Active Pharmaceutical Ingredients: Global Markets to 2022

  • ID: 4577292
  • Report
  • Region: Global
  • 164 Pages
  • BCC Research
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FEATURED COMPANIES

  • Aurobindo Pharma
  • BASF AG
  • Lonza
  • Mylan N.V.
  • MORE

This report (Active Pharmaceutical Ingredients: Global Markets to 2022) covers an overview of the pharmaceutical industry landscape and active pharmaceutical ingredients (API), along with the current trends and dynamics shaping the API market landscape. API sourcing trends and regulatory guidelines that impact the procurement of API are studied here. The increasing importance of API outsourced manufacturing activities and the impact on the pharmaceutical industry are covered in the report.

The API market is segmented into categories: molecular entity, manufacturer type, end use and region. The API market is segmented into two molecular entity groups: natural and synthetic API. Synthetic APIs are further segmented into chemical synthesis, biocatalytic and cell culture. Under the category of molecular entity, APIs are segmented into small molecules and large molecules. By sourcing type, the market is segmented into captive market, merchant market and contract manufacturing organization (CMO). In terms of end use, the market is segmented into clinical trial use and commercial use.

In terms of geography, this report analyzes the market by the following regions: North America, Europe, Asia-Pacific, Latin America and the Middle East. The API market is very fragmented. Therefore, attempts have been made to present the market share held by selected companies.

Report Includes

  • 38 data tables and 32 additional tables
  • Detailed overview of global market for active pharmaceutical ingredients (APIs) within the pharmaceutical industry
  • Country specific data and analysis for United States, Canada, Mexico, France, Germany, U.K., Italy, Spain, China, India, Japan, Brazil, South Africa, and UAE
  • Segmentation of the global market by molecular entity, manufacturer type, end use, and geographical region
  • Identification of factors such as challenges, trends and emerging opportunities that impact the future market dynamics
  • A look at the current regulatory updates, new developments, mergers and acquisitions and partnership activities, and patent expiry shaping the API market landscape
  • Examination of vendor landscape and detailed profiles of the major vendors in the global API market, including Teva Pharmaceutical Industries, Cambrex Corp., BASF, Dishman Group, Lonza, and Sun Pharma
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Note: Product cover images may vary from those shown
2 of 5

FEATURED COMPANIES

  • Aurobindo Pharma
  • BASF AG
  • Lonza
  • Mylan N.V.
  • MORE

Chapter 1 Introduction
Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Information Sources
Methodology
Geographic Breakdown
Analyst's Credentials

Chapter 2 Summary and Highlights
Highlights

Chapter 3 Active Pharmaceutical Ingredients-Introduction
Pharmaceutical Industry Overview
Patent Expiry and Its Impact on the Pharmaceutical Market
Changes in Pharmaceutical Drug Development
Drug Discovery and Development Process
Target Identification and Validation
Technologies for Drug Discovery
API-Definition
Sources of APIs
API Production Methods
API Production-Route of Synthesis
Production Methods
Regulatory Perspective on Production Methods
Active Pharmaceutical Ingredient Market
Market Dynamics
Market Drivers
Market Challenges
Emerging Trends
Current State of Active Pharmaceutical Ingredient Regulations
Harmonization of API GMP Standards and Supply Chain Integrity

Chapter 4 Active Pharmaceutical Ingredients Market by Manufacturer/ Service Provider
Introduction and Global Markets
The API Market by Manufacturer Type
Captive Market: Market Analysis
Overview
Market Size and Forecast
Merchant Market: Market Analysis
Overview
Market Size and Forecast
Contract Manufacturing Organizations (CMOs): Market Analysis
Overview
Market Size and Forecast

Chapter 5 API Market by End Use
Introduction and Global Markets
Clinical Trial: Market Analysis
Overview
Market Size and Forecast
Commercial: Market Analysis
Overview
Market Size and Forecast

Chapter 6 API by Origin
Introduction and Market Analysis
Natural Origin: Types and Market Analysis
Plants Sources
Animal Sources
Others
Market Size and Forecast
Synthetic APIs: Types and Market Analysis
Overview
Market Size and Forecast
Chemical Synthesis: Introduction and Market Analysis
Biocatalysis: Introduction and Market Analysis
Cell Culture Methods: Introduction and Market Analysis

