Biologics Safety Testing Market Analysis

Global Biologics Safety Testing Market Overview

Biologics Safety Testing Market Size valued at USD 3.1 Billion in 2022. The Biologics Safety Testing market industry is projected to grow from USD 3.52 Billion in 2023 to USD 9.76 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 13.60% during the forecast period (2023 - 2032). Increased investment in research and development and the growing prevalence of the chronic diseases are the key market drivers encauraging the growth of market. 

Source: The Secondary Research, Primary Research, MRFR Database and Analyst Review

Advanced medications known as biologics are used to treat conditions like rheumatoid arthritis and cancer. These biologics are made up of big molecules like monoclonal antibodies and recombinant proteins, and since they are used to treat various diseases, their safety guarantees patient safety. The market is expanding due to several key factors, including the booming biotechnology and pharmaceutical sectors, rising investments, and rising manufacture of new biologics because of the high disease burden. Additionally, goods or biologicals generated from biotechnology are now widely used in healthcare, especially in prevention, illness diagnosis, and therapy. However, some unresolved potential safety issues typically result from these goods' production procedures and intricate structural and biological characteristics. 

Therefore, these products must undergo extensive and systematic biological safety testing before conducting clinical research, allowing for an adequate safety assessment. The market is expected to expand during the course of the forecast period as a result. The market is fueled by expansion in the biotechnology and pharmaceutical industries, significant R&D spending by the biggest names in the life sciences industry, and an increase in recent pharmaceutical releases. However, the market growth is constrained by severe government requirements for biosimilar approval and hefty medication development costs. Government support for funding the development of biologics and ensuring their safety is also anticipated to open attractive market expansion potential. Additionally, the government is anticipated to be driven by the high rates of microbiological contamination and bioburden while manufacturing pharmaceuticals and biologics.

As a result, the market may be driven by all these behaviors. Due to the rising frequency and prevalence of these disorders, there is projected to be an increase in the demand for and research into various medications, diagnostics, cell treatments, and active biological products. The expansion of biotechnology and pharmaceutical businesses, significant R&D expenditures by the key market participants in the life science sectors, and an increase in the release of novel drugs in recent years. The market for biologics safety testing is expanding due to strict rules being implemented for biologics screening to find, identify, and remove any contaminants from these agents. Thus, the significant investments made by drug and biopharmaceutical companies in the R&D of effective and therapeutically improved biologics will spur market growth.

Biologics Safety Testing Market Trends

• Growing investment in biopharmaceutical R&D is driving the market growth

Market CAGR for biologics safety testing is being driven by the rising investment in biopharmaceutical R&D. The prevalence of chronic diseases like diabetes, cancer and neurological and cardiovascular diseases has grown rapidly worldwide. The demand and research for different drugs, diagnostics, cell therapies and active biological products are anticipated to grow owing to the increased incidence and prevalence of these diseases. The rise in biotechnology and pharmaceutical companies, large R&D investment by the major market players in the life science industries and the rise in the number of novel drug introductions in recent years.

There has been a drastic increase in the burden of chronic infectious and chronic ailments like heart ailments, hyperglycemia, and cancer throughout the globe. This has caused a fast rise in the demand for biologics like monoclonal antibodies, recombinant proteins, gene therapies, stem cell therapies, and transplant tissue. The stringent guidelines implementations on biologics testing in order to detect, identify, and remove any kind of contaminants from these agents are fueling the rise of the biologics safety testing market. Therefore, the notable spending by pharmaceutical and biopharmaceuticals firms on the R&D of efficacious and therapeutically advanced biologics will boost the market expansion by boosting the amount of volume of tests which needs to assess their safety. Several key market players and SMEs of life sciences companies outsource their services when lacking the infrastructure for quality assurance, which in turn helps in reducing the overall expenditure.

The growing trend towards personalized medicine and targeted therapies has resulted in the development of biologics tailored to specific patient populations, growing the demand for biologics safety testing. The growing implementation of the safety rules by regulatory authorities has increased public awareness of drug safety. These stringent guidelines and standards boost the utilization of safety testing products by quality assurance personnel. Thus, driving the Biologics Safety Testing market revenue.

