The Market for Bioengineered Protein Drugs

Report Highlights

• In 2002, drug companies sold nearly $33 billion in protein drugs, and they are projected to approach $40 billion in 2003.
• Rising at an average annual growth rate (AAGR) of 12.2%, this market is expected to reach $71 billion in 2008.
• Replacement proteins constitute the bulk of the market and will rise at an AAGR of 9.8% from $31.4 billion in 2003 to $50 billion in 2008.
• Monoclonal antibodies and fusion proteins will rise from $8.5 billion in 2003 to $20.1 billion in 2008.
• These products effectively strip market share from older, less effective therapies. Most notably, a number of monoclonal antibodies are in the last stages of clinical trials for the treatment of autoimmune disease and cancer and promise to be blockbuster products.

INTRODUCTION

Protein drugs represent one of the fastest sales growth areas within pharmaceuticals. From literally zero sales a decade ago, there now are multiple blockbuster protein drugs. Driving the growth are a number of new drugs that are markedly superior to existing small-molecule drugs. While protein-based therapeutics remarkably can be more expensive than traditional small-molecule drugs (for example, the widely used TNF-alpha inhibitors cost more than $10,000 per patient per year), patients, doctors and insurers all agree that the new therapies are superior to their cheaper predecessors. In addition, many biologics can treat diseases that are untouched by small-molecule drugs.

While growth of protein drugs should be healthy, industry participants in the market also face serious and new challenges. Notably, lawmakers are threatening to introduce bills governing the introduction of generic drugs, and several leading drugs will lose their patent protection within the timeframe of this study. This can be historically important, since there are neither generic protein drugs currently on the market, nor is there any framework for their introduction.

At the same time, the drug discovery process has been turned upside down through the use of technologies such as high-throughput screening, genomics, proteomics, rational drug design and others. In particular, the immune system is one of the most complex systems known to man; these new technologies are revealing hundreds of possible targets for the treatment of immune disease.

This in-depth BCC study examines recent commercial developments in therapeutic proteins. These have had the highest sales growth rates of any drug type over the past decade. Indeed, one of the limiting factors to sales over the past several years has been lack of capacity to produce enough therapeutic proteins. Growth will remain high over the next five years, as a multitude of new proteins will reach the market; these drugs will both improve upon current treatments and treat previously untreatable diseases.

SCOPE OF STUDY

This report provides:

• Coverage of proteins that are used for therapeutic purposes
• Analysis of protein-based drugs in clinical trials and, like all drugs, their historically high failure rates
• Unbiased market forecasts for the period through 2008
• Examination of current technologies underlying the market and details the effects of new technologies on this market
• Profiles of the major companies involved in the production and modification of protein drugs.

METHODOLOGY AND SOURCES

This report uses a combination of direct and indirect sources. Direct sources include interviews and conversations with scientists and analysts. Indirect sources include company news releases, governmental and nongovernmental agencies, scientific journals and the popular press.

Sales were gathered from the most recently available data and represent worldwide sales. In nearly all cases, this involved year-end 2002 sales. If these figures were not available, then the latest available figures were used.

In some cases, data was not available. In these cases estimates were made using patient populations, percentages treated with other drugs and average sales prices. In these cases it is clearly stated that these estimates are "rough."

Estimates of future worldwide growth depended primarily upon a baseline growth estimate of 8%. According to multiple estimates by research institutes, nongovernment and industry sources, overall pharmaceutical sales have grown at 8% over the past 4 decades. Sales in the U.S. have been growing much faster over the past few years as evidenced by National Institute for Health Care Management's latest study that estimated that U.S. prescription drug sales rose 17% last year. However, drug growth outside the U.S. has been much smaller. Furthermore, we predict that U.S. sales will revert to the mean on the back of numerous patent expirations

Estimates for future sales growth within individual markets depended upon: patent expirations, percentage of the market penetrated, generic competition, competing drug classes, the introduction of new drugs, demographic growth and shifts, recent study results, and other variables. In each case where a forecast is made, the most important factors are listed. All figures for 2008 refer to the end of the year.

Sales are presented in millions of dollars, unless otherwise noted.

ANALYST CREDENTIALS

Robert J. Cyran has a Master's degree in Economics from the University of Birmingham, U.K. For the past several years he has worked as an editor and biotechnology correspondent for various publications, among them Forbes Magazine and Worldlyinvestor.com. He is also the author of two BCC reports, C-202 New Developments in Enzyme Inhibitors and Receptor Blockers and C-141 New Advances and Treatments in Immune Diseases.