Chapter 7 API Market by Molecule Type
Introduction and Global Markets
Small Molecules: Types and Market Analysis
Market Size and Forecast
Branded Small Molecule APIs
Generic APIs
Biologics: Types and Market Analysis
Top-Selling Biologics
Market Size and Forecast
Branded Biologic APIs
Biosimilar APIs

Chapter 8 API Market by Region
Introduction and Regional Market
North America
Overview
Market Size by Country
Europe
Overview
Market Size by Country
Asia-Pacific
Overview
Market Size by Country
Rest of the World
Overview

Chapter 9 Supplier Landscape and Key Industry Development
Supplier Landscape
Reasons for Fragmentation
List of Other Key API Manufacturers by Region
Porter’s Five Force Analysis
Threat of New Entrants
Threat of Substitute Products or Services
Bargaining Power of Customers (Buyers)
Bargaining Power of Suppliers
Intensity of Competitive Rivalry

Chapter 10 Company Profiles
TEVA PHARMACEUTICAL INDUSTRIES, INC
Business Overview
Operating Segments
Financial Operations
Business of APIs
Products and Services
Development and Strategies
CAMBREX CORP
Business Overview
Financial Information
Business of API
Products and Services
Development and Strategies
SIEGFRIED AG
Business Overview
Drug Substance Business Segment
Drugs Product Business
Financial Operations
Business of API
Products and Services
Development and Strategies
CORDENPHARMA INTERNATIONAL GMBH
Business of API
Products and Services
Development and Strategies
AUROBINDO PHARMA
Business Overview
Financial Operations
Products and Services
Development and Strategies
BASF AG
Business Overview
Financial Operations
Product and Services
Development and Strategies
DISHMAN GROUP
Business Overview
Financial Operations
Key Manufacturing Plants
Products and Services
Development and Strategies
MYLAN N.V.
Business Overview
Financial Operations
Products and Services
ALBANY MOLECULAR RESEARCH, INC. (AMRI)
Business Overview
Financial Operations
Business of API
Manufacturing Plants
Products and Services
Development and Strategies
HETERO
Business Overview
Products and Services
AVID BIOSERVICES, INC
Business Overview
Financial Operations
Services
HALO PHARMA
Business Overview
Services
Capabilities of Halo’s API Development and Manufacturing Services
LONZA
Business Overview
Financial Operations
Products and Services
SUN PHARMACEUTICAL INDUSTRIES, LTD
Business Overview
Financial Operations
Products and Services
DR REDDY’S LABORATORY
Business Overview
Financial Operations

