Global Pharmaceutical Contract Manufacturing Market to 2028 - Highly Fragmented Market Characterized by Multiple Acquisitions and Mergers
DUBLIN, Sept. 7, 2018 /PRNewswire/ --
The "Pharmaceutical Contract Manufacturing Market (2nd Edition), 2018-2028" report has been added to ResearchAndMarkets.com's offering.
The present pipeline of pharmaceutical products is increasingly complex and requires specialized facilities, equipment and operational expertise. Small molecule drugs account for nearly 90% of the therapeutics in the pharmaceutical market. In fact, in 2017, FDA's Center for Drug Evaluation and Research approved 34 small molecule drugs; this represents an annual growth of nearly 56%, signifying the growing importance of contract manufacturing in the overall pharmaceutical industry. The costs associated with acquiring manufacturing capabilities are exorbitant and, therefore, it is difficult for companies with limited finances and capacity constraints to succeed by themselves. The aforementioned constraints have led many of the smaller players in the industry and, at times, certain pharma giants as well, to outsource a significant part of their business operations to contract service providers. Third-party service providers are known to offer significant cost-benefits, access to larger production capacities and reductions in time-to-market.
Over the years, the contract manufacturing market has grown into a prominent and promising segment of the overall pharmaceutical industry. Since 2000, close to 150 new CMOs have been established, offering cost-efficient solutions to several stakeholders in the industry.
The current global CMO market is highly fragmented but characterized by multiple acquisitions and mergers as stakeholders strive to broaden their respective service portfolios. This has enabled several CMOs to start offering end-to-end services, ranging from drug development, including preliminary R&D, preclinical and clinical trials, to commercial scale production and regulatory filings.
Despite the fact that the pharmaceutical sector is amongst the most highly regulated industries, we expect the demand for core competencies to continue to drive sponsor companies to outsource various parts of their manufacturing operations. Amidst tough competition, the availability of advanced tools and technologies is an important differentiating factor and will grant a competitive edge to certain CMOs over other stakeholders in the industry. However, given the ongoing innovation in production technologies and the steadily evolving pipeline of small molecules, the pressure on the contract manufacturing industry is expected to increase in the coming years. This is likely to require CMOs to devise and implement different business strategies and models in order to cope with the evolving demand.
One of the key objectives of this report was to evaluate the current opportunity and the future potential of the pharmaceutical contract manufacturing market over the coming decade. Based on various parameters, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2018-2028.
In addition, we have provided the likely distribution of the market based on [A] type of business segment (API and FDF), [B] regional evolution of the market covering North America (the US, Canada and Mexico), Europe (Italy, Germany, France, Spain, the UK and rest of Europe), Asia-Pacific (China, India, Japan, Australia and rest of Asia) and rest of the world, [C] type of API product (branded and generic) within the aforementioned regions, [D] type of FDFs manufactured (solids, liquids/semi-solids and injectables), [E] type of packaging forms (tablet/capsule/blister packing, ointment/gel/tube, vial, ampoule, sachet/pouch/bag, glass/plastic bottle and pre-filled syringe), [F] scale of API manufacturing (clinical, commercial, and both) and [G] size of manufacturers (small sized, mid-sized, large and very large companies).
To account for the uncertainties associated with the growth of pharmaceutical contract manufacturing market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market's evolution.
Key Topics Covered:
1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Types of Manufacturers in the Contract Manufacturing Industry
3.3. An Overview of the Pharmaceutical Contract Manufacturing Industry
3.4. Evolution of the Pharmaceutical Contract Manufacturing Industry
3.4.1. Traditional CMOs
3.4.2. Modern CMOs
3.5. The Need for Outsourcing in the Pharmaceutical Industry
3.6. Recent Trends in the Pharmaceutical Contract Manufacturing Industry
3.6.1. Tactical Partnership
3.6.2. Integrated End-to-End Business Model
3.6.3. Strategic Long-Term Alliance
3.6.4. Flexible Short-Term Partnership
3.6.5. Software Service Providers
3.7. Services Offered by CMOs
3.8. Selecting a CMO Partner
3.9. Risks and Challenges in Contract Manufacturing Industry
4. COMPETITIVE LANDSCAPE
4.1. Chapter Overview
4.2. Pharmaceutical CMOs: List of Industry Players
