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| Global Generic Drugs Market |
Generic
drugs market growth is buoyed by increasing number of
patented expiries for drugs each year. According to the IMS data
small-molecule products worth US$ 121 Bn are expected to lose patents
in developed markets, such as U.S and Europe between 2014 and 2018.
The IMS also forecasts that biologic products valued at US$ 48 Bn are
expected to lose patent protection over the next three years i.e from
2017 and 2020, which is expected to drive growth of the generic drugs
market. Global generics market is highly competitive with many Asia
Pacific companies entering the developed markets such as the U.S.,
Germany, France, and UK. Recent past has witnessed spurt in mergers
and acquisitions between generic drug manufacturers, with major
players focusing on enhancing their product portfolio through such
inorganic strategies. For instance, Teva Pharmaceutical Industries
Pvt. Ltd., Pfizer, Inc., Mylan, Sun Pharmaceutical, and Fresenius
Kabi entered into acquisitions to increase their revenue share in the
generic drugs market.
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Competitive
Analysis - Top 10 generic drug manufacturers, in terms of revenue, in
2016, are as follows:
•
Teva Pharmaceutical Industries
•
Mylan N.V.
•
Novartis International AG
•
Pfizer, Inc.
•
Allergan Plc
•
Sun Pharmaceuticals
•
Fresenius KABI
•
Endo International
•
Lupin Limited
•
Sanofi
Teva
Pharmaceuticals Industries strengthened its position in the generic
drugs market through acquisition of the generic segment of Allergan,
plc for US$ 40.5 billion in August 2016. This resulted in significant
growth in revenue contribution of its generic drug segment, pegged at
US$ 9.5 billion in 2016.
Mylan
ranks second in the list of generic drug manufacturers, and this is
due to the acquisition valued at US$ 7.2 Bn of Sweden’s Meda by
Mylan, in year 2016. This also aided Mylan to increase its sales of
over-the-counter drugs and expand its presence in new emerging
markets such as China, Southeast Asia, Russia, and the Middle East.
Sandoz—Novartis
Group’s business segment dealing in generic medicines—reported
rampant growth of 9% Y-o-Y in 2016, in sales volume, with revenue
pegged at US$ 9 Bn. However, it was partially offset by a 6% erosion
in price. Pfizer is at the fourth position (US$ 4.6 Bn revenue in
2016). Pfizer acquired Hospira in 2015, in order to increase its
product portfolio of both generic and branded products. Pfizer offers
over 220 injectable medications, plus other off-brand products, which
is expected to aid in gaining high revenue in near future. Patent
loss of Viagra in 2017, will lead to significant generic competition
from Teva and Mylan.
Allergan
though ranked at fifth position, sold its generics assets to Teva in
2015, and the deal closed in August 2016, which takes the company out
of the race for generic drug manufactures for 2017, till the company
receives new approval for generic drug manufacturing. This can favor
Aspen Pharma to enter the top 10 generic drug manufacturers league in
2017. Sun Pharmaceuticals Ltd., headquartered in Mumbai, India,
generated over US$ 3.6 Bn in generic sales in 2016. Sun
Pharmaceutical doubled its size by the acquisition of Ranbaxy
Laboratories in 2015, thus expanding its product portfolio. However,
growth was hampered when the FDA issued a warning letter in 2015 for
the Halol, India, API plant, which supplies the generic products in
the U.S. Owing to this, Sun Pharmaceuticals is unable to receive new
generic drug approvals.
Fresunius
Kabi, a generic arm of the Fresenius German Healthcare Group,
reported a 4% growth in revenue from the U.S. in 2016 driven by
strong sales of sterile injectable drugs. In 2017, the company
entered into agreement to buy Akorn—a generic drugs
manufacturer—for US$ 4.5 Bn, further strengthening its position in
the market. For Endo Pharmaceuticals, till 2014, the generic segment
did not generate significant revenue. However, following its
acquisition of Par Pharmaceutical in 2015, revenue of Endo
Pharmaceutical increased by 12.2% from 2012-2014. Following the
acquisition, Endo enhanced its product portfolio with the addition of
around 100 products, which also included profitable generic products.
Lupin,
in 2016, completed acquisition of U.S.-based Gavis and obtained its
first manufacturing site in the U.S., along with 60 ANDA filings
pending approval with the FDA. This aided the company to increase its
footprint in the highly lucrative U.S. market.
Increase
in number of competitor’s for generic drugs market put the pressure
on manufacturers of pricing. Moreover, price celling actions by
respective governments is further aggravating the profit margins of
generic drug manufacturers. Considering the challenges of pricing
pressure as generics outfits feel the pinch with thin margins, the
market is expected to exhibit steady growth in the future.
Being
a very lucrative market with a number of patent expires in the near
future, it is essential for competitive analysis for market players.
This could aid one in devising a unique strategy and process to
sustain in this highly competitive generic drugs market.
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