Active Pharmaceutical Ingredients (API) Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028

Active Pharmaceutical Ingredients (API) Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028


The global active pharmaceutical ingredients (API) market size reached US$ 222.9 Billion in 2022. Looking forward, IMARC Group expects the market to reach US$ 303.9 Billion by 2028, exhibiting a growth rate (CAGR) of 5.6% during 2023-2028.

Active pharmaceutical ingredient (API), is the term that is used to refer to the biologically active component of a drug (e.g. tablet, capsule). A drug is usually composed of several components. The API represents the primary ingredient. Other ingredients are commonly known as "excipients. Sometimes a drug can contain several APIs and its effect on a patient depends on the dosage prescribed and can vary from person to person. In combination therapies, two or more than two active ingredients are used to treat different symptoms in different ways. Stringent quality control is a mandate when it comes to the manufacturing of drugs as the API represents the main component considered while making the prescription.

Pharmaceutical manufacturing occurs in two general steps. In the first step, manufacturers convert raw materials into APIs. The second step involves creating the final formulation by mixing APIs and excipients into tablets, capsules, solutions, etc. and finally packaging the drug for the end users. Manufacturers either sell APIs in the open market (also known as the merchant market) or use them as inputs to make their final formulations. The global API market is extremely competitive with a number of large and small manufacturers. Firms that engage in API manufacturing generally specialize and target their manufacturing based on a combination of the firms in-house skills and market opportunities. Catalyzed by lower costs, API manufacturing has gradually been shifting from the historical leaders in Western countries to manufacturers based in India and China.

The global demand of APIs is currently exhibiting strong growth. One of the major drivers of this market is the rising number of blockbuster patent expiries creating a significant opportunity for generic APIs. Moreover, there has been a strong demand for APIs for biologicals. The global market for biologicals is currently exhibiting strong growth catalyzed by their high potency and ability to treat diseases beyond the scope of small molecule drugs. This is creating a strong demand for APIs for branded biological drugs and their biosimilar versions. Other factors catalyzing the global demand of APIs include ageing population, rising expenditures on healthcare, increasing prevalence of lifestyle diseases, etc.

Key Market Segmentation:

IMARC Group provides an analysis of the key trends in each sub-segment of the global active pharmaceutical ingredients (API) market report, along with forecasts at the global, regional and country level from 2023-2028. Our report has categorized the market based on drug type, type of manufacturer, type of synthesis and therapeutic application.

Breakup by Drug Type:

Innovative Active Pharmaceutical Ingredients (API)

Generic Active Pharmaceutical Ingredients (API)

Based on the drug type, the market has been segmented as innovative active pharmaceutical ingredients and generic active pharmaceutical ingredients.

Breakup by Type of Manufacturer:

Captive Manufacturers

Merchant API Manufacturers

Innovative Merchant API Manufacturers

Generic Merchant API Manufacturers

Based on the type of manufacturer, the market has been segmented as captive manufacturers and merchant API manufacturers.

Breakup by Type of Synthesis:

Synthetic Active Pharmaceutical Ingredients (API)

Market Breakup by Type

Innovative Synthetic APIs

Generic Synthetic APIs

Biotech Active Pharmaceutical Ingredients (API)

Market Breakup by Type

Innovative Biotech APIs

Biosimilars

Market Breakup By Product

Monoclonal Antibodies

Vaccines

Cytokines

Fusion Proteins

Therapeutic Enzymes

Blood Factors

Market Breakup By Expression System

Mammalian Expression Systems

Microbial Expression Systems

Yeast Expression Systems

Transgenic Animal Systems

Others

Based on the type of synthesis, the market has been segmented as synthetic active pharmaceutical ingredients and biotech active pharmaceutical ingredients.

Breakup by Therapeutic Application:

Oncology

Cardiovascular and Respiratory

Diabetes

Central Nervous System Disorders

Neurological Disorders

Others

Based on the therapeutic application, the market has been segmented as oncology, cardiovascular & respiratory, diabetes, central nervous system disorders, neurological disorders and others.

Breakup by Region:

North America

United States

Canada

Europe

Germany

France

United Kingdom

Italy

Spain

Russia

Others

Asia Pacific

China

Japan

India

South Korea

Australia

Indonesia

Others

Latin America

Middle East and Africa

Region-wise, the market has been segmented into North America, Europe, Asia Pacific, Middle East and Africa, and Latin America.

Competitive Landscape:

The competitive landscape of the market has also been examined with some of the (active pharmaceutical ingredients companies) key players being Pfizer, Inc., Novartis International AG, Sanofi, Boehringer Ingelheim, Bristol-Myers Squibb, Teva Pharmaceutical Industries Ltd., ELI Lilly and Company, GlaxoSmithKline, Merck & Co., Inc. and Abbvie Inc.

