SYS-CON MEDIA Authors: Roberto Medrano, Dmitriy Stepanov, Gilad Parann-Nissany, Srinivasan Sundara Rajan, Sean Houghton

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HPAPIs and Cytotoxic Drugs Manufacturing Market, 2014 - 2024

LONDON, Aug. 11, 2014 /PRNewswire/ -- Reportbuyer.com has added a new market research report:

HPAPIs and Cytotoxic Drugs Manufacturing Market, 2014 - 2024

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INTRODUCTION

With the rising demand for targeted therapies, high potency compounds such as high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become the key focus of researchers and manufacturers worldwide. HPAPIs, which include cytotoxic APIs, are drug substances that are formulated to manufacture high potency drug products. Cytotoxic drugs are a category of highly potent drug products and, due to their increased utility in the treatment of cancer indications, have gained wide attention in recent years.

Some of the key benefits of these compounds include low dosage requirement and lower side effects. 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 pharmaceutical industry. The market is currently dominated by contract manufacturers. 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 more crucial. SAFC, Lonza and Evonik are amongst the pioneers in the field of manufacturing highly potent compounds. In addition, new entrants such as Medichem and Wuxi Pharma have also recently sprung up.

The growing number of investments and partnerships in this field are evident of the current market intensity. Majority of the investments in recent years have been expansion programs which reflect that manufacturers are keen to expand their existing production facilities to meet the growing demand. Looking at the ongoing focus, we certainly believe that stakeholders will continue to invest in this area. The current market landscape will gradually evolve as manufacturers look to gain competitive advantage in the near future.

SCOPE OF THE REPORT

The 'HPAPIs and Cytotoxic Drugs Manufacturing Market, 2014-2024' report provides an extensive study of the rapidly growing manufacturing market of HPAPIs and cytotoxic drugs. Due to their numerous advantages and increased applications in treatment of cancer and other disorders, HPAPIs and cytotoxics have emerged as one of the key focus areas of researchers across the globe. When compared to conventional therapeutic products, these compounds offer multiple advantages. The focus of this report is primarily to understand the likely future evolution of contract manufacturing of HPAPIs and cytotoxics over the next decade.

The report covers various aspects such as analysis of CMOs involved in HPAPI/Cytotoxics manufacturing, pharmaceutical companies with in-house capabilities, regulatory guidelines, key drivers and upcoming opportunities for various stakeholders. Though a few pharmaceutical companies have in-house capabilities, a sizeable proportion of this market is covered by contract manufacturing. The future growth in the market will primarily be driven by the rapidly expanding market for oncology drugs; majority of the high potency and cytotoxic drugs are being developed for treatment of cancer. With evolving clinical research, use of HPAPIs and cytotoxics in other therapeutic areas such as glaucoma, hormonal imbalances and respiratory disorders have also been identified.

Despite some of these key benefits and a promising future, the study also highlights considerable challenges associated with production of these compounds. Due to their highly toxic nature, they can lead to occupational hazards, if not handled carefully. In addition, cross-contamination with other products can be highly detrimental for the patients. Thus, adequate containment strategies and proper classification of hazards is essential for the uptake of this market.

The base year for the report is 2013; actual sales data of respective companies has been presented for the latest year. The report provides short-mid term and long term market forecasts for the period 2014 - 2019 and 2019 - 2024, respectively. The research, analysis and insights presented in this report is backed by a deep understanding of key insights gathered both from secondary and primary research.

