Active Pharmaceutical Ingredients (API) Global Market

Active Pharmaceutical Ingredients (API) Global Market
2019
[Synthesis {Synthetic API (By customer base [Branded and
Generic]), Biotech API (By product type [Monoclonal
antibodies, Recombinant proteins, Vaccines and Others],
By customer base [Biologics and Biosimilar]), HPAPI (By
customer base [Branded and Generic])}; Business type
{Captive (By customer type [Branded captive and Generic
captive]) Merchant (Merchant by type [Branded merchant
API and Generic merchant API])}; Therapeutic application
(Infectious diseases, Oncology, Cardiovascular disorders,
CNS, Pulmonary disorders, Gastrointestinal, Endocrine
disorders, Metabolic disorders, Genitourinary disorders,
Musculoskeletal disorders and Others); REGION (North
America, Europe, Asia-Pacific and Rest of the World)]
– Forecast to 2025
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–Forecast to 2025
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LIST OF COMPANIES MENTIONED IN REPORT
Company Head Quarters
Aarti Drugs Ltd India
Aash biotech Pvt Ltd. India
AbbVie U.S.
ABC international pharma srl. Italy
Abclonal U.S.
J.H Whitney Capital Partners LLC (Accupac,
U.S.
Inc.)
Achaogen Inc. U.S.
ACIC Pharmaceutical Inc. Canada
Adimmune corporation Taiwan
Aesica Pharmaceuticals U.K.
AGC group Japan
AGC biologics U.S.
Ajantha Pharma India
Ajinomoto Bio-Pharma Services U.S.
Akorn U.S.
Albany Molecular Research Inc (AMRI) U.S.
Albemarle Corporation U.S.
Alcami Corporation U.S.
Alembic Ltd. India
Alfachemicals U.K.
Alkem Laboratories Ltd. India
Alkermes Plc Ireland
Allchem U.K.

–Forecast to 2025
Allergan Plc Ireland
Almac group U.K.
Almelo Private Limited India
Alpic remedies India
Alven Laboratories Czech Republic
Ambio Pharma Inc. U.S.
Amega Biotech Argentina
Amgen U.S.
Amneal Pharmaceuticals LLC U.S.
Amoytop Biotech China
Ampac fine chemicals U.S.
Angelini Acraf S.p.A. Italy
APICORE US LLC U.S.
Apotex Fermentation Inc Canada
AqVida GmbH Germany
Arena pharmaceuticals U.S.
Arene Lifesciences Limited India
Arevipharma GmbH Germany
Ariston Pharma Novatech Pvt., Ltd. India
Aspire Lifesciences Pvt., Ltd. India
AstraZeneca Plc. U.K.
Aurobindo Pharma Ltd. India
Avra Laboratories Pvt., Ltd. India
Azad Pharma AG Switzerland
Bachem holding AG Switzerland

–Forecast to 2025
Bal Pharma Ltd. India
BASF Germany
Baxter International Inc. U.S.
Bayer Pharma Chemicals Germany
Biocodex S.A. France
Biocon Ltd. India
Biogen U.S.
BioMax Pharma U.K.
Biomerin Pharmaceutical Inc. U.S.
Biophore India Pharmaceuticals Pvt., Ltd. India
Biosortia Pharmaceuticals U.S.
Biotechnica Pharma Global Algeria
Biovian Finland
Blanver Farmoquimica Brazil
Boehringer Ingelheim GmbH. Germany
Brammer bio U.S.
Brawn Laboratories Ltd. India
Bristol-Myers Squibb U.S.
Cadila Pharmaceuticals Limited India
Cambrex Corporation U.S.
Catalent U.S.
Cayman Chemicals U.S.
Celgene U.S.
Celltrion Inc. South korea
Century Pharmaceuticals Ltd. India

–Forecast to 2025
Cerbios-Pharma Sa Switzerland
CFM Group (AMSA S.P.A) Italy
Changzhou Pharmaceutical Factory China
ChemCon GmbH Germany
China Chemical & Pharmaceutical Co., Ltd. Taiwan
Chongqing Huapont Pharmaceutical Co., Ltd. China
Cipla Limited India
CKD Bio South Korea
Coba pharma Spain
Corden Pharma Germany
Crystalia Brazil
CSL Ltd Australia
CTX Lifesciences India
Daiichi Sankyo Chemical Pharma Co Ltd. Japan
Daito Pharmaceutical Co., Ltd. Japan
Dalton research molecule Canada
DCS Pharma AG Switzerland
Dishman Pharmaceuticals India
Divis Laboratories India
Dong Wha Pharm Ind Co Ltd. Korea
Dr.Reddy’s Laboratories India
EirGen Pharma Ireland
Eisai Japan
Eli Lilly Pharmaceuticals U.S.
Emcure Pharmaceuticals Ltd. India

