Active pharmaceutical ingredients are biologically active components of a medicine which are mainly responsible for causing effects. The API’s are generally manufactured through a variety of processes which include chemical synthesis, fermentation process, recombinant DNA technology, Isolation, and recovery from natural sources. From the past few decades, the necessity to produce active pharmaceutical ingredients on a large scale has increased the demand for the manufacturers to make efforts to strengthen their marketing capacity in the developed and regulated markets by improving production yields, modifying manufacturing processes, and increasing sales in the international markets. API is classified as Synthetic, Biotech and HPAPI.
Biotech API is driving API market by an increase in their application, technological advancements and advantages of biologics and biosimilars. Biologics produced from living organisms or contain components of living organisms. Biologics include recombinant proteins, tissues, genes, allergens, cells, blood components, blood, and vaccines. Biosimilars are the biotherapeutic products which are similar in terms of quality, safety, and efficacy to a biologic drug. Biosimilars are developed using unique living cells and biological systems when biological medicines are expired. Hence the active ingredients in biosimilars are not identical to that of biologics.
Some of the technological advancements of biotech API manufacturing are Single-use bioreactors these systems are composed of plastic material, which has been sealed and sterilized with gamma radiation. Single use bioreactors have become significant tool in the manufacturing of biotech API and HPAPI. It is beneficial for both downstream and upstream processes. Mammalian cell-based API Manufacturing is a standardized and reproducible process, culture materials are storable, ability to incorporate changes in virus strains and no need of adapting the virus seed strains to make them suitable for growth. Advantages of biologics and biosimilars are high effectiveness when compared to small molecule drugs, highly specific against the target; fewer side effects and low toxicity.
Biologics, such as vaccines, proteins, enzymes, hormones, blood factors, monoclonal antibodies (mAb), allergenic, somatic cells, cell therapies, gene therapy, and tissues, are produced by cell line optimization and development procedures. Biologics are not new, the development of human growth hormone, insulin, started decades ago, but the applications have increased exponentially with the unlocking of new genetic information and a new understanding of subcellular cascades and disease processes. The earlier biologics such as insulin was extracted from slaughtered pigs and cattle, which showed an allergic reaction in many patients. After years of research in engineering a different cell to produce necessary biologics, insulin was produced in 1978 using E. coli with the least allergic reaction. Now the focus is on genetic engineering technology where cell lines produce these products, with more compatibility inhuman. Efforts are being put forth in optimizing existing host cell systems and alternative host systems, including plants, insect cells, yeasts, and transgenic animals so as to obtain protein/biologic of desired structure, expression, and higher yield. From 2012 to 2018 there are totally 75 FDA approved biologics and they are produced using different cell lines such as CHO, NS0/SP/2/0, E. coli, yeast, HEK293, and others.
According to IQ4I analysis global active pharmaceutical market is expected to grow at a single-digit CAGR to reach 307.2 billion by 2025. High uptake of biologics across diverse therapeutic areas, increasing aged population and regional penetration, patent expiration, technological advancement like continuous flow manufacturing, single-use system and mammalian cell-based production, expansion of local manufacturers and enhanced focus by pharma companies for developing biologic drugs are few factors driving the API market. Biotech API market is expected to grow at a strong CAGR due to technological advancements, increased demand for biologics and expansion of local manufacturers are some of the factors driving the market, whereas, high capital investments, complex manufacturing procedures, stringent regulations, and financial crisis are the factors hampering the market growth.
Geographically, North America dominated the market with the largest share due to increased government focus on generic drugs, technological advancement and rising demand for biologic and specialty drugs. The Asia Pacific is expected to grow at a faster rate due to enhanced healthcare standards in countries like India and China and skilled manpower with low cost and rising demand for biologic medicine.
The major companies manufacturing biotech APIs are AbbVie (U.S.), Aurobindo Pharma (India), Cambrex Corporation (U.S.), Cipla (India), Eli Lilly (U.S.), Lonza group (Switzerland), Roche Holdings (Switzerland), Pfizer (U.S.), Biogen Inc (U.S.), Merck (U.S.), Novasep (France), Emcure Pharmaceuticals Ltd (India), Century Pharmaceuticals Ltd (India), Generex Biotechnology Cooperation (Canada), University of York (U.K.) and GlaxoSmithKline (U.K.).
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