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TRANSCRIPT
1 This report is solely for the use of customer personnel. No part of it may be circulated, quoted or reproduced for distribution outside the customer organization without prior written approval from Tecnova India.
© Tecnova, 2015. All Rights Reserved - Privileged and Confidential
We Deliver the
India Advantage
Tecnova Global
Indian Pharmaceutical Industry Overview
2 This report is solely for the use of customer personnel. No part of it may be circulated, quoted or reproduced for distribution outside the customer organization without prior written approval from Tecnova India.
Executive Summary
• Pharmaceutical sector growing @ 14.5% CAGR, to reach USD 60bn
• Healthcare industry growing @ 17%, to reach USD 300bn 2020 Growth Forecast
• 10% market share by volume of drugs produced internationally
Global Footprint
• 20% of global generics exports accounted for by India Leading Exporter
• USD 25bn market size by 2016 Growth in Generics
• More than USD 12bn foreign investments received in last decade and a half
Top 5 Investment Sector
3 This report is solely for the use of customer personnel. No part of it may be circulated, quoted or reproduced for distribution outside the customer organization without prior written approval from Tecnova India.
Contents
Industry Overview
• Page 4
Industry Analysis
• Page 11
Industry Drivers
• Page 17
Future Outlook
• Page 32
Credentials • Page 35
4 This report is solely for the use of customer personnel. No part of it may be circulated, quoted or reproduced for distribution outside the customer organization without prior written approval from Tecnova India.
© Tecnova, 2015. All Rights Reserved - Privileged and Confidential
We Deliver the
India Advantage
Industry Overview
India is expected to become one of the top 5 markets globally
5 This report is solely for the use of customer personnel. No part of it may be circulated, quoted or reproduced for distribution outside the customer organization without prior written approval from Tecnova India.
Why India?
Improving Demographics
• Increased affordability of drugs owing to
growing middle class and decreasing poverty
levels
• Growing health insurance penetration
• With increasing penetration of chemists,
especially in rural India, OTC drugs will be
readily available
• Drugs produced in more ~65 therapeutic classes
• 60,000+ generic brands 500+ APIs
manufactured
• ~100 manufacturing plants have received US
FDA approval (largest outside US)
Low Production Cost
Capabilities Across Spectrum Supportive Government Policies
• 60% lower than that of the US and 50% of
European production costs
• To support the Make in India initiative, the
government has announced Phar a Visio 2020‟ to make India the global leader in end-to-
end drug manufacturing
6 This report is solely for the use of customer personnel. No part of it may be circulated, quoted or reproduced for distribution outside the customer organization without prior written approval from Tecnova India.
Structure Of Indian Pharmaceutical Sector
Pharmaceutical Industry
Active Pharmaceutical
Ingredients (API)
Branded Generic
Contract Research and Manufacturing Services (CRAMS)
Formulations
Chronic Therapy
Cardiovascular
Neurological
Anti – Diabetes
Oncology
Acute Therapy
Anti – Infective
Gastrointestinal
Respiratory
Analgesics
Vitamins/ Neutraceuticals
Biosimilars
7 This report is solely for the use of customer personnel. No part of it may be circulated, quoted or reproduced for distribution outside the customer organization without prior written approval from Tecnova India.
