Upload
ketaki-jadhav
View
222
Download
0
Embed Size (px)
Citation preview
8/8/2019 PHARMA GSBD Full and Final
1/43
OPPORTUNITY FOR
PHARMACEUTICALOUTSOURCING
IN INDIA
GROUP 3
8/8/2019 PHARMA GSBD Full and Final
2/43
GROUP MEMBERS
AVELINE PERIS
HARINI SUGANDH AGARWAL
PRANAV PRAKASH
KETAKI JADHAV
HENAL PACNMATIYA
VISHAKHA VERMA
8/8/2019 PHARMA GSBD Full and Final
3/43
CONTENTS
Industry overview
Indian Scenario
Leading Companies in India which export
Growth potential
Reforms/Policies
Advantages
Challenges Recommendations
Comparison with IT/BPO
8/8/2019 PHARMA GSBD Full and Final
4/43
PHARMACEUTICAL INDUSTRY
TRENDS- GLOBAL SCENARIO Projected of the global pharmaceutical market in 2010 , 4 - 6%
exceeding $825 billion.
The global pharmaceutical market sales expected grow th at a
4 7% CAGR through 2013.
Global pharmaceutical market value is expected to expand to
$975+ billion by 2013
Growth driven by stronger near-term growth in the US market
and is based on the global macro economy, the changing
combination of innovative and mature products apart from the
rising influence of healthcare access and funding on market
demand.
8/8/2019 PHARMA GSBD Full and Final
5/43
OUTSOURCING
Used more strategically as a part of business
strategy.
Drug discovery till manufacturing of the products
Pharmaceutical firms have long outsourced
functions such as manufacturing, packaging,
clinical trials and sales force mobilization.
Biotechnology companies
8/8/2019 PHARMA GSBD Full and Final
6/43
WHY PHARMA COMPANIES
OUTSOURCE
Cost benefit advantage
Faster and cheaper
Improve manufacturing efficiencies
Reduce excess production capacity by divesting
facilities
Divert resources to focus on other competencies to establish consistency and efficiency across
international networks
8/8/2019 PHARMA GSBD Full and Final
7/43
LEADING SERVICE PROVIDERSFUNCTIONS SERVICE PROVIDERS
Drug Discovery/Medicinal Chemistry Aurigene, Divi's Laboratories,Syngene, Suven Lifesciences, GVKBio
Pre-clinicals Vimta Labs, Lambda TherapeuticResearch, Lotus Labs
Central Lab Services SRL Ranbaxy, Vimta Labs
Clinical Research Quintiles, Syngene, Chembiotek,Aurigene, Synchron, Reliance,Covance, Parexel
Manufacturing & Formulations Jubilant Organosys (speciality chemicals/bulk drugs), ShasunChemicals (Custom Synthesis),Medreich, Elder, Divi'sLaboratories
Bio-informatics and other IT services Strand Genomics, TCS, Satyam,
Infosys, GVK Bio, Ocimum, JubilantBiosys
8/8/2019 PHARMA GSBD Full and Final
8/43
INDIAN PHARMACEUTICAL INDUSTRY
Estimated worth $ 4.5 billion- growth at 8-9%
India's bio-tech industry at 17% growth with
revenues of Rs 137 Billion Second largest in world in terms of volume
Ranks 14th in terms of value at over Rs 1 lakh crore
Growth is fuelled by exports, increased 25% in 2008-
09
Highly organized sector
Meets around 70% of domestic needs
8/8/2019 PHARMA GSBD Full and Final
9/43
INDIAN PHARMACEUTICAL INDUSTRY
Produces almost every type of medicines
De-licensing of the pharma industry
Low costs of production and R&D
Exports drug, intermediaries, active
pharmaceutical ingredients, finished dosage
formulations, bio-pharmaceuticals and clinicalservices.
Top five destinations for such exports are USA,
Germany , Russia, UK and China.