–Forecast to 2025
Enaltec Labs Private Limited. India
Ercros Spain
Estechpharma Co., Ltd. South Korea
Esteve Química Sapin
Everest Organics Limited. India
Evonik Industries AG Germany
Fareva group France
Farmabios Italy
Ferring pharmaceuticals Switzerland
Fis Fabbrica Italiana Sintetici S.p.A. Italy
Flamma S.p.A. Italy
Florentis Pharmaceuticals Pvt., Ltd. India
Formosa Laboratories Inc. Taiwan
Fuji Chemical Industry Co., Ltd. Japan
GE Healthcare Bio-Sciences AB Sweden
Gentec Pharmaceutical Group S.A Spain
Gilead Sciences, Inc. U.S.
Gland Pharma Limited. India
GlaxoSmithKline Plc. U.K.
Glenmark Generics Ltd. India
Gnosis S.p.A. Italy
Granules India Ltd. India
GVK Industries Limited (GVK Bioscience) India
Haoyuan Chemexpress Co.Ltd. China
Harman Finochem Limited. India

–Forecast to 2025
Heni Chemical Industries India
Heraues Holding GmbH Germany
Hetero Labs Ltd. India
Hikma pharmaceuticals U.K.
Honour Lab Ltd. India
Hovione Portugal
Huvapharma Bulgaria
Hybio Pharmaceutical Co., Ltd. China
Ibio Inc U.S.
Icrom S.p.A. Italy
Inabata Pharmasynthese France
Inalco pharmaceuticals Italy
Indena Italy
InSight Biopharmaceutical Israel
Intas Pharmaceuticals Ltd. India
Interquim, S.A. Spain
Jeil Pharmaceutical Co. Ltd. Korea

Johnson and Johnson (Janssen
U.S.
Pharmaceutica NV, Belgium)
Jubilant lifesciences (Jubilant generics Ltd.) India
Katsura Chemical Co.,Ltd. Japan
Kern Pharma, S.L. Spain
Kleos pharma France
Kongo Yakuhin Co., Ltd. Japan
Kosher Pharmaceuticals India
Krka Pharmaceuticals Slovenia

–Forecast to 2025
Kyowa Hakko Kirin Japan
ofichem bv Netherlands
Lannett Co. Inc. U.S.
Laurus Labs. India
Lebsa Spain
LGM Pharma. U.S.
Libbs Brazil
Liptis Pharmaceuticals U.S.
Lonza group Switzerland
Lotus Pharmaceutical Co., Ltd. Taiwan
Lupin India
Lusochimica S.p.A Italy
Macleods pharmaceutical Ltd. India
Magle Chemoswed AB Sweden
Mallinckrodt Pharmaceuticals U.K.
Medichem S.A Spain
Megafine Pharma Ltd India
Mehta API Inida
Merck group (Merck KGaA) Germany
Metrochem API India
Micro Labs Ltd. U.S.
Minakem S.A. Belgium
Moehs Iberica S.L. Spain
Molcan Corporation Canada
Morepen India

–Forecast to 2025
MSN Organics Pvt, Ltd. India
Mylan N.V U.S.
NanoMedex Pharmaceuticals U.S.
Natco Pharma Ltd. India
Neovacs Kinoid France
Neuland laboratories Ltd. India
Neuraxpharm Arzneimittel (INKE) Germany
Nifty Labs Pvt Ltd. India
Norchim France
Novartis AG Switzerland
Novasep France
Novo Nordisk Denmark
Novocap, Argentina
Olainfarm JSC. Latvia
Olon S.P.A. Italy
Oncobiologics U.S.
Optimus Drugs Private Ltd. India
Orchid Chemicals & Pharmaceuticals Ltd. India
Orion (Fermion) Finland
Paratek pharmaceutical U.S.
PCAS France
Pellets Pharma Limited India
Perrigo Ireland
Pfizer U.S.
Pfanstiehl U.S.

