Reportlinker Adds Pharmaceutical Contract Manufacturing: Industry and Market Prospects 2010-2025

Oct 07, 2010, 12:13 ET from Reportlinker

NEW YORK, Oct. 7 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Pharmaceutical Contract Manufacturing: Industry and Market Prospects 2010-2025

http://www.reportlinker.com/p0306324/Pharmaceutical-Contract-Manufacturing-Industry-and-Market-Prospects-2010-2025.html

Report Details

-- opportunities and challenges for the sector and its customers

How will the contract manufacturing sector adapt to the needs of pharma from 2010 onwards? Our new report will show you trends and prospects there. How will the sector and its customers face challenges and opportunities? We show commercial benefits for the pharma contract manufacturing sector and its customers, including revenue trends for 2010-2025. You can have that report today, staying ahead.

Contract manufacturing is an expanding sector, with rising prominence. Which of its segments will grow fastest from 2010? What are the commercial trends to watch? How will companies perform? You will discover how the worldwide market for pharmaceutical contract manufacturing will perform from 2010 to 2025.

Contract manufacturing services in emerging countries are increasingly prominent. That trend is accelerated by rising numbers of contract manufacturing organisations (CMOs) in those countries and the globalisation of pharma manufacturing. Our report shows how you can benefit, saving time and aiding your work.

This report covers all the important considerations for those within the contract pharma manufacturing industry. We also provide an understanding of the sector for companies that are considering the outsourcing of production. This sector will expand and extend its capabilities from 2010 onwards.

Pharma contract manufacturing has been changing, a trend that will continue. Cost-efficiencies and rapid time-to-market are crucial. There is rising competition and demand. Increasingly specialised requirements will appear – especially for biological products. Demand for APIs will particularly influence contract manufacturing from 2010 onwards. Our report shows you its technological and commercial potential, revealing opportunities and challenges.

Analysis of the pharma contract manufacturing sector to meet your needs

Our new report examines the contract manufacturing sector critically. We harness primary and secondary research to meet your needs. We provide revenue forecasts, market share analyses and other data. You will discover market strengths, weaknesses, opportunities and threats. We include many tables, figures and expert interviews, as shown in the contents listing with this message.

Why you should buy Pharmaceutical Contract Manufacturing: Industry and Market Prospects 2010-2025

Our report gives you the following benefits in particular:

  • You will receive hard data for the contract manufacturing sector – and much more – including our revenue predictions from 2010 to 2025
  • You will receive analyses for the overall market and its main components, helping you to stay ahead
  • You will find out potential revenues in leading national markets (US, Japan, Germany, France, UK, Italy, Spain, India, China) from 2010 to 2025
  • You will discover how the pharmaceutical contract manufacturing sector will change and adapt from 2010 to 2025
  • You will find out how the sector can deliver improved services for APIs, finished dosage forms and other requirements
  • You will discover opportunities for established companies and new market entrants from 2010 to 2025, as well as their customers
  • You will discover the drivers, restraints, competition and opportunities influencing the sector
  • You will discover expert views from our survey, including full interview transcripts
  • You will find out where contract manufacturing is heading – technologically and commercially – from 2010 onwards.

Our study gives you answers and trends, saving you time and aiding your decisions.

You can have this report today

Our new report can benefit everybody interested in pharmaceutical manufacturing. We forecast commercial potential, discovering trends. Do you want to harness those opportunities? Please let us know how we can help. You can stay ahead by ordering our report now.

