Biologics Safety Testing Market by Product & Service (Instruments, Consumables, Services), Application (mAbs, Vaccine, Cell & Gene Therapy), Test Type (Sterility Test, Endotoxin, Mycoplasma, Bioburden), End User (Biopharma, CDMO) - Global Forecast to 2027

Biologics Safety Testing Market by Product & Service (Instruments, Consumables, Services), Application (mAbs, Vaccine, Cell & Gene Therapy), Test Type (Sterility Test, Endotoxin, Mycoplasma, Bioburden), End User (Biopharma, CDMO) - Global Forecast to 2027

The global biologics safety testing market is projected to reach USD 6.8 billion by 2027 from USD 3.6 billion in 2022, at a CAGR of 13.3% during the forecast period. The growth of the global biologics safety testing market is driven by factors such as the strict regulatory scenario implemented for quality control testing for biopharmaceutical production, increase in the number of approved biologics products worldwide, growing use of biologics safety testing reagents and kits for cell culture contamination detection, and increases in R&D spending and government support will significantly boost biologics testing activities.

“By product & service segment, the service segment accounted for the largest share of the Biologics Safety Testing market”

Based on product and service, the biologics safety testing market is segmented into consumables, services, and instruments. In 2021, the services segment accounted for the largest market share. The large share of this segment can be attributed to large biopharmaceutical companies routinely outsource numerous tasks, such as process and product validation, process monitoring and quality control, toxicology, and other preclinical studies.

”By application, the monoclonal antibodies development and manufacturing segment accounted for the largest market share of the Biologics safety testing market “

Based on application, the biologics safety testing market is segmented into monoclonal antibodies development and manufacturing, vaccines development and manufacturing, blood and blood products development and manufacturing, cellular and gene therapy products development and manufacturing, and other applications. In 2021, the monoclonal antibodies development and manufacturing segment accounted for the largest market share. The large share of this segment can be attributed to the growing number of regulatory approvals.

“Asia Pacific: The fastest-growing region in the biologics safety testing market.”

The biologics safety testing market in the Asia Pacific region is projected to register the highest growth during the forecast period. Factors such as growth in the outsourcing industry in the Asia Pacific region, vastly expanding R&D funding by biopharmaceutical companies and government, minimized outsourcing costs, and rising patient population resulting in growing manufacturing of biologics are expected to drive market growth.

“North America accounted for the largest share of the Biologics safety testing market in 2021”

North America accounted for the largest share of the biologics safety testing market in 2021. Rapid growth in the biopharmaceutical industry is the major factor driving the growth of the North American biologics safety testing market. High number of pre-registration and other-phase drugs in the pipeline by pharmaceutical companies and biotechnology/gene therapy/genomics companies and the presence of major market players in this region are also driving the market for biologics safety testing in North America.

Breakdown of primaries

The study contains insights from various industry experts, ranging from component suppliers to Tier 1 companies and OEMs. The break-up of the primaries is as follows:

By Respondent– Supply Side- 80%, Demand Side-20%

By Designation— CXOs - 20%, Executives - 25%, Mangers - 55%

By Region— North America - 40%, Europe - 30%, APAC – 20%, LATAM & MEA- 10%

The Biologics Safety Testing market is dominated by a few globally established players such Charles River Laboratories, Inc. (US), Lonza (Switzerland), Thermo Fisher Scientific, Inc. (US), Merck KGaA (Germany), F. Hoffmann-La Roche Ltd. (Switzerland), Agilent Technologies, Inc. (US), Labcorp (US), SGS SA (Switzerland), WuXi AppTec (China), Sartorius AG (Germany), Associates of Cape Cod, Inc. (US), bioMérieux SA (France), Eurofins Scientific (Luxembourg), FUJIFILM Wako Pure Chemical Corporation (Japan), Almac Group (UK), Bio-Rad Laboratories, Inc. (US), QIAGEN (Germany) , Pacific BioLabs (US), InvivoGen (US), Microcoat Biotechnologie GmbH (Germany), PromoCell GmbH (Germany), Samsung Biologics (South Korea), GenScript (China), Maravai Lifesciences (US), Accugen Laboratories, Inc. (US) and Nelson Laboratories, LCC (US)

Research Coverage:

The report segments the Biologics Safety Testing market based on region (Asia Pacific, Europe, North America, Latin America and Middle East and Africa), product and service (consumables, services, and instruments), application (monoclonal antibodies development and manufacturing, vaccines development and manufacturing, blood and blood products development and manufacturing, cellular and gene therapy products development and manufacturing, and other applications.), and test types (endotoxin tests, sterility tests, mycoplasma tests, bioburden tests, virus safety tests, residual host-cell proteins and DNA detection tests, and other biologics safety tests). The report also provides a comprehensive review of market drivers, opportunities, challenges and restrains in the Biologics Safety Testing market.

Key Benefits of Buying the Report:

The report will help the leaders/new entrants in this market with information on the closest approximations of the revenue numbers for the overall market and the sub-segments. This report will help stakeholders understand the competitive landscape and gain more insights to better position their businesses and plan suitable go-to-market strategies. The report also helps stakeholders understand the pulse of the Biologics Safety Testing market and provides them information on key market drivers, restraints, challenges, and opportunities.