–Forecast to 2025
Pharmispania Spain
Phyton Biotech LLC Canada
Pierre Fabre France
Piramal Enterprises Ltd. India
Polpharma B2B Poland
Prajna Generics Pvt. Ltd. India
Precise Group India
ProBiogen AG Germany
Princeton BioMolecular Research, Inc. U.S.
Rablon Healthcare Pvt Ltd. India
Raks Pharma Pvt Ltd. India
Recipharm AB Sweden
Regeneron U.S.
Reine Lifescience India
Reliance Life Sciences Pvt., Ltd. India
Reva Pharma Pvt., Ltd. India
Roche Switzerland
Rochem International Inc. U.S.
RPG Life Sciences India
Rxn Chemicals Pvt. Ltd. India
Saamya Biotech India
Sajjala Bio Labs India
Sandoz International GmbH Germany
Saneca Pharmaceuticals Slovakia
Sanofi S.A. France

–Forecast to 2025
Scinopharm Taiwan Ltd. Taiwan
Servier France
Shenzhen Haorui Industrial Dev. China
Shilpa Medicare Limited India
Shiono Chemical Co., Ltd. Japan
Shire pharmaceuticals U.S.
Shouyuan Chemical China
Shreeji Pharma International India
Siegfried Holdinngs AG Switzerland
Sigma-Aldrich U.S.
Sigmapharm Laboratories Llc. U.S.
SM Biomed SDN. BHD Malaysia
Smilax Laboratories Limited India
SMS Pharmaceuticals Limited India
Solara A Pharma Sciences Ltd. India
Srini Pharmaceuticals Ltd. India
Standard Chemical & Pharmaceutical Co. Taiwan
Sterling Biotech Ltd. India
Strides Shasun Limited India
Sumitomo Dainippon Pharma Co., Ltd. Japan
Sun Pharmaceutical Industries Ltd. India
Suven Life Science Ltd. India
Suzhou Ryway Biotech China
Symbiotec Pharma lab Pvt., Ltd India
Synergene Active Ingredients Pvt, Ltd. India

–Forecast to 2025
Syn-tech chem. And Pharma.Co., Ltd. Taiwan
Takeda Pharmaceutical Company Ltd. Japan
Taro Pharmaceutical Industries Ltd. Israel
Temad Co. Iran
Tetraphase pharmaceuticals U.S.
Teva Pharmaceuticals industries Ltd. Israel
Therapeutic Md Inc. U.S.
Theravance Biopharma U.S.
Thermo Fisher Scientific corporation U.S.
Torrent Pharmaceuticals, Ltd. India
Trifecta Pharmaceuticals LLC U.S.
Trimax Bio Sciences (P) Limited India
Umicore Belgium
Unichem Laboratories Ltd. India
Union Quimico Farmaceutica, S.A. Spain
Unique Biotech Ltd. India
USV Ltd. India
Vaishali Pharma Ltd. India
Venus Remedies (Venus pharma GMbH) India
Vertex Pharmeceuticals U.S.
Viruj Pharma India
Vivimed labs Ltd. India
Wanbury Ltd. India
Watson Pharma Private Ltd. Ireland
Wavelength Pharmaceuticals Israel

–Forecast to 2025
Wellona pharmaceuticals India
Welt Care Lifesciences Pvt., Ltd. India
Wockhardt limited India
WuXi AppTec (STA Pharmaceutical Co., Ltd.) China
Xellia Pharmaceuticals Denmark
Yabao Pharmaceutical Group Co., Ltd. China
Yangtze River Pharmaceutical Group China
Yung Zip Chemical Industrial Co., Ltd. Taiwan
Zambon group (Zach) Italy
Zcl Chemicals Ltd. India
Zhejiang Hisun Pharmaceutical Co., Ltd. China
Zhejiang Huahai Pharmaceutical Co., Ltd. China

