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Pharma Market Analysis
By Raghvendra Singh Rao
Under guidance of Mr Abdul Kader Bengali
INITIATION
PLANNING
EXECUTION
CLOSURE
Project Details & Methodology
Identify the requirements, types,
design practices for clean rooms
Identify the global/national market
structure, key points governing the
clean room industry
Identify the on ground requirements
and design practices followed with key
players of the segment
Correlate the market scenario and
ground level requirements with key
notes for inclusion of PIDILITE Profile
in the segment
CLEANROOMAPPLICATIONS
(PHARMA)
TechnicalResearchProject
Identify the global/national market
structure, key points governing the clean
room industry
Identify the on ground requirements and
design practices followed with key players
of the segment
Correlate the market scenario and ground
level requirements with key notes for
inclusion of PIDILITE Profile in the
segment
Process 1
Clean Room Classifcation
MULTI USE
• Medicines
• Food &
Beverages
• Electronics
• Coating
Industries
• Horticulture &
Agro
• Automobile
• Defence &
Space
MEDICINES
• External drugs
• Internal oral drugs
• Betelactum drugs
• Powder & tablets
• Saline’s & injections
• Packing units of bulk
drugs
• Raw material
quarantines
• Microbiology
laboratories
• Chemical analysis
laboratory
TYPE I
•Drug
Manufacturing:
•API’s Bulk
Manufacturers
•Formulations
•Injectable
•Biotechnology
R&D
•Drug Marketing
Companies
TYPE II
• Hard Wall
• Positive Air
Pressure (Mostly
Used)
• Negative
• Explosion
• Soft Wall (Single Air
Pass)
• Dry Wall (Sensitive)
TYPE III
•ISO 1
•ISO 3; Class 1
•ISO 8; Class
100,000
•ISO 9; Room Air
Cleanroom (ISO 14644-1) specified as a room in which the concentration of airborne particles is controlled, and
which is constructed and used in a manner to minimize the introduction, generation, and retention of particles
inside the room and in which other relevant parameters, for example, temperature, humidity, and pressure, are
controlled as necessary.
Clean Room Design: MCI Guidelines
The cleanroom design should be based on the current Good Manufacturing Practices
(cGMP), for example type of product, process requirements, like temperature humidity,
class of air filtration (HVAC), equipment, room dimensions, etc. by following User
Requirement Specifications (URS).
The cleanroom design specifications should be prepared for example, functional
specifications, technical specifications, drawings of all components etc. The design
specifications should be documented and qualified (DQ). The cleanroom erection should be
executed according to DQ with proper monitoring and control during the period. The
cleanroom should be installed according to DQ.
It should be qualified for installation (IQ) with the details documented. It should be
qualified for operations (OQ) by ensuring that all required operating parameters of all
equipment, systems, including HVAC, are operating within acceptable limits as required by
process. The OQ should be documented.
The performance of cleanroom should be checked, documented and qualified initially after
DQ, IQ, OQ and should be performed periodically as required by process.
Identify the requirements, types, design
practices for clean rooms
Identify the on ground requirements and
design practices followed with key players
of the segment
Correlate the market scenario and ground
level requirements with key notes for
inclusion of PIDILITE Profile in the
segment
Process 2
Pharma Market Analysis
$13.8 Billion
Domestic Pharma Sector in
FY2013
CAGR: 21.5%
$50 Billion
Pharma Sector growth by
2020
CAGR: 5.2%
$7.2 Billion
Pharma Sector export in
FY2013
40%
Govt Expenditure Pharma Sector
development in FY2014
$37 Billion
57%
Pharma Industries in Gujarat,
Maharashtra & Telangana
100%
FDI allowed for Pharma
Industries
Wef FY2014
543
US FDA approved Pharma
Plants in India
Highest outside USA
Pharma Market Analysis
(-)25%
Tax Relief decreased from
200% to 150%
85%
Bulk Drug In-House
Manufacturing sufficiency
Present 47.6%
$4.41 Billion
Bulk Drug Capital of India
50K Jobs by FY21
100%
Tax Relief to Start-up firms from
APR16 to MAR19
17
Pharma SEZ’s planned, 11
Exporting
6
Pharma Parks Approved in
Hyderabad
175
MoU to be signed in Vibrant
Summit, Gujarat
Agreement Conceived
Pharma Market Analysis
0
50
100
150
200
250
300
350
400
450
500
337
27
205
127
205
183
425
31
194
149
499
273
Distribution of Pharma Industry
Sales in 2011 (in US $ Billions) Projected Sales in 2020 (in US $ Billions)
India &
China
30%
15%
5%
7%
7%
36%
Concentration of
Manufacturing Units
Maharashtra
Gujarat
Tamil Nadu
Andra Pradesh
West Bengal
Others
0
500
1000
1500
2000
2500
3000
3500
1928
1129
694
528
472
3423
1211
397
62
199
98
422
No of Existing Pharma Plants
Formulations Bulk Drugs
Identify the requirements, types, design
practices for clean rooms
Identify the global/national market
structure, key points governing the clean
room industry
Correlate the market scenario and ground
level requirements with key notes for
inclusion of PIDILITE Profile in the
segment
Process 3
Pharma On-Ground Analysis
FLOORING
TYPE
1. Tremix de-
watered
2. Epoxy/PU
3. Acid Proof
4. Tile
5. Kota Stone
ISSUES
1. Poor Surface
preparation
2. Moisture 4%
maximum.