EXAMPLE HIGHLIGHTS

1. Oncology is the leading domain for HPAPIs and cytotoxic drugs. Around 60% of the HPAPIs are being developed for treatment of cancer. The trend is likely to continue and the anti-cancer market will drive the growth of HPAPIs and cytotoxics in the future.
2. A good proportion of HPAPI / cytotoxics manufacturing is currently outsourced. In fact, specifically for ADCs, the outsourcing proportion is as high as 75%-80%. During our research, we identified 76 CMOs (with over 100 production facilities worldwide) which are focused in this area. SAFC and Lonza are amongst some of the CMOs which are well-known.
3. Having said this, big pharma companies such as Merck, Roche, Pfizer and AbbVie have also established in-house capabilities.
4. Many CMOs offer commercial scale manufacturing of these compounds. A relatively less number of players, including Corden Pharma and Aptuit, provide one stop shop service ranging from manufacturing of APIs to formulation and fill/finish of the drug product.
5. North America and Europe are the predominant regions where HPAPI and cytotoxic drugs production facilities are located. The US accounts for 27% of the total HPAPI production facilities and 31% of the cytotoxic drugs production facilities. Companies have also recently moved their focus to developing countries in order to take advantage of relatively lower costs.
6. CMOs have regularly engaged in investment programs to expand their production set ups. Since 2006, there have been more than 60 investments to add new facilities and / or to expand existing capacities.
7. Stakeholders have also inked numerous partnerships to combine their manufacturing expertise. Of the 35 recent partnerships that we studied during our research, an overwhelming proportion was manufacturing collaborations and merger/acquisitions.

RESEARCH METHODOLOGY

Most of the data presented in this report has been gathered by secondary research. We have also conducted interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will shape up across different regions and drug segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Other analysts' opinion reports

While the focus has been on forecasting the market over the coming nine years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES

Chapter 2 provides an executive summary of the insights captured in our research. The summary offers a high level view on the likely evolution of manufacturing of HPAPIs and cytotoxic drugs.

Chapter 3 provides a general introduction on HPAPIs and cytotoxics. We have also explained, in detail, specific containment requirements for handling HPAPIs and cytotoxics.

Chapter 4 identifies the contract manufacturers actively involved in HPAPIs/cytotoxics market. The chapter provides details on production capabilities of these CMOs, specifically focussing on the scale of operation, OEL limits and geographic location of their facilities. It also highlights leading pharmaceutical companies which have in-house capabilities. In addition, we have also discussed the current regulatory landscape.

Chapter 5 provides a detailed analysis of CMOs focussed in the HPAPI market. An in-depth review including regional distribution, analysis by scale of operation and OEL limits has been covered in this chapter. The chapter also provides a high-level view on production specifications of leading manufacturers in the market.

Chapter 6 provides a detailed analysis of CMOs involved in cytotoxic drugs manufacturing. In addition to the regional distribution, it covers a comprehensive review of other parameters such as scale of operation, OEL limits, and fill/finish capabilities.

Chapter 7 introduces the 'one stop shop' model with respect to HPAPI and cytotoxics manufacturing. The chapter includes case studies of two leading companies, Aptuit and Corden Pharma who have adopted this model.
Chapter 8 presents the detailed forecasting analysis for both HPAPIs and cytotoxic drugs contract manufacturing. Due to the uncertain nature of the market, we have presented three different growth tracks outlined as conservative, base and optimistic scenarios.

Chapter 9 includes profiles of the key contract manufacturers in the market. Each company profile includes information such as geographical presence, manufacturing capabilities, investments, partnerships and financial performance.

Chapter 10 analyses the recent developments which have shaped the market. The chapter contains information about the investments and partnerships which have taken place in the past few years. It also contains a brief section on technological advancements.

Chapter 11 provides a SWOT analysis capturing the key elements likely to influence future growth.

Chapter 12 provides specific details on the emerging field of Antibody Drug Conjugates (ADCs). This new class of therapeutic agents are likely to act as one of the key drivers of the cytotoxic drugs market. The chapter contains detailed information on in house manufacturing and contract manufacturing of ADCs.

Chapter 13 is a collection of transcripts of interviews conducted with stakeholders (e.g. Helsinn and Corden Pharma) during the course of this study. In addition to detailed interviews, we had also conducted a comprehensive survey to learn more about manufacturing capabilities / capacities of about 75 players in the industry.