–Forecast to 2025
1 EXECUTIVE SUMMARY
Active pharmaceutical ingredient (API) is any substance or combination of substances used

in a finished pharmaceutical product (FPP), with pharmacological activity and has direct
effect in the cure, mitigation, treatment of the disease, or to have direct effect in restoring,
correcting or modifying physiological functions in human beings. API manufacturing involves
conversion of raw materials like fine chemicals and intermediates into active ingredient,
which will be used for formulating drug product.
According to IQ4I analysis, Active pharmaceutical ingredients global market is expected to

grow at a CAGR of 7.7% to reach $307.2 billion by 2025. Adoption of biologics in disease
management and increasing regulatory approvals in the last few years, increasing scope of
HPAPI market, patent expiration of major drugs, increasing trend of outsourcing and
increase in geriatric population are some of the factors driving the market growth. Whereas
contamination of API, fierce competition between API players, high cost for the
manufacturing of APIs, requirement of highly skilled technicians, stringent regulatory policies
and rising environmental concerns are the factors that are hindering API market growth.
The global API market is segmented based on synthesis, business type, therapeutic
applications and geography. Depending on synthesis the market is classified into synthetic
API, biotech API and HPAPI (High Potent Active Pharmaceutical Ingredient). Synthetic API
holds the maximum share in 2018 and expected to grow at a high single digit CAGR from
2018 to 2025. The major factors driving the synthetic chemical API market are patent
expiration of synthetic drugs (small molecule drugs), increasing number of small molecules
in clinical trials, increasing outsourcing by the pharmaceutical companies, CMOs invest to
expand manufacturing facilities, rise in incidence of chronic and age-related diseases, rapid
growth in oncology market, technological advancement like cryogenic and continuous flow
manufacturing. Biotech API holds the second largest share in 2018 and expected to grow at
a high single digit CAGR from 2018 to 2025. Biotech API is further segmented into
monoclonal antibodies, recombinant proteins, vaccines and others. Monoclonal antibodies
accounted for the largest share in 2018, growing at double digit CAGR from 2018 to 2025.
Increased investment in R&D by pharmaceutical companies for developing biologic drugs,
adoption of biological therapies in disease management, increasing outsourcing are few
factors driving the biotech API market. HPAPI segment is expected to grow at a high single
digit CAGR from 2018 to 2025. Rapid growth in oncology market, low toxicity and lower side
effects, technological advancements in HPAPI, increasing outsourcing, increasing incidence
of chronic and age related diseases are few factors driving the HPAPI market growth.

–Forecast to 2025
API market based on business type is segmented into captive and merchant. Captive market
accounted for the largest revenue in 2018 and is expected to grow at a mid single digit
CAGR from 2018 to 2025. Merchant market is expected to grow at a high single digit CAGR
from 2018 to 2025, due to increasing outsourcing, advanced manufacturing facilities, lack of
in-house manufacturing capability, high capital investment and cost of API manufacturing.
Among applications, oncology market accounted for the largest share in 2018 and is
expected to grow at a high single digit CAGR from 2018 to 2025. Infectious diseases
segment is the second largest segment and expected to grow at a high single digit CAGR
from 2018 to 2025. Patent expiration of major drugs, increased generic drug sales, high
uptake of biologics, increase in chronic and infectious diseases are the factors driving API
application market whereas stringent regulations are hindering the market growth.
According to IQ4I analysis, during 2017-2018 majority of the ANDA approvals received by
generic API manufacturers were focused on therapeutic areas like infectious diseases,
musculoskeletal disorder, cardiovascular disorders, endocrinology and oncology. Some of
the high demand API based on ANDA approvals are Efavirenz (Atripla), Epinephrine
(Epipen) for infectious diseases, Dexmedetomidine (Brecedex), Azelaic acid (Finacea) for
musculoskeletal disorder, Dorzolamide (Cosopt), Buprenorphine (Suboxone) for
cardiovascular disorders, Abiraterone (Zytiga), Arsenic trioxide (Trisenox ) for oncology.
Similarly, our analysis of patent expiration data indicates that during 2019-2021 some of the
key drugs going off patent are Pramlintide, Erlotinib, Rivastigmine, Ipratropium,
Dexlansoprazole, Axitinib, Asenapine, Dasatinib, Nebivolol, Indinavir, Hydrocodone,
Fluticasone furoate, Rivaroxaban and others, which creates opportunity for generic API
manufacturers.
Geographically, API market is segmented into North America, Europe, Asia-Pacific and Rest
of the world regions. North American region dominated the global API market and is
expected to grow at a high single digit CAGR from 2018 to 2025. Patent expiration of the
major drugs, rising demand for biotech APIs from government and private companies,
market entry of biosimilars, increasing scope of high potent drugs and increase in the
prevalence of chronic diseases such as cancer, musculoskeletal disorder, cardiac disease
are some of the major factors that are driving the market growth. Asia pacific market is
expected to grow at a double digit CAGR from 2018 to 2025. Low labor cost, abundance
availability of raw materials, infrastructure facility, rise in generic drugs demand, increased
production capabilities, the presence of large number of domestic and international players,
and concentration of CMO companies are some of the factors that are driving the market
growth.

