Active Pharmaceutical Ingredients (API) Market (By Manufacturer Type: In House Manufacturing and Contract Manufacturing; By Drug Type: Branded or Innovative Prescription Drugs, Generic Prescription Drugs, Over-the-counter [OTC] Drugs; By API Type; By Application; By End User) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2021-2030

Published Date : Sep 2021 | No. of Pages : 150+ Pages | Category : Healthcare

The global active pharmaceutical ingredients market size is expected to reach around US$ 328 billion by 2030. The global active pharmaceutical ingredients market size was valued at US$ 169 bn in 2020 and is anticipated to grow at a CAGR of 6.1% from 2021 to 2030.

Active Pharmaceutical Ingredients (API) Market Size 2021 to 2030

An active pharmaceutical ingredient (API) is any substance or mixture of substances used in the finished pharmaceutical product (FPP) that is intended to provide pharmacological action or to otherwise have a direct impact in the diagnosis, remedy, mitigation, therapy, or prevention of disease, or to have a direct effect in repairing, correcting, or altering physiological functions in humans.

The global active pharmaceutical ingredients (API) market has experienced significant growth in the last decade, due to increase in incidence of chronic diseases

Increase in Abbreviated New Drug Applications (ANDA) drives demand for active pharmaceutical ingredients (API). 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 drug unless the patent of a drug expires. Hence, as billion dollar drugs lose patents, 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 increases the number of API manufacturers, as pharmaceutical drug manufacturers did not have enough in-house capacity to meet the demand.

Currently, majority of API manufacturers is concentrated in Asia 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 incidence of chronic diseases drives the global active pharmaceutical ingredients (API) market. According to the International Diabetes Federation, in 2019, 463 million people across the world were diagnosed with diabetes. Moreover, the number of new cancer cases per year is expected to increase to 23.6 million by 2030. Apart from cancer, a number of other diseases have shown rise in prevalence rates. Rise in prevalence of cancer, cardiovascular diseases, and diabetes; surge in sedentary lifestyle; and increase in geriatric population are the key drivers of the active pharmaceutical ingredients (API) market.

Lung cancer is the leading cause of cancer deaths in Asia Pacific. China alone accounts for over 50% of all cancer cases in the region. Changes in lifestyle and socio-cultural factors are the leading causes of cervical cancer. Major countries affected by breast cancer in Asia Pacific are India, Thailand, and China.

Small molecule drugs account for major share of the current drug pipeline. Despite new biologic entities entering the market, small molecules are experiencing a surge in usage in the clinical pipeline. Maximum number of FDA approvals in the last decade have been for small molecule drugs, and the trend is likely to continue during the forecast period.

In House Manufacturing to Dominate Global Market

In terms of manufacture type, the global active pharmaceutical ingredients (API) market has been segmented into in house manufacturing and contract manufacturing. The in house manufacturing segment dominated the global active pharmaceutical ingredients (API) market in 2020 and the trend is projected to continue during the forecast period. Global players, such as Merck KGaA, prefer in-house production of APIs. This is a major factor driving the segment. These players believe that in house manufacture provides control of the process from start to finish. It offers the flexibility to adapt as and when required. This is especially useful when a company wants to respond to the market quickly and make a consumer-led change to the product, as it does not have to go through another company or rely on anyone else. These factors are anticipated to boost the growth of the segment during the forecast period.

Labor costs constitute majority of the cost of any manufacturing process. Outsourcing manufacturing eliminates the responsibility and costs involved in hiring the staff required to do the job properly. This is a major factor likely to drive the demand for contract manufacturing in the near future.

Branded or Innovative Prescription Drugs to be Highly Lucrative

Based on drug type, the global active pharmaceutical ingredients (API) market has been categorized into branded or innovative prescription drugs, generic prescription drugs, and OTC drugs. The branded or innovative prescription drugs segment accounted for a prominent share of the global active pharmaceutical ingredients (API) market in 2020. According to TMR Research, medicine use has continued to rise, with people in the U.S. filling 5.8 billion prescriptions in 2018, an increase of 2.7% over the previous year. This was largely driven by more patients receiving existing branded drugs and using newly launched drugs.

Synthetic to be Highly Attractive API

In terms of API type, the global active pharmaceutical ingredients (API) market has been classified into synthetic, biological, and plant extracts. The synthetic segment accounted for a significant share of the global active pharmaceutical ingredients (API) market in 2020. This can be attributed to higher availability of raw materials and easier protocols for the synthesis of these molecules.

Cardiovascular to be Major Application of API

Based on application, the global active pharmaceutical ingredients (API) market has been divided into anti-infective, cardiovascular, neurological, metabolic disorder, respiratory, oncology, and others. The cardiovascular segment accounted for a major share of the global active pharmaceutical ingredients (API) market in 2020. Drug therapy is a major treatment modality in cardiovascular disease. Hypertension and cardiovascular diseases (CVD) are quite common conditions, and account for significant medical disability and death worldwide. New classes of cardiovascular drugs would be effective for the treatment of hypertension and CVD and decrease their socioeconomic consequences. New drug approval is one of the prominent factors that drives the demand for APIs. These factors are expected to propel the segment during the forecast period.

High Use of API in Pharmaceutical & Biotechnology Industry

In terms of end user, the global active pharmaceutical ingredients (API) market has been categorized into pharmaceutical & biotechnological industry, CROs, CMOs, and others. The pharmaceutical & biotechnological industry segment accounted for a major share of the global active pharmaceutical ingredients (API) market in 2020. A large number of pharmaceutical & biotechnology companies and their preference for in-house manufacturing of finished dose products drives the segment. Additionally, pharma companies are opening their own manufacturing plants in emerging markets instead of imports to sell products, which drives the segment.