4.2.1. Distribution by Year of Establishment
4.2.2. Distribution by Geographical Location
4.2.3. Distribution by Company Size
4.2.4. Distribution by Type of Business Segment
4.2.5. Distribution by Type of FDF Offered
4.2.6. Distribution by Scale of Operation
4.2.7. Distribution by Type of Service Offering
4.2.8. Distribution by Location of Manufacturing Facilities
4.2.9. Distribution by Type of Primary Packaging Form Offered
5. REGULATORY LANDSCAPE FOR PHARMACEUTICAL CONTRACT MANUFACTURERS
5.1. Chapter Overview
5.2. Regulatory Guidelines in North America
5.2.1. The US Scenario
5.2.2. Canadian Scenario
5.3. Regulatory Guidelines in Europe
5.4. Regulatory Guidelines in Asia-Pacific and Rest of the World
5.4.1. Chinese Scenario
5.4.2. Indian Scenario
5.4.3. Japanese Scenario
5.4.4. South Korean Scenario
5.4.5. Australian Scenario
5.4.6. Brazilian Scenario
5.5. Pharmaceutical CMOs: Information on Approval from Various Regulatory Authorities
5.6. Bubble Analysis: Regional Regulatory Summary
6. COMPANY PROFILES
6.1. Chapter Overview
6.2. Importance of One-Stop-Shops
6.3. Company Profiles of One-Stop-Shops
6.4. Players in North America
6.4.1. Albany Molecular Research (AMRI)
6.4.2. Catalent Pharma Solutions
6.4.3. DPT Laboratories
6.4.4. Thermo Fisher Scientific (Through Acquisition of Patheon)
6.5. Players in Europe
6.5.1. Aenova Group
6.5.2. Almac Group
6.5.3. CordenPharma
6.5.4. Fresenius Kabi
6.5.5. Glatt
6.5.6. Groupe SYNERLAB
6.5.7. Hovione
6.5.8. Recipharm
6.5.9. Siegfried
6.6. Players in Asia-Pacific
6.6.1. CMIC Group
6.6.2. Nectar Lifesciences
6.6.3. WuXi AppTec
7. CASE STUDY: COMPARISON OF SMALL MOLECULES AND LARGE MOLECULES
7.1. Chapter Overview
7.2. Small Molecules and Large Molecules Drugs/Therapies
7.2.1. Comparison of Key Characteristics
7.2.2. Comparison of Manufacturing Processes
7.2.3. Comparison of Key Manufacturing Challenges
7.3. Manufacturing of Large Molecules (Biologics): List of Biopharmaceutical CMOs
8. KEY INSIGHTS
8.1. Chapter Overview
8.2. Multipotentialite Service Providers: Heat Map Analysis
8.3. Pharmaceutical CMOs: Geographical Landscape
8.4. Pharmaceutical CMOs: Analysis by Geography, Company Size and Business Segment
9. CAPACITY ANALYSIS
9.1. Chapter Overview
9.2. Key Assumptions and Methodology
9.3. Pharmaceutical Contract Manufacturing: Installed Global Capacity
9.3.1. Distribution by Size of CMOs
9.3.2. Distribution by Scale of Operation
9.3.3. Distribution by Location of Headquarters
9.3.4. Distribution by Location of Manufacturing Facilities
9.4. Concluding Remarks
10. MARKET FORECAST
10.1. Chapter Overview
10.2. Forecast Methodology and Key Assumptions
10.3. Overall Pharmaceutical Contract Manufacturing Market, 2018-2028
10.3.1. Pharmaceutical Contract Manufacturing Market for API Manufacturing, 2018-2028
10.3.2. Pharmaceutical Contract Manufacturing Market for FDF Manufacturing, 2018-2028
10.4. Pharmaceutical Contract Manufacturing Market, 2018-2028: Distribution by Regions
11. SWOT ANALYSIS
12. FUTURE OF THE PHARMACEUTICAL CONTRACT MANUFACTURING MARKET
12.1. Chapter Overview
12.2. Anticipated Growth in Outsourcing Activities
12.3. Growing Focus on Emerging Markets
12.4. Expansion of Capabilities and Emergence of One-Stop-Shops
12.5. Adoption of New Technologies and Focus on Innovation to Support Further Growth
12.6. Use of Big Data and Advanced Analytics to Improve Manufacturing Processes
12.7. Implementation of Cybersecurity Solutions to Safeguard Valuable Customer Data
12.8. Concluding Remarks
13. EXECUTIVE INSIGHTS
13.1. Chapter Overview
13.2. Ajinomoto Althea
13.3. Bachem
13.3.1. Company Snapshot
13.3.2. Interview Transcript: Thomas Frh, Chief Executive Officer
13.4. Sovereign Pharma
13.4.1. Company Snapshot
13.4.2. Interview Transcript: Piyush Desai, Director, Operations
13.5. Batavia Biosciences
13.5.1. Company Snapshot
13.5.2. Interview Transcript: Claire Otjes, Assistant Marketing Manager
13.6. Polymun Scientific
13.6.1. Company Snapshot
13.6.2. Interview Transcript: Dietmar Katinger, Chief Executive Officer
13.7. Rentschler Biopharma
13.7.1. Company Snapshot
13.7.2. Interview Transcript: Birgit Schwab, Senior Manager Strategic Marketing
13.8. WACKER Biotech
13.8.1. Company Snapshot
13.8.2. Interview Transcript: Sebastian Schuck, Head of Business Development
13.9. CiVentiChem
13.9.1. Company Snapshot
13.9.2. Interview Transcript: Bhaskar VenePalli, President and Chief Executive Officer
13.10. CordenPharma
13.10.1. Company Snapshot
13.10.2. Interview Transcript: Roberto Margartia, Business Development Director
13.11. Helsinn Group
13.11.1. Company Snapshot
13.11.2. Interview Transcript: Allison Vavala, Senior Manager, Business Development
13.12. Novasep
13.12.1. Company Snapshot
13.12.2. Interview Transcript: Kevin Daley, Market Director Pharmaceuticals
14. APPENDIX 1: TABULATED DATA
15. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
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