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2014
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[SYNTHESIS (Synthetic chemical API, Biotech API and HPAPI), CUSTOMER BASE (Synthetic chemical API, Biotech API and HPAPI), BUSINESS TYPE (Captive and Merchant) and THERAPEUTIC APPLICATION (Anti-infectives, Oncology, Cardiovascular and hematopoietic system, CNS, Respiratory, Gastrointestinal, Hormonal-related and Metabolic disorders, Genitourinary disorders, Musculo-skeletal diosorders and Others), REGION (North America, Europe, Asia-Pacific and Rest of the World)]
Active Pharmaceutical Ingredients (API) Global Market
– Forecast to 2020
Copyright © 2014 IQ4I
All Rights Reserved. This document contains highly confidential
information and is the sole property of IQ4I. No part of it may be
circulated, copied, quoted, or otherwise reproduced without the
approval of IQ4I.
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1.1 REPORT DESCRIPTION
The global active pharmaceutical ingredient market is expected to reach approximately $175
billion by 2020, growing at a CAGR of around 6% during forecast period. Active pharmaceutical
ingredient is any substance or mixture of substances used in a finished pharmaceutical product
with pharmacological activity used for diagnosis, cure, mitigation, treatment and prevention of
diseases. Very less number of finished pharmaceutical product manufacturers has their own
API manufacturing unit and nobody can make all required APIs in-house. It is basically not easy
for API manufacturers in developing countries to ensure a product with quality at a reasonable
price. API manufacturing involves conversion of raw materials into API and mixing API and
excipients for final formulations. These formulations in the form of tablets, capsules or solutions
are packaged and then marketed.
Patent expiration of major drugs that increased generic drug sales, government initiatives,
increasing aged population and regional penetration, local manufacturer expansion and high
uptake of biologics are some of the factors that are driving the market growth. Whereas financial
crisis, stringent regulatory policies, less investment in pharmaceutical industry and fragmented
market are the factors that are hindering API market growth.
The global API market is segmented based on synthesis, customer base, business type and
therapeutic applications. Depending on synthesis the market is classified into synthetic chemical
API, biotech API and HPAPI (Highly Potent Active Pharmaceutical Ingredient). Biotech API is
further segmented into mammalian cell culture, monoclonal antibodies, recombinant proteins,
vaccines, insulin analog, growth hormones and interferons. Mammalian cell culture accounted
for the largest share in 2013, while monoclonal antibody segment is the fastest growing
segment by 2020. Despite low production yields, high manufacturing cost and highly unstable
cell culturing method mammalian culture is the largest due to post-translational mechanism
present in living cells. Monoclonal antibodies are growing at a faster pace due to demand for
biotech APIs and increasing venture capital investments that drives the market.
By-customer base the API market is segmented into synthetic chemicals API, biotech API and
HPAPI. Synthetic chemical API is further classified into branded/innovative and generic/non-
branded API. Branded API accounted for the largest share whereas, generic is the fastest
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growing segment. Biotech API is further divided into biologics and biosimilars where biologics
accounted for the largest share.
Depending on business type the API market is segmented into captive and merchant. Captive
market accounted for the largest revenue in 2013. Based on the therapeutic applications the
global API market is categorized into eleven crucial application areas such as anti-infectives,
oncology, cardiovascular and hematopoietic system, central nervous system, gastrointestinal
disorder, respiratory system, hormonal-related disorder, metabolic disorder, genito-urinary
disorder, musculo-skeletal disorder and others. Anti-infectives segment dominated the
application market with a largest in 2013 whereas oncology segment is the fastest growing
segment with a CAGR of approximately 8% by 2020. Patent expiration of major drugs,
increased incidence of various cancer diseases and aged population, high government
investments for cancer research and healthcare awareness are the factors that drives the
market whereas stringent regulations, failure of crucial drugs in last stage of clinical trial, and
economical crisis are the factors that hampers the market growth.
Geographically API market is segmented into North America, Asia-Pacific, Europe and Rest of
the world regions. North America dominated the global API market during the forecast period.
Asia Pacific region is the fastest growing with a CAGR of more than 7.5% by 2020 due to patent
expirations of drugs, low operation costs, services of Contract Manufacturing Organizations
(CMO) and high investments in medical research. Moreover the high cost of skilled labor and
energy are the major factors that forced European market to shift their base to countries such as
India and China.
Major players in the API market include Teva Active Pharmaceutical Industries Limited (Israel),
Ranbaxy Laboratories (India), Dr. Reddy's Lab (India), Boehringer Ingelheim GmbH (Germany),
Lonza group (Switzerland), Lupin (India), Novartis (Switzerland), Aurobindo pharma (India), and
Albemarle Corporation (U.S.).
