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Cytotoxic Drugs and HPAPI Manufacturing

Cytotoxic Drugs and HPAPI Manufacturing Market (4th Edition) by Type of Product (HPAPIs and Highly Potent Finished Dosage Forms), Company Size (Small, Mid-sized, Large and Very Large), Scale of Operation (Preclinical, Clinical and Commercial), Type of Molecule (Small Molecules and Biologics), Type of Highly Potent Finished Dosage Form (Injectables, Oral Solids, Creams and Others), and Key Geographies (North America (US, Canada and Mexico), Europe (UK, Italy, Germany, France, Spain, and Rest of Europe), Asia-Pacific (China, India, and Rest of Asia-Pacific) and Rest of the World: Industry Trends and Global Forecasts, 2022-2035

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Report Description

Aided by the ongoing advancements in clinical pharmacology and oncology research, as well as the rising demand for targeted therapies, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have emerged as one of the key areas of interest for researchers and drug developers worldwide. As is well known, HPAPIs are pharmacologically active compounds which are capable of eliciting a biological response even at extremely low concentrations. Specifically, HPAPIs are categorized on the basis of their toxicity, occupational exposure limit (OEL) and pharmacological potency. OEL is defined as the maximum admissible exposure to a physical or chemical hazard, for a specific period of time (usually 8 hours), without endangering the health and safety of workers; typically, highly potent compounds have an OEL less than or equal to 10 µg / m3. It is worth highlighting that HPAPIs offer a range of benefits over conventional APIs, including high target specificity, retention (in their active form) within the body for longer durations, and fewer side effects. As a result, at present, such products are being developed / evaluated for the treatment of a myriad of indications, including asthma, autoimmune disorders, cancer, diabetes and hormone imbalances.

Frequently Asked Questions

Q1. What are the current opportunities within the HPAPI and cytotoxic drug market?

The cytotoxic drugs and HPAPI manufacturing market is presently considered as one of the most powerful and dynamic sectors of the pharmaceutical industry. At present, more than 40% of the total number of drugs are highly potent in nature. Further, around 60% of the HPAPIs are being developed against oncological indications. Considering the upsurge in demand for novel anti-cancer therapeutics, including antibody-drug conjugates (ADCs), high potency compounds have generated significant interest among several researchers and industry stakeholders. 

Q2. What is the need for contract manufacturing organizations (CMOs) in the HPAPI and cytotoxic drug domain?

The manufacturing of highly potent APIs and cytotoxic drugs requires an adequate working environment (to prevent cross contamination within multi-product assets), stringent manufacturing protocols (to comply with the established regulatory standards) and a trained workforce (to satisfactorily handle highly potent materials). In addition, it requires an expensive infrastructure, which is often complex to engineer, install and maintain. As a result, various companies rely on third party service providers to leverage their technologies for manufacturing highly potent and cytotoxic compounds and achieve greater operational flexibility. The inherent expertise of CMOs is believed to be capable of enabling reduction in the time-to-market a product and offer significant cost-benefits.

Q3. What is the current market landscape and recent trends in the HPAPI and cytotoxic drug contract manufacturing domain?

Presently, close to 145 companies have the required capabilities to offer HPAPI and cytotoxic drug manufacturing services across different scales of operation. In addition, several contract service providers are entering into strategic alliances in order to consolidate their presence in this field and enhance their existing capabilities to meet the growing demand for high potency molecules. It is worth mentioning that close to 50% of the expansion activities carried out in this market have been focused on improving the existing manufacturing facilities for highly potent molecules, through the addition of new structures and equipment.

Q4. What are the key challenges faced by HPAPI and cytotoxic drug CMOs?

The primary challenge faced during the manufacturing of highly potent APIs and cytotoxic drugs is related to limiting / altogether preventing cross-contamination of the highly potent molecule with other molecules being produced at the same site. Further, the lack of information related to safe exposure levels and toxicity of new chemical entities can risk the lives of workers and harm the environment. As a result, comprehensive management systems are required for safe handling and containment of highly potent molecules. In addition, proper cleaning techniques and waste treatment systems are extremely essential while producing such compounds.

Q5. What are the key value drivers in the HPAPIs and cytotoxic drugs contract manufacturing market?

The increasing demand for cytotoxic drugs has led to a rise in the number of HPAPIs in the overall pharmaceutical development pipeline. In order to cater to the growing demand for the production of such drug candidates, there is a requirement for safe manufacturing and containment technologies. Even though some pharmaceutical companies have made considerable investments to establish in-house capabilities, the capital-intensive nature and specialized containment requirements make the role of contract manufacturers crucial, specifically for small and mid-sized players.

Q6. How is the revenue generation potential associated with cytotoxic drugs and HPAPI manufacturing market likely to evolve in the coming years?

