Global Active Pharmaceutical Ingredient (API) Market – Industry Trends and Forecast to 2031

Global Active Pharmaceutical Ingredient (API) Market, By Molecule (Small Molecule and Large Molecule), Type (Innovative Active Pharmaceutical Ingredients and Generic Innovative Active Pharmaceutical Ingredients), Type of Manufacturer (Captive API Manufacturer and Merchant API Manufacturer), Synthesis (Synthetic Active Pharmaceutical Ingredients and Biotech Active Pharmaceutical Ingredients), Chemical Synthesis (Acetaminophen, Artemisinin, Saxagliptin, Sodium Chloride, Ibuprofen, Losartan Potassium, Enoxaparin Sodium, Rufinamide, Naproxen, Tamoxifen, and Others), Type of Drug (Prescription Drugs and Over-the-Counter), Usage (Clinical and Research), Potency (Low-to-Moderate Potency Active Pharmaceutical Ingredients and Potent-to-Highly Potent Active Pharmaceutical Ingredient), Therapeutic Application (Cardiology, CNS and Neurology, Oncology, Orthopedic, Endocrinology, Pulmonology, Gastroenterology, Nephrology, Ophthalmology, and Other Therapeutic Application) – Industry Trends and Forecast to 2031.

Active Pharmaceutical Ingredient (API) Market Analysis and Size

The active pharmaceutical ingredients (APIs) market is pivotal in providing the essential components for pharmaceutical formulations. In painkillers such as crocin and paracetamol API is the active ingredient responsible for alleviating pain. The demand for paracetamol remains high due to their widespread use of API drugs for pain relief. This drives growth in the API market, with manufacturers focusing on quality, efficiency, and compliance to meet global pharmaceutical standards.

Global active pharmaceutical ingredient (API) market size was valued at USD 237.81 million in 2023 and is projected to reach USD 393.58 million by 2031, with a CAGR of 6.50 % during the forecast period of 2024 to 2031. In addition to the market insights such as market value, growth rate, market segments, geographical coverage, market players, and market scenario, the market report curated by the Data Bridge Market Research team includes in-depth expert analysis, import/export analysis, pricing analysis, production consumption analysis, patent analysis, and consumer behavior.  

Report Scope and Market Segmentation       

Market Definition

Active pharmaceutical ingredients (APIs) are the primary components in medications responsible for their therapeutic effects. They are the biologically active substances that treat medical conditions. APIs can be synthetic or derived from natural sources and are formulated into various dosage forms such as tablets, capsules, or injections. Once ingested or administered APIs interact with the body to produce the desired therapeutic effect. They undergo stringent quality control measures to ensure the safety and efficacy of pharmaceutical products.

Active Pharmaceutical Ingredient (API) Market Dynamics

Drivers

• Growing Demand for Pharmaceutical Products

As the global population grows and ages, the prevalence of various medical conditions rises, driving the need for medications. APIs serve as the essential components in drug formulations, making them indispensable in meeting this growing demand. Additionally, advancements in healthcare access and awareness further fuel the demand for APIs to develop and manufacture a wide range of pharmaceutical products. Thus, the increasing demand for pharmaceutical products acts as a major driver for the active pharmaceutical ingredients (APIS) market growth.

• Increasing Prevalence of Chronic Diseases

The escalating prevalence of chronic diseases worldwide for the active pharmaceutical ingredients (APIs) market. Conditions such as diabetes, cardiovascular diseases, and cancer are becoming more prevalent due to factors such as aging populations and lifestyle changes. APIs are vital components in the formulation of medications to manage chronic diseases, fueling demand for these ingredients. Consequently, active pharmaceutical ingredients manufacturers require a steady supply of APIs to meet the growing need for effective treatments, which is driving the market growth.

Opportunities

• Rising Geriatric Population Requiring Medication

As people age, they typically require more medication to manage chronic conditions such as hypertension, arthritis, and dementia. APIs are essential components in formulating drugs for these ailments, driving demand for API production. With the elderly population projected to increase significantly in the coming years, pharmaceutical companies will increasingly rely on APIs to meet the growing demand for medications tailored to the needs of older adults. Thus, the rising geriatric population globally is a key driver for the active pharmaceutical ingredients (APIS) market growth.

• Technological Advancements in API Production

Technological advancements in active pharmaceutical ingredient (API) production drive efficiency, quality, and innovation in the pharmaceutical industry. Improved manufacturing processes, such as continuous manufacturing and biocatalysis, enhance API yield and purity while reducing costs and environmental impact. Automation and data analytics optimize production workflows, leading to faster development and scale-up of API manufacturing. These advancements enable pharmaceutical companies to meet growing demand, develop complex APIs, and maintain competitiveness in the global market.

Restraints/Challenges

• Pricing Pressures from Generic API Competitors

Pricing pressures from generic API competitors pose a significant challenge for the Active Pharmaceutical Ingredients (APIs) market. Generic API manufacturers often offer similar products at lower prices, intensifying competition and eroding profit margins for branded API producers. As a result, companies may struggle to maintain profitability and invest in research and development for new APIs. Additionally, pricing pressures may lead to cost-cutting measures that compromise quality or innovation, impacting the overall competitiveness of the API market.

