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Reportlinker Adds Evolving Trends in Biopharmaceutical Licensing: Deal Assessments, Drivers and Resistors Report


businesswire
Press Release Source: ReportLinker On Monday October 19, 2009, 7:36 am EDT

NEW YORK--(BUSINESS WIRE)--Reportlinker.com announces that a new market research report is available in its catalogue.

Evolving Trends in Biopharmaceutical Licensing: Deal assessments, drivers and resistors

http://www.reportlinker.com/p0114852/Evolving-Trends-in-Biopharmaceutical-Licensing-Deal-assessments-drivers-and-resistors.html

Evolving Trends in Biopharmaceutical Licensing: Deal assessments, drivers and resistors

Large Pharma companies have become heavily dependant upon alliances and in-licensing to gain access to technologies/new molecular entities from Biopharma. This reliance has strengthened Biopharma’s bargaining position, and is reflected in negotiation tactics which aim to expand their role beyond product discovery and development towards an active participation in the the future of their products. This is emphasized by the growing complexity of licensing deals, as Biopharma attempts to secure marketing and commercialization rights within partnership deals.

Furthermore, recent increases in internal Biopharma consolidation are an indicator of the ability of well-established Biopharma companies to effectively compete against traditional big Pharma.

‘Evolving Trends in Biopharmaceutical Licensing’ is a report published by Business Insights that provides a detailed analysis of licensing strategies in the biopharmaceutical industry over the 2001-08 period. This report examines the growth of the biopharmaceutical industry, deal-making trend data, drivers and challenges facing biopharmaceutical licensing, and profiles of biopharmaceutical licensing among leading companies. The future prospects of the industry are assessed and the potential impact of political/regulatory factors upon licensing and alliances is identified. This report also investigates the influence of the recent upsurge in M&A activity and provides recommendations on the strategies that can sustain future growth.

Key Findings

-Several top-ranked Biopharma companies have matched the consistent sales growth of major traditional pharma companies. A key component of this success has been the increasing reliance of big Pharma to improve R&D productivity and rejuvenate sales of marketed portfolios through licensing and partnership deals.

-Big Pharma has been acquiring Biopharma companies at an increasing rate, resulting in this becoming the fastest-growing M&A sector in 2008 with deal values up 87%. Intense competition and financial uncertainty has also prompted a surge in biopharma consolidation, with 52 biopharma/biopharma deals in 2007.

-Considerable potential for Biopharma licensing deals still exists, particularly within the OAD class of drugs and non-invasive insulin drug delivery technologies.

-The total deal size of early-stage alliances with biopharma has increased six-fold, with total deal values in 2007 estimated at $18bn. This has been driven by the relatively lower costs of discovery and lead development, despite the higher risk of failure.

-Co-development/co-promotion deals accounted for 30% of licensing deals over 2006-07. Licensing deals will continue to become more complex due to biopharma’s desire to remain involved in their product lifecycle beyond the stages of discovery and development

Use this report to...

• Examine the licensing landscape of the biopharma industry with this report’s analysis of Biopharma and Pharma licensing and alliance activity and an examination of specific approaches utilized by both sectors.

• Discover the drivers and challenges facing Biopharma licensing, understand how

Biopharma companies are preparing to exploit new opportunities and assess deal-making trends across clinical trials phases and key therapeutic areas.

• Evaluate the strategies of leading companies involved in biopharmaceutical licensing with this report’s analysis of deal activities amongst leading players and identify the changing dynamics of Biopharma/Pharma partnerships.

• Assess the future prospects of the Biopharma industry and how current market and political/regulatory factors will impact the dynamics of licensing and alliances, as well as potential strategies for sustaining growth.

Explore issues including...

Biopharmas reduced reliance on Pharma. Biopharma is sustaining its efforts to increase its role outside of product development/discovery to become actively engaged in the future of their products. As such, it is becoming increasingly difficult to differentiate big Pharma from major Biopharma companies.

Optimizing revenue potential. Biopharma are increasingly targeting high value therapy areas, such as oncology and inflammatory disease, bringing them into direct competition with major Pharma.

Future competitive strategies. With licensing deals increasing in value and complexity, Biopharma companies are looking to increase their involvement by forming long-term, partnership-based relationships. This active engagement in licensing deals will typically involve the negotiation of equity investment and the co-promotion and co-marketing of a drug that allows Biopharma to generate additional downstream revenues.

Drug development potential. The emergence of several new Biopharma companies with innovative technology platforms has created immense potential for intra-Biopharma licensing trends to continue developing novel drugs that can successfully differentiate themselves within the marketplace.

Discover...

• How will the increasing competition for attractive Biopharma licensing candidates affect deal terms and values?

• How can Biopharma companies improve their licensing strategies to ensure future growth?

• What have been the major trends in licensing agreements between Biopharma and Pharma over 2001-08?

• Which strategies have Biopharma used to reduce their reliance on Pharma?

• How has the value, volume and competition for Biopharma licensing deals changed over 2001-08?

• What have been the strategies of successful Biopharma and Pharma deal-makers?

• Why are Biopharma and Pharma increasingly adopting M&A strategies instead of entering into licensing agreements?

