Active Pharmaceutical Ingredients (API) Market Size Estimated to Observe Significant Growth by 2027

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

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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.

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

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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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.