Determining who's ahead in biopharmaceuticals is like trying to hit a moving target. Regional growth trends change rapidly,
companies are acquired or moved, and drug candidates don't always make it through clinical trials. The industry's variability
makes analyzing company performance on anything other than revenue difficult, but establishing benchmarks for regional growth
and trends is important for defining:
- Where biomanufacturing is taking place today, and where it will be done in the future
- Why manufacturing is more important than basic revenue to biotech clusters
- What trends are emerging in regional manufacturing
- Which threats to regional clusters are inhibiting growth.
To meet this need, BioPlan's Top 1000 Global Biopharmaceutical Manufacturing Facilities has accurately defined the market and created an open resource to provide real-time updates required to make current decisions
and assess emerging trends.
Eric S. Langer
The global open database is based on BioPlans's 11+ years of comprehensive analysis of this industry. The site rates biopharmaceutical
facilities on reported or estimated bioreactor capacity, related high-value employment, commercialized biological products,
and pipeline products. The
http://www.Top1000bio.com/ website provides free instant access and updates through a Wiki-type option where industry professionals are encouraged and
expected to provide nonconfidential input (1). This article briefly presents the methodology used to develop the BioManufacturing
Facility Index Scores, and presents initial conclusions supported by the current data, such as how global regions rank relative
to each other. The article also discusses other findings supported by current data, including the finding that innovation
and new recombinant protein and monoclonal antibody (mAb) manufacturing are the primary driving forces in regional biomanufacturing
clusters. Company innovation, research and development (R&D), and operational intensity are among the factors shown to be
most associated with higher facility index scores. These factors, in turn, relate to other parameters indicative of commercial
success. More importantly, though, is the database's ability to track real-time trends. BioPlan encourages individuals to
visit the site and update the information so that it provides ongoing global and microtrend analysis on a real-time basis.
The Index Score is proportional to facilities’/companies’:
Product innovation is the key to industry leadership
Innovation in product development and manufacturing appears to be the best predictor of where a facility, company, region,
or biomanufacturing cluster will rank. Companies manufacturing more innovative marketed products clearly tend to have the
highest reported capacities and find the highest facility ratings. In simplistic terms, biopharmaceutical products and manufacturers
can be divided into two groups.
The first group includes innovative, R&D-dependent products, generally developed and manufactured in the West, and with distribution
targeted to major Western markets. This category includes essentially all recombinant proteins and mAbs, and those requiring
the largest manufacturing capacity.
The second group includes lesser or non-R&D-dependent products, including most classic, long-manufactured, non-recombinant
products, notably many traditional vaccines and blood/plasma derivative products. Most of these facilities, by their nature,
produce large numbers of products, but may not depend on product innovation, high-level employment, or labor-intensive operations.
This is also consistent with projections that innovation leads to commercial product manufacture and company success.
Using 11 years of product analysis from our Biopharmaceutical Products in the US and European Markets database and other resources, BioPlan finds that product innovation has shown itself to be the primary driver in biopharmaceutical
manufacturing (2). The relationship between innovation and superiority in manufacturing capacity and high-value employment
also appears to drive long-term company profitability. Examination of the highest-ranking facilities shows that nearly all
are US and European biopharmaceutical manufacturers of innovator products, generally developed by these same companies. Thus,
companies such as Genentech/Roche and Amgen dominate the top-ranked companies with by far the largest capacities and highest
ratings, along with a few major contract manufactruing organizations (CMOs), such as Lonza and Boehringer Ingelheim.
Manufacturing of innovative, rather than me-too biogeneric and biosimilar, products is a primary driver in regional biomanufacturing
cluster development. There are a large and growing number of companies worldwide that are developing biosimilars/biogenerics,
with some already having progressed to manufacturing. Most companies, however, have yet to advance to approval and commercial
manufacturing, and their manufacture is generally on a much smaller scale than innovative product manufacture, particularly
as performed by manufacturing facilities based in traditional major (bio)pharmaceutical markets, such as the US and western
Examination of the top-ranking facilities shows relatively few outside of the US and western Europe, and the higher-ranking
facilities elsewhere tend to be vaccine or blood/plasma products manufacturers. These products tend to be less innovative
with more competition on balance, bringing fewer regional cluster benefits, (e.g., having lower profit margins, and less high-value
employment), to their owners and to the local cluster, region, and country where they are located. Innovative products typically
tend to be manufactured on a scale about an order of magnitude (10 times) greater than performed by biosimilar/biogeneric
manufacturers. For example, a US or European innovator company might produce most of the world's supply of a potent therapeutic
enzyme using a dedicated 500-L bioreactor, while others producing much the same or a similar product for international markets
may only be using a 50-L bioreactor. Also, products manufactured at cGMP standards in larger facilities are generally marketed
in their home territories and also command higher selling prices and profit margins.
The study's findings generally confirm the well-documented phenomenon that just a few companies, mostly manufacturers of blockbuster
mAbs (> $1 billion per year), by far collectively control the most manufacturing capacity, probably on the order of 90% by
bioreactor capacity. However, this does not detract from the importance of rankings of the rest of the Top 1000. The largest
facilities used for blockbuster mAb manufacture account for relatively few of the total number of global facilities. Further
analysis may include evaluating the extent to which the largest blockbuster mAb manufacturing facilities alter regional and
parent company rankings. That is, how do these relatively few, but overwhelmingly large facilities affect distribution of
Still to be evaluated is the impact that multiple, smaller commercial product biomanufacturing facilities, with low Index
numbers (ranking), can have on regional clusters, when compared with fewer, larger facilities with an equivalent total Index
number. Small facilities are important in that they create high-value employment and diversity, with each representing significant
investment, earning profits for their shareholders, paying regional taxes, and providing steady high-value employment benefits
for the regions where they are located.
By examining facilities ranking, we can quantify the extent to which biomanufacturing facilities tend to cluster near each
other. We see that factors such as local/regional biopharmaceutical and related R&D appear only indirectly related to biomanufacturing
capacity and its regional clustering. For example, the Maryland suburbs of Washington, DC, have by far the largest number
of biomedical scientists, with more than 10,000 alone affiliated with the National Institutes of Health, a large number of
local biotech companies, as well as FDA. Despite this concentration of biopharmaceutical expertise and companies, the region
tends to be made up of smaller facilities with relatively little major capacity in the area compared with many others that
have far less local R&D.