–Forecast to 2025
In 2018, FDA approved 59 drugs, of that 42 were small molecules and 17 were biologics
which accounts to about 28.8% of total approvals which has risen from 26.1% from the year
2017. Few biologic drugs approved in 2018 are Trogarzo, Ilumya, Crysvita, Aimovig,
Poteligeo, Emgality, Libtayo and Takyzyro. Due to increased demand for biotech API
manufacturers are expanding their manufacturing capacity in order to maintain their
leadership. For instance, in April 2018, Lonza opened the world’s largest dedicated cell and
gene therapy manufacturing facility in Pearland, Greater Houston, TX (USA), with 300,000
square feet area. In the last few years, though there is an increase in the growth of biologics
market, small molecules continue to dominate the global therapeutics market. Many small
molecules are going off-patent, paving way for generics into the market through ANDA
approval. In 2018, 23 new drugs received ANDA approval, creating a favorable opportunity
for API manufacturers.
The global small molecules manufacturing installed capacity is estimated to be xx million

Litres in 2018. Total small molecule utilization volume is xx million litres at x.x% capacity
utilization rate and is expected to grow at a CAGR of x.x% from 2018 to 2025 to reach xx
million litres volume by 2025, at x.x% capacity utilization rate. The global biologics
manufacturing installed capacity is estimated to be xx million Litres in the year 2018 at x.x%
capacity utilization and is expected to grow at a CAGR of x.x% from 2018 to 2025 to reach
xx million litres volume by 2025, at x.x% capacity utilization rate. The global API production
in 2018 was estimated to be xx Metric tons of which small molecules API production is xx
Metric tons and biologics API production is xx Metric tons.
Even though, the Active pharmaceutical ingredients global market witnessed some of the
strategic acquisition and mergers by API manufactures to expand their respective service
portfolios, the market remained fragmented with the major players in the sector occupying
minimum market share and the remaining player’s occupied major share in this market.
Some of the contract API manufacturing organizations (CMOs) are transforming into
Contract development and manufacturing organization (CDMO) by offering end to end
services, ranging from development activities including clinical trials to commercial scale
production and regulatory filings.
Major players in the API market include AMRI (U.S.), Aurobindo pharma (India), Boehringer
Ingelheim GmbH (Germany), Cambrex Corporation (U.S.), Divis Laboratories (India), Olon
S.p.A (Italy), Lonza group (Switzerland), Pfizer Inc. (U.S.), Sanofi SA (France), Seigfried
Holdings AG (Switzerland), Thermo Fisher Scientific (Patheon N.V.) (U.S.) and Teva
Pharmaceutical Industries Limited (Israel).

–Forecast to 2025
FIGURE 1
ACTIVE PHARMACEUTICAL INGREDIENTS GLOBAL MARKET SCENARIO,

BY REGION (2017-2025) CAGR (%)
North America: x.x% Europe: x.x%

Synthetic API: x.x% Synthetic API: 60.8%
Biotech API: 30.3% Biotech API: x.x%
HPAPI: x.x% HPAPI: x.x%
Asia Pacific: x.x%

Synthetic API: 76.7%
Biotech API: x.x%
HPAPI: x.x%
ROW: x.x%
Synthetic API: x.x%
Biotech API: x.x%
HPAPI: x.x%
FIGURE 2
API GLOBAL MARKET SHARE, BY SYNTHESIS (2018 V/S 2025) (%)
2018 2025
25.4%
Synthetic API Biotech API HPAPI

–Forecast to 2025
FIGURE 3
BIOTECH API GLOBAL MARKET SHARE, BY PRODUCT TYPE,

(2018 V/S 2025) (%)
2018 2025
14.0%
Monoclonal antibodies Recombinant proteins Vaccines Others
FIGURE 4
API GLOBAL MARKET SHARE, BY APPLICATION (2018 V/S 2025) (%)
2018 2025
Oncology Infectious diseases Central nervous system

