Authoritative Outsourcing Insights

Biopharm Knowledge Publishing is developing a series of expert Guides to key outsourcing issues in the pharmaceutical and biotechnology industries.

Biosimilars: A Growing Market
Cardiac Toxicity NEW
Central and Core Laboratories NEW
Clinical Trial Supply
Contract Research Annual Review 2011 NEW
EvaluatePharma® Yearbook - Company Performance Tables NEW
Factor Xa Inhibitors NEW
Generics in Japan NEW
Hepatitis C NEW
How to Forecast Generic Pharmaceutical Prices NEW
Immunogenicity to Biologics
Manufacturing in the Global Pharmaceuticals Industry NEW
Outlook 2011 NEW
Outsourcing Chemistry Services Made Easy
PartneringDesk Reports
Pharmaceutical Market Trends, 2010 - 2014 NEW
Quality for Biologics NEW
Systems Biology in Biotech and Pharma NEW
The Future of Biosimilars – Market Forecasts to 2015,
Opportunity Analysis and Regulatory Pathways
NEW
The Future of Contract Research Outsourcing - Market Forecasts to 2015,
Geographical Landscape and Competitive Benchmarking
NEW
The Rise of Mid-Sized Pharma
Toxicology and Pharmacology NEW
Virtual Pharma
World Market for Addiction Disorders, 2009 - 2016 NEW


Central and Core Laboratories

A definitive report on the current status and future prospects of Central Clinical Pathology Laboratories, Central ECG Analysis Laboratories and Central Bio-imaging Laboratories.

The Central and Core Laboratories market is now worth more than $2.2 billion a year and is vital to the successful development of new drugs. It is a completely outsourced and truly global business dominated by major players.

Choosing the right Central Laboratory and handling the relationship effectively is vital to the successful management of clinical trials, as is the complex business of getting samples from the patient to the laboratory.

In a publishing breakthrough this 320 page report gives comprehensive coverage of the Central Laboratories market, the major companies involved, the processes, including testing and logistics and the future challenges for the market. It is a vital resource for anyone involved in drug development, clinical trials, the central labs market and logistics.

Contents include:

  • Overview of capabilities and facilities
  • Role of Central Labs in clinical trials
  • History of the Central Labs business
  • Contract Considerations
  • Review of the current market
  • Analysis of costs
  • Financial and value analysis
  • Logistics
  • Review of leading companies
  • Regulatory and QA issues
  • Biomarkers and Central Labs
  • ECG laboratories
  • Imaging laboratories
  • Future trends and challenges

The comprehensively-referenced report is published by Biopharm Knowledge Publishing and is edited by Dr Graham Hughes, one of the leading experts on pharmaceutical outsourcing.

Contributors include:

Dr Graham Hughes
Richard Barrett
David Cockburn
Dr Colin Miller
Tim Stiles

This 320 page report provides a full picture of a fast-growing industry now worth more than $2 billion and vital to the success of drug development. It also gives a complete guide to managing the outsourcing and logistics process.

At just £1195 ($1850) for a 320 page report, Central and Core Laboratories is vital information for an affordable price. The report is required reading for executives in pharmaceutical companies, contract research organisations and laboratories, logistics and transportation companies as well as equipment suppliers and those investing in this expanding business area.

Download the table of contents Click for PDF file.

Download the list of tables & graphs Click for PDF file.

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click here to order

Contract Research Annual Review 2011

The Complete Picture of the Contract Research Market

The contract research market grew to $28 billion last year, increasing by 15%. But that top line figure conceals a rapidly changing market and a sharp fall in profitability. Many major CROs have seen profit fall by more than 50%. The industry is rapidly re-shaping itself to match the changing needs of a pharmaceutical industry that is realigning its R&D strategies to improve effectiveness and to face a new set of demands from the market. 22 strategic alliances with CROs were announced by major pharma companies in 2010/11 as the industry was finally forced to embrace the idea of strategic outsourcing. This review provides a complete picture of the CRO market, looks at trends and developments, explains why they have happened and how they will affect the future of the industry.

Completely revised and re-formatted for 2011 the Contract Research Annual Review also contains thought provoking pieces from senior managers at leading CROs.

With 29 graphs and 18 tables, this unique 180-page review includes:

  • Market size
  • Market growth
  • A special section on alliances
  • Details of mergers, acquisitions and joint ventures.
  • A 90-page news section covering leading CROs.
  • Analysis of the CRO market by:
    • Type of company
    • Service offering
    • Therapy class
  • Market trends including:
    • M&A activity
    • CROs in developing regions

Written by industry expert Dr. Graham Hughes the Contract Research Annual Review costs just £395 ($585)

Download the table of contents Click for PDF file.

Download the list of tables & graphs Click for PDF file.

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click here to order

Hepatitis C

Therapeutic Class Overview

Hepatitis C is a major disease world wide with infection global rates as high as 3 - 4 million per year. While sexual transmission is not now regarded as a major factor the disease does have high co-infection rates with HIV, while in California 82% of those diagnosed have previously been in prison.

Treatment with biological drugs is complex and may vary between genotypes. This new report provides a complete, detailed picture of the disease, the market and the companies operating in it.

Contents include:

  • Market overview
  • Market leading companies
  • Unmet needs
  • Full pipeline and drug analysis
    • Interferons
    • NS3-protease inhibitors
    • NS5B-polymerase inhibitors
    • Other direct HCV inhibitors
    • Combination trials of DAA
  • Disease definition and progress
  • Genotypes 1, 2, 3, 4
  • Clinical trial design
  • Pipeline failures
  • Market forecasts to 2015

Hepatitis C Therapeutic Class Overview costs £1245 ($1995) and is essential reading for corporate management and those in, marketing and sales, R&D, and regulatory affairs. It is aimed at biotech, big pharma, analysts, producers of biosimilars / biogenerics, regulatory agencies and clinical research organisations.

Download the table of contents Click for PDF file.

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For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com


Outlook 2011

- Global Pharmaceutical and Biotechnology Markets

The Global Pharmaceutical Model is changing. Major pharmaceutical companies continue to under-perform in a market constrained by patent expiry, generic competition and a lack of new blockbuster drugs. There are signs of improvement, with the outcome of new clinical trials and new launches expected to reshape market dynamics.

But despite that companies other than the majors need to be analysed and understood to find the route to real growth in pharmaceuticals. This unique new report from Mehta Partners, Outlook 2011, provides a detailed analysis of sectors where there are real opportunities for growth; it looks at rising stars, at emerging companies in India and Japan and at biotech.

