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2024: Global Biologics Safety Testing Solutions Market Growth to $5.9 Billion

In 2024, costs in the global market for biologics safety testing solutions reached $5.9 billion. More than a third of this amount was provided by the North American region. Such data are provided in a Fortune Business Insights study, the results of which were published on December 19, 2025.

Biologics are drugs produced on the basis of living structures (cells, tissues, microorganisms) or their components (proteins, nucleic acids) using biotechnology. Such drugs are more targeted than conventional chemical agents and are used to treat complex diseases, including cancer, diabetes, autoimmune disorders, etc. Biologics are complex in structure: due to the large molecular weight, they are often injected. Such agents include growth hormone, interferons, monoclonal antibodies, vaccines, bacteriophages, etc.

Testing of biologics is necessary to confirm safety, exclude toxicity, determine possible side effects and risks: this is especially important for agents affecting immunity. Biologics are sensitive to storage conditions: tests confirm that they do not degrade and retain their properties during transportation and storage.

Against the background of the development of biotechnologies, including cell and gene therapies, there is an increasing need for thorough and frequent safety testing, the study says. The production of new generation biologics is associated with a high risk of contamination, and therefore requires the implementation of strict safety protocols at each stage. At the same time, genetic testing helps predict how the patient will respond to the drug, choose the desired dosage and avoid ineffective treatment. All these factors contribute to the expansion of the market. Analysts point to the growing popularity of automated microbiological systems that increase testing efficiency.

One of the main market restrictions is the shortage of qualified specialists. In addition, difficulties can be observed with access to modern equipment. Meanwhile, the identification of even minor pollution entails tough measures by regulatory authorities, including stopping production, destroying batches of products and possible penalties.

Analysts segment the market into testing kits/reagents, instruments and services. In 2024, the lion's share of revenue was provided by services. More than a third of total sales in monetary terms were for testing kits/reagents, approximately 20% - for instruments. From a geographical point of view, North America leads with 37.97%, or $2.24 billion. Significant industry players on a global scale are:

• Merck KGaA;
• SGS Société Générale de Surveillance SA;
• Thermo Fisher Scientific;
• Becton Dickinson (BD);
• Sartorius AG;
• Charles River Laboratories;
• Eurofins Scientific;
• Lonza;
• Waters Corporation;
• Reading Scientific Services;
• Abzena.

In 2025, the market for biologics safety testing solutions is expected to reach $6.4 billion. At the same time, North America will have $2.01 billion, Europe - $1.84 billion, Asia-Pacific - $1.65 billion. Latin America's contribution is estimated at $0.32 billion. Fortune Business Insights analysts forecast a compound percentage CAGR of 8.73% going forward. Thus, by 2032, costs may increase to $11.5 billion.^[1]

2021: Ukraine's withdrawal from the agreement with the CIS on the creation of an interstate reserve of biologics

On April 21, 2021, it became known about Ukraine's withdrawal from the agreement with the CIS on biological drugs. The corresponding bill was approved by the government of the country.

Withdraw from the agreement on the creation of the Interstate Reserve of Biologics and Other Means of Animal Protection in the Member States of the Commonwealth of Independent States, committed in Moscow on April 12, 1996, the document says.

According to RIA Novosti, we are talking about an agreement concluded in 1996 - then the countries pledged to create an interstate reserve of biologics and other means of animal protection in the CIS through equity participation.

Ukraine withdraws from agreement with the CIS on the creation of an interstate reserve of biological drugs

As indicated in the explanatory note to the bill approved by the Cabinet of Ministers of Ukraine, Ukraine's further participation in the agreement is inappropriate, since the country has not used drugs from this reserve for 10 years. In addition, the reserve is located in Russia, and the drugs included in it in most cases are focused on diseases common in the Russian Federation.

The modern needs of Ukraine in the safety of their own animal husbandry cannot satisfy these drugs, said Prime Minister of Ukraine Denis Shmygal.

This is not the first agreement with the CIS from which Ukraine leaves. In March 2021, the country withdrew from the signed agreements within the framework of the Commonwealth of Independent States (CIS) on cooperation in the field of cellular communications, and on February 23 - from the CIS agreements on aviation. On April 1, 2019, the treaty of friendship, cooperation and partnership between Russia and Ukraine ended.^[2]

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