The Global Microbial API Market involves production of microbial origin APIs that are used for producing various antibiotics and therapeutic biological drugs. Microbial APIs are produced from microbial fermentation process involving fermentation of microorganisms such as bacteria, fungi and yeast. The major advantages of microbial APIs are reliable supply, ability to produce for large volumes, low cost of production and minimal chances of product contamination. With rising prevalence of various infections and increasing demand for cost-effective generics and biosimilars, the dependence on microbial APIs is growing substantially.

Key Takeaways

Key players operating in the Global Microbial API are SGS SA, Intertek Group Plc, Bureau Veritas SA, Eurofins Scientific SE, ALS Limited, TUV SUD AG, Mérieux NutriSciences Corporation,, Microbac Laboratories Inc., National Technical Systems Inc., EMSL Analytical Inc, Institut fur Produktqualität GmbH, Campden BRI. These players conduct rigorous testing and certification of microbial APIs to ensure their safety, efficacy and consistency in production.

The demand for Microbial API Market Size is growing rapidly owing to increasing incidence of infectious diseases, rising generic prescription and greater acceptance of biosimilars in developing nations. According to WHO, infectious diseases accounted for approximately 26% of global deaths in 2019. This growing disease burden is driving the need for cost-effective treatment options.

Advancements in fermentation and downstream processing technologies have enabled large scale, consistent production of complex microbial APIs. New platforms like continuous processing and 3D fermentation are helping enhance the yields and productivity of microbial fermentation. This is allowing greater volumes of APIs to be made available at lower costs.

Market Trends

One of the key trends in the Global Microbial API Market is the shift towards single-use technologies from conventional stainless steel-based equipment to prevent cross-contamination. Several players are adopting single-use bioreactors, tubing, connectors, and containers to ensure product purity.

There is also a rising focus on developing novel microbial strains with improved productivity through genetic engineering and process optimization. Customized strains capable of expressing complex molecules are expanding the scope of molecules that can be commercially produced through fermentation route.

Market Opportunities

Outsourcing of microbial API development and manufacturing is emerging as a major opportunity in this market. Several pharmaceutical companies lack in-house microbial fermentation capabilities and are outsourcing these activities to contract manufacturing organizations.

Developing markets in Asia Pacific and Latin America hold significant potential for microbial API companies. Rising income levels and improved access to healthcare is propelling the demand for generics in these regions.

Impact of COVID-19 on Global Microbial API Market

The COVID-19 pandemic had a significant impact on the growth of the global microbial API market. In the initial stages of the pandemic, supply chain disruptions and restrictions on transportation led to shortages of key starting materials (KSMs) and microbial cultures required for API production. This adversely affected the manufacturing operations of various API manufacturers.

As countries imposed nationwide lockdowns to curb the spread of the virus, the demand from end-use industries such as pharmaceuticals and nutraceuticals also declined sharply. The shutdown of several manufacturing facilities and temporary closure of several dosage formulation units resulted in a decline in API consumption.

However, with the development and approval of vaccines against COVID-19, the demand for fermentation-based APIs picked up once again. Several pharmaceutical companies ramped up their manufacturing capacities of sterile injectable APIs to meet the surge in demand for vaccines. The future growth prospects of the market also look positive with increasing R&D investments towards development of novel biologics and monoclonal antibodies for treatment of viral diseases.

Manufacturers are also focusing on developing single-use technologies and continuous bioprocessing to enhance production flexibility and meet demand fluctuations. Adoption of advanced manufacturing technologies and enhanced biosecurity measures will be crucial for long term growth in the post pandemic period.

Geographical Concentration of Global Microbial API Market

In terms of value, North America accounts for the largest share of the global microbial API market, driven by presence of major API manufacturers and pharmaceutical companies in the US. Europe is another prominent regional market supported by stringent regulatory guidelines regarding API production.

The market in Asia Pacific region has been witnessing fastest growth and the trend is expected to continue in the coming years. This can be attributed to factors like rising generic drug consumption, growing biosimilars market, and expansions by various international API companies in countries like India and China. Additionally, favorable government policies and low manufacturing costs are attracting significant foreign investments in the biopharmaceutical industry in Asia Pacific.

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