Mehta Partners also predicts that outsourcing, or “externalising” of R&D will continue to be the best approach – 56% of NMEs approved last year were in-licensed.

This new report makes sense of a rapidly changing pharmaceutical market and provides unparalleled insight and analysis that will enable you to seek out the capabilities that are needed for success and the companies that have those capabilities.

In all the 500+ page report looks at five market sections:

  • Rising Stars
  • Mature Biotech
  • Indian Generics
  • Global Pharma
  • Japan - Global and Emerging

For each market place the report provides a detailed sector overview and then recommends the companies that will succeed and explains why.

Each company analysis includes a detailed drug-by-drug pipeline analysis with explanations of how a drug will perform in its therapy area and why. And there is an in-depth look at the current portfolio with generic exposure analysis and sales projections to 2015.

The table of contents, below, will give you a good idea of the type of highly-detailed information that is contained in the report and we would be very happy to give you a full demonstration over the web or face to face - just call 01256 336632 to arrange a demonstration.

£6650 ($9950)

Download the table of contents Click for PDF file.

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For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com


The Future of Biosimilars – Market Forecasts to 2015, Opportunity Analysis and Regulatory Pathways

Biosimilars represents an exciting opportunity - and a potential threat to originator companies. The nature of the products, their production and the complex regulatory environment make entering the market difficult. This report provides insights into biosimilars market and its growth to 2015. Further, the distribution of revenues across key geographies such as the US, the top five countries in Europe and Japan are provided in the report. The report discusses the latest developments in the regulatory landscape and the evolving biosimilars approval pathways in Europe, the US and Japan. In-depth analysis into the individual segments of biosimilars market, their market forecasts and potential are also provided. The study analyzes the competitive landscape including benchmarking of the leading companies in the biosimilars market. Finally, a key trends analysis of mergers and acquisitions and licensing agreements involving biosimilars, is also provided.

The scope of this report includes:

  • Analysis on the regulations for biosimilars market in the leading geographies of the world - the US, the UK, Germany, France, Italy, Spain, and Japan.
  • Market forecasts and potential for the biosimilars market from 2008 to 2015. The key biologics classes included are human growth hormones, granulocyte colony stimulating factors, insulins, interferons and erythropoietins.
  • Market characterization data for biosimilars including market size, market share and market potential.
  • Key drivers and restraints that have a significant impact on the market.
  • Competitive landscape of global biosimilars market including benchmarking of the leading companies. The key companies discussed in this report are Teva, Sandoz, Hospira Inc, STADA Arzneimittel AG, Ratiopharm, Dr.Reddy's Laboratories and Biocon Ltd.
  • Key M&A activities, licensing agreements that have taken place between 2008 and 2009 in the global biosimilars market.

The report will enable business development and marketing executives strategizing their product launches to:

  • Build effective strategies to launch pipeline products by identifying the latest regulatory developments in the US, Europe and Japan.
  • Develop market-entry and market expansion strategies by identifying the geographic markets poised for strong growth.
  • Exploit in-licensing and out-licensing opportunities by identifying products that could fill their portfolio gaps.
  • Develop key strategic initiatives by studying the key strategies of top competitors.
  • Reinforce R&D pipelines by identifying licensing strategies for acquiring new delivery mechanisms that have more efficiency and better safety.

This report is essential reading for anyone in the pharmaceutical, biotech and outsourcing industries from corporate management through development and research to marketing and sales. It gives an authoritative, detailed and clear explanation of the factors that will affect the market for biosimilars and their implications for the market and for the pharmaceutical industry.

£2350 ($3500)

Table of Contents Click to download PDF file.

List of Tables Click to download PDF file.

List of Figures Click to download PDF file.

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For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com


Pharmaceutical Market Trends, 2010 - 2014:

Key market forecasts & growth opportunities

A detailed trend analysis of the global pharmaceutical market to the end of 2009 and forecasts until 2014. This 142 page report presents a series of market forecasts and growth opportunities in order to help inform pharmaceutical decision-making, particularly in the areas of corporate planning, portfolio management and market forecasting.

The report is divided into five key sections. Chapters 2-5 present historical trends for key pharmaceutical markets, key therapy areas, key products and key companies. The final report chapter outlines future pharmaceutical trends and key growth opportunities.

The data and analysis contained within the report are derived from Delphi Pharma, Company Trends Database to provide a comprehensive, consistent and up-to-date single-point reference for understanding key pharmaceutical market trends in 2010.

“The global pharmaceutical market grew to $808 billion in 2009, at a compound annual growth rate of 9.3% between 1999 and 2009. Year-on-year growth in the global pharmaceutical market decreased to 4.6% in 2009, largely as a result of cost containment in the US and major European markets and the impact of several blockbuster patent expiries in 2008 and 2009.”

Findings from the report include:

  • 125 pharmaceutical drugs generated more than $1billion in global sales. The top 100 blockbuster drugs generated sales of US$285.
  • The top 10 companies ranked by pharmaceutical sales generated total sales of $317 billion.
  • The global pharmaceutical market is forecast to grow to $1,033 billion in 2014, an equivalent CAGR of 5.0% over the next five years.
  • The leading therapy areas by global pharmaceutical sales in 2009 were CNS with a 15.8% market share and cardiovascular with 14.5%.
  • The CNS pharmaceutical market will decrease from $127.8 billion in 2009 to $118.5 billion in 2014, a CAGR of -1.5%.
  • In 2009 there were a total of 14 cardiovascular blockbuster products with combined sales amounting to $50.7 billion.
  • The US pharmaceutical market grew by 3.0% in 2009 to $300.3 billion with highest growth in mail services and clinics.
  • The major five Germany, France, Italy, Spain and the UK, together accounted for over 60% of all European pharmaceutical sales in 2009.
  • Pfizer had the greatest number of blockbuster products in 2009 with 14, which includes five inherited through the acquisition of Wyeth.

Readers of the report will find:

  • Comprehensive guidance on market trends for key countries, regions, therapy areas, products and companies.
  • Country profiles for leading pharma markets with market segment trends and five year forecasts.
  • Therapy area profiles for leading classes, Alimentary/metabolism, Antineoplastic/immunomodulatory, Anti-infectives market, CNS, Cardiovascular and Respiratory market with key products and sales forecasts.
  • Detailed profiles of 10 leading pharmaceutical and biotech products in 2009, including five year future sales forecasts.
  • Detailed profiles of 10 leading pharmaceutical companies in 2009, including 2014 sales forecasts (AstraZeneca, Bristol Myers-Squibb, Eli Lilly, GlaxoSmithKline, Johnson and Johnson, Merck & Co, Novartis, Pfizer, Roche, Sanofi-Aventis Wyeth).

