$300+ Billion Active Pharmaceutical Ingredient (API) Market by 2025 - Increasing Scope of the HPAPI Market Augments Demand

DUBLIN, May 9, 2019 /PRNewswire/ -- The "Active Pharmaceutical Ingredients (API) Global Market - Forecast to 2025" report has been added to ResearchAndMarkets.com's offering.

According to analysis, the global Active Pharmaceutical Ingredient market is expected to grow at a high CAGR to reach $307.2 billion by 2025.

Adoption of biologics in disease management and increasing regulatory approvals in the past year, 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. The global API market is mainly segmented by synthesis, by business type, by application and by geography.

API market based on synthesis is further divided into synthetic API, Biotech API, and HPAPI. Synthetic API holds a major share in 2018 and is expected to grow at a mid-single digit CAGR from 2018 to 2025. The major factors driving the synthetic chemical API market are patent expiration of synthetic (small molecule drugs), increasing number of small molecules in clinical trials, increasing outsourcing by the pharmaceutical companies, CMOs investments 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.

Based on the customer, the synthetic API is further divided into branded API and generic API. Branded API accounted for the largest share in 2018 and is expected to grow at a mid-single digit CAGR from 2018 to 2025. Generic API is expected to grow at a high single-digit CAGR from 2018 to 2025, due to Patent expiry of blockbuster drugs, rising healthcare expenses, increasing outsourcing and shift towards the generic medicines led by the government initiatives.

Biotech API is expected to grow at a high single-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, increasing biologics approvals in the past year, increasing chronic and autoimmune illnesses, increasing number of branded drugs going off-patent creating a scope for biosimilars, requirement of novel biologics therapeutics for rare diseases, increasing demand for antibody conjugates are few factors driving the biotech API market. Biotech API is further segmented into monoclonal antibodies, recombinant proteins, vaccines and others (stem cell therapy and gene therapy).

Monoclonal antibodies accounted for the highest share in 2018 and expected to grow at a double-digit CAGR from 2018 to 2025. Development of next-generation antibodies such as antibody-drug conjugates and rising venture capital investments and applications of monoclonal antibodies are the factors booming monoclonal antibodies market growth.

Based on the customer, biotech API is further divided into biologics and biosimilars. Biologics accounted for the largest share in 2018 and is expected to grow at a high single-digit CAGR from 2018 to 2025. Biologics market is driven globally due to the adoption of biological therapies in disease management, increasing biologics approvals in the past year, increasing chronic and autoimmune illnesses and increasing elderly population globally.

Biosimilars are expected to grow at a mid-double-digit CAGR from 2018 to 2025. Factors driving the biosimilar drug market are patent expiry of biological drugs, low cost compared to biologics health care expenditure, increase in chronic diseases, growing geriatric population, demand for quality healthcare.

HPAPI is expected to grow at a high single-digit CAGR from 2018 to 2025. Rapid growth in the oncology market, low toxicity and lower side effects, technological advancements in HPAPI, increasing outsourcing, increasing the incidence of chronic and age-related diseases are few factors driving the HPAPI market growth.

Based on customer, HPAPI is further divided into branded API and generic API. Branded API is accounted the largest share in 2018 and is expected to grow at a high single-digit CAGR from 2018 to 2025, increased development of targeted therapy APIs, increased investments in the manufacturing of branded HPAPI are the factors driving the market.

Generic API is expected to grow at a high single-digit CAGR from 2018 to 2025. Patent expiry of blockbuster drugs, rising healthcare expenses and shift towards the generic medicines led by the government initiatives are some of the factors driving the generic HPAPI market.

By business type, the global API market is divided into captive API and merchant API. Captive market holds major share in 2018 and is expected to grow at a mid-single digit CAGR from 2018 to 2025, captive API is further divided into branded captive API and generic captive API, branded captive API accounted for the largest share in 2018 and is expected to grow at a mid-single- digit CAGR from 2018 to 2025.

Merchant API market is the fastest growing segment with a high single-digit CAGR from 2018 to 2025. Novel drugs patent expiry, high cost of innovative drugs and complications in innovative drug manufacturing are some of the factors driving the growth of the Merchant API market. Merchant API market is further divided into branded merchant API and generic merchant API.

Generic merchant API accounted for the largest share in 2018 and is expected to grow at a double-digit CAGR from 2018 to 2025. Increasing outsourcing, advanced manufacturing facilities, lack of in-house manufacturing capability, high capital investment and cost of API manufacturing are the factors driving the Merchant API market.