Table of Contents

1. Executive Summary

1.1 Contract Pharma Manufacturing 2010-2025

1.2 Aims, Scope and Format of the Report

1.3 Research & Analysis Methods

2. Introduction to Pharma Outsourcing of Manufacturing

2.1 Contract Pharma Described

2.1.1 Evolving Nature of Contract Research Organisations (CROs) and Contract Manufacturing Organisations (CMOs)

2.2 Contract Development and Manufacturing Organisations (CDMO)

2.3 Why Are Pharma Companies Interested in Contract Pharma?

2.3.1 Small/Mid-sized Pharma and Biotech Have a Flexible Attitude to Outsourcing

2.3.2 Lack of Capacity is Still a Major Reason to Outsource

2.3.3 Tactical vs. Strategic Use of Outsourcing

2.4 The Changing Nature of the Pharmaceutical Market is Affecting the CRM Market

2.4.1 The Rise of Generics

2.4.2 Pipelines are Becoming Expensive

2.4.3 The Decline of the Traditional Blockbuster

2.5 Biopharmaceutical Drug Discovery and Development by Contract Pharma Companies will Continue to Increase

2.6 Disadvantages of Outsourcing in the Pharmaceutical Industry Can be Overcome

3. Regulatory Aspects of Pharma Outsourcing for Manufacturing

3.1 Legal Liabilities and Regulatory Considerations in Outsourced Manufacturing

3.2 Summary of GMP Requirements

3.3 Compliance with FDA Provisions is Vital

3.4 EU Regulations and the Qualified Person Role

3.5 Q7A Guidance for Active Pharmaceutical Ingredient (API) and Excipient Production

3.6 Harmonisation of GMP Standards

3.7 EU API Makers for Good Manufacturing Practices Inspections

3.8 Enforcing cGMP Compliance for APIs in EU

3.9 EU Requirements for Outsourcing Services

3.10 Good Manufacturing Practice (GMP) Compliance

3.11 API Requirements Challenge Outsourcing Services from China

3.12 Summary: Globalisation Benefits Pharma Harmonisation

4. The Outsourcing Decision

4.1 Reasons to Outsource

4.1.1 Outsourcing as a Tactical Decision

4.1.2 Outsourcing as a Strategic Decision

4.2 Cost-Benefit Analysis of Outsourcing

4.3 Risks Associated with Outsourcing Incur Hidden Costs

4.3.1 Errors and Delays Can Cost Millions

4.3.2 Regulatory Compliance Must be Assured

4.3.3 IP and Other Sensitive Data May be at Risk

4.3.4 Management of Outsourcing Requires Continued Monitoring

4.4 Technology Transfer Considerations

4.5 The Virtual Company

4.5.1 'Virtuality' Helps Control Rising Costs

4.5.2 Strong Project and Operations Management is Vital

4.5.3 The Challenges of Virtual Companies are Relevant Across the Industry

4.6 Key Requirements for Successful Outsourcing

4.6.1 Trust and Accountability

4.7 Summary: Planning the Guiding Principle for Outsourcing

5. Pharma Contract Manufacturing Industry and Market 2010-2025

5.1 The World Contract Manufacturing Market in 2010

5.2 Growing Market for Contract Manufacturing Services

5.2.1 Revenue Forecast for Total Pharma Contract Manufacturing Market, 2010-2016

5.2.2 Revenue Forecast for Total Pharma Contract Manufacturing Market, 2017-2025

5.3 Breakdown of the Pharma Contract Manufacturing Market

5.3.1 Revenue Forecast for API Market, 2010-2016

5.3.2 Revenue Forecast for API Market, 2017-2025

5.3.3 Revenue Forecast for Dosage Forms Market, 2010-2016

5.3.4 Revenue Forecast for Dosage Forms Market, 2017-2025

5.4 Leading National Markets for Pharma Contract Manufacturing, 2010-2025

5.4.1 The US Pharma Contract Manufacturing Market, 2010-2025

5.4.2 The Japanese Pharma Contract Manufacturing Market, 2010-2025

5.4.3 The Leading European Pharma Contract Manufacturing Markets, 2010-2025

5.4.4 Emerging Pharma Contract Manufacturing Markets

5.4.5 The Indian Pharma Contract Manufacturing Market, 2010-2025

5.4.6 The Chinese Pharma Contract Manufacturing Market, 2010-2025

5.5 Summary of the Chapter

6. Contract Manufacturing Sector to Provide Marked Benefits to Clients

6.1 Reasons for Outsourcing

6.2 Commercial Drivers of Outsourcing

6.3 Commercial Restraints for Outsourcing

6.4 API Manufacturers Closely Linked with Innovative Pharmaceutical Developers

6.5 Various Outsourcing Partners

6.6 Selecting an Appropriate CMO

6.7 Management of the Supply Chain for Cost-Efficient Contract Manufacturing

6.8 Mergers and Acquisitions for Pharmaceutical Manufacturing

6.8.1 Alliances with CMOs – a Growing Trend in the US

6.8.2 Patheon Forms Alliance with India's Kemwell

6.9 Interview with Manish Badonia, Cadila

6.9.1 Contract Manufacturing Outsourcing to Asia will Grow due to Cost Competitiveness

6.9.2 Alliance Formation for Moving up the Value Chain

6.9.3 Quality Control for Contract Pharma to Improve Further