8/8/2019 PHARMA GSBD Full and Final
10/43
INDIAINDIA {{ GRADUALLY BUILDING AGRADUALLY BUILDING A
TRACK RECORDTRACK RECORD
8/8/2019 PHARMA GSBD Full and Final
11/43
INDIAN PHARMACEUTICAL EVOLUTION
Phase II
Government Control
Indian Patent Act 1970
Drug prices capped
Local companies begin
to make an impact
Phase III
Development Phase
Process
development
Production
infrastructure
creation
Export initiatives
Phase IV
Growth Phase
Rapid expansion of
domestic market
International market
development
Research orientation
Phase V
Innovation and Research
New IP law
Discovery Research
Convergence
1970 1980 1990 2000 2010
Phase I
Early Years
Market sharedomination byforeign companies
Relative absenceof organizedIndian companies
8/8/2019 PHARMA GSBD Full and Final
12/43
MOVING UP THE VALUE CHAIN
Specialty
Products
Innovative
Products
TIME
Generic exports
to under-developed &
developing
countries
Generic
exports to
developedcountries
API
Exports
VALUE
8/8/2019 PHARMA GSBD Full and Final
13/43
WHY INDIA NOW?
Export procedures simplified
No import duty
Drug laws amended to permit global studies
Patent act amended; IPR in place
Untapped patient population
GCP compliant IRBs
GCP guidelines ICH compliant Start up time reduced to 8-12 weeks
CAP certified central labs
13
8/8/2019 PHARMA GSBD Full and Final
14/43
ADVANTAGE INDIA Competent workforce , Large skill base and Vast talent pool
Unmatched Cost Competitiveness
Cost-effective chemical synthesis
Legal & Financial Framework Information & Technology
Globalisation
Consolidation
Strong Local Industry
Speed
Availability Of Capital
8/8/2019 PHARMA GSBD Full and Final
15/43
WHY OUTSOURCING INDIA? Greatest potential for cost saving
Regulatory Compliance
Good Service and On time delivery
Govt. policies favoring R & D
Growth in health insurance sector
Biggest market with vast potential
8/8/2019 PHARMA GSBD Full and Final
16/43
OUTSOURCING
OPPORTUNITIES
INDIA
BULK DRUGS &FORMULATIONS
MANUFCATURING CONTRACTMARKETING AND
SALES
INTERNATIONAL
CLINICALTRIALS
TECHNICALSERVICES
HERBALSNEUTRACEUTICALS
BIOINFORMATICSBIOSTATISTICS
SOFTWAREDEVELOPMENT
PRIMARYPACKAGINGMATERIALS
PLANT MACHINERYAND PHARMAEQUIPMENT
CONTRACT
R & D
MEDICINAL
CHEMISTRY
OUTSOURCING OPPORTUNITIES IN INDIA
8/8/2019 PHARMA GSBD Full and Final
17/43
MNC PHARMA COMPANIES
BRISTOL
MYERS
SQUIBB
ROCHE MERCK
WYETH
ELI LILLYNOVARTI
S
AVENTIS
PFIZER
ASTRA
ZENECA
GSK
8/8/2019 PHARMA GSBD Full and Final
18/43
OUTSOURCING IN
PHARMACEUTICAL INDUSTRY
Drug Discovery And Development (R&D)
Contract Research and Manufacturing Services
(CRAMS)
IT Services
Business Process Outsourcing (BPO)
8/8/2019 PHARMA GSBD Full and Final
19/43
PRODUCT GROUPS COVERED
Bulk drugs / drug intermediates
Drug formulations
Herbals / Ayurvedics / Homeopathic / Unani
Medicinal Plants
Bio-tech / Biological products
Diagnostics and Surgicals
NeutraceuticalsCollaborative /contract research
Clinical trials
Pharma consultancy services etc.