By therapeutic applications, API market is segmented into infectious diseases, oncology, cardiovascular disorders, central nervous system, a pulmonary disorder, gastrointestinal disorder, endocrine disorders, metabolic disorders, genito-urinary disorders, musculoskeletal disorders and others. In the application segment, Oncology holds a major share in 2018 and expected to grow at a high single-digit CAGR from 2018 to 2025.

In synthetic API, infectious diseases accounted the largest share in 2018 and is expected to grow at a high single-digit CAGR from 2018 to 2025, oncology is expected to grow at a high single-digit CAGR from 2018 to 2025.

In biotech API, musculoskeletal disorders accounted the largest share in 2018 and the share is expected to grow at a high single-digit CAGR from 2018 to 2025, oncology is expected to grow at a double-digit CAGR from 2018 to 2025.

In HPAPI, oncology accounted for the largest share in 2018 and is expected to grow at a high single-digit CAGR from 2018 to 2025. Biotech API and HPAPI is driving the market growth at a faster pace due to rising targeted therapy demand in the last 15 years for the treatment of diseases, mainly in the oncology sector.

Active pharmaceutical Ingredients market by region is segmented as North America, Europe, Asia-Pacific and Rest of the world (ROW) where North America holds the largest share in 2018 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 the scope of highly potent drugs and increase in the prevalence of chronic diseases such as cancer, musculoskeletal disorder, cardiac disease are some of the major factors driving the North America API market.

Asia-Pacific region is expected to grow at a high single-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 a large number of domestic and international players, and concentration of CMO companies are some of the factors that are driving the market growth.

Some of the key players of Active Pharmaceutical Ingredient (API) market are Lonza Group (Switzerland), Boehringer Ingelheim GmbH (Germany), Teva Pharmaceutical Industries LTD (Israel), Sanofi (France), Patheon N.V (U.S), Aurobindo pharmaceuticals. (India), Seigfried Holdings A.G (Switzerland), Olon S.p.A (Italy), Pfizer Inc. (U.S.), GlaxoSmithKline plc. (U.K.), Cambrex Corporation (U.S.) and AMRI, (U.S.).

Key Topics Covered

1 Executive Summary

2 Introduction
2.1 Key Takeaways
2.2 Scope Of The Report
2.3 Report Description
2.4 Markets Covered
2.5 Stakeholders
2.6 Research Methodology

3 Market Analysis
3.1 Introduction
3.2 Market Segmentation
3.3 Factors Influencing Market
3.3.1 Drivers And Opportunities
3.3.1.1 Adoption Of Biologics In Disease Management And Increasing Regulatory Approvals In The Past Year
3.3.1.2 Increasing Scope Of HPAPI Market
3.3.1.3 Patent Expiration Of Major Drugs
3.3.1.4 Increasing Trend Of Outsourcing
3.3.1.5 Increase In Geriatric Population
3.3.2 Restraints And Threats
3.3.2.1 Contamination Of API
3.3.2.2 Fierce Competition Between API Players
3.3.2.3 High Cost For Manufacturing APIs
3.3.2.4 Requirement Of Highly Skilled Technicians
3.3.2.5 Stringent Regulatory Policies And Environmental Concerns
3.4 Regulatory Affairs
3.4.1 International Organization For Standardization
3.4.1.1 ISO 9001: 2015 Quality Management System
3.4.1.2 ISO 13408 Aseptic Processing
3.4.1.3 ISO 14644-1 Clean Room Standards
3.4.2 U.S.
3.4.3 Canada
3.4.4 Mexico
3.4.5 Europe
3.4.6 China
3.4.7 India
3.4.8 Japan
3.4.9 Australia
3.4.10 South Korea
3.4.11 Latin America
3.4.12 Middle East
3.5 Technological Advancements
3.5.1 Introduction
3.5.2 Automation And Control
3.5.3 Continuous Manufacturing
3.5.4 Cryogenic Technology
3.5.5 Single - Use System (SUS)
3.5.6 Mammalian Cell Based Production
3.6 Porter's Five Force Analysis
3.8 Market Share Analysis
3.9 API Manufacturing Units
3.10 Global Pharmaceutical API Production Volume
3.11 Patent Expiry And ANDA Approvals
3.12 Companies Acquisition, Merger And Expansions
3.13 Collaboration And Agreement Between API Manufacturers
3.14 Selected Top Selling API
3.15 API Manufacturers Revenue And Capabilities Table