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The report provides an in depth market analysis of the above mentioned segments across the
following regions:
North America
Europe
Asia-Pacific
Rest of the World (RoW)
FIGURE 1
GLOBAL API MARKET SHARE ANALYSIS,
BY MAJOR PLAYERS (2013)
Source: Annual/Financial Reports, SEC Filings, Investor/Corporate presentations, International Federation
of Pharmaceutical Manufacturers & Associations (IFPMA), American Pharmaceutical Manufacturers' Association
(APMA), European Generic medicines Association (EGA), EFPIA, JPMA, IPA, & Expert Interviews
XX%
XX%XX%
XX%
XX%
XX% XX%
Teva Active Pharmaceutical IndustriesLupin
Sun Pharma
Dr. Reddy's Laboratories
Fresenius Kabi
Novartis
Others
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FIGURE 2
GLOBAL API MARKET SNAPSHOT, BY REGION (2013)
Source: Annual/Financial Reports, SEC Filings, Investor/Corporate presentations, International Federation
of Pharmaceutical Manufacturers & Associations (IFPMA), American Pharmaceutical Manufacturers' Association
(APMA), European Generic medicines Association (EGA), EFPIA, JPMA, IPA, & Expert Interviews
Ma
rke
t Si
ze (
$B
N)
Ma
rke
t Si
ze (
$B
N)
0.0
20.0
40.0
60.0
80.0
2012 2013 2014 2020
North America
0.0
10.0
20.0
30.0
40.0
50.0
2012 2013 2014 2020
Europe
0.0
20.0
40.0
60.0
80.0
2012 2013 2014 2020
Asia-Pacific
0.0
5.0
10.0
15.0
2012 2013 2014 2020
ROW
XX%
XX%
XX%
XX%
North America
Europe
Asia-Pacific
ROW
API Market Share 2013
Ma
rke
t Si
ze (
$B
N)
Ma
rke
t Si
ze (
$B
N)
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TABLE 1
API MARKET, GLOBAL MARKET REVENUE,
BY SYNTHESIS (2012-2020) ($BN)
TABLE 2
Synthesis 2012 2013 2014 2020 CAGR%
(2014-2020)
Synthetic Chemicals XX XX XX XX XX
Biotech API XX XX XX XX XX
HPAPI XX XX XX XX XX
Total XX XX XX 173.5 6.0
Source: Annual/Financial Reports, SEC Filings, Investor/Corporate presentations, International Federation
of Pharmaceutical Manufacturers & Associations (IFPMA), American Pharmaceutical Manufacturers' Association
(APMA), European Generic medicines Association (EGA), EFPIA, JPMA, IPA, & Expert Interviews
Synthetic chemicals commanded the largest revenue of $XX billion of the API global market in
2013. The market is expected to grow at a CAGR of XX% from 2014 to 2020 to reach $XX
billion by 2020. Biotech API is also expected to grow at a strong CAGR of XX% during the
forecast period.
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FIGURE 3
GOBAL API MARKET SHARE, BY THERAPEUTIC
APPLICATIONS (2013) ($BN)
Source: Annual/Financial Reports, SEC Filings, Investor/Corporate presentations, International Federation
of Pharmaceutical Manufacturers & Associations (IFPMA), American Pharmaceutical Manufacturers' Association
(APMA), European Generic medicines Association (EGA), EFPIA, JPMA, IPA, & Expert Interviews
CAGR - XX%
CAGR - XX%
CAGR - XX%
CAGR - XX%
CAGR – XX%
CAGR – XX%
CAGR - XX%
CAGR - XX%
CAGR - XX%
CAGR - XX%
CAGR - XX%
0.0 3.0 6.0 9.0 12.0 15.0 18.0 21.0 24.0 27.0 30.0
Anti-infectives
Cardiovascular and hematopoietic system
Central nervous system
Gastrointerstinal
Oncology
Respiratory system
Hormonal Related disorders
Metabolic disorders
Genito-Urinary disorders
Musculo-Skeletal disorders
Others
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TABLE 3
API GLOBAL MARKET REVENUE,
BY THERAPEUTIC APPLICATIONS (2012-2020) ($BN)
Application 2012 2013 2014 2020 CAGR%
(2014-2020)
Anti-infectives XX XX XX XX XX
Oncology XX XX XX XX XX
Cardiovascular and hematopoietic system
XX XX XX XX XX
Central nervous system XX XX XX XX XX
Respiratory system XX XX XX XX XX
Gastrointestinal XX XX XX XX XX
Hormonal Related disorders
XX XX XX XX XX
Metabolic disorders XX XX XX XX XX
Genito-Urinary disorders XX XX XX XX XX
Musculo-Skeletal disorders
XX XX XX XX XX
Others XX XX XX XX XX
Total XX XX XX XX XX
Source: Annual/Financial Reports, SEC Filings, Investor/Corporate presentations, International Federation
of Pharmaceutical Manufacturers & Associations (IFPMA), American Pharmaceutical Manufacturers' Association
(APMA), European Generic medicines Association (EGA), EFPIA, JPMA, IPA, & Expert Interviews
Anti-infectives commanded the largest revenue of $XX billion of the API global Therapeutic
application market in 2013. The market is expected to grow at a CAGR of XX% from 2014 to
2020 to reach $XX billion by 2020. Oncology is also expected to grow at a strong CAGR of XX%
during the forecast period.
