Jim Miller
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Of all the questions I get from contract services providers about industry trends and developments, the most commonly asked
one focuses on the threat of competition from contract research organizations (CROs) and contract manufacturing organizations
(CMOs) in India and China. Even when companies are not feeling immediate competitive heat, the long-term prospect of having
to face off with low-cost emerging market competitors, especially those in India and China, is always a top-of-mind concern
for CRO and CMO executives.
To gauge just how big and immediate the threat of Asian competition is to Western service providers, I traveled to India in
December 2010, where I attended CPhI India and visited several CROs and CMOs. My friend and colleague, Mak Jawadekar, known
to many in the industry for his role in outsourcing activities at Pfizer, accompanied me and provided invaluable introductions
and insights.
This was my first opportunity to see the Indian pharmaceutical industry first hand, and I came away very impressed with the
quality of the operations, the technology, and the entrepreneurial zeal of the industry leadership.
Targeting generics
Without question, what impressed me the most is the big bet the Indian pharmaceutical industry is making on the opportunity
presented by the expiration of patents in the next few years. Most of the generic-drug companies I visited have 20–30 products
in development for which they anticipate filing abbreviated new drug applications in the next several years. The US and European
markets are major targets for their generic products, but these companies ship products all over the world and have significant
sales in Africa, Latin America, and other Asian countries as well.
The generic-drug companies are in high-gear and are investing in large state-of-the-art manufacturing and development facilities
to meet the anticipated demand. One executive of a CMO of active pharmaceutical ingredients (APIs) I talked with cited a figure
of an anticipated three-fold increase in unit volumes for generic APIs and formulations. The new manufacturing facilities
that these generic-drug companies are building are impressive; facilities of 200,000 ft2 or more with state-of-the-art design and equipment are typical. In addition to the new facilities springing up around Hyderabad,
the traditional center of the Indian pharmaceutical industry, large, new pharmaceutical clusters are being developed in areas,
such as Vizag, a coastal city in Andhra Pradesh state, and Ahmedabad, in Gujarat. State governments are setting up special
economic zones with subsidies and tax incentives to attract development to these centers.
One of the most interesting characteristics of these facilities is the predominance of equipment made within India; the displays
of the Indian equipment manufacturers at CPhI India were truly impressive. One brand new injectables facility we visited had
vial washing and prep equipment made in India, fillers made in Europe, and a freeze dryer made in China. The availability
of high-quality locally made manufacturing equipment is an important source of cost advantage for Indian manufacturers as
it lowers their capital-investment requirements.
Contract development and services are a significant part of the business for these generic-drug companies—around 30% in some
cases—but they are not the driver of their near-term growth strategies. Contract services are viewed as a way to leverage
existing capacity, build relationships, and support a deepening scientific base. However, the focus of these companies is
on the opportunities in generic drugs, and I don't see them becoming a disruptive force in the CMO industry in the foreseeable
future.
The big risk to the CMO industry is that the generic-drug companies may be building too much capacity as they each seek to
cash in on the patent expirations. If this proves to be the case, we could see some Indian generic-drug companies turn more
aggressively to contract manufacturing to fill their underutilized facilities. Were this to happen, it could create pricing
chaos in the CMO industry and put European and North American CMOs at a considerable disadvantage.