4 API Global Market, By Synthesis
4.1 Introduction
4.2 Synthetic API
4.2.1 Synthetic API By Customer Base
4.2.1.1 Branded Synthetic API
4.2.1.2 Generic Synthetic API
4.3 Biotech API
4.3.1 Introduction
4.3.1.1 Monoclonal Antibodies
4.3.1.2 Recombinant Proteins
4.3.1.3 Vaccines
4.3.1.4 Others
4.3.2 Biotech API By Customer Base
4.3.2.1 Biologic API
4.3.2.2 Biosimilar API
4.4 HPAPI
4.4.1 HPAPI By Customer Base
4.4.1.1 Branded HPAPI
4.4.1.2 Generic HPAPI

5 API Global Market, By Business Type
5.1 Introduction
5.2 Captive API By Type
5.2.1 Branded Captive API
5.2.2 Generic Captive API
5.3 Merchant API By Type
5.3.1 Branded Merchant API
5.3.2 Generic Merchant API

6 API Global Market, By Application
6.1 Introduction
6.2 Infectious Diseases
6.3 Oncology
6.4 Cardiovascular Disorders
6.5 Central Nervous System
6.6 Pulmonary Disorders
6.7 Gastrointestinal Disorders
6.8 Endocrine Disorders
6.9 Metabolic Disorders
6.10 Genitourinary Disorders
6.11 Musculoskeletal Disorders
6.12 Other Applications

7 Regional Analysis
7.1 Introduction
7.2 North America
7.2.1 U.S.
7.2.2 Rest Of North America
7.3 Europe
7.3.1 Italy
7.3.2 Germany
7.3.3 France
7.3.4 Rest Of Europe
7.4 APAC
7.4.1 China
7.4.2 Japan
7.4.3 India
7.4.4 Rest Of APAC
7.5 RoW
7.5.1 Brazil
7.5.2 Rest Of LATAM
7.5.3 Middle East & Others

8 Competitive Landscape
8.1 Introduction
8.2 Expansions
8.3 Approvals
8.4 Acquisitions
8.5 Agreements And Collaboration
8.6 Others

9 Major Companies
9.1 Albany Molecular Research Inc.
9.1.1 Overview
9.1.2 Financials
9.1.3 Product Portfolio
9.1.4 Key Developments
9.1.5 Business Strategy
9.1.6 SWOT Analysis
9.2 Aurobindo Pharma Limited
9.3 Boehringer Ingelheim GmbH
9.4 Cambrex Corporation
9.5 Divis Laboratories
9.6 GlaxoSmithKline plc
9.7 Lonza Group Ltd.
9.8 Olon S.P.A.
9.9 Thermo Fisher Scientific (Patheon N.V.)
9.10 Pfizer Inc.
9.11 Sanofi
9.12 Siegfried Holding AG
9.13 Teva Pharmaceuticals Industries Limited