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TABLE 4
BIOTECH API GLOBAL MARKET REVENUE,
BY TYPE (2012-2020) ($BN)
Type 2012 2013 2014 2020 CAGR%
(2014-2020)
Mammalian cell culture XX XX XX XX XX
Monoclonal antibodies XX XX XX XX XX
Recombinant proteins XX XX XX XX XX
Vaccines XX XX XX XX XX
Insulin analog XX XX XX XX XX
Growth hormones XX XX XX XX XX
Interferon’s XX XX XX XX XX
Total XX XX XX XX XX
Source: Annual/Financial Reports, SEC Filings, Investor/Corporate presentations, International Federation
of Pharmaceutical Manufacturers & Associations (IFPMA), American Pharmaceutical Manufacturers' Association
(APMA), European Generic medicines Association (EGA), EFPIA, JPMA, IPA, & Expert Interviews
Mammalian cell culture commanded the largest revenue of $XX billion of the Biotech API market
in 2013. The market is expected to grow at a CAGR of XX% from 2014 to 2020 to reach $XX
billion by 2020. Monoclonal antibodies are also expected to grow at a strong CAGR of XX%
during the forecast period.
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FIGURE 4
GOBAL SYNTHETIC CHEMICALS API MARKET SHARE, BY CUSTOMER
BASE (2013 V’S 2020)
Source: Annual/Financial Reports, SEC Filings, Investor/Corporate presentations, International Federation
of Pharmaceutical Manufacturers & Associations (IFPMA), American Pharmaceutical Manufacturers' Association
(APMA), European Generic medicines Association (EGA), EFPIA, JPMA, IPA, & Expert Interviews
XX%
XX%
XX%
XX%
Branded/Innovative API
Generic/Non-Branded API
2013 2020
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TABLE 6
BIOTECH API GLOBAL MARKET REVENUE,
BY CUSTOMER BASE (2012-2020) ($BN)
Customer base 2012 2013 2014 2020 CAGR%
(2014-2020)
Biologics XX XX XX XX XX
Biosimilars XX XX XX XX XX
Total XX XX XX XX XX
Source: Annual/Financial Reports, SEC Filings, Investor/Corporate presentations, International Federation
of Pharmaceutical Manufacturers & Associations (IFPMA), American Pharmaceutical Manufacturers' Association
(APMA), European Generic medicines Association (EGA), EFPIA, JPMA, IPA, & Expert Interviews
Biologics commanded the largest revenue of $XX billion of the Biotech API market in 2013. The
market is expected to grow at a CAGR of XX% from 2014 to 2020 to reach $XX billion by 2020.
Asia-Pacific is also expected to grow at a strong CAGR of XX% during the forecast period.
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FIGURE 5
GOBAL API MARKET REVENUE,
BY BUSINESS TYPE (2012 - 2020)
Source: Annual/Financial Reports, SEC Filings, Investor/Corporate presentations, International Federation
of Pharmaceutical Manufacturers & Associations (IFPMA), American Pharmaceutical Manufacturers' Association
(APMA), European Generic medicines Association (EGA), EFPIA, JPMA, IPA, & Expert Interviews
XX XXXX
XXXX
XXXX
XXXX
XX XX XXXX
XXXX
XXXX
XX
0.0
20.0
40.0
60.0
80.0
100.0
120.0
2012 2013 2014 2015 2016 2017 2018 2019 2020
Captive Merchant
Mar
ket S
ize
($B
N)
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1.1.1 RESEARCH SOURCES
TABLE 7
API MARKET: RESEARCH SOURCES
Primary Sources Secondary Sources
Supply Side: Top-level Executives,
Marketing Managers, Sales Managers,
Regional Managers
Demand Side: Managers, sales
professionals, research scientists,
consultants from Synthetic drug
manufacturing firms, Biotech drug
manufacturing firms, and Academic
research
Others: Independent Consultants and
Freelancers
IQ4I Repository
API Company-Specific annual reports,
SEC filings, corporate presentations &
Press releases
Associations and Groups : International
Federation of Pharmaceutical
Manufacturers & Associations (IFPMA),
American Pharmaceutical Manufacturers'
Association (APMA), European Generic
medicines Association (EGA), EFPIA,
JPMA, IPA, & Expert Interviews.