Chapter 14 summarises the overall report. In this chapter, we provide a recap of the key takeaways and our independent opinion based on the research and analysis described in previous chapters.

Chapter 15 is an appendix which provides tabulated data and numbers for all the figures provided in the report.

Chapter 16 is an appendix which provides a list of companies and organizations mentioned in the report.

TABLE OF CONTENTS
1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Context and Background
3.2. HPAPIs: Definition
3.2.1. Containment Measures
3.2.2. Classification of HPAPIs
3.3. Cytotoxic Drugs: Definition
3.3.1. Containment Measures
3.4. Role of CMOs in the Pharmaceutical Industry
3.4.1. Contract Manufacturing in HPAPIs and Cytotoxic Drugs

4. MARKET OVERVIEW
4.1. Chapter Overview
4.2. HPAPIs/Cytotoxic Drug Manufacturers
4.3. In-house Capabilities
4.4. Regulatory Landscape

5. HPAPI MANUFACTURING MARKET
5.1. Chapter Overview
5.2. HPAPI Capability Analysis
5.3. Analysis by Scale of Operation
5.4. Regional Analysis
5.4.1. Laboratory Scale
5.4.2. Development Scale
5.4.3. Commercial/Industrial Scale
5.4.4. Regional Distribution
5.5. Analysis by Occupational Exposure Limit (OEL)
5.6. CMOs: Production Capabilities
5.6.1. AAIPharma
5.6.2. Aesica
5.6.3. Ajinomoto Omnichem
5.6.4. Ampac Fine Chemicals
5.6.5. Aptuit
5.6.6. Asymchem Laboratories
5.6.7. Cambrex
5.6.8. Cerbios Pharma
5.6.9. Corden Pharma
5.6.10. Pfanstiehl
5.6.11. Helsinn Advanced Synthesis
5.6.12. Farmabios SpA
5.6.13. IRIX Pharmaceuticals

6. CYTOTOXIC DRUGS MANUFACTURING MARKET
6.1. Chapter Overview
6.2. Cytotoxics Capability Analysis
6.2.1. Analysis by Scale of Operation
6.3. Regional Analysis
6.3.1. Laboratory Scale
6.3.2. Development Scale
6.3.3. Commercial/Industrial Scale
6.3.4. Regional Distribution
6.3.5. Analysis by Operational Exposure Limits (OEL)
6.3.6. Fill/Finish Capacity Analysis

7. CASE IN POINT: THE 'ONE STOP SHOPS'
7.1. Introduction
7.2. Case Studies
7.2.1. Corden Pharma
7.2.2. Aptuit

8. MARKET SIZE AND FORECAST
8.1. Chapter Overview
8.2. Forecast Methodology
8.3. Cytotoxic Drugs Manufacturing Market, 2014- 2024
8.3.1. Cytotoxic Drugs Contract Manufacturing Market, 2014 - 2024
8.3.1.1. Background
8.3.1.2. Key Drivers
8.3.1.3. Overall CMO Market Forecast (Base Scenario), 2014 – 2024
8.4. HPAPI Contract Manufacturing Market, 2014-2024

9. PROFILES OF LEADING COMPANIES
9.1. Chapter Overview
9.2. Sigma-Aldrich Fine Chemicals (SAFC)
9.2.1. Financial Performance
9.2.2. SAFC Commercial: The Contract Manufacturer
9.2.3. HPAPI/Cytotoxics Drugs Contract Manufacturing Facilities
9.2.4. Investments and Expansions
9.2.5. Manufacturing Experience

9.3. Lonza
9.3.1. Financial Performance
9.3.2. HPAPI/Cytotoxics Drugs Contract Manufacturing Facilities
9.3.3. Lonza: Potency Classification System
9.3.4. Investments and Expansions
9.3.5. Other Developments

9.4. Evonik
9.4.1. Financial Performance
9.4.2. HPAPI/Cytotoxics Drugs Contract Manufacturing Facilities
9.4.3. Investments and Expansions

