GLOBAL MICROBIAL API MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2023 - 2030)

The global microbial API market size is expected to reach US$ 96.11 Bn by 2030, from US$ 61.21 Bn in 2023, at a CAGR of 6.7% during the forecast period.

Microbial API typically refers to active pharmaceutical ingredients related to microbes. API is the substance that is biologically active. In the realm of microbiology and drug development, a microbial API might be an antibiotic or other antimicrobial substance produced through microbial fermentation or other bioprocesses that involve microorganisms. These APIs are crucial for the treatment of infectious diseases caused by bacteria, fungi, viruses, or parasites.

Global Microbial API Market Regional Insights:

• North America is expected to dominate the global microbial API market over the forecast period owing to the presence of major players and advanced healthcare infrastructure in the region. The U.S. accounts for the largest share of the North American market due to factors such as high healthcare spending and well-developed healthcare infrastructure in countries like the U.S. and Canada. Leading pharmaceutical firms have their major manufacturing and research and development (R&D) facilities located in the region, which helps drive significant internal consumption of microbial API. Additionally, the region has stringent regulatory frameworks related to drug development and manufacturing, which ensure firms source API only from high-quality suppliers, thereby stimulating greater domestic production within North America. Another important factor in the regions' prominence is its close proximity to several quality contract manufacturing organizations, which aids pharmaceutical companies in reducing overall costs and lead times.
• Europe region is expected to be the second largest market for the global microbial API market during the forecast period. Increasing healthcare expenditures have boosted market opportunities. The increasing prevalence of diseases such as cancer, the growing generics market, increased R&D spending on drug discovery, the low production cost of microbial APIs, and others are key factors propelling market growth.
• The Asia Pacific market is expected to hold the third-largest market share for the global microbial API market during the forecast period. Several factors, such as rapidly growing pharmaceutical industries within India and China, an influx of international investments towards manufacturing facilities, and the development of large indigenous drug makers, have augmented overall microbial API consumption in Asia Pacific. Government initiatives aimed at promoting domestic manufacturing are also propelling market growth in this region.

Figure 1. Global Microbial API Market Share (%), by Region, 2023

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Global Microbial API Market- Analyst View:

The microbial API market is expected to grow steadily over the next decade. The market is driven by rising investments in R&D of novel antibiotics and an increasing focus on the development of microbial-based therapies for chronic diseases such as cancer, diabetes and others. Developed regions, such as North America, dominate the market due to the presence of major pharmaceutical companies and government support for antibiotic development programs. However, Asia Pacific is expected to emerge as the fastest-growing market owing to expanding biologic manufacturing capabilities and a growing generic drug industry in countries like China and India.

On the other hand, stringent regulatory requirements for approval of novel antibiotics and a long review timeline pose a significant challenge to the market. The contract manufacturing and outsourcing trend is also expected to propel the growth of the market.

Global Microbial API Market Drivers:

• Rising Demand for Biosimilars: The rising demand for affordable biologics and biosimilars has driven immense interest in microbial fermentation and API production. Biosimilars offer significant cost savings compared to their reference biologic products and are expected to disrupt the biologics market over the forecast period. As biologics face patent expiries and lose exclusivity, pharmaceutical companies are focused on providing more cost-effective treatment options. This has spurred heavy R&D investments in biosimilar development utilizing microbial systems. Producing complex biologic molecules in living microbial hosts offers several economic and technical advantages over traditional mammalian cell culture Microbes can be easily cultured in large fermentors at low costs. Well-established fermentation processes are amenable for large scale, predictable manufacturing of consistent product quality.
• Advancements in Fermentation and Downstream Processing Technologies: Rapid advancements in fermentation and downstream processing technologies over the past decade have revolutionized microbial manufacturing capabilities. Sophisticated molecular biology and pathway engineering tools have enabled the fine-tuning of microbial hosts for the hyper production of diverse protein drugs. Real-time monitoring systems and advanced control strategies help maximize productivity while maintaining consistency. Continual improvements in fermenter designs allow for higher cell densities and product titers and have significantly boosted overall yields. In the downstream sector, new continuous separation methods employing techniques such as simulated moving bed chromatography have boosted purification capabilities multifold. Advanced analytics powered by machine learning and artificial intelligence are supporting real-time process decisions. Advanced filtration solutions are allowing for easier recovery and purification of products. These technological upgrades are directly enhancing cost-efficiency and helping overcome prior limitations in product quality and yield.

