Active Pharmaceutical Ingredients (API) Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2020-2027

The global active pharmaceutical ingredients market size was valued at US$ 162 bn in 2018 and is expected to grow at a CAGR of 5.7% from 2020 to 2027.

The global active pharmaceutical ingredients market size is expected to expabnd over US$ 257,480.6 mn by 2027, increase in abbreviated new drug applications (ANDA) in the past few years and rise in government prioritization for biomedical innovation are projected to drive the global active pharmaceutical ingredients (API) market during the forecast period.

The study has considered the base year as 2019, which estimates the market size of market and the forecast period is 2020 to 2027. The report analyzes and forecasts the market size, in terms of volume (thousand units) and value (USD million), for the market. The report provides a detailed analysis of various forces acting in the market (drivers, restraints, opportunities, and challenges). The report covers key players and comprehensively analyzes their market shares and core competencies. It also tracks and analyzes competitive developments such as joint ventures, mergers & acquisitions, new product launches, expansions, and other activities carried out by key industry participants.

A Key Driver

• In order to market a generic drug, a company needs to file Abbreviated New Drug Application (ANDA). An ANDA approval implies that the generic drug is comparable to the original drug in terms of dosage form, strength, route of administration, quality, performance characteristics, and intended use.
• However, companies cannot manufacture a generic drug unless the patent of the original drug expires. Hence, when a billion dollar drug loses patent, other drug manufacturers grab the opportunity to manufacture low cost generics and file for ANDA to the U.S. FDA. The pharmaceutical industry has suffered significantly due to patent expiry of blockbuster drugs in the past few years. Demand for low cost substitutes is high in low- and middle-income countries in Asia Pacific, Africa, and Latin America. This in turn has increased the number of active pharmaceutical ingredients (API) manufacturers, as pharmaceutical drug manufacturers do not have enough in-house capacity to meet the demand.
• Currently, majority of the API manufacturers are concentrated in Asian Pacific, primarily India, China, and Taiwan. Teva Active Pharmaceutical Ingredients (TAPI), Aurobindo, and Sun Pharma are the leading API manufacturers in the region.

Increase in Government Prioritization of Biomedical Innovation Globally to Fuel Market

Governments across the world have prioritized biomedical innovation. Accelerated regulatory review by the FDA for innovative medicines boosts the global active pharmaceutical ingredients market. The FDA has approved more than 45 drugs in 2017. Drugs approved by the FDA are used for the treatment of relapsed or refractory acute lymphoblastic leukemia, relapsed breast cancer, moderate-to-severe plaque psoriasis, advanced or metastatic urothelial carcinoma, acute bacterial skin infections, Chagas disease, open-angle glaucoma or ocular hypertension, type 2 diabetes mellitus, and septic or other distributive shock.

Increase in the Incidence of Acute and Chronic Diseases Globally to Fuel Market

Rise in the prevalence of cancer, cardiovascular diseases, and diabetes; sedentary lifestyles; and a rise in the aging population are key factors driving the active pharmaceutical ingredients (API) market. As per the National Cancer Institute, in 2016, there were an estimated 15.5 million cancer survivors in the U.S.. The number of cancer survivors is expected to increase to 20.3 million by 2026. As per an EU government agency survey, almost 49 million people were living with cardiovascular disease in the EU in 2017. Lung cancer is the leading cause of cancer deaths in Asia Pacific. China alone accounts for more than 50% of all cancer cases in this region. Changes in lifestyle and socio-cultural factors are propelling the incidence of cervical cancer. Major countries affected by breast cancer in Asia Pacific are India, Thailand, and China.

The Dominant In-house API Manufacturing Segment is Estimated to Lose Market Share During the Forecast Period

The in-house API manufacturing segment includes the active pharmaceutical ingredients produced for the internal consumption of a pharmaceutical company. The revenue of the in-house API manufacturing segment has declined in the past few years due to outsourcing of API production. High degree of competition and reduced profitability are the key factors attributed to the increased preference for outsourcing API production over in-house API manufacturing.

The Synthetic Chemical API Segment is Projected to Lead the Active Pharmaceutical Ingredients Market

Around 66.0% of the APIs currently available in the market constitute synthetic chemical APIs, popularly known as small molecules. Although the top-selling drugs are biologics, the number of these drugs is quite small as compared to the small molecule drugs. Currently, over 3,000 small molecule drugs are available in the market, which provides significant business opportunities for synthetic API production.