Chapter 11 Appendix
Abbreviations

List of Tables
Summary Table : Global Market for API, by Manufacturer, Through 2022
Table 1 : Advantages and Disadvantages of Using Natural APIs
Table 2 : Advantages and Disadvantages of Using Synthetic APIs
Table 3 : Top Selling Brands and Their Patent Expiry, 2012-2017
Table 4 : API Manufacturers: Manufacturing Facility Expansion
Table 5 : Regulatory Requirements of GMP and Supply Chain Integrity for APIs
Table 6 : Global Market for APIs, by Manufacturer, Through 2022
Table 7 : Global Market for Captive APIs, by Region, Through 2022
Table 8 : Global Market for Merchant API, by Region Through 2022
Table 9 : Global Market for CMO API, by Region, Through 2022
Table 10 : Global Market for API, by End Use, Through 2022
Table 11 : Global Market for Clinical Trial API, by Region, Through 2022
Table 12 : Global Market for Commercial API, by Region, Through 2022
Table 13 : Global Market for API, by Origin, Through 2022
Table 14 : Global Market for Natural API, by Region, Through 2022
Table 15 : Global Market for Synthetic APIs, by Region, Through 2022
Table 16 : Global Market for Synthetic APIs, by Type, Through 2022
Table 17 : Advantages and Disadvantages of the Biocatalytic Process
Table 18 : Cell Culture Types: Attributes and Applications
Table 19 : Global Market for APIs, by Molecule Type through 2022
Table 20 : Characteristics of Small Molecules, by Parameters
Table 21 : Top Selling Small Molecule Drugs, 2015
Table 22 : Global Market for Small Molecule APIs, by Type Through 2022
Table 23 : Global Market for Branded Small Molecule APIs, by Region, Through 2022
Table 24 : Global Market for Generic Small Molecule APIs, by Region, Through 2022
Table 25 : Characteristics of Large Molecules/ Biologics, by Parameters
Table 26 : Top Selling Biologics, 2015
Table 27 : Global Market for Large Molecule APIs, by Region, Through 2022
Table 28 : Global Market for Large Molecule APIs, by Type, Through 2022
Table 29 : Global Market for Branded APIs, by Region, Through 2022
Table 30 : Global Market for Biosimilar APIs, by Region, Through 2022
Table 31 : Global Market for API, by Region, Through 2022
Table 32 : North America Market for APIs, by Country, Through 2022
Table 33 : Europe Market for APIs, by Country, Through 2022
Table 34 : Asia-Pacific Market for APIs, by Country, Through 2022
Table 35 : RoW Market for APIs, by Country, Through 2022
Table 36 : Primary Research and Company annual reports
Table 37 : Other API Manufacturers, Europe
Table 38 : Other API Manufacturers, Asia-Pacific
Table 39 : Key Industry Developments in API Market, March 2015-October 2017
Table 40 : Teva Pharmaceutical Financials, 2015-2017
Table 41 : Teva Pharmaceutical API Manufacturing Facilities
Table 42 : Teva Pharmaceutical Products and Services
Table 43 : Cambrex Financials, 2015-2017
Table 44 : Cambrex API Manufacturing Facilities
Table 45 : Cambrex Products and Services
Table 46 : Siegfried Financials, 2015-2017
Table 47 : Siegfried Products and Services
Table 48 : Cordon Pharma Manufacturing Facilities
Table 49 : Cordon Pharma Products and Services
Table 50 : Aurobindo Pharma Financials, 2015-2017
Table 51 : Aurobindo Pharma Products and Services
Table 52 : BASF Financials, 2015-2017
Table 53 : BASF Products and Services
Table 54 : Dishman Group Financials, 2015-2017
Table 55 : Dishman Group Manufacturing Facilities
Table 56 : Dishman Group Products and Services
Table 57 : Mylan Financials, 2014-2016
Table 58 : Mylan Products and Services
Table 59 : AMRI Financials, 2014-2016
Table 60 : AMRI Manufacturing Facilities
Table 61 : AMRI Products and Services
Table 62 : Avid Bioservices Financials, 2015-2017
Table 63 : Halo Pharma Capabilities
Table 64 : Lonza Financials, 2015-2017
Table 65 : Lonza Products and Services
Table 66 : Sun Pharmaceutical Financials, 2015-2017
Table 67 : Sun Pharmaceutical Products and Services
Table 68 : Dr Reddy’s Laboratory Manufacturing Facilities
Table 69 : Dr Reddy’s Laboratory Financials, 2015-2017

