Active Pharmaceutical Ingredients (API) Market:
Executive Summary
Active Pharmaceutical Ingredients (APIs) are active substances in a drug intended to achieve pharmacological activity which is having direct effect on diagnosis or treatment of disease. APIs are synthesized by chemical synthesis, fermentation, biotechnological methods or enhanced from natural source. API market is mainly driven by the factors such as patent expiration of blockbuster drugs, increased generic medicine sales and high uptake of biologics. High Potential Active Pharmaceutical Ingredients (HPAPI) is booming in API market globally as these compounds are very effective in treatment of diseases such as cancer, respiratory disorders and hormonal imbalances and HPAPI growth is mainly driven by its therapeutic applications in oncology.
As estimated by IQ4I Research the global Active Pharmaceutical Ingredient market is valued to be $XX billion in 2015 and poised to grow at a CAGR of X% to reach $258.5 billion by 2022. API market is segmented by synthesis including synthetic chemicals, HPAPI and biotech API. In synthesis API market, synthetic chemicals holds major share of XX% and biotech API is fastest growing segment at a CAGR of XX%. Biotech API is further segmented into monoclonal antibodies, recombinant proteins, vaccines and others. Recombinant proteins accounted for highest share of XX% in 2015 and monoclonal antibodies is fastest growing segment at X% CAGR. By customer base it is segmented into synthetic chemicals, biotech API and HPAPI, synthetic chemicals are further segmented as branded/innovative and generic/non branded. Biotech API is segmented as biologics/innovative and biosimilars/non branded. By business type, captive market holds major share with XX% and merchant market is fastest growing segment with a CAGR of XX% from 2015 to 2022. By therapeutic applications, it is segmented into anti-infectives, oncology, cardiovascular and hematopoietic system, central nervous system, respiratory system, gastrointestinal, hormonal related disorders, metabolic disorders, genito-urinary disorders, musculo-skeletal disorders and others. In application segment, anti-infectives holds major share of XX% and oncology is fastest growing segment at a CAGR of X%. Geography segment is divided into North America, Europe, Asia-Pacific, rest of the world (ROW) where North America holds largest share of XX% and Asia-Pacific is fastest growing region with a CAGR of X% from 2015 to 2022.
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In addition, capacity utilization rate and number of manufacturing units by landscape are identified. North America holds largest share in API market due to patent expiry of drugs, aging population, rising demand for anti-cancer drugs, established R&D infrastructure for novel drug development and increased generic medicine sales. Asia-Pacific (APAC) holds second major share and is fastest growing market followed by Europe and Rest of the world. Emerging countries such as China, India and Italy are major contributors due to low labor and manufacturing costs, government emphasis on healthcare reforms.
Factors such as government initiations for biomedical research, rising cancer prevalence across the world, increasing regional penetration, rising population with life style and aged related disorders, increasing mergers and acquisitions and expansion of local manufacturers are providing growth opportunities for API market whereas stringent regulatory affairs, financial crisis, less investors for API manufacturing ingredients and high market fragmentation are hampering API market growth.
The Active Pharmaceutical Ingredient global market is a highly competitive market hence all the existing players in this market are involved in developing new and advanced therapeutics to maintain their market shares. Some of the key players contributing at global level for Active Pharmaceutical Ingredient (API) market growth are Albemarle Corporation (U.S.), Aurobindo Pharma Limited (India), Boehringer Ingelheim GmbH (Germany), Fresenius Kabi (Germany), Lupin Pharmaceuticals Inc (India), Teva Pharmaceutical Industries LTD (Israel), Lonza Group (Switzerland), Novartis AG (Switzerland), Sun Pharmaceutical Industries LTD (India) and Dr. Reddy’s Laboratories (India).
