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Active Pharmaceutical Ingredients: Global Markets

Publisher Name :
Date: 30-Dec-2020
No. of pages: 148

Report Scope:

This report is 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 APIs are studied here. The increasing importance of outsourced API manufacturing activities and the impact on the pharmaceutical industry are covered in the report.

In this report, the API market is segmented into molecular entity, manufacturer type, end use, and region. Further, it 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 the 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, and Rest of the World (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:

- 27 data tables and 32 additional tables
- An overview of the global active pharmaceutical ingredients (API) market
- Estimation of the market size and analyses of market trends, with data from 2018, 2019, estimates for 2020 and projection of CAGR through 2025
- Highlights of quantitative and qualitative data of the API market by molecular entity, manufacturer type, origin, end use and region
- Detailed description of API sources, production methods, route of synthesis, and contract manufacturing organizations
- Information on regulatory perspective on production methods of API and discussion on harmonization of API GMP standards and supply chain integrity
- Impact analysis of coronavirus on the global economy; and discussion on impact of COVID-19 on API industry
- Identification of market drivers, restraints and other forces impacting the global market and evaluation of current market trends, market size, market forecast, and technological advancements within the industry
- Discussion on issues like patent expiry and its impact on the pharmaceutical market, and details of changes in pharmaceutical drug development
- Coverage of events like mergers & acquisitions, joint ventures, collaborations or partnerships, and other key market strategies
- Company profiles of major players of the industry, including Actavis PLC, BASF AG, Cambrex Corp., GlaxoSmithKline PLC and Sun Pharmaceutical Industries Ltd.

Summary:

The global API market reached REDACTED in 2019 and is expected to grow at a REDACTED compound annual growth rate (CAGR) over the next five years, driven by the increasing demand for pharmaceutical products such as generics and biological drugs, price impacts from COVID-19 and the increasing demand for critical drugs, which are in short supply due to the pandemic. The global API market is expected to reach REDACTED by 2025.

Reasons for Doing This Study:

This dynamic market is changing the context of new developments, such as product launches, mergers and acquisitions, and partnership activities. The pharmaceutical market landscape has been undergoing myriad changes relative to outsourcing activities and patent expiry. The perceptions of different stakeholders in the pharmaceutical industry and the overall attractiveness of the market are the focus of the analysis in this report.

Active Pharmaceutical Ingredients: Global Markets

Table of Contents

Chapter 1 Introduction
Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Information Sources
Methodology
Geographic Breakdown
Analyst's Credentials
BCC Custom Research
Related BCC Research Reports
Chapter 2 Summary and Highlights
Highlights
Chapter 3 Active Pharmaceutical Ingredients - Introduction
Pharmaceutical Industry Overview
Patent Expiry Impact on the Pharmaceutical Market
Changes in Pharmaceutical Drug Development
Drug Discovery and Development Process
Target Identification and Validation
Technologies for Drug Discovery
Pharmaceutical Business Model
Pharmaceutical Market Dynamics
The Cost of Drug Development
Global Pharmaceutical Supply Chain
API Defined
Sources of APIs
API Production Methods
API Production: Route of Synthesis
Production Methods
Active Pharmaceutical Ingredient Market
Market Dynamics
Market Drivers
Market Challenges
Emerging Trends
Impact of COVID on API Production and Supply Chain
API Pricing Trends and Increases Amidst COVID-19
Porter's Five-Force Analysis in the API Market
Threat of New Entrants
Threat of Substitute Products or Services
Bargaining Power of Customers (Buyers)
Bargaining Power of Suppliers
Intensity of Competitive Rivalry
Current State of Active Pharmaceutical Ingredient Regulations
Harmonization of API GMP Standards and Supply Chain Integrity
CMO/CDMO Regulations
Regulation in the U.S.
Regulation in Europe
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 Active Pharmaceutical Ingredients 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 Active Pharmaceutical Ingredients by Origin
Introduction and Market Analysis
Natural Origin: Types and Market Analysis
Plant 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 Active Pharmaceutical Ingredients 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 Active Pharmaceutical Ingredients Market by Region
Introduction
North America
Overview
Market Size by Country
Europe
Overview
Market Size by Country
Asia-Pacific
Overview
API Production in Asia-Pacific
Market Size by Country
Rest of the World
Overview
Chapter 9 Supplier Landscape and Key Industry Developments
Supplier Landscape
Captive Manufacturers
Merchant API Manufacturers
CMOs/CDMOs
API Fragmentation: -Reasons for Fragmented Industry Structure
Recent Industry and Investment Activities
Impact of COVID-19 on API Manufacturers
Chapter 10 Company Profiles
ABBVIE CONTRACT MANUFACTURING
AESICA PHARMACEUTICALS LTD.
AUROBINDO PHARMA
ACTAVIS PLC
ALBANY MOLECULAR RESEARCH INC. (AMRI)
AVID BIOSERVICES INC.
BASF AG
BOEHRINGER INGELHEIM
CAMBREX CORP.
CIPLA
CSPC PHARMACEUTICAL GROUP
CORDEN PHARMA INTERNATIONAL GMBH
DISHMAN GROUP
DIVIS LABORATORIES LTD.
DR REDDY’S LABORATORY
FAREVA GROUP
GLAXOSMITHKLINE PLC
HALO PHARMA
HETERO
JOHNSON MATTHEY PHARMACEUTICAL MATERIALS INC.
JUBILANT LIFE SCIENCES LTD.
LONZA
LUPIN
MERCK KGAA
MYLAN N.V.
NOVARTIS AG
PATHEON
PFIZER CENTREONE
PIRAMAL PHARMA SOLUTIONS
SHANDONG XINHUA PHARMACEUTICAL CO. LTD.
SIEGFRIED AG
SUN PHARMACEUTICAL INDUSTRIES LTD.
TEVA PHARMACEUTICAL INDUSTRIES, INC.
WUXI APPTEC
ZHEJIANG CHEMICALS IMPORT/EXPORT CORP.
ZHUHAI UNITED LABORATORIES CO. LTD.
Chapter 11 Appendix: Abbreviations
Abbreviations

