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Global Active Pharmaceutical Ingredient (API) Market – Industry Trends and Forecast to 2030

  • Pharmaceutical
  • Upcoming Report
  • Dec 2022
  • Global
  • 350 Pages
  • No of Tables: 220
  • No of Figures: 60

Global Active Pharmaceutical Ingredient (API) Market – Industry Trends and Forecast to 2030

Market Size in USD Billion

CAGR - 6.5% Diagram

Diagram Forecast Period 2022–2030
Diagram Market Size (Base Year) USD 223.30 Billion
Diagram Market Size (Forecast Year) USD 369.56 Billion
Diagram CAGR 6.5%

Global Active Pharmaceutical Ingredient (API) Market, By 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 and 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 & Neurology, Oncology, Orthopedic, Endocrinology, Pulmonology, Gastroenterology, Nephrology, Ophthalmology, Other Therapeutic Application) – Industry Trends and Forecast to 2030.

Active Pharmaceutical Ingredient (API) Market Analysis and Size

The growing demand for pharmaceutical drugs is projected to increase the global active pharmaceutical ingredients (API) market during the forecast period. Several market players are looking to influence their production capabilities in Asian countries to offer APIs to several other drugmakers. Furthermore, producers use exact measures to assess the strength of API in each drug.

Data Bridge Market Research analyses that the active pharmaceutical ingredient (API) market is expected to reach USD 369.56 million by 2030, which is USD 223.3 million in 2022, and is expected to undergo a CAGR of 6.50% during the forecast period 2023 to 2030. 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 also includes in-depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Active Pharmaceutical Ingredient (API) Market Scope and Segmentation

Report Metric

Details

Forecast Period

2023 to 2030

Base Year

2022

Historic Years

2021 (Customizable to 2015 - 2020)

Quantitative Units

Revenue in USD Million, Volumes in Units, Pricing in USD

Segments Covered

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 and 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 & Neurology, Oncology, Orthopedic, Endocrinology, Pulmonology, Gastroenterology, Nephrology, Ophthalmology, Other Therapeutic Application)

Countries Covered

U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America

Market Players Covered

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), UCB S.A. (Belgium), 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)

Market Opportunities

  • Increasing Demand of Highly Potent Active Pharmaceutical Ingredients
  • Higher Adoption of Synthetic API

Market Definition

The active pharmaceutical ingredient (API) is an active component of a drug. Drugs consist of different components, where the primary ingredient is the API. Other ingredients are usually named as excipients, and these elements should be biologically innoxious. The procedure for optimizing and compositing this mixture of ingredients that is used in medicine is known as formulation. There are few drugs that have multiple active APIs to treat numerous symptoms. Most of the production of APIs has been performed by the local pharmaceutical companies.

Active Pharmaceutical Ingredient (API) Market Dynamics

Drivers

  • Rising Incidence of Chronic Diseases

Rise in prevalence of chronic diseases boosts the market. In 2019, as per the International Diabetes Federation, around 463 million people globally were diagnosed with diabetes. Furthermore, the number of new cancer cases each year is projected to rise upto 23.6 million by 2030. Besides cancer, many other diseases have shown increased incidence rates. Thus, these increasing chronic disease cases increase the market's need and growth.

  • Growing Approvals from ANDA

The rising approvals in Abbreviated New Drug Applications (ANDA) increases the demand for active pharmaceutical ingredients (API). A company needs to file Abbreviated New Drug Application (ANDA) to market a generic drug. An ANDA approval means that the generic drug is somewhat similar to the original drug with respect to the dosage form, route of administration, strength, quality, performance characteristics, and intended use. Thus, these approvals are helping in faster adoption of APIs.

Opportunities

  • Higher Adoption of Synthetic API

The major procedures in the API process may include multi-step drug synthesis and fermentation, crystallization, drying, packing, purification, milling, labeling, and testing. Some drugs treated to an API may be a bulk-finished product. Furthermore, active pharmaceutical ingredients in pediatric formulations have drawn major attention from regulatory agencies globally, because of the safety concerns. In numerous drug pipelines, small molecule drugs are attracting much popularity currently. The small molecule drugs have the highest number of regulatory approval, and the increasing trend is projected to continue in the coming future. This factor is boosting the market growth.   

  • Increasing Demand of Highly Potent Active Pharmaceutical Ingredients

Highly potent active pharmaceutical ingredients also known as HPAPIs indicate a huge shift in the fact that pharmaceutical companies use small molecules to offer new medicines. Consequently, a pipeline of effective drugs with lower doses has developed. HPAPIs' advantages, which includes the requirement for a lower therapeutic dose, capacity to bind to specific receptors, and high efficiency, can be credited to their increasing demand among producers and customers. Several API manufacturers are adopting HPAPIs to differentiate themselves from the competition as the generic API industry becomes gradually competitive. This increases the market growth.

Restraints/Challenges

  • Late Approvals from Organizations

There are several companies that cannot manufacture a drug unless the patent of a drug termintates. Therefore, various chances make the billion dollar drugs lose patents. This hampers the market growth.

