세계의 원료의약품(API) 시장

※ 본 상품은 영문 자료로 한글과 영문목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문목차를 참고해주시기 바랍니다.

세계의 원료의약품(API) 시장 규모는 예측기간 중 5.1%의 CAGR로 확대되고, 2020년 1,354억 달러에서 2025년에는 1,733억 달러 규모로 성장할 것으로 예측됩니다. 제조 부문별로 보면 사내 제조 부문이 기간 중 4.8%로 확대되고, 2020년 529억 달러에서 2025년에는 670억 달러로 성장할 전망입니다. 또한 CMO 부문은 5.7%의 CAGR로 확대되고, 2020년 387억 달러에서 2025년에는 511억 달러 규모로 성장할 것으로 예측됩니다.

세계의 원료의약품(API : Active Pharmaceutical Ingredients) 시장을 조사했으며, 시장 정의와 개요, 신종 코로나바이러스 감염증(COVID-19) 및 기타 시장 영향요인 분석, 규제 상황, 기술·제조 동향, 시장 규모 추정과 예측, 제조업체와 서비스 프로바이더 구분·최종사용·원료·분자 종류·지역/주요 국가 등 각종 세분화별 내역, 경쟁 상황, 주요 기업 개요 등을 정리했습니다.

제1장 서론

제2장 요약과 하이라이트

제3장 서론

• 제약 산업 개요
• 의약품 시장에 대한 특허 만료의 영향
• 의약품 개발의 변화
• Drug Discovery & Development 프로세스
• 타겟 선정 및 검증
• Drug Discovery용 기술
• 제약 비지니스 모델
• 시장 역학 : 의약품
• 의약품 개발 비용
• 세계의 의약품 공급망
• API 정의
• API 원료
• API 제조 방법
• API 제조 : 합성 루트
• 제조 방법
• 원료의약품 시장
• 시장 역학
• 성장 촉진요인
• 성장 억제요인
• 새로운 동향
• API 생산과 공급망에 대한 COVID-19의 영향
• API 가격 동향 : COVID-19의 영향
• Porter's Five Forces 분석
• 규제 상황

제4장 시장 분석과 예측 : 제조업체·서비스 프로바이더별

• 자사용
• 판매용
• CMO
  • 개요
  • 시장 규모와 예측

제5장 시장 분석과 예측 : 최종사용별

• 임상시험
• 상용
  • 개요
  • 시장 규모와 예측

제6장 시장 분석과 예측 : 원료별

• 자연 유래
  • 식물 유래
  • 동물 유래
  • 기타
    • 개요
    • 시장 규모와 예측
• 합성 API
  • 화학 합성
  • 생체 촉매
  • 세포 배양법
    • 개요
    • 시장 규모와 예측

제7장 시장 분석과 예측 : 분자 종류별

• 소분자
  • 브랜드화 API
  • 범용 API
    • 개요
    • 시장 규모와 예측
• 생물제제
  • 톱 셀링 생물제제
  • 브랜드화 API
  • 바이오시밀러 API
    • 개요
    • 시장 규모와 예측

제8장 시장 분석과 예측 : 지역·주요 국가별

• 북미
• 유럽
• 아시아태평양
• 기타 지역
  • 개요
  • 시장 규모와 예측 : 국가별

제9장 공급업체 상황과 주요 전개

• 공급업체 상황
• 자사용 제조업체
• 상용 API 제조업체
• CMO/CDMO
• API 단편화
• 최근의 전개·투자 활동
• COVID-19의 영향

제10장 기업 개요

• 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.

제11장 부록 : 약어

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

Highlights:

The global market for active pharmaceutical ingredients (APIs) should grow from $135.4 billion in 2020 to $173.3 billion by 2025, at compound annual growth rate (CAGR) of 5.1% for the period of 2020-2025.

The captive segment market for active pharmaceutical ingredients (APIs) should grow from $52.9 billion in 2020 to $67.0 billion by 2025, at a CAGR of 4.8% for the period of 2020-2025.

The CMO segment market for active pharmaceutical ingredients (APIs) should grow from $38.7 billion in 2020 to $51.1 billion by 2025, at a CAGR of 5.7% for the period of 2020-2025.

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.

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