The cytotoxic drugs and HPAPI manufacturing market is projected to grow at a CAGR of approximately 12% in the coming years. Currently, in terms of type of molecule, the market is likely to be driven by highly potent small molecules. However, this trend is expected to change in the foreseen future, as the demand for highly potent biologics, such as cell and gene therapies, increases further. In addition, in terms of scale of operation, majority share of the contract service revenues is expected to be generated by commercial scale manufacturing operations. Specifically, in terms of geography, the cytotoxic drugs and HPAPI manufacturing market in Asia-Pacific is likely to grow at a relatively faster pace (~13%), in the long term.

Scope of the Report

The “Cytotoxic Drugs and HPAPI Manufacturing Market (4th Edition), 2022-2035: Distribution by Type of Product (HPAPIs and Highly Potent Finished Dosage Forms), Company Size (Small, Mid-sized, Large and Very Large), Scale of Operation (Preclinical, Clinical and Commercial), Type of Molecule (Small Molecules and Biologics), Type of Highly Potent Finished Dosage Form (Injectables, Oral Solids, Creams and Others), and Key Geographies (North America (US, Canada and Mexico), Europe (UK, Italy, Germany, France, Spain, and Rest of Europe), Asia-Pacific (China, India, and Rest of Asia-Pacific) and Rest of the World” 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. The study also features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in this field. The table below highlights various market segmentations done in the report.

Market Segmentations

Report Attribute Details

Forecast Period

2022 – 2035

Type of Product

 HPAPI and highly potent finished dosage form

Type of Highly Potent Finished Dosage Form

 Injectables, oral solids, creams and others

Type of Molecule

 Small molecules, biologics

Scale of Operation

Preclinical, clinical, commercial

Company Size

 Small, Mid-sized, Large, Very Large
Key Geographical Regions North America, Europe, Asia-Pacific, MENA, Latin America, Rest of the World

 

Amongst other elements, the report includes:

  • A general overview of HPAPIs and cytotoxic drugs, along with information on the different types of HPAPIs and challenges associated with the handling of HPAPIs. The chapter also lays emphasis on the growing need for outsourcing the manufacturing of highly potent compounds, and provides details related to the regulatory considerations in this domain.
  • A detailed assessment of the overall landscape of companies offering contract manufacturing services for HPAPI and cytotoxic drugs, along with information on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, location of manufacturing facility, area of manufacturing facility (less than 10,000 sq. ft., 10,000 to 40,000 sq. ft., 40,001 to 80,000 sq. ft. and more than 80,000 sq. ft.), scale of operation (preclinical, clinical and commercial), type of product manufactured (HPAPIs and highly potent finished dosage forms), type of highly potent finished dosage form (capsules, tablets, liquids / injectables, granules and others), Occupational Exposure Limit (less than 0.1 µg/m3, 0.1 µg/m3 to 1 µg/m3 and more than 1 µg/m3), type of molecule manufactured (small molecules and biologics), type of primary packaging system (blisters, vials, prefilled syringes, ampoules, syringes and others), regulatory certifications / accreditations received and type of service(s) offered (analytical testing, process development / pre-formulation, scale-up, packaging, stability studies, formulation development, regulatory support and fill / finish).
  • A detailed competitiveness analysis of HPAPI and cytotoxic drug contract manufacturers, taking into consideration supplier strength (based on company size and their experience in this field) and service strength (based on scale of operation, number of highly potent finished dosage form, number of primary packaging system and number of service(s) offered).
  • Elaborate profiles of prominent players (shortlisted based on a proprietary criterion) offering contract manufacturing services for HPAPI and cytotoxic drugs, across North America, Europe and Asia-Pacific. Each profile features a brief overview of the company, along with details related to its HPAPI and cytotoxic drug-related service portfolio, dedicated facilities, recent developments and an informed future outlook.
  • An insightful analysis of the recent collaborations within the HPAPI and cytotoxic drug manufacturing industry, based on several relevant parameters, such as year of partnership, type of partnership (acquisitions, manufacturing agreements, research and development agreements, product development and commercialization agreements, technology licensing agreements and others), scale of operation (preclinical, clinical and commercial), type of product (HPAPI and high potent FDFs), most active players (in terms of number of deals inked) and regional distribution of partnership activity that have been undertaken in this domain, during the period 2014-2022.
  • A detailed analysis of the recent expansions undertaken by several HPAPI and cytotoxic drug contract manufacturers, based on various relevant parameters, such as year of expansion, type of expansion (capacity expansions, facility expansions and new facility addition), company size (small, mid-sized, large and very large companies), location of headquarters, scale of operation (preclinical, clinical and commercial), type of product (HPAPI and high potent FDFs), location of expanded facility, area of expanded facility, amount invested in expansions, most active players (in terms of number of recent expansions) and geographical distribution.
  • An estimate of the overall installed capacity for the manufacturing of HPAPIs, based on information reported by various industry stakeholders in the public domain. The analysis highlights the distribution of global installed capacity, based on company size (small, mid-sized and large), scale of operation (preclinical, clinical and commercial) and key geographical regions (North America, Europe, Asia-Pacific and Rest of the World).
  • A regional capability assessment framework, which compares the HPAPI and cytotoxic drug manufacturing capabilities across key geographies, based on several parameters, such as the number of HPAPI and cytotoxic drug contract manufacturers, number of HPAPI and cytotoxic drug manufacturing facilities, number of facility expansions and installed HPAPI capacity in that particular geographical region.
  • A detailed discussion on affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the industry’s evolution highlighting the relative effect of each SWOT parameter on the overall HPAPI and cytotoxic drug manufacturing market. 
  • A case study on companies offering manufacturing services for antibody drug conjugates (ADCs). The chapter also highlights the key components of ADCs and the key challenges associated with the manufacturing of these products. Further, the chapter presents a list of players that provide contract manufacturing services for ADCs.