Key Questions Answered in This Report

1. How big is the active pharmaceutical ingredient market?

2. What is the expected growth rate of the global Active Pharmaceutical Ingredients (API) market during 2023-2028?

3. What are active ingredients in pharmaceutical industry?

4. What are the key factors driving the global Active Pharmaceutical Ingredients (API) market?

5. What has been the impact of COVID-19 on the global Active Pharmaceutical Ingredients (API) market?

6. What is the breakup of the global Active Pharmaceutical Ingredients (API) market based on the drug type?

7. What is the breakup of the global Active Pharmaceutical Ingredients (API) market based on the type of manufacturer?

8. What is the breakup of the global Active Pharmaceutical Ingredients (API) market based on the type of synthesis?

9. What is the breakup of the global Active Pharmaceutical Ingredients (API) market based on the therapeutic application?

10. What are the key regions in the global Active Pharmaceutical Ingredients (API) market?

11. Who is the biggest API manufacturer?

12. Who are the key players/companies in the global Active Pharmaceutical Ingredients (API) market?


1 Preface
2 Scope and Methodology
  2.1 Objectives of the Study
  2.2 Stakeholders
  2.3 Data Sources
2.3.1 Primary Sources
2.3.2 Secondary Sources
  2.4 Market Estimation
2.4.1 Bottom-Up Approach
2.4.2 Top-Down Approach
  2.5 Forecasting Methodology
3 Executive Summary
4 Introduction
  4.1 Overview
  4.2 Key Industry Trends
5 Global Active Pharmaceutical Ingredients (API) Market
  5.1 Market Overview
  5.2 Market Performance 
  5.3 Impact of COVID-19
  5.4 Market Breakup by Drug Type
  5.5 Market Breakup by Type of Manufacturer
  5.6 Market Breakup by Type of Synthesis 
  5.7 Market Breakup by Therapeutic Application
  5.8 Market Breakup by Region
  5.9 Market Forecast
  5.10 SWOT Analysis
5.10.1 Overview
5.10.2 Strengths
5.10.3 Weaknesses
5.10.4 Opportunities
5.10.5 Threats
  5.11 Value Chain Analysis
  5.12 Porters Five Forces Analysis
5.12.1 Overview
5.12.2 Bargaining Power of Buyers
5.12.3 Bargaining Power of Suppliers
5.12.4 Degree of Competition
5.12.5 Threat of New Entrants
5.12.6 Threat of Substitutes
5.13 Price Analysis
5.13.1 Price Indicators
5.13.2 Price Structure
6 Market Breakup by Drug Type
6.1 Innovative Active Pharmaceutical Ingredients (API)
6.2 Generic Active Pharmaceutical Ingredients (API)
7 Market Breakup by Type of Manufacturer
7.1 Captive Manufacturers 
7.2 Merchant API Manufacturers 
7.2.1 Innovative Merchant API Manufacturers
7.2.2 Generic Merchant API Manufacturers   
8 Market Breakup by Type of Synthesis 
8.1 Synthetic Active Pharmaceutical Ingredients (API)
8.1.1  Market Breakup by Type
8.1.1.1  Innovative Synthetic APIs
8.1.1.2  Generic Synthetic APIs
8.2 Biotech Active Pharmaceutical Ingredients (API)
8.2.1  Market Breakup by Type
8.2.1.1  Innovative Biotech APIs
8.2.1.2  Biosimilars
8.2.2  Market Breakup by Product 
8.2.2.1  Monoclonal Antibodies 
8.2.2.2  Vaccines 
8.2.2.3  Cytokines 
8.2.2.4  Fusion Proteins 
8.2.2.5  Therapeutic Enzymes 
8.2.2.6  Blood Factors
8.2.3 Market Breakup by Expression System 
8.2.3.1  Mammalian Expression Systems 
8.2.3.2  Microbial Expression Systems
8.2.3.3  Yeast Expression Systems 
8.2.3.4  Transgenic Animal Systems
8.2.3.5  Others
 9  Market Breakup by Therapeutic Application
9.1 Oncology
9.2 Cardiovascular and Respiratory
9.3 Diabetes 
9.4 Central Nervous System Disorders
9.5 Neurological Disorders  
9.6 Others
10  Market Breakup by Region
  10.1 North America 
10.1.1 United States
10.1.2 Canada
  10.2 Europe
10.2.1 Germany
10.2.2 France
10.2.3 United Kingdom
10.2.4 Italy
10.2.5 Spain
10.2.6 Russia
10.2.7 Others
  10.3 Asia Pacific
10.3.1 China
10.3.2 Japan
10.3.3 India
10.3.4 South Korea
10.3.5 Australia
10.3.6 Indonesia
10.3.7 Others
  10.4 Latin America
  10.5 Middle East and Africa
11  API Manufacturing Process
  11.1 Product Overview
  11.2 Raw Material Requirements
  11.3 Manufacturing Process
  11.4 Key Success and Risk Factors
12  Competitive Landscape
  12.1 Market Structure
  12.2 Key Players
  12.3 Profiles of Key Players
12.3.1 Pfizer, Inc. 
12.3.2 Novartis International AG 
12.3.3 Sanofi 
12.3.4 Boehringer Ingelheim 
12.3.5 Bristol-Myers Squibb 
12.3.6 Teva Pharmaceutical Industries Ltd.  
12.3.7 ELI Lilly and Company 
12.3.8 GlaxoSmithKline 
12.3.9 Merck & Co., Inc. 
12.3.10 Abbvie Inc

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