Overview


According to FutureWise analysis the market for Active Pharmaceutical Ingredient (API) in 2023 is US$ 228.50 billion, and is expected to reach US$ around 379 billion by 2031 at a CAGR of 6.60%.

The chemical compounds that provide a medicine its pharmacological properties are active pharmaceutical ingredients or APIs. The therapeutic impact of the drug is provided by its physiologically active ingredients. Pharmaceutical products, also called completed dosage forms, such as tablets, capsules, injections, creams, or syrups, are made using formulations of APIs and other inert substances. Depending on the nature of the substance, processes, including chemical synthesis, fermentation, extraction, or biotechnological techniques, are used in the creation and manufacture of APIs. APIs can be chemically synthesized in laboratories or derived from natural sources like plants or microbes. Variables like accessibility, affordability, scalability, and legal restrictions influence the selection of an API synthesis technique.

The two main steps of drug development in the pharmaceutical industry are discovering and creating a new molecule and producing the actual medicine. Scientists identify and develop potential medication molecules during the development phase, and after extensive testing and regulatory approval, these compounds become active pharmaceutical ingredients. The API is a crucial element in the pharmaceutical supply chain.Pharmaceutical businesses either produce their own APIs in-house or outsource the product to specialized API producers. These producers are in charge of creating superior APIs that adhere to exacting regulatory criteria and requirements. APIs must adhere to stringent rules and quality requirements to ensure consistency, efficacy, and safety. API producers must follow regulations set forth by regulatory agencies, including the EMA and the U.S. Food and Drug Administration (FDA). These recommendations address various topics, such as quality assurance, good manufacturing practices (GMP), purity, stability, and documentation.

FutureWise Market Research has published a report that provides an insightful analysis of Active Pharmaceutical Ingredient Market trends that are affecting the overall market growth. This report will provide a detailed analysis of market share, regional insights, and competitor analysis that includes the stature of key manufacturers operational in this industry.

According to the analysis conducted by FutureWise research analysts, the Active Pharmaceutical Ingredient Market is estimated to register a considerable growth rate over the forecast period. This report lists the market segments and potential prospects available across this industry, in addition to providing crucial information on the total valuation currently held by the industry. Moreover, this report will assist key management individuals in an organization to enhance their decisions pertaining to business expansion as well as strategic changes for increasing customer base. 

  • Pfizer Inc.
  • Novartis International AG
  • Sanofi
  • Boehringer Ingelheim
  • Bristol-Myers Squibb
  • Teva Pharmaceutical Industries Ltd.
  • Eli Lilly and Company
  • GlaxoSmithKline plc
  • Merck & Co., Inc.
  • AbbVie Inc.
  • F. Hoffmann-La Roche Ltd.
  • AstraZeneca
  • Cipla, Inc.
  • Mylan N.V.
  • Dr. Reddy’s Laboratories Ltd
  • Sun Pharmaceutical Industries Ltd.
  • API Pharma Tech
  • BDR Pharmaceuticals Internationals Pvt. Ltd.
  • Sreepathi Pharmaceuticals Limited
  • Shilpa Medicare Limited
  • Albemarle Corporation
  • Viatris Inc.
  • Aurobindo Pharma
  • Biocon

(Note: The list of the major players will be updated with the latest market scenario and trends)

Recent developments by key players in API Market:

  • In December 2021, The Novasep facility in Chasse-sur-Rhône, France, which offers services and technology to the life sciences sector, invested about EUR 6 million to update its capabilities with reference to the newer generation APIs in areas like cancer, the central nervous system (CNS), and infectious illnesses.
  • In August 2021, The US FDA authorised Teva Pharmaceutical and MEDinCell to market TV-46000/mdc-IRM as a new medication (risperidone extended-release injectable suspension for subcutaneous use). This drug is used to treat schizophrenia.