Industry Segments
• Expected to be 3rd largest global generic API market by 2016 with 7.2% market share
• India accounts for 2nd highest Abbreviated New Drug Applications (ANDAs)
• Over 3000 or 35.7% of Drug Master Files (DMF) filed with US – highest outside of US
APIs
• With more than 1,000 players, market is fragmented
• Currently industry size of CRAMS is estimated to be USD 8bn CRAMS
• About 77% pharmaceutical manufacturers in India produce Formulations
• USD 11.2bn current domestic market size
• Largest exporter of Formulations by volume, with 14% market share
Formulations
• USD 1.5bn market size of Biosimilars by 2016 end
• Government plans to allocate USD 70mn for developing Biosimilars Biosimilars
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6
12
60
0
10
20
30
40
50
60
70
2005 2013 2020F
Indian Pharmaceutical Sector Revenues (USD billion)
• India is forecasted to be one of the top three pharmaceutical markets by 2020 on
account of incremental growth and top five market globally by size
Pharmaceutical Sector Revenues
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Industry Trends
• Pharmaceutical major Lupin Ltd acquired Brazil based Medquímica for an undisclosed amount, and has announced 2 acquisitions in US and Germany
• Marksans Pharma has acquired Time – Cap Laboratories Inc, New York
Overseas Expansion
• Currently 7 – 10% of revenue is spent on R&D by Indian Pharma companies
• With growing competition, expenditure on R&D is on the rise as companies are looking to increase their drug pipelines in order to bring new drugs to the market
R&D
• Increased collaboration between MNCs and Indian pharmaceutical companies to develop generic versions of drugs
• LAZOR alliance formed by leading pharmaceutical companies to improve efficiency and reduce operating costs as well as share best practices
Joint Ventures
10 This report is solely for the use of customer personnel. No part of it may be circulated, quoted or reproduced for distribution outside the customer organization without prior written approval from Tecnova India.
Date announced Indian company Foreign company Value
(USD million)
Type
December, 2014 Panacea Biotec Ltd Apotex Inc NA JV
November, 2014 Curatio Healthcare Sequoia Capital 15.8 Acquisition
December, 2013 Torrent Pharmaceutical Elder Pharmaceuticals Ltd 322 Acquisition
March, 2013 Unichem Laboratories Mylan 30 Acquisition
December, 2012 Shantha Biotech Sanofi Aventis 783 Acquisition
December, 2012 Claris Life sciences Otsuka Pharmaceutical 250 JV
September, 2012 Agila Specialties Mylan, A Canonsburg 1,850 Acquisition
September, 2011 Natco Pharma Litha NA JV
September, 2010 Piramal Abbot 3,720 Acquisition
May, 2010 Glenmark Sanofi 615 JV
December, 2009 Orchid Chemicals Hospira 400 Acquisition
Inbound M&A/ JV in Indian Pharma
• 44 deals worth USD 4bn in Healthcare sector for 2013, up 44% in terms of deal
value from 2012
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© Tecnova, 2015. All Rights Reserved - Privileged and Confidential
We Deliver the
India Advantage
Industry Analysis
Generics dominates the Indian Pharma market
12 This report is solely for the use of customer personnel. No part of it may be circulated, quoted or reproduced for distribution outside the customer organization without prior written approval from Tecnova India.
Revenue Segmentation
• Generics form the largest segment
of the Indian pharmaceutical sector
with 72% share of revenue
• India is the largest provider of
generic medicines globally
accounting for 20% of global exports
(volume)
• Over the Counter (OTC) medicines
constitutes 19% of the market
(revenue)
• The remaining 9% is attributed to
patented drugs (revenue)
72%
19%
9%
Revenue by Sub Segment 2013
Generics
OTC
Patented
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16%
13%
11%
9% 8%
7%
7%
29%
Market Share by Value (2014)
Anti-Infectives
Cardiovascular
(CVS)
Gastrointestinal
Respiratory
Vitamins &
Minerals
Analgesic/ Pain
Anti-diabetic
Top 3 Segments: Anti – Infective,
Cardiovascular and Gastrointestinal Drugs
• Anti-infective drugs has historically
been the largest segment, 16%
market share in 2014
• Cardiovascular segment is expected
to keep rising on account of cardiac
cases and lifestyle disease, (13% )
