Pharmaceutical Microbiology Quality Control Market Size, Share, By Component, Testing Type, Method, Molecular Type, End User, and Region - Trends, Analysis and Forecast till 2035

• Pharmaceutical microbiology quality control market size was valued at USD 12.18 Billion in 2024.
• The target market is projected to grow at USD 40.85 Billion in 2035.
• The market is growing at a CAGR of  12.9%

Market Overview:

Pharmaceutical microbiology quality control (QC) is the process to identify microorganisms at every stage of a pharmaceutical production for safety, purity, and efficacy of the product. Target market is driven by the strong regulatory rules for production of pharmaceutical products and, increasing R & D activities in pharmaceutical products. In addition, focus on patient safety and growing range of generic medicines are another factors propelling the market growth. Furthermore, technological advancements, which increases the efficiency and cost-effectiveness of production is also anticipated to create opportunities for growth of the global market over the forecast period.

Key Takeaways:

• North America held the largest share of the market in 2024 due to the increasing cases of chronic diseases, such as cancer, and increasing medical expenditure. 
• Asia Pacific is expected to be the fastest-growing market during the forecast period owing to increasing health consciousness among consumers, and rising focus on patient safety.

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Key Drivers of Target Market:

Rising Global Pharmaceutical Production to Fuel Market Growth

As microbiological quality control is essential for ensuring fundamental contamination control increasing production of pharmaceutical products by collaborations and acquisitions are expected to create opportunities for expansion of microbiological quality control services.

• For Instance, In March 2024, several pharma multinational corporations (MNCs) are increasingly turning to Indian companies to expand market reach in the country’s pharmaceuticals sector. Sanofi's partnerships with Dr Reddy's, Cipla, and Emcure, AstraZeneca and Mankind Pharma teaming up for asthma medication distribution.

Restraints:

Contamination Control May Impede Market Expansion

Preventing and controlling contamination is main focus of pharmaceutical microbiology. However, this can be very challenging as microbes are omnipresent. Minor contamination can also have serious consequences.

• Counterbalance Statements: Adopting sterilization techniques to avoid contamination and following the basic microbiology rules while working can help to minimize the risk of contamination.

Opportunities:

Trends in Microbiological Quality Control Advancements Fuel the Market Expansions

Microbiological quality control plays an important role for ensuring safety of pharmaceutical products. Rapid Microbiological tests, such as polymerase chain reaction and many more developed for detection of microbial contamination. These advancement enable quicker and more accurate identification of microorganisms. 

• For Instance, in January 2023, Clever Culture Systems’ (CCS) parent company LBT Innovations Limited has been engaged by AstraZeneca, to undertake a full product development project for their new APAS Pharma analysis module (artificial intelligence software) to be used on the APAS Independence instrument. The APAS Pharma analysis module will be developed to identify microbial growth on settle plates used in sterility monitoring during drug manufacturing.

The pharmaceutical microbiology quality control market is classified into component, testing type, method, molecular type, end-user, and region.

Component:

Based on the component, the pharmaceutical microbiology quality control market is categorized into product and services. Among this services segment dominates the target market due to the high demand, and widespread usage.

Testing Type:

The pharmaceutical microbiology quality control market by testing type is bifurcated into tradition testing and rapid testing. Rapid testing dominates the target market with CAGR of 40.4% in 2023. This is due to its widespread usage, cost and time saving, and others.  

Method:

 The target market by method is categorized into growth-based, viability-based, cellular component-based, nucleic acid-based, culture-based, and others. Throughout this growth-based testing method held the largest share of the market with 40.3% in 2023, due to wide application and usage.

• For Instance, in January 2024, Rapid Micro Biosystems, Inc., an innovative life sciences technology company announced that Samsung Biologics selected the Growth Direct platform to automate its microbial quality control processes to deliver increased efficiency, more robust data integrity and scalable quality control operations.

Molecular Type:

The pharmaceutical microbiology quality control market by molecular type is categorized into small molecule and large molecules. Small molecules segment dominates the market growth due to its distinct advantages and applications.

