Market Overview

Report Segment | Healthcare | Report ID – HGRI4454

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Microbial API Market Market Overview:

The market for Microbial API was valued at XX Mn USD in the year 2023 and expected to reach XX Mn by the year 2030. The CAGR for the market is XX% during the period 2019 -2030.

Microbial APIs are widely used in the production of active pharmaceutical ingredients for drugs and are derived from microbial sources. The growth in this market is directly proportional to the increasing demand for biological drugs, as they are non-toxic, easily accessible, and provide high specificity. The process carried out by microorganisms is called fermentation, which produces secondary metabolites. Microbial APIs are formed through the conversion of carbon and nitrogen into intermediate chemicals by these organisms.

The rise in various ailments, such as infectious diseases and Alzheimer’s disease, is driving the increasing demand for this market. It is further fueled by the broad-spectrum activity of microbial APIs, making them a valuable tool for curing multiple bacterial infections. Additionally, they are effective against bacterial resistance.

The market is expected to grow in the near future due to ongoing research and development efforts, including the discovery of novel antibiotics from new microbial sources such as extremophiles and symbionts. Other advancements include the extensive use of genetic engineering to modify microorganisms for the production of specific drugs, combination therapies, personalized medicines, and nanotechnology, which uses nanoparticles to deliver microbial APIs directly to the site of action.

Market Dynamics

Microbial API Market Drivers:

Broad-Spectrum Activities: Microbial APIs are used for a wide range of treatments, including managing hormone imbalances, vaccines against infectious diseases, anticancer cytotoxic medicines, and therapies for various medical conditions.

Chronic Diseases: The high prevalence of chronic diseases is a major factor propelling market growth, as microbial APIs play a vital role in their treatment.

Nutritional Requirements: In the coming years, the demand for microbially derived vitamins is expected to increase due to the growing need to meet nutritional requirements, driving market growth further.

Microbial API Market Restraints:

Cost of Development: The development process is time-consuming and expensive, primarily due to the fermentation process. The process must be meticulously carried out to deliver intermediate chemicals in the correct quantities, adding to the cost.

Stability Issues: One of the major concerns with microbial API drugs is the degradation of these drugs over time, which complicates storage and transportation.

Allergic Reactions: Since these drugs are derived from microorganisms, some individuals may develop allergic reactions, posing a challenge for widespread use.

Microbial API Market Opportunities:

Genetic Engineering: Scientists are utilizing genetically modified microorganisms to produce more specific and targeted API drugs. Companies like Ginkgo Bioworks are leading advancements in this area, offering insights into the future potential of microbial API development. Additionally, businesses like Finch Therapeutics are using next-generation sequencing to isolate potential therapeutic microbes from patients’ microbiomes.

Nanotechnology: Researchers are exploring the use of nanoparticles to deliver microbial API medications directly to infection sites. This approach may reduce side effects while increasing the effectiveness of treatments.

Microbial API Market Trends:

Technological Advancements: Innovations such as single-use bioreactors and continuous fermentation are enhancing the productivity and cost-effectiveness of API manufacturing. These technological improvements make microbial API production more appealing and competitive for manufacturers.Increasing Demand from Emerging Markets: The demand for APIs is growing rapidly in emerging economies like China, India, and Brazil. This surge is driven by the rising prevalence of infectious diseases, increasing disposable incomes, and government initiatives to improve healthcare infrastructure.

Segments Outlook

Host Segment Overview: 

Mammalian segment shows the largest growth which is followed by bacterial segment because mammalian hosts can create proteins that closely mimic human proteins, they are widely used for the synthesis of recombinant therapeutic proteins, which is why they dominate the market. Nevertheless, compared to microbes, mammalian cells have more exacting needs, such as a richer growth media, stricter development conditions, and a longer growth period. Furthermore, compared to a microbial system, the procedure of introducing genes and creating clones in a mammalian system is more complex. Additionally, a variety of transfection techniques have been created and put to the test in order to successfully introduce genes and create pools with high efficiencies. 

Type of Biomolecules Segment Overview: 

Antibodies produced in laboratories using recombinant DNA technology dominate this category. These antibodies are derived from the immune system and can identify specific targets, such as bacteria, viruses, and cancer cells. In medical applications, antibodies are often preferred over traditional APIs because they enhance the immune system’s ability to fight diseases.

The increasing use of these APIs, particularly in oncology, has led to significant investments in antibody-based products. Companies like Lonza are focusing on developing innovative APIs to expand their market share.

A key trend in the market is the rise of contract and custom API manufacturing, driven by the need for advanced manufacturing processes and sterile production facilities.

Site Segment Overview: 

Pharmaceutical companies now mostly outsource their drug development processes due to the rise in demand for customised goods, the need for increased productivity and efficiency throughout the value chain, and ongoing pressure from regulatory bodies on drug pricing. The need for outsourcing services is being driven by pharmaceutical companies’ emphasis on cutting costs in the areas of formulation research, API manufacturing, analytical & testing services for solid dose manufacture, and clinical trial management.

Molecule Segment Overview: 

The market for APIs is being driven by innovative molecules due to increased funding for research and development centres. Numerous innovative advanced items are now in the developmental stage and are anticipated to be released over the projected period due to the increased research endeavours in this industry. Furthermore, growth is anticipated as new competitors enter this market. The market for generic drugs is expected to grow profitably in developing nations like Brazil and India because of the significant unmet clinical requirements and adoption of over-the-counter medications. 

