Growing at a CAGR of 12.7% between 2022 and 2030, the biologics safety testing market value is expected to reach USD 9,370.3 million by 2030. The growth can be ascribed to the increasing prevalence of contagious and non-contagious ailments, thereby resulting in a rising dependence of the population on biologics.
Other key drivers for the market are the growing research and development activities, advancements in gene therapies, significant number of product launches and collaborations among industry players, and technological advancements in the field.
There has been a tremendous surge in the adoption of biologics or biotechnology-based products in many aspects of medicine, such as the detection, prevention, and treatment of ailments. The growing adoption of the same has made their safety testing essential, due to their ease of contamination during the production phase. Hence, these products need thorough safety testing to ensure that they are sterile and free of contaminants throughout their life.
Moreover, the significant adoption of gene and cell therapies for the treatment of severe ailments, including cancers, Apert syndrome, cystic fibrosis, albinism, ankylosing spondylitis, and Angelman syndrome, is projected to fuel the biologics safety testing market advance over this decade. This is because gene therapies have proven to be efficacious for the treatment of many lethal illnesses. Additionally, the production of gene and cell therapies is complex due to the high probability of the presence of contaminants in the final product.
In addition, the growing biotechnology and pharmaceutical sectors, along with the increasing expenditure on the development of cutting-edge labs, are other major contributors to the market growth.
In addition, the top players in the biologics safety testing market are involved in product launches and acquisitions, to give themselves a competitive edge. For instance, in November 2022, a German company, namely Merck KGaA, invested more than EUR 290 million for the expansion of its biosafety testing capacity in Rockville, Maryland, U.S. This initiative was undertaken to increase the firm’s capacity to carry out analytical development and biosafety testing.
Furthermore, in July 2022, Luxembourg-based company Eurofins Scientific SE acquired Hungary-based laboratory Wessling. The acquisition helped Eurofins Scientific SE in expanding its biopharma product testing business.
Moreover, in June 2022, Switzerland-based firm Lonza Group Ltd. released a human-serum-based system, namely PyroCell Monocyte Activation. The test aids in the detection of non-endotoxin pyrogen impurities in pharmaceutical formulations.
Additionally, the growing public and private funding in pharmaceutical and clinical research and development and the rising consumer awareness regarding their health are contributing to the growth of the market.
On the basis of end user, biopharmaceutical companies lead the market. This is because the increasing frequency of disease outbreaks over the past years has significantly fueled the demand for biologics. Moreover, a large number of countries are spending heavily on their healthcare sector and encouraging the administration of vaccines for severe viral infections, such as the novel coronavirus, measles, Ebola, and Zika.
The Asia-Pacific market is expected to exhibit a CAGR of 15% during the forecast period. This can be ascribed to the growing prevalence of severe ailments, large pool of patients, and robust government policies supporting research and development initiatives in the region.
Moreover, the growing expenditure on the healthcare sector and the rising consumer awareness regarding the benefits and importance of the safety testing of biopharmaceuticals are driving the market. Further, professional associations, such as the Asia Pacific Biosafety Association, promote biosafety and biosecurity by training healthcare practitioners in the region in these aspects of medical sciences.
Some key players in the market are Charles River Laboratories International Inc., Lonza Group Ltd., Merck KGaA, InvivoGen, F. Hoffmann-La Roche Ltd., Agilent Technologies Inc., Société Générale de Surveillance SA, WuXi AppTec, bioMérieux SA, and Microcoat Biotechnologie GmbH.