The demand for pharmaceutical products, especially APIs, is driven by rising healthcare costs, particularly in emerging economies. The need for APIs to make essential medications increases as nations invest more in their healthcare infrastructure and work to provide access to affordable healthcare. The growing prevalence of cancer, diabetes, cardiovascular disease, and respiratory disorders significantly influences the API market. APIs are the main ingredients in creating medications to address these chronic illnesses. The rising global toll of chronic diseases fuels the need for APIs. Generic medicine manufacturers can enter the market once the brand-name drug patents expire, necessitating the demand for API providers. APIs that are bioequivalent to the original branded pharmaceuticals are necessary for generic medications. Blockbuster medication patent expirations provide chances for generic drug producers, which raises the need for APIs. For instance, Erenumab, a novel API by Dr. Reddy's Laboratories, was introduced as a migraine treatment in 2022. This API is a subcutaneous injection given once a month to prevent migraines. The FDA, EMA, and other national agencies, which set strict regulatory criteria and quality standards, are essential in developing the API business. The need for high-quality API producers is fueled by the assurance of safety, efficacy, and quality provided by compliance with these standards driving the API market. However, cost inflation is a significant barrier in the API business because it is fiercely competitive. When choosing API suppliers, pharmaceutical companies, especially those that make generic medications, strongly emphasize the most affordable solutions which pressures API producers to keep their prices low while upholding quality standards. The profitability of API manufacturers is also impacted by changes in the cost of raw materials, the price of energy, and manufacturing costs thereby limiting the market growth.

By Drug Type

  • Prescription Drugs
  • Over-the-counter Drugs

By Manufacturer

  • Captive (In-House) Manufacturer
  • Merchant (Contract) Manufacturer

By Therapeutic Application

  • Communicable Diseases
  • Oncology
  • Diabetes
  • Cardiovascular Disease
  • Pain management
  • Respiratory Diseases
  • Other Therapeutic Applications

By Synthesis

  • Synthetic
    • Type
      • Innovative Synthetic API
      • Generic Synthetic API
  • Biotech
    • Type
      • Innovative Synthetic API
      • Generic Synthetic API
    • Product
      • Monoclonal Antibodies
      • Hormones
      • Cytokines
      • Recombinant Proteins
      • Therapeutic Enzymes
      • Vaccines
      • Blood Factors
    • Expression System
      • Mammalian Expression Systems
      • Microbial Expression Systems
      • Yeast Expression Systems
      • Insect Expression Systems
      • Other Expression Systems

By End-Use

  • Pharmaceutical And Biotechnology Industry
  • Contract Research Organizations
  • Contract Manufacturing Organizations
  • Other End-User

By Region

  • North America
  • Europe
  • Asia- Pacific
  • Latin America
  • Middle East and Africa

This market research report also emphasizes factors affecting the growth rate in various regions listed above. A deep-down analysis of the region will also be provided in the final version of this market which is based on the conclusion of primary interviews and secondary data points gathered during the process.

By region, the market is segmented into North America, Latin America, Europe, Asia-Pacific, and Middle East & Africa. North America registered the highest share in the market in 2022. This is due to the high demand for APIs in the United States, the largest pharmaceutical market in the world. The rising prevalence of chronic illnesses like CDVs, cancer, and diabetes drives the US market. The US Food and Drug Administration (FDA) is one of the most stringent regulatory agencies in the world. This ensures the quality and safety of APIs manufactured in North America. Several large API manufacturers in North America, such as Pfizer, Teva Pharmaceutical Industries, and Mylan are key players in the API market. These companies can manufacture APIs in large volumes to meet the demand for APIs in the US. 

  • Tier 1 players- established companies in the market with a major market share
  • Tier 2 players
  • Emerging players which are growing rapidly
  • New Entrants

  • Growth prospects
  • SWOT analysis
  • Key trends
  • Key data-points affecting market growth

  • To provide with an exhaustive analysis on the active pharmaceuticals market By Drug Type, By Manufacturer, By Therapeutic Application, By Synthesis, By End-Use, and By Region
  • To cater comprehensive information on factors impacting market growth (drivers, restraints, industry-specific restraints and opportunities)
  • To forecast and evaluate micro-markets and the overall market
  • To predict the market size, in key regions (along with countries)— North America, Europe, Asia Pacific, Latin America and Middle East and Africa
  • To record, evaluate and analyse competitive landscape mapping- technological advancements, product launches, expansions and mergers

  • We have a flexible delivery model and you can suggest changes in the scope/table of content as per your requirement
  • The customization Mobility Care offered are free of charge with purchase of any license of the report
  • You can directly share your requirements/changes to the current table of content to: sales@futurewiseresearch.com