Cardiovascular disorders Musculoskeletal disorders Metabolic disorders
Pulmonary disorders Gastrointestinal disorders Endocrine disorders
Others Genitourinary disorders

–Forecast to 2025
FIGURE 5
NORTH AMERICA API MARKET SHARE, BY SYNTHESIS AND BIOTECH API

MARKET, BY TYPE (2018 V/S 2025) (%)
API By Synthesis
60.0%
Market share (%)
40.0%
10.5%
20.0%
0.0%
Synthetic API Biotech API HPAPI
2018 2025
Biotech API By Type

60.0%
Market share (%)
40.0%
20.0%
0.0%
Monoclonal Recombinant Vaccines Others
antibodies Proteins
FIGURE 6
ITALY API MARKET REVENUE, BY APPLICATION (2018) ($MN),

CAGR (%)
10.0
Oncology
9.0
8.0
MSD
7.0 CNS
Metabolic
disorder, 863.2
% CAGR (2015-2018)
6.0
5.0
4.0 Endocrine Infectious

Pulmonary CVD
disease
3.0 Others
GID,
538.5
2.0
Genitourinary
1.0
0.0
- 500.0 1,000.0 1,500.0 2,000.0 2,500.0
Market size 2018 ($Mn)

–Forecast to 2025
FIGURE 7
SMALL MOLECULE API PRODUCTION BY APPLICATION (2018),

IN-HOUSE V/S CMO (2017 – 2025) (TONS) AND GLOBAL
MANUFACTURING CAPACITIES (2018) (LITRES)
Total Small Molecule

1,20,000.0
Manufacturing Volume:
xx Mn Lts
API production (Tons)
90,000.0
Total Small Molecule
60,000.0
CMO Volume: xx Mn lts
30,000.0
-
Small Molecule CMO
Utilized Volume:
xx Mn lts
6,00,000
5,00,000
API production (Tons)
4,00,000 The total small molecule

manufacturing volume is
3,00,000
estimated to be xx million
2,00,000 litres and CMO manufacturing
volume is estimated to be xx
1,00,000
million litres or x.x%. The
- current CMO utilization
2017 2018 2019 2020 2021 2022 2023 2024 2025 volume is xx million litres or
CMO In-house x.x%.
FIGURE 8
GLOBAL TOTAL API AND CMO PRODUCTION

(2017 – 2025) (METRIC TONS)
Total Small Molecule API Production (MT) Small Molecule CMO API Production (MT)
6,00,000 3,00,000
5,00,000 2,50,000
Metric Tons
Metric Tons
4,00,000 2,00,000
3,00,000 1,50,000
2,00,000 1,00,000
1,00,000 50,000
0 0
2017 2018 2019 2025 2017 2018 2019 2025
Total Biologics API Production (MT) Biologics CMO API Production (MT)
1400 500
1200
400
1000
Metric Tons
Metric Tons
800 300
600 200
400
100
200
0 0
2017 2018 2019 2025 2017 2018 2019 2025

–Forecast to 2025
FIGURE 9
API GLOBAL MARKET SHARE, BY GEOGRAPHY (2018) (%)
14.0
12.0 China, 13.7%

France
Brazil
10.0
ME & Others U.S.
Germany
% CAGR (2018-2025)
8.0 Rest of
Japan
APAC
India
6.0 Rest of EU, 11.8%
Rest of Italy
4.0
LATAM
Rest of NA
2.0
0.0
0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 35.0% 40.0% 45.0%
% Market Share (2018)

