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Key Market Insights

• Presently, close to 500 players claim to have the required capabilities to provide a wide array of services for pharmaceutical drug development across preclinical, clinical and commercial scales.
• The market is characterized by the presence of both established players and new entrants that offer end-to-end services, ranging from pre-formulation studies to regulatory support.
• With more than 1,350 facilities, pharmaceutical contract manufacturers have established global presence; majority of these players are based in emerging geographies.
• In order to meet the rising demand for APIs and finished products, CMOs have made elaborate investments to expand their existing capacities and capabilities; this trend is most pronounced in the US and India.
• In pursuit of a competitive edge and to eventually establish themselves as one-stop shops, stakeholders are actively consolidating their capabilities related to small molecule manufacturing through mergers and acquisitions.
• The installed global contract manufacturing capacity, spread across various geographies, is presently estimated to be close to 160 million litres.
• Though existing capacity is sufficient to meet the current annual demand of small molecule APIs, we anticipate that stakeholders will continue to invest in building incremental capacity to meet the long-term demand.
• Increase in number of approvals and manufacturing complexity related to small molecule drugs is anticipated to drive the growth in contract manufacturing market at a CAGR of 6.5%, till 2030.
• The projected future opportunity is likely to be well-distributed, in terms of service revenues, across different types of packaging forms, end-users and key geographical regions.

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Table of Contents

1. 
   PREFACE

1.1.                       Scope of the Report

1.2.                       Research Methodology

1.3.                       Key Questions Answered

1.4.                       Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

3.1.                       Chapter Overview

3.2.                       Types of Manufacturers

3.3.                       Overview of Pharmaceutical Contract Manufacturing

3.4.                       Evolution of Pharmaceutical Contract Manufacturing

3.4.1.                    Traditional Pharmaceutical CMOs

3.4.2.                    Modern Pharmaceutical CMOs

3.5.                       Need for Outsourcing in the Pharmaceutical Industry

3.6.                       Recent Trends in the Pharmaceutical Contract Manufacturing Industry

3.6.1.                    Tactical Partnerships

3.6.2.                    Integrated End-to-End Business Model

3.6.3.                    Software Service Providers             

3.7.                       Services Offered by CMOs

3.8.                       Key Considerations While Selecting a CMO Partner

3.9.                       Risks and Challenges Associated with Outsourcing Pharmaceutical                                                              Manufacturing Operations