However, the lack of qualified professionals to perform biological safety testing procedures and huge investment prices connected with biological safety cabinets can restrain the market growth. Additionally, the reluctance to accept the product on the market is also anticipated to be the restraining factor to the market growth.

Biologics Safety Testing Market Segment Insights

Biologics Safety Testing Product & Services Insights

The Biologics Safety Testing market segmentation, based on products & services, includes Consumables, Instrument and Services. The services segment dominates the market, accounting for the largest market revenue due to the biopharmaceutical manufacturers’ limited financial resources, the requirement to minimize the time to market, capacity constraints, significant investments needed to set up manufacturing facilities, and the increasing drug pipelines, all of these factors have fueled a shift towards outsourcing biologics safety testing to service providers. Further, the consumable segment is expected to experience the fastest growth throughout the forecast period.

 Figure 1: Biologics Safety Testing Market, by Product & Services, 2022 & 2032 (USD Billion)

Source: The Secondary Research, Primary Research, MRFR Database and Analyst Review

Biologics Safety Testing Test Type Insights

The Biologics Safety Testing market segmentation, based on test type, includes Sterility Test, Bioburden Test, and Endotoxin Test. The bioburden testing segment dominates the market and accounts for the largest market share. Organization like World Health Organization has also come up with guidance for health managers and workers on the standard processes and infrastructure which must be in place for better sterilization and decontamination of medical devices. All these reasoms are anticipated to fuel the demand for proper sterilization, thus driving the demand for bioburden testing, serving as an effective tool in the validation and revalidation of the sterilization processes and the assessment of the cleaning process efficiency and regular monitoring of manufacturing processes for ensuring the safety.

News:At its new €22 million facility close to Nantes, Clean Cells, a division of the French company Clean Biologics, which makes starting materials and offers services for the quality control of biopharmaceutical products, has started conducting analytical activities. The new location, which has a 5,300m2 area, provides four times the amount of laboratory space as the old building and, according to the company, marks a "major milestone" in its development. A brand-new cutting-edge monitoring system is anticipated to provide better pharmaceutical organization. With the execution of new tests to satisfy market demands, the company hopes to expand its activities in cutting-edge fields like gene therapy as a result of the makeover. According to Clean Cells, it will be able to provide new and enhanced innovation platforms in the future, such as next-generation sequencing.

Biologics Safety Testing Regional Insights

By region, the study gives market insights into the North America, Europe, Asia-Pacific and the Rest of the World. The North American Biologics Safety Testing market area dominates the market due to the rapid growth in the biopharmaceutical industry, rise in the development of structure-based drug designs, increasing governments and academic investments, surging demand for high-quality research tools for data reproducibility and increasing consumer awareness of product safety.

Further, the prime countries studied in the market report are The US, Canada, the UK, German, France, Italy, Spain, Japan, India, China, Australia, South Korea, and Brazil.

Figure 2: BIOLOGICS SAFETY TESTING MARKET SHARE BY REGION 2022 (USD Billion) 

Source: The Secondary Research, Primary Research, MRFR Database and Analyst Review

Europe's Biologics Safety Testing market accounts for the second-largest market revenue due to the presence of several research organizations, key market players, ad a well-established universal healthcare system in this region. Further, the German Biologics Safety Testing market held the largest market share, and the UK Biologics Safety Testing market was the rapid-growing market in the European region.

The Asia-Pacific Biologics Safety Testing Market is expected to grow at the rapid CAGR from 2023 to 2032. This is due to rising investment by the government and private sectors in the biopharmaceutical and pharmaceutical industries in this region. Moreover, China’s Biologics Safety Testing market held the largest market share, and the Indian Biologics Safety Testing market was the rapid-growing market in the Asia-Pacific region.

Biologics Safety Testing Key Market Players & Competitive Insights

Leading market players are investing hugely in research and development in order to expand their product lines, which will help the Biologics Safety Testing market grow even more. Market players are also undertaking a variety of strategic activities to spread their footprint, with important market developments inclusive of new product launches, mergers and acquisitions, contractual agreements, higher investments, and collaboration with other organizations. To spread and survive in a more competitive and rising market climate, the Biologics Safety Testing industry must offer cost-effective items.