• With increased R&D spend on
Gastroenterology, this segment is
expected to grow at a tremendous
rate, currently at 11% share
• 50% of the market is covered by top
four segments
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6,9 8,1
10 11,3
12,6
15,1
18,1
21,8
26,1
0,8 0,9 1,1 1,3 1,5 1,8 2,2 2,7 3,3
0
5
10
15
20
25
30
20
08
20
09
20
10
20
11
20
12
20
13
20
14
20
15
F
20
16
F
Generic drug sales Patented drug sales
Patented Vs Generic Drugs Sales (USD billion)
Patented Drugs Maintain Market Share
• Patented drugs are expected to
hold a 10 – 11% market share,
notwithstanding the continuous
growth in the generics segment
• 90% of the prescription drug
market is catered to by generics
• Generic drug market will
continue growing on account of
the continuing Patent Cliff that
started in 2012
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2 2,2
2,7 3
3,3
3,9
4,7
5,5
6,6
0
1
2
3
4
5
6
7
20
08
20
09
20
10
20
11
20
12
20
13
20
14
20
15
F
20
16
F
OTC Drug Market (USD billion)
OTC Drugs To Drive Rural Penetration
• OTC segment growing @ 16%
CAGR
• OTC drugs are expected to
witness tremendous growth
owing to demand generated from
increased rural penetration
• New classification of select drugs
and cosmetics will further
increase the share of OTC
segment
16 This report is solely for the use of customer personnel. No part of it may be circulated, quoted or reproduced for distribution outside the customer organization without prior written approval from Tecnova India.
0%
5%
10%
15%
20%
25%
2,5% 3,5% 4,5% 5,5%
Cipla
Sun
Pharma
GSK
Ranbaxy
Zydus
Cadila
Lupin
Competitive Market – Top Four Firms
Account For Over 20% Market Share
Market Share
Major Players
Re
ven
ue
Gro
wth
• 40% market share (revenue) is
held by the top 10 companies
(Mar’14 LTM)
• Cipla is the market leader with
5% market share
• Sun Pharma posted 20% revenue
growth, the highest amongst
major players in this period
1. Bubble size denotes overall revenues
2. Ranbaxy has recently been acquired by Sun Pharma
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© Tecnova, 2015. All Rights Reserved - Privileged and Confidential
We Deliver the
India Advantage
Industry Drivers
Indian Pharma industry is driven by exports
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2
3
4
5 5
7
9
10
0,4 0,6 0,7 0,9 1,1 1,2 1,7 1,8
0
2
4
6
8
10
12
FY06 FY07 FY08 FY09 FY10 FY11 FY12 FY13
Exports Imports
Exports Vs Imports (USD billion)
Exports Driving High Growth
• Pharmaceutical exports have
grown @ CAGR of 68% in last
decade
• India exports to over 200
countries in the world with US
being the key market
• Currently Japan is being
targeted as the next big export
opportunity by Indian
Pharmaceutical manufacturers
19 This report is solely for the use of customer personnel. No part of it may be circulated, quoted or reproduced for distribution outside the customer organization without prior written approval from Tecnova India.
Exports By Region
• 34% of total pharmaceutical
exports were accounted for by
the Americas
• Indian exports of Anti-Retroviral
Therapy (ART) and anti-Malarial
drugs to Africa has been growing
at double digit rates
• An overall export target of USD
25bn has been set for 2016
34%
26%
20%
20%
Exports By Region (2013)
Americas
Europe
Asia
Others
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Growth Drivers
• Growing per capita income driving demand for better healthcare
• Influx of private players with new products in the health insurance space and increased state coverage
• Increase in lifestyle related diseases
• Increased penetration of disease testing and diagnostic centres
• Global hub for generic drugs manufacturing
• Cost efficient
• 546 USFDA approved and registered sites
• Increasing penetration of pharmacies
• Indigenously developed drugs are exempted from DPCO (Drug Price Control Order)
• New facility approval time has been drastically reduced
• Emphasis on specialty Pharma education
• Disbursement of funds to families classified as BPL
Demand
Side
Drivers
Supply
Side
Drivers
Government
Support
21 This report is solely for the use of customer personnel. No part of it may be circulated, quoted or reproduced for distribution outside the customer organization without prior written approval from Tecnova India.
