Outsourcing.doc - International BioPharmaceutical Association

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OUTSOURCING IN BIOPHARMACEUTICAL
INDUSTRY


THE INDIAN PERSPECTIVE




Author:

Srilakshmi
K
akumanu

EMail:

laxmi_sreenivas@rediffmail.com







Summary
:

In recent years, cost pressures in the pharmaceutical industry
have led to a rapid expansion of the mark
et for outsourcing skills like
manufacturing, R & D processes and sales functions.

Contract
Research Organizations (CROs) are of particular interest as their
work relates to the discovery of compounds and their subsequent
development into marketable produc
ts. The benefits and pitfalls of
outsourcing have been topics of debate in the pharmaceutical industry
for some decade’s now.

However
,

it is evident that the CRO market is
growing and that more strategic partnership are being forged. This
article deals wit
h the Clinical Research Outsourcing Overview, and
the part played by India in near future.




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A brief history of outsourcing in the Biopharmaceutical industry
:


Outsourcing is often defined as the delegation of non
-
core operations or jobs from internal
pr
oduction with in a business to an external entity (such as sub
-
contractor) that specializes in that
operation. Outsourcing is a business decision that is often made to lower costs or focus on
competencies. The pres
sure

to reduce costs and increase producti
vity has been a strong driving
force for the growth of the biopharma outsourcing sector. The increasing market and R&D costs
are forcing the industry to evaluate outsourcing as a cost reducing option
.


Outsourcing in biopharma industry began in 1980s and e
xploded in the 1990s in these core areas:
Clinical trials, contact manufacturing and sales force solutions. Cost effectiveness is the leading
reason companies initially choose to outsource, but it is certainly not the only important function
served. Speed
, flexibility, expertise, innovation and efficiency are all important drives in the
decision to outsource
.




Outsourcing is not a new concept to pharmaceutical companies; however, its use increased
dramatically in the mid
-
1990s, and it is expected to cont
inue to increase going forward. It is
estimated by 2004 nearly 42% of all pharmaceutical drug development expenditures will be
committed to outsourcing, as compared to the 4% that was outsourced in the early
-
1990s. Some
estimate that there are currently ov
er 1,200 organizations involved in the clinical research,
including pharmaceutical and biotechnology in
-
house clinical research, site management
organizations (SMOs), academic medical centers, private research sites, and contract research
organizations (CR
Os).

.

Greater complexity in drug discovery, development and regulatory processes is encouraging the
view that outsourcing is the means to
easily

and cost
-
effectively gain access to specialized
resources, technology and expertise.

The need to reach the
global market will also encourage
partnering

the international CROs local presence in new markets such as India and China.


Drug Discovery
:

Service providers can screen through and test compounds against the large
number of targets now available. These
ser
vice
providers are able to better master new
discovery
techniques and tools.

Discovery work can be conducted faster and cheaper through such outsourcing service providers.


Contact Manufacturing
:

Outsourcing partnerships can include the use of contract man
ufactures
to conduct all activities from preclinical development to commercial manufacturing.


R
egulation:

FD
A

& ICH have created challenges for pharma companies in keeping up
with

federal regulations and guidelines regarding drug regulation and submission
. These challenges
are encouraging pharma companies to seek partners that can assist them
with

regula
tory
submissi
ons
.


M
arketing
:

The pharmaceutical industry has both a private responsibility to generate profits for
its own shareholders and a social respo
nsibility to patients. To address these challenges pharma
companies may opt to partner with industry marketing experts.


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OUTSOURCING MARKET SIZE & GROWTH:


Pharma clients have increased their outsourcing expenditure with an anticipated 40% of
drug
discover
y

expenditure presently commi
t
ted to outsourcing. The pharma outsourcing industry was
estimated at $48 billion US in 2002 and will rise to over $60 billions US in 2005.


Outsourcing enables biopharma companies to focus on their core capabilities. The bioph
arma
industry utilizes a combination of outsourcing models from outsourcing aspects of
drug

discovery research, the clinical trial process or development and manufacturing process.
Applying external skills and expertise directly when and where they are re
quired avoids
dependence
o
n fixed resources. This flexibility reduces the need to reallocate or recruit
additional personnel with a corresponding reduction in overhead costs. The early stage
requirements for services can be categorized by phase
s

as follows
:




Target validation with access to targets and target information critical.




Lead identification including access to chemically diverse libraries.




Lead optimization with medical chemistry and lead optimization services key to ensuring
that successful le
ads enter the clinical phase.


