pidilite pharmaceutical scope

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

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PPLI

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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 global/national market

structure, key points governing the clean

room industry


of the segment



Process 2


$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


(-)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


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



room industry

Identify the on ground requirements and

design practices followed with key

players of 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.


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.


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



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



• 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



room industry


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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THANK YOU धन्यवाद

pidilite pharmaceutical scope

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