Use this report to:

  1. Rapidly gain an overview into the global and regional pharmaceutical market and the top 10 companies and products.
  2. Find the new areas of pharmaceutical market growth and key opportunities for delivering successful sales growth over the next five years.
  3. Support internal planning and decision-making with an external perspective founded on detailed analysis and transparent market forecasts.

Report Coverage:

The report methodology provides a detailed but transparent analysis of key pharmaceutical market trends, including key markets, therapy areas, products and companies. Historical trends are formed over a three-year time horizon and future forecasts are made using a five-year future time period. Thus, the data and analysis relate to the nine-year time horizon from 2005 to 2014.

£1495 ($2345)

Table of Contents Click for PDF file.

List of Figures and Tables Click for PDF file.

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For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com


The Future of Contract Research Outsourcing - Market Forecasts to 2015, Geographical Landscape and Competitive Benchmarking

The contract research market is changing. This report provides key data, information and analysis of the global contract research outsourcing market. It provides market overview, competitive landscape and market trends information on the contract research outsourcing market as well as comprehensive information on the different service models present in the industry and key analytical content on the market dynamics. The report also reviews the competitive landscape in terms of mergers and acquisitions, strategic partnerships and service agreements.

Content includes:

  • Overview of contract research outsourcing and key reasons why pharmaceutical and biotechnology companies outsource to contract research organizations
  • Comprehensive analysis of the fully-integrated and functional service models of contract research outsourcing
  • Market size (2006-2015) and company share data for global contract research outsourcing market
  • Qualitative analysis of market drivers, restraints and trends
  • Geographic landscape covering the emerging regions such as Central and Eastern Europe, Latin America, India and China for contract research outsourcing
  • Competitive landscape covering key players Quintiles, Covance, PPD, Charles River Laboratories and PAREXEL International
  • M&A landscape and opportunity analysis of the emerging markets
  • Regulatory landscape of the US and key European countries in the contract research outsourcing market

The report will enable you to:

  • Develop key strategies to reduce expenditure on R&D by outsourcing to the contract research organizations
  • Develop a clear knowledge and understanding of how companies use contract research outsourcing to improve drug development productivity
  • Make informed decisions related to contract research outsourcing by building a thorough understanding of the benefits and drawbacks of contract research outsourcing
  • Identify leading contract research outsourcing destinations and the best practices for entering into contract research outsourcing agreements in different countries
  • Identify key players best positioned to take advantage of the emerging market opportunities
  • Make informed decisions related to the M&A activities in the contract research outsourcing market
  • Overcome the regulatory hurdles in the contract research outsourcing market
  • Make more informed business decisions from the insightful and in-depth analysis of the global contract research outsourcing market and the factors shaping it

Table of Contents Click to download PDF file.

List of Figures Click to download PDF file.

List of Tables Click to download PDF file.

£2350 ($3500)

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For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com


Factor Xa Inhibitors

New generation oral anticoagulants - will they change the market?

Factor Xa inhibitors have the capacity to be the future of the oral anticoagulant market - but 2010 and the first half of 2011 will be a key time with outcome of the ROCKET - AF and ADVANCE -3 trials and the FDA approval of Pradaxa.

The new class must show clear advantages over warfarin and the new warfarin analogues in indications including: stroke prevention in AF; ACS, VTE prevention and medically ill patients; and in VTE treatment. On top of that the drugs need to compete with each other for market share.

This new report gives a complete picture of the market and provides an in-depth analysis of how the new generation of anticoagulants will perform, explaining the key issues:

  • Xarelto
    • Complete response letter in VTE prevention
    • Do bleeding risk /liver toxicity issues impact AF opportunity?
    • Can Preclinical findings spoil the show for Xarelto?
    • What we expect from the ROCKET AF landmark study and why?
  • Pradaxa
    • FDA Verdict on Pradaxa approval in AF- is RELY data reliable?
  • Can Xarelto beat Pradaxa?
  • Can Apixaban's better pharmacokinetics translate to best efficacy in AF to shake up the early entrants?

The report also looks at early stage Xa inhibitors including betrixaban plus warfarin analogues and genetic variant testing.

Table of Contents Click to download PDF file.

Figures and Tables Click to download PDF file.

£1345 ($1995)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click here to order

Biosimilars: A Growing Market

Developments, regulation, companies & commercial opportunities

The biologicals segment has been the fastest growing segment of the pharmaceuticals market in recent years, with sales of the leading products (not including insulins) reaching $60 billion.

Although a number of major companies have significant biological capabilities few, apart from Novartis, have yet clearly developed strategies to compete in the biosimilars market. Since Sandoz pioneered the development of biosimilar drugs in 2001 there has been a steady breakdown of regulatory resistance. However, there are considerable entry barriers hindering companies that wish to enter this field of therapeutics.

Biosimilars - A Growing Market is a unique report that provides the reader with a comprehensive review of the current and future market for biosimilar products.

Some key findings from the report:

  • Few companies apart from Novartis have yet clearly developed strategies to compete in the biosimilars market.
  • The biosimilars market segment is poorly developed but is expected to become a significant commercial segment capturing a healthy percentage share of the biologicals market.
  • Many forecasts of the biosimilars market are over-optimistic, and assume a rapid resolution of the legislative impasse in the US and overlook the strength of Amgen's patent position with respect to epoetin alfa.
  • Assuming a later passing of US legislation the value of the biosimilars market segment will continue to be dominated by European sales revenues in 2012, and this is likely to account for about 0.6% of the fast-growing biologicals market.
  • The anti-TNF segment offers the best commercial opportunity with the three leading products all likely to face competition from biosimilars in Europe by 2016.

Report Structure

Chapter 1 focuses on the development history of biosimilars and provides an overview of the environment.

Chapter 2 considers the progress towards the development of approval pathways for this class of agents in the US and Japan, together with the current European framework. It also briefly addresses the position in other markets.

Chapter 3 discusses the substantial hurdles that must be surmounted by those companies that wish to develop and market biosimilars. And these are additional to the regulatory hurdles that are discussed in chapter 2.