One of the key objectives of the report was to evaluate the current opportunity and the future growth potential of the HPAPI and cytotoxic drug manufacturing market over the coming years. We have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the period 2022-2035. The report also features a likely distribution of the current and forecasted opportunity across important parameters, such as [A] type of product (HPAPI and highly potent finished dosage form), [B] type of highly potent finished dosage form (injectables, oral solids, creams and others), [C] type of molecule (small molecules and biologics), [D] scale of operation (preclinical, clinical and commercial), [E] company size (small, mid-sized, large and very large) and [F] key geographies (North America, Europe, 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 market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified. 

The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. 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 (Ex-Group Product Manager and Ex-Director-Business Development); Abul Khair (Business Development Associate, Catalent)
  • Roberto Margarita (Business Development Director, CordenPharma)
  • Klaus Hellerbrand (Managing Director, ProJect Pharmaceutics)
  • Kevin Rosenthal (Ex-Business Head, Formulations and Finished Products, Alphora research)
  • Mark Wright (Ex-Site Head, Grangemouth, Piramal Healthcare)
  • Allison Vavala (Ex-Senior Manager, Business Development, Helsinn)
  • Valentino Mandelli (Marketing and Sales Manager, Pharma, Cerbios-Pharma) 
  • Javier E. Aznarez Araiz (Ex-Business Development, Idifarma)

Contents

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 Contract Manufacturing Capabilities in North America
12.4. HPAPI and Cytotoxic Drug Contract Manufacturing Capabilities in Europe
12.5. HPAPI and Cytotoxic Drug Contract Manufacturing Capabilities in Asia-Pacific
12.6. HPAPI and Cytotoxic Drug Contract 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
13.3. HPAPI and Cytotoxic Drug Contract Manufacturers: Make versus Buy Decision Making
13.3.1. Scenario 1
13.3.2. Scenario 2
13.3.3. Scenario 3
13.3.4. Scenario 4
13.4. 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
18.12.2. Interview Transcript: Javier E. Aznárez Araiz, Ex-Business Development Technician

