Pharmaceutical Contract Manufacturing Market, 2028

Wednesday, 06. June 2018 13:56

Dublin, June 06, 2018 (GLOBE NEWSWIRE) -- The "Pharmaceutical Contract Manufacturing Market (2nd Edition), 2018-2028" report has been added to ResearchAndMarkets.com's offering.

The Pharmaceutical Contract Manufacturing Market (2nd Edition), 2018-2028' report provides a comprehensive study on the current scenario of contract manufacturing services related to pharmaceutical products. The study features an in-depth analysis, highlighting the capabilities of a diverse set of pharmaceutical CMOs.

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.

The report features detailed transcripts of interviews held with the following stakeholders:

  • Scott Goldstein (Associate Director, Drug Product Manufacturing, Ajinomoto Althea)
  • Thomas Frh (CEO, Bachem)
  • Piyush Desai (Director, Operations, Sovereign Pharma)
  • Claire Otjes (Assistant Manager, Marketing, Batavia Biosciences)
  • Dietmar Katinger (CEO, Polymun Scientific)
  • Birgit Schwab (Senior Manager, Strategic Marketing, Rentschler Biopharma)
  • Sebastian Schuck (Head, Business Development, WACKER Biotech)
  • Bhaskar Venepalli (President and CEO, CiVentiChem)
  • Roberto Margarita (Director, Business Development, CordenPharma)
  • Allison Vavala (Senior Manager, Business Development, Helsinn Group)
  • Kevin Daley (Director, Pharmaceuticals Marketing, Novasep)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

Example Highlights

  • Over 500 companies across the world are currently offering pharmaceutical contract manufacturing services. Service providers offer a variety of pharmaceutical services; these range from formulation services, stability studies/stability testing, method development/analytical development/process development, clinical trial material manufacturing, scale-up, registration batch manufacturing, commercial production and packaging and labelling service. It is worth highlighting that several CMOs offer end-to-end services across all scales of operations; examples of such players include (in alphabetical order) Aenova, Alcami Pharma, AMRI, Catalent, CMIC Group, CordenPharma, Dalton Pharma Services, Fresenius Kabi, Hovione, Recipharm, Siegfried and WuXi AppTec.
  • At present, the market is highly fragmented and is a mix of established companies (>200 employees, 52%), mid-sized companies (>50 employees, 26%) and small-sized companies (<50 employees, 21%) offering contract manufacturing services at various scales of operations. 46% of the companies are specifically providing FDF manufacturing services while 23% are specifically providing API manufacturing services. The remaining 31% of the companies offer both API and FDF contract manufacturing services.
  • Regulatory authorities play an active role in making pharmaceutical industry one of the most highly regulated industries across the world. We observed that 79% of the CMOs have received operational approval and certification from the USFDA. This is followed by the companies that have received operational approval from the European Medicines Agency (33%), World Health Organization (30%) and UK Medicines and Healthcare products Regulatory Agency (20%). In addition, several CMOs have sought/received operational approval and certification from the regulatory bodies in other regions such as Australia, Brazil, China, Canada, India and South Africa.
  • The current global contract pharmaceutical installed manufacturing capacity is estimated to be over 115 million liters. It is also worth mentioning that, amongst all the CMOs we evaluated, established CMOs contribute a significant proportion (78%) to the overall supply. Having said that, relatively small-sized or mid-sized companies are one of the key driving forces behind the heightened pace of pharmaceutical research and development. In addition, of the total installed capacity, over 75% of the total installed capacity is being used for both clinical and commercial production.
  • Amidst increasing competition in the outsourcing domain, CMOs are actively investigating and adopting several innovative tools and strategies in order to advance the development of drugs with higher success rates and improve the overall productivity. Examples of such strategies (in no specific order) include usage of big data analytics, green chemistry (such as solvent reduction and replacement, refining a chemical route and biocatalysis to optimize API synthesis), continuous process manufacturing system, digital medicines, 3D printed pill technologies, robotics and automation instruments for packaging, adoption of improved waste management and environment friendly strategies along with the integration of cybersecurity solutions.
  • Driven by increasing global demand and rapid approval of small molecule drugs by the USFDA, we expect the overall contract manufacturing market in the pharmaceutical domain to grow at an annualized rate of 4.8% between 2018 and 2028. The growth is likely to be higher in emerging markets of Asia-Pacific and rest of the world.
  • In terms of type of API product (branded and generic), generic APIs hold the current major share of the market (84%) while the remaining share (16%) of the total outsourced API market is occupied by branded APIs. Within the contract FDF market, solid dose compounds (~50%) currently dominate the market followed by injectables (33%) and semi-solid/liquid compounds (17%). The future growth is likely to be driven by injectables dose manufacturing primarily due to increased focus on complex disease areas and the growing trend of self-administration.
  • In terms of type of FDF, the most popular type is primary packaging of tablets/capsules/blisters, which currently hold 26% of the total FDF contract manufacturing market. This is further followed by glass/plastic/dropper bottles (21%) and vials/cartridge (15%). Other packaging forms such as ampoules, ointments/gels/tubes and sachets/pouches/infusion bags also hold a considerable share of the current FDF contract manufacturing market.
  • North America currently holds the largest share (34.3%) in the overall contract manufacturing market and is anticipated to continue to grow at an annualized growth rate of 2.9%. This is followed by Asia-Pacific and Europe that account for 34.1% and 30.3% share of the overall contract manufacturing market, respectively. However, markets in Asia-Pacific are expected to grow at a significantly higher CAGR of 7.1%, owing to inherent advantages such as relatively low labor costs and less stringent regulatory constraints.

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

For more information about this report visit https://www.researchandmarkets.com/research/kgwpt8/pharmaceutical?w=12




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