List of Tables
Summary Table : Global Market for Active Pharmaceutical Ingredients (APIs), by Manufacturer Type, Through 2025
Table 1 : Average Cost of Drug Development, by Stage, 2018
Table 2 : Advantages and Disadvantages of Using Natural APIs
Table 3 : Advantages and Disadvantages of Using Synthetic APIs
Table 4 : Most Significant PE Deals in India Pharma, 2020
Table 5 : API Manufacturers: Manufacturing Facility Expansion
Table 6 : List of Key APIs and their Price Hikes, January 2020-April 2020
Table 7 : Regulatory Requirements of GMP and Supply Chain Integrity for APIs
Table 8 : Global Market for APIs, by Manufacturer Type, Through 2025
Table 9 : Global Market for Captive APIs, by Region, Through 2025
Table 10 : Global Market for Merchant APIs, by Region, Through 2025
Table 11 : Global Market for CMO APIs, by Region, Through 2025
Table 12 : Global Market for APIs, by End Use, Through 2025
Table 13 : Global Market for Clinical Trial APIs, by Region, Through 2025
Table 14 : Global Market for Commercial APIs, by Region, Through 2025
Table 15 : Global Market for APIs, by Origin, Through 2025
Table 16 : Global Market for Natural APIs, by Region, Through 2025
Table 17 : Global Market for Synthetic APIs, by Origin, Through 2025
Table 18 : Advantages and Disadvantages of the Biocatalytic Process
Table 19 : Cell Culture Types: Attributes and Applications
Table 20 : Global Market for APIs, by Molecule Type, Through 2025
Table 21 : Characteristics of Small Molecules
Table 22 : Global Market for Small Molecule APIs, by Region, Through 2025
Table 23 : Global Market for Small Molecule APIs, by Type, Through 2025
Table 24 : Global Market for Branded Small Molecule APIs, by Region, Through 2025
Table 25 : Global Market for Generic Small Molecule APIs, by Region, Through 2025
Table 26 : Characteristics of Large Molecules/Biologics
Table 27 : Global Market for Large Molecule APIs, by Region, Through 2025
Table 28 : Global Market for Large Molecule APIs, by Type, Through 2025
Table 29 : Global Market for Branded Biologic APIs, by Region, Through 2025
Table 30 : Global Market for Biosimilar APIs, by Region, Through 2025
Table 31 : Global Market for APIs, by Region, Through 2025
Table 32 : Medical Countermeasure (MCM) Drug Manufacturing Sites, 2020
Table 33 : North American Market for APIs, by Country, Through 2025
Table 34 : European Market for APIs, by Country, Through 2025
Table 35 : Asia-Pacific Market for APIs, by Country, Through 2025
Table 36 : RoW Market for APIs, by Country, Through 2025
Table 37 : Key API Manufacturers
Table 38 : Key India API Pharma Stocks with Varying Degree of Dependency on China for API Materials
Table 39 : Key Indian API Pharma Stock Gains Since February 2020
Table 40 : Aurobindo Pharma: Products and Services
Table 41 : AMRI: Manufacturing Facilities
Table 42 : AMRI: Products and Services
Table 43 : BASFAG: Products and Services
Table 44 : Cambrex Corp.: Manufacturing Facilities
Table 45 : Cambrex Corp.: Products and Services
Table 46 : Cordon Pharma International GmbH: Manufacturing Facilities
Table 47 : Cordon Pharma International GmbH: Products and Services
Table 48 : Dishman Group: Manufacturing Facilities
Table 49 : Dishman Group: Products and Services
Table 50 : Dr Reddy’s Laboratory: Manufacturing Facilities
Table 51 : Halo Pharma: Capabilities
Table 52 : Lonza: Products and Services
Table 53 : Mylan N.V.: Products and Services
Table 54 : Siegfried AG: Products and Services
Table 55 : Sun Pharmaceutical Industries Ltd.: Products and Services
Table 56 : Teva Pharmaceutical Industries, Ltd.: Manufacturing Facilities
Table 57 : Teva Pharmaceutical Industries, Ltd.: Products and Services
Table 58 : Abbreviations Used in this Report