Chapter 4 examines the blossoming European market for biosimilars. The regulatory barriers to their approval in both Japan and the US have ensured that few biosimilars are yet available in those markets.

Chapter 5 highlights the key factors that suggest that the successful development and marketing of a biosimilar product is commercially advantageous. It also covers, subject to the availability of suitable enabling legislation in the US and Japan, which biosimilars products might enter the market.

Chapter 6 analyses the impact of biosimilars upon specialist, generic and market pharmaceutical companies. A number of key companies are profiled.

Chapter 7 looks to the future and considers which factors will impact the market for biosimilars. The high cost of these products and the increasing pressure that they place on healthcare budgets is likely to prove a major driver in the adoption and uptake of biosimilars, even in the US market.

The report concludes by assessing the market outlook over the period 2010-20, which is forced to rely on certain key assumptions owing to current uncertainties as to when biosimilar products will become available in the US.

Table of Contents Click to download PDF file.

Author Click to download PDF file.

£1495 ($2345)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
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Toxicology and Pharmacology

Outsourcing, History, Process and Regulation; Technical, Political and Economic Challenges

Toxicology and pharmacology are challenging areas in the clinical trial process. Although the results gained are vital for the safety of medicines and are required by regulatory bodies around the world, the processes involved, especially animal testing, remain controversial. Almost all of the work is outsourced and the major companies involved have come under considerable pressure from activist groups.

This 150 page report gives a detailed analysis of the market and of the issues involved. Contents include:

  • The development of toxicology
  • A review of the major companies involved
  • Principles and practices in outsourcing
    • Essentials of a contract
    • Negotiation
  • Regulatory environment
    • USA
    • Europe
    • Japan
    • ICH
    • GLP
  • The pre-clinical market
  • Non-animal testing
    • Validating organisations
    • Validation studies
  • Future Challenges
    • Technical
    • Economic

Written by industry experts Dr Graham Hughes and Dr Richard Barrett the report will enable you to:

  • Understand the processes and issues
  • Manage the outsourcing process
  • Assess the toxicology market
  • Analyse challenges for the future
  • Understand the global regulatory environment
  • Assess the major providers

Toxicology and Pharmacology is essential reading for everyone involved in clinical trials and drug development including senior staff in pharmaceutical companies and CROs, trial managers and staff and those staff directly involved in toxicology and pharmacology testing, product, process and analytical development, R&D, and regulatory affairs. It is aimed at biotech, big pharma, CROs, providers of analytical services and regulatory agencies. The report gives an authoritative, detailed and clear explanation of the issues surrounding toxicology testing, its implications for the market and for the biotech and pharmaceutical industries.

Download the table of contents Click for PDF file.

£595 ($995)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click here to order

Generics in Japan

The largest untapped market for generics and biosimilars

Japan is the second largest pharmaceutical market in the world. But only 5% of the market, by value, is taken by generic drugs. Like other major industrialised nations Japan has an ageing population and ageing populations take a disproportionate share of healthcare spend. For Japan the problem is very marked; it has the highest life expectancy of any major country and spends 45% of its healthcare budget on geriatric care. In 2002 Japanese healthcare insurance was on the verge of bankruptcy.

Now the government is acting to make healthcare more effective and to reduce costs. One of the methods it is using is to increase the take up of generic drugs - it aims to treble the market for generics to 15% by value by 2012, taking spend to $12 billion.

This highly detailed new report provides a complete picture of the market, its rules and regulations and how it will change over the coming years. It gives a detailed description of the hospital and GP systems, the importance of wholesalers and the likely results of the changes to the system introduced by the government, including DPC hospitals and the new prescription system.

Contents include:

Introduction to the Japanese market
An analysis of the Japanese pharma industry
Wholesale and pharmacy systems
Healthcare system and costs
Healthcare reform
Why generic penetration is historically low
The impact of current and proposed reforms
Regulations for generics
Prospects and regulations for biosimilars
Detailed analysis of major Japanese innovator companies
Detailed analysis of Japanese generic companies

The report contains a detailed case study of Daiichi’s acquisition of Ranbaxy and will help you to understand:

The size of the generic opportunity
How the Japanese pharma market works
The role of GPs and pharmacies
Changes to the hospital system
Attitudes to generics
How pharma is reacting to the changes

Written by Mehta partners this report is essential reading for all companies involved in the Japanese market and for companies who want to take advantage of a large, fast-growing market opportunity. It aims at senior managers, company strategists and sales and marketing departments as well as providing vital information for those involved in regulatory affairs and clinical trials.

Download the table of contents Click for PDF file.

Download the list of charts and graphs Click for PDF file.

Download the list of tables Click for PDF file.

£810 ($1310)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click here to order

World Market for Addiction Disorders, 2009 - 2016

Future Therapies for Substance Dependence and Impulse Control

Examine the market for addiction pharmacotherapies currently estimated at US$3.2 billion

The substance dependence field is transforming into a high-growth market opportunity. Supported by the success of Pfizer's recently launched Chantix/Champix, which is on track for blockbuster status in the smoking cessation sector, pharmacotherapies in development for alcohol, narcotic, and nicotine dependencies are poised to radically change the addiction treatment landscape in this difficult-to-treat patient population.

The report estimates that the current market for addiction disorders is valued at US$3.2 billion and this is forecast to increase 19% to US$3.8 billion by 2016.

The World Market for Addiction Disorders, 2009 2016: Future Therapies for Substance Dependence and Impulse Control, will introduce the reader to a specialty pharmaceutical market which is positioned for high-growth based on analysis of marketed and pipeline drugs, company activities, and addiction disorder demographics.

Therapy area forecasting and illustrative comparative sales data is presented to gain insight into leading products with sales estimates to 2016.

This 80 page report will provide an in-depth analysis of the global addiction pharmacotherapeutic market, Including analyses of key therapy areas, R&D programs, and innovating companies and products.