Companies Mentioned

• Aarti Drugs Ltd
• Aash Biotech Pvt Ltd.
• Abbvie
• ABC International Pharma Srl.
• ABClonal
• J.H Whitney Capital Partners LLC (Accupac, Inc.)
• Achaogen Inc.
• Acic Pharmaceutical Inc.
• Adimmune Corporation
• Aesica Pharmaceuticals
• AGc Group
• AGc Biologics
• Ajantha Pharma
• Ajinomoto Bio-Pharma Services
• Akorn
• Albany Molecular Research Inc (AMRI)
• Albemarle Corporation
• Alcami Corporation
• Alembic Ltd.
• Alfachemicals
• Alkem Laboratories Ltd.
• Alkermes Plc
• ALLChem
• Allergan Plc
• Almac Group
• Almelo Private Limited
• Alpic Remedies
• Alven Laboratories
• Ambio Pharma Inc.
• Amega Biotech
• Amgen
• Amneal Pharmaceuticals LLC
• Amoytop Biotech
• Ampac Fine Chemicals
• Angelini Acraf S.P.A.
• Apicore Us LLC
• Apotex Fermentation Inc
• Aqvida GmbH
• Arena Pharmaceuticals
• Arene Lifesciences Limited
• Arevipharma GmbH
• Ariston Pharma Novatech Pvt., Ltd.
• Aspire Lifesciences Pvt., Ltd.
• Astrazeneca Plc.
• Aurobindo Pharma Ltd.
• Avra Laboratories Pvt., Ltd.
• Azad Pharma AG
• Bachem Holding AG
• Bal Pharma Ltd.
• Basf
• Baxter International Inc.
• Bayer Pharma Chemicals
• Biocodex S.A.
• Biocon Ltd.
• Biogen
• Biomax Pharma
• Biomerin Pharmaceutical Inc.
• Biophore India Pharmaceuticals Pvt., Ltd.
• Biosortia Pharmaceuticals
• Biotechnica Pharma Global
• Biovian
• Blanver Farmoquimica
• Boehringer Ingelheim GmbH.
• Brammer Bio
• Brawn Laboratories Ltd.
• Bristol-Myers Squibb
• Cadila Pharmaceuticals Limited
• Cambrex Corporation
• Catalent
• Cayman Chemicals
• Celgene
• Celltrion Inc.
• Century Pharmaceuticals Ltd.
• Cerbios-Pharma Sa
• Cfm Group (Amsa S.P.A)
• Changzhou Pharmaceutical Factory
• Chemcon GmbH
• China Chemical & Pharmaceutical Co., Ltd.
• Chongqing Huapont Pharmaceutical Co., Ltd.
• Cipla Limited
• Ckd Bio
• Coba Pharma
• Corden Pharma
• Crystalia
• Csl Ltd
• Ctx Lifesciences
• Daiichi Sankyo Chemical Pharma Co Ltd.
• Daito Pharmaceutical Co., Ltd.
• Dalton Research Molecule
• Dcs Pharma AG
• Dishman Pharmaceuticals
• Divis Laboratories
• Dong Wha Pharm Ind Co Ltd.
• Dr.Reddy's Laboratories
• Eirgen Pharma
• Eisai
• Eli Lilly Pharmaceuticals
• Emcure Pharmaceuticals Ltd.
• Enaltec Labs Private Limited.
• Ercros
• Estechpharma Co., Ltd.
• Esteve Qumica
• Everest Organics Limited.
• Evonik Industries AG
• Fareva Group
• Farmabios
• Ferring Pharmaceuticals
• Fis Fabbrica Italiana Sintetici S.P.A.
• Flamma S.P.A.
• Florentis Pharmaceuticals Pvt., Ltd.
• Formosa Laboratories Inc.
• Fuji Chemical Industry Co., Ltd.
• GE Healthcare Bio-Sciences Ab
• Gentec Pharmaceutical Group S.A
• Gilead Sciences, Inc.
• Gland Pharma Limited.
• Glaxosmithkline Plc.
• Glenmark Generics Ltd.
• Gnosis S.P.A.
• Granules India Ltd.
• GVK Industries Limited (Gvk Bioscience)
• Haoyuan Chemexpress Co.Ltd.
• Harman Finochem Limited.
• Heni Chemical Industries
• Heraues Holding GmbH
• Hetero Labs Ltd.
• Hikma Pharmaceuticals
• Honour Lab Ltd.
• Hovione
• Huvapharma
• Hybio Pharmaceutical Co., Ltd.
• Ibio Inc
• Icrom S.P.A.
• Inabata Pharmasynthese
• Inalco Pharmaceuticals
• Indena
• Insight Biopharmaceutical
• Intas Pharmaceuticals Ltd.
• Interquim, S.A.
• Jeil Pharmaceutical Co. Ltd.
• Johnson And Johnson (Janssen Pharmaceutica Nv, Belgium)
• Jubilant Lifesciences (Jubilant Generics Ltd.)
• Katsura Chemical Co.,Ltd.
• Kern Pharma, S.L.
• Kleos Pharma
• Kongo Yakuhin Co., Ltd.