Demand Drivers
Accessibility
• Over USD 200bn to be spent on medical
infrastructure
• Pharma and health insurance companies are
investing in penetrating rural and newly urbanized
areas
• Market share of hospitals to increase to 25% in 2020
from 13% in 2010
• 73 million households to be added to the middle
class by 2025 on account of rising incomes
• 650 million people expected to be covered by health
insurance by 2020
Acceptability
Affordability Epidemiological Factors
• Greater awareness of available medication options
• Prevalence of self medication to boost OTC market
• Acceptance of biologics and preventive medicine to
rise
• India is a medical tourism hub with growing YoY
patient inflow
• Patient pool expected to increase over 20% in the
next 10 years, mainly due to rise in population
• New diseases and lifestyle changes to boost demand
• Increasing prevalence of lifestyle diseases
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India’s Share Of Wallet
• Share of healthcare expenditure in households has consistently increased from
4% in 1995 and is expected to be 13% in 2025
56
41 34
24
5
6
5
5
14
12
12
10
4
8
9
11
11
16
19
20
1 2
3
6
3 5
6
9
4 7 9 13
1995 2005 2015 (F) 2025 (F)
Healthcare
Education and Recreation
Communication
Transportation
Personal Products and
Services
Household Projects
Housing and Utilities
Apparel
Food, Beverages and Tobacco
Discretionary
Items
Necessities
Share of Average Household Consumption (%)
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50 55
64 70
78 88
100
116 134
18%
21% 22%
23% 24% 24% 25%
26% 27%
0%
5%
10%
15%
20%
25%
30%
0
20
40
60
80
100
120
140
160
20
08
20
09
20
10
20
11
20
12
20
13
20
14
20
15
F
20
16
F
% Pharma Sales of Total Healthcare Spend
Healthcare Expenditure Pharma Sales
Growing Pharmaceutical Spend
• Increasingly affluent and
consumer oriented middle
class population of over 350
million
• Today at least 50 million
Indians can afford to buy
branded medicines which is
equal to about 80% of the UK
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8 9
11
13 14
16
19
23
27
0
5
10
15
20
25
30
20
08
20
09
20
10
20
11
20
12
20
13
20
14
20
15
F
20
16
F
Per Capita Sales of Pharmaceuticals (USD)
Growing Per Capita Pharmaceutical Sales
• Per capita sales of
pharmaceuticals is expanding
@ 16% CAGR
• Need gaps being created in the
market owing to growing per
capita sales of pharmaceuticals
25 This report is solely for the use of customer personnel. No part of it may be circulated, quoted or reproduced for distribution outside the customer organization without prior written approval from Tecnova India.
Supply Side Drivers
• Between 2013 and 2017, patent drugs worth USD 78bn will go off – patent
• This presents a great opportunity to the Indian Pharma sector, as it is expected to fill the market with generic versions of these drugs
Patent Expiry
• MNCs are expected to launch patented drugs in India owing to product patents
• Increased prevalence of lifestyle diseases will boost the sale of drugs in this segment
Launch of Patented
Drugs
• Pharma companies have increased spending to tap rural markets and develop better medical infrastructure
• USD 200bn earmarked to be spent on improving healthcare infrastructure by the government
Medical Infrastructure
• OTC drugs market is expected to be USD 6bn+ by 2016 from USD 3.0bn in 2011
• Increased penetration of chemists, especially in rural regions, would increase the availability of OTC drugs in the country
OTC Drugs
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Government Support
• The government has invested USD 1.1bn in the PPP fund to support R&D in India, with the fund being focused mainly on vaccines, drugs and pharmaceuticals
• Increased incentives to domestic firms to conduct R&D
Public Private Partnership
(PPP)
• 1970 Patents Act amended to make it TRIPS compliant and introduction of product patents in India in 2005 gave a boost to the discovery of new drugs
• India has reiterated its commitment to IP protection following the introduction of product patents
• Increased likelihood of technology transfer from developed nations
Patents
• Approval times have been drastically reduced and the process itself simplified by the CDSCO to enable Indian Pharmaceutical companies compete globally
Quicker Approvals