Report Highlights Include:

  • The current market for addiction disorders is valued at US$3.2 billion, up from US$2 billion in 2005
  • Critical analysis of alcohol, cocaine, opiate, and nicotine addictions
  • Review of epidemiological, aetiological, and demographic data for addiction disorders
  • Analysis of over 10 key marketed products and inclusion of 34 R&D candidates identified in preclinical to clinical stages of development for addiction disorders
  • Sales estimates (US$) to 2012 for major therapy areas
  • Strategic insights for life-cycle optimization and product development
  • Critical evaluation of leading addiction pharmacotherapies
  • Emerging markets identified and sector analysis
  • Trend analysis of industry events and activities over past 2 years
  • Detailed R&D themes and clusters by addiction area
  • Data generation on sector and market values between 2004 and 2012 and therapy forecasts by 2020 (US$)
  • High revenue-yielding prospects identified with projected sales estimations
  • R&D pipeline positioning for novel candidates
  • Market insights for product development and drug promotion

What you can learn from this report:

  • Which addiction therapies are the current and potential future market leaders
  • How companies are reformulating products for addiction indications
  • Which premarket addiction pharmacotherapies are identified as high-value products
  • Which companies are developing drugs for addiction disorders
  • Sales predictions to 2016 for addiction pharmacotherapies
  • What the likely impact of pipeline products will be on value growth of the addiction market over the 10 years
  • Which addiction subsectors could be niche market opportunities
  • What the future outlook holds for addiction pharmacotherapies
  • Insight into R&D trends for alcohol, cocaine, opiate, and nicotine addictions
  • Which molecules and compounds are main R&D clusters for dependency disorders
  • Which of the pipeline candidates are top prospects in the addiction market over the next decade and to 2025

Report Contains:

  • Detailed survey and analysis of the current and future global addiction disorder market
  • Comprehensive update on key marketed products indicated for alcohol, narcotic, and nicotine dependency disorders
  • Review of epidemiological, demographic, aetiological, and therapeutic data associated with addiction disorders
  • Market analysis and insight of key addiction pharmacotherapies and pipelines
  • Market value predictions of individual marketed products to 2016
  • Insight and trend analysis of pipeline products for addiction disorders
  • Review of promising pipeline products and potential market opportunities
  • Extensive coverage of the R&D pipeline for addiction disorders
  • Guide to leads for potential licensing opportunities

Companies Mentioned in this Report include
Acrux
Alkermes
Biotie Therapies
Brookwood Pharmaceuticals
Catalyst Pharma Partners
Celtic Pharmaceuticals
Cephalon
Drug Abuse Sciences
Elbion
Eli Lilly
Forest Laboratories
GlaxoSmithKline
Impax Laboratories
InterveXion Therapeutics
J&J
Janssen-Cilag
Krele Pharma
Merck Serono
Nabi Biopharmaceuticals
Pfizer
Sanofi-Aventis
Somaxon Pharma.
STADA
Synosia Therapeutics
Targacept
Teva Pharmaceuticals
Titan Pharmaceuticals
WorldMeds

World Market for Addiction Disorders is essential reading for corporate management, marketing and sales and those in product development, R&D, and regulatory affairs. This report gives an authoritative, detailed and clear explanation of the issues surrounding addiction markets and its opportunities for the biotech and pharmaceutical industries.

Download the table of contents Click for PDF file.

Download the list of tables and figures Click for PDF file.

£1495 ($2345)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click here to order

Systems Biology in Biotech and Pharma

A new paradigm for innovation

Growth in the pharmaceutical market has slowed – almost to a standstill.  One reason is that governments and other payers are cutting costs in a faltering world economy.

But a more fundamental problem is the failure of major companies to discover, develop and market new drugs.  Major drugs losing patent protection or being withdrawn from the market are simply not being replaced by new therapies – the pharmaceutical market model is no longer functioning effectively and most pharmaceutical companies are failing to produce the innovation needed for success.

This new report looks at a vital strategy which can bring innovation to a market in need of new ideas and new products - Systems Biology.

Systems Biology employs a rational approach, via a mix of analytical and systemic routes, to delineate the emerging properties of biological networks.  It aims to explain and predict, quantitatively, molecular, cellular, tissue, organ and whole-body processes.  By using multi-scale models in silico, Systems Biology is expected to bring numerous benefits to pharmaceutical discovery and development as the properties of a system can be studied over a wide range of length and time scales.

Systems Biology can reduce the number of compounds that need to be synthesised in discovery by using refined algorithms to weed out compounds with poor pharmacokinetic of toxicology profiles.  And it will save time and money by selecting the drugs which are more likely to succeed in clinical development.

This new 230 page report is written by industry and academic expert Dr Ales Prokop, one of the leading experts in Systems Biology. He is affiliated with Vanderbilt University, Nashville, TN, USA and NanoDelivery International, Prague, Czech Republic. It will enable you to:

  • Understand the nature and processes involved in Systems Biology
  • See how its benefits relate to pharmaceutical innovation
  • Delineate the costs and cost savings involved
  • Understand why Systems Biology improves on current approaches to drug discovery
  • Relate Systems Biology to advances in genetic profiling and personalised medicine

Contents include:

  • Tools and lead optimisation
  • Virtual chemistry screening
  • Lead discovery and molecular interactions
  • In silico screening
  • Computational Systems Biology in cell biology
  • Pharmacology and pharmacokinetics
  • Formulation and production
  • Clinical model-based drug development

Systems Biology is essential reading for corporate management and those in product, process and analytical discovery and development, product quality and characterisation, R&D, and regulatory affairs.  It is aimed at biotech, big pharma, producers of biosimilars, contract manufacturers, providers of analytical services, and clinical research organizations. This report gives an authoritative, detailed and clear explanation of the issues surrounding Systems Biology, its implications for the market and for the biotech and pharmaceutical industries.

Download the table of contents Click for PDF file.

Download the list of figures Click for PDF file.

About the Author Click for PDF file.

£1450 ($2345)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click here to order

Manufacturing in the Global Pharmaceuticals Industry

- Key drivers, company strategies and regulations (3rd ed)

Manufacturing in the Global Pharmaceuticals Industry - Key drivers, company strategies and regulations (3rd ed) is the only report available that covers this crucial area of the pharmaceutical industry in such depth. The concentration in recent years on creating organisations that are market or customer-led, or research-driven has taken the focus away from the manufacturing process, although it is clear that the most successful organisations integrate all these activities to remain market leaders.

Global pharmaceutical manufacturing is in a state of flux. There is excess capacity in manufacturing facilities for finished dosage forms and a shortfall for biotechnology manufacturing. The situation in APIs is not so clear-cut, and the trend for multinationals to grow through M&A has led to the need to rationalise facilities. Meanwhile, local companies from emerging markets wishing to expand into new markets and exporting must be able to satisfy ever more stringent quality standards.

This report tackles the challenges of manufacturing in a global marketplace by providing unique insight into the strategies a successful company will adopt. By using examples, case studies and scenarios to aid clarification of the more technical aspects of the manufacturing process, you can be assured your decisions are made with full understanding of the key issues.