List of Figures
Summary Figure : Global Market for API, by Manufacturer, 2016-2022
Figure 1 : Global Market Share for the Pharmaceutical Industry, by Region, 2016
Figure 2 : API Production, by Chemical Synthesis
Figure 3 : API Production, by Biological Process
Figure 4 : API Production, by Natural Sources-Extraction Process
Figure 5 : Global Market for APIs, 2016-2022
Figure 6 : Active Pharmaceutical Ingredients: Market Dynamics
Figure 7 : Number of ANDA Filings, Drug Approvals and Approval Success Rate, 2013-2017
Figure 8 : Number of BLA Approvals, 2008-2015
Figure 9 : Trends in U.S. FDA Foreign Inspection, 2011-2016
Figure 10 : Number of FDA Inspections in Foreign Countries, by Country, 2011-2016
Figure 11 : Trends in FDA Warning Calls, 2015-2016
Figure 12 : Global Market for APIs, by Manufacturer, 2016-2022
Figure 13 : Global Market Share for API, by Manufacturer, 2016
Figure 14 : Global Market Share for APIs, by Manufacturer, 2022
Figure 15 : Global Market for Captive API, 2016-2022
Figure 16 : Global Market for Captive APIs, by Region, 2016-2022
Figure 17 : Global Market Share for Captive APIs by Region, 2016
Figure 18 : Global Market Share for Captive APIs, by Region, 2022
Figure 19 : Global Market for Merchant API, 2016-2022
Figure 20 : Global Market for Merchant API, by Region, 2016-2022
Figure 21 : Global Market Share for Merchant API, by Region, 2016
Figure 22 : Global Market Share for Merchant API, by Region, 2022
Figure 23 : Global Market for CMO API, 2016-2022
Figure 24 : Global Market for CMO API, by Region, Through 2022
Figure 25 : Global Market Share for CMO API, by Region, 2016
Figure 26 : Global Market Share for CMO API, by Region, 2022
Figure 27 : API Production Flow: From Clinical Development to Large Scale Manufacture
Figure 28 : Global Market for API, by End Use, Through 2022
Figure 29 : Global Market Share for API, by End Use, 2016
Figure 30 : Global Market Share for API, by End Use, 2022
Figure 31 : Global Market for Clinical Trial API, 2016-2022
Figure 32 : Number of New Molecular Entities (NMEs) in Different Phases of Drug Development, 2012-2016
Figure 33 : Biologics Research and Development
Figure 34 : Biologics Development, by Therapeutic Area
Figure 35 : Funding Scenario, 2012-2017
Figure 36 : Orphan Drug Clinical Development, 2012-2016
Figure 37 : Clinical Trials, by Region, 2015
Figure 38 : Mortality Rates of Selected Diseases, by Country, 2020
Figure 39 : Global Market for Clinical Trial API, by Region, 2016-2022
Figure 40 : Global Market Share for Clinical Trial API, by Region, 2016
Figure 41 : Global Market Share for Clinical Trial API, by Region, 2022
Figure 42 : Global Market for Commercial API, 2016-2022
Figure 43 : Global Market for Commercial API, by Region, Through 2022
Figure 44 : Global Market Share for Commercial API, by Region, 2016
Figure 45 : Global Market Share for Commercial API, by Region, 2022
Figure 46 : Global Market for API, by Origin, Through 2022
Figure 47 : Global Market Share for API, by Origin, 2016
Figure 48 : Global Market Share for API, by Origin, 2022
Figure 49 : Global Market for Natural APIs, by Region, 2016-2022
Figure 50 : Global Market for Natural APIs, by Region, Through 2022
Figure 51 : Global Market Share for Natural APIs, by Region, 2016
Figure 52 : Global Market Share for Natural APIs, by Region, 2022
Figure 53 : Global Market for Synthetic APIs, 2016-2022
Figure 54 : Global Market for Synthetic APIs, by Region, Through 2022
Figure 55 : Global Market Share for Synthetic APIs, by Region, 2016
Figure 56 : Global Market Share for Synthetic APIs, by Region, 2022
Figure 57 : Global Market for Synthetic APIs, by Type, Through 2022
Figure 58 : Global Market for Chemical Synthetic APIs, 2016-2022
Figure 59 : Global Market for Biocatalytic APIs, 2016-2022
Figure 60 : Global Market for Cell Culture APIs, 2016-2022
Figure 61 : Global Market for APIs, by Molecule Type, 2016-2022
Figure 62 : Global Market Share for APIs, by Molecule Type, 2016
Figure 63 : Global Market Share for APIs, by Molecule Type, 2022
Figure 64 : Number of Small Molecules in Clinical Pipeline
Figure 65 : Number of Small Molecules Approved, 2010-2016
Figure 66 : Global Market for Small Molecule APIs, 2016-2022
Figure 67 : Global Market for Small Molecule APIs, by Type 2016-2022
Figure 68 : Global Market Share for Small Molecule APIs, by Type, 2016
Figure 69 : Global Market Share for Small Molecule APIs, by Type, 2022
Figure 70 : Global Market for Branded Small Molecule APIs, 2016-2022
Figure 71 : Global Market for Branded Small Molecule APIs, by Region, Through 2022
