Active Pharmaceutical Ingredients: Global Markets to 2022
Report Scope
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
- Chapter 1 Introduction
- Study Goals and Objectives
- Reasons for Doing This Study
- Scope of Report
- Information Sources
- Methodology
- Geographic Breakdown
- Analyst's Credentials
- Related BCC Research Reports
- 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 : BCC Research, 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