IQ4I Research · further segmented into mammalian cell culture, monoclonal antibodies, recombinant...

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2014

IQ4I Research & Consultancy Pvt. Ltd.

[email protected]

www.iq4i.com

[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.

IQ4I Research & Consultancy Pvt. Ltd. Page 2


–Forecast to 2020



–Forecast to 2020



–Forecast to 2020

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



–Forecast to 2020

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.).



–Forecast to 2020

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



–Forecast to 2020

FIGURE 2

GLOBAL API MARKET SNAPSHOT, BY REGION (2013)




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)



–Forecast to 2020

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




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.



–Forecast to 2020

FIGURE 3

GOBAL API MARKET SHARE, BY THERAPEUTIC

APPLICATIONS (2013) ($BN)




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



–Forecast to 2020

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




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.



–Forecast to 2020

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





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.



–Forecast to 2020

FIGURE 4

GOBAL SYNTHETIC CHEMICALS API MARKET SHARE, BY CUSTOMER

BASE (2013 V’S 2020)




XX%

XX%

XX%

XX%

Branded/Innovative API

Generic/Non-Branded API

2013 2020



–Forecast to 2020

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





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.



–Forecast to 2020

FIGURE 5

GOBAL API MARKET REVENUE,

BY BUSINESS TYPE (2012 - 2020)




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)



–Forecast to 2020

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



–Forecast to 2020

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



–Forecast to 2020

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



–Forecast to 2020

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



–Forecast to 2020

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.



–Forecast to 2020

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