• Kosher Pharmaceuticals
• Krka Pharmaceuticals
• Kyowa Hakko Kirin
• Ofichem BV
• Lannett Co. Inc.
• Laurus Labs.
• Lebsa
• Lgm Pharma.
• Libbs
• Liptis Pharmaceuticals
• Lonza Group
• Lotus Pharmaceutical Co., Ltd.
• Lupin
• Lusochimica S.P.A
• Macleods Pharmaceutical Ltd.
• MAGle Chemoswed Ab
• Mallinckrodt Pharmaceuticals
• Medichem S.A
• Megafine Pharma Ltd
• Mehta Api
• Merck Group (Merck Kgaa)
• Metrochem Api
• Micro Labs Ltd.
• Minakem S.A.
• Moehs Iberica S.L.
• Molcan Corporation
• Morepen
• Msn Organics Pvt, Ltd.
• Mylan N.V
• Nanomedex Pharmaceuticals
• Natco Pharma Ltd.
• Neovacs Kinoid
• Neuland Laboratories Ltd.
• Neuraxpharm Arzneimittel (Inke)
• Nifty Labs Pvt Ltd.
• Norchim
• Novartis AG
• Novasep
• Novo Nordisk
• Novocap,
• Olainfarm Jsc.
• Olon S.P.A.
• Oncobiologics
• Optimus Drugs Private Ltd.
• Orchid Chemicals & Pharmaceuticals Ltd.
• Orion (Fermion)
• Paratek Pharmaceutical
• Pcas
• Pellets Pharma Limited
• Perrigo
• Pfizer
• Pfanstiehl
• Pharmispania
• Phyton Biotech LLC
• Pierre Fabre
• Piramal Enterprises Ltd.
• Polpharma Bb
• Prajna Generics Pvt. Ltd.
• Precise Group
• Probiogen AG
• Princeton Biomolecular Research, Inc.
• Rablon Healthcare Pvt Ltd.
• Raks Pharma Pvt Ltd.
• Recipharm Ab
• Regeneron
• Reine Lifescience
• Reliance Life Sciences Pvt., Ltd.
• Reva Pharma Pvt., Ltd.
• Roche
• Rochem International Inc.
• Rpg Life Sciences
• Rxn Chemicals Pvt. Ltd.
• Saamya Biotech
• Sajjala Bio Labs
• Sandoz International GmbH
• Saneca Pharmaceuticals
• Sanofi S.A.
• Scinopharm Taiwan Ltd.
• Servier
• Shenzhen Haorui Industrial Dev.
• Shilpa Medicare Limited
• Shiono Chemical Co., Ltd.
• Shire Pharmaceuticals
• Shouyuan Chemical
• Shreeji Pharma International
• Siegfried Holdinngs AG
• Sigma-Aldrich
• Sigmapharm Laboratories LLC.
• SM Biomed Sdn. Bhd
• Smilax Laboratories Limited
• Sms Pharmaceuticals Limited
• Solara A Pharma Sciences Ltd.
• Srini Pharmaceuticals Ltd.
• Standard Chemical & Pharmaceutical Co.
• Sterling Biotech Ltd.
• Strides Shasun Limited
• Sumitomo Dainippon Pharma Co., Ltd.
• Sun Pharmaceutical Industries Ltd.
• Suven Life Science Ltd.
• Suzhou Ryway Biotech
• Symbiotec Pharma Lab Pvt., Ltd
• Synergene Active Ingredients Pvt, Ltd.
• Syn-Tech Chem. And Pharma.Co., Ltd.
• Takeda Pharmaceutical Company Ltd.
• Taro Pharmaceutical Industries Ltd.
• Temad Co.
• Tetraphase Pharmaceuticals
• Teva Pharmaceuticals Industries Ltd.
• Therapeutic Md Inc.
• Theravance Biopharma
• Thermo Fisher Scientific Corporation
• Torrent Pharmaceuticals, Ltd.
• Trifecta Pharmaceuticals LLC
• Trimax Bio Sciences (P) Limited
• Umicore
• Unichem Laboratories Ltd.
• Union Quimico Farmaceutica, S.A.
• Unique Biotech Ltd.
• USV Ltd.
• Vaishali Pharma Ltd.
• Venus Remedies (Venus Pharma GmbH)
• Vertex Pharmeceuticals
• Viruj Pharma
• Vivimed Labs Ltd.
• Wanbury Ltd.
• Watson Pharma Private Ltd.
• Wavelength Pharmaceuticals
• Wellona Pharmaceuticals
• Welt Care Lifesciences Pvt., Ltd.
• Wockhardt Limited
• Wuxi Apptec (Sta Pharmaceutical Co., Ltd.)
• Xellia Pharmaceuticals
• Yabao Pharmaceutical Group Co., Ltd.
• Yangtze River Pharmaceutical Group
• Yung Zip Chemical Industrial Co., Ltd.
• Zambon Group (Zach)
• ZCL Chemicals Ltd.
• Zhejiang Hisun Pharmaceutical Co., Ltd.
• Zhejiang Huahai Pharmaceutical Co., Ltd.

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