• Limited Availability of Raw Material

Many APIs rely on specific raw materials sourced from natural or synthetic origins, and disruptions in the supply chain can lead to shortages or price fluctuations. Factors such as environmental regulations, geopolitical tensions, and natural disasters can all impact the availability of raw materials, making it challenging for API manufacturers to maintain consistent production. This constraint can hinder the timely delivery of APIs to pharmaceutical companies, affecting drug manufacturing and ultimately patient access to medications. Hence, the limited availability of raw materials is a critical restraint in the active pharmaceutical ingredients (APIs) market growth.

This market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the contact Data Bridge Market Research for an Analyst Brief, our team will help you make an informed market decision to achieve market growth.

Recent Developments

• In 2022, Pfizer entered into an agreement with Acuitas to deliver a lipid nanoparticle delivery system for use in mRNA vaccines such as COMIRNATY (tozinameran) and therapeutics. This innovation facilitates wider adoption of mRNA therapeutics, propelling the active pharmaceutical ingredient market growth by providing more efficient and scalable delivery solutions for novel treatments
• In 2022, Sanofi and IGM announced a strategic collaboration agreement to streamline and optimize the development and commercialization of IgM antibody agonists for oncology, immunology, and inflammation target. This collaboration accelerates the introduction of innovative treatments, expanding the pipeline of active pharmaceutical ingredients and fostering market growth by addressing unmet medical needs in oncology, immunology, and inflammation
• In 2021, U.S. FDA approved a new drug by Teva Pharmaceutical and MEDinCell to treat schizophrenia. Furthermore, legal issues are decelerating the establishment of new API facilities.  This approval stimulates demand for Active Pharmaceutical Ingredients (APIs) used in its production

Active Pharmaceutical Ingredient (API) Market Scope

The market is segmented into eight notable segments based on molecule, type, synthesis, chemical synthesis, type of drug, usage, potency, and therapeutic application. The growth amongst these segments will help you analyze meager growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Molecule

• Small Molecule
• Large Molecule

 Type

• Innovative Active Pharmaceutical Ingredients
• Generic Innovative Active Pharmaceutical Ingredients

Type of Manufacturer

• Captive API Manufacturer
• Merchant API Manufacturer

Synthesis

• Synthetic Active Pharmaceutical Ingredients
• Biotech Active Pharmaceutical Ingredients

Chemical Synthesis

• Acetaminophen
• Artemisinin
• Saxagliptin
• Sodium Chloride
• Ibuprofen
• Losartan Potassium
• Enoxaparin Sodium
• Rufinamide
• Naproxen
• Tamoxifen
• Others

Type of Drug

• Prescription Drugs
• Over-the-Counter

Usage

• Clinical
• Research

 Potency

• Low-to-Moderate Potency Active Pharmaceutical Ingredients
• Potent-to-Highly Potent Active Pharmaceutical Ingredient

Therapeutic Application

• Cardiology
• CNS and Neurology
• Oncology
• Orthopedic
• Endocrinology
• Pulmonology
• Gastroenterology
• Nephrology Ophthalmology
• Other Therapeutic Application

Active Pharmaceutical Ingredient (API) Market Regional Analysis/Insights

The market is analyzed and market size insights and trends are provided by based molecule, type, synthesis, chemical synthesis, type of drug, usage, potency, and therapeutic application as referenced above.

The countries covered in the market report are U.S., Canada, Mexico, Germany, Italy, U.K., France, Spain, Netherlands, Belgium, Switzerland, Turkey, Russia, rest of Europe, China, India, South Korea, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific, South Africa, Saudi Arabia, U.A.E., Egypt, Israel, Rest of Middle East and Africa, Brazil, Argentina, and Rest of South America.

North America is dominating the market because of the increasing healthcare expenditures and well-established healthcare infrastructure.

Asia-Pacific is expected to be the fastest-growing region in the market because of the increased consumption demand for active pharmaceutical ingredients.

The country section of the report also provides individual market-impacting factors and changes in regulation in the market domestically that impact the current and future trends of the market. Data points such as down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.   

Healthcare Infrastructure Growth Installed Base and New Technology Penetration

The market also provides you with a detailed market analysis for every country growth in healthcare expenditure for capital equipment, installed base of different kind of products for the market, the impact of technology using lifeline curves and changes in healthcare regulatory scenarios and their impact on the market. The data is available for the historic period 2016-2021.

Competitive Landscape and Active Pharmaceutical Ingredient (API) Market Share Analysis

The market competitive landscape provides details by competitors. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, and application dominance. The above data points provided are only related to the companies' focus related to the market.

Some of the major players operating in the market are:

• Novartis AG (Switzerland)
• Sanofi (France)
• Pfizer Inc. (U.S.)
• Johnson & Johnson Private Limited (U.S.)
• Abbott (U.S.)
• Teva Pharmaceutical Industries Ltd. (Israel)
• Bausch Health Companies Inc. (Canada)
• Sunovion Pharmaceuticals Inc. (U.S.)
• Jazz Pharmaceuticals, Inc. (U.K.)
• AstraZeneca (U.K.)
• GSK plc (U.K.)
• H. Lundbeck A/S (Denmark)
• Takeda Pharmaceutical Company Limited (Japan)
• Sumitomo Dainippon Pharma Co., Ltd. (Japan)
• Cadila Pharmaceuticals (India)