Paid Sources : Factiva, OneSource,
Hoovers, Bloomberg
Social Networking & Databases: LinkedIn,
Melt-Water, Zintro
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1.2 RESEARCH METHODOLOGY
FIGURE 6
API MARKET: RESEARCH APPROACH
• Bottom-up and Top-down approach
• Data triangulation
• Qualitative & Quantitative analysis
• Active Pharmaceutical Ingredient market segmentation
• Market size, CAGR and market trends validation
• Market size of sub segments and market shares of major players
• Upcoming trends and technological advancements in synthesis,
customer base, HPAPI and therapeutic applications
• Validation of factors influencing market and regional market shares
• Technical information of API
• Strategic insights, financial revenues and competitive intelligence of
key players
• Synthesis, customer base, business type and applications of API
• Market trends and growth scenario of sub markets and parent market
Market
Breakdown
Primary
Research
Secondary
Research
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1.2.1 MARKET SIZE ESTIMATION
The global API market size, its different segments and sub-segments is analyzed using both
top-down and bottom-up approaches. The market size and revenue calculated using research
methodology involves primary and secondary research of major players in the market, factors
influencing the market, market segmentation and geographical market scenario.
Secondary research of major players include the study of their annual and financial reports,
press release while primary research involves interviews from the supply side (CEOs, directors,
strategic growth managers, international/regional marketing managers, and marketing
executives) and the demand side (reference pharmaceutical drug manufacturers, purchase
managers).
Primary and secondary sources helped in verification of percentage shares, splits, and
breakdowns. This data is consolidated with detailed inputs and presented in this report.
FIGURE 7
API MARKET: TOP-DOWN AND BOTTOM-UP APPROACH
Global Pharmaceutical
market
Market share of Synthetic and Biotech
API manufacturers
Regional market shares
Market share of sub
segments in regional markets
Sub segments
market size and
CAGR
Overall
market size and CAGR
Market share of the players in
the overall APIMarket and sub markets
Top players revenue TEVA (Israel),
Ranbaxy laboratories (India), Albemarle corporation (U.S.), Dr Reddy’s laboratories (India),
Lonza group (Switzerland),
Lupin (India), and Boehringer Ingelheim GmbH (Germany).
Global API market
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FIGURE 8
API MARKET: FORECASTING MODEL
Historical Data
and trends of
APIMarket
Evolution
Company
developmentsApplications
Download Pattern
Regulatory
Landscape
Factors Influencing
Market GrowthMarket Opportunities
• Expansion of local
manufacturers
• Increase in mergers and
acquisitions
Agreements & Joint
ventures Contributed for
XX%.
New product launch
Contributed for XX %
Technology
Evolution
Supply chain
trendAdoption pattern Regulations
Market ShareMarket Sizing
analysis
Geographical
Usage
Market Penetration
• Government initiatives
• Emerging markets such as
Latin America, China, India
and Japan
• Increasing trend in biotech
API
Market Restraints
• Financial crisis
• Stringent regulatory affairs
• Market fragmentation
• Less investment on API
market
Investments
In July 2014, Hospira
acquired Orchid’s API
manufacturing and R&D
facility which improved cost
position of company.
Market Drivers
• Patent expiration of major
drugs
• Increasing regional penetration
aged population
• High uptake of biologics
.Historical Market Data
Impact Analysis of Market
Trends
Market Size & Forecast by
Types
Market Size & Forecast by
Synthesis type & Applications
Global API Market Size,
Segmental share and
CAGR from 2014-2020
Market Trend and
Growth Forecasting
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1.2.2 MARKET BREAKDOWN & DATA TRIANGULATION
FIGURE 9
API MARKET: MARKET BREAKDOWN & DATA TRIANGULATION
Demand & Supply
side
•Synthetic API
manufacturers
•Biotech API
manufacturers
• Formulations
Market share of API
Market in Global
Pharmaceutical market
Top -down
Primary
Research
Bottom -up
Secondary
Research
APIMarket
(~ Bn)
(2013)
•Financial/Annual reports
•Investor Presentations
•SEC filings
•Scientific Journals
•Organizations/
Associations & Groups
Major player analysis
of key players:. Teva,
Ranbaxy, Dr. Reddy’s,
Lupin, Lonza group,
Novartis, Aurobindo,
Sunpharma.
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