19. APPENDIX 1: TABULATED DATA

20. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

List Of Figures

Figure 2.1. Executive Summary: Overall Market Landscape
Figure 2.2. Executive Summary: Partnerships and Collaborations
Figure 2.3. Executive Summary: Recent Expansions
Figure 2.4. Executive Summary: Capacity Analysis
Figure 2.5. Executive Summary: Market Sizing and Opportunity Analysis
Figure 3.1 Characteristics of HPAPIs
Figure 3.2 Categorization of HPAPIs
Figure 3.3 Different Types of HPAPIs
Figure 4.1 HPAPIs 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 Location of Headquarters (Region-wise)
Figure 4.4 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Headquarters (Country-wise)
Figure 4.5 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Company Size and Location of Headquarters
Figure 4.6 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Manufacturing Facility (Region-wise)
Figure 4.7 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Manufacturing Facility (Country-wise)
Figure 4.8 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Area of Manufacturing Facility
Figure 4.9 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Scale of Operation
Figure 4.10 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Product Manufactured
Figure 4.11 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Manufacturing Facility and Type of Product Manufactured
Figure 4.12 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Finished Dosage Form
Figure 4.13 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Occupational Exposure Limit (OEL)
Figure 4.14 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Molecule Manufactured
Figure 4.15 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Primary Packaging System
Figure 4.16 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Regulatory Certification / Accreditation Received
Figure 4.17 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Service(s) Offered
Figure 5.1 Company Competitiveness Analysis: HPAPI Contract Manufacturers based in North America
Figure 5.2 Company Competitiveness Analysis: HPAPI Contract Manufacturers based in Europe
Figure 5.3 Company Competitiveness Analysis: HPAPI Contract Manufacturers based in Asia-Pacific and Rest of the World
Figure 5.4 Company Competitiveness Analysis: Highly Potent FDF Contract Manufacturers based in North America
Figure 5.5 Company Competitiveness Analysis: Highly Potent FDF Contract Manufacturers based in Europe
Figure 5.6 Company Competitiveness Analysis: Highly Potent FDF Contract Manufacturers based in Asia-Pacific and Rest of the World
Figure 5.7 Company Competitiveness Analysis: HPAPI and Highly Potent FDF Contract Manufacturers based in North America
Figure 5.8 Company Competitiveness Analysis: HPAPI and Highly Potent FDF Contract Manufacturers based in Europe
Figure 5.9 Company Competitiveness Analysis: HPAPI and Highly Potent FDF Contract Manufacturers based in Asia-Pacific and Rest of the World
Figure 9.1 Partnerships and Collaborations: Cumulative Year-wise Trend, 2014-2022
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 Scale of Operation
Figure 9.5 Partnerships and Collaborations: Distribution by Type of Product
Figure 9.6 Partnerships and Collaborations: Distribution by Type of Partnership and Type of Product
Figure 9.7 Partnerships and Collaborations: Distribution of Amount Invested Via Acquisitions (USD Million)
Figure 9.8 Partnerships and Collaborations: Distribution by Type of Partner
Figure 9.9 Most Active Players: Distribution by Number of Partnerships
Figure 9.10 Partnerships and Collaborations: Intracontinental and Intercontinental Deals
Figure 9.11 Partnerships and Collaborations: International and Local Deals
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 Year and Type of Expansion
Figure 10.4 Recent Expansions: Distribution by Company Size and Location of Headquarters
Figure 10.5 Recent Expansions: Distribution by Scale of Operation
Figure 10.6 Recent Expansions: Distribution by Type of Expansion and Scale of Operation
Figure 10.7 Recent Expansions: Distribution by Type of Product
Figure 10.8 Recent Expansions: Distribution by Type of Expansion and Type of Product
Figure 10.9 Recent Expansions: Distribution by Location of Expanded Facility
Figure 10.10 Recent Expansions: Distribution by Type of Expansion and Location of Expanded Facility
Figure 10.11 Recent Expansions: Distribution by Expanded Facility Area (sq. ft.)
Figure 10.12 Recent Expansions: Distribution by Amount Invested on Expansions (USD Million)
Figure 10.13 Most Active Players: Distribution by Number of Recent Expansions
Figure 10.14 Recent Expansions: Continent-wise Distribution
Figure 10.15 Recent Expansions: Country-wise Distribution
Figure 11.1 HPAPI Manufacturing Global Installed Capacity: Distribution by Range of Installed Capacity (Liters)