4. REGULATORY LANDSCAPE FOR PHARMACEUTICAL CONTRACT MANUFACTURERS

4.1.                       Chapter Overview

4.2.                       Regulatory Guidelines in North America

4.2.1.                    The US Scenario

4.2.2.                    Canadian Scenario

4.3.                       Regulatory Guidelines in Europe

4.4.                       Regulatory Guidelines in Asia-Pacific and Rest of the World

4.4.1.                    Chinese Scenario

4.4.2.                    Indian Scenario

4.4.3.                    Japanese Scenario

4.4.4.                    South Korean Scenario

4.4.5                     Australian Scenario

4.4.6.                    Brazilian Scenario

4.5.                       Analysis of Pharmaceutical CMOs by Approval Received from Regulatory Authorities

4.6.                       Regional Summary of Regulatory Scenario (Bubble Analysis)

5. PHARMACEUTICAL CMOs: CURRENT MARKET LANDSCAPE

5.1.                       Chapter Overview

5.2.                       Pharmaceutical CMOs: List of Industry Players

5.2.1.                    Analysis by Year of Establishment

5.2.2.                    Analysis by Company Size

5.2.3.                    Analysis by Location of Headquarters

5.2.4.                    Analysis by Type of Business Segment

5.2.5.                    Analysis by Type of API Manufactured

5.2.6.                    Analysis by Type of FDF Offered

5.2.7.                    Analysis by Type of Molecule

5.2.8.                    Analysis by Type of Service(s) Offered

5.2.9.                    Analysis by Type of Primary Packaging Form Offered

5.2.10.                  Analysis by Scale of Operation

5.2.11.                  Analysis by Location of Manufacturing Facility

5.2.11.1 Pharmaceutical Contract Manufacturing Facilities in North America

5.2.11.2 Pharmaceutical Contract Manufacturing Facilities in Europe

5.2.11.3 Pharmaceutical Contract Manufacturing Facilities in Asia-Pacific and Rest of the World

6. REGIONAL CAPABILITY

6.1.                       Chapter Overview

6.2.                       Key Assumptions and Methodology

6.3.                       Regional Capability Analysis of Pharmaceutical CMOs

6.3.1                     Analysis of CMOs based in North America

6.3.2.                    Analysis of CMOs based in Europe

6.3.3.                    Analysis of CMOs based in Asia-Pacific and Rest of the World

7. COMPANY PROFILES

7.1.                       Chapter Overview

7.2.                       Key Benefits Key Benefits Offered by the One-Stop-Shop Model

7.3                        Profiles of Players Operating as One-Stop-Shops

7.4.                       North America

7.4.1.                    AMRI Global

7.4.1.1.                 Company Overview

7.4.1.2.                 Service Portfolio

7.4.1.3.                 Manufacturing Capabilities and Facilities

7.4.1.4.                 Recent Developments and Future Outlook

7.4.2.                    Altasciences

7.4.2.1.                 Company Overview

7.4.2.2.                 Service Portfolio

7.4.2.3.                 Manufacturing Capabilities and Facilities

7.4.2.4.                 Recent Developments and Future Outlook

7.4.3.                    Cambrex

7.4.3.1.                 Company Overview

7.4.3.2.                 Service Portfolio

7.4.3.3.                 Manufacturing Capabilities and Facilities

7.4.3.4.                 Recent Developments and Future Outlook

7.4.4.                    Catalent

7.4.4.1.                 Company Overview

7.4.4.2.                 Financial Information

7.4.4.3.                 Service Portfolio

7.4.4.4.                 Manufacturing Capabilities and Facilities

7.4.4.5.                 Recent Developments and Future Outlook

7.4.5.                    DPT Laboratories

7.4.5.1.                 Company Overview

7.4.5.2.                 Service Portfolio

7.4.5.3.                 Manufacturing Capabilities and Facilities

7.4.5.4.                 Recent Developments and Future Outlook

7.4.6.                    Thermo Fisher Scientific

7.4.6.1.                 Company Overview

7.4.6.2.                 Financial Information

7.4.6.3.                 Service Portfolio

7.4.6.4.                 Manufacturing Capabilities and Facilities

7.4.6.5.                 Recent Developments and Future Outlook

7.5.                       Europe

7.5.1.                    Aenova Group

7.5.1.1.                 Company Overview

7.5.1.2.                 Financial Information

7.5.1.3.                 Service Portfolio

7.5.1.4.                 Manufacturing Capabilities and Facilities

7.5.1.5.                 Recent Developments and Future Outlook

7.5.2.                    Almac

7.5.2.1.                 Company Overview

7.5.2.2.                 Service Portfolio

7.5.2.3.                 Recent Developments and Future Outlook

7.5.3.                    Corden Pharma

7.5.3.1.                 Company Overview

7.5.3.2.                 Service Portfolio

7.5.3.3.                 Manufacturing Capabilities and Facilities

7.5.3.4.                 Recent Developments and Future Outlook

7.5.4.                    Fresenius Kabi

7.5.4.1.                 Company Overview

7.5.4.2.                 Financial Information

7.5.4.3.                 Service Portfolio

7.5.4.4.                 Manufacturing Capabilities and Facilities

7.5.4.5.                 Recent Developments and Future Outlook

7.5.5.                    Glatt

7.5.5.1.                 Company Overview

7.5.5.2.                 Service Portfolio

7.5.5.3.                 Manufacturing Capabilities and Facilities

7.5.5.4.                 Recent Developments and Future Outlook

7.5.6.                    Hovione

7.5.6.1.                 Company overview

7.5.6.2.                 Service Portfolio