8/8/2019 PHARMA GSBD Full and Final
20/43
DRUG DISCOVERY
ANDDEVELOPMENT (R&D)
The drug innovation process
The key drivers for Outsourcing/ Offshoring of
R&D
Outsourcing across the R&D Value Chain
City Wise Vendor Analysis
Other Emerging Trends
8/8/2019 PHARMA GSBD Full and Final
21/43
THE DRUG INNOVATION PROCESS
8/8/2019 PHARMA GSBD Full and Final
22/43
ROAD TO MARKET
8/8/2019 PHARMA GSBD Full and Final
23/43
C.R.O.
CROs expand the speed and capacity of product
development pipeline while maintaining Quality
and High Levels of Regulatory Compliance
CROs help companies reduced R&D costs
Drug Companies with a high reliance on CROsstay closer to schedule than those making less use
of CROs.
8/8/2019 PHARMA GSBD Full and Final
24/43
EMERGING CRO MARKET IN INDIA
8/8/2019 PHARMA GSBD Full and Final
25/43
C.R.O. IN INDIA
Fast speed of patient enrollment
Shorter time for clinical trials upto 75% faster
SPEED OFPATIENT
ENROLLMENT
Heterogeneous mix of people
Vast and diverse disease and patient population
GENE POOLADVANTAGE
Highly trained nurses physicians and technicalpersonnel
India has great IT skillsTALENT POOL
8/8/2019 PHARMA GSBD Full and Final
26/43
C.R.O. IN INDIA
Numerous world class medical facilities thatmeet global requirements for Clinical TestingINFRASTRUCTURE
30- 35% cheaper than in the USCOST
Compliance with Global Ethical and RegulatoryStandards, such as ISO, ICH, GSP, GLBQUALITY
8/8/2019 PHARMA GSBD Full and Final
27/43
OUTSOURCING ACROSS THE
R&D VALUE CHAIN
8/8/2019 PHARMA GSBD Full and Final
28/43
R&D VALUE CHAIN
8/8/2019 PHARMA GSBD Full and Final
29/43
R&D VALUE CHAIN
8/8/2019 PHARMA GSBD Full and Final
30/43
R&D VALUE CHAIN
8/8/2019 PHARMA GSBD Full and Final
31/43
OUTSOURCING HUBS
8/8/2019 PHARMA GSBD Full and Final
32/43
GROW
TH
Manufacturingand MarketingCompanies
LittleOutsourcing
before 2000
Late 1990s
ContractManufacturing GSK
Clinical Trials andSite Management GSK
Clinical DateManagement - GSK
Early 2000
Contract Manufacturing Pfizer , Novartis, EliLilly, Wyeth
IT Services- -GSK, Astra
Zeneca, WyethDiscovery GSK, Pfizer,Eli Lily
Clinical Trials And SiteManagement - Aventis,Pfizer, Astra Zeneca, EliLilly
Clinical DataManagement - Wyeth
Late 2000 ( 2005
Onwards)Contract Manufacturing Merck, BMS
IT Services- -GSK, Pfizer
Discovery Novartis,Wyeth
Clinical Trials And Site
Management - Novartis,Merck
Clinical Data Management Pfizer
BPO
F&A - GSK
Content Development -
GSK
8/8/2019 PHARMA GSBD Full and Final
33/43
INDIA HIGH ON THE OUTSOURCING
LIST FOR CLINICAL TRIALS ! A number of 122 Clinical trials are conducted in India next to
Taiwan,Mexico,Poland,Brazil.
GlaxoSmithKline, among the worlds top ten global pharma majors, is
currently carrying out the largest number of clinical trials in India. UK-based pharma major is conducting 13 drug trials in India for the
treatment of diseases such as cancer,arthritis,heart disease and constipation.
Johnson & Johnson, Eli Lilly are conducting respectively eight studies in
India.
Suven Life Sciences & Sipra Labs are also actively invloved in the Trials.
Clinical Trials in India, costs 50% to 60% less than the average cost in the
US.