3. Bonding
/detaching.
4. Inappropriate
Primer.
5. For repair works,
the contamination
with older one.
6. Weather and
Poor content.
7. Grade
Demarcation:
Retail vs Project
CC SCOPE
1. Floor Hardeners
2. Epoxy/PU
3. Floor Lining
PIDILITE ANALYSIS
1. 5-8% of the total
project cost.
$338.71 Billion
(Global) by 2020.
CAGR:6.2% Asia
2. FOSROC for
Floor Hardeners
3. CIPY
POLYURETHANE
for Epoxy/PU
Flooring
4. Lead time in
supply or apply
5. Moisture Issue is
persistent
6. Floor Lining notPIL’s presence in the segment is negligible and a strong recognition should be created.
Pharma On-Ground Analysis
WATERPROOFING
TYPE
1. Membrane
Based
-PU/Epoxy
-Liquid
2. Brick Bat Coba
3. Waterproofing
Plaster
ISSUES
1. Material
Selection
2. Damping
3. Leakage
4. Applicator Issues
5. Grade
Demarcation:
Retail vs Project
CC SCOPE
1. Membrane
Based
- Spray applied
polyurethane w/p
system for roofs with
screed
-Liquid w/p membrane
-Bitumen based torch
applied membrane for
flat roofs
2. Coating Based
-Heavy load
reinforced acrylic w/p
coat
-Heavy load
cementitious w/p
coating
PIDILITE ANALYSIS
1. 2-3% of the total
project cost. $226.1
Billion Global.
CAGR 7.1% Asia
Pacific
2. Expert Analysis
3. Failure of
suggested products
4. Use of Brick Bat
Coba
5. Unknown to
Basement/ Podium/
Wet Areas Products
6. Retail impact is
huge for repair
plantsPIL’s presence in the segment is huge but in the Pharma industry we are still unknown.
Pharma On-Ground Analysis
COATINGS
TYPE
1. PU/Epoxy
Coatings
-High Gloss
-Anti-Slip
-Anti-Carbonation
-Thickness
2. Acrylic Emulsion
ISSUES
1. Fungal &
Microbial action
2. Sulphur action
3. Thickness/
Waterproofing
action
4. Bubble formation
5. Temperature
resistance
CC SCOPE
1. PU/ Epoxy based
coatings with
variants
2. Acrylic based
anti-fungal & anti-
microbial paints
PIDILITE ANALYSIS
1. 2-4% of total
project cost. Market
is huge. Segment is
unpredictable.
2. Clubbing of
products required`
3. Market leader is
Asian Paints for
Acrylic
4.Micobial Impact:
Food for thought
5. Penetration
Space is limited
6.
Flooring+Coatings
PIL’s presence in the segment is negligible and a strong recognition should be created.
Pharma On-Ground Analysis
HEAT INSULATION, SEALANTS AND GROUTS
TYPE
1. PUF Paneling
for insulation
2.Grout &
Sealants:
- Cement based
- Epoxy based
- Pre-Mixed
- Caulk based
ISSUES
1. Costly
Application of Heat
Insulation.
