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Effective Licensing & Commercialisation of Drug Delivery Systems 2006

Published by: PharmaVentures Ltd.

Published: Oct. 1, 2006 - 161 Pages


Table of Contents


1 Introduction

2 Market Overview

2.1 Types of Drug Delivery

2.2 Development of the Drug Delivery Market

2.3 The Current and Evolving Market

2.4 Future Market Challenges

2.5 Drug Delivery Companies

2.5.1 Principal Players in Drug Delivery

2.5.2 The Changing Landscape: M&A Activity

2.5.3 The True Scope of the Drug Delivery Sector

3 Key Drivers in Drug Delivery

3.1 Improving the Therapeutic Index

3.2 Patient Compliance

3.3 Patent Prolongation

3.4 Life Cycle Management

4 Commercialisation Strategies

4.1 Introduction

4.2 Returns to Innovation

4.3 Drug Delivery Product Offerings

4.4 Exploitation Strategies

4.5 Business Models

4.6 Product, Strategy and Business Models for Drug Delivery Technology

4.7 Applicability to Segments of the Pharmaceutical Product Life Cycle

4.8 Assessment of Attractiveness of Each Option

4.8.1 Divestment to a Service-Based Company

4.8.2 Licensing to Pharmaceutical Companies

4.8.3 Sales of Devices

4.8.4 Service Offering

4.8.5 Development of Drugs in Collaboration with other Companies

4.8.6 In-House Drug Development

4.9 Compatibility of Product Offerings

4.10 Conclusion

5 Alliances in Drug Delivery

5.1 Drug Delivery Deals Database

5.2 Drug Delivery Deal Activity

5.3 Financial Analysis of Drug Delivery Deals

6 Major Pharmaceutical Company Drug Delivery Deal Activity

6.1 Pfizer

6.2 Johnson & Johnson

6.3 Sanofi-Aventis

6.4 GlaxoSmithKline

6.5 Novartis

6.6 Roche

6.7 AstraZeneca

6.8 Bristol-Myers Squibb

6.9 Abbott Laboratories

6.10 Merck & Co

7 Valuation Methods

7.1 Integrated Benchmarking and ENPV Calculation

7.2 Other Methods

7.3 Benchmarking

7.3.1 Feasibility Search

7.3.2 Information Gathering and Analysis

7.3.3 Approximate Valuation

7.3.4 Refinement of Valuation

7.4 Expected Net Present Value

7.5 Agreement Structure

7.5.1 Value Sharing

7.5.2 Risk Sharing

7.6 Valuation of Drug Delivery Systems

7.6.1 Enabling Technology

7.6.2 Enhancing Technology

8 Drug Delivery Alliance Development Process

8.1 Needs Identification

8.1.1 Driving Factors

8.1.1.1 Market Drivers

8.1.1.2 Technology Drivers

8.1.2 Tools for Needs Identification

8.1.2.1 Portfolio Analysis

8.1.2.2 Value Chain Analysis

8.2 Identifying Opportunities and Partners

8.3 Development of Commercial Relationships

9 Drug Delivery Agreements




List of Tables




Table 1 - Typical maximum doses per administration

Table 2 - Marketed recombinant biopharmaceuticals among the top 200 selling prescription drugs

Table 3 - Publicly quoted speciality pharmaceutical companies that focus on drug delivery

Table 4 - Elan’s M&A activity

Table 5 - Major US patent expirations, 2006-2008

Table 6 - Strategies for the exploitation of innovation

Table 7 - Business models

Table 8 - Generic strategies for commercialisation

Table 9 - Product offerings and target segments

Table 10 - Compatibility of product offerings

Table 11 - Number of drug delivery deals by therapeutic area, 1997-2005

Table 12 - Number of drug delivery deals by product type, 1997-2005

Table 13 - Average total deal values for drug delivery deals, 1996-2005

Table 14 - Average upfront payments for drug delivery deals, 1996-2005

Table 15 - Average equity investment payments for drug delivery deals, 1996-2005

Table 16 - Average milestone payments for drug delivery deals, 1996-2005

Table 17 - Top ten pharmaceutical companies by 2005 worldwide healthcare revenue

Table 18 - Pfizer drug delivery deals

Table 19 - Pharmacia drug delivery deals

Table 20 - Johnson & Johnson drug delivery deals

Table 21 - ALZA drug delivery deals

Table 22 - sanofi-aventis drug delivery deals

Table 23 - Aventis drug delivery deals

Table 24 - Sanofi Synthélabo drug delivery deals

Table 25 - GlaxoSmithKline drug delivery deals

Table 26 - Novartis drug delivery deals

Table 27 - Roche drug delivery deals

Table 28 - AstraZeneca drug delivery deals

Table 29 - Bristol-Myers Squibb drug delivery deals

Table 30 - Abbott drug delivery deals

Table 31 - Merck & Co. drug delivery deals

Table 32 - Benchmarking methodology overview

Table 33 - Sources of information

Table 34 - Cumulative probabilities

Table 35 - Example ENPV calculation

Table 36 - Pharmaceutical industry event calendars

Table 37 - Key factors leading to successful alliances between companies

Table 38 - Drug delivery deals with agreements from the SEC




List of Figures




Figure 1 - Pharmaceutical company R&D drug delivery projects by route of delivery

