Analysis of the Oral Solid Drug Dosage Excipients Market

Analysis of the Oral Solid Drug Dosage Excipients Market

Key Blockbuster Drugs Patent Expiration is Expected to Boost

Excipient Market Growth

North America

NC51-39

April 2013

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Research Team

Nandhini Rajagopal Senior Research Analyst

Chemicals, Materials, and Foods

Lead Analyst Research Manager

Shomik Majumdar Vice President-Consulting

Chemicals, Materials and Foods

Jeannette Garcia Corporate Communications

Chemicals, Materials and Foods

+1.210.477.8427

[email protected]

For more information:

mailto:[email protected]

mailto:[email protected]

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Contents

Section Slide Numbers

Executive Summary 5

Market Overview 9

Total Market -

• Industry Challenges 26

• External Challenges: Drivers and Restraints 29

• Regulatory Trends 37

• Forecasts and Trends 40

Binders and Fillers Segment Breakdown 49

Coatings Segment Breakdown 78

Sweeteners Segment Breakdown 94

Super-disintegrants Segment Breakdown 113

Flavors Segment Breakdown 132

Preservatives Segment Breakdown 142

Colors Segment Breakdown 161

Glidants, Lubricants, and anti-adherents segment breakdown 171

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Contents

Section Slide Numbers

Others Segment Break down 190

The Last Word (Conclusions and Implications) 200

Appendix 203

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Executive Summary

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Executive Summary

Source: Frost & Sullivan analysis.

• The North American oral solid drug dosage excipient market generated a revenue of

$1193.4 million in 2012. Revenue is expected to increase to $1708.9 million in 2019, at

a compound annual growth rate (CAGR) of 5.4 percent from 2012 to 2019.

• Binders and fillers segment held the highest market share in terms of revenue (47.6

percent in 2012).

• In 2012, super-disintegrants accounted for a 4.3 percent market share in terms of

revenue; they are expected to grow the fastest, at a CAGR of 6.3 percent from 2012 to

2019.

• The market is driven by high patent expiries during the forecast period, which is

expected to intensify the demand from pharmaceutical formulators. However, import of

generics from low cost countries hinders growth.

• The market for total solid drug dosage excipient market is highly fragmented, as key

participants differ for each chemistry.

• The key market participants includes, Colorcon Inc., Ashland, FMC Biopolymers, JRS

Pharma, DMV Fonterra, Roquette, Meggle, Gelita, J.M Hubber, and Dow Wolff

Cellulosics.

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Forecast Period

Market Growth

Rate

5.4 %

(CAGR, 2012-2019)

Number of

Competitors

45–50

Executive Summary—Market Engineering Measurements

Market Stage

Growth

Market Revenue

$1193.4 M

(2012)

Market

Units/Volume

258,705.1

tons (2012)

Average Price

Per Unit/Kg

$4.6

Market Size for

Last Year of

Study Period

$1708.8M

(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])

Total Oral Solid Drug Dosage Excipient Market: North America, 2012

Market Overview

For a tabular version click here. Stable Increasing Decreasing

Note: All figures are rounded. The base year is 2012. Source: Frost & Sullivan analysis.

(active market competitors in

base year)

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Executive Summary—CEO’s Perspective

2

By establishing a partnership, suppliers are

encouraged to offer value added services in

terms of payment options and timeline, price,

quality, and supply consistencies.

3 For the vast commoditized excipient volume,

the supplier needs to focus on competitive

pricing and value addition

4

Loss of exclusivity of a drug opens up new

opportunities for drug manufacturers. This

increases the volume of drug sales,

subsequently increasing the excipient sales.

1

Focusing on high margin segments like

coating polymers, co-processed excipients,

coating systems, and super disintegrants to

increase profit.


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Market Overview—Definitions

• This research service covers the North American oral solid drug dosage excipients market. Based

on their functionality, excipient are segmented as binders & fillers, disintegrants, coatings, flavors,

colors, sweeteners, glidants, adhesives, lubricants and others.

• Units are defined in terms of tons. Unit shipment forecasts are based on the volume of excipients

used in oral solid drug dosage formulations.

• Base year for the study is 2012 with a market history since 2009 and forecasts up to 2019.

