table 18.58 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of Asia Pacific, Conservative, Base and Optimistic Scenarios, 2020-2030 (USD Billion)
Table 18.59 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the Rest of World, Conservative, Base and Optimistic Scenarios, 2020-2030 (USD Billion)
Table 18.60 ADC Contract Manufacturers: Distribution by Location of Headquarters
Table 18.61 ADC Contract Manufacturers: Distribution by Year of Establishment
Table 18.62 ADC Contract Manufacturers: Distribution by Company Size
Table 18.63 ADC Contract Manufacturers: Distribution by Services Offered
Table 18.64 ADC Contract Manufacturers: Distribution by Location of Headquarters and Services Offered
Table 18.65 ADC Contract Manufacturers: Distribution by Location of Manufacturing Facilities
Table 18.66 ADC Contract Manufacturers: Distribution by Scale of Operation

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

AB SCIEX
Abbvie Contract Manufacturing
Abzena
Accucaps Industries
ACES Pharma
ADC Biotechnology
ADC Therapeutics
Aenova Group
Aesica Pharma
Agno Pharma
Ajinomoto Bio-Pharma Services
ALB Technology
Albany Molecular Research
Alcami
Alkermes Contract Pharma Services
Allergan
Almac Group
Alphora Research
Alteogen
Amatsigroup
AMPAC Fine Chemicals
Antengene
Antitope
Aptuit
Arch Pharmalabs
Ardena
Arena Pharmaceuticals
Ash Stevens
Aspen Oss
Aspyrian Therapeutics
AstraZeneca
Asymchem Laboratories
Atossa Therapeutics
Avanthera
Avista Pharma Solutions
Bakhu Pharma
Baxter International
BerGenBio
Berlin Chemie
Beta Pharma
Biopharma Solutions
Bio-Synthesis
BioTechnique
BioVectra
Blanver
Bliss Biopharmaceutical
Bristol-Myers Squibb
Bryllan
BSP Pharmaceuticals
Cambrex
Cambridge Major Laboratories
Capsugel
CARBOGEN AMICS
Catalent Pharma Solutions
Cedarburg Pharmaceuticals
Cellectis
CellMosaic
Celon Laboratories
Cerbios-Pharma
ChemCon
ChemConnection
ChemSun Pharmaceutical
Claris Injectables
Clovis Oncology
CMC Biologics
Coldstream Laboratories
Concortis Biosystems
Consort Medical
CordenPharma
Creative Biolabs
Crystal Pharma
Custom Pharma Services
CytomX
Cytopharma
Dalton Pharma Services
Dizal Pharmaceutical
Dorizoe Lifesciences
Dottikon ES
DSM Pharmaceuticals
Eagle Pharmaceuticals
EirGen Pharma
Encap Drug Delivery
Endo Ventures
EriGenix
Euticals
Evonik
Excella
Farmabios
Farmhispania Group
Fermion
FineTech Pharmaceuticals
Flamma
Formex
Formosa Laboratories
For‐Robin
Fred Hutchinson Cancer Research Center
Fresenius Kabi
Gadea Pharmaceutical
GEA Pharma Systems
Gentec
Goodwin Biotechnology
GP Pharm
GTP Technology
H.I.G. Capital
Halo Pharma
Haupt Pharma
Helsinn Advanced Synthesis
Heraeus
Hovione
ICROM
IDT Australia
IDT Biologika
Impact Therapeutics
Indena
Intas
Irix Pharmaceuticals
IRIX Pharmaceuticals
Johns Hopkins University
Johnson Matthey Pharma Services
Kuecept
Kyongbo Pharmaceutical
Labochim
Laboratorio Varifarma
Lee’s Pharmaceutical
Levena Biopharma
Lonza
MAB Discovery
MabPlex
Mac-Chem
MacroGenics
Magle Chemoswed
Mayne Pharma
MediaPharma
Medichem
MEI Pharma
Merck
Mersana Therapeutics
Metrics Contract Services
Minafin Group
Morgridge Institute for Research
Morphotek
MuseChem
NBE-Therapeutics
NerPharMa
NMS Group
Normon
Novartis
Novasep
OBI Pharma
Olon
Omni-Chem
Oncotec Pharma
OsoBio
Oxford BioTherapeutics
Palobiofarma
Patheon
PCI Pharma Services
Penn Pharma
Pensatech Pharma
Pfanstiehl
Pfizer
Pfizer CenterSource
Pfizer CentreOne
Pharmaceutics International
Pharmacyclics
Pharmascience
Pharmatek
Pharmatory
Phoenix Molecular Designs
Pierre Fabre Medicament Production
Piramal Pharma Solutions
PolyTherics
PrasFarma
Procos
ProJect Pharmaceutics
PSC Investments
QS Pharma
Quality Assistance
Quotient Sciences
Recipharm
Redwood Bioscience
Regis Technologies
Richman Chemical
Rottendorf Pharma
SAFC
Saltigo
Sandoz
Sanofi
Sartorius Stedim Biotech
Scientific Centre of Monaco
ScinoPharm
Shanghai Miracogen
Siegfried
SK Group
Solasia Pharma
Somatek
Sonnet BioTherapeutics
Sorrento Therapeutics
STA Pharmaceutical
Stason Pharmaceuticals
Symbiosis Pharmaceutical Services
Symphogen
Synaffix
Syngene
Syntagon
Syn-The-All Pharmaceutical (STA)
Synthon
TBD-Biodiscovery
Telix Pharmaceuticals
TESARO
Teva api
Teva Pharmaceutical
The Carlyle Group
The Chemistry Research Solution (TCRS)
The Institute for Research in Biomedicine (IRB)
Thermo Fisher Scientific
Transporin
Triphase Accelerator Corporation
Tsinghua University
TUBE Biopharmaceuticals
Uman Pharma
UniTao Pharmaceuticals
UPM Pharmaceuticals
Uquifa
Vaccinex
VUAB Pharma
WaterStone Pharmaceuticals
Wuxi Biologics
Wuxi PharmaTech

Methodology

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Table of Contents

Companies Mentioned (Partial List)

Methodology

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