Figure 2 - Drug delivery mergers and acquisitions, 1997-2005

Figure 3 - Effect of controlled release formulations

Figure 4 - Doses of chemotherapeutic agent required to achieve maximum effect

Figure 5 - Estimated value in 2004 worldwide sales of the top 200 prescription drugs by year of US patent expiry

Figure 6 - Life cycle management

Figure 7 - All deal activity, 1997-2005

Figure 8 - Drug delivery deal activity, 1997-2005

Figure 9 - All deals according to deal type, 1997-2005

Figure 10 - Drug delivery deals according to deal type, 1997-2005

Figure 11 - All deals according to types of company involved, 1997-2005

Figure 12 - Drug delivery deals according to types of company involved, 1997-2005

Figure 13 - Percentage of all deals with some financial information, 1997-2005

Figure 14 - Percentage of drug delivery deals with some financial information, 1997-2005

Figure 15 - Integrated valuation methods

Figure 16 - Ideal benchmarking deal cluster

Figure 17 - Example pharmaceutical deal force field

Figure 18 - Attrition by therapeutic area

Figure 19 - Success rates for life cycle management projects

Figure 20 - Pharmaceutical product decision tree

Figure 21 - Enhanced revenues due to drug delivery system

Figure 22 - Enhancement of patent life

Figure 23 - Drug delivery alliance development process




Appendix: The Drug Delivery Report:




Product and Service Locator




List of Abbreviations




COGS cost of goods sold

COPD chronic obstructive pulmonary disorder

DPI dry powder inhaler

ENPV expected net present value

I/M intramuscular

IPO initial public offering

IRR internal rate of return

LCM life cycle management

M&A merger and acquisition

MDI metered dose inhaler

NCE new chemical entity

NSAID non-steroidal anti-inflammatory drugs

R&D research and development

S/C subcutaneous

SEC Securities & Exchange Commission

SMI soft mist inhaler

TI therapeutic index

Abstract

Drug delivery is one of the most important sectors in the pharmaceutical industry and an area in which effective deal making is essential for survival and growth. Many smaller companies specialising in drug delivery systems rely upon deals for revenues, and larger pharmaceutical companies need access to their expertise and innovative technologies for the development of new products.

Effective deal making is particularly important in the present economic climate. The general downturn in equity markets over recent years has significantly weakened public share offerings as a means of raising the money that is required for rapid growth of drug delivery companies. Indeed, the NASDAQ biotech index fell by 45% during 20021 and the market for IPOs all but evaporated. The index had recovered to 80% of its 2001 value at the end of 2003, and grown a further 7% in 2004. At the end of 2005, it had reached 87% of the 2001 value. Nevertheless, as can be seen by the increase in the number of deals recorded in PharmaVentures’ PharmaDeals® Agreement, companies have been increasingly reliant upon the development of strategic alliances for gaining access to the funds that are required for product development and corporate expansion.

Effective Licensing & Commercialisation of Drug Delivery Systems 2006 encompasses issues that are vitally important to successful deal making within the drug delivery sector. The report begins with an assessment of the current and evolving drug delivery market, drug delivery companies and the challenges that are facing the drug delivery sector. The key driving factors that underlie the drug delivery sector are considered, including improving the therapeutic index of drugs, improving patient benefit and compliance, increasing the length of patent protection and product life cycle management. The report also reviews the business strategies that are employed for the commercialisation of drug delivery systems and there is an in-depth analysis of drug delivery alliances and their financial terms.

Integral to this report is a searchable management tool, available via the PharmaDeals® web site, which includes over 2000 drug delivery deals that transpired from May 1996 to the end of December 2005. This comprehensive source of drug delivery deals enables the gathering of competitive deal information including financial information. In addition, the database assists in obtaining knowledge of company relationships and partnerships that are vital to most drug delivery companies’ strategic business objectives.

The report also examines the drug delivery deal making activity of the top 10 pharmaceutical companies by healthcare sales, and identifies the deals with which these companies have been engaged to help recognise potential partners amongst the largest healthcare companies. The valuation methodologies that can be used when formulating deal terms are also described, including principles and rationale, deal bench marking and financial spreadsheet modelling.

The report includes an account of the process by which drug delivery deals are typically established from the initial steps of identifying the corporate needs, business opportunities and potential partners, through to the establishment of feasibility studies and full commercial alliances. Additionally, examples of genuine drug delivery agreements are provided that cover a variety of deal types including feasibility studies, licensing, collaborative R&D, commercialisation and product supply. These agreements, less the redacted portions, can be accessed via the PharmaDeals® web site.

The drug delivery sector represents a dynamic, rapidly evolving sector as companies continue to vie for positions that will maximise commercial returns. Both markets and technologies continue to drive the sector, and it will be interesting to witness its evolution over the ensuing years.

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