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Medical Device

Think Globally, Act Locally !!
By- Ms. Soumya Mishra

Table of Content
Understanding Medical Device Market Internationally
-Market Size and Growth
-Economic Indicator
-Market Understanding
Features & Benefits of Drug Eluting Stents
How to place YUKON CHOICE PC in market ?
Pricing & Schemes

Global Medical Device Market

Market Size

Current Global Annual Revenue $ 270 bn


5% to 6% annually


Global Annual Revenue to reach $ 500bn by 2018

CAGR to reach 6.1 % by 2017

Medtech projected revenue growth is expected to

outperform Pharma revenue growth 5% Vs 3.8% by 2018

Research and Development spending 3-4% year on

year growth

Whereas, Regulatory affair and Quality Assurance

expenses are growing 3-5 times the budget as it was 5
years ago

Top Revenue Slot Segment Market

The Cardiovascular
segment is anticipated
to witness growth due
to an increase in the
number of heart

According to WHO estimates, in 2002, 16.7 million people around the

globe die of cardiovascular diseases each year. This represents
about 1/3 of all deaths globally
By 2020 heart disease and stroke will become the leading cause of both
death and disability worldwide, with the number of fatalities projected
to increase to over 20 million a year

Cardio Medical Device Market

By 2015, this market will be valued at nearly
$48 billion, a compound annual growth rate
(CAGR) of 8.7%.
Surgical Device Type



Interventional Cardiac



Cardiac Rhythm Management



Traditional Cardiac Surgery



Features of Drug Eluting Stents

A drug-eluting stent (DES) is a peripheral or
coronary stent (a scaffold) placed into
narrowed, diseased peripheral or coronary
arteries that slowly releases a drug to block cell

Features of DES
(1)A stent with catheter-based deployment and optimized features for
enhanced deliverability to the lesion site
(2) A drug-carrier vehicle that permits elution of the drug or biologic into the
vessel wall at the required concentrations and kinetic profile
(3) A pharmacological agent possessing specific properties that interfere
with local neointimal formation

Benefits of Drug Eluting Stents

(1)By decreasing the rate of restenosis, drug-eluting stents
one of the most important advances in interventional cardiology.
Clinical trials
have confirmed a reduction of as much as 50 to 70 percent in
(2) target
DES may
be considered among patients with STEMI undergoing primary
by DES compared to BMS.

(3) The reduced risk of reblocked arteries from drug-eluting stents

the need for repeat angioplasty procedures, which carry the
risk of
complications such as heart attack and stroke.

Country Profile
Economic Indicators

History has shown that an outsider (i.e., a company not belonging to the leading corporations) may
unexpectedly introduce a competitive and successful product with a lower price so that the major companies
are compelled to reduce the price of their own products, triggering an overall lowering of the costs. We
foresee that some of the manufacturers of new eluting-stent designs may purposely target the non-US
market with lower regulatory barriers as a profitable field of expansion, so that the non-US patient in
Europe, South America, Far East, and Africa may soon benefit from a low-priced, nonFood and Drug
Administration-approved drug-eluting stent.

Country Profile
Total Market Size & Growth Rate
Total Market SizePharmaceuticals: USD 659 MN in 2013
Healthcare: USD 2.07 BN in 2013

Growth Rate- Pharmaceuticals: 15.3% and expected CAGR of 17% (2011-2016)

- Healthcare: 12.6%

Market Analysis
Diseases in Kenya

Name of Disease

% Growth Rate



Respiratory System


Skin Diseases




Rheumatism, Joint Pain etc.

Urinary Tract Infection

Eye Infections


Dental Disorders


All other diseases


* Health Ministry Information System (HMIS) Annual Report 2009

Market Analysis
Diseases in Kenya- Segregation

Market Analysis
Market Share for Pceutical product by Therapeutic
Therapeutic Category

P'ceutical Products

Antibiotics, antimalarial, sulphonamide, anti

tuberculosis preparation, antiamoebics, antivirals,
antifungals, vaccines, sera and immunoglobulins
Analgesics and antipyretics,anti-inflammatory
agents, hypnotics, sedatives and tranquilize,
Products acting on CNS
anticonvulsants, CNS stimuli
ants, muscle relaxants, antihistamines,
antidepressants, anesthetics, etc.
Expectorants and cough suppressants, inhalations,
Products acting on
bronchial spasm relaxants, re
Respiratory System
aspiratory stimulants, etc.
Stomatological preparations, antacids, tonics,
Products acting on
gastrointestinal and
preparations, laxatives, antidiarrheal, insulin
metabolic disorder
preparations, vitamins, mineral supplements,
anabolic agents for system in use
Products acting on the cardiovascular and genital
Other Pharmaceutical urinary systems, cytotoxins, vaccines, dermatological
preparations, ophthalmic drugs, hormonal products,
diagnostic and contraceptive agents, etc.