7.5.6.3.                 Manufacturing Capabilities and Facilities

7.5.6.4.                 Recent Developments and Future Outlook

7.5.7.                    Recipharm

7.5.7.1.                 Company Overview

7.5.7.2.                 Financial Information

7.5.7.3.                 Service Portfolio

7.5.7.4.                 Manufacturing Capabilities and Facilities

7.5.7.5.                 Recent Developments and Future Outlook

7.5.8.                    Siegfried

7.5.8.1.                 Company Overview

7.5.8.2.                 Financial Information

7.5.8.3.                 Service Portfolio

7.5.8.4.                 Manufacturing Capabilities and Facilities

7.5.8.5.                 Recent Developments and Future Outlook

7.6.                       Asia-Pacific and Rest of the World

7.6.1.                    CMIC Group

7.6.1.1.                 Company Overview

7.6.1.2.                 Financial Information

7.6.1.3.                 Service Portfolio

7.6.1.4.                 Recent Developments and Future Outlook

7.6.2.                    Nectar Lifesciences

7.6.2.1.                 Company Overview

7.6.2.2.                 Financial Information

7.6.2.3.                 Service Portfolio

7.6.2.4.                 Manufacturing Capabilities and Facilities

7.6.2.5.                 Recent Developments and Future Outlook

7.6.3.                    Syngene

7.6.3.1.                 Company Overview

7.6.3.2.                 Financial Information

7.6.3.3.                 Service Portfolio

7.6.3.4.                 Manufacturing Capabilities and Facilities

7.6.3.5.                 Recent Developments and Future Outlook

7.6.4.                    WuXi AppTec

7.6.4.1.                 Company Overview

7.6.4.2.                 Financial Information

7.6.4.3.                 Service Portfolio

7.6.4.4.                 Manufacturing Capabilities and Facilities

7.6.4.5.                 Recent Developments and Future Outlook   

8. MAKE VERSUS BUY DECISION FRAMEWORK

8.1.                       Chapter Overview

8.2.                       Assumptions and Key Parameters

8.3.                       Pharmaceutical Contract Manufacturers: Make versus Buy Decision Making

8.3.1.                    Scenario 1

8.3.2.                    Scenario 2

8.3.3.                    Scenario 3

8.3.4.                    Scenario 4

8.4.                       Concluding Remarks

9. MERGERS AND ACQUISITIONS

9.1.                       Chapter Overview

9.2.                       Merger and Acquisition Models

9.3.                       Pharmaceutical Contract Manufacturing: Mergers and Acquisitions

9.3.1.                    Cumulative Year-wise Trend

9.3.2.                    Analysis by Type of Agreement

9.3.3.                    Analysis by Type of Acquisition

9.3.4.                  Analysis by Focus Area

9.3.5.                  Analysis by Type of Business Segment

9.3.6.                    Analysis by Type of Service(s) Offered

9.3.7.                    Analysis by Scale of Operation

9.3.8.                    Analysis by Geography

9.3.9.                    Analysis by Location of Manufacturing Facility

9.3.10.                  Most Active Acquirers: Analysis by Number of Acquisitions

9.3.11.                  Analysis by Key Value Drivers

9.3.11.1.               Analysis by Year of Acquisition and Key Value Drivers

9.4.                       Key Acquisitions: Analysis by Deal Multiples

10. RECENT EXPANSIONS

10.1.                     Chapter Overview

10.2.                     Pharmaceutical Contract Manufacturing Market: Expansions

10.2.1.                  Cumulative Year-wise Distribution

10.2.2.                  Analysis by Purpose of Expansion

10.2.3.                  Analysis by Year and Purpose of Expansion

10.2.4.                  Analysis by Type of Business Segment

10.2.5.                  Analysis by Type of Molecule

10.2.6.                  Analysis by Type of Service(s) Offered

10.2.7.                  Analysis by Scale of Operation

10.2.8.                  Analysis by Capital Invested

10.2.9.                  Analysis by Location of Headquarters

10.2.10. Analysis by Purpose of Expansion and Location of Headquarters

10.2.11. Analysis by Location of Manufacturing Facility

10.2.12. Most Active Players: Analysis by Number of Recent Expansions

11. CAPACITY ANALYSIS

11.1.                     Chapter Overview

11.2.                     Key Assumptions and Methodology

11.3.                     Pharmaceutical Contract Manufacturing: Global Production Capacity

11.3.1.                  Analysis by Company Size

11.3.2.                  Analysis by Scale of Operation

11.3.3.                  Analysis by Location of Headquarters

11.3.3.1.               Analysis of Capacity Installed in North America

11.3.3.2.               Analysis of Capacity Installed in Europe

11.3.3.3.               Analysis of Capacity Installed in Asia-Pacific

11.4.                     Concluding Remarks

12. DEMAND ANALYSIS

12.1.                     Chapter Overview

12.2.                     Key Assumptions and Methodology

12.3.                     Overall Annual Demand for Small Molecule APIs, 2021-2030

12.3.1.                  Analysis by Scale of Operation

12.4.                     Correlation Between Annual Demand and Capacity

13. MARKET FORECAST

13.1.                     Chapter Overview

13.2.                     Forecast Methodology and Key Assumptions

13.3.                     Global Pharmaceutical Contract Manufacturing Market, 2021-2030

13.3.1.                  Pharmaceutical Contract Manufacturing Market, 2021 and 2030: Distribution by Business Segment

13.1.2.                  Pharmaceutical Contract Manufacturing Market, 2021 and 2030: Distribution by Type of API Manufactured

