• According to Transparency Market Research’s latest report on the global active pharmaceutical ingredients market for the historical period 2017–2018 and forecast period 2019–2027, 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
  • According to the report, the global active pharmaceutical ingredients (API) market was valued at US$ 169.1 Bn in 2018 and is projected to expand at a CAGR of 5.4% from 2019 to 2027
global active pharmaceutical ingredients market

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Increase in Abbreviated New Drug Applications in Recent Past: 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.

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Biologics Poised to be Key Pipeline Trend

  • Usage of biologics as potent agents in the treatment of cancer and asthma is an emerging trend in the active pharmaceutical ingredients market. Several biologics are under clinical trials to evaluate their efficacy in treating a population which still has high unmet needs, such as those with exacerbations and severe asthma.
  • The pulmonary drugs market witnessed the emergence of promising new treatment options, with GSK’s launch of monoclonal antibody Nucala in November 2015 and Teva’s Cinqair in March 2016
  • Biologics such as AstraZeneca’s benralizumab and tralokinumab and Roche’s Lebrikizumab are in the pipeline phase 3 to be assessed for asthma treatment. Hence, biologics are emerging strong in clinical studies and are likely to drive the global active pharmaceutical ingredients market, especially during their anticipated launch years and thereafter.
  • In December 2017, the FDA approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer

Stringent Regulatory Policies and Unfavorable Drug Price Control Policies to Hamper Market

  • Increase in demand for generic drugs induced the European Union to update import policies for APIs. According to the new policies, API exporters must comply with the good manufacturing practice (GMP) standards used by the EU, as stipulated by the International Conference for Harmonisation (ICH Q7). Manufacturing plants must present with a written document for each API that is exported which confirms that the plant conforms to all the EU manufacturing standards.
  • Pharma industry representatives are unhappy with government drug price control policy.
  • Government-backed agencies push the pharma industry to make drugs and medical devices affordable and prevent overcharging. For instance, the reduction in prices of stents and knee implants by more than 50% hampers the pharma business.
  • Countries set prices for new medicines based on the therapeutic value that the medicine offers; however, the value is usually assessed through health technology assessment and/or economic evaluation

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Global Active Pharmaceutical Ingredients (API) Market: Competitive Landscape

  • This report profiles major players in the global active pharmaceutical ingredients (API) market based on various attributes such as company overview, financial overview, product portfolio, business strategies, and recent developments
  • The global active pharmaceutical ingredients (API) market is moderately fragmented, with the presence of a few large players in international markets and several small players in regional markets.
  • 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.

Global Active Pharmaceutical Ingredients (API) Market: Key Developments

Key players in the global active pharmaceutical ingredients (API) market are engaged in regulatory approvals, technologically advanced products, launch of new products, and acquisition & collaborative agreements with other companies. These strategies are likely to fuel the growth of the global active pharmaceutical ingredients (API) market. A few strategies adopted by players operating in the global active pharmaceutical ingredients (API) market are:

  • In December 2019, Alkem Laboratories Ltd, a Mumbai-based pharmaceutical company, announced the acquisition of assets related to active pharmaceutical ingredient (API), Dronabinol, from the U.S.-based AbbVie, Inc.
  • In October 2019, Novartis announced a strategic decision of job cuts at its Ringaskiddy campus in Ireland. The company stated that the present facility does not offer long-term competitive option. It plans to outsource API manufacturing to external supply partners by mid-2022.
  • In June 2019, Piramal Pharma Solutions announced lab space expansion of its Michigan, the U.S.-based facility. This facility is dedicated to the production of high potency active pharmaceutical ingredients (HPAPIs) with low exposure levels.

The report on the global active pharmaceutical ingredients (API) market discusses individual strategies, followed by company profiles of manufacturers of active pharmaceutical ingredients (API). The competitive landscape section has been included in the report to provide readers with a dashboard view and a company market share analysis of key players operating in the global active pharmaceutical ingredients (API) market.

