Outsourcing pharmaceutical production is not new, and the
benefits to big pharma companies are well documented. However, rapid changes in
the kinds of drugs, the delivery technologies they will require, the expertise
to scale-up new biopharmaceuticals, and even changes in capacity demand are all
on the horizon for the contract manufacturing marketplace. One thing is for
certain, contract manufacturing organizations (CMOs) will need to adapt to the
changing needs of the pharma industry in the new age of drug discovery.
This research study on the status and outlook for pharmaceutical outsourcing
is looking into such pressing issues as:
- current and future capacity and demand
- delivery and production technologies that CMOs will need to master
- the state of "manufacturing R&D"—the research into
effective scale-up
- the demands of government and industry partners in the QC realm
- the effects of industry trends, such as consolidation and specialization
Kalorama has conducted scores of interviews with executives and engineers at
pharmaceutical companies and at CMOs to validate projections and to assess
expectations and on both sides of this large and important marketplace.
Scope and Methodology
This report analyzes the state of the manufacturing segment of the
pharmaceutical outsourcing business, reporting figures on the three key markets
of North America, Europe, and Japan. The report profiles several companies
involved in marketing their manufacturing services to the pharmaceutical
companies, including Quintiles, Cammbrex, Genzyme, and others. The report
generally reviews the nature and direction of where the pharmaceutical contract
industry, specifically contract manufacturing, is headed and the challenges it
faces. Discussions of contract research work, while not the focus of this
report, are included in some areas because they represent a more mature model of
outsourcing in the pharmaceutical industry as a whole and can be instructive.
Market forecasts are based on an examination of current market conditions and
on investigations into the development of new products by key suppliers. This
information also is weighted with projected timing and the probability of
receiving FDA approval to market products. The information is the result of data
gathered from company product literature and other corporate brochures and
documents, as well as information found in the scientific and trade press. In
addition, multiple interviews were conducted with key company executives and
industry analysts. Research was conducted from June 2001 to November 2001.
Capacity Crunch Drives Pharmaceutical Manufacturing Outsourcing Growth
New York, January 7, 2002 /PR Newswire — Contract manufacturing in
the pharmaceutical industry will experience double-digit growth for the
foreseeable future, according to a new study released today from Kalorama
Information and available at MarketResearch.com, and a coming scarcity in
manufacturing capacity will be a major factor in the upsurge in global
outsourcing activity.
According to the new study, The Pharmaceutical Contract Manufacturing
Marketplace, the global pharmaceutical outsourcing market stands at
approximately $8 billion. However, the tsunami of new chemical entities in the
pipeline, especially the huge number of biopharmaceuticals in development, will
help to push the size of the market well past the $10 billion mark in less than
three years as traditional manufacturers realize that capacity and specialized
expertise are in short supply.
"Biomanufacturing capacity is definitely on everyone' s mind," notes
Steven Heffner, Acquisitions Editor for Kalorama Information. "But our
research doesn' t necessarily indicate the dire shortfalls in capacity that
some analysts have been predicting. We believe there are too many variables in
the late-stage development process to assume the worst."
In addition to the overall growth in outsourcing dollar volume, the number of
pharmaceutical contract manufacturing organizations worldwide also continues to
grow, according to the study. And the spectrum of services offered and the
geographic spread of contract organizations also continues to widen as virtual
pharmaceutical companies with more manufacturing needs become more common. The
report examines these and other market trends, especially the importance of
long-term strategic partnerships as the outsourcing industry matures.
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