The global active pharmaceutical ingredients (API) market is consistently growing, in line with the increases in size of the pharmaceutical industry. While small molecules make up the largest part of the API market, biologics, such as proteins, peptides and monoclonal antibodies, are taking an increasing share. According to the Chemical Pharmaceutical Generic Association (CPA), the biopharma market as a whole is moving from blockbuster drugs (therapeutics with annual sales of $1 billion or more) to so-called nichebusters for smaller markets. As a result, the API market is focusing more on ingredients for higher-cost drugs that target complex or rare diseases. India and China produces more than three-quarters of APIs globally, with North America and Europe concentrating more on these higher-value or more specialist products. [1]
Niche and small-batch APIs are produced in smaller quantities than bulk APIs. Examples include antibiotics for serious or resistant bacterial infections, drugs for rare and orphan diseases, targeted and precision therapeutics, immunotherapies, drugs used in regenerative medicine, radiopharmaceuticals and highly potent APIs (HPAPIs), as well as cell and gene therapies and other advanced therapy medicinal products (ATMPs). They can also include drugs that have a short shelf life, and generic drugs that are hard to make or that have few competitors. Niche APIs range from small molecules to complex biologics. [2, 3]
APIs for the antibiotic chloramphenicol, and for small molecule and biologic immune regulators, can provide opportunities for small and mid-size API manufacturing companies, or for companies that can optimize their in-house processes and switch over production lines rapidly to make the most of slack time between larger manufacturing jobs.
Small batch manufacturing
Being able to manufacture small and very small batches of drugs supports niche API opportunities, but it can be a challenge to make this economically viable as the costs per unit can be high. Using technologies and processes that can reduce the risk of error and contamination, including single-use technologies, automation, robotics, modular production lines and cleanrooms, and ready-to-use containers for packaging, are especially important when there need to be quick changeovers between short production runs. [4]
An introduction to chloramphenicol
Chloramphenicol is a small molecule broad-spectrum antibiotic initially isolated from cultures of Streptomyces venezuelae in 1947. It was the first broad-spectrum antibiotic to be produced in bulk. It acts by interfering with bacterial protein synthesis. It is used as an oral or intravenous (IV) treatment for meningitis, rickettsial infections, plague, typhoid and other severe salmonella infections, systemic anthrax, cholera, meningitis caused by Haemophilus influenza, Neisseria meningitidis, or Streptococcus pneumoniae, tularemia and tularemic meningitis (caused by Francisella tularensi infections) and Burkholderia infections in cystic fibrosis.
Chloramphenicol has been associated with serious and fatal blood dyscrasias, including aplastic anemia, hypoplastic anemia, thrombocytopenia and granulocytopenia. Neonates and premature babies receiving chloramphenicol or born to mothers receiving chloramphenicol late in pregnancy or during labor may develop grey baby syndrome, a type of circulatory collapse. Chloramphenicol should only be used for serious infections when other, less potentially toxic anti-infectives are unsuitable or ineffective. Patients should remain in hospital and blood tests, including monitoring of plasma drug concentrations, must carried out throughout the course of antibiotics. Treatment should be switched from IV chloramphenicol to a suitable oral anti-infective as soon as possible. The FDA has withdrawn all oral drug products using chloramphenicol. [5-7]
Chloramphenicol is used as an eye or ear drop or eye ointment for the management and treatment of superficial infections including bacterial conjunctivitis and otitis externa, and as prophylaxis for surgical wound infections, for example in plastic surgery and eye surgery. [7]
The chloramphenicol market
According to Dataintelo, the global chloramphenicol market was worth an estimated $...
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