EU OTC market
• There are significant differences in the OTC
market dynamics (regulatory and otherwise)
of various European countries.
• The UK and Germany can be considered to
have highly developed and progressive OTC
markets, while the Latin countries (i.e. France,
Italy and Spain) lag some distance behind.
• Throughout Europe, access to OTCs is increasing.
• In Germany and the UK, the increased access is
derived mainly from pioneering switches from
Rx-to-OTC; while, in the Latin countries, the
increased access is derived mainly from the
opening up of distribution channels and from an
easing of advertising restrictions.
• The Centralized Procedure for Rx-to-OTC switches
has opened the gateway for switches to take
place simultaneously across all 27 EU member
• The first two Centralized Procedure switches both
took place in 2009: GSK’s weight loss product,
orlistat 60mg (branded as Alli); and Nycomed’s
proton pump inhibitor, pantoprazole 20mg
(various brand names).
• The new switches are part of the so-called
“collaborative care” model, whereby
consumers rely heavily on the advice of
pharmacists (or other healthcare
professionals) in making their OTC purchases.
• On the basis of this collaborative care model,
many new products and indications are likely
to become available OTC.
US OTC market
• US OTC sales increased by 4.5% to reach
$15.1bn (RSP) in 2008, compared to growth of
just 1.3% in the prescription sector. But this
growth seems to be in a declining phase till Q4
• The US boasts one of the most liberal OTC
markets in the world, with all products
permitted to be sold through any retail outlet.
• All OTCs are also free from price controls, and
may be advertised to consumers.
• The US OTC market is saturated in terms of
established OTC ingredients, and is
characterized by a large number of private
labels and generics, and by a large mass
• In recent years, market growth has been
driven by products that have been newly
switched from Rx-to-OTC.
Key recent switches USA
• McNeil’s antihistamine Zyrtec (cetirizine),
• GSK’s weight loss aid Alli (orlistat),
• Duramed’s emergency contraceptive Plan B
• Novartis’ PPI Prevacid 24HR (lansoprazole)
• Merck’s PPI combination product Zegerid OTC
(omeprazole + sodium bicarbonate).
US OTC sales (RSP $m) by major
therapeutic market, 2010
US: OTC sales (RSP $m) by therapeutic
• The Australian OTC pharmaceuticals market had total
revenues of $3,820.8m in 2013, representing a compound
annual growth rate (CAGR) of 3.9% between 2009 and
• The traditional medicines segment was the market's most
lucrative in 2013, with total revenues of $1,369.7m,
equivalent to 35.8% of the market's overall value.
• The performance of the market is forecast to decelerate,
with an anticipated CAGR of 2% for the five-year period
2013 - 2018, which is expected to drive the market to a
value of $4,211.5m by the end of 2018.
• The Australian OTC pharmaceuticals market consists of the retail sale
of traditional medicines including
• Cough and cold preparations (tablets, mixtures, lozenges, topical
• Vitamins and minerals (multi-vitamins, single minerals, single
vitamins, tonics, cod liver oil),
• Indigestion preparations (tablets, powders, mixtures),
• Analgesics (Paracetamol, Ibuprofen, Aspirin and other analgesics),
• Medicated skin products (anti-bacterials, acne treatments, anti-
fungal, disinfectants and other).
• Topical OTC medicines (anesthetic products, anti-itch products,
• Plasters & bandages (adhesive bandages/plasters, first aid tape,
gauze pads/rolled gauze, liquid bandages and other tape or bandage),
• First aid kits and
• Other including anti-smoking aids, rectal medications, eye/ear drops,
sleeping aids, and motion sickness.
• The OTC pharmaceutical market, in most of
the emerging geographies, is characterized by
the presence of multiple local players with
multinational companies dominating the
• The local players are able to maintain a
presence in these competitive markets is due
to their strong distribution channels and low
• Global pharmaceutical companies utilize the OTC
market as a strategic platform for the lifecycle
management of a product. To defer generic
competition after patent expiry, manufacturers
switch their product into the OTC category after
conducting required clinical studies.
• However, the growth of the OTC market has
changed the way it is perceived and
manufacturers have started to consider OTC
products as one of the key market segments to
drive the growth of a company.
• The leading players in the OTC market in
emerging countries include J&J, GSK, Bayer,
Novartis and Sanofi-Aventis.
• The key to success in emerging countries is the
right time of entry into the market, innovative
products and efficient marketing and