Table of Contents
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the report
- Interviewed licensing executives
- Chapter summary
- Definitions
- Key findings
- CHAPTER 2 DRIVERS AND RESISTORS OF LICENSING
- Both Pharma and Biotech face the same challenges
- Drivers and resistors of licensing facing Pharma and Biotechs today
- Drivers for the licensee
- In-licensing compensates for declining internal R&D
- To maintain and build upon a company' s pipeline and portfolio,
selective in-licensing is frequently employed
- Resistors for the licensee
- In-licensed products offer a lower ROI than those developed in-house
- Competition for products drives up costs of licensing deals, so
Pharma turn to licensing at an early-stage of development
- Drivers for the licensor
- Generating cash
- Sharing the risk
- Accessing external resources and capabilities
- Resistors for the licensor
- CHAPTER 3 HOW TO SUCCESSFULLY NAVIGATE THE LICENSING PROCESS
- The key to successful licensing
- The licensing strategy
- Identifying an opportunity
- In-licensing - evaluating needs and identifying potential candidates
- Out-licensing - overcoming limitations
- Partners of choice
- Licensing evaluations
- Signing the deal and managing the alliance
- Alliance management structure
- Novel twists on licensing strategies - case study analysis
- Debiopharm - the consummate licensor
- Versant Ventures joins in with Lilly' s Chorus
- Pharma looks outside its traditional portfolios
- Deal values
- Deal structures
- Upfront payments
- Milestone payments
- R&D costs
- Royalties
- Deal structure for marketed products
- CHAPTER 4 PRODUCT LICENSING DEALS AND TRENDS
- Introduction
- Large Pharma turn to in-licensing to compensate for flagging internal
R&D pipelines
- Reliance on licensing deals
- Eisai forecast to experience the largest increase in dependency on
in-licensed products
- Merck & Co. set to shift its dependence from in-house to
in-licensed products by 2012
- Boehringer Ingelheim set to decrease its reliance on externally
sourced products
- Sanofi-Aventis expected to focus on in-licensing in the future
- In-licensing used to offset deficiencies in internal pipelines and
portfolios
- Deals continue to rise through 2005-06
- Deals for drugs in clinical development predominate
- In-licensing forms the majority of clinical stage drug deals
- Licensing and co-development deals are most frequently for compounds
in preclinical and Phase I development
- Continued rise in the number of preclinical and clinical
out-licensing deals by big Pharma, but deals for marketed drugs fall
sharply
- Marketing, promotion and distribution deals most commonly associated
with marketed products
- Leading dealmakers
- Japanese companies raise their deal-making profile
- Leading in-licensor companies
- AstraZeneca in-licenses to strengthen its neuroscience portfolio
- Novartis carried out the greatest number of Phase I and equal
highest number of Phase III deals
- Leading co-developers
- Novartis and Bayer-Schering performed the largest number of
co-development deals
- Roche continues to strengthen key therapy areas through
co-development
- Few companies entered into co-development deals for drugs in Phase
III or above
- More co-development between large Pharma and large Pharma/Biotech
expected in the future
- Companies continue to enter deals for anti-infective and oncology
products
- Resurgence in deals for oncology drug candidates
- Continued rise in anti-infective and CNS drug deals
- Small molecules remain the target of choice for licensing deals, but
it will be the biologics driving market growth
- Leading out-licensors
- Bayer Schering AG out-license products
- BMS enters out-licensing agreements to share risk and costs
- Roche performed the highest number of marketed drug deals
- Sanofi-Aventis transfers Exubera global rights to Pfizer
- Big Pharma predicted to increase out-licensing deals in the future
- Marketing, promotion and distribution deals
- Top companies predominantly enter marketing and promotion deals as
partners
- Abbott uses marketing agreements to bolster its position in the
respiratory market
- Chugai enhances its position in the cardiovascular market through
marketing and promotion deals
- CNS and anti-infective therapies are the most popular targets for
marketing and promotion deals
- CHAPTER 5 TECHNOLOGY LICENSING DEALS AND TRENDS
- Introduction
- The importance of technology deals
- Drug discovery deals take a dive
- Leading technology dealmakers
- Merck & Co. remains the dominant drug discovery dealmaker
- Biologic technologies overtake small molecules in terms of drug
discovery deals
- Therapeutic antibodies and recombinant proteins are the key biologic
technologies targeted in drug discovery deals
- Types of drug discovery deal
- Assays and arrays
- Bioinformatics
- Biopharmaceutical discovery and development
- CHAPTER 6 BIBLIOGRAPHY
- Datamonitor reports
- Websites
- Publications and online articles
- Glossary of terms
- List of Tables
- Table 1: Top 20 pharmaceutical companies, 2005-06
- Table 2: A complementary strategy - strengths that Pharma and Biotechs
bring to a licensing deal
- Table 3: Ophthalmology licensing deals, 2005-06
- Table 4: Current treatments for AMD, 2006
- Table 5: Proportion of upfront payment in terms of total deal costs
increases with drug development, 2005-06
- Table 6: Upfront and milestone payments made by GSK, 2005-06
- Table 7: Royalty rates for in-licensed compounds
- Table 8: Top 20 pharmaceutical companies forecast to grow by only an
average of 2.6% CAGR, 2006-12