Manufacturing locally to reduce the operational costs is one of the key business tactics utilized by manufacturers in the Biologics Safety Testing industry to benefit the clients and increase the market sector. In recent years, the Biologics Safety Testing industry has offered some of the most significant benefits to the medicine. Major participants in the Biologics Safety Testing market, including BioPharma, Redberry, Eurofins Scientific, Lonza Group Ltd, Charles River Laboratories International Inc., Promega Corporation, Thermo Fisher Scientific, Microsoft Biotechnologie GnbH, BioRad Laboratories Inc., Samsung Biologics and others, are trying to increase market demand by investing in the research and development operations.

Charles River Laboratories International Inc., an American pharmaceutical company that specializes in various preclinical and clinical laboratory, cell and gene therapy services for the medical devices, pharmaceuticals and biotechnology industry. The company provides several drug discovery, basic research, and assessment services. The company offers solutions aiming at therapy sections related to the central nervous system, cardiovascular, metabolic, inflammation, oncology, respiratory and many other disorders. In January 2021, the company partnered with JADE Biomedical in order to expand its biological testing solutions capability geographically and assist in raising the demand for biologics therapeutics, mainly gene and cell therapies. This partnership helped JADE to expand its current Good Manufacturing Practice product testing operations globally in Shanghai into a second facility and hence build upon its recent offering of broad biologic quality management and testing services.

LONZA Group Ltd is the leader in manufacturing custom active ingredients, intermediates and other pharmaceutical components supplier to the life science industry through biotechnology and chemical platforms. The company emphasizes allowing treatments that prevent any illness and help in living healthier lifestyles. The company optimizes scientific innovation and manufacturing technologies helping the customers to serve their consumers and patients. In April 2021, the company expanded its product, "PyroTec PRO Automated Robotic Solutions," in order to test endotoxin. This product is compatible with the product of the companies like PYROGENT-500 Turbidimetric LAL Assay, PyroGene rFC Assay, and Kinetic-QCL Chromogenic LAL Assay.

Key Companies in the Biologics Safety Testing market include

• BioPharma


• Redberry


• Eurofins Scientific


• Lonza Group Ltd


• Charles River Laboratories International Inc.


• Promega Corporation


• Thermo Fisher Scientific


• Microsoft Biotechnologie GnbH


• BioRad Laboratories Inc.


• Samsung Biologics

Biologics Safety Testing Industry Developments

July 2022:Wessling Hungary, which is a food, environmental, and BioPharma product testing laboratory in Hungary, was acquired by Eurofins Scientific. This acquisition will help expand the biopharma testing business of Eurofins in Europe.

March 2020:Sanofi and Regeneron started the development of their biologic Kevzara in order to treat patients with Covid-19. Kevzara, developed jointly by both companies, also inhibits the IL-6 pathways. This testing plays an important role in ensuring the purity of the vaccines and other biological products.

December 2020:A new product, "Red One Automated Bioburden Detection," was introduced by Redberry; this product enables instantaneous bioburden detection of microorganisms and has been fabricated for water and pharmaceutical testing.

Biologics Safety Testing Market Segmentation

Biologics Safety Testing Product & Services Outlook

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  Consumables

  
  


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  Instrument

  
  


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  Services

  
  

Biologics Safety Testing Test Type Outlook

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  Sterility Test

  
  


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  Bioburden Test

  
  


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  Endotoxin Test

  
  

Biologics Safety Testing Regional Outlook

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  North America

  
  

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  US

  
  


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  Canada

  
  

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  Europe

  
  

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  Germany

  
  


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  France

  
  


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  UK

  
  


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  Italy

  
  


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  Spain

  
  


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  Rest of Europe

  
  

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  Asia-Pacific

  
  
  
  
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    China

    
    
  
  
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    Japan

    
    
  
  
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    India

    
    
  
  
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    Australia

    
    
  
  
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    South Korea

    
    
  
  
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    Australia

    
    
  
  
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    Rest of Asia-Pacific

    
    
  
  
  
  


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  Rest of the World

  
  
  
  
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    Middle East

    
    
  
  
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    Africa

    
    
  
  
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    Latin America