The global industrial microbiological QC market size was valued at USD 13,847.35 million in 2022. It is estimated to reach USD 22,785.61 million by 2031, growing at a CAGR of 5.69% during the forecast period (2023–2031).
Product safety is a global concern and is becoming visible among the public. Government regulators and product manufacturers are keenly focused on maintaining the optimum quality of the products. The manufacturers are subjected to stringent regulations to guarantee the product's microbiological quality control and composition. The microbial quality control tests are carried out throughout the production process, ranging from raw material to product dispatch.
The environment of the production process is also monitored at regular intervals using microbiological tests. Industrial microbiological QC products and services can be defined as market offerings utilized for conducting microbiological quality control testing to improve the quality of industrial products. Industrial microbiology is the branch of applied microbiology that involves the utilization of microorganisms in industrial processes such as pharmaceutical drug development, food pathogens testing, vaccine production, industrial fermentation, wastewater, and industrial chemical treatment.
The use of novel rapid detection technologies has recently received more attention for screening microbes during the quality control process, particularly for assessing raw materials, product stability, and product contamination, among other things. Additionally, microbiological QC testing in different industries has enabled them to obtain reproducible and reliable results for final release and in-process testing to meet the growing requirements and demands of end products. With the increasing importance of conducting industrial microbiological QC testing in various manufacturing stages, key players in the industry are taking initiatives to develop new methodologies for the control of microorganisms in an industrial process.
Several key players, including emerging and legacy companies, are actively adopting key business strategies and product upgrades to contribute significantly to the global industrial microbiological QC market. For instance, in April 2021, Lonza Group AG recently expanded its popular PyroTec PRO Automated Robotic Solution for endotoxin testing. This will allow quality control (QC) microbiologists to choose the endotoxin test methodology best suited for testing requirements.
Microbiological QC is critical in developing and releasing a pharmaceutical product in a market to restrict product recalls and regulatory consequences. Microbiological QC also plays an essential role in ensuring a sterile environment in a pharmaceutical laboratory. It is worth mentioning here that there have been instances in which the drugs are affected by microorganisms, adversely impacting the pharmaceutical process in several ways and at different production levels.
For instance, in December 2017, Sun Pharmaceuticals Industries, Inc. and its subsidiaries issued a voluntary recall of two batches of Riomet (metformin hydrochloride oral solution) due to the presence of Scopulariopsis Brevicaulis. This product recalls it impacted the companies' financial results and damaged the brand image. Therefore, it has become imperative to establish technologically advanced microbiological QC testing solutions, driving market growth.
Productivity and operational efficiency improvements are now more critical than ever. However, the cost associated with the implementation of industrial microbiological quality control (QC) products significantly decreases the benefits concerning cost savings. The cost of quality accounts for a considerable portion of a company's total cost, which is approximately 20% to 30% of the sales revenue in industrial companies. The high-quality price is also associated with the growing costs of various tests such as sterility testing, bio-burden testing, and water testing, which can significantly contribute to hindering the market growth.
The utility of quality control in the pharmaceutical and biotechnology industries has created a need to develop technologically advanced solutions to screen microbes throughout different manufacturing phases. The pharmaceutical and biotechnology companies developing cell and gene therapy products are at constant risk of contracting cell line contamination due to mycoplasma and endotoxins. This has created a need to develop rapid microbiological quality control kits that efficiently detect mycoplasma and endotoxins in low quantities.
Additionally, the companies operating in the market, including bioMérieux SA, F. Hoffmann-La Roche Ltd, Sartorius AG, and Lonza Group AG, are significantly investing in developing and launching new products based on technologies such as RT-PCR and NAT. For instance, in July 2020, bioMerieux SA launched its new BIOPIRE MYCOPLASMA, based on nucleic acid amplification technique (NAT), for detecting mycoplasma in pharmaceutical products used for biotherapeutics, including hormones, antibodies, and cell and gene therapies. Therefore, the growing significance of developing technologically advanced products for conducting quality control tests across the pharmaceutical manufacturing process is expected to create lucrative opportunities in the global industrial microbiological QC market.
The global industrial microbiological QC market is bifurcated into the offering, technology, application, and end-user.
Based on the offering, the global market is divided into products and testing services.
The testing services segment is the most significant contributor to the market and is expected to exhibit a CAGR of 5.60% over the forecast period. Testing services offered in the industrial microbiological QC market are primarily conducted in product testing laboratories, food and beverage companies, pharmaceutical and biotechnology companies, research and academic institutions, and regulatory and environmental agencies. These services include in-house and outsourced services that are conducted for multiple applications across a variety of industries. The growth in this market can be accredited to the increasing public and regulatory concern about product safety and increasing demand for rapid technological advancements, primarily led by initiatives in the pharmaceutical and biotechnology industries.
Based on technology, the global market is divided into conventional culture-based methods and rapid microbiological methods.
The rapid microbiological methods segment accounts for the largest market share and is anticipated to exhibit a CAGR of 7.24% over the forecast period. In most testing services settings, rapid microbiological methods represent alternative microbiological methods that enable users to acquire microbiology test results faster than conventional culture-based methods. Technologies such as polymerase chain reaction (PCR), flow cytometry, MALDI-TOF/mass spectrometry, and membrane filtration dominate the rapid microbiological methods for industrial microbiological QC. The growing applicability of the technology and its reputation as a hallmark of sophisticated technological advancement is attracting significant traction in this area as manufacturers and service providers aim to provide better molecular technologies, particularly for pharmaceutical and food and beverage markets.