- Table 9: Product deals made by Japanese headquartered companies during
2005-06
- Table 10: Key anti-infective drug in-licensing and co-development
deals, 2005-06
- Table 11: Small molecules remain the focus of in-licensing and
co-development deals during 2005-06
- Table 12: Drug discovery and delivery deals made by the top 20
pharmaceutical companies, 2000-06
- Table 13: Leading companies licensing biopharmaceutical discovery and
development technologies, 2005-06
- List of Figures
- Figure 1: The key drivers and resistors facing licensees and licensors
in today' s pharmaceutical industry
- Figure 2: Factors responsible for declining revenues
- Figure 3: The number of in-licensing deals rose rapidly in 2005-06
following gradual growth over previous years
- Figure 4: Factors determining a licensee' s profits
- Figure 5: In-licensed products offer a lower ROI than those developed
in-house
- Figure 6: The rising cost of in-licensing, 2000-05
- Figure 7: Resurgence in the in-licensing of preclinical compounds,
2005-06
- Figure 8: The pros and cons of in-licensing at different stages of
drug development
- Figure 9: Factors leading to partnership breakdown during licensing
deals
- Figure 10: Overview of the pharmaceutical licensing process
- Figure 11: Key elements that need to be considered when developing a
company' s licensing strategy
- Figure 12: Key factors to be evaluated when identifying a suitable
in-licensing opportunity
- Figure 13: Merck & Co.' s ' Submit your discovery' licensing
opportunity profile template
- Figure 14: Factors which can tip the balance in favor of initiating or
delaying the out-licensing decision for a licensor
- Figure 15: Partner' s of choice must satisfy several hard and soft
factors
- Figure 16: Novartis' s strategic alliance process
- Figure 17: Poor deal management can have major detrimental effects on
the alliance performance
- Figure 18: Debiopharm' s business model
- Figure 19: Licensing agreement between Lilly' s Chorus and Versant
Ventures
- Figure 20: Weighing up upfront payments
- Figure 21: Mean upfront payments for licensing and co-development
deals made by the top 20 Pharma, 2005-06
- Figure 22: Total and mean upfront payments by licensor, 2005-06
- Figure 23: Mean milestone payments for licensing and co-development
deals made by the top 20 Pharma, 2005-06
- Figure 24: Total and mean milestone payments by licensor, 2005-06
- Figure 25: Externally developed drugs will not be sufficient to offset
revenue losses from in-house products for GSK, 2006-12
- Figure 26: Top 20 pharmaceutical companies forecast to grow by only an
average of 2.6% CAGR, 2006-2012
- Figure 27: Companies increasing their in-licensing dependence during
2006-12
- Figure 28: Companies decreasing their in-licensing dependence during
2006-12
- Figure 29: In-licensed products are not expected to offset revenue
decline from in-house products for Eisai, 2006-12
- Figure 30: Externally sourced products help drive Merck & Co.' s
sales growth during 2006-12
- Figure 31: Boehringer Ingelheim set to decrease its reliance on
externally sourced products during 2005-06
- Figure 32: Summary of how product sourcing is forecast to effect
company sales by 2012
- Figure 33: In-licensing deals in 2005-06 versus 2000-04
- Figure 34: In-licensing deals are the most frequent type of deal
carried out by the top 20 pharmaceutical companies, 2005-06
- Figure 35: Deals per stage of drug development, 2005-06
- Figure 36: Development stage of product' s licensed, by type of deal,
during 2005-06
- Figure 37: Licensing and co-development deals are most frequently made
for compounds in preclinical and Phase I development, 2005-06
- Figure 38: Resurgence in the in-licensing of preclinical compounds,
2005-06
- Figure 39: Continued rise in the number of preclinical and clinical
out-licensing deals, but deals for marketed drugs fall sharply, 2000-06
- Figure 40: Definition of source and partner companies
- Figure 41: Novartis was the leading dealmaker during 2005-06
- Figure 42: Novartis and AstraZeneca were the top in-licensors during
2005-06
- Figure 43: Number of in-licensing deals versus sales growth, 2005-06
- Figure 44: Novartis and Bayer-Schering were the top co-developers
during 2005-06
- Figure 45: The ratio of deals per therapy area has changed little
between 2000-04 and 2005-06
- Figure 46: The number of oncology and anti-infective in-licensing and
co-development deals grew strongly during 2005-06
- Figure 47: Novartis entered into the greatest number of small molecule
in-licensing and co-development deals, 2005-06
- Figure 48: Significant increases in deal numbers were made across all
biologic categories during 2005-06
- Figure 49: Bayer-Schering and BMS were the top out-licensors during
2005-06
- Figure 50: Out-licensing deal territories, 2005-06
- Figure 51: Novartis was the leading company to enter marketing,
promotion and distribution deals during 2005-06
- Figure 52: Marketing and promotion deals by therapy area, 2005-06
- Figure 53: The drug development process, including stages where drug
delivery technologies can be applied
- Figure 54: Drug discovery and technology deals made by the top 20
pharmaceutical companies, 2000-06
- Figure 55: Merck & Co. and Novartis performed the most technology
deals during 2005-06
- Figure 56: Biologic technologies overtake small molecules in terms of
drug discovery deals, 2000-06
- Figure 57: Therapeutic antibodies and recombinant proteins were the
key biologics targeted in drug discovery deals, 2005-06
- Figure 58: Drug discovery technologies, 2005-06
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