This timely third edition will enable you to:

  • Assess the pros and cons of outsourcing manufacturing functions and develop key strategies to effectively measure supplier and contractor performance
  • Understand and prepare for the latest regulations applicable to manufacturing and their variations globally
  • Develop strategies to effectively manage contractor relationships
  • Understand the definitions used in validation, and how extra investment in validation will improve performance
  • Build competencies for manufacturing that meet the objectives of: speed of delivery, reduction in product cost, overall quality, optimisation of capital spend, maintenance of customer inventory, minimisation of regulatory impact, optimisation in the number of manufacturing sites, maintenance of strategic sourcing for disaster management planning
  • Understand the 'New Paradigm' in international manufacturing and how it relates to the pharmaceutical industry.

Use this report help with:

  • Planning a global manufacturing strategy
  • Regulations and quality assurance issues
  • The 'New Paradigm' in manufacturing
  • The key drivers and changes in today's manufacturing environment
  • Making the right investment decision

Download the table of contents Click for PDF file.

List of Tables Click for PDF file.

£870 ($1365)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click here to order

Manufacturing in the Global Pharmaceuticals Industry is produced by Urch Publishing


How to Forecast Generic Pharmaceutical Prices

- A Practical Methodology to Calculate Future Generic Prices

”Finally. A model for predicting the price fall of generics – proven to have worked for 99% of drugs“

It has long been recognised that prices paid by chemists and doctors for a generic product decline in the weeks and months after generic launch and patent expiry. But calculating how quickly this happens can often only be guessed at - until now

How to Forecast Generic Pharmaceutical Prices - A practical method to estimate future generic product prices is a unique guide that will help you be able to forecast future generic prices before and after launch.

Specifically designed to be instantly usable, this publication, presents a tried and tested methodology to predict how the price of a generic medicine will fall after patent expiry and launch.

The practical guide, which is produced in association with WaveData, a medical price analysis company, will allow users to build spreadsheets and forecast products prices as required.

The model presented is based on solid methodology drawing from over 6 year's work (over 60,000 hours) cataloguing 6 million pharmaceutical prices. A 120 real-life examples of generic product were studied to find patterns of price decay.

The model takes into account both regional drug reimbursement policies and the brand value of the product.

20 tables provide detailed percentage points according to the number of generic licence holders entering the marketplace post patent-expiry.

The model works in the absence of government price capping, where the price decay happens as a result of competition between suppliers (free pricing) rather than statuary price reductions, and the reimbursement price is high enough to allow free pricing.

5 Reasons to Invest in this Report

  • Stop using "rule of thumb" to calculate the decline in price
  • Adopt the suggested methodology immediately
  • Easily understandable, designed for the non-statistician
  • Follow clear instructions to build your own spreadsheet models
  • Adjust the number of expected competitors with first 3 years of launch

This unique guide is a must have for all:

  • Pricing and reimbursement executives
  • Marketing Managers in Generic Drug Companies
  • Strategy directors in pharmaceutical companies
  • Consultancies with an interest in pharmaceutical markets

Buy this report and get a year's FREE subscription to PROfesy CR an online modelling tool to forecast generic erosion.

Download the table of contents Click for PDF file.

£2500 ($3920)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click here to order

How to Forecast Generic Pharmaceutical Prices is produced by Urch Publishing


Quality for Biologics

This report is available either as the complete publication or in separate sections. The sections are:

  1. Manufacturing to Ensure Product Quality
  2. Characterisation and Analytical Methods
  3. Impurity Profiles and Product Variation
  4. Regulation

See below for detailed contents for each section

Biologic drugs are complicated biological products that are normally difficult to define in molecular terms and that can be inconsistent in their exact composition. This can make it difficult to assure product quality and therefore to ensure safety and efficacy. There is no perfect solution and the commercial cost of quality is high, but the cost of getting it wrong can be considerably greater or even disastrous. Considerable time and expense can be saved by having an educated approach to manufacturing and process development, characterisation and analytical methods, product variation and also to regulatory issues.  This unique new report provides a detailed and complete guide to the processes and methods involved.

Quality for Biologics is produced and edited by Nicole Lyscom PhD and is written by top industry experts from leading companies and organisations including:

  • Genentech
  • Amgen
  • Roche
  • Eli Lilly
  • UCB
  • LFB
  • Boehringer Ingelheim
  • Paul Ehrlich Institute
  • Parexel Consulting

The report covers all aspects of the subject including

  • Critical quality attributes
  • Manufacturing process parameters
  • Process Analytical Technology
  • Physicochemical analysis
  • Bioassays
  • Formulation and specifications
  • Product- and process-related impurities
  • Aggregation
  • Non-clinical testing
  • Clinical development,
  • Post-marketing quality control
  • Regulatory authority expectations
  • Risk management
  • Comparability concerns

Quality for Biologics is essential reading for corporate management and those in product, process and analytical development, product quality and characterisation, R&D, and regulatory affairs.  It is aimed at biotech, big pharma, producers of biosimilars / biogenerics / follow-on biologics, contract manufacturers, providers of analytical services, providers of manufacturing and analytical equipment, regulatory agencies and clinical research organizations. This case-study rich report gives an authoritative, detailed and clear explanation of the issues surrounding quality for biologics, its implications for the market and for the biotech and pharmaceutical industries.

Download the table of contents:

Full Report: Click for PDF file.
Manufacturing: Click for PDF file.
Characterisation: Click for PDF file.
Impurities: Click for PDF file.
Regulation: Click for PDF file.

Report Synopsis Click for PDF file.

Prices:

Full Report:£1495 ($2325)
Manufacturing:£395 ($615)
Characterisation:£495 ($765)
Impurities:£495 ($765)
Regulation:£395 ($615)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click here to order

EvaluatePharma® Yearbook - Company Performance Tables

Benchmark a Changing Market

In a fast-changing pharmaceutical market it is vital to be able to measure company performance easily and accurately – find out which companies are winning in the areas that count and which are suffering in changing circumstances. The new EvaluatePharma® Yearbook gives you the information that you need, in context.

The Yearbook provides information and data of the highest quality, taken directly from the EvaluatePharma® database and it will enable you to:

  • Benchmark company revenue and expenditure
  • Analyse company performance
  • Assess mergers and acquisitions
  • Understand patent expiry issues
  • Match R&D spend to performance
  • Analyse sales by therapy area, licensing, acquisitions etc
  • Analyse winners and losers by therapy area

All of the detailed information in the Yearbook is put in context by explanations of the new pharmaceutical market place, how it works and how companies perform within it.