Figure 11.2 HPAPI Contract Manufacturing Installed Capacity: Distribution by Company Size
Figure 11.3 HPAPI Contract Manufacturing Installed Capacity: Distribution by Scale of Operation
Figure 11.4 HPAPI Contract Manufacturing Installed Capacity: Distribution by Location of Manufacturing Facility
Figure 11.5 HPAPI Contract Manufacturing Capacity Installed in North America
Figure 11.6 HPAPI Contract Manufacturing Capacity Installed in Europe
Figure 11.7 HPAPI Contract Manufacturing Capacity Installed in Asia-Pacific
Figure 11.8 HPAPI Contract Manufacturing Capacity Installed in Rest of the World
Figure 12.1. Regional Capability Analysis: HPAPI and Cytotoxic Drug Contract Manufacturing in North America
Figure 12.2. Regional Capability Analysis: HPAPI and Cytotoxic Drug Contract Manufacturing in Europe
Figure 12.3. Regional Capability Analysis: HPAPI and Cytotoxic Drug Contract Manufacturing in Asia-Pacific
Figure 12.4. Regional Capability Analysis: HPAPI and Cytotoxic Drug Contract Manufacturing in Rest of the World
Figure 12.5. Regional Capability Analysis: Comparison of HPAPI and Cytotoxic Drug Contract Manufacturing Capabilities across Different Regions
Figure 13.1 Make versus Buy Decision Making: Framework
Figure 13.2 Make versus Buy Decision Making: Possible Scenario Descriptions
Figure 14.1 Global HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2022-2035 (USD Billion)
Figure 14.2 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2022-2035: Distribution by Type of Product (USD Billion)
Figure 14.3 HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Distribution by Company Size (USD Billion)
Figure 14.4 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2022-2035: Distribution by Scale of Operation (USD Billion)
Figure 14.5 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2022-2035: Distribution by Type of Molecule (USD Billion)
Figure 14.6 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2022-2035: Distribution by Type of Highly Potent Finished Dosage Forms (USD Billion)
Figure 14.7 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2022-2035: Distribution by Geography (USD Billion)
Figure 14.8 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in North America, 2022-2035 (USD Billion)
Figure 14.9 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the US, 2022-2035 (USD Billion)
Figure 14.10 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Canada, 2022-2035 (USD Billion)
Figure 14.11 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Mexico, 2022-2035 (USD Billion)
Figure 14.12 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Europe, 2022-2035 (USD Billion)
Figure 14.13 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the UK, 2022-2035 (USD Billion)
Figure 14.14 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Italy, 2022-2035 (USD Billion)
Figure 14.15 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Germany, 2022-2035 (USD Billion)
Figure 14.16 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in France, 2022-2035 (USD Billion)
Figure 14.17 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Spain, 2022-2035 (USD Billion)
Figure 14.18 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of Europe, 2022-2035 (USD Billion)
Figure 14.19 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.20 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in China, 2022-2035 (USD Billion)
Figure 14.21 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in India, 2022-2035 (USD Billion)
Figure 14.22 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the Rest of Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.23 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of the World, 2022-2035 (USD Billion)
Figure 15.1 HPAPIs and Cytotoxic Drugs Contract Manufacturing: SWOT Analysis
Figure 15.2 Comparison of SWOT Factors: Harvey Ball Analysis
Figure 16.1 Key Components of an ADCs
Figure 16.2 ADC Manufacturing: Key Process Steps
Figure 16.3 Key Parameters while Selecting a CMO Partner
Figure 16.4 ADC Contract Manufacturing Service Providers: Distribution by Year of Establishment
Figure 16.5 ADC Contract Manufacturing Service Providers: Distribution by Company Size
Figure 16.6 ADC Contract Manufacturing Service Providers: Distribution by Location of Headquarters
Figure 16.7 ADC Contract Manufacturing Service Providers: Distribution by Type of Service(s) Offered
Figure 16.8 ADC Contract Manufacturing Service Providers: Distribution by Location of Headquarters and Type of Service(s) Offered
Figure 17.1 Concluding Remarks: Overall Market Landscape
Figure 17.2 Concluding Remarks: Company Competitiveness Analysis
Figure 17.3 Concluding Remarks: Partnerships and Collaborations
Figure 17.4 Concluding Remarks: Recent Expansions
Figure 17.5 Concluding Remarks: Capacity Analysis
Figure 17.6 Concluding Remarks: Market Forecast and Opportunity Analysis