Global Microbial API Market Opportunities:

• Emerging markets in Asia Pacific and Latin America: Emerging markets in Asia Pacific and Latin America provide tremendous opportunities for growth in the global microbial API market. These regions are witnessing rapid economic development, which is increasing the healthcare spending capabilities of both individuals and governments. This is creating a growing demand for generic and affordable medicines. Microbial APIs have shown tremendous potential in addressing this demand as they are used to manufacture affordable generic drugs to treat many common illnesses at much lower costs as compared to synthetic medication. As healthcare infrastructure also develops in these regions, there is an increased focus on establishing local manufacturing capabilities of microbial APIs. This provides the pharmaceutical industry with an opportunity to cater to regional needs.
• The Increasing healthcare expenditure: Increasing healthcare expenditure is a powerful driver for the global microbial API market. As countries around the world allocate more resources to their healthcare systems, this financial influx helps to improve healthcare infrastructure, expand the availability of medical services, and increase access to advanced medical technologies, including pharmaceuticals and APIs.

Global Microbial API Market Trends:

• Increasing adoption of generic drugs: The increasing adoption of generic drugs is positively influencing the microbial API market. As generic drugs offer cost-effective alternatives to branded medications, more patients are opting for generic options to treat diseases such as diabetes, cancer, hypertension, and other conditions. The easy availability and lower prices of generic drugs have encouraged people to seek medical help for health issues. This is expected to encourage pharmaceutical companies to develop more cost-effective generic drugs.
• Shift towards biologics from conventional drugs: The shift towards biologics from conventional drugs is expected to have a significant impact on the microbial API market. Biological drugs are increasingly becoming the preferred treatment option over traditional pharmaceuticals owing to their targeted mechanisms of action, improved efficacy, and favorable safety profiles. As biologics are large, complex molecules, they are capable of acting with higher specificity on certain biomolecular targets, such as in pain pathways. This allows them to achieve better clinical outcomes with fewer side effects for chronic pain conditions like arthritis, lower back pain, and neuropathic pain, which cannot be adequately managed with conventional oral analgesics. Thus, the shift from conventional drugs to biologics is also expected to increase the demand for microbial APIs.

Global Microbial API Market Restraints:

• Stringent regulatory framework: A strict regulatory framework plays a significant role in shaping the growth of the global microbial API market. Microbial APIs are subject to extensive regulation owing to health and safety concerns. Regulatory authorities such as U.S. Food and Drug Administration (FDA) and European Medicinal Agency (EMA) closely monitor the manufacturing, quality testing, and clinical trials of microbial APIs. Obtaining regulatory approvals is a long-drawn and expensive process involving compliance with current good manufacturing practices (CGMP) guidelines at all stages of production. This puts a substantial compliance burden on manufacturers in terms of time and cost.
• High capital investment requirements: High capital investment requirements are expected to hinder the growth of the global microbial API market. Manufacturing APIs through microbial fermentation involves establishing sophisticated facilities with specialized equipment, such as fermenters. These facilities need to meet stringent CGMP compliance standards to ensure product quality and safety. Additionally, there is a need for continuous investment in R&D to develop robust microbial strains, optimize the fermentation process, isolate and purify new APIs. Developing such advanced infrastructure and capabilities requires sizable capital outlays.

Recent Developments:

• On August 24, 2023, Antheia, Inc., a pharmaceutical ingredient manufacturing company, announced the successful completion of its first 116,000 L manufacturing unit in the U.S. with a commercially relevant fermentation for the manufacturing of active pharmaceutical ingredients (APIs) for producing critical medicines for Antheia's pipeline.
• On November 27, 2023, Rusan Pharma Ltd., an India-based pharmaceutical company, announced that it had launched a new microbial and conventional active pharmaceutical ingredient (API) manufacturing facility in Madhya Pradesh, India. The company has invested around US$ 36.1 million in its manufacturing unit.

Figure 2. Global Microbial API Market Share (%), by Type, 2023

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Top companies in Microbial API Market:

• Merck & Co., Inc.
• Topfond Pharmaceutical Co., Ltd.
• DSM
• CSPC Pharmaceutical Group Limited.
• KOLON LIFE SCIENCE
• Teva Pharmaceutical Industries Ltd.
• Lonza
• Akums Lifesciences Ltd.
• AbbVie Inc.
• Xellia Pharmaceuticals
• BASF
• Reddy's Laboratories
• Lupin

Definition: Microbial APIs refer to therapeutic substances or active pharmaceutical ingredients produced through microbial fermentation using various microorganisms such as bacteria, fungi, or yeast. There are mainly two types of microbial APIs: small molecule APIs and large molecule APIs.

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