–Forecast to 2025
2 MARKET OVERVIEW
2.1 DRIVERS AND OPPORTUNITIES
2.1.1 ADOPTION OF BIOLOGICS IN DISEASE

MANAGEMENT AND INCREASING REGULATORY
APPROVALS IN THE PAS T YEAR
Biologic drugs continue to gain traction in the pharmaceutical industry mainly due to their
efficacy in treating certain diseases which are otherwise difficult to manage through
conventional therapies. Diseases such as Crohn’s disease, rheumatoid arthritis and cancer
which do not attain remission through conventional treatments have been treated effectively
by biologic drugs. Biologics are typically given either subcutaneously (with a needle through
the skin) or intravenously (through an IV tube).
Crohn’s disease causes inflammation, swelling, and irritation in the lining of the digestive
tract which can lead to surgery if not treated precisely. Doctors often prescribe biologics to
patients with refractory Crohn’s disease or moderate to severe symptoms that do not
respond to conventional medication. Humira (adalimumab), Cimzia (certolizumab pegol) and
Remicade (infliximab) are some of the anti-TNF drugs and Tysabri (natalizumab) and
Entyvio (vedolizumab) are anti-integrin antibodies which have been largely used in Crohn’s
disease management. Abatacept is an FDA approved biologic drug useful in treating
rheumatoid arthritis.
In 2018, FDA approved 59 drugs, of that 42 were small molecules and 17 were biologics
which accounts to about 28.8% of the total approvals, which has risen from 26.1% from the
year 2017. Few biologic drugs approved in 2018 include Trogarzo, Ilumya, Crysvita,
Aimovig, Poteligeo, Emgality, Libtayo and Takyzyro which are monoclonal antibodies. Other
biologics approved includes gene therapy, recombinant protein and an Enzyme. Approvals
are an indication of global acceptance of biologics and have helped biopharma companies to
focus more on biologic drugs and further increase outsourcing services to CMOs, CDMOs
and CROs. Also, there are few drugs which are specific for the treatment of some
neurological diseases such as hereditary transthyretin-mediated amyloidosis in adults that
can be treated with antisense nucleotide. Other conditions for which approvals were granted
include HIV, plaque psoriasis and migraine to name a few.

–Forecast to 2025
3 INTRODUCTION
3.1 RESEARCH METHODOLOGY
The research on active pharmaceutical ingredient market involved both secondary and
primary research. The secondary research was carried out on company websites, annual
reports, SEC filings, articles, press releases, journals and paid sources to identify and collect
both the qualitative and quantitative data related to active pharmaceutical ingredient. The
primary sources were experts from supply side such as CEOs, directors,
international/regional marketing managers and marketing executives. All the primary sources
were interviewed to acquire and verify critical qualitative and quantitative information and
also to assess the future forecast of the all segments of the active pharmaceutical ingredient
market. Along with these the additional information extracted was about the key players in
this industry with their market revenues, products and developments. The factors
responsible for growth and restriction of the active pharmaceutical ingredient market along
with the future opportunities were also determined through secondary research and verified
through primary sources.
The following illustrative figure shows the market research methodology applied in making
this report on the global active pharmaceutical ingredient market.
3.1.1 MARKET SIZE ESTIMATI ON
The global active pharmaceutical ingredient market, its segments and sub-segments were
estimated and validated through secondary and primary research. The active
pharmaceutical ingredient market shares splits, and breakdowns were determined using
secondary sources and verified through primary sources to get the final quantitative and
qualitative data. This data is consolidated and added with detailed inputs and analysis from
IQ4I and presented in this report.

–Forecast to 2025
FIGURE 10
ACTIVE PHARMACEUTICAL INGREDIENT GLOBAL MARKET:

TOP-DOWN AND BOTTOM-UP APPROACH
Global pharmaceutical market
Global active pharmaceutical

ingredient (API) market
Overall
Market Size
Market Share of synthesis, business types and CAGR
and application
Regional Market Shares

Market share of Synthetic API
Market Share of Sub and Biotech API is considered
Segments in Regional
Markets
Sub Segments
Market Size Pharmaceutical API production volume in tons
and (A) (therapeutic application market/average
CAGR selling price ($/kg))
Pharmaceutical Manufacturing Capacity (B) =
((A)/Average volume per Litre)
The top-down approach was used to derive the API global market by considering first the
Pharmaceutical market, thereby deriving the market share of API. The market was further
classified based on synthesis, customer base, business type, application, and region.
Different percentage splits were applied for different segments of the API market. Market
shares and geographical splits differ in each of the disciplines. The bottom-up approach
included the total API production volume in tons and average selling price ($/kg) of individual
application market. The combined synthetic API, biotech API and HPAPI manufacturing
revenue is equal to overall API market.

