The global microbial API market accounts for manufacturing commoditized fermentation-derived ingredients for active pharmaceutical ingredients (APIs) as well as biologics such as vaccines, monoclonal antibodies, and therapeutic enzymes. It involves producing microbial metabolites through carefully controlled fermentation of microorganisms like bacteria, fungi, and yeast in bioreactors. Microbial APIs offer advantages like high purity, fewer impurities, complexity, and uniformity in production compared to plant and animal-derived ingredients. Growing demand for generic injectables and biologics is fueling the need for affordable and sustainable production of microbial metabolites.
The Global Microbial API Market is estimated to be valued at US$ 61.21 BN in 2024 and is expected to exhibit a CAGR of 6.7% over the forecast period 2024 To 2031.
Key Takeaways
Key players operating in the global microbial API market 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. Key players focus on strengthening analytical testing capabilities and expanding production facilities to meet the growing demand from generic drug manufacturers.
The demand for affordable treatment options and expansion of healthcare access in developing nations is driving the demand for generic drugs. As Microbial API Market Demand is inexpensive to produce at scale, generic drug companies prefer them over alternatives. This is expected to support the growth of the global microbial API market during the forecast period.
Globally, governments and regulatory agencies are encouraging local production of APIs to boost self-sufficiency and address supply chain disruptions. Leading pharmaceutical companies are investing in developing nations like India and China to establish localized manufacturing and distribution networks. This is anticipated to promote the global expansion of the microbial API market.
Market key trends
One of the key trends gaining traction in the global microbial API market is the shift towards continuous manufacturing processes. Traditionally, microbial fermentation was conducted using batch processing in large stainless-steel tanks. However, continuous fermentation helps achieve higher product yields, tighter quality control, smaller footprint, and reduced costs of goods. Several market players are actively investing in continuous biomanufacturing technologies like perfusion and hollow-fiber fermentation. This is expected to make microbial API synthesis more efficient and economic.
Porter’s Analysis
Threat of new entrants: New entrants face high levels of regulatory barriers to enter the microbial API market as they need to undergo approvals, registration and comply with complex cGMP regulations which holds back potential new players.
Bargaining power of buyers: Large pharmaceutical companies that procure microbial API in bulk have high bargaining power as they can negotiate for better prices and payment terms from API manufacturers.
Bargaining power of suppliers: The microbial API market has few large players that control majority of market share giving them strong bargaining power over buyers for price and supply terms.
Threat of new substitutes: There exist very few substitutes to microbial fermentation derived APIs hence threat of new substitutes replacing existing microbial APIs is low.
Competitive rivalry: The microbial API market sees intense competition among existing large players to gain market share and expand capacities.
Geographical regions where market in terms of value is concentrated: North America and Europe account for over 60% of global microbial API market value due to strong presence of API manufacturers and formulation companies in these regions along with high R&D investments. Stringent regulations also drive demand for high quality microbial APIs.
The fastest growing region for the given market: Asia Pacific region is expected to witness highest CAGR during the forecast period driven by expansion of domestic formulation industry, rising biologics production and increasing investments by international players to establish manufacturing facilities and tap growing pharmaceutical markets in China, India and other Asian countries.
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
Money Singh is a seasoned content writer with over four years of experience in the market research sector. Her expertise spans various industries, including food and beverages, biotechnology, chemical and materials, defense and aerospace, consumer goods, etc.