Jim Miller
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How big is the market for contract-manufacturing services? Pharm-Source gets that question morethan any other. Published estimates
of market size vary widely and often seem to be exaggerated or inflated.
MEASURING THE MARKET
Determining the size of the contract-manufacturing market is a methodological challenge. The biggest obstacle is the fact
that most CMOs are either privately owned and do not report their financial results or are part of larger corporations that
usually do not break out their CMO revenues in their financial reports. Although good research can overcome some of these
problems, determining market size ends up requiring some amount of "guesstimation."
Another methodological problem is defining what is included as "contract manufacturing." Many published reports are unclear
about what they are measuring, which can lead to widely divergent market-size estimates. Understanding a given market size
estimate requires that the reader and user fully appreciate what is being measured. Some of the dimensions that must be considered
are discussed below:
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Which products are included in the market? The definition can include prescription products, over-the-counter (OTC), and nutritional products. Although prescription
and OTC products are both governed by drug GMPs, nutritional products often are not, so the market dynamics and participants
tend to be different, albeit with some overlap.
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Is the product being manufactured proprietary to the client or is it generic? Some estimates of the contract-manufacturing market appear to include generic APIs, which are really commodities that can
be bought by any company looking to manufacture a generic or OTC drug. There also are generic or OTC drug products that the
manufacturer licenses to a customer to be packaged under the customer's name, the so-called "private label" business. By contrast,
pure contract manufacturing involves a CMO manufacturing an API or drug product using the client's proprietary process or
proprietary formulation.
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What regulatory standards must be met? Many manufacturers in emerging markets offer contract manufacturing, but they do not operate under North American, Western
European, or Japanese regulatory standards. These companies are competing in a different market and under a different set
of terms than manufacturers that meet higher regulatory requirements.
Given the potentially broad dimensions of the CMO industry, users of market-size data must be clear about the applicability
of the data they are using. PharmSource recently published its own estimate of the size of the dose CMO market, Dose CMOs
by the Numbers—2012 Edition. We measured the market for contract manufacturing of a client's formulation under FDA, Western
European, or Japanese GMP standards and built our estimate based on extensive research of company revenues and revenue modeling.
We (PharmSource) arrived at a contract-dose manufacturing market size of $13.7 billion in 2011. That was up 7% from 2010,
but that growth rate includes revenue from facilities that became contract-manufacturing sites during the year after they
were acquired by CMOs from biopharmaceutical/pharmaceutical companies. The organic growth rate (i.e., the growth of revenues
at facilities that were in CMO networks in 2010) was 6%. We estimate that overall, dose CMOs accounted for 22% of the biopharmaceutical/pharmaceutical
industry's dose-related cost-of-goods in 2011.
Of course, size and growth are not the only dimensions that matter for the health of the industry. Contract-dose manufacturing
suffers from overcapacity, especially for solid-dose forms, and the intense competition to sell capacity means that only a
minority of dose CMOs make reasonable profits. Further, global biopharmaceutical/pharmaceutical companies continue to show
a strong preference for building captive manufacturing, shutting CMOs out from some of the most attractive segments of the
market.
We continue to believe that a consolidation of the industry will happen sooner rather than later, driven by developments in
the broader economic and financial environment. When that happens, the industry may not be so big or growing at the same rate,
but it will be getting healthier.