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Growth Oriented Policy Measures
• Steps taken to reduce approval time for new facilities
• Export license NOCs issued in 2 weeks – 85% reduction in TAT
Improved Turnaround
• Tax breaks provided to pharmaceutical sector, weighted tax deduction @ 150% on R&D expenditure
• 100% FDI (Foreign Direct Investment) allowed through the automatic route
• Full exemption from customs and excise duty for HIV/AIDS drugs and diagnostic kits supplied under National AIDS Control Program funded by the Global Fund to fight AIDS, TB and Malaria (GFATM)
Taxation, Duties & FDI
• USD 640mn government funded venture fund on the anvil to boost drug discovery and strengthen pharmaceutical infrastructure
Industry Infrastructure
• The government intends to provide support by way of infrastructure and R&D in the public and private domain, to make India one of the leading destinations for end – to – end drug discovery and innovation; with a target of 10 – 20% global drug discovery to originate in India by 2020
Pharma Vision 2020
• MOUs with USFDA, WHO, Health Canada, etc. to boost growth in the Indian Pharma sector by benefiting from their expertise
Global Partnerships
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51 54
65 72
77
88
101
116
133
14 16 20 23 26
31 37
44
53
0
20
40
60
80
100
120
140
20
08
20
09
20
10
20
11
20
12
20
13
20
14
20
15
F
20
16
F
Healthcare expenditure Expenditure by Government
Share of Government Expenditure (USD billion)
Government Spend On The Rise
• Share of government
expenditure of total healthcare
grew from 27.5% to 36.6%
during same period
• Government healthcare spend
grew from USD 14bn in 2008 to
USD 37bn in 2014 and is
expected to grow @ 18% CAGR
to USD 53bn by 2016
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37 38
45 49
51
57
64
72
80
14 16
20 23
26
31
37
44
53
0
10
20
30
40
50
60
70
80
90
20
08
20
09
20
10
20
11
20
12
20
13
20
14
20
15
F
20
16
F
Private Public
Public Vs Private Expenditure on Healthcare (USD billion)
Rising Share Of Private Sector Spend
• Private sector expenditure is
expected to grow @ 12% CAGR
• Private se tor’s healthcare
spend grew from USD 37bn in
2008 to USD 64bn in 2014 and
is expected to reach USD 80bn
by 2016
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35
130 20
25
55
120
80
240
110
140
0
100
200
300
400
500
600
700
2010 2020F
Private Insurance
Government
Employee
Insurance
Employee State
Insurance Corp
Rashtriya
Swasthya Bima
Yojana
State Insurance
Population Covered by Health Insurance (millions)
Health Insurance Penetration Growth
• Currently penetration of health
insurance is 20%, in India and is
forecasted to be ~40% by 2018
• By 2015, spending through
health insurance would reach
8.4% of the total health
spending, up from 6.4% in
2009
• Private insurance coverage
would increase nearly 15%
annually till 2020
31 This report is solely for the use of customer personnel. No part of it may be circulated, quoted or reproduced for distribution outside the customer organization without prior written approval from Tecnova India.
Factors Driving Health Insurance Growth
Rising healthcare costs have increased
need for health insurance
380 million people are expected to be
covered by government sponsored
programs like RSBY and ESIC
All major private companies are
providing insurance cover to their
employees and their families
Increased awareness of health
insurance among people of India
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© Tecnova, 2015. All Rights Reserved - Privileged and Confidential
We Deliver the
India Advantage
Future Outlook
India will keep expanding its global manufacturing footprint
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100
85
40
0
10
20
30
40
50
60
70
80
90
100
US Europe India
Relative Cost of Production
Cost Efficient Global Manufacturing Hub
• 40% lower cost of setting up a
manufacturing unit and 50%
lower labor costs as compared to
Western countries
• 546 US FDA approved company
sites, highest outside US and
2,633 FDA approved drug
products
• One of the largest pools of skilled
workforce including managerial
and technical skills
34 This report is solely for the use of customer personnel. No part of it may be circulated, quoted or reproduced for distribution outside the customer organization without prior written approval from Tecnova India.