Table of Contents

Evolving Trends in Biopharmaceutical Licensing Executive Summary 10

Introduction to biopharmaceutical licensing 10

Biopharmaceutical deals and trends 11

Drivers and resistors facing biopharmaceutical licensing 12

Companies involved in biopharmaceutical licensing 13

The evolutionary pattern of biopharmaceutical licensing 14

Chapter 1 Introduction to biopharmaceuticals and licensing 16

Summary 16

Introduction 17

Overview of the biopharmaceutical industry 17

The Biopharma-Pharma relationship 18

The licensing process 21

Meeting the licensing challenge 22

Biopharma continues to shine 24

Chapter 2 Biopharmaceutical deals and trends 26

Summary 26

Introduction 27

Biopharmaceutical licensing trends 27

Number and average value of Biopharma licensing deals 28

Licensing deal partners 30

Biopharma’s standing: out-licensing versus in-licensing deals 31

Licensing deal types 32

Licensing trends in drug development 34

The rising costs of early-stage licensing 35

Mid-stage deal-making: lucrative prospects 40

Therapeutic focus in Biopharma licensing 41

Chapter 3 Drivers and resistors of biopharmaceutical licensing 44

Summary 44

Introduction 45

Overview of drivers and resistors in biopharmaceutical licensing 45

Key drivers 46

Generating cash 46

Pharma turns to Biopharma to maintain revenue growth; Biopharma gaining an upper hand 48

Risk sharing 50

Access to expertise 50

Key resistors 52

Reduced control 52

Increasing complexity of licensing deals: positive for Biopharma but with a higher risk attached 52

Stricter regulatory and political environments 53

Future strategic direction 58

Chapter 4 Leading companies involved in biopharmaceutical licensing 62

Summary 62

Introduction 63

Who is looking to Biopharma and why? 63

Two sides of the Pharma coin: GlaxoSmithKline and Roche 64

GlaxoSmithKline: a Biopharma façade? 64

Roche: building upon an established presence in Biopharma 71

The Biopharma/Pharma dynamic 76

Amgen: the leading Biopharma 76

Gilead: diversification after market domination 80

Cephalon: a Biopharma out-licensor 83

Alnylam: a developer of novel therapeutics based on RNA interference 85

Chapter 5 The evolutionary pattern of biopharmaceutical licensing 90

Summary 90

Introduction 91

The big deals of 2008: a sign of what is to come? 91

Who holds the future to ImClone? 91

The Roche and Genentech saga 92

Biopharma to Biopharma: Genzyme and Isis 93

Takeda looks to Biopharma for entry to the US market 94

Pfizer and Wyeth 95

Are M&As the new licensing? 97

Potential arrival of biosimilars: a catalyst for Biopharma M&A 98

The financial crisis and the future of Biopharma 99

The promise of emerging markets 101

Keys to future success 104

Recommendations and strategies for future Biopharma licensing deals and alliances 105

Chapter 6 Appendix 110

MedTRACK data 110

Index 111

List of Figures

Figure 1.1: Number of NMEs and BLAs approved by the US FDA 19

Figure 1.2: Strengths of Biopharma and Pharma 21

Figure 1.3: Overview of the pharmaceutical licensing process 23

Figure 1.4: Global sales* of Biopharma vs. Pharma 24

Figure 2.5: Number and average value of Biopharma licensing deals, 2001–08 28

Figure 2.6: Number of top 20 Biopharma licensing deals by partner, 2001–08 30

Figure 2.7: Number of Biopharma in- and out-licensing deals by partner, 2004–08 31

Figure 2.8: Biopharma licensing by deal type, 2001–08 32

Figure 2.9: Biopharma out-licensing distribution by clinical stage, 2001–08 34

Figure 2.10: Early-stage deal models with associated pros & cons 36

Figure 2.11: Early-stage alliances—number of deals and deal size, 2001–08 37

Figure 2.12: Trends in technology, Biopharma out-licensing, 2002–07 38

Figure 2.13: Number of Biopharma out-licensing deals ($100m+ nominal deal value) by clinical stage, 2005–08 40

Figure 2.14: Therapeutic focus in Biopharma licensing deals, 2005–08 41

Figure 3.15: Drivers and resistors facing biopharmaceutical licensing 46

Figure 3.16: Biopharma R&D spend 47

Figure 3.17: Biopharma funding 47

Figure 3.18: Progression of Biopharma’s involvement in licensing deals 49

Figure 3.19: Estimated last patent expiry dates of selected proteins 56

Figure 3.20: Future strategic directions for Biopharma in meeting current challenges 58

Figure 4.21: Biopharma’s transition via forward and downward integration 64

Figure 5.22: Announced number of Biopharma mergers & acquisitions, 2001–08 97

Figure 5.23: Drug patent expiries in the US, 2008-2012 100

Figure 5.24: Future licensing and alliance scenarios for Biopharma 104

List of Tables

Table 4.1: GSK’s licensing and alliance activity, 2008 67

Table 4.2: GSK’s licensing and alliance activity, 2007 68

Table 4.3: GSK’s licensing and alliance activity, 2006 69

Table 4.4: GSK’s licensing and alliance activity, 2005 70

Table 4.5: Roche’s licensing and alliance activity, 2008 71

Table 4.6: Roche’s licensing and alliance activity, 2007 72

Table 4.7: Roche’s licensing and alliance activity, 2006 73

Table 4.8: Roche’s licensing and alliance activity, 2005 74

Table 4.9: Amgen’s licensing and alliance activity, 2007-08 77

Table 4.10: Amgen’s licensing and alliance activity, 2005-06 78

Table 4.11: Gilead’s licensing and alliance activity, 2005–07 80

Table 4.12: Cephalon’s licensing and alliance activity, 2005–07 83

Table 4.13: Alnylam’s licensing and alliance activity, 2005–07 85

Table 5.14: Sales in 7MM and pharmerging markets ($m), 2003-07 101

To order this report:

Evolving Trends in Biopharmaceutical Licensing: Deal assessments, drivers and resistors

http://www.reportlinker.com/p0114852/Evolving-Trends-in-Biopharmaceutical-Licensing-Deal-assessments-drivers-and-resistors.html

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