The Yearbook provides detailed information about the top 150 companies, including:

  • Revenue
  • Income
  • Growth
  • R&D expenditure
  • M&A activity
  • Patent expiry
  • Staffing levels
  • Expenditure

With 41 tables of detailed EvaluatePharma® information this 140 page report is edited by former Scrip Magazine Journalist Jacky Law.

It is essential reading for everybody in the pharmaceutical market from senior executives and corporate strategists, through marketing and sales departments to market analysts and pharmaceutical outsourcing companies.

Download the table of contents Click for PDF file.

Download the list of tables Click for PDF file.

£1450 ($2900)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click here to order

The Rise of Mid-Sized Pharma

What makes mid-sized companies successful – and what big Pharma can learn from them

Since the year 2000 mid-sized pharmaceutical companies have out performed their larger rivals – they have grown more rapidly, produced better profits and have performed far better on the world’s stock markets.

There are many reasons why this has happened; big pharma is facing a multitude of serious problems that it did not realise were important just a few years ago.  Now there are major issues with public perception, an innovation deficit and increased regulation.  The lessons for big Pharma are clear and this report provides a challenging analysis of the factors involved, including:

  • The failure of the blockbuster model
  • R&D productivity
  • Therapy Focus
  • Specialist markets
  • Informed consumers
  • The cost of drugs
  • Tougher regulation
  • Drug withdrawals

The report, written by former Scrip Magazine journalist Jacky Law is published by Biopharm Knowledge Publishing in association with EvaluatePharma® and includes more than 20 tables of EvaluatePharma® information, clearly defining the market and providing evidence to substantiate the arguments made.  Interviews with leading industry experts Jo Pisani of PwC and Mike Ward of Nomura Code also form a key part of the report.

This report is essential reading for anyone in the biotech, pharmaceutical and clinical outsourcing industries from corporate management through development and research to marketing and sales.  It gives an authoritative, detailed and clear explanation of the issues surrounding mid-sized Pharma and their implications for the market and for the biotech and pharmaceutical industries.

Download the table of contents Click for PDF file.

Download the list of EvaluatePharma® tables Click for PDF file.

£795 ($1245)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click here to order

Cardiac Toxicity

Cardiac Toxicity – drugs causing heart muscle, valve damage or potentially fatal arrhythmias in patients - has been implicated in 28% of drug withdrawals in the USA over the last 30 years.

The significance for patients, regulators and the pharmaceutical industry is immense.  If cardiac toxicity is discovered during a drug’s development the programme will, almost invariably, be terminated.  If cardiac toxicity is discovered after launch then the drug may be withdrawn or new labelling will almost certainly be required.

The consequences for the global pharmaceutical industry can be huge, with major drugs being withdrawn and companies being sued for negligence.  But often cardiac events are so rare that they may only be found many years after launch and after thousands, or even millions, of patients have been treated.  And when cardiac events do occur the exact mechanism involved may remain a mystery.

This unique report covers all aspects of cardiac toxicity, from physiology and pharmacology to regulation by the FDA and EMEA.  It looks at:

  • Physiology
  • Pharmacology
  • Pre-clinical determination of cardiac toxicity
  • Determination of potential cardiac toxicity in early phase clinical testing (QTc studies)
  • The implications for the clinical trial process
  • Regulation
  • The commercial implications

It will help you to:

  • Understand the physiology and pharmacology of the heart and how cardiac toxicity may be provoked
  • See which classes of drugs carry most risk
  • Plan for the clinical trial process
  • Manage the regulatory process
  • Understand the commercial implications

The report is edited by Dr Graham Hughes and includes a chapter on the commercial implications written by Yann Bonduelle and Jo Pisani of PwC.

Key industry and academic figures have also contributed significant chapters to the report:

  • Professor Derek Terrar,
    Professor of Cardiac Electrophysiology, University of Oxford, Fellow in Physiological Sciences (Medicine) Worcester College, Oxford
  • Thomas E Donnelly, PhD,
    Senior Vice President, Quality Assurance and Compliance, Reliance Clinical Research Service
  • Daniel B. Goodman, MD,
    Medical Director
    Entelligent Solutions, Inc
  • Eileen M. Daniel,
    Vice President of Operations
    Reliance Clinical Research Services

This report, published in association with Oxford Cardiac Pharmacology is essential reading for anyone in biotech, pharmaceuticals or contract research. It will appeal to Corporate Management, Development, R&D, Pre-clinical and Clinical Safety, Regulatory Compliance, Quality, Marketing and Sales. It gives an up to date, authoritative, detailed and clear explanation of the issues surrounding cardiac toxicity and its implications for the pharmaceutical market.

Download the table of contents Click for PDF file.

Download the introduction Click for PDF file.

£1495 ($2275)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click here to order

Immunogenicity to Biologics

Implications of reactions against biotech drugs

Understanding immunogenicity, a detrimental and potentially dangerous response to therapeutic proteins, is vitally important for the successful development and marketing of biotech drugs. Failure to predict and minimise levels of immunogenicity may have harmful and sometimes disastrous results for both patients and the industry.

This comprehensive new report written by leaders in the field, gives you the information you need to understand immunogenicity and to implement relevant safety strategies. The commercial implications are covered in a section written by experts at PricewaterhouseCoopers (PwC).

This unique 170-page report includes chapters by the following industry experts:

Dr Stephen Swanson, Director, Clinical Immunology, Amgen
Meenu Wadhwa, Head, Cytokines and Growth Factors, Biotherapeutics, NIBSC
Robin Thorpe, Head, Biotherapeutics, NIBSC
Dr Deborah Finco-Kent, Immunogenicity Lead, Drug Safety R&D, Pfizer
Dr Ingrid Caras, Senior Director, Bioanalytical & Development Sciences, PDL Biopharma,
Dr Bonita Rup, Senior Director, Bioanalytical R&D, Drug Safety and Metabolism, Wyeth Research
Dr Christian Schneider, Acting Head, EU Cooperation/Microbiology, Paul-Ehrlich-Institute
Dr Harald Kropshofer, Global Coordinator & Head, Immunosafety of Biologics, F. Hoffman La Roche

Plus an additional chapter on the commercial implications by PwC experts Jo Pisani and Yann Bonduelle.

