Niche API Opportunities: Chloramphenicol and Immune Regulators

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 $1.2 billion in 2023, rising to $1.8 billion by 2032, growing by a CAGR (combined annual growth rate) of 4.5%. This is driven by a growing prevalence of bacterial infections, including antibiotic-resistant infections, a rising number of surgical procedures worldwide and an increasing demand for effective antibiotics. Europe and North America are the biggest chloramphenicol markets, but emerging markets such as India and China are increasing. [8]

An introduction to immune regulators

Immune regulators, also known as immunomodulators, regulate the immune response through stimulation or suppression. Their action can be specific or non-specific: [9]

• Specific action immunomodulators have an effect when an antigen or immunogen is present, e.g. vaccines

• Non-specific action immunomodulators (immunosuppressants or immunostimulants):

• Type I – acts on the normal immune system

• Type II – acts on the immunosuppressed immune system

• Type III – acts on normal and immunosuppressed immune systems

Immunosuppressants reduce activation of the immune system, and are used to prevent organ transplant rejection. They also play a role in managing autoimmune diseases, such as rheumatoid arthritis, lupus, Crohn’s disease, psoriasis/psoriatic arthritis, Sjögren’s disease and multiple sclerosis. Immunosuppressants include glucocorticoids, cytostatic drugs and monoclonal antibodies. [9]

Immunostimulants can be used to treat immunodeficiency diseases. They can also be used in bacterial and viral infections, which could become increasingly important as these become ever more resistant to antibiotics and antivirals. [9]

Immunotherapies are used to turn the body’s own immune system against cancer cells, and include checkpoint inhibitors, cytokines, chimeric antigen receptor (CAR) T-cell therapies, monoclonal antibodies, cancer vaccines, and agonists and adjuvants that activate cell pathways. [10, 11]

The immunomodulators market

The global immunomodulators market was worth around $217.5 million in 2023 and is expected to grow at a CAGR of 6.2%, reaching $329.8 million by 2030, according to Grand View Research. The biggest immunomodulator market in 2023 was North America, but the Asia-Pacific market is growing rapidly. [12]

Immunosuppressants make up the largest product share of the immune regulators market, driven by a growing number of transplants, and these are largely antibodies. Antibody-based immunomodulators are also increasingly being used for indications such as multiple sclerosis, Crohn’s disease, rheumatoid arthritis, and non-Hodgkin’s lymphoma. There is expected to be a growth in immunostimulants as generics for HIV, cancer and multiple sclerosis enter the market. Precision medicine allows healthcare professionals to tailor immunomodulator treatment to individuals, based on molecular signatures and genomic profiles. [12, 13]

References

1.Outlook of Active Pharmaceutical Ingredients: the post-pandemic reshaping. CPA - Chemical Pharmaceutical Generic Association. February 2025. Available from: https://www.cpa-italy.org/en/pubblications/studi-di-mercato/outlook-of-active-pharmaceutical-ingredients-the-post-pandemic-reshaping/1.html.

2.Niche Active Pharmaceutical Ingredients and How to Source Them. LGM Pharma. Last accessed: 31 July 2022. Available from: https://lgmpharma.com/blog/niche-active-pharmaceutical-ingredients-and-how-to-source-them/.

3.Beyond 2022: The Unfolding Story of Niche APIs. LGM Pharma. Last accessed: 5 August 2024. Available from: https://lgmpharma.com/blog/beyond-2022-the-unfolding-story-of-niche-apis/.

4.How small and micro batches are changing pharmaceutical processes. Manufacturing Chemist, 27 September 2023. Available from: https://manufacturingchemist.com/how-small-and-micro-batches-are-changing-pharmaceutical.

5.Chloramphenicol. DrugBank. Last accessed: 24 June 2025. Available from: https://go.drugbank.com/drugs/DB00446.

6.Drugs.com: Chloramphenicol. American Society of Health-System Pharmacist. Last accessed: 24 June 2019. Available from: https://www.drugs.com/monograph/chloramphenicol.html.

7.Oong, G.C. and P. Tadi. Chloramphenicol. StatPearls. Last accessed: 3 July 2023. Available from: https://www.ncbi.nlm.nih.gov/books/NBK555966/.

8.Chloramphenicol Market Report | Global Forecast From 2025 To 2033. Data Intelo. 2025. Available from: https://dataintelo.com/report/global-chloramphenicol-market.

9.Sharma, Y., M. Arora, and K. Bala, The potential of immunomodulators in shaping the future of healthcare. Discover Medicine, 2024. 1(37).

10.Immunomodulators. Cleveland Clinic. Last accessed: 10 May 2023. Available from: https://my.clevelandclinic.org/health/drugs/24987-immunomodulators.

11.Luke, J. Immunomodulators: Checkpoint Inhibitors, Cytokines, Agonists, and Adjuvants. Cancer Research Institute. Last accessed: 10 July 2025. Available from: https://www.cancerresearch.org/immunotherapy-by-treatment-types/immunomodulators.

12.Immunomodulators Market Size, Share & Trends Report: Immunomodulators Market Size, Share & Trends Analysis Report By Solution, By Product (Immunosuppressants, Immunostimulants), By Application (Oncology, Respiratory, HIV), By Region, And Segment Forecasts, 2024 - 2030. Grand View Research. August 2024. Available from: https://www.grandviewresearch.com/industry-analysis/immunomodulators-market.

13.Precedence Research: Immunomodulators Market Size to Worth Around US$ 1,237.66 Bn by 2033. BioSpace. 3 October 2024. Available from:

"https://www.biospace.com/press-releases/immunomodulators-market-size-to-worth-around-us-1-237-66-bn-by-2033"

About the Author

Based in the north of England, Suzanne Elvidge is a freelance medical writer with a 30-year experience in journalism, feature writing, publishing, communications and PR. She has written features and news for a range of publications, including BioPharma Dive, Pharmaceutical Journal, Nature Biotechnology, Nature BioPharma Dealmakers, Nature InsideView and other Nature publications, to name just a few. She has also written in-depth reports and ebooks on a range of industry and disease topics for FirstWord, PharmaSources, and FierceMarkets. Suzanne became a freelancer in 2006, and she writes about pharmaceuticals, consumer healthcare and medicine, and the healthcare, pharmaceutical and biotechnology industries, for industry, science, healthcare professional and patient audiences.