According to Frost & Sullivan, the contact research industry will obtain revenues in the range of
$14.4 billion by 2007


NEW MARKETS
:


In recent years, areas such as
Eastern

Europe, Latin America and Asia have become lucrativ
e to
sponsors to access large

untreated
patient’s

populations.

Center watch

reports 20
-
30% of clinical
trails are being conducted in developing countries. China is the fastest growing pharma market in
Asia. Phase II


IV stu
d
ies are being conducted in Chi
na.


India the second largest pharma market in Asia boasts an enormous untreated patient population,
a strong technological infrastructure IP regime and regulatory environment that will become
increasingly aligned with the developed world.


The

cost of
drug development has soared during the past ten years compelling pharmaceutical
and biotechnology companies to look for new, smarter ways of conducting clinical research.
Driven by mounting market pressures, companies are increasingly implementing outsourc
ing
strategies to increase revenues through faster drug development. By decreasing their in
-
house
facilities and staff, and outsourcing more of their R&D functions, pharmaceutical and
biotechnology companies are reshaping the drug development services indu
stry



Contract research has evolved from providing limited preclinical and clinical trial services in the
1970s to a full
-
service industry today that encompasses broader relationships with clients,
covering the entire drug development process, including p
reclinical safety evaluation,
pharmacology, study design, clinical trial management, data collection, statistical analysis,
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product support, and regulatory services. Pharmaceutical companies are now using drug
development services companies not only to cov
er gaps in capacity, but also to increase their
skills base, help to control costs, and reduce drug development timelines. CROs were first
organized as outsourcing service companies that provided only clinical trial management. Today,
many CROs have expand
ed their scope of services to provide comprehensive management of the
complex drug trial processes for their client companies, as well as providing access to vast areas
of expertise
.


OUTSOURCING TO INDIA:


Pharmaceutical industry

in India

The Indian phar
maceutical industry is one of the world's largest
, ranking4th

in terms of volume
and 13th in terms of value in the global pharmaceutical market.



In 2002, pharmaceutical sales were US$4.5 billion, growing at 8
-
9% per year. However,
the pharmaceutical market

in India is small when seen in relationship to its population, a
fact reflected in the per capita pharmaceutical expenditure in this country
-

about
US$4.50 per person per year in 2002.



The mix of pharmaceutical consumption is skewed towards anti
-
infectiv
es and vaccines,
with medications for 'lifestyle' chronic diseases comprising a smaller (25% in 2002), but
fast growing, segment in the industry (Ranbaxy website).



The biggest sales in the domestic pharmaceutical industry are in the antibiotics market.
Whi
le drugs for lifestyle diseases and chronic conditions comprise a smaller proportion
of sales, they are the fastest growing area of medications.



There were over 20,000 registered manufacturers in 2003. These are predominantly small
manufacturers, focusing
on either active pharmaceutical ingredients (APIs) or
formulations.



In the absence of a comprehensive intellectual property regulation regime*, Indian
companies have focused their energies on process chemistry and manufacturing. As a
result, the leading In
dian pharmaceutical companies have become some of the most
efficient manufacturing units in the world. Their expertise in process chemistry and
manufacturing have allowed them to position themselves as the lowest cost provider of
quality pharmaceuticals, a
nd they have exploited this advantage to make forays in the
global generic market. *Note: Indian Patent laws from January 2005 are TRIPS
compliant, offering greater protection of intellectual property in India.

(source: India
-

The Emerging R&D Collaborati
ve Opportunity
-

Bridgehead
International)


Biotechnology in India




The Indian biotechnology industry is at an early stage of development compared to
Europe and the US. However, the sector is growing rapidly, as evidenced by the increase
in the number of c
ompanies and the number of initiatives by State governments to grow
their respective biotechnology industries.

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There are approximately 200 biotech companies in India with combined revenues of $500
million employing 25,000 scientists in R&D programs.



Ther
e are 40 National Research Laboratories employing 15,000 scientists.



The top 10 players in terms of revenue currently in the Indian biotech marketplace are:
Biocon, Serum Institute of India, Panacea Biotec, Nicholas Piramal, Novo N,
Venkateshwara Hatcheri
es, Wockhardt, GSK, Bharat Serums & Vaccines and Eli Lilly &
Company.



Biocon and Serum are ranked in the top 20 biotechs globally by revenue (Source:
Biospectrum industry Overview 2004).



Investment within the sector is also on the rise with a 25.99% incr
ease in 2004 to
$136million during 2004. In 2005 this is forecast to grow by a further 33% to
$183million.