6.10 Contract Pharma for Biotech Products

6.10.1 Failure in Early Efforts in Contract Biologic Manufacturing

6.10.2 Cost Benefits of Outsourced Manufacturing in Biotech Sector

6.10.3 The Future of Pharma Biotech Outsourcing

6.10.4 Custom Peptides are an Opportunity for APIs to Move up the Value Chain

6.10.5 One More Step for Outsourcing Contract Pharma Manufacturing to Asia

6.11 Western Companies Can Compete by Moving into Speciality API Manufacturing

6.12 Contract Pharma for Improved Process Tools

6.13 Chinese API Export Growing Rapidly

6.14 Outsourcing to Low-Cost Geographic Areas

6.15 Low Cost Services in India and China Drive Prices Down

6.16 Main Tendencies in Current Asian IP Law

6.17 Patent Protection Status in Indian Pharmaceutical Industry

6.18 Recommendation for Improvement of China's Intellectual Property Rights

6.19 Interview with Dr Zhang Zhicheng, National Intellectual Property (IP) Strategy Formulation Office, SIPO, China

6.19.1 International Framework: IP Protection for Contract Manufacturing

6.19.2 IP Holders Get the Profits

6.19.3 Changing IP Situation in the Developing Countries

6.19.4 Innovation-Oriented Industry Development in China

7. The Pharma Contract Manufacturing Sector in India

7.1 Contract Manufacturing in India

7.2 Drivers for Contract Manufacturing Outsourcing to India

7.3 Contract Manufacturing and Role of Indian Companies

7.3.1 Outsourcing for Generics

7.3.2 Sourcing Generics from Non-Competitors

7.3.3 Divis Laboratories' Business Model

7.3.4 Granules India in Production of Generic Prescription Medicines and OTCs

7.3.5 Matrix Acquired by PharmaLinkFHI/Novella, a Global CRO

7.3.6 Neuland Focused on Anti-Bacterials

7.3.7 Natco Chose Chronic Diseases

7.4 Enforcing cGMP Compliance for APIs in EU

7.5 Expansion of Indian Biotechnology Sector

7.6 Interview with Dr Jagdish N Sheth, Business School, Emory University

7.6.1 India's Key Strength

7.6.2 India's Edge over China in Pharmaceutical Business

7.6.3 Need for Routine Inspection of Outsourcing Sites

7.6.4 Need for Creation of Economic Zone for Pharmaceutical Industry

7.6.5 India as an Emerging Market

7.6.6 Vertical Integration Recommended for India's Companies

7.6.7 India's Emergence as a Major Pharmaceutical Market

8. Contract Pharma for Specialised Areas

8.1 Value-Added Services and Contract Pharma

8.2 One-Stop Shop (CRO and CMO)?

8.3 Interview with Manish Badonia, Cadila

8.3.1 One-Stop Shop: CROs and CMOs

8.3.2 Value-Added Services in Global Settings

8.4 Interview with Wesley Wheeler, Patheon

8.4.1 Outsourcing for Analytical Testing Services

8.5 CMOs Venture into Development and Product Extensions

8.6 The Use of CROs in Drug Discovery and Development is Increasing in Pharma Industry

8.6.1 Contract Research for Drug Discovery at Suven Life Sciences

8.7 Interview with Dr Debra Sponholtz, Chembiotek

8.7.1 CROs Offer a Full Range of Services

8.8 Outsourcing Electronic Data Management

8.9 Outsourcing of Data Management in India

8.9.1 GlaxoSmithKline to Outsource Data Management

8.9.2 Wyeth (Pfizer): Outsourced Data Management

8.10 Planning Required for Regulatory Affairs Outsourcing

8.11 Outsourcing Bioequivalence Studies for Generic Drugs

8.12 Requesting a Waiver from a Bioequivalence Trial

8.13 Bioequivalence Studies for New Drug Applications

8.14 Interview with Helmut Schutz, BEBAC

8.14.1 When in Vivo Bioequivalent Studies are Waived for ANDA

8.14.2 Success of Outsourcing Dissolution Testing/ Bioequivalence Studies

8.14.3 Success of Off-Shoring in Vivo Bioequivalence Studies to India

8.15 Interview with Dr Daniel Abran, Sandoz

8.15.1 Waivers of in Vivo BE Studies (Biowaivers) for Abbreviated New Drug Applications

8.15.2 Comparative Clinical Trial Requirement for ANDA

8.16 Interview with Manish Badonia, Cadila

8.16.1 Prospects for Outsourcing Bioequivalence Studies

8.17 Outsourced Biostorage Becomes a Strategic Consideration

8.18 Contract Pharma for Lyophilisation

8.19 Contract Packaging Services

8.19.1 Contract Packaging is Not Just Boxes and Packs

8.19.2 Advantages Offered by Contract Packaging Organisations

9. Conclusions from this Study

9.1 Growth Rates will Vary According to Sector

9.2 Contract Pharma Manufacturing Encompasses Requirements in Biotechnology

9.3 Outsourcing for Value-Added Services

9.4 Concluding Remarks

List of Tables

Table 2.1 Top 10 Pharma Biotech Products, 2009

Table 2.2 Top 10 Biotech Companies: Revenues and Market Shares, 2009

Table 5.1 Pharmaceutical Contract Manufacturing: World Revenue Forecast, 2010-2016