  • Unavailability of Appropriate Treatments

The requirement of high capital for the production of APIs is because the process needs extremely systematic protocols, which results in the outsourcing of various APIs. It cannot be afforded by the low and middle economic countries. Thus, the demand for low cost substitutes is more in low- and middle-income countries in Africa, Asia Pacific, and Latin America.

This active pharmaceutical ingredient (API) 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 active pharmaceutical ingredient (API) market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

COVID-19 Impact on Global Active Pharmaceutical Ingredient (API) Market

The COVID-19 pandemic had a major significant impact on the global APIs market. Several scientists developed a list of compounds that target COVID-19. Presently, there are around 155 compounds in clinical trials and 45 molecules in preclinical development to protect COVID-19. The API market underwent immense changes because of the supply chain disruption by COVID-19. Countries such as India are favored over China for exporting API due to geopolitical situations and the increasing demand to decrease dependence on China for different API products.

Recent Developments

  • In 2021, U.S. FDA approved a new drug by Teva Pharmaceutical and MEDinCell to treat schizophrenia. Furthermore, legal issues are decelerating down the establishment of new API facilities.

Global Active Pharmaceutical Ingredient (API) Market Scope

The active pharmaceutical ingredient (API) market is segmented on the basis of molecule, type, type of manufacturer, synthesis, chemical synthesis, type of drug, usage, potency and therapeutic application. The growth amongst these segments will help you analyze meagre 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 Active Pharmaceutical Ingredients

Type of manufacturer

  • Captive API Manufacturer
  • Merchant API Manufacturer

Synthesis

  • Synthetic Active Pharmaceutical Ingredients
  • Biotech Active Pharmaceutical Ingredients

Indications

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

Type of drugs

  • Prescription drugs
  • Over the counter drugs

Usage

  • Clinical
  • Research

Potency

  • Low-to-moderate potency active pharmaceutical ingredients
  • Potent-to-highly potent active pharmaceutical ingredient

Therapeutic application

  • Cardiology
  • CNS & neurology
  • Oncology
  • Orthopaedic
  • Endocrinology
  • Pulmonology
  • Gastroenterology
  • Nephrology
  • Ophthalmology
  • Other Therapeutic Application

 Distribution Channel

  • Hospital Pharmacy
  • Retail Pharmacy
  • Online Pharmacies
  • Others

Active Pharmaceutical Ingredient (API) Market Regional Analysis/Insights

The active pharmaceutical ingredient (API) market is analyzed and market size insights and trends are provided by molecule, type, type of manufacturer, synthesis, chemical synthesis, type of drug, usage, potency and therapeutic application as referenced above.

The major countries covered in the active pharmaceutical ingredient (API) market report are the U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

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

Asia-Pacific is considered to have the most lucrative period 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 impacts the current and future trends of the market. 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.   

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

The active pharmaceutical ingredient (API) market competitive landscape provides details by competitor. 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, application dominance. The above data points provided are only related to the companies' focus related to active pharmaceutical ingredient (API) market

Key players operating in the active pharmaceutical ingredient (API) market include:

  • 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)
  • UCB S.A. (Belgium)
  • 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)


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Research Methodology:

Data collection and base year analysis are done using data collection modules with large sample sizes. The stage includes obtaining market information or related data through various sources and strategies. It includes examining and planning all the data acquired from the past in advance. It likewise envelops the examination of information inconsistencies seen across different information sources. The market data is analysed and estimated using market statistical and coherent models. Also, market share analysis and key trend analysis are the major success factors in the market report. To know more, please request an analyst call or drop down your inquiry.

The key research methodology used by DBMR research team is data triangulation which involves data mining, analysis of the impact of data variables on the market and primary (industry expert) validation. Data models include Vendor Positioning Grid, Market Time Line Analysis, Market Overview and Guide, Company Positioning Grid, Patent Analysis, Pricing Analysis, Company Market Share Analysis, Standards of Measurement, Global versus Regional and Vendor Share Analysis. To know more about the research methodology, drop in an inquiry to speak to our industry experts.

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Data Bridge Market Research is a leader in advanced formative research. We take pride in servicing our existing and new customers with data and analysis that match and suits their goal. The report can be customized to include price trend analysis of target brands understanding the market for additional countries (ask for the list of countries), clinical trial results data, literature review, refurbished market and product base analysis. Market analysis of target competitors can be analyzed from technology-based analysis to market portfolio strategies. We can add as many competitors that you require data about in the format and data style you are looking for. Our team of analysts can also provide you data in crude raw excel files pivot tables (Fact book) or can assist you in creating presentations from the data sets available in the report.

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FREQUENTLY ASK QUESTIONS

The active pharmaceutical ingredient (API) market size will be worth USD 369.56 million by 2030.
The growth rate of the active pharmaceutical ingredient (API) market is 6.50% in the forecast period by 2030.
Type, synthesis, type of drug, usage, potency & therapeutic application are the factors on which the active pharmaceutical ingredient (API) market research is based.
Rising incidence of chronic diseases & growing approvals from ANDA are the growth drivers of the active pharmaceutical ingredient (API) market.
Major companies in the active pharmaceutical ingredient (API) 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), UCB S.A. (Belgium), 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).
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