Partnering has also played a major role in the biotech industries growth. Biocon is
leading the way forming partnerships with North American compani
es Nobex and Bristol
Myers Squib. This in part has resulted in the need for Biocon to build a new 50,000 sq ft
R&D facility to house a further 200 scientists.


Table
1

Outsourcing opportunities in
India


CONTRACT R&D

Intermediates,

commodity chemicals,

s
pecialty chemicals,

fine chemicals

Bulk active synthesis / bulk biologics

Formulation , manufacturing
-
excipients,

formulation oral solids,

formulation steriles,

formulation inhalers

International clinical trials

Technical services

Turn key projects

P
lant machinery and pharmaceutical equipment

Primary packaging materials/secondary packaging

Bioinformatics,

biostatistics,

software development

Herbals and neutraceutical development





Economic




Strong R&D capabilities, stemming from the largest gene
ric drugs exporting industry in
the world



Existing backwards engineering expertise is now being re
-
directed toward innovation,
with generic companies moving into novel drug discovery



World class IT industry reflected in skills in bioinformatics



R&D costs 1
/8 of western countries



Manufacturing costs 1/5 to 2/5 of western countries

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Clinical trials development 50
-
60% lower than in western countries

(Source
-

Burrell & Co India 2nd quarter 2005)


Political



Government encourages 100% foreign direct investment in

special economic zones such
as the Hyderabad, Bangalore and Pune bioclusters



Proposed exemption of import duties on key R&D equipment



Indian patent laws from January 2005 are TRIPS Compliant, offering greater protection
of intellectual property in India



S
implified regulatory system

The Indian biotech sector is growing at 37.42 per cent and inched closer to US$ 1.5 billion in
revenues during 2005
-
06. The bio
-
pharma segment still dominates this sector with US$ 1 billion
in revenues.

Following the bio
-
pharma
segment is bio
-
services growing at 69.29 per cent with revenues of Rs
720 crore
(approx: US$ 160 million)
during 2005
-
06. Bio
-
services clocked revenues of Rs 425
crore in 2004
-
05 and Rs 275 crore in 2003
-
04.

Agri
-
bio with a lot of buzz around introduction

of transgenic crop varieties grew at 81.21 per
cent to
touch revenue

of Rs 598 crore in 2005
-
06. This segment clocked revenues of Rs 330
crore in 2004
-
05 and Rs 130 crore in 2003
-
04.

With demand for organic industrial inputs growing, industrial biotech g
rew by 17.19 per cent to
touch 375 crore in 2005
-
06. This segment clocked revenues of Rs 320 crore in 2004
-
05 and Rs
238 crore in 2003
-
04. The bio
-
informatics segment grew by 20 per cent to touch Rs 120 crore in
2005
-
06.

ADVANTAGES

Indian companies can of
fer an attractive option with both strong API cash flows with more than
75 US FDA approved plants. The industry is on the threshold of strong growth, driven by
consolidation in the global generics market, untapped potential in the domestic market, if
distr
ibution
-
led reforms take place in the country, says the report highlighting the issues and
opportunities in Indian pharmaceuticals, biotech and healthcare sectors.

US biopharmaceutical companies prefer India to China for their immediate expansion plans
th
rough outsourcing to get a foothold into the market. Though lack of knowledge of the market
and the Indian regulatory issues are an issue, the US companies
are;

however, keen to strike
alliances with Indian companies.

The domestic pharmaceutical sector ha
s the potential to double its existing market size by the
year 2010 and thereby become the second major manufacturing base in the world next to China
provided it is supported by the right regulatory framework
.

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With patent protection in place and foreign in
vestors eagerly eyeing India's wealth of human
resources, and its massive domestic market, significant growth opportunities abound for Indian
companies.

The patent change regime in 2007
-
08 would open a huge international market worth $65 billion
for the I
ndian pharma industry, the report said.

The Indian government's decision to allow 100 percent foreign direct investment into the drugs
and pharmaceutical industry has steadily aided the growth of contract research in the country. Of
course, fearing the d
ishonoring of patents in the country, technology transfer to 100 percent
Indian subsidiaries of MNCs was not done on a comprehensive basis so far; the new regime
should aid this. The Indian pharmaceutical industry is also getting increasingly US FDA
compli
ant to harness the growth opportunities in areas of contract manufacturing and research.