Table 5.2 Pharmaceutical Contract Manufacturing: World Revenue Forecast, 2017-2025 Table 5.3 API Market: World Revenue Forecast, 2010-2016

Table 5.4 API Market: World Revenue Forecast, 2017-2025

Table 5.5 Finished Dosage Forms Market: World Revenue Forecast, 2010-2016

Table 5.6 Finished Dosage Forms Market: World Revenue Forecast, 2017-2025

Table 5.7 Pharma Contract Manufacturing Market: World Revenue Forecasts by Class, 2010-2016

Table 5.8 Pharma Contract Manufacturing Market: World Revenue Forecasts by Class, 2017-2025

Table 5.9 Pharma Contract Manufacturing (CM) National Market Forecasts, 2010-2015, 2020 & 2025

Table 6.1 Alliances for APIs in India, 2010

Table 6.2 Relationship Build-Up for Contract Manufacturing in India, 2010

Table 6.3 SWOT Analysis for Contract Manufacturing Services from Developing Countries, 2010

Table 6.4 Top US DMF Holders in India and China, 2007-2008

Table 7.1 FDA-Approved Manufacturing Sites in India, 2010

Table 9.1 Pharma Contract Manufacturing Market: World Revenue Forecast, 2010, 2012, 2015, 2018, 2020 & 2025

List of Figures

Figure 2.1 Examples of Contract Services During the Pharma Product Lifecycle, 2010

Figure 2.2 The Role of Contract Pharma Organisations in Drug Development, 2010

Figure 2.3 Comparison of R&D Costs and the Number of Approved NMEs, 2010

Figure 5.1 Pharmaceutical Contract Manufacturing: World Revenue Forecast, 2010-2016

Figure 5.2 Pharmaceutical Contract Manufacturing: World Revenue Forecast, 2017-2025

Figure 5.3 API Market: World Revenue Forecast, 2010-2016

Figure 5.4 API Market: World Revenue Forecast, 2017-2025

Figure 5.5 Finished Dosage Forms Market: World Revenue Forecast, 2010-2016

Figure 5.6 Finished Dosage Forms Market: World Revenue Forecast, 2017-2025

Figure 5.7 Pharma Contract Manufacturing Market: World Revenue Forecasts by Class, 2010-2025

Figure 5.8 US Pharma CM Market: Revenue Forecast, 2010-2025

Figure 5.9 Other Leading Pharma CM National Markets: Revenue Forecasts, 2010-2025

Figure 5.10 Pharma CM Revenue Shares in Leading National Markets, 2010

Figure 5.11 Pharma CM Revenue Shares in Leading National Markets, 2015

Figure 5.12 Pharma CM Revenue Shares in Leading National Markets, 2020

Figure 5.13 Pharma CM Revenue Shares in Leading National Markets, 2025

Figure 6.1 Top Ten Biotech Drugs: World Sales, 2009

Figure 7.1 Path up the Value Chain for Indian Pharma Companies, 2010

Figure 9.1 Pharma Contract Manufacturing Market: Revenue Trends, Overall and by Class, 2009-2025

Companies Listed

Abbott Laboratories

Accenture

Actelion Pharmaceuticals

Aditya Dispomed Products

Advanced Biotech Products

Advanced Medical Optics

Advanced Micronic Devices

Advantage Dental Laboratories

Alps International

Altana

American Ortho-Tech

Amgen

Anaesthetics India

Angiosyn

Angiplast

Anhui BBCA Biochemical

Apothecaries Sundries Manufacturing Company

Appasamy Associates

Appasamy Ocular Devices

Ashva Technologies

Aurobindo Pharma

Aurolab

Avecia

Axitec

Baxter International

BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies

Bharat Enterprises

Bilink International,

Biogen Idec

Biogenex Life Sciences

Biotech Vision Care

Bristol-Myers Squibb

Cadila Pharmaceuticals

Carbogen Amcis

Catalent Pharma Solutions

Celgene

Celltrion

Cephalon

Cephas Medical

Ceradyne India Ceramics

Chembiotek

Chifeng Arker Pharmaceutical Technology

Chinese State Food and Drug Administration (SFDA)