9.5. Carbogen Amcis
9.5.1. Financial Performance
9.5.2. HPAPI/Cytotoxics Drugs Contract Manufacturing Facilities
9.5.3. Investments and Expansions
9.5.4. Recent Partnerships and Acquisitions

9.6. Novasep
9.6.1. Financial Performance
9.6.2. HPAPI/Cytotoxics Drugs Contract Manufacturing Facilities
9.6.3. Investments and Expansions

9.7. Piramal Healthcare Pharma Solutions
9.7.1. Financial Performance
9.7.1.1. Piramal Healthcare Pharma Solutions: FY2013 Performance
9.7.2. Manufacturing Capability
9.7.3. Investments and Expansions
9.7.4. ADC Manufacturing Experience

9.8. Albany Molecular Research (AMRI Global)
9.8.1. HPAPIs and Cytotoxics Capabilities and Experience
9.8.2. Investments and Expansions
9.8.3. Financial Performance

9.9. BSP Pharmaceuticals
9.9.1. Manufacturing Capabilities
9.9.2. Manufacturing Experience
9.9.3. Investments and Future Plans

9.10. Pierre Fabre Laboratories
9.10.1. Financial Performance
9.10.2. Pierre Fabre Medicament Production (PFMP)
9.10.3. Manufacturing Capabilities
9.10.4. Manufacturing Experience

9.11. Catalent Pharma Solutions
9.11.1. Financial Performance
9.11.2. Manufacturing Capability
9.11.3. Investments and Expansions

10. RECENT DEVELOPMENTS
10.1. Chapter Overview
10.2. CMO Investments in New Facilities and Facility Expansions
10.2.1. Growing Number of Investments over the years
10.2.2. SAFC Leads the Investments Activity
10.3. Deals and Partnerships
10.3.1. Analysis by Type of Partnership
10.3.2. Trend of Partnerships
10.4. Technological Advancements
10.4.1. Prospects for Single-use Systems in High Potency/ Cytotoxics Manufacturing
10.4.2. Continuous Flow Processing

11. SWOT ANALYSIS
11.1. Chapter Overview
11.2. Strengths
11.3. Weaknesses
11.4. Opportunities
11.5. Threats

12. EMERGING FOCUS: CONTRACT MANUFACTURING OF ADCs
12.1. Background
12.2. Steps Involved in Manufacturing an ADC
12.3. Challenges Facing the ADC Manufacturers
12.4. In-House Manufacturing of ADCs
12.5. Presence of Contract Manufacturers
12.5.1. Linkers
12.5.2. Cytotoxins
12.5.3. Conjugation
12.6. CMOs Investing in ADC Capabilities
12.7. Contract Manufacturers Collaborating to Provide ADC Capabilities

13. INTERVIEW TRANSCRIPTS
13.1. Interview 1: Corden Pharma
13.2. Interview 2: Helsinn
13.3. Interview 3: Catalent Pharma Solutions
13.4. Interview 4: BSP Pharmaceuticals
13.5. Interview 5: Piramal Healthcare

14. CONCLUSION
14.1. Oncological Drugs will Lead the Demand for HPAPIs and Cytotoxics Manufacturing
14.2. Multiple Drivers to Result in a Healthy Growth Rate
14.3. CMOs Likely to Play a Pivotal Role
14.4. US and Europe will Remain Key Manufacturing Sites
14.5. A Multi-billion Dollar Rapidly Expanding Market
14.6. Concluding Remarks

