generics to impact north american oral solid drug dosage excipients market
DESCRIPTION
Listen On Demand: https://www.brighttalk.com/webcast/5561/97349 This briefing will investigate the increase in volume of drugs and the relative increase in excipients volume. Why you should listen On Demand? 1. Understand the different types of excipients used in solid drug dosage forms, their price, current market size and future market scenario. 2. Learn key unmet needs and success factors for oral solid drug dosage excipients. 3. Identify the drivers and restraints of the market.TRANSCRIPT
North American Oral Solid Drug Dosage North American Oral Solid Drug Dosage Excipients MarketExcipients Market
Blockbuster Drug Patent Expiration Expected to Boost Market GrowthBlockbuster Drug Patent Expiration Expected to Boost Market Growth
Dr. Nandhini Rajagopal,
Industry Analyst
Chemicals, Materials, and Foods
22nd Jan
© 2012 Frost & Sullivan. All rights reserved. This document contains highly confidential information and is the sole property of Frost & Sullivan. No part of it may be circulated, quoted, copied or otherwise reproduced without the written approval of Frost & Sullivan.
Focus Points
Focus PointsFocus Points
Outlook for Oral Solid Drug Dosage Excipients Market
Anticipating Demand for Excipients 3
Opportunity Analysis of Oral Solid Drug Dosage Excipients 4
1
Key Performance Challenges, Drivers, and Restraints2
2
Focus PointsFocus Points
Go To Market Strategy for Key Success6
Excipient Functional Groups 5
Facing the Change – Strategic Recommendations8
Key Competitive Factors in the Selection of an Excipient Supplier7
Outlook for Oral Solid Drug Excipients—A Snapshot
Major Growth Factors
End-user Needs Assessment
Unmet Needs
Scramble to attain a ‘Comprehensive’ solutions
portfolio
Strategic Recommendations
• Patent Expiration
• Multi-
• Easier drug-
administration
• Enhanced bio-
availability
• Longer shelf-life
• Improved sensory
parameters
• Tailor made excipients
• Identifying new
1
2
3
Oral Solid Drug
Dosage Excipients
Outlook
Industry Challenges
High Margin Products
Foresee the demand and customize according to
customer needs
Pioneering in new technologies and innovative products.
• Multi-functional excipients
• Povidone
• Acrylics
• CrosCarmellose Sodium
• Sodium starch glycolate
• Hypromellose
• Low return on investments• Increasingcommoditization of products
new applications for existing excipients
2
3
Excipients—Product Segmentation
Binders and Fillers: Microcrystalline cellulose, sodium carboxy methyl cellulose, methyl cellulose, hypromellose, specialty lactose, partially pre-gelatinized starch, povidone, calcium phosphate, calcium carbonate, gelatin
Super-disintegrants: CrossCarmellose Sodium, sodium starch glycolate, Crospovidone
Coatings: Intermediate release coating, controlled or modified coating
Flavors and Colors
Total Oral Solid Drug Dosage Market: North America, 2012
4
Flavors and Colors
Preservative: Antimicrobials and antioxidants
Glidants, lubricants, and anti-adherents: Magnesium stearate, Talc, silica
Sweeteners: Aspartame, acesulfame, polyols
Others: Buffers and adsorbents
Drivers and Restraints
Oral Solid Drug Dosage Market: Key Market Drivers and Restraints, North America, 2013-2019
1-2 years 3-4 years 5-7 years
Several key block buster drug patent expirations is expected to boost excipient market growth
Multifunctional excipients are accelerating market growth
Growth in controlled and sustained release
coatings drives the market
Mark
et
Dri
vers
5
Source: Frost & Sullivan analysis.
Regulatory issues leading to decrease in domestic market growth
New product development barriers slows the pace of development
Low-cost competition from emerging markets inhibits market growth
coatings drives the market
Mark
et
Restr
ain
ts
Impact: High Medium Low
Anticipating Demand for Excipients
Blockbuster products worth $73,850 million are expected to lose patent
protection in the United States
between 2009 and 2017.
Nu
mb
er
of
Pate
nte
d
Dru
g E
xp
irati
on
s
6
Potential earnings for generic manufacturers is $18.25 billion.
Owing to this, the potential revenue gain for excipient
manufacturers is $91.4 million.
Oral Solid Drug Dosage Excipients—Opportunity Analysis
Market Stage
Growth
Market Revenue
$1193.4
M
Market Units/Volume
258,705.1
tons
Average Price Per Unit/Kg
$4.6
Market Size for Last Year of Study Period
$1708.8M
Total Oral Solid Drug Dosage Excipient Market: North America, 2012Market Overview
7
Forecast Period Market Growth Rate
5.4 %
(CAGR, 2012-2019)
Number of Competitors
45–50
(2012) (2012) (2019)
Base Year Market Growth Rate
4.8%
Customer Price Sensitivity
6
(scale:1 [Low] to 10 [High])
Degree of Technical Change
7
(scale:1 [Low] to 10 [High])
Stable IncreasingDecreasing Note: All figures are rounded. The base year is 2012. Source: Frost & Sullivan analysis.
