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Research and Markets Announces the Addition of Specialty Pharmaceuticals: Driving Industry Growth

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Research and Markets has announced the addition of Specialty Pharmaceuticals: Driving Industry Growth into the Next Decade to their offering.

High-volume, big-population drugs have fuelled the industry’s growth over the past 15 years.

But with increasing uncertainty about the ROI of primary care drug development, big pharma is looking for additional avenues of growth.

Specialty Pharmaceuticals: Driving Industry Growth into the Next Decade is a window into the complex world of specialty medicine: its stakeholders, its evolving regulatory environment, and its economics.

Based on extensive thought-leader interviews, this report is both a manual and a guidebook to competing and prospering in the world of specialty pharmaceuticals. Specifically, it provides:

Strategies for

- Sustaining a specialty franchise by building relationship equity with specialists
- Identifying and communicating with hard-to-reach patient populations
- Generating referrals, raising awareness, working with disease associations and patient groups

Data that capture

- Cost, time, and approval rate comparisons between specialty and primary care R&D
- Trends in specialty drug sales, pricing, and health care expenditures
- Specifics about the large- and small-molecule specialty pipelines in big pharma Insight into
- Pricing and uptake prospects for biogenerics and orally delivered proteins
- The impact on practice economics of Medicare CAP and the shift away from buy-and-bill
- Positioning specialty products for managed care

Specialty Pharmaceuticals: Driving Industry Growth into the Next Decade delivers the case studies, the recommendations, and the insider insights to help you navigate the shifting terrain of specialty markets: the gathering cost pressures, rising competitive heat, disruptive technologies, changing regulatory guidelines, new reimbursement paradigms, and more.

The report also drills down into two specialty disease commercial opportunities - pulmonary arterial hypertension and scleroderma - detailing the epidemiology, the drugs in development, and the opportunities for improving on the current standard of treatment.

Big pharma has awakened to the specialty opportunity, and is busy filling its pipelines and aligning its organizations in order to bring to market novel drugs for small but desperately needy patient populations.

Lilly currently has 14 proteins in development targeting specialty diseases, constituting about 30% of its early stage pipeline.

And Pfizer’s CEO Jeffrey Kindler boasted in his first major presentation since assuming office that Pfizer, with 35 protein projects in R&D, was on course to generate $1.5 billion in protein therapeutics in 2006, and would triple that number by 2010.

Biotech companies, which already dominate most specialty disease categories, are capitalizing on the shifting momentum with the hope of vaulting into the ranks of the top 10 pharma companies.

The phenomenal productivity of specialty drug R&D and the impressive commercial performance of a growing stable of specialty products beg a larger question: will big pharma be able to synergize both its specialty and primary care sales forces and to navigate the looming challenges of pricing, biogenerics, and tightening regulations in order to meet the challenge of building a prosperous specialty business?

Topics Covered

Chapter 1. Introduction: The Ascendancy of the Primary Care Model Definition of a Specialty Pharmaceutical

1.1. Background: Evolution of the Industry’s Focus on Primary Care Markets
1.2. The Impact of the Blockbuster Model on the Current Structure and Economics of the
1.3. The Uninsurable Risk of High-Volume Drugs
1.4. The Stirrings of a Shift

Chapter 2. The Emerging Portfolio Balance

2.1. Drivers behind Big Pharma’s Interest in Specialty Markets
2.2. Hoffman-La Roche Case Study: The Big Pharma Specialist
2.3. Other Examples from Industry

Chapter 3. The World of the Specialist

3.1. The Specialist Emerges as a Key Player in the Health Care Economy
3.2. Specialist Practice Economics
3.3. Detailing to Specialists
3.4. The Specialist-Focused Strategy

Chapter 4. The World of the Patient

4.1. Profile of the Specialty Care Patient
4.2. Reaching the Specialty Care Patient
4.3. A 3-Step Method for Reaching New Patients: A Case Study of Pegasys for Hepatitis C

Chapter 5. Regulatory and Reimbursement Issues

5.1. FDA Regulatory Pathways for Specialty Care Products
5.2. Managed Care and Specialty Drugs
5.3. Biogen Idec’s Amevive: A Case Study in Positioning a Specialty Product for Managed Care

Chapter 6. Analysis of two Specialty Disease Markets: Pulmonary Arterial Hypertension and Scleroderma

6.1 Pulmonary Arterial Hypertension
6.2. Scleroderma

Chapter 7. Conclusions: Implications and Considerations

7.1. Factors Impacting the Future Commercial Vitality of Specialty Disease Markets
7.2. Some Strategic Implications of Big Pharma’s Embrace of Specialty Products

Experts Interviewed for this Report



Company Index with web sites

List of Tables and Figures

Companies Mentioned: Bayer, Eli Lilly, GSK, Hoffman-La Roche, Pfizer