Presentation Overviews
Competitive Landscape Seminar Series: Biologics and Biosimilars will deliver in-depth presentations that offer vital insights around the biologics and biosimilars markets that are essential for successful business planning.
Competitive Landscape of Biologics: Key Players and Market Forecast
Ben Duncan
Decision Resources estimates the global biologics market (which we currently define as antibody-based therapies and recombinant proteins) at just under $110 billion in 2010, increasing to nearly $149 billion by 2017 – a CAGR of 4.3 percent. If we include vaccines and the range of DNA/RNA and cell-based therapies expected to enter the market by the end of the forecast period, then that number rises to more than $180 billion, accounting for around a quarter of global pharmaceutical sales in 2017. Needless to say, these numbers represent a significant investment on the part of the world's leading companies into biologic therapies. In this talk we will provide an overview of:
- The forecasts and dynamics for the biologics market out to 2017, including analysis of the leading players in the space.
- The deal trends by company and therapeutic area within the biologics arena.
- The therapeutic/disease areas that are receiving the greatest R&D resources— and an analysis on the risks involved in developing biologic therapeutics.
- The dynamics of market penetration—do biologics always succeed?
Biosimilar ESAs in Europe: What Strategies and Tactics Have Been Taken and What Has Worked?
Jennifer Robinson
Among the first biosimilars to launch, erythropoiesis stimulating agents (ESAs) have set a mixed precedent for other biosimilars. Developers of biosimilar monoclonal antibodies are looking to ESAs for lessons learned in how to successfully promote biosimilars in general. This presentation will answer the following questions:
- Which biosimilar ESAs have been the most successful, and why?
- How have payer-focused versus physician-focused strategies varied in their success with ESAs to date?
- How will strategies promoting biosimilar ESAs evolve with changing payer dynamics in the EU5, and with launch into a U.S. market where the Medicare bundle will impact uptake?
- What lessons have we learned from promotion of biosimilar ESAs, and which of these lessons apply to monoclonal antibodies and fusion proteins?
Bringing Biosimilar Insulins to Life: New Challengers Emerge to Claim a Piece of the $14 Billion Insulin Market
Donny Wong, Ph.D.
While multiple insulins and insulin analogs have reached blockbuster status in major markets, their development, production and sales support are uniquely challenging and thus pose major barriers to biosimilar entry. However, a flurry of recent deal-making activity will change the face of the future insulin market as new alliances emerge that will challenge a market that has been for decades dominated by only three companies (Eli Lilly, Novo Nordisk and Sanofi).
This presentation will answer the following questions:
- How will recent deals between Eli Lilly and Boehringer Ingelheim, Pfizer and Biocon, GlaxoSmithKline and Bioton impact sales of branded insulins?
- What strategies will the three major players in the insulin market employ in response to these new challengers?
- What are other drug development efforts of note that will potentially impact the insulin market?
Rituximab: Paving the Way for Therapeutic Biosimilar Monoclonal Antibodies in Oncology
Andrew Merron, Ph.D.
The approval of rituximab biosimilars will herald the first entrance of biosimilar monoclonal antibodies in oncology. As a blockbuster drug, branded rituximab has much to lose; Decision Resources estimated G7 2010 sales for non-Hodgkin’s Lymphoma (NHL) are in excess of $3.6 billion and the emergence of biosimilar versions will considerably affect Roche’s hold over the market. This presentation will focus on rituximab use in NHL and chronic lymphocytic leukemia (CLL) and will answer the following questions:
- What level of clinical trial data do hematologist-oncologists expect in order to trigger a change in their prescribing practices from branded rituximab to biosimilar rituximab, irrespective of approval requirements?
- What are the drivers and constrainers for biosimilar rituximab use in NHL and CLL?
- What are the forecasted change in sales for branded rituximab and biosimilar rituximab over the next ten years in NHL and CLL?
- Who are the key players threatening rituximab patient share?
- How will the entrance of biosimilar rituximab affect other approved and emerging anti-CD20 monoclonal antibodies in NHL and CLL?
- How will pharmaceutical spending cuts impact the use of biosimilar rituximab in Europe? What are European payers’ opinions of biosimilar rituximab market entry in NHL and CLL?
- Why will other blockbuster monoclonal antibodies in oncology (notably, trastuzumab and bevacizumab) look to rituximab as a model for biosimilar market access?
Biologics in Breast Cancer – What Threatens Herceptin’s Dominance?
Niamh Buckley, Ph.D.
Currently, Roche/Genentech/Chugai’s Herceptin dominates sales in the breast cancer market despite being licensed in only a minority of patients. However, there are clinical, regulatory and economic factors that will impact future sales of Herceptin in breast cancer. This presentation will focus on the role and future commercial outlook of Herceptin in breast cancer and will answer the following questions:
- What are the market forces driving and constraining use of Herceptin?
- Which near-term and long-term market events will most significantly impact sales of Herceptin in breast cancer?
- How will biosimilars impact branded sales of Herceptin?
- How will Roche adapt to the entry of biosimilar trastuzumab?
- To what extent will non-biological agents threaten Herceptin?
Market Access for Biologics—An Increasingly Challenging Obstacle Course
Neil Grubert, M.A.
With treatment costs of thousands of dollars per year, biologics are among the most expensive drugs in common use. In the past, healthcare payers generally accepted high prices and granted these agents relatively generous reimbursement terms, a situation that has understandably encouraged the biopharmaceutical industry to invest heavily in this sector. However, faced with relentlessly increasing healthcare expenditures, governments and other payers are redoubling their efforts to cut costs. Not surprisingly, prescription drugs are a prime target in payers’ cost-containment strategies, and the high prices of biologics inevitably attract particular attention. This talk will answer the following questions:
- How have the prices of biologics evolved in recent years and how do prices compare among leading markets?
- What coverage do payers offer to biologics and how are they experimenting with new approaches to reimbursement?
- What cost-containment measures are frequently applied to biologics?
How Will Cost-Cutting Hurdles Impact Speed and Breadth of Uptake of Biologics Across the EU5; A Focus on Crohn’s Disease and Ulcerative Colitis
Janie Cox, Ph.D.
European countries have traditionally invested heavily in their public healthcare systems. However, the current economic climate dictates that each EU5 country must strive to cut healthcare costs, and the pharmaceutical market is a prime target. In 2010, the EU5 countries implemented a number of significant cost-containment strategies, including branded drug price cuts and caps and radical changes to some healthcare systems. Such cost-cutting efforts undoubtedly have an ongoing impact on the premium-priced biologic therapies that play a pivotal role in the treatment of immune indications. This presentation will draw upon insights from interviewed payers, predominantly payers with regional and/or national influence, in order to answer the following questions:
- How are payers seeking to control physicians’ use of these agents?
- Which countries in the EU5 are the most rapid adopters of new biologics in these immune indications? How have reimbursement policies in these markets supported or hindered uptake of biologics?
- How will reimbursement policies that were announced in 2010 across the EU5 likely impact the uptake of biologics in the future?
- What can marketers do to minimize the impact of countries’ cost-cutting strategies?
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