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December 2024
The global biological safety testing products and services market size was estimated at US$ 4.90 billion in 2023 and is projected to grow to US$ 15.07 billion by 2034, rising at a compound annual growth rate (CAGR) of 10.75% from 2024 to 2034. The Growing concern regarding the safety of products in the pharma and biotech industry drives the growth of the market.
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The materials and personal protective equipment that keep lab workers safe are combined to form the category of biosafety equipment. One crucial piece of equipment that helps lab personnel handle poisons or infectious agents properly is a biosafety cabinet. A crucial addition to the biosafety equipment in the laboratory is personal protective equipment. In order to shield laboratory personnel from harmful substances and infectious agents, personal protection equipment is worn in the form of gloves, masks, lab coats, and other wearing gear (including respirators and safety eyewear). Biological safety services might involve risk assessments, the creation and revision of biosafety policies and procedures, instruction on safe laboratory techniques, training, and advice on the layout and design of biosafety facilities.
Biological safety testing is enhanced by AI investment because it opens up new possibilities for insights-driven decision-making and precision treatment. Predictive skills are improved by AI-powered analytics, allowing for proactive risk management and improving health outcomes. The use of AI and digital technologies in biological safety assessment opens up a wide range of prospects for industry expansion. Businesses may stimulate creativity, maximize productivity, and set themselves up for long-term success in a changing market by utilizing technology.
| Company Name | Merck KGaA |
| Headquarters | New Jersey, U.S., North America |
| Recent Development | In April 2024, Merck, a well-known company in science and technology, produced the first comprehensive, validated genetic stability test of its type. Using whole genome sequencing and analytics, the AptegraTM CHO genetic stability assay expedites clients' biosafety testing and, consequently, their transition to commercial production. |
| Company Name | FUJIFILM Wako Pure Chemical Corporation |
| Headquarters | Tokyo, Japan, Asia Pacific |
| Recent Development | In June 2024, filmed by Fujifilm, the next-generation monocyte activation test (MAT)*1 for in vitro*2 pyrogen testing, LumiMATTM Pyrogen Detection Kit (LumiMAT), and the recombinant protein reagent PYROSTARTM Neo+ for the detection of bacterial endotoxins are the two new tests that Wako Pure Chemicals Corporation has announced the release of. In July 2024, the LumiMAT and PYROSTARTM Neo+ testing kits were released globally as an alternative to the conventional pyrogen and endotoxin tests. |
The biological safety testing products and services market is growing due to the growing investment in pharmaceutical industries; the world is dealing with a large number of health issues, especially chronic conditions, which leads to an increased demand for therapeutics. Private organizations and governments are making efforts to increase the production of medicines and therapeutics, which will directly impact the market’s growth.
For instance,
In August 2024, Pharmaceutical startup Vivint Pharma revealed intentions to build a cutting-edge injectables production facility in Hyderabad's Genome Valley. Telangana's standing as a major center for life sciences would be reinforced by the company's ₹400 crore investment in the new facility, which has the capacity to employ 1000 people.
The biological safety testing products and services market faces obstacles due to strict government regulations. The products developed in pharma industries and experiments conducted in pharma, biotech, and healthcare industries deal with various biological and chemical substances that need to be handled and disposed of safely. Strict regulations are needed to reduce biorisk, but it leads to extra investments in equipment, advanced testing infrastructure, and other needs.
As R&D continues, advances in technology will continue. With better systems and equipment, the biological safety testing products and services market will grow exponentially. Technological advances will increase accuracy, decrease time consumed in testing, reduce human errors, and increase safety. All these factors will also reduce the burden of strict regulatory actions. With better resources, better products will be developed in a short amount of time, which will be able to fulfill the growing demand for medicines and therapeutics.
