Active Pharmaceutical Ingredients (APIs) are active substances in a drug intended to achieve pharmacological activity which is having a direct effect on disease treatment. APIs are synthesized by chemical synthesis, fermentation, biotechnological methods or enhanced from the natural source. According to IQ4I 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.
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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. Biotech API accounted for the share of xx% in 2020 and is expected to grow at a high single digit CAGR from 2020 to 2027. 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 are 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 accounted for the share of xx% in 2020 and 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.
By business type, the global API market is divided into captive API and merchant API. The Captive market held the major share in 2020 and is expected to grow at a high single digit CAGR from 2020 to 2027. The captive API is further divided into branded captive API and generic captive API. 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. The Merchant API market is further divided into branded merchant API and generic merchant API. The Generic merchant API accounted for the largest share in 2020 and is expected to grow at a low teen CAGR from 2020 to 2027. 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.
By therapeutic applications, the global API market is segmented into infectious diseases, oncology, cardiovascular disorders, central nervous system, pulmonary disorder, gastrointestinal disorder, endocrine disorders, metabolic disorders, genito-urinary disorders, musculoskeletal disorders, and others such as others such as ophthalmology, autoimmune diseases, ENT, dental, dermatology, and pain management. In the application segment, infectious disease accounted for the largest share in 2020 because of the global-wide rapid spread of COVID-19 and increased incidence of other infectious diseases such as tuberculosis, HIV, pneumonia, influenza, hepatitis, and others. 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. Under biotech API and HPAPI, the oncology segmented contributed for the largest share of xx% and xx% in 2020 respectively, and is forecasted to grow at a high single digit CAGR of xx% and xx% from 2020 to 2027.
The active pharmaceutical Ingredients market by region is segmented as North America, Europe, Asia-Pacific, and the Rest of the world (ROW). By geography, North America held the largest share in 2020 due to patent expiration of the major drugs, rising demand for biotech APIs, market entry of biosimilars, increasing scope of highly potent drugs, and increase in the prevalence of chronic diseases such as cancer, cardiac disease, diseases associated with central nervous system, and musculoskeletal disorder coupled with high healthcare expenditure. Asia-Pacific is the fastest-growing region with a high single digit CAGR from 2020 to 2027 owing to low labor cost, abundance availability of raw materials, infrastructure facility, rise in generic drug demand, increased production capabilities, the presence of a large number of domestic and international players, and concentration of CMO companies.
Some of the key players of Active pharmaceutical Ingredient (API) market are Lonza Group (Switzerland), Boehringer Ingelheim GmbH (Germany), Teva Pharmaceutical Industries Ltd (Israel), Sanofi S.A. (France), Thermo Fisher Sceintific Inc. (Patheon N.V, U.S), Divis Laboratories (India), Olon S.p.A (Italy), Pfizer Inc. (U.S.), Permira funds (Cambrex Corporation U.K.), Carlyle Group (AMRI, U.S.), and others.
The report provides an in-depth market analysis of the above-mentioned segments across the following regions:
• North America
o Rest of North America
o Rest of Europe
o Rest of APAC
• Rest of the World (RoW)
o Rest of Latin America
o Middle East and Others
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