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The biological safety testing products and services market size has grown rapidly in recent years, rising from $4.77 billion in 2023 to $5.4 billion in 2024, reflecting a compound annual growth rate (CAGR) of 13.2%. This historical growth is driven by the prevalence of target diseases, the rising production of next-generation biologics, increasing demand for biologics, greater adoption of testing tools, the expansion of the pharmaceutical and biotechnology industries, and heightened emphasis on regulatory compliance. Looking ahead, the market is expected to grow significantly, reaching $8.93 billion by 2028 at a CAGR of 13.4%. This future growth can be attributed to the rising importance of evaluating safety and effectiveness in treating health problems, increased development of new therapeutics and treatments, growing interest in cell and gene therapies, heightened investments in the biopharmaceutical sector, and government initiatives to promote biopharmaceutical safety. Major trends anticipated during this period include technological advancements, increased demand for bioburden testing, rising investments in biopharmaceuticals and biologics, regulatory compliance driving adoption, and mergers and acquisitions among key players.

The growing demand for gene therapies is expected to propel the growth of the biological safety testing products and services market going forward. Gene therapy, which uses genes to treat or prevent disease by replacing, modifying, or supplementing faulty genes, is expanding due to increased investment, research, and supportive regulatory environments. Biological safety testing products and services ensure viral vectors and genetic materials are contaminant-free and safe for use. For instance, in January 2024, according to the American Society of Gene & Cell Therapy, a US-based non-profit medical and scientific organization, the number of gene therapies in Phase III clinical trials grew by 10% in Q4 2023, marking the first quarterly increase since Q3 2022. Therefore, the growing demand for gene therapies is driving the market for biological safety testing products and services.

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What Are The Key Trends That Influence Biological Safety Testing Products And Services Market Share Analysis?
Major companies operating in the biological safety testing products and services market are developing rapid animal-free bacterial endotoxin testing to enhance patient safety and expedite drug development.​ This innovative approach aims to reduce testing time and improve reliability without the use of animal-based products. For instance, in January 2024, Charles River Laboratories International, a US-based pharmaceutical and biotechnology company, introduced the Endosafe Trillium cartridge, which employs recombinant technology to detect and quantify endotoxins without using animal-derived materials. It is the first rapid animal-free bacterial endotoxin test that features a faster turnaround time and eliminates the need for animal-derived reagents, thus enhancing sustainability and ethical testing practices. This product aims to provide rapid, accurate results while reducing reliance on the traditional Limulus amebocyte lysate (LAL) derived from horseshoe crabs​.

How Is The Global Biological Safety Testing Products And Services Market Segmented?
1) By Product: Reagents And Kits; Instruments; Services
2) By Test Type: Endotoxin Tests; Sterility Tests; Cell Line Authentication And Characterization Tests; Bioburden Tests; Adventitious Agent Detection Tests; Residual Host Contamination Detection Tests; Other Test Types
3) By Application: Vaccines And Therapeutics; Blood And Blood-Based Products; Gene Therapy; Tissue And Tissue-based Products; Stem Cell

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The Biological Safety Testing Products And Services Global Market Report 2024 provides an overview of the biological safety testing products and services market for the time series: historic years (2010 – 2021) and ten years forecast (2023 – 2032). The biological safety testing products and services market forecast analyzes biological safety testing products and services market size, biological safety testing products and services market share, leading competitor and their market positions.

The Table Of Content For The Biological Safety Testing Products And Services Market Include:

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