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Table of content:
1 EXECUTIVE SUMMARY 25
2 INTRODUCTION 29
2.1 KEY TAKE AWAYS 29
2.2 REPORT DESCRIPTION 29
2.3 MARKETS COVERED 31
2.4 STAKEHOLDERS 33
2.5 RESEARCH METHODOLOGY 33
2.5.1 MARKET SIZE ESTIMATION 34
2.5.2 MARKET CRACK DOWN & DATA TRIANGULATION 37
2.5.3 SECONDARY SOURCES 38
2.5.4 KEY DATA POINTS FROM SECONDARY RESOURCES 39
2.5.5 PRIMARY SOURCES 40
2.5.6 KEY DATA POINT FROM PRIMARY SOURCES 40
2.5.7 ASSUMPTIONS 40
3 MARKET ANALYSIS 42
3.1 INTRODUCTION 42
3.2 MARKET SEGMENTATION 43
3.3 FACTORS INFLUENCING MARKET 45
3.3.1 DRIVERS AND OPPORTUNITIES 46
3.3.1.1 Patent expiration of major drugs enhanced generics sales 46
3.3.1.2 Government initiation on biomedical research 47
3.3.1.3 Increasing scope of HPAPI market 47
3.3.1.4 High uptake of biologics across diverse therapeutic areas 48
3.3.1.5 Increasing regional penetration and aged population 49
3.3.1.6 Increasing mergers and acquisitions 50
3.3.1.7 Expansion of local API manufacturers 50
3.3.1.8 Global API outsourcing 51
3.3.2 RESTRAINTS AND THREATS 52
3.3.2.1 Delay in approval of new drugs 52
3.3.2.2 Low investment in API market due to economic downturn 53
3.3.2.3 High production cost for manufacturing APIs 54
3.3.2.4 Fierce competition between API players 54
3.3.2.5 Stringent regulatory policies 55
3.3.2.6 Global Financial crisis 56
3.3.2.7 High market fragmentation and genericization of branded drugs 56
3.3.3 BURNING ISSUES 57
3.3.3.1 Contamination in formulation and bulk drugs 57
3.3.3.2 Inflate drug prices 58
3.3.4 WINNING IMPERATIVE 58
3.3.4.1 Low cost labor market 58
3.3.5 Market trends 59
3.4 REGULATORY AFFAIRS 60
3.4.1 U.S. 60
3.4.2 EUROPE 61
3.4.3 ASIA PACIFIC 62
3.4.4 REST OF THE WORLD 63
3.5 PORTER’S FIVE FORCE ANALYSIS 64
3.5.1 THREAT OF NEW ENTRANTS 65
3.5.2 THREAT OF SUBSTITUTES 65
3.5.3 RIVALRY AMONG EXISTING COMPETITORS 65
3.5.4 BARGAINING POWER OF BUYERS 66
3.5.5 BARGAINING POWER OF SUPPLIERS 66
3.6 SUPPLY CHAIN ANALYSIS 67
3.7 CAPACITY UTILIZATION 70
3.8 API MANUFACTURING UNITS 72
3.9 SELECTED TOP SELLING API 73
3.10 MARKET SHARE ANALYSIS 81
4 GLOBAL API MARKET OVERVIEW 83
4.1 BY SYNTHESIS 83
4.1.1 SYNTHETIC CHEMICALS API 86
4.1.2 BIOTECH API 88
4.1.2.1 Introduction 88
4.1.2.2 Monoclonal antibodies 91
4.1.2.3 Recombinant proteins 94
4.1.2.4 Vaccines 96
4.1.2.5 Others 99
4.1.3 HPAPI 100
4.2 BY CUSTOMER BASE 103
4.2.1 SYNTHETIC CHEMICALS 104
4.2.1.1 Branded/Innovative Synthetic chemicals 105
4.2.1.2 Generic/Non- Branded Synthetic chemicals 106
4.2.2 BIOTECH API 108
4.2.2.1 Biologics 109
4.2.2.2 Biosimilars 111
4.2.3 HPAPI 114
4.3 BY BUSINESS TYPE 117
4.3.1 CAPTIVE 119
4.3.2 MERCHANT 120
5 GLOBAL API MARKET, BY THERAPEUTIC APPLICATION 123
5.1 INTRODUCTION 123
5.2 ANTI-INFECTIVES 128
5.3 ONCOLOGY 135
5.4 CARDIOVASCULAR AND HEMATOPOIETIC SYSTEM 139
5.5 CENTRAL NERVOUS SYSTEM 145
5.6 RESPIRATORY SYSTEM 149
5.7 GASTROINTESTINAL 155
5.8 HORMONE-RELATED DISORDERS 160
5.9 METABOLIC DISORDERS 164
5.9.1 DIABETES 165
5.9.2 OBESITY 166
5.10 GENITOURINARY DISORDERS 171
5.11 MUSCULOSKELETAL DISORDERS 176
5.12 OTHERS 181
5.12.1 ANESTHESIA 181
5.12.2 EYE 181
5.12.3 ENT (EAR NOSE THROAT) DISORDERS 182
6 REGIONAL MARKET ANALYSIS 187
6.1 INTRODUCTION 187
6.2 NORTH AMERICA 190
6.3 EUROPE 201
6.4 ASIA PACIFIC 213
6.5 REST OF THE WORLD 228
7 COMPANY DEVELOPMENTS 239
7.1 INTRODUCTION 239
7.2 APPROVAL 240
7.3 AGREEMENTS, PARTNERSHIPS, COLLABORATIONS & JOINT VENTURES 249
7.4 NEW PRODUCT LAUNCH 254
7.5 MERGERS AND ACQUISITIONS 257
7.6 OTHER DEVELOPMENTS 261
8 MAJOR PLAYER PROFILES 262
8.1 ALBEMARLE CORPORATION 262
8.2 AUROBINDO PHARMA LIMITED 270
8.3 BOEHRINGER INGELHEIM GMBH 285
8.4 DR. REDDY’S LABORATORIES LIMITED 296
8.5 FRESENIUS KABI 310
8.6 LONZA GROUP LTD 318
8.7 LUPIN LIMITED 328
8.8 NOVARTIS INTERNATIONAL AG 338
8.9 SUN PHARMACEUTICALS INDUSTRIES LTD 349
8.10 TEVA ACTIVE PHARMACEUTICAL INGREDIENTS 360
Continuous…
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