• Average prices are presented in U.S. dollars. Average price is, weighted average price of its

segments.

• Revenue is defined as manufacturers revenue (BASF, JRS Pharma, Ashland, etc.), which implies

sales derived through selling excipients for pharmaceutical companies (Pfizer Inc., Novartis AG,

GlaxoSmithKline plc., AstraZeneca, Sanofi-Aventis).


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Market Overview—Product Segmentation


Pharmaceutical Excipients

Binders and

Fillers

Super-

disintegrants Coatings

Flavors and

Colors

• Microcrystalline

cellulose

• Sodium carboxy methy l

cellulose

• Methyl cellulose

• Hypromellose

• Specialty lactose

• Partially pre-gelatinized

starch

• Povidone

• Calcium phosphate

• Calcium carbonate

• Gelatin

• CrossCarmellose

sodium

• Sodium starch

glycolate

• Crospovidone

• Intermediate

release

coating

• Controlled or

modified

coating

Total Oral Solid Drug Dosage Market: North America, 2012

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Market Overview—Product Segmentation (Continued)


Pharmaceutical Excipients

Sweeteners

Glidants,

Lubricants, and

Anti-adherents Preservatives Others

• Aspartame

• Acesulfame

• Polyols

• Magnesium

sterate

• TALC

• Silica

• Antimicrobials

• Antioxidants

• Buffers

• Adsorbents


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Market Overview—Key Questions This Study Will Answer

Key factors driving and restricting growth in this market?

At what stage in the lifecycle is the market and how is it expected to grow?

Major participants in the market and their market shares?

Market forecast by segments?

Key competitive factors driving this market?

Which segments are poised to grow in future?


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MEASUREMENT NAME MEASUREMENT TREND

Market Stage Mature —

Market Revenue (2012) $1193.4M ▲

Market Units/Volume (2012) 258,705.1 T

Average Price Per Unit $4.6 ▲

Market Size for Last Year of Study Period (2019) $1708.8 ▲

Base Year Market Growth Rate 4.8% ▲

Forecast Period Market Growth Rate (CAGR, 2012-2019) 5.4% —

Customer Price Sensitivity (scale of 1 to 10, Low to High) 6 ●

Degree of Technical Change (scale of 1 to 10, Low to High) 7 ▲

Number of Competitors (active market competitors in base year) Approximately 45-50 ●

Market Engineering Measurements

TREND Decreasing Stable Increasing

Total Oral Solid Drug Dosage Excipients Market: North America, 2012

Market Overview


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Market Overview—Segmentation

Binders and Fillers, 47.6%

Coatings, 26.6%

Flavors and Colors, 6.3%

Sweeteners, 5.8%

Disintegrants, 4.3%

Preservatives, 2.8%

Glidants, Lubricants, and

Anti-adherents2.1%

Others, 4.5%

Revenue Percent Sales Breakdown Total Oral Solid Drug Dosage Excipients Market: North America, 2012


Others* include buffers and

adsorbents

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Total Oral Solid Drug Dosage Market —Value Chain

Supplier of excipients

such as binders,

disintegrants,

sweeteners.

Key Participants

• FMC Biopolymer

• Dow Wolff

Cellulosic

• JRS Pharma

Manufacturer of

coating systems.

Key Participants

• Colorcon Inc.,

• Ashland

Specialties

• Seppic

Distributors

Key Participants

• Mutchler

Chem

• Biddle Sawyer

Corp

Pharmaceutical

companies (end

users)

Key Participants

• Pfizer

• Merck

Commoditized and specialized products

with technical services

Coating raw materials for

specialized coating systems


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Industry Challenges


Total Oral Solid Drug Dosage Excipient Market : Key Industry Challenges , North

America, 2013-2019

3-4 years 1-2 years Challenges 5-7 years

Low Return on Investment

Increasing Commoditization of Products

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Drivers and Restraints

Oral Solid Drug Dosage Market: Key Market Drivers and Restraints, North America, 2013-2019


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

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

M

ark

et

Restr

ain

ts

Impact: High Medium Low

Analysis of the Oral Solid Drug Dosage Excipients Market

Health & Medicine

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