–Forecast to 2025
FIGURE 11
ACTIVE PHARMACEUTICAL INGREDIENT GLOBAL MARKET

SEGMENTATION
API Global Market
Synthesis type Business type Application Region
Synthetic API Biotech API HPAPI Captive API Infectious disease NA EU APAC RoW
Synthetic API by HPAPI by
By product type Branded
customer base Customer base Oncology
Captive U.S. Italy China Brazil
Monoclonal
Branded API Branded API Generic
antibodies CVD Rest of
Captive Others Germany Japan
Recombinant LATAM
Generic API Generic API
proteins Middle East
Merchant API CNS
France India and Others
Vaccines
Branded Pulmonary
Merchant disorder Others Others
Others Generic
GI disorder
Merchant
Biotech API by
customer base Endocrine
disorder
Biologics
Metabolic
disorder
Biosimilar
Genitourinary
disorder
MSD
Others

–Forecast to 2025
4 COMPANY PROFILES
4.1 LONZA GROUP LTD
4.1.1 OVERVIEW
6,000.0 5,668.8 170.0

5,186.5
Lonza Group Ltd. 165.0
R&D Expenses ($Mn)

5,000.0
4,195.4
Revenue ($Mn)
160.0
4,000.0 163.7
Founded: 1897 159.5 155.0
3,000.0
Headquarters: Switzerland 150.0
2,000.0
No. of employees: 15,275 145.0
146.2
Revenue: $5,668.8 Mn 1,000.0 140.0
R&D Expenses: $163.7 Mn - 135.0
2016 2017 2018
Total revenue R&D Expenses
Revenue by Segment ($Mn) Revenue by Geography ($Mn)

79.8 10.2 5.1
83.9
2,481.5 763.1
3,191.4 2,667.7
2,059.0
N & Cent America Europe Asia

Pharma and Biotech Specialty Ingredients
LATAM & Europe ANZ South Africa
Other Countries

–Forecast to 2025
4.1.2 ASSUMPTIONS
Market Assumptions
The global API market revenue is estimated

to be X% to X% of the Pharmaceutical global
Market revenue
market. The value is cross validated through
bottom-up approach as well.
The CAGR for the forecast period (2018 -

2025) is assumed to be normalized and the
Market growth effect of inflation, recession, economic
downturn, regulatory or policy changes, or
other factors are not considered.
The % split for the Synthetic API/ Biotech

Synthetic API/ Biotech API/ HPAPI market API/HPAPI market by therapeutic
by therapeutic applications applications was considered based on its
revenue contribution of overall API market.
The market shares are analysed purely

based on the absolute data, in case of the
Segmental & Sub segmental market shares data non availability for the sub markets the
parent market trend has been assumed for
the forecasted period.
Market share analysis of key players is

performed in two ways that is based on the
primary research rankings (Market
Market Share
penetration of players) and the other method
is based on the estimated API revenues of
key players.

–Forecast to 2025
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LIST OF COMPANIES MENTIONED IN REPORT

Company Head Quarters

Aarti Drugs Ltd India

Aash biotech Pvt Ltd. India

ABC international pharma srl. Italy

ACIC Pharmaceutical Inc. Canada

Adimmune corporation Taiwan

Aesica Pharmaceuticals U.K.

AGC group Japan

AGC biologics U.S.

Ajantha Pharma India

Ajinomoto Bio-Pharma Services U.S.

Albany Molecular Research Inc (AMRI) U.S.

Albemarle Corporation U.S.

Alcami Corporation U.S.

Alembic Ltd. India

Alkem Laboratories Ltd. India

Alkermes Plc Ireland

IQ4I Research & Consultancy Pvt. Ltd. Page 22

Company Head Quarters

Allergan Plc Ireland

Almac group U.K.

Almelo Private Limited India

Alpic remedies India

Alven Laboratories Czech Republic

Ambio Pharma Inc. U.S.

Amega Biotech Argentina

Amneal Pharmaceuticals LLC U.S.

Amoytop Biotech China

Ampac fine chemicals U.S.

Angelini Acraf S.p.A. Italy

APICORE US LLC U.S.

Apotex Fermentation Inc Canada

AqVida GmbH Germany

Arena pharmaceuticals U.S.

Arene Lifesciences Limited India

Arevipharma GmbH Germany

Ariston Pharma Novatech Pvt., Ltd. India

Aspire Lifesciences Pvt., Ltd. India

AstraZeneca Plc. U.K.

Aurobindo Pharma Ltd. India

Avra Laboratories Pvt., Ltd. India