15. APPENDIX I: Tabulated Data

16. APPENDIX II: List of Companies

LIST OF FIGURES

Figure 2.1 HPAPI Manufacturing: CMO Market Map
Figure 2.2 Cytotoxic Drugs Manufacturing: CMO Market Map
Figure 3.1 OEB System Used by Fresenius Kabi
Figure 3.2 Different forms of HPAPIs
Figure 5.1 HPAPI Production Facilities: Distribution by Scale of Operation
Figure 5.2 HPAPI CMOs: Regional Presence (Laboratory Scale)
Figure 5.3 HPAPI CMOs: Regional Presence (Development Scale)
Figure 5.4 HPAPI CMOs: Regional Presence (Commercial/Industrial Scale)
Figure 5.5 HPAPI Production Facilities: Regional Distribution
Figure 5.6 HPAPI CMOs: Categorization on the Basis of OELs
Figure 6.1 Cytotoxic Drugs Production Facilities: Distribution by Scale of Operation
Figure 6.2 Cytotoxic Drugs CMOs: Regional Presence (Laboratory Scale)
Figure 6.3 Cytotoxic Drugs CMOs: Regional Presence (Development Scale)
Figure 6.4 Cytotoxic Drugs CMOs: Regional Presence (Commercial/Industrial Scale)
Figure 6.5 Cytotoxic Drugs Production Facilities: Regional Distribution
Figure 6.6 Cytotoxic Drugs CMOs: Categorization on the Basis of OELs
Figure 8.1 Cytotoxic Drugs Sales Forecast, 2014 - 2024: Base Scenario (USD Billion)
Figure 8.2 ADCs: Level of Outsourcing
Figure 8.3 Cytotoxic Drugs Contract Manufacturing Market, 2014 - 2024: Base Scenario (USD Billion)
Figure 9.1 SAFC: Revenues, FY 2013 (USD Million)
Figure 9.2 SAFC Commercial: Revenues, FY 2013 (USD Million)
Figure 9.3 Lonza: Revenues, FY 2013 (USD Million)
Figure 9.4 Lonza: Potency Classification System
Figure 9.5 Evonik: Revenues, FY 2013 (USD Million)
Figure 9.6 Dishman: Revenues, FY 2013-14 (INR million)
Figure 9.7 Novasep: Revenues, FY 2013 (USD Million)
Figure 9.8 Piramal Enterprises: Revenues, FY 2013-2014 (INR Billion)
Figure 9.9 Piramal Healthcare Pharma Solutions: Revenues, FY 2012-2013 (INR Billion)
Figure 9.10 AMRI Global: Revenues, FY 2013 (USD Million)
Figure 9.11 Pierre Fabre Laboratories: Revenues, FY 2013 (USD Million)
Figure 9.12 Catalent: Revenues, FY 2013 (USD Million)
Figure 10.1 CMO Investments, 2006-2014: Split by Type of Investment
Figure 10.2 HPAPI and Cytotoxics: Leading players by Investments
Figure 10.3 HPAPIs and Cytotoxics: Distribution by Type of Partnership
Figure 10.4 HPAPI and Cytotoxics: Deals and Partnerships, 2006 - 2014
Figure 14.1 HPAPI and Cytotoxic Drugs Manufacturing Market (USD Billion) Forecast: 2014, 2019 and 2024