The Cost Advantage:


The Ernst & Young 2004 Global pharma report notes that India has a pool of trained chemists,
companies with an excellent track record of innovatio
n and US PDA approved manufacturing
facilities with cost savings of up to 30
-
50%. Labor costs in India are typically in the range of 10
-
15% of similar costs in the US. Clinical trails can also cost as little as 50% of those conducted in
Western countries.


The Research Infrastructure:


India has 3
-
4 million scientists, the 2
nd

largest concentration in the world following the US.
Majority of these scientists are English speaking and are willing to work for less than a fifth of
the salaries of their Western
counterparts:


India boasts having more than 70 FDA approved plants and 200 manufacturing facilities certified
as having good MP. These plants use state of the art technology with cost competitiveness
ensured during plant , development, maintenance and op
erating including labor, raw materials,
sourcing and capital costs. With hospitals treating a wide range of diseases, companies can
efficiently access a range of therapeutic areas with a single hospital.


Drawbacks:

Much of this is attributed to short com
ings in the current Indian regulatory environment. India
still offers no date protection. There is also the issue of domestic drug pricing.

Indian pharma sector has been marred by lack of product patent, which prevents global pharma
companies to introduce
new drugs in the country and discourages innovation and drug discovery.

Indian pharma sector has been marred by lack of product patent, which prevents global pharma
companies to introduce new drugs in the country and discourages innovation and drug discove
ry.
But this has provided an upper hand to the Indian pharma companies. These are the major
weakness of the country that the government is addressing to.

In an attempt to develop a world
-
class pharmaceuticals industry, the Prime Minister's Office
(PMO) is

working on a policy for the sector.

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The new drug policy is an all encompassing policy framework that is being drafted by an expert
committee to provide guidelines to the pharma industry. The main objectives of this policy are:
to ensure availability of e
ssential pharma products at reasonable prices; to strengthen the
indigenous capability to produce cost effective and quality products and export pharmaceuticals
by reducing barriers to trade in the sector; to strengthen the system of quality control over
p
roduction and distribution; to encourage R&D in the sector; and to create an incentive
framework for the industry which promotes new investment into the industry.

The industry has been long expecting reforms in the numerous policies that govern the sector
.
One of the most crucial areas that the policy seeks to address is pricing of drugs, which has been
a bone of contention between the industry and the authorities ever since the price control was
instituted.

A healthy future


At an average growth rate of
9 per cent per year, the pharmaceutical industry in India is well set
for rapid expansion. As a result of the expansion, the Indian pharmaceutical and healthcare
market is undergoing a spurt of growth in its coverage, services, and spending in the public a
nd
private sectors. The healthcare market has opened a window of opportunities in the medical
device field and has boosted clinical trials in India. Many multinational companies have
penetrated into India with an aim to market drugs and conduct clinical tr
ails.

Thus, Indian pharmaceutical research, manufacturing, and outsourcing have received an impetus,
thereby, creating an image of a potential healthcare market and a land of opportunities in
pharmaceuticals. The economic liberalization policies coming to

force in the 1990s and the
strong emergence of private sector in the Indian economy has heightened the pace of
development of the pharmaceutical industry and will continue to do so. The Indian
Pharmaceutical industry has shown tremendous progress in terms

of infrastructure development,
technology base and wide range of products. The industry produces bulk drugs belonging to all
major therapeutic groups requiring complicated manufacturing process and has also developed
excellent Good Manufacturing Practices

(GMP) compliant facilities for the production of
different dosage forms. The strength of the industry is developing cost effective technologies in
the shortest possible time for drug intermediates and bulk actives without compromising on
quality. This is
realized through country's strengths in organic synthesis and process engineering
.


C
o
mpanies outsourcing manufacturing to India
. Indian manufacturers have demonstrated the
capability of developing quality drugs at a fraction of the developed world cost.


Table

2
:

Companies outsourcing manufacturing to India


COMPANY

OUTSOURCED ACTIVITY

AVENTIS

Manufacturing
e.
g.,
glibenclamide

ASTRAZENECA

Research & manufacturing facilities ;India to become center for
TB research

BAYER

API and bulk supplies

BRISTOL MYE
RS
Manufacturing
e.g.

doxycycline,

amoxicillin API

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COMPANY

OUTSOURCED ACTIVITY

SQUIBB

CHIRON

API and bulk supplies

ELI LILLY

Manufacturing
e.g.