List Of Tables

Table 3.1 APIs and HPAPIs: Occupational Exposure Limit
Table 3.2 Occupational Exposure Limit and Occupational Exposure Band System: International Safety Systems
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 HPAPI and Cytotoxic Drugs Contract Manufacturers: List of Service Providers
Table 4.2 HPAPI and Cytotoxic Drugs Contract Manufacturers: Information on Scale of Operation, Type of Product Manufactured and Type of Highly Potent Finished Dosage Forms
Table 4.3 HPAPI and Cytotoxic Drugs Contract Manufacturers: Information on Occupational Exposure Limit, Type of Molecule Manufactured and Type of Primary Packaging System
Table 4.4 HPAPI and Cytotoxic Drugs Contract Manufacturers: Information on Regulatory Certification / Accreditation and Type of Service(s) Offered
Table 6.1 Leading HPAPI and Cytotoxic Drug Manufacturers in North America
Table 6.2 AbbVie: Company Snapshot
Table 6.3 AbbVie: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
Table 6.4 AbbVie: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
Table 6.5 AbbVie: Recent Developments and Future Outlook
Table 6.6 Cambrex: Company Snapshot
Table 6.7 Cambrex: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
Table 6.8 Cambrex: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
Table 6.9 Cambrex: Recent Developments and Future Outlook
Table 6.10 Catalent: Company Snapshot
Table 6.11 Catalent: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
Table 6.12 Catalent: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
Table 6.13 Catalent: Recent Developments and Future Outlook
Table 6.14 Pfizer CentreOne: Company Snapshot
Table 6.15 Pfizer CentreOne: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
Table 6.16 Pfizer CentreOne: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
Table 6.17 Pfizer CentreOne: Recent Developments and Future Outlook
Table 6.18 Piramal Pharma Solutions: Company Snapshot
Table 6.19 Piramal Pharma Solutions: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
Table 6.20 Piramal Pharma Solutions: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
Table 6.21 Piramal Pharma Solutions: Recent Developments and Future Outlook
Table 7.1 Leading HPAPIs and Cytotoxic Drug Manufacturers in Europe
Table 7.2 Abzena: Company Snapshot
Table 7.3 Abzena: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
Table 7.4 Abzena: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
Table 7.5 Abzena: Recent Developments and Future Outlook
Table 7.6 Aenova: Company Snapshot
Table 7.7 Aenova: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
Table 7.8 Aenova: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
Table 7.9 Aenova: Recent Developments and Future Outlook
Table 7.10 CARBOGEN AMCIS: Company Snapshot
Table 7.11 CARBOGEN AMCIS: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
Table 7.12 CARBOGEN AMCIS: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
Table 7.13 CARBOGEN AMCIS: Recent Developments and Future Outlook
Table 7.14 Hovione: Company Snapshot
Table 7.15 Hovione: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
Table 7.16 Hovione: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
Table 7.17 Hovione: Recent Developments and Future Outlook
Table 7.18 Lonza: Company Snapshot
Table 7.19 Lonza: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
Table 7.20 Lonza: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
Table 7.21 Lonza: Recent Developments and Future Outlook
Table 8.1 Leading HPAPI and Cytotoxic Drug Manufacturers in Asia-Pacific
Table 8.2 Intas Pharmaceuticals: Company Snapshot
Table 8.3 Intas Pharmaceuticals: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
Table 8.4 Intas Pharmaceuticals: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
Table 8.5 Intas Pharmaceuticals: Recent Developments and Future Outlook
Table 8.6 Scinopharm: Company Snapshot
Table 8.7 Scinopharm: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
Table 8.8 Scinopharm: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
Table 8.9 Scinopharm: Recent Developments and Future Outlook
Table 8.10 STA Pharmaceutical (a WuXi AppTec company): Company Snapshot
Table 8.11 STA Pharmaceutical (a WuXi AppTec company): HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
Table 8.12 STA Pharmaceutical (a WuXi AppTec company): Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
Table 8.13 STA Pharmaceutical (a WuXi AppTec company): Recent Developments and Future Outlook
Table 8.14 Syngene: Company Snapshot
Table 8.15 Syngene: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
Table 8.16 Syngene: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
Table 8.17 Syngene: Recent Developments and Future Outlook
Table 8.18 Teva API: Company Snapshot
Table 8.19 Teva API: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
Table 8.20 Teva API: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
Table 8.21 Teva API: Recent Developments and Future Outlook
Table 9.1 HPAPI and Cytotoxic Drugs Contract Manufacturing: List of Partnerships and Collaborations, 2014-2022
Table 10.1 HPAPI and Cytotoxic Drugs Contract Manufacturing: List of Recent Expansions, 2014-2022
Table 11.1 Capacity Analysis: Company Size of CMO
Table 11.2 Capacity Analysis: Average Capacity by Company Size of CMO
Table 11.3 HPAPI Manufacturing Installed Global Capacity: Total Capacity by Company Size (Liters)
Table 16.1 Commonly Used Cytotoxins for ADCs
Table 16.2 ADC Contract Manufacturing Service Providers: List of Companies
Table 16.3 ADC Contract Manufacturing Service Providers: Information on Type of Service(s) Offered
Table 18.1 HPAPI Project Service: Company Snapshot
Table 18.2 BSP Pharmaceuticals: Company Snapshot
Table 18.3 ILC Dover: Company Snapshot
Table 18.4 Catalent: Company Snapshot
Table 18.5 CordenPharma: Company Snapshot
Table 18.6 ProJect Pharmaceutics: Company Snapshot
Table 18.7 Alphora Research: Company Snapshot
Table 18.8 Piramal Healthcare: Company Snapshot
Table 18.9 Helsinn: Company Snapshot
Table 18.10 Cerbios-Pharma: Company Snapshot
Table 18.11 Idifarma: Company Snapshot
Table 19.1 HPAPIs and Cytotoxic Drugs Contract Manufacturers: Distribution by Year of Establishment
Table 19.2 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Company Size
Table 19.3 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Headquarters (Region-wise)
Table 19.4 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Headquarters (Country-wise)
Table 19.5 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Company Size and Location of Headquarters
Table 19.6 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Manufacturing Facility (Region-wise)
Table 19.7 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Manufacturing Facility (Country-wise)
Table 19.8 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Area of Manufacturing Facility (sq. ft.)
Table 19.9 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Scale of Operation