Anti-infective Drugs and Cardiovascular Drugs Lead the Market

In terms of therapeutic, the market has been categorized into anti-infective drugs, metabolic disorders drugs, cardiovascular drugs, oncology drugs, central nervous system drugs, respiratory diseases drugs and others. The anti-infective drugs segment is likely to account for a leading share of the market during the forecast period. Increase in the incidence of cardiovascular diseases is anticipated to fuel the cardiovascular drugs segment during the forecast period.

Asia Pacific Offers Significant Business Development Opportunity

North America and Asia Pacific accounted for a key share of the global active pharmaceutical ingredients market in 2017. The regions are likely to gain market share by the end of 2026. High adoption of biotech/biological APIs and government initiatives to promote innovative medicine have contributed to the leading share held by these regions in the global active pharmaceutical ingredients market. Asia Pacific is projected to be a highly attractive region of the active pharmaceutical ingredients market. The market in Asia Pacific is projected expand at a high CAGR of over 6.0% during the forecast period, due to the significant scale of drug production in the region. China and India are part of top three countries globally in terms of drug volume production. The market in Latin America and Middle East & Africa is anticipated to expand at a moderate growth rate during the forecast period.

Leading players operating in the global active pharmaceutical ingredients (API) market are 

• Teva Pharmaceutical Industries Ltd.
• Sun Pharmaceutical Industries Ltd.
• Aurobindo Pharma, Pfizer, Inc.
• Boehringer Ingelheim International GmbH.
• Merck & Co., Inc.
• Novartis AG
• F. Hoffmann-La Roche Ltd
• Bayer AG.

Report Segmentation:

Global Active Pharmaceutical Ingredients (API) Market, by Manufacturer

• In-house API Manufacturing
• API Contract Manufacturing

Global Active Pharmaceutical Ingredients (API) Market, by APIs

• Synthetic Chemical API
• Biotech/Biological API
• Plant Extracts API
• High-potency API
• Classical Fermentation API

Global Active Pharmaceutical Ingredients (API) Market, by Drug

• Branded or Innovative Prescription Drugs
• Generic Prescription Drugs
• over-the-counter (OTC) Drugs
• Others

Global Active Pharmaceutical Ingredients (API) Market, by Therapeutic

• Anti-infective Drugs
• Metabolic Disorders Drugs
• Cardiovascular Drugs
• Oncology Drugs
• Central Nervous System Drugs
• Respiratory Diseases Drugs
• Others 

Global Active Pharmaceutical Ingredients (API) Market, by Region

• North America
  • U.S.
  • Canada
• Europe
  • U.K.
  • Germany
  • France
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • Australia & New Zealand
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • GCC
  • South Africa
  • Israel
  • Rest of Middle East & Africa

The Active pharmaceutical ingredients (API) market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.

The report provides size (in terms of volume and value) of Active pharmaceutical ingredients (API) market for the base year 2019 and the forecast between 2020 and 2027. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.

This report focuses on the global Active pharmaceutical ingredients (API) market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Active pharmaceutical ingredients (API) market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted Active pharmaceutical ingredients (API) market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.

In terms of production side, this report researches the Active pharmaceutical ingredients (API) capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.

In terms of consumption side, this report focuses on the consumption of Active pharmaceutical ingredients (API) by regions (countries) and application.

Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Active pharmaceutical ingredients (API) market. These figures have been provided in terms of both revenue and volume for the period 2016 to 2027. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.

With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Active pharmaceutical ingredients (API) market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Active pharmaceutical ingredients (API) market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.

The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.

Overall, this is an in-depth research report specifically for the Active pharmaceutical ingredients (API) industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.

Active pharmaceutical ingredients (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 ingredients (API) market.

Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Active pharmaceutical ingredients (API) market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.

Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Active pharmaceutical ingredients (API) market. These factors have benefited the growth of the global market for Active pharmaceutical ingredients (API). Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.

New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Active pharmaceutical ingredients (API). The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).

In this study, the years considered to estimate the market size of Active pharmaceutical ingredients (API) are as follows:

• History Year: 2016-2019
• Base Year: 2019
• Estimated Year: 2020
• Forecast Year 2020 to 2027

Reasons to Purchase this Report:

- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Research Methodology:

In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

Market Size Estimation

Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).

The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.

Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.

All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.

Market Breakdown and Data Triangulation

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.

Secondary Sources

Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.

Primary Sources

 In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.

The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.

The study objectives of this report are:

• To analyze and study the global market capacity, production, value, consumption, status (2016-2019) and forecast (2020-2027);
• Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
• Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
• To define, describe and forecast the market by type, application and region.
• To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
• To identify significant trends and factors driving or inhibiting the market growth.
• To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
• To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
• To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
• To strategically profile the key players and comprehensively analyze their growth strategies.