Table of Contents


  • 1.   Market Introduction
    •   1. Objectives of the Study
        2. Market Definition
        3. Market Scope
         3.1. Years Considered for the Study
         3.2. Market Covered
        4. Currency
        5. Limitations
        6. Stakeholders
  • 2.   Research Methodology
    •   1. Research Data
         1.1. Secondary Data
          1.1.1. Key Data from Secondary Sources
         1.2. Primary Data
          1.2.1. Key Data from Primary Sources
        2. Market Size Estimation
        3. Market Breakdown and Data Triangulation
        4. Assumptions for the Study
  • 3.   Executive Summary
    •   1. Market Outlook
        2. Segment Outlook
        3. Competitive Insights
  • 4.   Active Pharmaceutical Ingredient (API) Market Variables, Trends and Scope
    •   1. Market Lineage Outlook
        2. Penetration and Growth Prospect Mapping
        3. Industry Value Chain Analysis
        4. Cost Analysis Breakdown
        5. Technology Overview
        6. Regulatory Framework
         6.1. Reimbursement Framework
         6.2. Standards and Compliances

  • 5.   Market Overview
    •   1. Market Dynamics
         1.1. Market Driver Analysis
          1.1.1. Increasing focus of Active Pharmaceutical Ingredient (API) Market Companies on Brand Protection
          1.1.2. Untapped Opportunities in Emerging Regions
         1.2. Market Restraint Analysis
          1.2.1. High Cost Associated with Implementation of Predictive Analysis
         1.3. Industry Challenges
          1.3.1. Presence of Ambiguous Regulatory Framework
  • 6.   Active Pharmaceutical Ingredient (API) Market Analysis Tools
    •   1. Industry Analysis - Porter’s
         1.1. Supplier Power
         1.2. Buyer Power
         1.3. Substitution Threat
         1.4. Threat from New Entrants
         1.5. Competitive Rivalry
        2. Pestel Analysis
         2.1. Political Landscape
         2.2. Environmental Landscape
         2.3. Social Landscape
         2.4. Technology Landscape
         2.5. Legal Landscape
        3. Major Deals And Strategic Alliances Analysis
         3.1. Joint Ventures
         3.2. Mergers and Acquisitions
         3.3. Licensing and Partnership
         3.4. Technology Collaborations
         3.5. Strategic Divestments
        4. Market Entry Strategies
        5. Case Studies
  • 7.   Active Pharmaceutical Ingredient (API) Market, By Drug Type Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Prescription Drugs
        2. Over-the-counter Drugs

  • 8.   Active Pharmaceutical Ingredient (API) Market, By Manufacturer Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Captive (In-House) Manufacturer
        2. Merchant (Contract) Manufacturer

  • 9.   Active Pharmaceutical Ingredient (API) Market, By Therapeutic Application Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Communicable Diseases
        2. Oncology
        3. Diabetes
        4. Cardiovascular Disease
        5. Pain management
        6. Respiratory Diseases
        7. Other Therapeutic Applications

  • 10.  Active Pharmaceutical Ingredient (API) Market, By Synthesis Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Synthetic
         1.1. Type
          1.1.1. Innovative Synthetic API
          1.1.2. Generic Synthetic API
        2. Biotech
         2.1. Type
          2.1.1. Innovative Synthetic API
          2.1.2. Generic Synthetic API
         2.2. Product
          2.2.1. Monoclonal Antibodies
          2.2.2. Hormones
          2.2.3. Cytokines
          2.2.4. Recombinant Proteins
          2.2.5. Therapeutic Enzymes
          2.2.6. Vaccines
          2.2.7. Blood Factors
         2.3. Expression System
          2.3.1. Mammalian Expression Systems
          2.3.2. Microbial Expression Systems
          2.3.3. Yeast Expression Systems
          2.3.4. Insect Expression Systems
          2.3.5. Other Expression Systems

  • 11.  Active Pharmaceutical Ingredient (API) Market, By End-Use Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Pharmaceutical And Biotechnology Industry
        2. Contract Research Organizations
        3. Contract Manufacturing Organizations
        4. Other End-User

  • 12.   North America Active Pharmaceutical Ingredient (API) Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. U.S.A
         2.2. Canada
         2.3. Mexico
        3. Market Size (USD Million) Forecast for North America 2023-2031