2. Heat Insulation
supports Modular
Shuttering.
3. Flow ability and
workability issues
of sealants &
grouts.
4. Thickness range
CC SCOPE
1. PUF Panels
2. Sealants &
Grouts in all
variants
PIDILITE ANALYSIS
1. High cost but
sales driven
2. Market Leader is
SIKA for grouts &
sealants
3. Development of
cheaper product
4. Applicator
availability
5. Products
available with rigid
specifications. Multi
Variant products.
6. Research driven
PIL’s presence in the segment is negligible and a strong recognition should be created.
Pharma On-Ground Analysis
•Purely Consultant
driven industry
•Selection on
recommendations
•Effective network
required
CONSULTANT
DRIVEN
•Quarterly/ half yearly
by projects team
•Every 3 years by US
FDA or MHRA
•License cancellation
INSPECTIONS
•Pidilite Product
profile is not known
except Fevicol
•Variety of products
are available, need
updating
UNAWARENESS
•ISO 14644-4
•US FED STD209E
•Medical Council of
India
GUIDELINES
•IS Code to be
published soon
•Pharma Vision 2020
•Self-Sufficiency with
Global Presence
GoI INITIATIVES
•Retention of suppliers
is long term
•Multiple links to
various industries
•Bio-tech/Plastics
COMMITMENTS
•High lag
•Warehouse
•Temperature
controlled storage
•Apply time
SUPPLY-APPLY
Identify the requirements, types, design
practices for clean rooms
Identify the global/national market
structure, key points governing the clean
room industry
Identify the on ground requirements and
design practices followed with key players
of the segment
Process 4
Recommendations
11-12%
Domestic Pharma Sector
Growth
15-18%
Epoxy/ PU sales in Flooring
2001: 4%
Resins
Traditional oxy-chloride and
vinyl replaced
8.4%
CAGR of W/P market
$3.2 Billion Industry FY2015
Applicator
Training, Expertise, Trust
4.7%
Coating Industry Growth
Brick Bat Coba
No awareness
No Expertise
Heat Insulation, grouts &
sealants
Retail vs Project
No market demarcation
Product Variety
Non-availability of products
Pricing
No kit based pricing
Recommendations
No Campaign
Industry is unaware about
PIDILITE
Warehouse
Temperature controlled ready to
use
Display Samples
Flooring+Coating+W/P
Penetration Space
Market is stringent to new
entrants
High Profile Projects
Refrences for PIDILITE
ISO, US FDA
Study of codes for references
Pharma Events
Attendance in yearly
meets/events
Dedicated Team
Communication, Expertise
Recommendations
• Knowledge of all the
available products
across categories.
• Unbiased to targets
• As per client
requirement
DEDICATED
TEAM
• A catalog of industrial
products
• Demo samples
• Humid region
applications
AVAILABLE
PRODUCTS
• Maharashtra, Gujarat
and Telangana
• Supply-Apply work
process
• Initially economical
prices
PRESENCE
• Training & Learning
• Work with PIDILITE
Assurance
• Stringent criteria for
failures
APPLICATOR
• Work with
region/industry specific
• Economical vs Quality
• Trial & Feedback
CLUBBED
KIT
• Use W/P as a milestone
• Closely-related
industries
• Focus on w/p, then
flooring with samples
MILESTONES
• Variants to different
segments
• Heat Insulation, grouts
& sealants pushed
• Floor lining dimension
RESEARCH
• Medical Council
• Start-up meets
• Sample Labs
• Pharma Magazines
• Fortnight mails
• Online Catalog
EVENTS
SWOT Analysis
STRENGTHS
• Continuous Development for New Products
• Product Development & Marketing
• Existing Strong Distribution/Channel Network
• Some products already in portfolio
• Strength of PIL brand
WEAKNESS
• Application + Engineering Support
• High Degree of Dependency on Suppliers
• Limited/Non availability applicators
• Awareness
• High warehouse costs for imported resins with special
storage requirements
• Lack of Product Approvals from Consultants, OEM’s &
Project Reference List