End-User Segment Overview: 

Microbial APIs are extensively used in hospitals to treat various bacterial infections and resistance caused by bacteria. Hence this segment demonstrates progressive growth. The advancements in the domains of synthetic biology and molecular biology are among the primary driving forces behind the increasing emphasis on fermentation and the growth of biopharmaceutical companies. Modifying pharmaceutical production processes can be done more specifically and creatively with the help of synthetic biology, which includes the controlled evolution of biosynthetic pathways. In the years to come, fermentation in the pharmaceutical industry will likely be greatly impacted by the quick developments in molecular biology and engineering techniques. Nevertheless, the production of API by full fermentation requires a great degree of skill.

Regional Outlook

Microbial API Market Market Regional Outlook:

North America: North America has the highest healthcare expenditure and is always a pioneer in health technology. Microbial API market demand is ever increasing due to advancements in the API manufacturing which leads to efficient and cost effective production. The need for high-purity microbial APIs is rising in North America due to the trend towards biologics and specialty pharmaceuticals. In North America, the United States has the highest demand for  Microbial API market due to its larger population as compared to Mexico or canada, its extensively high healthcare investment, large number of ageing population, hence large number of people who are suffering from chronic diseases. 

Asia Pacific: Asia Pacific market shows the market dominance due to growing population and increasing prevalence of disease conditions. Many API producers in the region, especially those in China and India, provide scalable and affordable manufacturing capabilities.Within the Asia Pacific area, China has the biggest demand for microbiological APIs. This is brought on by the region’s sizable and expanding population, rising standard of living, and high rate of infectious illness. The need for microbiological APIs is rising quickly in emerging economies in the region, including China, India, and Southeast Asian nations, as a result of developing healthcare systems and an increase in the incidence of infectious diseases.

Europe: 

Advanced medical treatments that rely on microbial APIs are in high demand due to the substantial resources allocated to healthcare by Western European countries, especially Germany, France, and the United Kingdom. The need for premium microbial APIs for targeted therapeutics is being driven by Europe, which is leading the way in personalised medicine. The need for efficient therapies for chronic illnesses is heightened by Europe’s ageing population, which is driving up demand for microbial active pharmaceutical ingredients. Strict regulatory policies in Europe guarantee the efficacy and safety of microbial APIs, building consumer and healthcare provider confidence.

Middle East & Africa: 

In the MEA region, the demand for microbiological APIs is being driven by rising healthcare awareness and expanding access to healthcare. The healthcare infrastructure in the Middle East and North Africa (MEA) area is expanding, especially in Saudi Arabia, the United Arab Emirates, and Qatar. The need for microbial APIs for a range of medicinal applications is rising as a result of this expansion. The demand for microbial API-based therapies is rising as chronic illnesses like diabetes and cardiovascular disease become more common. The MEA region’s microbiological API market is expanding as a result of government spending on health care facilities and programmes to fight infectious illnesses.

Key Players

Microbial API Market Market Players Mapping:

• Merck & Co., In
• North China Pharmaceutical Co Ltd
• Topfond Pharmaceuticals Co., Ltd 
• DSM
• Tianjin Tianyao Pharmaceuticals Co., Ltd
• CSPC Pharma
• Kolon Lifescience 
• Northeast Pharm
• Shandong Lukang Pharmaceuticals Co,. Ltd
• Teva Pharmaceuticals Industries Ltd
• Lonza
• Luwei Pharmaceuticals Co,. Ltd
• Jiangshan

• In March 2023, Merck & Co. presented positive findings from a Phase 2 clinical trial assessing MK-7662, an experimental antibiotic which is intended to treat serious bacterial infections, such as bloodstream infections (BSIs), ventilator associated pneumonia (VAP), and hospital acquired pneumonia (HAP). The experiment demonstrated a good success rate and positive clinical response. 
• In August 2021, AstraZeneca got approval from FDA for AZD4142, an investigational antibiotic, as a breakthrough for treatment of community acquired pneumonia (CAP)

Report Coverage

Microbial API Market Market Coverage:

By Host:

• Mammalian 
• Bacterial
• Fungal

By type :

• Antibody
• Amino acids
• Vitamins
• Nucleotides
• Organic Acid
• Biological Products
• Hormones
• Vaccine

By Site:

• In-house 
• Outsourced

By Molecule:

• Innovative
• Generic

By End-user application:

• Hospitals
• Research Laboratories
• Academic Laboratories
• Pharmaceutical Companies
• Biopharmaceutical Companies
• Others

By Region:

• North America
  • US
  • Canada
  • Mexico
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Rest of APAC
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Russia
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • Rest of South America
• MEA
  • UAE
  • Saudi Arabia
  • Qatar
  • South Africa
  • Rest of MEA

Microbial API Market Market Report Outlook

Microbial API Market Market Coverage	2019- 2030
Fastest Growing Region	Asia Pacific
Microbial API Market Market Forecast	2024 – 2030
Historical Data	2019 – 2022
Base Year	2023
Competition Benchmarking	10 + Key Players Mapping
Report Format	PPT + PDF + Excel

Microbial API Market Market Players Mapping:

Jiangshan

Merck & Co., In

North China Pharmaceutical Co Ltd

Topfond Pharmaceuticals Co., Ltd 

DSM

Tianjin Tianyao Pharmaceuticals Co., Ltd

CSPC Pharma

Kolon Lifescience 

Northeast Pharm

Shandong Lukang Pharmaceuticals Co,. Ltd

Teva Pharmaceuticals Industries Ltd

Lonza

Luwei Pharmaceuticals Co,. Ltd