APIs

GLAXO SMITHKLINE

Clinical data management and manufacturing

MERCK&Co

Manufacturing
e.g.

cephalosporins

NOVARTIS

Research & manufac
turing

ROCHE

Research,

clinical development,

commercial operations

WYETH

Manufacturing
e.g.

intermediates





Companies outsourcing clinical services to India:


Increasingly companies are expanding their investments and leveraging the advantages India
o
ffers beyond manufacturing. This market is growing at a rate of 20% per annum. The Indian
Government has further aided this industry by approving an amendment to schedule
Y

of its
drugs and cosmetics Act allowing international drug companies to conduct mu
lti center Phase 1
and II trial
s

through out the country. The amendment also permits for new DNA and other
products,

providing an incentive for global biotech companies to conduct clinical trails for
biologicals in India.


Table
3
:

C
ompanies outsourcing
C
l
inical
S
ervices


C
ompany

Non manufacturing outsourced activity


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Exploratory studies


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Clinical Research Market Size & Growth in India:


Center watch estimated

the size of the Indian Clinical Trail market in 2002 to be in the range of
$30
-

$35 million US. The estimated number of GLP trained investigators was 200


250.
Center watch has predicted that by 2010, the industry will spend approx $250
-

$300 million

US
on clinical trails in India. McKinsey estimates this number to be much higher in the range of $1
to $1.5 billion US. A US $10billion industry today, Indian pharma will grow to US $25 billion
by 2010.

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The India pharma exports have tremendous potential

to grow at around 18% by 2007
-
08. These
are about 250 large and 8000 small units. These units produce the complete range of pharma
formulations.


The generics business remains at the heart of every thing India does well and so it should,
considering tha
t India accounts of 22% of the global generics market. Bearing in mind that $65
billion of prescription medicines in Europe and the US are lose their patents in 2007
-
08, India is
ideally positioned to sweep up much of that new business.


Home to some of t
he top technical universities in Asia, as well as a large community of
entrepreneurial

western trained graduates India teams with resourceful scientists and managers.
The combination improved IP protection and local
pharmaceutical

companies embarking on
in
novative R&D projects of their own has changed the way MPCs th
at once denounced Indian
pharma companies

now partner with them and increasingly entrusts with vital R&D assignments.


There are 3 primary advantages to shifting some proportion of bio
-
pharma
c
e
utical R&D to India.


1)

Alleviating bottlenecks in the R&D pipeline


Conducting R&D in India can ease
backlogs and capacity shortages particularly in labor intensive phases of early stage
chemistry and of data management during clinical study.

2)

Reducing R
&D costs


Established Indian vendors pay wages that are typically less than
1/3
rd

and may be as little as 1/5
th

of those paid by their counterparts in US, Europe and
Japan

3)

Accelerating clinical trails


India’s population provides MPCs with an ideal patie
nt base
for drug studies.


India’s strengths translate into attractive opportunities
:


India’s greatest allure is its promise of near immediate gratification for MPCs that seek to
enhance chemistry related activities and accelerate clinical trails.


Prov
en
prowess

in chemistry and Data management
: Indian vendors in bio
-
pharma R&D
have developed capabilities in scale
-
up, process optimization and manufacturing. The strong
domestic capabilities in Data Management and Information Technology have long made Ind
ia an
attractive location for the labor intensive activities involved in clinical data management and
biometrics. India’s recent shift to drug discovery has triggered the domestic pharmaceutical
industry to expand its repertoire in chemistry. Indian vend
ors are offering services in Drug
design, analytical chemistry and assay development.


Speed and agility in Clinical trails
: The biggest factor driving clinical studies to India today is
the critical competitive advantage that the country holds over weste
rn locals.


Emerging skills in preclinical trails
: Indian services in preclinical have evolved in response
two moves by local companies. First many vendors have been upgrading labs and vivaria, the
centers that manage and house research organisms and sampl
es. Second, many have also been
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developing expertise in conducting pharmacokinetic, drug
-
me
t
abolism and toxicity in rodents
and to a lesser extent in dogs.


A long term option on Biology:

Over the past 5 years the India’s department of biotechnology
has sp
ent more than $230 million US to advance the biotech space. The agency has spread its
investments across local
pharmaceutical

companies, public projects establishing bio
-
tech parks
and education institutions building or expanding graduate programs in biolo
gy.


.

Biopharmaceutical Contract Manufacturing: The Future Includes Asia


In the conclusion of the interview survey, both the contractors and the biomanufacturing
directors at pharmaceutical and biotechnology companies were asked their opinions about the
future of the industry. For both groups, outsourcing to Asia is an important trend, which will
have a significant impact on the industry in the next five to 10 years. A CMO respondent
summed up the majority opinion:

“Up until recently it was not a big fact
or, but now competition from developing regions cannot
be ignored. This will have an impact on North American and European contract manufacturing
organizations. The nature of the impact really depends on (1) the acceptance of the Asian market,
(2) if the c
ontractors there can meet strict quality standards, and (3) if it is possible to effectively
manage projects in those countries. Within the next five years, I think this will have a significant
impact on the CMO business.”