• Bottom line management
OPPORTUNITIES
• Past Failures of market leaders like CIPY
• Premium Rates
• Growth Rates in market
• GoI support
• Manpower Utilization
• Existing market penetration with w/p
• SBU and Single window supplier
THREATS
• Buyers'/ Consultants market
• Service oriented industry
• Improper application due to other contractors
• High impact of failure
• Lack of specification
• Cost of product development, mostly imported
• MNC and garage based units, China
FINAL PRESENTATION
આભાર ‫شکریہ‬ ‫کا‬ ‫آپ‬
THANK YOU धन्यवाद

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Pharma Clean Room Market Analysis and Product Opportunities

  • 1. Pharma Market Analysis By Raghvendra Singh Rao Under guidance of Mr Abdul Kader Bengali
  • 2. INITIATION PLANNING EXECUTION CLOSURE Project Details & Methodology Identify the requirements, types, design practices for clean rooms Identify the global/national market structure, key points governing the clean room industry Identify the on ground requirements and design practices followed with key players of the segment Correlate the market scenario and ground level requirements with key notes for inclusion of PIDILITE Profile in the segment CLEANROOMAPPLICATIONS (PHARMA) TechnicalResearchProject
  • 3. Identify the global/national market structure, key points governing the clean room industry Identify the on ground requirements and design practices followed with key players of the segment Correlate the market scenario and ground level requirements with key notes for inclusion of PIDILITE Profile in the segment Process 1
  • 4. Clean Room Classifcation MULTI USE • Medicines • Food & Beverages • Electronics • Coating Industries • Horticulture & Agro • Automobile • Defence & Space MEDICINES • External drugs • Internal oral drugs • Betelactum drugs • Powder & tablets • Saline’s & injections • Packing units of bulk drugs • Raw material quarantines • Microbiology laboratories • Chemical analysis laboratory TYPE I •Drug Manufacturing: •API’s Bulk Manufacturers •Formulations •Injectable •Biotechnology R&D •Drug Marketing Companies TYPE II • Hard Wall • Positive Air Pressure (Mostly Used) • Negative • Explosion • Soft Wall (Single Air Pass) • Dry Wall (Sensitive) TYPE III •ISO 1 •ISO 3; Class 1 •ISO 8; Class 100,000 •ISO 9; Room Air Cleanroom (ISO 14644-1) specified as a room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room and in which other relevant parameters, for example, temperature, humidity, and pressure, are controlled as necessary.
  • 5. Clean Room Design: MCI Guidelines The cleanroom design should be based on the current Good Manufacturing Practices (cGMP), for example type of product, process requirements, like temperature humidity, class of air filtration (HVAC), equipment, room dimensions, etc. by following User Requirement Specifications (URS). The cleanroom design specifications should be prepared for example, functional specifications, technical specifications, drawings of all components etc. The design specifications should be documented and qualified (DQ). The cleanroom erection should be executed according to DQ with proper monitoring and control during the period. The cleanroom should be installed according to DQ. It should be qualified for installation (IQ) with the details documented. It should be qualified for operations (OQ) by ensuring that all required operating parameters of all equipment, systems, including HVAC, are operating within acceptable limits as required by process. The OQ should be documented. The performance of cleanroom should be checked, documented and qualified initially after DQ, IQ, OQ and should be performed periodically as required by process.