Based on application, the global market is bifurcated into food and beverage testing, pharmaceutical testing, cosmetic and personal care testing, biotechnology testing, agriculture and fermentation testing, paper testing, water testing, environmental testing, and other industry testing.
The skin tightening segment owns the highest market share and is predicted to exhibit a CAGR of 5.03% over the forecast period. The food and beverage industry is the largest industrial microbiological quality control market and is one of the most strictly regulated markets. Food and beverage testing is further segmented into meat and poultry products, packaged foods, dairy products, juice and carbonated drinks, wine and beer, baked foods, fruits and vegetables, and other products. Food and beverage items also witness one of the highest cases of food recalls due to microbiological contamination from several sources. As a result, this is the dominating market in terms of product revenue for the industrial microbiological QC market. Growing demand for food across a consistently growing population correlates with a growing need for safer products for consumption, thereby necessitating an increasing trend for microbiological QC of these products, translating into tremendous growth over the forecast period.
Based on the end-user, the global market is bifurcated into product testing laboratories, food and beverage companies, pharmaceutical and biotechnology companies, research and academic institutions, regulatory and environmental agencies, and others.
The product testing laboratories segment dominates the global market and is predicted to exhibit a CAGR of 6.62% during the forecast period. Product testing laboratories comprise the primary outsourcing services providers to all significant application industries, led by food and beverage, pharmaceutical, and biotechnology. These service providers offer highly sophisticated and streamlined services that aim to reduce the economic burden on the manufacturing industry by cutting down manufacturing costs for quality control. Similarly, by adhering to quality control regulations, product testing laboratories ensure superior quality services. An overall growing trend for outsourcing quality control services is the major driving factor for this market. Owing to an increasing number of product testing laboratories, primarily in Europe, North America, and Asia-Pacific, and a rising trend of outsourcing, this end-user segment is expected to grow significantly through the forecast period.
Based on region, the global industrial microbiological QC market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Rest-of-the-World (RoW).
Europe is the most significant shareholder global industrial microbiological QC market and is estimated to grow at a CAGR of 4.95% over the forecast period. The region's growth is primarily attributed to the increasing research activities to develop new products of industrial microbiological QC. Additionally, the growing number of standalone laboratories offering testing services creates tremendous opportunities for market growth in the region. The manufacturing companies in the region are proactive in adopting key business strategies such as mergers and acquisitions and synergistic activities to provide optimum solutions to the end users, thereby increasing the market's competitiveness. For instance, in January 2020, Primerdesign Ltd, a wholly owned subsidiary of Novacyt S.A., partnered with VGS Invest Holding Sarl Group to distribute certain molecular diagnostic products in France for the aquamarine and aquaculture markets. Under the terms of this partnership, the molecular diagnostics products would be utilized for the early detection of diseases, including microbial infections, impacting animal health during food production. These business strategies will continue bolstering the overall industrial microbiological QC market scenario.
North America is anticipated to exhibit a CAGR of 5.18% over the forecast period. North America majorly comprises the U.S. and Canadian markets. The U.S. dominated the global industrial microbiological QC market for product revenue because of increasing research on the development of novel therapeutics, including drugs for cell and gene therapy and immunotherapy, rising consciousness among consumers regarding food quality, and the increasing emergence of companies offering novel industrial microbiological QC products. With several major pharmaceutical and biotechnology companies focusing on developing transformative medicines and diagnostics coupled with the stringent regulations of the FDA for conducting microbial QC, the demand for these products is expected to grow significantly. Additionally, the growing focus on standardizing guidelines on incorporating microbiological QC testing, particularly in the food and beverage, cosmetics, and dairy industries, is expected to further bolster the demand for novel industrial microbiological QC products during the forecast period.
The Asia-Pacific region is a global leader in terms of rapid advancements in technology, primarily led by China and Japan. In addition, the region comprises a large number of high-potential countries, which offer lucrative opportunities to manufacturers who are involved in the development of industrial microbiological QC products. With the increasing disposable income in the region to obtain products free from health risks, the region is expected to witness a massive growth in the upcoming years. Additionally, the region harbors a highly flourishing pharmaceutical, biotechnology, and food and beverage industries, which is expected to create high demand for microbiological QC testing products to assess and screen microbial organisms through different manufacturing stages. Furthermore, the rapid adoption of emerging technologies for conducting microbial QC is anticipated to continue to bolster the growth of the Asia-Pacific industrial microbiological QC market.
Latin America is a key emerging region for multinational industrial microbiological QC companies, with Brazil, Mexico, and Argentina offering lucrative opportunities in terms of product adoption. These countries are working meticulously to enhance the adoption of rapid microbial testing solutions across emerging economies in the Latin America region. A swift growth has been observed in the region due to the presence of various industrial sectors, with evolving technologies primarily making headway into the market. Although the economically developing regions in Latin America are likely to grow in industrial microbiological QC in the future, they need to catch up to other regions. However, the region is a significant target for product launches, particularly by the U.S. and European companies.
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