DUBLIN–()–The “Active Pharmaceutical Ingredient (API) Global Market – Forecast To 2027” report has been added to ResearchAndMarkets.com’s offering.

APIs are synthesized by chemical synthesis, fermentation, biotechnological methods or enhanced from the natural source. According to analysis, the global Active Pharmaceutical Ingredient market is expected to grow at a high single digit CAGR from 2020 to 2027 to reach $364,169.4 million by 2027.

Adoption of biologics in disease management and increasing regulatory approvals in the past year, increasing scope of HPAPI market, patent expiration of major drugs, increasing trend of outsourcing, and increase in geriatric population are some of the factors driving the market growth. The global API market is mainly segmented by synthesis, by business type, by application, and by geography.

The global API market based on synthesis is further divided into synthetic API, Biotech API, and HPAPI.

By synthesis, the synthetic API held the major share in 2020 and is expected to grow at a high single digit CAGR from 2020 to 2027. The major factors driving the synthetic chemical API market are patent expiration of synthetic (small molecule drugs), an increasing number of small molecules in clinical trials, increasing outsourcing by the pharmaceutical companies, CMOs investments to expand manufacturing facilities, rise in the incidence of chronic and age-related diseases, rapid growth in the oncology market, technological advancement like cryogenic and continuous flow manufacturing.

Increased investment in R&D by pharmaceutical companies for developing biologic drugs, adoption of biological therapies in disease management, increasing outsourcing, increasing biologics approvals in the past year, increasing chronic and autoimmune illnesses, increasing number of branded drugs going off-patent creating a scope for biosimilars, requirement of novel biologics therapeutics for rare diseases, increasing demand for antibody conjugates, bi or multispecific monoclonal antibodies, and vaccines to contain novel coronavirus infections are few factors driving the biotech API market.

Biotech API is further segmented into monoclonal antibodies, recombinant proteins, vaccines, and others (stem cell therapy and gene therapy). Monoclonal antibodies accounted for the largest share in 2020 and is expected to grow at a high single digit CAGR from 2020 to 2027.

The development of next-generation antibodies such as antibody-drug conjugates and rising venture capital investments and applications of monoclonal antibodies are the factors booming monoclonal antibodies market growth. The vaccine segment is forecasted to grow at a low teen CAGR from 2020 to 2027 owing to the worldwide demand for novel vaccines to treat the coronavirus diseases which emerged as a global pandemic.

Based on the customer base, the global biotech API is further segmented into biologics and biosimilars.

Biologics accounted for the largest share in 2020 and is expected to grow at a high single digit CAGR from 2020 to 2027. The Biologics market is driven globally due to the adoption of biological therapies in disease management, increasing biologics approvals in the past year, increasing chronic and autoimmune illnesses, and increasing the elderly population. Biosimilars is expected to grow at an exponential CAGR from 2020 to 2027 owing to patent expiry of biological drugs, low cost compared to biologics, increase in chronic diseases, growing geriatric population, and demand for quality healthcare.

Based on the customer base, the global synthetic API is further divided into branded API and generic API. The Branded API accounted for the largest share in 2020 and is expected to grow at a mid single digit CAGR from 2020 to 2027. The Generic API is expected to grow at a high single digit CAGR from 2020 to 2027, due to the patent expiry of blockbuster drugs, rising healthcare expenses, and shift towards generic medicines led by government initiatives.

The branded captive API accounted for the largest share in 2020 and is expected to grow at a high single digit CAGR from 2020 to 2027 owing to patent protection of blockbuster drugs. Increasing outsourcing, advanced manufacturing facilities, lack of in-house manufacturing capability, high capital investment, and cost of API manufacturing are some of the factors driving the Merchant API market.

The oncology division is expected to grow at a double digit CAGR from 2020 to 2027 driven mainly by the rising incidence of cancer cases, lifestyle changes, increasing geriatric population, high demand for anti-cancer drugs. Currently, there is a trend towards precision medicine which further boosts the global oncology API market growth.

The global API market by therapeutic application is segmented into synthetic API application, biotech API application, and HPAPI application market. In synthetic API application, infectious disease accounted for the largest share in 2020 and oncology is expected to grow at a high single digit CAGR from 2020 to 2027.

Market Analysis

Factors Influencing Market

Drivers and Opportunities

  • Increasing Incidence and Prevalence of Chronic Diseases
  • Adoption of Biologics in Disease Management and Increasing Regulatory Approvals in the Past Year
  • Increasing Scope of HPAPI Market
  • Patent Expiration of Major Drugs
  • Increasing Trend of Outsourcing
  • Increase in the Geriatric Population

Restraints and Threats

  • Contamination of API
  • High Cost for Manufacturing Apis
  • A Requirement of Highly Skilled Technicians
  • Fierce Competition Between API Players
  • Stringent Regulatory Policies and Environmental Concerns

Regulatory Affairs

  • International Organization for Standardization
  • Iso 9001: 2015 Quality Management System
  • Iso 13408 Aseptic Processing
  • Iso 14644-1 Clean Room Standards

Technological Advancements

  • Automation and Control
  • Continuous Manufacturing
  • Cryogenic Technology
  • Single – Use System (Sus)
  • Mammalian Cell Based Production
  • Cell Free Based Approach for the Production of Proteins
  • Advancements in Hpapi Manufacturing

Major Companies

  • Carlyle Group (Albany Molecular Research Inc)
  • Boehringer Ingelheim International GmbH
  • Divis Laboratories
  • Lonza Group Ltd.
  • Olon S.P.A.
  • Permira Funds (Cambrex Corporation U.K.)
  • Pfizer Inc.
  • Sanofi
  • Teva Pharmaceutical Industries Limited.
  • Thermo Fisher Scientific Inc

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