North America to Dominate API Market

In terms of region, the global active pharmaceutical ingredients (API) market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global active pharmaceutical ingredients (API) market in 2020, followed by Asia Pacific. Rise in prevalence of lifestyle diseases and increase in healthcare expenditure are anticipated to boost the market in North America during the forecast period.

The active pharmaceutical ingredients (API) market in Asia Pacific is anticipated to expand at a significant CAGR from 2021 to 2031. Favorable government initiatives, changing lifestyles leading to the development of diseases, rise in investment in R&D, and technological developments in drug manufacturing processes boost the market in the region.

Competitive Landscape and Market Share Analysis

The active pharmaceutical ingredients market competitive landscape provides details by vendors, including company overview, company total revenue (financials), market potential, global presence, active pharmaceutical ingredients sales and revenue generated, market share, price, production sites and facilities, SWOT analysis, product launch. For the period 2017-2020, this study provides the active pharmaceutical ingredients sales, revenue and market share for each player covered in this report.

  • Crucial data regarding the major contenders, product portfolio, market remuneration, and production patterns are documented in the report.
  • The report presents the pricing models followed by each company, alongside the gross margins and market share held by each company.

Key players operating in the global market include Merck & Co., Inc., Teva Pharmaceutical Industries Ltd., Sanofi, Pfizer, Inc., Novartis AG, Mylan N.V., Lonza, WuXi AppTec Co., Ltd., Piramal Pharma Solutions, Hisun USA, Inc., Ipca Laboratories Ltd., AbbVie, Inc., Alembic Pharmaceuticals Limited, BASF SE, Biocon Ltd., Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Cambrex Corporation, Dr. Reddy's Laboratories Ltd., Eli Lilly and Company, and GlaxoSmithKline plc.

Market: Segmentation

Market By Manufacture Type

    • In House Manufacturing
    • Contract Manufacturing

Market By Drug Type

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

Market By API Type

    • Synthetic
    • Biological
    • Plant Extracts

Market By Application

    • Anti-infective
    • Cardiovascular
    • Neurological
    • Metabolic Disorder
    • Respiratory
    • Oncology
    • Others

Market By End User

    • Pharmaceutical & Biotechnological Industry
    • CROs
    • CMOs
    • Others

Market By Region

    • North America
      • U.S.
      • Canada
    • Europe
      • Germany
      • U.K.
      • 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 Countries
      • South Africa
      • Rest of Middle East & Africa

This report focuses on active pharmaceutical ingredients market includes crucial information on market share, market size, and growth rate for the forecast period 2021 to 2030 at the global level, regional level and company level. From a global perspective, this report represents overall active pharmaceutical ingredients market size by analyzing historical data and future prospect. The study highlights deep analysis on the major drivers of the market, restraints, and challenges to help the business owners, suppliers, and marketing personnel in planning effective strategies for the forecast period. This will help the business and manufacturers to lead the market and gain prominent position in future. The report also presents vital information through graphical representation on factors like table, charts, and statistics. The study includes drivers and restraints of the global active pharmaceutical ingredients market.

The research not only conducts forecasts in terms of value, but also evaluates the market on the basis of essential parameters, such as Year-on-Year (Y-o-Y) growth. This helps providers to recognize the future opportunities as well predictability of the market.

In order to understand and assess opportunities in this market, the report is categorically divided into five key sections on the basis of segments. The report analyzes the global market in terms of value (US$ dollers) and volume (Million Units).

The research report includes specific segments by region (country), by company, by all segments. This study provides information about the growth and revenue during the historic and forecasted period of 2017 to 2030. Every segment is further sub-segmented into several sub-segmented that are deeply analyzed by experts to offer valuable information to the buyers and market players. Understanding the segments helps in identifying the importance of different factors that aid the market growth.

Major Key Points Covered in Report:

Executive Summary: It includes key trends of the active pharmaceutical ingredients market related to products, applications, and other crucial factors. It also provides analysis of the competitive landscape and CAGR and market size of the active pharmaceutical ingredients market based on production and revenue.

Production and Consumption by Region: It covers all regional markets to which the research study relates. Prices and key players in addition to production and consumption in each regional market are discussed.

Key Players: Here, the report throws light on financial ratios, pricing structure, production cost, gross profit, sales volume, revenue, and gross margin of leading and prominent companies competing in the Active pharmaceutical ingredients market.

Market Segments: This part of the report discusses about product, application and other segments of the active pharmaceutical ingredients market based on market share, CAGR, market size, and various other factors.

Research Methodology: This section discusses about the research methodology and approach used to prepare the report. It covers data triangulation, market breakdown, market size estimation, and research design and/or programs.

Research Methodology

The research methodology adopted by analysts for compiling the global active pharmaceutical ingredients market report is based on detailed primary as well as secondary research. With the help of in-depth insights of the market-affiliated information that is obtained and legitimated by market-admissible resources, analysts have offered riveting observations and authentic forecasts for the global market.

During the primary research phase, analysts interviewed market stakeholders, investors, brand managers, vice presidents, and sales and marketing managers. Based on data obtained through interviews of genuine resources, analysts have emphasized the changing scenario of the global market.

For secondary research, analysts scrutinized numerous annual report publications, white papers, market association publications, and company websites to obtain the necessary understanding of the global active pharmaceutical ingredients market.

The study objectives of this report are:

  • To analyze and study the global market capacity, production, value, consumption, status (2017-2021) and forecast (2021-2030);
  • 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.

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