Figure 72 : Global Market for Generic Small Molecule APIs, 2016-2022
Figure 73 : Global Market for Generic Small Molecule APIs, by Region, 2016-2022
Figure 74 : New Biological Entities Approved, 2010-2016
Figure 75 : Global Market for Biologics/Large Molecules APIs, 2016-2022
Figure 76 : Global Market for Large Molecule APIs, by Region, 2016-2022
Figure 77 : Global Market Share for Large Molecule APIs, by Region, 2016
Figure 78 : Global Market Share for Large Molecule APIs, by Region, 2022
Figure 79 : Global Market for Large Molecule APIs, by Type, Through 2022
Figure 80 : Global Market Share for Large Molecule APIs, by Type, 2016
Figure 81 : Global Market Share for Large Molecule APIs, by Type, 2022
Figure 82 : Global Market for Branded APIs, 2016-2022
Figure 83 : Global Market for Branded APIs, by Region, 2016-2022
Figure 84 : Global Market for Biosimilar APIs, 2016-2022
Figure 85 : Global Market for Biosimilar APIs, by Region, 2016-2022
Figure 86 : Global Market for APIs, by Region, 2016-2022
Figure 87 : Global Market Share for APIs, by Region, 2016
Figure 88 : Global Market Share for APIs, by Region, 2022
Figure 89 : North America Market for APIs, by Country, 2016-2022
Figure 90 : North America Market Share for APIs, by Country, 2016
Figure 91 : North America Market Share for APIs, by Country, 2022
Figure 92 : Europe Market for APIs, by Country, 2016-2022
Figure 93 : Europe Market Share for APIs, by Country, 2016
Figure 94 : Europe Market Share for APIs, by Country, 2022
Figure 95 : Asia-Pacific Market for APIs, by Country, 2016-2022
Figure 96 : Asia-Pacific Market Share for APIs, by Country, 2016
Figure 97 : Asia-Pacific Market Share for APIs, by Country, 2022
Figure 98 : RoW Market for APIs, by Country, 2016-2022
Figure 99 : RoW Market Share for APIs, by Country, 2016
Figure 100 : RoW Market Share for APIs, by Country, 2022
Figure 101 : Global Market Share of Selected API Manufacturers, 2016
Figure 102 : Porter’s Five Force Analysis-Overview
Figure 103 : Threat of New Entrants
Figure 104 : Threat of Substitute Products or Services
Figure 105 : Bargaining Power of Customers (Buyers)
Figure 106 : Bargaining Power of Suppliers
Figure 107 : Intensity of Competitive Rivalry
Figure 108 : Teva Pharmaceutical Revenue, by Business Segment, 2015-2017
Figure 109 : Teva Pharmaceutical Revenue Share, by Business Segment, 2017
Figure 110 : Teva Pharmaceutical Revenue, by Region, 2015-2017
Figure 111 : Teva Pharmaceutical Revenue Share, by Region, 2017
Figure 112 : Cambrex Revenue, by Region, 2015-2017
Figure 113 : Cambrex Revenue Share, by Region, 2017
Figure 114 : Siegfried Revenue, by Product, 2015-2017
Figure 115 : Siegfried Revenue Share, by Product, 2017
Figure 116 : Aurobindo Pharma Revenue, by Business Segment, 2015-2017
Figure 117 : Aurobindo Pharma Revenue Share, by Business Segment, 2017
Figure 118 : Aurobindo Pharma Revenue, by Region, 2015-2017
Figure 119 : Aurobindo Pharma Revenue Share, by Region, 2017
Figure 120 : BASF Revenue, by Business Segment, 2015-2017
Figure 121 : BASF Revenue Share, by Business Segment, 2017
Figure 122 : BASF Market, by Region, 2015-2017
Figure 123 : BASF Revenue Share, by Region, 2017
Figure 124 : Dishman Group Revenue, by Product, 2015-2017
Figure 125 : Dishman Group Revenue Share, by Product, 2017
Figure 126 : Mylan Revenue, by Region, 2014-2016
Figure 127 : Mylan Revenue Share, by Region, 2016
Figure 128 : AMRI Revenue, by Business Segment, 2014-2016
Figure 129 : AMRI Revenue Share, by Business Segment, 2016
Figure 130 : AMRI Revenue, by Region, 2014-201
Figure 131 : Lonza Revenue, by Business Segment, 2015-2017
Figure 132 : Lonza Revenue Share, by Business Segment, 2017
Figure 133 : Lonza Revenue, by Region, 2015-2017
Figure 134 : Lonza Revenue Share, by Region, 2017
Figure 135 : Sun Pharmaceutical Revenue, by Business Segment, 2015-2017
Figure 136 : Sun Pharmaceutical Revenue Share, by Business Segment, 2017
Figure 137 : Dr Reddy’s Laboratory Revenue, by Business Segment, 2015-2017
Figure 138 : Dr Reddy’s Laboratory Revenue Share, by Business Segment, 2017
Figure 139 : Dr Reddy’s Laboratory Global Generics Revenue, by Region, 2015-2017
Figure 140 : Dr Reddy’s Laboratory Global Generics Revenue Share, by Region, 2017
Figure 141 : Dr Reddy’s Laboratory PSAI Revenue, by Region, 2015-2017
Figure 142 : Dr Reddy’s Laboratory PSAI Revenue Share, by Region, 2017

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  • Aurobindo Pharma
  • BASF AG
  • Lonza
  • Mylan N.V.
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