13.1.3.                  Pharmaceutical Contract Manufacturing Market, 2021 and 2030: Distribution by Type of FDF Offered

13.1.4.                  Pharmaceutical Contract Manufacturing Market, 2021 and 2030: Distribution by Scale of Operation

13.1.5.                  Pharmaceutical Contract Manufacturing Market, 2021 and 2030: Distribution by Type of Packaging Form

13.1.6.                  Pharmaceutical Contract Manufacturing Market, 2021 and 2030: Distribution by Type of End-Users

13.1.7.                  Pharmaceutical Contract Manufacturing Market, 2021 and 2030: Distribution by Geography

13.1.7.1. Pharmaceutical Contract Manufacturing Market in North America, 2021-2030

13.1.7.1.1.            Pharmaceutical Contract Manufacturing Market in North America, 2021-2030: Distribution by Business Segment

13.1.7.1.2.            Pharmaceutical Contract Manufacturing Market in North America, 2021-2030: Distribution by Type of API Manufactured

13.1.7.1.3.            Pharmaceutical Contract Manufacturing Market in North America, 2021-2030: Distribution by Type of FDF Offered

13.1.7.1.4.            Pharmaceutical Contract Manufacturing Market in North America, 2021-2030: Distribution by Scale of Operation

13.1.7.1.5.            Pharmaceutical Contract Manufacturing Market in North America, 2021-2030: Distribution by Type of Packaging Form

13.1.7.1.6.            Pharmaceutical Contract Manufacturing Market in North America, 2021-2030: Distribution by Type of End-Users

13.1.7.2. Pharmaceutical Contract Manufacturing Market in Europe, 2021-2030

13.1.7.2.1.            Pharmaceutical Contract Manufacturing Market in Europe, 2021-2030: Distribution by Business Segment

13.1.7.2.2.            Pharmaceutical Contract Manufacturing Market in Europe, 2021-2030: Distribution by Type of API Manufactured

13.1.7.2.3.            Pharmaceutical Contract Manufacturing Market in Europe, 2021-2030: Distribution by Type of FDF Offered

13.1.7.2.4.            Pharmaceutical Contract Manufacturing Market in Europe, 2021-2030: Distribution by Scale of Operation

13.1.7.2.5.            Pharmaceutical Contract Manufacturing Market in Europe, 2021-2030: Distribution by Type of Packaging Form

13.1.7.2.6.            Pharmaceutical Contract Manufacturing Market in Europe, 2021-2030: Distribution by Type of End-Users

13.1.7.3. Pharmaceutical Contract Manufacturing Market in Asia-Pacific, 2021-2030

13.1.7.3.1.            Pharmaceutical Contract Manufacturing Market in Asia-Pacific, 2021-2030: Distribution by Business Segment

13.1.7.3.2.            Pharmaceutical Contract Manufacturing Market in Asia-Pacific, 2021-2030: Distribution by Type of API Manufactured

13.1.7.3.3.            Pharmaceutical Contract Manufacturing Market in Asia-Pacific, 2021-2030: Distribution by Type of FDF Offered

13.1.7.3.4.            Pharmaceutical Contract Manufacturing Market in Asia-Pacific, 2021-2030: Distribution by Scale of Operation

13.1.7.3.5.            Pharmaceutical Contract Manufacturing Market in Asia-Pacific, 2021-2030: Distribution by Type of Packaging Form

13.1.7.3.6.            Pharmaceutical Contract Manufacturing Market in Asia-Pacific, 2021-2030: Distribution by Type of End-Users

13.1.7.4. Pharmaceutical Contract Manufacturing Market in Latin America, 2021-2030

13.1.7.4.1.            Pharmaceutical Contract Manufacturing Market in Latin America, 2021-2030: Distribution by Business Segment