List of Figures
Summary Figure : Global Market for Active Pharmaceutical Ingredients (APIs), by Manufacturer Type, 2018-2025
Figure 1 : Drug Development, by Phase
Figure 2 : End-to-End Pharmaceutical Supply Chain
Figure 3 : API Supply Chain
Figure 4 : Global API Supply Chain Network
Figure 5 : Chemical Synthetic Process
Figure 6 : Biological Process
Figure 7 : Natural Sources-Extraction Process
Figure 8 : Global Market for APIs, 2018-2025
Figure 9 : Active Pharmaceutical Ingredients: Market Dynamics
Figure 10 : Survey on Impact of COVID-19 on the Pharma Supply Chain, 2020
Figure 11 : Impact of COVID-19 on Pharma Supply Chain
Figure 12 : Supply Chain Disruption in the Pharmaceutical Value Chain
Figure 13 : Key Antibiotic API Price Hikes, January 2020-April 2020
Figure 14 : Price Hikes for Key Antimalarial & Antiviral APIs, January 2020-April 2020
Figure 15 : Price Hikes for Key Pain & Anti-inflammatory APIs, January 2020-April 2020
Figure 16 : Price Hikes for Key Vitamin APIs, January 2020-April 2020
Figure 17 : FDA cGMP Manufacturing Guidance Documents
Figure 18 : FDA Site Inspections and Possible Actions
Figure 19 : European cGMP Guidelines Documentation
Figure 20 : European Site Inspection Outcomes
Figure 21 : Global Market for APIs, by Manufacturer Type, 2018-2025
Figure 22 : Global Market for Captive APIs, by Region, 2018-2025
Figure 23 : Global Market for Merchant APIs, by Region, 2018-2025
Figure 24 : Global Market for CMO APIs, by Region, 2018-2025
Figure 25 : API Production Flow: From Clinical Development to Large Scale Manufacture
Figure 26 : Mortality Rates of Selected Disease, 2020
Figure 27 : Global Market for Clinical Trial APIs, by Region, 2018-2025
Figure 28 : Global Market for Commercial APIs, by Region, 2018-2025
Figure 29 : Global Market for Natural APIs, by Region, 2018-2025
Figure 30 : Global Market for Synthetic APIs, by Region, 2018-2025
Figure 31 : Global Market for Synthetic APIs, by Origin, 2018-2025
Figure 32 : Global Market for Small Molecule APIs, by Type, 2018-2025
Figure 33 : Global Market for Branded Small Molecule APIs, by Region, 2018-2025
Figure 34 : Global Market for Generic Small Molecule APIs, by Region, 2018-2025
Figure 35 : Global Market for Large Molecule APIs, by Region, 2018-2025
Figure 36 : Global Market for Large Molecule APIs, by Type, 2018-2025
Figure 37 : Global Market for Branded Biologic APIs, by Region, 2018-2025
Figure 38 : Global Market for Biosimilar APIs, by Region, 2018-2025
Figure 39 : Global Market for APIs, by Region, 2018-2025
Figure 40 : North American Market for APIs, by Country, 2018-2025
Figure 41 : European Market for APIs, by Country, 2018-2025
Figure 42 : Asia-Pacific Market for APIs, by Country, 2018-2025
Figure 43 : RoW Market for APIs, by Country, 2018-2025

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