DUBLIN–(BUSINESS WIRE)–The “Cytotoxic Drugs and HPAPI Manufacturing Market by Type of Product, Company Size, Scale of Operation, Type of Molecule, Type of Highly Potent Finished Dosage Form, and Key Geographies, Europe, Asia-Pacific and Rest of the World: Industry Trends and Global Forecasts, 2022-2035” report has been added to ResearchAndMarkets.com’s offering.
“Cytotoxic Drugs and HPAPI Manufacturing Market 2022-2035” 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.
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.
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.
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.
Scope of the Report
- 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, location of headquarters, location of manufacturing facility, area of manufacturing facility, scale of operation, type of product manufactured, type of highly potent finished dosage form, Occupational Exposure Limit, type of molecule manufactured, type of primary packaging system, regulatory certifications / accreditations received and type of service(s) offered.
- 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.
- Elaborate profiles of prominent players 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, scale of operation, type of product, most active players 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, company size, location of headquarters, scale of operation, type of product, location of expanded facility, area of expanded facility, amount invested in expansions, most active players 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, scale of operation and key geographical regions.
- 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.
Key Topics Covered:
1. PREFACE
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
5.5. Highly Potent FDF Contract Manufacturers: Company Competitiveness Analysis
5.6. HPAPI and Highly Potent FDF Contract Manufacturers: Company Competitiveness Analysis
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
6.4. Catalent
6.5. Pfizer CentreOne
6.6. Piramal Pharma Solutions
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
7.4. CARBOGEN AMCIS
7.5. Hovione
7.6. Lonza
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
8.4. STA Pharmaceutical (a WuXi AppTec company)
8.5. Syngene
8.6. Teva API
9. PARTNERSHIPS AND COLLABORATIONS
9.1. Chapter Overview
9.2. Partnership Models
9.3. HPAPI and Cytotoxic Drugs: List of Partnerships and Collaborations
10. RECENT EXPANSIONS
10.1. Chapter Overview
10.2. HPAPI and Cytotoxic Drugs: List of Recent Expansions
11. CAPACITY ANALYSIS
11.1. Chapter Overview
11.2. Key Assumptions and Methodology
11.3. HPAPI Contract Manufacturers: Global Installed Capacity
12. REGIONAL CAPABILITY ASSESSMENT ANALYSIS
12.1. Chapter Overview
12.2. Assumptions and Key Parameters
13. MAKE VERSUS BUY DECISION MAKING FRAMEWORK
13.1. Chapter Overview
13.2. Assumptions and Key Parameters
13.3. Concluding Remarks
14. MARKET SIZING AND OPPORTUNITY ANALYSIS
14.1. Chapter Overview
14.2. Forecast Methodology and Key Assumptions
14.3. Global HPAPI and Cytotoxic Drug Contract Manufacturing Market, 2022-2035
15. SWOT ANALYSIS
16. CASE-IN-POINT: CONTRACT MANUFACTURING OF ANTIBODY DRUG CONJUGATES
16.1. Chapter Overview
16.2. Key Components of Antibody Drug Conjugates
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
16.7. Concluding Remarks
17. CONCLUDING REMARKS
18 EXECUTIVE INSIGHTS
18.1. Chapter Overview
18.2. BSP Pharmaceuticals
18.2.1. Company Snapshot
18.2.2. Interview Transcript: Antonella Mancuso and Maria Elena Guadagno, Vice President and Chief Operating Officer and Business Director
18.3. Catalent
18.4. CordenPharma
18.5. ProJect Pharmaceutics
18.6. Alphora Research
18.7. Piramal Healthcare
18.8. Helsinn
18.9. Cerbios-Pharma
18.10. Idifarma
19. APPENDIX 1: TABULATED DATA
20. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
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