Table 19.10 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Product Manufactured
Table 19.11 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Manufacturing Facility and Type of Product Manufactured
Table 19.12 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Finished Dosage Form
Table 19.13 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Occupational Exposure Limit (OEL)
Table 19.14 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Molecule Manufactured
Table 19.15 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Primary Packaging System
Table 19.16 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Regulatory Certification / Accreditation Received
Table 19.17 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Service(s) Offered
Table 19.18 Partnerships and Collaborations: Distribution by Year of Partnership
Table 19.19 Partnerships and Collaborations: Distribution by Type of Partnership
Table 19.20 Partnerships and Collaborations: Distribution by Year and Type of Partnership
Table 19.21 Partnerships and Collaborations: Distribution by Scale of Operation
Table 19.22 Partnerships and Collaborations: Distribution by Type of Product
Table 19.23 Partnerships and Collaborations: Distribution by Type of Partnership and Type of Product
Table 19.24 Partnerships and Collaborations: Distribution of Amount Invested Via Acquisitions (USD Million)
Table 19.25 Partnerships and Collaborations: Distribution by Type of Partner
Table 19.26 Most Active Players: Distribution by Number of Partnerships
Table 19.27 Partnerships and Collaborations: Intracontinental and Intercontinental Deals
Table 19.28 Partnerships and Collaborations: International and Local Deals
Table 19.29 Recent Expansions: Distribution by Year of Expansion
Table 19.30 Recent Expansions: Distribution by Type of Expansion
Table 19.31 Recent Expansions: Distribution by Year and Type of Expansion
Table 19.32 Recent Expansions: Distribution by Company Size and Location of Headquarters
Table 19.33 Recent Expansions: Distribution by Scale of Operation
Table 19.34 Recent Expansions: Distribution by Type of Expansion and Scale of Operation
Table 19.35 Recent Expansions: Distribution by Type of Product
Table 19.36 Recent Expansions: Distribution by Type of Expansion and Type of Product
Table 19.37 Recent Expansions: Distribution by Location of Expanded Facility (Region-Wise)
Table 19.38 Recent Expansions: Distribution by Type of Expansion and Location of Expanded Facility
Table 19.39 Recent Expansions: Distribution by Expanded Facility Area (sq. ft.)
Table 19.40 Recent Expansions: Distribution by Amount Invested on Expansions (USD Million)
Table 19.41 Most Active Players: Distribution by Number of Recent Expansions
Table 19.42 Recent Expansions: Continent-wise Distribution
Table 19.43 Recent Expansions: Country-wise Distribution
Table 19.44 HPAPI Manufacturing Global Installed Capacity: Distribution by Range of Installed Capacity (Liters)
Table 19.45 HPAPI Contract Manufacturing Installed Capacity: Distribution by Company Size
Table 19.46 HPAPI Contract Manufacturing Installed Capacity: Distribution by Scale of Operation
Table 19.47 HPAPI Contract Manufacturing Installed Capacity: Distribution by Location of Manufacturing Facility
Table 19.48 HPAPI Contract Manufacturing Capacity Installed in North America
Table 19.49 HPAPI Contract Manufacturing Capacity Installed in Europe
Table 19.50 HPAPI Contract Manufacturing Capacity Installed in Asia-Pacific
Table 19.51 HPAPI Contract Manufacturing Capacity Installed in Rest of the World
Table 19.52 Global HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.53 HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Distribution by Type of Product, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.54 HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Distribution by Company Size, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.55 HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Distribution by Scale of Operation, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.56 HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Distribution by Type of Molecule, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.57 HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Distribution by Type of Highly Potent Finished Dosage Forms, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.58 HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Distribution by Region, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.59 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in North America, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.60 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the US, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.61 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Canada, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.62 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Mexico, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.63 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Europe, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.64 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the UK, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.65 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Italy, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.66 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Germany, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.67 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in France, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.68 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Spain, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.69 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of Europe, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.70 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Asia-Pacific, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.71 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in China, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.72 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in India, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.73 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of Asia-Pacific, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.74 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of the World, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
Table 19.75 ADC Contract Manufacturing Service Providers: Distribution by Year of Establishment
Table 19.76 ADC Contract Manufacturing Service Providers: Distribution by Company Size
Table 19.77 ADC Contract Manufacturing Service Providers: Distribution by Location of Headquarters
Table 19.78 ADC Contract Manufacturing Service Providers: Distribution by Type of Service(s) Offered
Table 19.79 ADC Contract Manufacturing Service Providers: Distribution by Location of Headquarters and Type of Service(s) Offered