End-User:

Based on end-user, the pharmaceutical microbiology quality control market is distributed into pharmaceutical manufacturers, biotechnology companies, and others. The pharmaceutical manufacturers holds the largest share of the market due to increasing usage, R & D activities, lower the risk of contamination, and others.

Region:

Geographically, the market is studies across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.  

North America: North America is expected to dominate the market during forecast period due to the increasing cases of chronic diseases such as cancer, increasing R & D activities, strategies owned by key market players and among others.

• For Instance, in April 2024, Parenteral Drug Association, Inc. (PDA) and U.K.-based Euromed Communications announced the publication of Industrial Pharmaceutical Microbiology Quality Control. This 500-page book includes 20 chapters from 19 industry leaders in pharmaceutical microbiology quality control. 

Asia Pacific: Asia Pacific is considered to be the fastest growing region in the target market. As countries, such as China, India and many more are leading the charge significantly due to increasing health consciousness among consumers, strong presence of key manufacturers, increasing usage, and others.

• For Instance, in June 2022, The Microbiology Application Training Lab (MAT Lab) in Jigani, Bangalore, is a first-of-its-kind technology hub by Merck in India. The lab invites pharma and biopharma companies to collaborate with Merck and develop and enhance their capability in Microbial analysis

Pharmaceutical microbiology quality control market Report Scope:

Segmentation:

By Product:

• Product
  • Instruments
  • Consumables
• Services

By Testing Type:

• Tradition Testing
• Rapid Testing

By Method:

• Growth-Based
• Viability-Based
• Cellular Component-Based
• Nucleic Acid-Based
• Culture-Based
• Others

By Molecular Type:

• Small Molecules
  • APIs
  • Excipients
  • Intermediates
  • Others
• Large Molecules
  • Monoclonal Antibodies
  • Cell & Gene Therapies
  • Therapeutics Proteins
  • Antibody Drug Conjugates
  • Others

By End User:

• Pharmaceutical Manufacturers
• Biotechnology Companies
• Others

By Region:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • U.K.
  • France
  • Russia
  • Italy
  • Spain
  • Netherland
  • Switzerland
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • Indonesia
  • Malaysia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East & Africa
  • GCC
  • Israel
  • South Africa
  • Rest of Middle East & Africa

The key players operating in the pharmaceutical microbiology quality control market include BIOMERIEUX, Charles River Laboratories, Merck KGaA, and among others. The key players are adopting strategies for the growth of the market such as huge distribution network, strong brand reputation, significant marketing, and fundamental investments.

List of Key Players in the Market:

• Thermo Fisher Scientific Inc.
• BIOMERIEUX
• Charles River Laboratories
• Merck KGaA
• Hardy Diagnostics
• IDEXX
• Q Laboratories
• Lucideon
• Eurofins Scientific
• Catalent, Inc.
• Perritt Laboratories
• WuXi AppTec
• Societe Generale de Surveillance SA.
• Sartorius AG
• Rapid Micrio Biosystems, Inc.
• Bio-Rad Laboratories, Inc.
• Creative Diagnostics
• HiMedia Laboratories
• BD

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• In October 2024, the U.S. Pharmacopeia (USP) announced the acquisition of Stratix Labs, a microbiology technology company based in Saint Paul, MN. This acquisition marks a significant milestone for USP's portfolio, as it will expand its microbiological solutions supporting microbial contamination control with broad applications across pharmaceuticals, including biologics and compounded medications.
• In July 2024, Indutrade, a Sweden-based technology and industrial business, has acquired Miclev Medical Products. Miclev Medical Products is a Sweden-based technical trading company specialising in products for detecting, identifying, eliminating, and protecting against microorganisms. Further, the product offering of Miclev Medical Products caters to the Nordic pharmaceutical and biotech industries. 

Analyst View:

The industry placed for substantial growth due to strong regulatory rules for production of pharmaceutical products, increasing R & D activities in pharmaceutical products, focus on patient safety and growing range of generic medicine. New product launches, advance technologies, and several collaborations and partnerships helps to boost the growth of the market in upcoming years.

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