Date post: | 08-Feb-2017 |
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Pharma Market Analysis
By Raghvendra Singh RaoUnder 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
CLEA
N R
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M A
PPLI
CATI
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HAR
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Tech
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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
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 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 2
Pharma Market Analysis
$13.8 BillionDomestic Pharma Sector in
FY2013CAGR: 21.5%
$50 BillionPharma Sector growth by
2020CAGR: 5.2%
$7.2 BillionPharma 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
IndustriesWef FY2014
543US FDA approved Pharma
Plants in IndiaHighest outside USA
Pharma Market Analysis
(-)25%Tax Relief decreased from
200% to 150%
85%Bulk Drug In-House
Manufacturing sufficiencyPresent 47.6%
$4.41 BillionBulk Drug Capital of India
50K Jobs by FY21
100%Tax Relief to Start-up firms from
APR16 to MAR19
17Pharma SEZ’s planned, 11
Exporting
6Pharma Parks Approved in
Hyderabad
175MoU to be signed in Vibrant
Summit, GujaratAgreement Conceived
Pharma Market Analysis
United States
Canada EU-Big 5 Japan Emerging Markets
ROW0
50
100
150200250
300350400
450500
337
27
205
127
205
183
425
31
194 149
499
273
Distribution of Pharma IndustrySales in 2011 (in US $ Billions)Projected Sales in 2020 (in US $ Billions)
India & China
30%
14%5%
7%
7%36%
Concentration of Manufacturing Units
Maharashtra
Gujarat
Tamil Nadu
Andra Pradesh
West Bengal
Others
Maha-rashtra
Gujarat West Bengal
Andra Pradesh
Tamil Nadu
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 PlantsFormulations Bulk Drugs
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
Process 3
Pharma On-Ground Analysis
FLOORINGTYPE
1. Tremix de-watered2. Epoxy/PU3. Acid Proof4. Tile5. Kota Stone
ISSUES1. Poor Surface preparation2. 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 SCOPE1. Floor Hardeners2. Epoxy/PU3. Floor Lining
PIDILITE ANALYSIS1. 5-8% of the total project cost. $338.71 Billion (Global) by 2020. CAGR:6.2% Asia2. FOSROC for Floor Hardeners3. CIPY POLYURETHANE for Epoxy/PU Flooring4. Lead time in supply or apply 5. Moisture Issue is persistent6. Floor Lining not done by Pidilite
PIL’s presence in the segment is negligible and a strong recognition should be created.
Pharma On-Ground Analysis
WATERPROOFINGTYPE
1. Membrane Based-PU/Epoxy-Liquid2. Brick Bat Coba3. Waterproofing Plaster
ISSUES1. Material Selection2. Damping3. Leakage4. Applicator Issues5. Grade Demarcation: Retail vs Project
CC SCOPE1. Membrane Based- Spray applied polyurethane w/p system for roofs with screed-Liquid w/p membrane-Bitumen based torch applied membrane for flat roofs2. Coating Based-Heavy load reinforced acrylic w/p coat-Heavy load cementitious w/p coating
PIDILITE ANALYSIS1. 2-3% of the total project cost. $226.1 Billion Global. CAGR 7.1% Asia Pacific2. Expert Analysis3. Failure of suggested products4. Use of Brick Bat Coba5. Unknown to Basement/ Podium/ Wet Areas Products6. Retail impact is huge for repair plants7. BASF’s low pricing
PIL’s presence in the segment is huge but in the Pharma industry we are still unknown.
Pharma On-Ground Analysis
COATINGSTYPE
1. PU/Epoxy Coatings-High Gloss-Anti-Slip-Anti-Carbonation-Thickness2. Acrylic Emulsion
ISSUES1. Fungal & Microbial action2. Sulphur action3. Thickness/ Waterproofing action4. Bubble formation5. Temperature resistance
CC SCOPE1. PU/ Epoxy based coatings with variants2. Acrylic based anti-fungal & anti-microbial paints
PIDILITE ANALYSIS1. 2-4% of total project cost. Market is huge. Segment is unpredictable.2. Clubbing of products required`3. Market leader is Asian Paints for Acrylic4.Micobial Impact: Food for thought5. Penetration Space is limited6. 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 GROUTSTYPE
1. PUF Paneling for insulation2.Grout & Sealants: - Cement based- Epoxy based- Pre-Mixed - Caulk based
ISSUES1. Costly Application of Heat Insulation. 2. Heat Insulation supports Modular Shuttering.3. Flow ability and workability issues of sealants & grouts.4. Thickness range
CC SCOPE1. PUF Panels2. Sealants & Grouts in all variants
PIDILITE ANALYSIS1. High cost but sales driven2. Market Leader is SIKA for grouts & sealants3. Development of cheaper product4. Applicator availability5. 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
Correlate the market scenario and
ground level requirements with key
notes for inclusion of PIDILITE Profile in
the segment
Process 4
Recommendations
11-12%Domestic Pharma Sector
Growth
15-18%Epoxy/ PU sales in Flooring
2001: 4%
ResinsTraditional oxy-chloride and
vinyl replaced
8.4%CAGR of W/P market
$3.2 Billion Industry FY2015
ApplicatorTraining, Expertise, Trust
4.7%Coating Industry Growth
Brick Bat CobaNo awareness
No ExpertiseHeat Insulation, grouts &
sealants
Retail vs ProjectNo market demarcation
Product VarietyNon-availability of products
PricingNo kit based pricing
Recommendations
No CampaignIndustry is unaware about
PIDILITE
WarehouseTemperature controlled ready to
use
Display SamplesFlooring+Coating+W/P
Penetration SpaceMarket is stringent to new
entrants
High Profile ProjectsRefrences for PIDILITE
ISO, US FDAStudy of codes for references
Pharma EventsAttendance in yearly
meets/events
Dedicated TeamCommunication, 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
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