Chongqing Carelife Pharmaceutical

Chongqing Daxin Pharmaceutical

Clininvent

Consultancy Services for Bioequivalence and Bioavailability Studies (BEBAC, Austria)

Covance

CSL

Cyber Approach

Dabur India

Dahlgren India

Damon Biotech

Degania Medical Devices

Dishman Group

Divis Laboratories

Dr. Reddy's Laboratories

Dr. Sabharwal's Manufacturing Labs

Dr. Sabharwal's Medicals

Dr. Sabharwal's Wound Care

Eastern Medikit Limited

Eclipsys India

Eli Lilly

Emory University

Encube Ethicals

Enkay (India) Rubber Co.

Epsilon Eye Care

eReady Monitors

Essilor Manufacturing

European Medicines Agency (EMA/EMEA)

Flexit Laboratories

Food and Drug Administration (FDA, US)

G K B Rx Lens

Ganko Opticians

GE Medical Systems (India)

General Surgical Company

Genetech

Geneva

Genzyme Corp

George Philips Medical Engineering

Gilead Sciences

Gillette Diversified Operations

Gkb Ophthalmics

Gkb Rx Lens

GlaxoSmithKline

Glenmark Pharmaceuticals

Gpc Medical

Grandeur Exports

Granules India

Gst Corporation

H.P. Industries

Harmony Plastics

Hero Exports

Hetero Drugs

Himedia Laboratories

Hindustan Syringes & Medical Devices

Hll Lifecare

Hollister Medical India

Hollister-Stier Laboratories

Hospital Equipment Manufacturing Company (India)

Hyperion Source

Ig Dental

Indica Chemical Industries

Indo Webal Surgical

Indo-German Surgical Corporation

Indus Medicare

Institute for OneWorld Health

Intermarket India Private Limited

Invitron

IPCA Laboratories

Iscon Surgicals

Johnson & Johnson

J.K. Ansell

Jai Surgicals

Jewel Consumer Care

JJ Orthodontics

Johari Digital Healthcare

Johnson & Johnson

Jubilant Organosys

Jullundur Surgical Works

Kanam Latex Industries

Kanam Latex Industries

Kdans Surgical

Kemwell

Khosla Surgical Industries

Kiran Medical Systems

Labotech Microscopes India

Larsen & Toubro

Laxmi Dental Export

Laxmi Electronics Moulds & Precision Engg

Lifeline Systems

LM First Aid Products

Lonza Group

Lupin Pharmaceuticals

M/S Orthopaedic Appliance Company

M/S Osi

Madhu Instruments

Marck Biosciences

Marian Personal & Hygiene Care Products

Matrix Clinical

Mcm Overseas Agencies

Medico Electrodes International

Medicure Instruments

Meditec Devices

Medsynaptic

Medtech Products

Merck & Co.

MGRM Medicare

Ministry of Science and Technology (India)

Modern Orthodontics

Mylan Pharmaceuticals

Natco Pharma

National Biotechnology Regulatory Authority (NBRA, India)

National Health Service (NHS, UK)

National Institutes of Health (NIH, US)

National IP Strategy Formulation Office (NIPSO, China)

Neuland Laboratories

Nicholas Piramal

Nipro Pharma Corporation

Northeast General Pharmaceutical Factory

Novartis

Novella Clinical

Novo Nordisk

Orchid Chemicals and Pharmaceuticals

Patheon

Perigo

Pfizer

PharmaLinkFHI

Polymed Therapeutics

Quintiles

Ranbaxy Laboratories

Rhodia Group

Roche

Sandoz

Sanofi-Aventis

Schering-Plough

Shadong XINHUA Pharm

Shandong New Time Pharmaceutical

Shanghai Sunve Pharmaceutical

Shasun Pharma Solutions

Solvay Pharmaceuticals

State Food and Drug Administration (SFDA, China)

Sun Pharmaceutical Industries

Suven Life Sciences

Takeda

Tata Consulting Services

The National Biotechnology Regulatory Authority (NBRA)

UCB

Verax Biomedical

Vetter Pharma Fertigung

Wockhardt

World Trade Organisation (WTO)

Wyeth

Zhejiang Jiuzhou Pharmaceutical

Zhejiang Medicine

Zhejiang NHU

Zhejiang Supor Pharmaceuticals

Zyday Cadila

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Pharmaceutical Industry: Pharmaceutical Contract Manufacturing: Industry and Market Prospects 2010-2025

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