As the industry becomes more pri
ce
-
competitive, the possibility of outsourcing certain projects
to lower
-
cost Asian regions, especially production of large
-
volume products, will become a
valuable alternative. The biopharmaceutical contract manufacturing industry is growing into a
truly g
lobal business.

Scenario after 2005 and beyond

Mushrooming of contract research organi
z
ation in 2005 and beyond will be somewhat affected
by the following, which also throws light on the shortcomings of India as major CRO hub unless
addressed properly and
adequately are the following:

Increasing lower cost differential & increasing salary structures in this area; Increasing
difficulties of sourcing experienced people in comparison to the growing need of such people;
Growing competitions from other Asian and

East European countries competing for similar
opportunities; Emerging of major corporate groups with deep pockets shying away small
competitors; Opening of research labs by the multinational themselves acting as internal CROs
like GE research centre at Ba
ngalore; Conflicting business plans, i.e. generic companies getting
into outsourcing service provider to its competitors.

Though the competitions amongst the custom synthesis and manufacturing companies are
primarily based on cost, capacity, quality, and
timing of production for the compound or
molecule being considered, the factors such as long term relationships and proven track records,
regulatory capabilities for DMF filing, past experience with FDA and other similar agencies etc.
also plays an importa
nt role.


The preferences of most of the major sponsoring companies involved with outsourcing activities
are not to share intellectual property rights with their outsourcing partners, however, this trend is
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bound to change in the near future, if these part
nering companies start participating in adding
value to the project as well. Indian
companies’

role in this direction will play a crucial role in
addressing the increasing global competitions. By providing proprietary novel enabling
technology support to t
he outsourced projects that are crucial to the needs of drug discovery and
development today, these CRAM space companies can soon be able to access revenues from the
sponsor companies by participating in joint ownership in the form of royalties, milestone
payments and enhanced service fees.

Conventional project wise outsourcing, project by project, is based on increasingly getting
converted into long
-
term reliable partnering in order to achieve consistency and achieving value
for money for the partnering co
mpanies as well as the competing CRO and CMOs. For these
types of alliances to be successful, the outsourcing service providers also are getting involved in
upgrading their skills and enhancing their technological capabilities. From simple outsourcing,
the

trend to slowly move towards building partnerships and alliances is being observed, where
free flow of information exchange and active involvement is also feasible. Pharmaceutical
companies soon will not just be expecting the outsourcing companies to appl
y newer innovative
technologies to their projects and provide cutting
-
edge solutions to their overall problems in
order to build long
-
term and lasting relationship. On a similar fashion the service providers are
slowly gearing up to become solution provide
r, one stop
centers

etc and are putting considerable
investments to enhance their capabilities and getting involved with in
-
house proprietary
technology developments and developing niche, innovative areas of expertise to merge ahead
with the emerging compe
titions rather than providing cost advantages alone.

With the starting of new patent regime with the beginning of 2005 and interesting changes
happening in the global pharmaceutical sector, emergence of virtual pharmaceutical companies,
drying up of the p
ipeline of blockbusters, CRO and CMOs of India are certainly poised for an
interesting time in coming years.


The study finds that the industry is valued at approximately $100 million, with an annual growth
rate of
approximately 40% to 50%
.


References



1.


Outsourcing

opportunities in Indian pharmaceutical industry,” Monitor group,
Sep

2003.


2.

“The Drug Research War,” Forbes.com 05/28/2004


3.

Center Watch,
www.centerwatch.com


4.


2010:

Indian clinical research odyssey”,

PharmaBiz.com, Feb. 26
, 2004
.


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“2010: Indian clinical research odyssey”, PharmaBiz.com
, June
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6.

“Outsourcing Drug Work”, Scientific American, Aug.16, 2004.


International Biopharmaceutical Association Publication



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13

of
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“Capability of Indian pharmaceutical industry to service world market”
,
Indian
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chem 2002 I
nternational conference
, Sep

20
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8.

“Center to announce biotech policy in Jan ’05,Bioinformatics policy in may”,
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9.

“Rising to the productivity
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A strategic framework for biopharma”
,
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Focus, July 2004.