AstraZeneca another global pharma company outsourcing significant
number of its trials to India
8/8/2019 PHARMA GSBD Full and Final
34/43
CHALLENGES FACED Growth in the domestic formulations market is
slowing down
Competition from cheap imports
Price wars between regional and local pharma
companies
MNC pharma companies are getting more aggressive
at protecting their patents and defending their marketshare after patent expiry.
Confusion in the grant of EMR, due to lack of
transparency in the process.
8/8/2019 PHARMA GSBD Full and Final
35/43
OTHER CHALLENGES
Regulatory obstacles
Lack of proper infrastructure
Expensive research equipments Lack of academic collaboration
Underdeveloped molecular discovery program
Divide between the industry and study curriculum
Severe competition
8/8/2019 PHARMA GSBD Full and Final
36/43
INDIA
PERCEPTIONS & REALITIESPerception RealityGCP awareness absent or low
Many sites in India are trained in GCP now
mandated by Government
Data integrity in question
Various audits of the study show no adverse
findingIn India U FDA has audited sites with no major
comments
Different languages cause
confusion and escalate costs
because of need to translate
documents
English used for all healthcare- related activities,
systems, procedures and drug labels. Only
patient-related documents need translation
Telecommunication poor
Connectivity poor
Telecommunication facilities good in urban
areas. Connectivity good EDC studies possible
electronic transmission of ECG, imagings
frequent.
8/8/2019 PHARMA GSBD Full and Final
37/43
STEPS TO STRENGTHEN THE INDUSTRY
1. Attain the right product-mix for sustained future
growth
2. Focus on core competencies will play an
important role
3. Can look at merger and acquisition options of
either companies or products.
4. Improve their R&D efforts and improve
distribution to penetrate markets.
8/8/2019 PHARMA GSBD Full and Final
38/43
GOVERNMENT INITIATIVES
Pharmaceutical units are eligible for weighted tax reduction
at 150% for the research and development expenditure
obtained
Two new schemes New Millennium Indian TechnologyLeadership Initiative and the Drugs and Pharmaceuticals
Research Program have been launched
Contemplating the creation of SRV or special purpose
vehicles with an insurance cover to be used for funding
new drug research
The Department of Pharmaceuticals is mulling the creation
of drug research facilities
8/8/2019 PHARMA GSBD Full and Final
39/43
ASSISTANCE TO EXPORTERS
Issue of RCMC certificates
Delegations to foreign countries
Buyer seller meetings
Foreign buyer details
Embassy assistance
Exhibition participation
Seminars and Conferences
Technology assistance
8/8/2019 PHARMA GSBD Full and Final
40/43
GROWTH OPPORTUNITIES
New drugs for neglected diseases
Under-penetrated Chinese markets
Global herbal market
R & D outsourcing
Diversify their process re-engineering skills
Drug discovery and development services
8/8/2019 PHARMA GSBD Full and Final
41/43
8/8/2019 PHARMA GSBD Full and Final
42/43
FUTURE SCENARIOAccording to a study by FICCI-Ernst & Young
India will open a probable US$ 8 billion market for MNCs
selling expensive drugs by 2015:
US$ 20 billion by 2015
The Minister of Commerce estimates investments of US$6.31 billion
Public spending on healthcare -7% of GDP in 2007 to 13% of
GDP by 2015
Dr Reddy's Laboratories has tied up with GlaxoSmithKline
Lupin, to tap opportunities of about US$ 200 million in the USoral contraceptives market
Indian pharmaceutical off-shoring industry is designated to
turn out to be a US$ 2.5 billion opportunity by 2012
8/8/2019 PHARMA GSBD Full and Final
43/43
CONCLUSION
India has an opportunity to become the Drug
Discovery R&D Outsourcing destination to the
world
Company can focus efforts on core competencies /
skills and contract critical services
Speed to market can be enhanced through
outsourcing strategic needs symbiotic relationship in marketing and
commercialization and outsource partners supply
new innovative products