For instance,
By product, the reagent & kits segment held the largest share of the biological safety testing products and services market in 2023. For biological safety testing, reagents and kits offer standardized parts and procedures, guaranteeing uniformity and repeatability between various labs and testing sites. Standardizing test findings reduces variability and makes comparing research easier. To guarantee dependability and performance uniformity, kits and agents are subjected to stringent quality control procedures. By ensuring the correctness of test findings and reducing the possibility of reagent-related mistakes, this quality assurance boosts trust in the reliability of biological safety testing results.
For instance,
By application, the vaccines and therapeutics segment dominated the biological safety testing products and services market in 2023. Public and global health are significantly influenced by immunization. Millions of deaths and cases of morbidity from infectious illnesses are avoided every year worldwide because of the use of vaccinations. Since vaccinations are used so extensively around the world, it is essential that they be as safe and effective as possible, given the state of science. Manufacturers of biopharmaceuticals are required to do extensive testing to guarantee that all biological materials used in the development process are described, safe, and devoid of contaminants.
By application, the gene therapy segment is expected to grow at the fastest rate in the biological safety testing products and services market during the forecast period. Gene therapy and gene-modified cell therapy developers provide patients all around the world with life-saving treatments. Biosafety testing and characterization are crucial as novel drugs for clinical research are developed in order to address safety problems well before the items are administered to people. Identification of procedural or commercialization obstacles is also essential in order to confidently, swiftly, and safely bring medicines that are desperately required to market.
By test type, the endotoxin tests segment held the dominant share of the biological safety testing products and services market in 2023. Businesses in the food and pharmaceutical sectors need to exercise great caution to ensure that their goods don't end up doing more damage than good. Bacterial endotoxins are one of the sneakiest dangers that these companies need to be aware of. Drug producers want to avoid epidemics of diseases brought on by these viruses at all costs.
For instance,
North America dominated the biological safety testing products and services market share by 36% in 2023. The market in North America is supported by the U.S., which is reinforced by the quickly growing pharmaceutical industry. Regional market expansion is also fueled by supportive government policies, a strong healthcare system, rising R&D expenditures, and the creation of cutting-edge technology. In the United States, the first automated biological safety method was carried out, providing excellent accuracy with little assistance from humans. The number of biosafety laboratories in the nation is also expanding quickly, which is fueling the market's expansion.
The Canadian medical device industry is mostly composed of small and medium-sized enterprises (SMEs) and exhibits great diversity. In 2022, it was estimated that Canada's medical device market will be valued at US$6.8 billion. The market is expected to grow at a rate of 5.4% per year until 2028. Nearly C$331 billion, or C$8,563 per person, was spent on healthcare in Canada in 2022. The United States continues to be the top supplier of medical equipment to Canada, accounting for US$3.2 billion in medical device exports into the Canadian market in 2022 (42.6% of total imports in this sector).
By region, Asia Pacific is expected to grow at the fastest rate during the forecast period. There are several factors that contribute to the growth of the biological safety testing products and services market in the Asia Pacific region. One major factor is its growing population, which demands more safe and high-quality therapeutics. Countries like China, India, and Japan majorly contribute to the growth.
When it comes to outsourcing pharmaceutical medication research and manufacturing at a reduced cost, China is the place to be. Numerous biotech and pharmaceutical businesses contract out to CROs for essential tasks, including drug research, clinical trials, and test kit manufacture. Therefore, the need for biological safety testing goods and services is being driven by the nation's contract development and research organizations, or CROs.
India is one of the leading countries that is contributing to the growth of the biological safety testing products and services market. The Indian government is focusing on producing various therapeutic drugs and medicines. For the betterment of public health, the government is taking initiatives and has started various pharmaceutical schemes. These schemes are useful for the growth of the market.
For instance,
| Sr. No. | Name of the Scheme | 2021-2022 Expenditure (In Crore) |
| 1 | National Economic Services | 14.80 |
| 2 | National Inst. Of Pharmaceutical Education and Research (NIPERS) | 234.34 |
| 3 | Development of the Pharmaceutical Industry | 124.42 |
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