  • 13.   Latin America Active Pharmaceutical Ingredient (API) Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Brazil
         2.2. Venezuela
         2.3. Argentina
         2.4. Rest of Latin America
        3. Market Size (USD Million) Forecast for Latin America 2023-2031

  • 14.   Europe Active Pharmaceutical Ingredient (API) Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Germany
         2.2. U.K
         2.3. France
         2.4. Italy
         2.5. Spain
         2.6. Russia
         2.7. Poland
         2.8. Rest of Europe
        3. Market Size (USD Million) Forecast for Europe 2023-2031

  • 15.   Asia Pacific Active Pharmaceutical Ingredient (API) Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Japan
         2.2. China
         2.3. India
         2.4. Australia and New Zealand
         2.5. ASEAN
         2.6. Rest of Asia Pacific
        3. Market Size (USD Million) Forecast for Asia Pacific 2023-2031

  • 16.   Middle East and Africa Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. GCC
         2.2. Israel
         2.3. South Africa
         2.4. Rest of MEA
        3. Market Size (USD Million) Forecast for MEA 2023-2031

  • 17.   Market Share Analysis and Competitive Landscape
    •   1. Global Landscape - Key Players, Revenue and Presence
        2. Global Share Analysis - Key Players (Tier 1, Tier 2, Tier 3)
        3. Global Emerging Companies
        4. North America - Market Share Analysis and Key Regional Players
        5. Europe - Market Share Analysis and Key Regional Players
        6. Asia Pacific - Market Share Analysis and Key Regional Players
        7. Global Key Player - Growth Matrix
  • 18.   Company Profiles (Competition Dashboard, Competitors Deep Dive, Products Offered and Financial Layouts)
    •   1. Pfizer, Inc.
         1.1. Company Overview
         1.2. Product Portfolio
         1.3. SWOT Analysis
         1.4. Financial Overview
         1.5. Strategic Overview
        2. Novartis International AG
         2.1. Company Overview
         2.2. Product Portfolio
         2.3. SWOT Analysis
         2.4. Financial Overview
         2.5. Strategic Overview
        3. Sanofi
         3.1. Company Overview
         3.2. Product Portfolio
         3.3. SWOT Analysis
         3.4. Financial Overview
         3.5. Strategic Overview
        4. Boehringer Ingelheim
         4.1. Company Overview
         4.2. Product Portfolio
         4.3. SWOT Analysis
         4.4. Financial Overview
         4.5. Strategic Overview
        5. Bristol-Myers Squibb
         5.1. Company Overview
         5.2. Product Portfolio
         5.3. SWOT Analysis
         5.4. Financial Overview
         5.5. Strategic Overview
        6. Teva Pharmaceutical Industries Ltd.
         6.1. Company Overview
         6.2. Product Portfolio
         6.3. SWOT Analysis
         6.4. Financial Overview
         6.5. Strategic Overview
        7. Eli Lilly and Company
         7.1. Company Overview
         7.2. Product Portfolio
         7.3. SWOT Analysis
         7.4. Financial Overview
         7.5. Strategic Overview
        8. GlaxoSmithKline plc
         8.1. Company Overview
         8.2. Product Portfolio
         8.3. SWOT Analysis
         8.4. Financial Overview
         8.5. Strategic Overview
        9. MerckCo., Inc.
         9.1. Company Overview
         9.2. Product Portfolio
         9.3. SWOT Analysis
         9.4. Financial Overview
         9.5. Strategic Overview
        10. AbbVie Inc.
         10.1. Company Overview
         10.2. Product Portfolio
         10.3. SWOT Analysis
         10.4. Financial Overview
         10.5. Strategic Overview
        11. F. Hoffmann-La Roche Ltd.
         11.1. Company Overview
         11.2. Product Portfolio
         11.3. SWOT Analysis
         11.4. Financial Overview
         11.5. Strategic Overview
        12. AstraZeneca
         12.1. Company Overview
         12.2. Product Portfolio
         12.3. SWOT Analysis
         12.4. Financial Overview
         12.5. Strategic Overview
        13. Cipla, Inc.
         13.1. Company Overview
         13.2. Product Portfolio
         13.3. SWOT Analysis
         13.4. Financial Overview
         13.5. Strategic Overview
        14. Mylan N.V.
         14.1. Company Overview
         14.2. Product Portfolio
         14.3. SWOT Analysis
         14.4. Financial Overview
         14.5. Strategic Overview
        15. Dr. Reddy’s Laboratories Ltd
         15.1. Company Overview
         15.2. Product Portfolio
         15.3. SWOT Analysis
         15.4. Financial Overview
         15.5. Strategic Overview
        16. Sun Pharmaceutical Industries Ltd.
         16.1. Company Overview
         16.2. Product Portfolio
         16.3. SWOT Analysis
         16.4. Financial Overview
         16.5. Strategic Overview
        17. API Pharma Tech
         17.1. Company Overview
         17.2. Product Portfolio
         17.3. SWOT Analysis
         17.4. Financial Overview
         17.5. Strategic Overview
        18. BDR Pharmaceuticals Internationals Pvt. Ltd.
         18.1. Company Overview
         18.2. Product Portfolio
         18.3. SWOT Analysis
         18.4. Financial Overview
         18.5. Strategic Overview
        19. Sreepathi Pharmaceuticals Limited
         19.1. Company Overview
         19.2. Product Portfolio
         19.3. SWOT Analysis
         19.4. Financial Overview
         19.5. Strategic Overview
        20. Shilpa Medicare Limited
         20.1. Company Overview
         20.2. Product Portfolio
         20.3. SWOT Analysis
         20.4. Financial Overview
         20.5. Strategic Overview
        21. Albemarle Corporation
         21.1. Company Overview
         21.2. Product Portfolio
         21.3. SWOT Analysis
         21.4. Financial Overview
         21.5. Strategic Overview
        22. Viatris Inc.
         22.1. Company Overview
         22.2. Product Portfolio
         22.3. SWOT Analysis
         22.4. Financial Overview
         22.5. Strategic Overview
        23. Aurobindo Pharma
         23.1. Company Overview
         23.2. Product Portfolio
         23.3. SWOT Analysis
         23.4. Financial Overview
         23.5. Strategic Overview
        24. Biocon
         24.1. Company Overview
         24.2. Product Portfolio
         24.3. SWOT Analysis
         24.4. Financial Overview
         24.5. Strategic Overview