TMR’s report on the global active pharmaceutical ingredients (API) market studies past as well as current growth trends and opportunities to gain valuable insights of these indicators for the market during the forecast period from 2019 to 2027. The report provides revenue of the global active pharmaceutical ingredients (API) market for the period 2017–2027, considering 2018 as the base year and 2027 as the forecast year. The report also provides the compound annual growth rate (CAGR) for the global active pharmaceutical ingredients (API) market during the forecast period.

The report has been prepared after an extensive primary and secondary research. Primary research involved bulk of research efforts, wherein analysts carried out interviews with industry leaders and opinion makers. Secondary research involved referring to key players’ product literature, annual reports, press releases, and relevant documents to understand the global active pharmaceutical ingredients (API) market.

Secondary research also included Internet sources, statistical data from government agencies, websites, company presentations, sales data, and trade associations. Analysts have employed a combination of top-down and bottom-up approaches to study various phenomenon in the global active pharmaceutical ingredients (API) market.

The report includes an elaborate executive summary, along with a snapshot of the growth behavior of various segments included in the scope of the study. Furthermore, the report sheds light on changing competitive dynamics in the global active pharmaceutical ingredients (API) market. These indices serve as valuable tools for existing market players as well as for entities interested in entering the global active pharmaceutical ingredients (API) market.

The report delves into the competitive landscape of the global active pharmaceutical ingredients (API) market. Key players operating in the global active pharmaceutical ingredients (API) market have been identified, and each one of these has been profiled for distinguishing business attributes. Company overview, financial standings, recent developments, and SWOT are some of the attributes of players in the global active pharmaceutical ingredients (API) market that have been profiled in this report.

Key Questions Answered in Global Active Pharmaceutical Ingredients (API) Market Report

  • What is the scope of growth of companies in the global active pharmaceutical ingredients (API) market?
  • What will be the Y-o-Y growth of the global active pharmaceutical ingredients (API) market between 2019 and 2027?
  • What is the influence of changing trends in technologies on the global active pharmaceutical ingredients (API) market?
  • Will North America continue to be the most profitable regional market for active pharmaceutical ingredient providers?
  • Which factors are anticipated to impede the growth of the global active pharmaceutical ingredients (API) market during the forecast period?
  • Which are the leading companies in the global active pharmaceutical ingredients (API) market?

Research Methodology

A unique research methodology has been utilized by TMR to conduct comprehensive research on the growth of the global active pharmaceutical ingredients (API) market and arrive at conclusions on its growth prospects. This research methodology is a combination of primary and secondary research, which helps analysts warrant the accuracy and reliability of the drawn conclusions.

Secondary methods referred to by analysts during the production of the global active pharmaceutical ingredients (API) market report include statistics from company annual reports, SEC filings, company websites, investor presentations, regulatory databases, government publications, and industry white papers. Analysts have also interviewed senior managers, product portfolio managers, CEOs, VPs, and market intelligence managers, who contributed to the production of TMR’s study on the active pharmaceutical ingredients (API) market as primary methods.

These primary and secondary methods have provided exclusive information during interviews which serves as a validation from the active pharmaceutical ingredients (API) market leaders. Access to an extensive internal repository and external proprietary databases enabled this report to address specific details and questions about the global active pharmaceutical ingredients (API) market with accuracy. The study also uses the top-down approach to assess the revenues for each segment and the bottom-up approach to counter-validate them. This has helped in reaching TMR’s estimates on future prospects of the global active pharmaceutical ingredients (API) market more reliably and accurately.

Regional Segmentation of Global Active Pharmaceutical Ingredients (API) Market

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • U.K.
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • 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

Global Active Pharmaceutical Ingredients (API) Market – Segmentation

Method of Manufacturing

In-house API Manufacturing

API Contract Manufacturing

Type of API

Synthetic Chemical API

Biotech/Biological API

Plant Extracts API

High-potency API

Classical Fermentation API

Type of Drug

Branded or Innovative Prescription Drugs

Generic Prescription Drugs

Over-the-counter (OTC) Drugs

Others

Therapeutic

Anti-infective Drugs

Metabolic Disorders Drugs

Cardiovascular Drugs

Oncology Drugs

Central Nervous System Drugs

Respiratory Diseases Drugs

Others

Region

North America

Europe

Asia Pacific

Latin America

Middle East & Africa

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