(active market competitors in base year)
Oral Solid Drug Excipients—Segmentation
Binders and Fillers47.6%
Colors
Glidants, Lubricants, and Anti-adherents
2.1%
Others*4.5%
Percent Revenue Sales BreakdownTotal Oral Solid Drug Dosage Excipients Market: North America, 2012
In terms of overall attractiveness—when measured by relative market size and growth—super-disintegrants and binders and fillers are top market grossers.
8
Coatings26.6%
Sweeteners5.8%
Super-disintegrants4.3%
Flavors3.9%
Preservatives2.8%
Colors2.4%
A clear balance between success probability and operational margin are factors to be maintained for a successful product launch.
Commodity Excipients Specialized Excipients
Low High
Low High
Low High
Low High
Low
Low
Low
Low
Low
Low High
High
High
High
High
High
Oral Solid Drug Dosage Excipients—Comparative Analysis
Probability of success
Time
Cost
Pricing
Marketing Investment
9
Source: Frost & Sullivan
Low
Low
Low
Low
Low
Low
High
High
High
High
High
High
Marketing Investment
Competitors
Point of differentiation
• Bargaining power of customers is high due to commodity market scenario and fragmented excipient manufacturer network allows intense competition in the commodity market scenario.
• Stringent regulations and safety requirements are the highest entry barriers for new product development• High R&D cost with extensive clinical trials to prove the efficacy of the product also adds up to the cost of
production of specialized excipients.
LowLow HighHigh Barriers to entry
LowLow HighHigh Product operational profit margin
2018-2020“Focus on R&D”
Business Expansion
2014-2015
Go to Market Strategy for Key Success
Setting up local manufacturing facilities in Asia-Pacific will be crucial to compete with the imports from low-cost countries.
Business Expansion
2016-2018“Grow market share”
Improving the drug
Immediate term
Medium Term
Long Term
10
2014-2015“Establish partnerships”
Time
Build track record in the AMR/ AMI
pilot projects
10
Source: Frost & Sullivan Analysis
Time
Identify new applications for existing excipients
Improving the drug delivery technologies
Manufacturing units in Asia-PacificFocusing on high
margin segments
Building long standing
relationships with customers
Increased bioavailability
Product differentiation through specialization
Key Competitive Factors
Price
Technical Service
Cost Competitiveness
Patented Products
Consolidation
11
Key Competitive
FactorsQuality
Price Consolidation
Value Added Services
Facing the Change—Strategic Recommendations
• Improve product line• React and respond as
needed • Plan ahead for future
Anticipate• Be the agent of the
industry change• Force rivals to follow
12
needed• Defend and protect
company’s presence in the market
React
• Plan ahead for future changes
• Instill competitive capabilities
• Invest in R&D• Strengthen distribution
• Force rivals to follow• Influence rules of the
game
Lead
Oral Solid Drug Dosage Excipients—Binders & Fillers Segment Detailed TOC
• Segment Overview & Breakdown
• Market Engineering Measurements
• Volume and Revenue Forecast & discussion
• Volume Percent Split by Product Type
• Percent Revenue Forecast by Product
• Revenue Forecast by Product
• Volume and Revenue Forecast Trends by Product Types
• Pricing Trends by Product Type & Discussion
• Competitive Analysis—Market Share
• Market Share Analysis Competitive Environment
13
• Market Share Analysis Competitive Environment
• Competitive Factors and Assessment
• Competitive Analysis – Market Share (Microcrystalline cellulose)
• Competitive Analysis – Market Share (Sodium carboxy methyl cellulose)
• Competitive Analysis – Market Share (Methyl cellulose)
• Competitive Analysis – Market Share (Hypromellose)
• Competitive Analysis – Market Share (Specialty Lactose)
• Competitive Analysis – Market Share (Partially pre-gelatinized starch)
• Competitive Analysis – Market Share (Povidone)
• Competitive Analysis – Market Share (Calcium Carbonate)
• Competitive Analysis – Market Share (Calcium Phosphate)
• Competitive Analysis – Market Share (Gelatin)
Next Steps
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join our GIL Global Community
14
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For Additional Information
Liz Clark
Corporate Communications
Chemical, Materials, and Food
(210) 477-8483
Dr. Nandhini Rajagopal
Industry Analyst
Foods, Drugs, and Cosmetics
(91) 44-66814069
17
Shomik Majumdar
Research Manager
Foods, Drugs, and Cosmetics
(650) 417-1466
Mark Hicks
Sales Manager
Chemical, Materials, & Food
(210) 247-2490