  • 19.   Pre and Post COVID-19 Impact
    •   1. Positive influence on the healthcare industry
        2. The financial disruption of the manufacturing sector
        3. Impact of COVID-19 on emerging companies
        4. Significant mandates in the healthcare regulations initiated by administrations
        5. The overall economic slowdown of the developing and developed nations
  • 20.   FutureWise SME Key Takeaway Points for Client

FAQ


The global API market is anticipated to experience significant growth over the next few years. Factors such as the increasing prevalence of chronic diseases, advancements in biotechnology, and a rise in geriatric population contribute to this growth. Projections often suggest a steady compound annual growth rate (CAGR), influenced by the need for new medicines and therapies.

Yes, the production and sale of APIs are highly regulated to ensure safety, quality, and efficacy of drugs. Regulations vary by country but typically involve stringent guidelines for manufacturing processes, testing, and documentation. Regulatory authorities like the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) oversee these standards.

Key factors influencing the API market trends include technological advancements in drug development, increased investment in research and development (R&D), government initiatives to encourage generic drug use, patent expiries of blockbuster drugs, and growing demand for highly potent APIs. Additionally, shifts towards personalized medicine and an increase in the outsourcing of API production are also impactful.

Yes, the global API market size is experiencing substantial growth. Factors contributing to this growth include an increasing incidence of chronic diseases, a surge in the geriatric population, advancements in biotechnological research, growth in pharmaceutical outsourcing, and a rise in investments in API manufacturing facilities.

Key changes and trends in the API market include increased focus on generic APIs due to their cost-effectiveness, the shift towards outsourcing API production, heightened demand for specialized and high-potency APIs, adoption of advanced manufacturing technologies, and growing emphasis on sustainable practices in API production.

Related Market

Drug Formulation Market

Read More

Pharmaceuticals Lipids Market

Read More

Phytochemical API Market

Read More

Small Molecule API Market

Read More

Heparin API Market

Read More

Antibiotic Active Pharmaceutical Ingredient Market

Read More

Insulin API Market

Read More

Acetaminophen API Market

Read More

Vitamin B12 API Market

Read More
Partner

Our Clients