Opportunity Areas
• India is a leading country for clinical trials market
• India continues to attract huge investments in the area on account of a genetically diverse population and significant availability of skilled doctors
Clinical Trials Market
• Demand for high – end drugs is expected to reach USD 8bn by 2015 end, owing to improving income levels and urbanization
• This could potentially drive demand for production of high – end drugs in India
High – End Drugs
• Demand for generic medicines in rural markets has seen tremendous growth, 70% of I dia’s population resides in rural areas
• Pharma companies are looking to make inroads into this nascent segment by investing in distribution networks as current levels of penetration are very low
Penetration in Rural Market
• Current market size is approximately USD 8bn, with significant investment opportunities
• With more than a 1,000 players, the market is fragmented and consolidation is expected to happen over the next few years
CRAMS
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© Tecnova, 2015. All Rights Reserved - Privileged and Confidential
We Deliver the
India Advantage
Credentials
Te nova’s a kground and experien e
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CA, CFA, CPA, CS
Strategy and
Management
Consultants
Engineers and
Statisticians
Others
Empanelled Government
Bodies
Financial Institutions
Regulatory Bodies
Distributors
Industry Associations
• Over three decades of experience
• Solely focused on India entry
consulting
• Successfully executed projects for
1,000+ clients
• 60% of our clients are Fortune
1000 companies
• 100+ consulting associates
• Highly qualified team members
from premier institutions like
IIMs, IITs, ISB among others
About Us
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• Target shortlisting
+ willingness check
• Due diligence
• Valuation
• Indian entity incorporation
• M&A/ set up greenfield facility
• Obtain regulatory approvals
• Product registration
• Land acquisition
• Recruitment of key executives
• Price negotiations
• Deal structuring
• Deal closure
• Post merger integration
• Market sizing and
dynamics
• Regulatory analysis
• Price build up
• End user industry analysis
• Competition assessment
• Feasibility analysis
• Distribution structure
M&A & JVs
India Market
Assessment
Entry Strategy and
Business Plan
Implementation
Services
Service Offering
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Success Stories
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1. India Focus
2. Relevant Experience 3. Full Service
Boutique
Consultants
4. Risk Management 5. Incubation
Service
1 We operate and specialize
only in India entry consulting
2 30+ years of managing 1000+
clients
3 Entire ecosystem of consulting
services under one roof
4 Handholding to help you navigate the
Indian market to avoid pitfalls that are
typical to India with minimal risk
5 A ility to a t as your Virtual Part er through our Incubation Service to enter
India with minimal
investment
How Tecnova Adds Value
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TECNOVA is a Strategy Consulting firm based in India specializing in providing workable strategy solutions and implementation assistance to
foreign companies for leveraging the “India advantage”. With over 1 million man-hours of consulting work, we work with senior management
teams of MNC’s to develop modular & flexible strategies to explore the Indian market and minimize the knowledge gap for doing business in
India. For new entrants to the Indian market, we provide strategic advice and implementation assistance to reduce entry risk and compress
gestation time for break even and profitability. For already existing Indian operations of foreign companies, we provide advisory and transaction services to increase profitability and improve performance. For more information about us, visit www.tecnovaglobal.com
We Deliver the
India Advantage
TECNOVA INDIA PVT. LTD.
335, Udyog Vihar, Phase IV,
Gurgaon,
Haryana,
INDIA 122 015
Ph: +91-124-435-6300
Fax: +91-124-430-8207