Active Pharmaceutical Ingredients (API) Market – Snapshot

The global active pharmaceutical ingredients (API) market is expanding due to an increase in the incidence of acute and chronic disease such as cancer across the globe. The global active pharmaceutical ingredients (API) market was valued at US$ 162,000.0 Mn in 2017. It is projected to reach a value of US$ 257,455.6 by 2026 and expand at a CAGR of 5.4% from 2018 to 2026. The global market is expanding at a relatively higher growth rate, owing to an increase in the incidence of cancer and orthopedic diseases.

global  active  pharmaceutical  ingredients  (api)market

Active pharmaceutical ingredients (APIs) of a good quality are essential for the manufacture of effective and safe medicines. However, not all pharmaceutical companies possess in-house API manufacturing capabilities, and a single company cannot produce all the APIs required for their formulation offerings.

High prevalence and incidence rates of cancers, dental carries, cardiovascular diseases, back pain, and periodontal diseases drive the active pharmaceutical ingredients market. Demand for low-cost medicines and increase in the number of ANDA filings are fuelling the global active pharmaceutical ingredients market.

The global active pharmaceutical ingredients market has been segmented based on manufacturer, APIs, drug, therapeutic, and region. In terms of manufacturer, the global market has been classified into in-house API manufacturing and API contract manufacturing. The in-house API manufacturing segment accounted for a key share of the global market, in terms of revenue, in 2017. The API contract manufacturing segment is estimated to expand at a signficant growth rate during the forecast period. The segment is estimated to gain significant market share by the end of 2026.

In terms of APIs, the active pharmaceutical ingredients market has been segmented into synthetic chemical API, biotech/biological API, plant extracts API, high-potency API, and classical fermentation API. The biotech/biological API segment is expected to expand at a significant CAGR from 2018 to 2026. The availability of new and innovative products in the market and increase in the preference for biotech/biological API by manufacturers are likely to propel the segment in the coming years.

In terms of drug, the global active pharmaceutical ingredients market has been split into branded or innovative prescription drugs, generic prescription drugs, OTC (over-the-counter) drugs, and others. The branded or innovative prescription drugs segment accounted for a leading share of the market in 2017. Increase in demand for low-cost drugs is anticipated to boost the generic prescription drugs segment from 2018 to 2026.

In terms of therapeutic, the global active pharmaceutical ingredients market has been split into anti-infective drugs, metabolic disorders drugs, cardiovascular drugs, oncology drugs, central nervous system drugs, respiratory diseases drugs, and others. Increase in cancer prevalence across the global is anticipated to drive the oncology drugs segment during the forecast period. In terms of region, the global active pharmaceutical ingredients market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global market and is projected to lose market share by the end of 2026. The market in North America is primarily driven by a rapid increase in the incidence of cancer and diabetes and a rise in the geriatric population in the U.S.. Moreover, an increase in the demand for innovative medicine in the U.S. is projected to fuel the active pharmaceutical ingredients market in the country during the forecast period. The market in Asia Pacific is projected to expand at a rapid pace during the forecast period. In Asia Pacific, Japan dominated the active pharmaceutical ingredients market, while the market in China is estimated to expand at an exponential CAGR during the forecast period.

Companies such as Teva Pharmaceutical Industries Ltd., Sun Pharmaceutical Industries Ltd., Pfizer Inc., Boehringer Ingelheim International GmbH., Merck & Co., Inc., Novartis AG, F. Hoffmann-La Roche Ltd., and Bayer AG accounted for a major share of the global active pharmaceutical ingredients market in 2017. Teva Pharmaceutical Industries Ltd. is a key producer of generic medicines and a recognized leader in innovative and specialty pharmaceuticals worldwide. Approximately 1,000 customers in over 100 countries use Teva’s active pharmaceutical ingredients (API). The company delivers high-quality and patient-centric health care solutions across the globe. It has a wide generic product portfolio, with more than 1,000 molecules in almost every therapeutic area. It has a strong presence in the market in North America, due to its strong distribution channels in the region. Novartis AG is a global health care company that develops and provides solutions to the changing needs of patients worldwide. Novartis received 16 approvals, made 16 submissions, and received six breakthrough therapy designations from the FDA in 2017. Companies are adopting the strategy of acquisitions and collaborations with parallel companies in order to improve and strengthen their geographic presence in the global market.

Active Pharmaceutical Ingredients (API) Market - Overview

Biotech/biological APIs have witnessed constant technological evolution, owing to a shift from synthetic chemical APIs to biotech/biological APIs in the global active pharmaceutical ingredients market.

Rise in demand for new drugs at a low cost and entry of domestic and global companies in the APIs market have led to innovative product offerings with new and advanced techniques. Any substance or combination of substances used in a finished pharmaceutical product (FPP) is known as active pharmaceutical ingredients (API). A finished dose of any drug is a combination of active pharmaceutical ingredients and excipients. An excipient is an inactive substance in a drug dose.

High-potency active pharmaceutical ingredients (HPAPIs) and antibody-drug conjugates are recent innovations in the market and require a special manufacturing set up. Most of these drugs are used in oncology. A large number of patents for small molecule APIs are expected to expire in the next few years, with many drugs losing patent protection in 2018. This is estimates to unlock a significant market opportunity for generic drug manufacturers, resulting in augmented demand for APIs. Large pharmaceutical companies are scaling down their small molecule manufacturing facilities to focus on biologic drugs, thereby presenting greater opportunities for contract manufacturing companies, particularly in Asia.

A key trend of collaborations and acquisitions of related companies to increase geographic presence has been observed in the last few years. For instance, in July 2017, Sun Pharmaceutical Industries Ltd. entered into a long-term manufacturing agreement with Samsung BioLogics for the manufacture of Ilumya.

The global active pharmaceutical ingredients market has been broadly segmented based on manufacturer, APIs, drug, therapeutic, and region. In terms of manufacturer, the global market has been classified into in-house API manufacturing and API contract manufacturing. The in-house API manufacturing segment accounted for a key share of the global market, in terms of revenue, in 2017. The API contract manufacturing segment is estimated to expand at a significant growth rate during the forecast period. Consequently, the segment is estimated to gain significant market share by the end of 2026.

In terms of region, the global active pharmaceutical ingredients market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global market and is projected to lose market share by the end of 2026. The market in North America is primarily driven by a rapid increase in the geriatric population, high adoption of new drugs, and rise in group dental practices in the U.S.. The market in Asia Pacific is projected to expand at a rapid pace during the forecast period. In Asia Pacific, Japan dominated the active pharmaceutical ingredients market, while the market in China is estimated to expand at a prominent CAGR during the forecast period. The report also profiles major players in the market based on various attributes such as company overview, financial overview, SWOT analysis, key business strategies, product portfolio, and recent developments. Major players operating in global active pharmaceutical ingredients market include 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, and Bayer AG..

The global active pharmaceutical ingredients market has been segmented as given below:

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
.