According to FutureWise analysis the market for Active Pharmaceutical Ingredient (API) in 2023 was US$ 236.01 billion, and is expected to reach US$ around 379.59 billion by 2031 at a CAGR of 6.1%.
Active pharmaceutical ingredients (APIs) are the chemical compounds responsible for the pharmacological effects of medicines. These physiologically active ingredients are essential for the therapeutic impact of drugs. Pharmaceutical products, which are also known as finished dosage forms, include a variety of formats such as tablets, capsules, injections, creams, and syrups. They are formulated using APIs along with other inert substances.
The development and manufacture of APIs utilize various processes depending on the nature of the substance. These methods may include chemical synthesis, fermentation, extraction, or biotechnological techniques. APIs can be produced through synthetic methods in laboratories or sourced from natural origins like plants or microbes. Factors such as availability, cost, scalability, and legal regulations play a significant role in determining the most appropriate synthesis method for an API.
The pharmaceutical industry follows a two-step process during drug development: the discovery and creation of a new molecule, and the subsequent production of the medicine itself. Initially, researchers focus on identifying and developing promising medication molecules. After undergoing extensive testing and securing regulatory approval, these molecules are established as active pharmaceutical ingredients.
APIs are integral to the pharmaceutical supply chain. Pharmaceutical companies may either manufacture their own APIs or outsource this production to specialized API manufacturers. These producers are tasked with creating high-quality APIs that comply with rigorous regulatory standards. APIs must meet strict quality criteria to ensure their consistency, efficacy, and safety. Regulatory bodies, such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), impose guidelines that cover various aspects, including 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 (API) Market trends that are affecting the overall market growth.
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Active Pharmaceutical Ingredient (API) Market Segmentation:
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
o Type
Innovative Synthetic API
Generic Synthetic API
• Biotech
o Type
Innovative Synthetic API
Generic Synthetic API
o Product
Monoclonal Antibodies
Hormones
Cytokines
Recombinant Proteins
Therapeutic Enzymes
Vaccines
Blood Factors
o 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
Competitive Landscape in Active Pharmaceutical Ingredient (API) Market:
• 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
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**Objectives of this Study: **
1. To provide a comprehensive analysis of the Active Pharmaceutical Ingredient (API) Market By Drug Type, By Manufacturer, By Therapeutic Application, By Synthesis, By End-Use and By Region.
2. To offer detailed insights into factors such as drivers, restraints, trends, and opportunities, as well as segmental and regional influences on market growth.
3. To evaluate current market trends and forecast micro-markets, presenting overall market projections in the form of data sets and PowerPoint presentations.
4. To predict the market size in key regions, including North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa.
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