This report will enable you to:

  • Understand the processes involved in immunogenicity
  • Find out how immunogenicity impacts on safety and efficacy
  • Grasp the commercial implications
  • Work out an immunogenicity assessment strategy
  • Manage your cooperation with the FDA and EMEA
  • Prepare for new launches

Contents include:

  • Factors contributing to immunogenicity
  • Impact on safety and efficacy
  • Commercial implications
  • Assay development and validation with special section on neutralising antibody assays
  • NEW US White Papers
  • Regulatory advice on working with the FDA and EMEA with NEW CHMP Guidelines
  • Risk management strategy
  • Risk minimisation and de-immunisation

This report is essential reading for anyone in biotech, biosimilars and pharmaceuticals, and for contract research. It will appeal to Corporate Management, Development, R&D, Pre-clinical and Clinical Safety, Regulatory Compliance, Quality, Marketing and Sales. It gives an authoritative, detailed and clear explanation of the issues surrounding immunogenicity and its implications for the market and the biotech, biosimilar and pharmaceutical industries.

Download the table of contents Click for PDF file.

£1450 ($2175)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click here to order



Biosimilars - Evolution or Revolution?

A detailed guide to the factors that will shape this vital market, including company strategies, comparability, regulation, the implications for clinical trials and legal issues. With a chapter written by PricewaterhouseCoopers looking at the commercial implications for the biotech and pharmaceutical markets

The market for biotech drugs grew by 18% last year and now exceeds $50 billion – that’s 10% of the global pharmaceutical market at nearly three times the growth rate.

But the first biotech drugs were launched in the mid 1980s and now patents have expired on drugs worth more than $13 billion. Until very recently generic competition was not possible but now in Europe, the EMEA has issued guidelines and the first biosimilar has been approved. In the USA the FDA still has to act, but the direction is becoming clearer. How this market develops will be vital for all the players involved – major pharma, biotechs, generic companies and CROs.

This unique, detailed, 200+ page report, includes a chapter on the commercial implications written by Jo Pisani and Yann Bonduelle, Pharmaceutical & Healthcare strategy consultants at PricewaterhouseCoopers. The report will enable you to:

  • See how the biotech landscape will change
  • Assess competition in specific markets
  • Understand how biosimilars will be approved
  • Grasp the details of the trials process
  • Understand the legal implications
  • Prepare for new launches

Contents include:

  • Strategies for entering the market
    • The opportunity
    • Development
    • Profit potential
    • Market structure
    • Substitution of biosimilars
  • Comparability
    • The impact of manufacturing
    • Preparation of comparability packages
    • Immunogenicity risk factors
    • Approved biosimilars
    • The future
  • Clinical trials
    • Protocol requirements
    • Factors affecting study size
  • Regulatory issues Europe
    • Clinical trial requirements
    • EU guidelines explained
    • Dealing with regulators
    • Role of the EC
    • Case studies and precedents
    • Routes to approval
  • Regulatory issues USA
    • The FDA position
    • Anticipated guidance
    • Case studies and precedents
    • Routes to approval in the US
  • Legal issues
    • The patent environment
    • Freedom to operate
    • Precedent
  • Opportunities and barriers
    • Commercial drivers
    • Drug markets
    • Country markets
    • Skill sets and core competencies


As well as the commercial analysis from PricewaterhouseCoopers the report is edited by Dr Nicole Lyscom and written by leading experts in the field including:

  • Dr Tim Oldham, VP Business Planning and Operations Effectiveness, Mayne Pharma
  • Dr Meena Subramanyam, Senior Director, Clinical science and Technology, Biogen Idec
  • Dr Peter H Kalinka, CEO and Managing Director, Accelsiors Group International
  • Dr Gabrielle Schaeffner, Principal Consultant, Parexel International, Germany
  • Dr Alan Liss, Senior Director, Biotechnology, Duramed Research Inc
  • Dr Antonio Maschino, Partner, D Young and Co

This report is essential reading for anyone in the pharmaceutical, biotech and outsourcing industries from corporate management through development and research to marketing and sales. It gives an authoritative, detailed and clear explanation of the factors that will affect the market for biosimilars and their implications for the market and for the pharmaceutical industry.


DOWNLOAD THE TABLE OF CONTENTS Click for PDF file.

£1950 ($3600)

For further information about this report, please contact Marianne O'Neill on +44 (0)1256 336632
or moneill@biopharmkp.com
Click here to order

Outsourcing Chemistry Services Made Easy

A Practical Guide for the Pharmaceutical and Biotech Industries

Pharmaceutical and biotech companies are outsourcing more of their work than ever before – the list includes drug discovery, development, manufacture and marketing.

This new report provides a clear, comprehensive guide to the processes involved in outsourcing chemical and biotech development and production.

It will help you to:

• Understand the rationale for outsourcing
• See how outsourcing fits into the R&D continuum
• Select process development providers
• Negotiate contracts
• Manage the outsourcing process
• Understand when to outsource – and when not to
• Minimise outsourcing risk

As well as the complete guide the report contains in-depth interviews with development service providers and outsourcers to give a real life understanding of the issues from both sides of the fence. And it has a full listing of service providers categorised by services offered and location.

Contents include:

• Rational for outsourcing
• Research and development continuum
• Selecting a process development provider
• Contract negotiation
• Managing outsourcing
• Risk management
• Outsourcing economics
• Interviews with outsourcing companies
• Interviews with outsourcers
• Outsourcing directory

This 120 page report is published by Biopharm Knowledge Publishing, part of the Technomark group and costs just £695 ($1290). It is written and edited by Dr Ed Sampler of Charnwood Molecular and Hooshang Zavareh of Chempharmaserve Ltd.

DOWNLOAD THE TABLE OF CONTENTS Click for PDF file.

£695 ($1290)

For further information about this report, please contact Marianne O'Neill on +44 (0)1256 336632
or moneill@biopharmkp.com
Click here to order


Clinical Trial Supply
Essential Ingredients for Success in Clinical Trials.
Published: March 2006

The definitive guide:
• Written by industry experts
• Edited and produced by the leading outsourcing publisher and consultancy

Contents include:
• Development, formulation and manufacture
• Analytical development
• Packaging and labelling
• The regulatory challenge
• Logistics and distribution
• Automation
• CTS in emerging markets
• Market size and trends



DOWNLOAD THE TABLE OF CONTENTS
Click for PDF file.
Price: £595 ($1075)
For further information about this report, please contact Marianne O'Neill on +44 (0)1256 336632
or moneill@biopharmkp.com
Click here to order

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