* Industrial sector Analysis Report, Ministry of health 2001

Market Share





Regulatory for
Pceutical Import in Kenya

Control of the profession of pharmacy and the trade in

pharmaceutical products is administered by the Ministry of Health
(MoH), through the PPB
Kenya largely imports medicinal and pharmaceutical products
sources such as Great Britain, India, Germany, France, the USA and
* Switzerland
Importers are expected to meet legal requirements, which include
- Provide samples to the Kenya Bureau of Standards (KEBS) for quality
checks and registration

- Meet the regulations of the national policy, which has been adopted
by the MOH
- This includes an essential drugs list, using WHO guidelines, whose
objective is to
promote the availability of quality pharmaceutical products at
affordable prices
- Pass regulatory quality control, monitoring and market surveillance as

Market Understanding
Market Condition of Kenya
- The market for pharmaceutical products in Kenya is estimated at
KShs 8 billion per
annum. The government, through Kenya Medical Supplies Agency
(KEMSA) is the
largest purchaser of drugs manufactured both locally and
imported, in the
- - ItThere
buys are
of registered
the drugs in
the Kenyan
through an
1,300 retail
system and distributes them to government medical
in Kenya,
manned by registered pharmacists and pharmaceutical technologists.
- Anti-infective
pharmacies areproducts
a 25% mark-up
on retail
sulfonamides), analgesics, antipyretics, bronchial relaxants
and cytotoxins account for the bulk of government and private
sector purchases of medicines in the Country.

Operational Development

The Kenya Medical Suppliers Agency (KEMSA), a division of the Ministry of

Health, largely carries
out the distribution of pharmaceutical products in Kenya. It distributes drugs
to government
public health facilities and private health facilities.

It is the largest purchaser of drugs in the country, through an open-tender

system and distributes them to public medical institutions. The tendering
been an
1st July
2003. Its policy
to make
system has
for drugs
is open
to both local
essential drugs and equipment primarily but not exclusively, to public
facilities. KEMSA
competes with other suppliers, e.g. the mission based medical supply facility
(MEDS) and
private wholesalers

Operational Development

Pharmaceutical products in Kenya are channeled through pharmacies,

chemists, health
facilities and shops. There are about 700 registered wholesale and
1,300 retail dealers in
Kenya, manned by registered pharmacists and pharmaceutical technologists.
The drugs on sale in Kenya are sold according to the outlet categorization, which
can be described as free-sales/OTC, pharmacy technologist dispensable, or
dispensable/prescription only.

Proposed Operational Strategies

Strategic partnerships with locally-trusted stakeholders can help

company navigate non-transparent elements of the market access process. In
doing so, they allow companies to leverage proven channels to enter the
market and reach target patient groups to optimize the go-to-market

Collaboration with public sector payers such as the government,

partnerships with NGOs and patient groups can help determine tender
requirements and/or opportunities to shape them, as well as identify clinical
KOLs who influence guideline development and care for particular patients.

Among private payers, distributors and community health workers can

support assessments of relevant payer channels and patient preferences to
define tactics for building brand loyalty.

Partnerships reduce risk in business operations, thus increasing sustainability of

the venture. The caveat here is that any partnership can only be as good as the
partner; the challenge is in establishing who is reliable and reputable

Competitor Matrix
Key Players in the industry
The key players in the industry include MNCs like
-Glaxo SmithKline
-Boots Pharmaceuticals
-Astra Zeneca
-Eli Lilly
And local establishments like
-Dawa Pharmaceutical Ltd
-Cosmos Pharmaceuticals

Product Pricing
Drug Market Pricing
The pricing structure norm for medicines is built on tradition and is
supposed to allow for a 10 per cent mark-up for the drug
manufacturer over production cost; a 15 per cent margin for
the distributor/wholesaler over the manufacturers or
importers price; and a 33 per cent margin for the retailer
above the wholesale price.

Discounts and Schemes

Since the Kenyan market for medicines is open and price sensitive,
some manufacturers/importers opt for different schemes of price
For example:
Buy 10 items and get one free (10 + 1) or buy six and get
one free (6 + 1) are schemes offering effective discounts of 10 per
cent to 16 per cent. In some cases, items are discounted by over 30
per cent at the retail outlet.

GPL- An Outlook Till Now

Currently GPL has USD 0.5 MN business and last year it was USD
1.2 MN, which was majorly the tendor business