  • 6. Identify the requirements, types, design practices for clean rooms Identify the on ground requirements and design practices followed with key players of the segment Correlate the market scenario and ground level requirements with key notes for inclusion of PIDILITE Profile in the segment Process 2
  • 7. Pharma Market Analysis $13.8 Billion Domestic Pharma Sector in FY2013 CAGR: 21.5% $50 Billion Pharma Sector growth by 2020 CAGR: 5.2% $7.2 Billion Pharma Sector export in FY2013 40% Govt Expenditure Pharma Sector development in FY2014 $37 Billion 57% Pharma Industries in Gujarat, Maharashtra & Telangana 100% FDI allowed for Pharma Industries Wef FY2014 543 US FDA approved Pharma Plants in India Highest outside USA
  • 8. Pharma Market Analysis (-)25% Tax Relief decreased from 200% to 150% 85% Bulk Drug In-House Manufacturing sufficiency Present 47.6% $4.41 Billion Bulk Drug Capital of India 50K Jobs by FY21 100% Tax Relief to Start-up firms from APR16 to MAR19 17 Pharma SEZ’s planned, 11 Exporting 6 Pharma Parks Approved in Hyderabad 175 MoU to be signed in Vibrant Summit, Gujarat Agreement Conceived
  • 9. Pharma Market Analysis 0 50 100 150 200 250 300 350 400 450 500 337 27 205 127 205 183 425 31 194 149 499 273 Distribution of Pharma Industry Sales in 2011 (in US $ Billions) Projected Sales in 2020 (in US $ Billions) India & China 30% 15% 5% 7% 7% 36% Concentration of Manufacturing Units Maharashtra Gujarat Tamil Nadu Andra Pradesh West Bengal Others 0 500 1000 1500 2000 2500 3000 3500 1928 1129 694 528 472 3423 1211 397 62 199 98 422 No of Existing Pharma Plants Formulations Bulk Drugs
  • 10. Identify the requirements, types, design practices for clean rooms Identify the global/national market structure, key points governing the clean room industry Correlate the market scenario and ground level requirements with key notes for inclusion of PIDILITE Profile in the segment Process 3
  • 11. Pharma On-Ground Analysis FLOORING TYPE 1. Tremix de- watered 2. Epoxy/PU 3. Acid Proof 4. Tile 5. Kota Stone ISSUES 1. Poor Surface preparation 2. Moisture 4% maximum. 3. Bonding /detaching. 4. Inappropriate Primer. 5. For repair works, the contamination with older one. 6. Weather and Poor content. 7. Grade Demarcation: Retail vs Project CC SCOPE 1. Floor Hardeners 2. Epoxy/PU 3. Floor Lining PIDILITE ANALYSIS 1. 5-8% of the total project cost. $338.71 Billion (Global) by 2020. CAGR:6.2% Asia 2. FOSROC for Floor Hardeners 3. CIPY POLYURETHANE for Epoxy/PU Flooring 4. Lead time in supply or apply 5. Moisture Issue is persistent 6. Floor Lining notPIL’s presence in the segment is negligible and a strong recognition should be created.
  • 12. Pharma On-Ground Analysis WATERPROOFING TYPE 1. Membrane Based -PU/Epoxy -Liquid 2. Brick Bat Coba 3. Waterproofing Plaster ISSUES 1. Material Selection 2. Damping 3. Leakage 4. Applicator Issues 5. Grade Demarcation: Retail vs Project CC SCOPE 1. Membrane Based - Spray applied polyurethane w/p system for roofs with screed -Liquid w/p membrane -Bitumen based torch applied membrane for flat roofs 2. Coating Based -Heavy load reinforced acrylic w/p coat -Heavy load cementitious w/p coating PIDILITE ANALYSIS 1. 2-3% of the total project cost. $226.1 Billion Global. CAGR 7.1% Asia Pacific 2. Expert Analysis 3. Failure of suggested products 4. Use of Brick Bat Coba 5. Unknown to Basement/ Podium/ Wet Areas Products 6. Retail impact is huge for repair plantsPIL’s presence in the segment is huge but in the Pharma industry we are still unknown.
  • 13. Pharma On-Ground Analysis COATINGS TYPE 1. PU/Epoxy Coatings -High Gloss -Anti-Slip -Anti-Carbonation -Thickness 2. Acrylic Emulsion ISSUES 1. Fungal & Microbial action 2. Sulphur action 3. Thickness/ Waterproofing action 4. Bubble formation 5. Temperature resistance CC SCOPE 1. PU/ Epoxy based coatings with variants 2. Acrylic based anti-fungal & anti- microbial paints PIDILITE ANALYSIS 1. 2-4% of total project cost. Market is huge. Segment is unpredictable. 2. Clubbing of products required` 3. Market leader is Asian Paints for Acrylic 4.Micobial Impact: Food for thought 5. Penetration Space is limited 6. Flooring+Coatings PIL’s presence in the segment is negligible and a strong recognition should be created.