LIST OF TABLES

Table 3.1 OEL Levels for Handling APIs and HPAPIs
Table 3.2 SafeBridge System of Classification
Table 3.3 Comparison of Classification Systems of SafeBridge, Merck and Lonza
Table 3.4 OEB System by Merck
Table 4.1 CMOs with HPAPI and Cytotoxics Production Facilities
Table 4.2 New Entrants in HPAPI and Cytotoxic Market
Table 4.3 Pharma Companies with In-house HPAPI and Cytotoxics Production Facilities
Table 4.4 US Guidelines for Handling Hazardous/Cytotoxic Drugs
Table 5.1 HPAPI: CMO Capability Analysis
Table 5.2 HPAPI CMOs: Analysis by OELs
Table 5.3 Aesica: Production Capacity
Table 5.4 Ajinomoto Omnichem: Production Capacity
Table 5.5 Pfanstiehl: Production Capacity
Table 5.6 Helsinn: HPAPI Production Capacity
Table 5.7 Helsinn: Cytotoxic API Production Capacity
Table 6.1 Cytotoxic Drugs: CMOs Capability Analysis
Table 6.2 Cytotoxic Drugs CMOs: Analysis by Occupational Exposure Limits (OELs)
Table 6.3 Cytotoxic Drugs CMOs: Fill/Finish Capability Analysis
Table 6.4 Cytotoxic Drugs CMOs: Distribution by Packaging Form
Table 7.1 Companies Providing One Stop Shop Services
Table 7.2 Corden Pharma: Production Facilities
Table 7.3 Corden Pharma: Production Capacity of Cytotoxic Drugs
Table 7.4 Corden Pharma: Acquisitions/Expansions
Table 7.5 Aptuit: Acquisitions/Expansions
Table 7.6 Aptuit: Production Facilities
Table 10.1 CMO Investments, 2006-2014
Table 10.2 HPAPI and Cytotoxics: Deals and Partnerships, 2003-2014
Table 12.1 HPAPI and Cytotoxics: SWOT Analysis
Table 12.1 List of Contract Manufacturers and Their Capabilities in ADC Manufacturing
Table 15.1 HPAPI Production Facilities: Regional Distribution
Table 15.2 HPAPI CMOs: Categorization on the Basis of OELs
Table 15.3 Cytotoxic Drugs Production Facilities: Regional Distribution
Table 15.4 Cytotoxic Drugs CMOs: Categorization on the Basis of OELs
Table 15.5 Cytotoxic Drugs Sales Forecast, 2014 - 2024: Base Scenario (USD Billion)
Table 15.6 Cytotoxic Drugs Sales Forecast, 2014 - 2024: Conservative Scenario (USD Billion)
Table 15.7 Cytotoxic Drugs Sales Forecast, 2014 - 2024: Optimistic Scenario (USD Billion)
Table 15.8 Cytotoxic Drugs Contract Manufacturing Market, 2014 - 2024: Base Scenario (USD Billion)
Table 15.9 Cytotoxic Drugs Contract Manufacturing Market, 2014 - 2024: Conservative Scenario (USD Billion)
Table 15.10 Cytotoxic Drugs Contract Manufacturing Market, 2014 - 2024: Optimistic Scenario (USD Billion)
Table 15.11 HPAPIs Contract Manufacturing Market, 2014 - 2024: Base Scenario (USD Billion)
Table 15.12 HPAPIs Contract Manufacturing Market, 2014 - 2024: Conservative Scenario (USD Billion)
Table 15.13 HPAPIs Contract Manufacturing Market, 2014 - 2024: Optimistic Scenario (USD Billion)
Table 15.14 SAFC: Revenues, FY 2013 (USD Million)
Table 15.15 SAFC Commercial: Revenues, FY 2013 (USD Million)
Table 15.16 Lonza: Revenues, FY 2013 (USD Million)
Table 15.17 Evonik: Revenues, FY 2013 (USD Million)
Table 15.18 Dishman: Revenues, FY 2013-14 (INR Million)
Table 15.19 Novasep: Revenues, FY 2013 (USD Million)
Table 15.20 Piramal Enterprises: Revenues, FY 2013-14 (INR Billion)
Table 15.21 Piramal Healthcare Pharma Solutions: Revenues, FY 2012-13 (INR Billion)
Table 15.22 AMRI Global: Revenues, FY 2013 (USD Million)
Table 15.23 Pierre Fabre Laboratories: Revenues, FY 2013 (USD Million)
Table 15.24 Catalent: Revenues, FY 2013 (USD Million)
Table 15.25 CMO Investments, 2006-2014: Split by Type of Investment
Table 15.26 HPAPI and Cytotoxics: Leading players by Investments
Table 15.27 HPAPIs and Cytotoxics: Distribution by Type of Partnership
Table 15.28 HPAPI and Cytotoxics: Deals and Partnerships, 2006-2014

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HPAPIs and Cytotoxic Drugs Manufacturing Market, 2014 - 2024

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