Dublin, Dec. 07, 2022 (GLOBE NEWSWIRE) -- 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.
Frequently Asked Questions
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.
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.
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.
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.
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.
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.
Key Topics Covered:
2. EXECUTIVE SUMMARY
3.1. Chapter Overview
3.2. High Potency Active Pharmaceutical Ingredients
3.2.1. Classification by Potency
184.108.40.206. Classification of HPAPIs
3.2.2. Different Types of HPAPIs
220.127.116.11. Antibody Drug Conjugates
18.104.22.168. Cytotoxic Drugs
22.214.171.124. Beta-Lactam Compounds
3.2.3. Considerations for Handling HPAPIs
3.2.4. Contract Manufacturing of HPAPIs and Cytotoxic Drugs
126.96.36.199. 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
5.4. 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
6.2.1. 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
6.5. Pfizer CentreOne
6.6. Piramal Pharma Solutions
7. COMPANY PROFILES: HPAPI AND CYTOTOXIC DRUG MANUFACTURERS IN EUROPE
7.1. Chapter Overview
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
7.4. CARBOGEN AMCIS
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
8.4. STA Pharmaceutical (a WuXi AppTec company)
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
18.5. ProJect Pharmaceutics
18.6. Alphora Research
18.7. Piramal Healthcare
19. APPENDIX 1: TABULATED DATA
20. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
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