List Of Companies

The following companies / institutes / government bodies and organizations have been mentioned in this report.

  1. AbbVie
  2. Abzena
  3. ACES Pharma
  4. Adare Pharma Solutions
  5. ADC Biotechnology
  6. ADC Therapeutics
  7. ADIENNE Pharma and Biotech
  8. Aenova
  9. AGC Pharma Chemicals (A subsidiary of AGC Group)
  10. Agno Pharma
  11. AIMEDBIO
  12. Ajinomoto Bio-Pharma Services
  13. ALB Technology
  14. Alcami
  15. Alkermes
  16. Almac
  17. Alphora Research
  18. Altasciences
  19. Alvogen
  20. Amneal Pharmaceuticals
  21. AMPAC Fine Chemicals (A SK pharmteco company)
  22. Angelini Fine Chemicals (A subsidiary of Angelini Pharma)
  23. ANI Pharmaceuticals
  24. Antengene
  25. ANVI Pharma
  26. Aptuit (An Evotec company)
  27. Ardena
  28. Arevipharma (Acquired by Yonsung Group)
  29. Aspen API
  30. Astellas Pharma
  31. Astorg
  32. AstraZeneca
  33. Asymchem Laboratories
  34. Aurigene Pharmaceutical Services
  35. Avra Laboratories (Acquired by Advent International)
  36. Baxter BioPharma Solutions
  37. Bio-Synthesis
  38. BioTechnique
  39. BioVectra
  40. BiVictriX Therapeutics
  41. BOC Sciences
  42. Boehringer Ingelheim
  43. Bolt Biotherapeutics
  44. Boryung Pharmaceutical
  45. Bright Peak Therapeutics
  46. Bristol Myers Squibb
  47. BrYet Health
  48. Bryllan
  49. BSP Pharmaceuticals
  50. Bushu Pharmaceuticals
  51. Byondis
  52. Cambrex
  53. Capsugel (A Lonza company)
  54. CARBOGEN AMCIS (A Dishman Carbogen Amcis Group company)
  55. Catalent
  56. CellMosaic
  57. Celon Laboratories
  58. Cerbios-Pharma
  59. ChemCon
  60. ChemPartner
  61. CordenPharma
  62. CoreRx
  63. Creative Biolabs
  64. CritiTech
  65. Curia
  66. Custom Pharmaceutical Services (A part of Dr. Reddy’s Laboratories)
  67. Cytopharma
  68. Daiichi Sankyo
  69. Dalton Pharma Services
  70. Dipharma
  71. Divi's Laboratories
  72. DOTTIKON EXCLUSIVE SYNTHESIS
  73. EirGen Pharma (Acquired by OPKO Health)
  74. Eisai
  75. Eli Lilly
  76. Enteris BioPharma (A subsidiary of SWK Holdings)
  77. Esteve
  78. Eurofins Scientific
  79. EVER Pharma
  80. Excella (Acquired by Fareva)
  81. Exelixis
  82. Fabbrica Italiana Sintetici
  83. Fareva
  84. Farmabios (A PharmaZell Group company)
  85. Farmhispania
  86. Femtogenix
  87. Fermion (A subsidiary of Orion)
  88. Flamma
  89. Formex (A subsidiary of Biotech Investment Group (BIG))
  90. Formosa Laboratories
  91. Fresenius Kabi
  92. Frontida BioPharm (Acquired by Adare Pharma Solutions)
  93. Fujimoto Chemicals
  94. GeneQuantum Healthcare
  95. Genmab
  96. GENTEC PHARMACEUTICAL GROUP
  97. Gilead Sciences
  98. Glycotope
  99. Goodwin Biotechnology
  100. GP Pharm
  101. GTP Bioways
  102. Gustave Roussy
  103. Helsinn Advanced Synthesis
  104. Heraeus
  105. Hovione
  106. ICROM
  107. Idifarma (Acquired by Ardena)
  108. IDT Australia
  109. Iksuda Therapeutics
  110. ImmunoGen
  111. Indena
  112. Ind-Swift Laboratories
  113. Intas Pharmaceuticals
  114. Janssen Biotech
  115. Kodiak Sciences
  116. Kohlberg
  117. Kyongbo Pharmaceutical (A subsidiary of Chong Kun Dang Pharmaceutical)
  118. LakePharma
  119. Laurus Synthesis
  120. LegoChem Biosciences
  121. Levena Biopharma (A subsidiary of Sorrento Therapeutics)
  122. Lonza
  123. Lotus Pharmaceuticals
  124. Lubrizol Life Science
  125. MabPlex
  126. Mac-Chem (A NMS Group Company)
  127. Magle Chemoswed
  128. Malladi Drugs & Pharmaceuticals
  129. Mayne Pharma
  130. McSAF
  131. MEDICHEM
  132. Merck
  133. Mersana Therapeutics
  134. Metrics Contract Services
  135. MilliporeSigma
  136. Minafin
  137. Minakem (A subsidiary of Minafin)
  138. Mitsubishi Tanabe Pharma
  139. Mubadala
  140. MuseChem
  141. Natco Pharma
  142. Navrogen
  143. NBE-Therapeutics
  144. NerPharMa
  145. NJ Bio
  146. Normon
  147. Novartis
  148. Novasep
  149. Oasmia Pharmaceutical
  150. OEP Pharma
  151. Olon
  152. Oncotec Pharma Produktion
  153. Oxford BioTherapeutics
  154. Parabolic Drugs
  155. Patheon (Acquired by Thermo Fischer Scientific)
  156. PCI Pharma Services
  157. Pensatech Pharma
  158. Pfanstiehl
  159. Pfizer
  160. Pfizer CentreOne
  161. Pharmacare Premium
  162. Pharmaceutics International
  163. Pharmascience
  164. PharmaZell
  165. PILA PHARMA
  166. Piramal Pharma Solutions
  167. PrasFarma
  168. Procos (A subsidiary of CBC)
  169. ProJect Pharmaceutics
  170. Pyxis Oncology
  171. Quadira Biosciences
  172. Quotient Sciences
  173. Recipharm
  174. Recro Pharma
  175. Regis Technologies
  176. RemeGen
  177. Richman Chemical
  178. SafeBridge Consultants (Acquired by Trinity Consultants)
  179. Sai Life Sciences
  180. Sanofi
  181. Sartorius
  182. ScinoPharm Taiwan
  183. Seagen
  184. Seattle Genetics
  185. SEQENS (Acquired by SK Capital Partners)
  186. Shionogi Pharma
  187. Siegfried
  188. Sigma-Aldrich Fine Chemicals (SAFC) (a Sigma-Aldrich company)
  189. SK biotek
  190. SK Capital
  191. Societal CDMO
  192. Sofpromed
  193. Somatek
  194. SOTIO Biotech
  195. STA Pharmaceutical (A WuXi AppTec company)
  196. Stason Pharmaceuticals
  197. Sterling Pharma Solutions
  198. Sutro Biopharma
  199. Swedish Orphan Biovitrum (SOBI)
  200. SWK Holdings
  201. Symbiosis Pharmaceutical Services
  202. Synaffix
  203. Synbias Pharma
  204. Syngene
  205. Synthon
  206. TBD-Biodiscovery
  207. Tergus Pharma
  208. Teva API
  209. TRIO Pharmaceuticals
  210. Tubulis
  211. University of Goettingen
  212. UPM Pharmaceuticals
  213. Vectura
  214. Veranova
  215. VERAXA Biotech
  216. VUAB Pharma (A SAFICHEM company)
  217. VxP Pharma
  218. Wavelength Pharmaceuticals (A subsidiary of SEQENS)
  219. WuXi Biologics
  220. ZNZ Pharma

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