13.1.7.4.2.            Pharmaceutical Contract Manufacturing Market in Latin America, 2021-2030: Distribution by Type of API Manufactured

13.1.7.4.3.            Pharmaceutical Contract Manufacturing Market in Latin America, 2021-2030: Distribution by Type of FDF Offered

13.1.7.4.4.            Pharmaceutical Contract Manufacturing Market in Latin America, 2021-2030: Distribution by Scale of Operation

13.1.7.4.5.            Pharmaceutical Contract Manufacturing Market in Latin America, 2021-2030: Distribution by Type of Packaging Form

13.1.7.4.6.            Pharmaceutical Contract Manufacturing Market in Latin America, 2021-2030: Distribution by Type of End-Users

13.1.7.5.               Pharmaceutical Contract Manufacturing Market in Middle East and North Africa, 2021-2030

13.1.7.5.1.            Pharmaceutical Contract Manufacturing Market in Middle East and North Africa, 2021-2030: Distribution by Business Segment

13.1.7.5.2.            Pharmaceutical Contract Manufacturing Market in Middle East and North Africa, 2021-2030: Distribution by Type of API Manufactured

13.1.7.5.3.            Pharmaceutical Contract Manufacturing Market in Middle East and North Africa, 2021-2030: Distribution by Type of FDF Offered

13.1.7.5.4.            Pharmaceutical Contract Manufacturing Market in Middle East and North Africa, 2021-2030: Distribution by Scale of Operation

13.1.7.5.5.            Pharmaceutical Contract Manufacturing Market in Middle East and North Africa, 2021-2030: Distribution by Type of Packaging Form

13.1.7.5.6.            Pharmaceutical Contract Manufacturing Market in Middle East and North Africa, 2021-2030: Distribution by Type of End-Users

14. KEY INSIGHTS

14.1.                     Chapter Overview

14.2.                     Integrated Contract Service Providers (Heat Map Analysis)

14.3.                     Analysis by Geography

14.4.                     Analysis by Geography, Company Size and Business Segment

15. SWOT ANALYSIS

15.1.                     Chapter Overview

15.2.                     Strengths

15.3.                     Weaknesses

15.4.                     Opportunities

15.5.                     Threats

15.6.                     Comparison of SWOT Factors

16. CASE STUDY: COMPARISON OF SMALL AND LARGE MOLECULES DRUGS / THERAPIES

16.1.                     Chapter Overview

16.2.                     Small Molecule and Large Molecule Drugs / Therapies

16.2.1.                  Comparison of General Characteristics

16.2.2.                  Comparison of Key Specifications

16.2.3.                  Comparison of Manufacturing Processes

16.2.4.                  Comparison of Key Manufacturing-related Challenges            

17. CONCLUDING REMARKS

18. EXECUTIVE INSIGHTS

18.1.                     Chapter Overview

18.2.                     Ajinomoto Althea

18.2.1.                  Company Snapshot

18.2.2.                  Interview Transcript: Scott Goldstein, Ex - Director, Business Development, Drug Product Manufacturing

18.3.                     Bachem

18.3.1.                  Company Snapshot

18.3.2.                  Interview Transcript: Thomas Fruh, Ex - Chief Executive Officer

18.4.                     CiVentiChem

18.4.1.                  Company Snapshot

18.4.2.                  Interview Transcript: Bhaskar VenePalli, President and Chief Executive Officer

18.5.                     CordenPharma

18.5.1.                  Company Snapshot

18.5.2.                  Interview Transcript: Roberto Margartia, Director, Business Development

18.6.                     Helsinn Group

18.6.1.                  Company Snapshot           

18.6.2.                  Interview Transcript: Allison Vavala, Director, Commercial Development

18.7.                     Novasep

18.7.1.                  Company Snapshot

18.7.2.                  Interview Transcript: Kevin Daley, Director, Pharmaceuticals Marketing

18.8.                     Sovereign Pharma

18.8.1.                  Company Snapshot

18.8.2.                  Interview Transcript: Piyush Desai, Director, Operations

18.9.                     Wavelength Pharmaceuticals

18.9.1.                  Company Snapshot

18.9.2.                  Interview Transcript: Ilan Avni, Vice President Business Development, Marketing, and IP

19. APPENDIX I: TABULATED DATA

20. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

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