  • 14. Pharma On-Ground Analysis HEAT INSULATION, SEALANTS AND GROUTS TYPE 1. PUF Paneling for insulation 2.Grout & Sealants: - Cement based - Epoxy based - Pre-Mixed - Caulk based ISSUES 1. Costly Application of Heat Insulation. 2. Heat Insulation supports Modular Shuttering. 3. Flow ability and workability issues of sealants & grouts. 4. Thickness range CC SCOPE 1. PUF Panels 2. Sealants & Grouts in all variants PIDILITE ANALYSIS 1. High cost but sales driven 2. Market Leader is SIKA for grouts & sealants 3. Development of cheaper product 4. Applicator availability 5. Products available with rigid specifications. Multi Variant products. 6. Research driven PIL’s presence in the segment is negligible and a strong recognition should be created.
  • 15. Pharma On-Ground Analysis •Purely Consultant driven industry •Selection on recommendations •Effective network required CONSULTANT DRIVEN •Quarterly/ half yearly by projects team •Every 3 years by US FDA or MHRA •License cancellation INSPECTIONS •Pidilite Product profile is not known except Fevicol •Variety of products are available, need updating UNAWARENESS •ISO 14644-4 •US FED STD209E •Medical Council of India GUIDELINES •IS Code to be published soon •Pharma Vision 2020 •Self-Sufficiency with Global Presence GoI INITIATIVES •Retention of suppliers is long term •Multiple links to various industries •Bio-tech/Plastics COMMITMENTS •High lag •Warehouse •Temperature controlled storage •Apply time SUPPLY-APPLY
  • 16. Identify the requirements, types, design practices for clean rooms Identify the global/national market structure, key points governing the clean room industry Identify the on ground requirements and design practices followed with key players of the segment Process 4
  • 17. Recommendations 11-12% Domestic Pharma Sector Growth 15-18% Epoxy/ PU sales in Flooring 2001: 4% Resins Traditional oxy-chloride and vinyl replaced 8.4% CAGR of W/P market $3.2 Billion Industry FY2015 Applicator Training, Expertise, Trust 4.7% Coating Industry Growth Brick Bat Coba No awareness No Expertise Heat Insulation, grouts & sealants Retail vs Project No market demarcation Product Variety Non-availability of products Pricing No kit based pricing
  • 18. Recommendations No Campaign Industry is unaware about PIDILITE Warehouse Temperature controlled ready to use Display Samples Flooring+Coating+W/P Penetration Space Market is stringent to new entrants High Profile Projects Refrences for PIDILITE ISO, US FDA Study of codes for references Pharma Events Attendance in yearly meets/events Dedicated Team Communication, Expertise
  • 19. Recommendations • Knowledge of all the available products across categories. • Unbiased to targets • As per client requirement DEDICATED TEAM • A catalog of industrial products • Demo samples • Humid region applications AVAILABLE PRODUCTS • Maharashtra, Gujarat and Telangana • Supply-Apply work process • Initially economical prices PRESENCE • Training & Learning • Work with PIDILITE Assurance • Stringent criteria for failures APPLICATOR • Work with region/industry specific • Economical vs Quality • Trial & Feedback CLUBBED KIT • Use W/P as a milestone • Closely-related industries • Focus on w/p, then flooring with samples MILESTONES • Variants to different segments • Heat Insulation, grouts & sealants pushed • Floor lining dimension RESEARCH • Medical Council • Start-up meets • Sample Labs • Pharma Magazines • Fortnight mails • Online Catalog EVENTS
  • 20. SWOT Analysis STRENGTHS • Continuous Development for New Products • Product Development & Marketing • Existing Strong Distribution/Channel Network • Some products already in portfolio • Strength of PIL brand WEAKNESS • Application + Engineering Support • High Degree of Dependency on Suppliers • Limited/Non availability applicators • Awareness • High warehouse costs for imported resins with special storage requirements • Lack of Product Approvals from Consultants, OEM’s & Project Reference List • Bottom line management OPPORTUNITIES • Past Failures of market leaders like CIPY • Premium Rates • Growth Rates in market • GoI support • Manpower Utilization • Existing market penetration with w/p • SBU and Single window supplier THREATS • Buyers'/ Consultants market • Service oriented industry • Improper application due to other contractors • High impact of failure • Lack of specification • Cost of product development, mostly imported • MNC and garage based units, China
  • 21. FINAL PRESENTATION આભાર ‫شکریہ‬ ‫کا‬ ‫آپ‬ THANK YOU धन्यवाद