Share on

North America Biologics Safety Testing Market Research Report – Segmented By Product & Services, Test Type, Application, End-User & Country (The United States, Canada and Rest of North America) – Industry Analysis on Size, Share, Trends, COVID-19 Impact & Growth Forecast (2022 to 2027)

Published: March, 2023
ID: 12696
Pages: 110
Formats: report pdf report excel report power bi report ppt

North America Biologics Safety Testing Market Size (2022 to 2027)

The size of the biologics safety testing market in the North American region is expected to grow at a CAGR of 13.51% from 2022 to 2027 and be worth USD 2.28 billion by 2027 from USD 1.21 billion in 2022.

Many firms are aggressively investing in biologics and biosimilars development. Biologics, such as proteins, peptides, and monoclonal antibodies, account for more than half of all drug candidates in the discovery stage. As a result, biologics are predicted to account for roughly half of the income earned by the top 100 pharmaceutical items in the future years.

Growing biopharmaceutical company investments in biologics and biosimilars are predicted to boost the number of authorized pharmaceuticals in North America. The rapidly growing pharmaceutical and biotechnology industries, increased investments, and rising manufacturing of new biologics due to the high disease load are primary factors driving North America's market expansion. In terms of revenue, biologics accounted for six of the top-eight drugs in 2019. For example, Humira (adalimumab), developed by AbbVie to treat rheumatoid arthritis, psoriasis, Crohn's disease, and other autoimmune disorders, produced USD 19 billion in sales, according to the Top 15 Best-selling Drugs of 2019 report. Humira had the quickest growth rate of any biological medicine.

Since its introduction, numerous pharmaceutical and biotechnology companies have been developing novel medicines and vaccines to tackle COVID-19. As a result, the North American market for biological safety testing was benefited from the increased R&D efforts in the recent past.

With developments in technology and new and enhanced safety testing methods across numerous industries, the biologics safety testing market is continually expanding. Highly skilled personnel are required to keep up with the constant developments in analytical technologies and safety testing techniques. Prior to using technology like PCR, spectrophotometers, and fully automated mycoplasma detection systems, they must grasp their safety, efficacy, and usefulness.

The success of biological safety testing is determined mainly by the analysts' knowledge and the ambient conditions in which the test is conducted. A scarcity of qualified specialists may impede the adoption of new technologies and procedures, restricting the growth rate of the North American market for biological safety testing.

This report on the North American biologics safety testing market has been segmented and sub-segmented into the following categories.

By Products & Services:

  • Consumables
  • Instrument
  • Services

By Test Type:

  • Sterility Tests
  • Bioburden Tests
  • Endotoxin Tests

By Application:

  • Vaccine Manufacturing
  • Monoclonal Antibodies Manufacturing
  • Cellular & Gene Therapy Products Manufacturing
  • Blood and Blood Products Manufacturing

By End-User:

  • Pharmaceutical and Biotechnology Companies
  • Contract Development and Manufacturing Companies
  • Research and Academia

By Country:

  • The United States
  • Canada
  • Rest of North America

Geographically, North American biologics safety testing held the majority of the share in the global market in 2022 and is projected to continue to do so in the future. The United States is likely to play a significant role in expanding this region's market. As a result of the outbreak of COVID-19, increasing R&D activities related to COVID-19 have had a positive impact on market growth.

The market's rise is directly attributed to the region's growing biotechnology and pharmaceutical sectors. However, the quick expansion of these companies can also be ascribed to factors such as breakthrough technologies and favorable government policies. Also, as pharmaceutical and medical device manufacturing processes become increasingly validated, demand for the market will increase. As of 2019, there were 4,676 drug manufacturing facilities in the U.S., according to the U.S. Food and Medication Administration (FDA).

In the United States, 48 new biologic drugs were licensed in 2019 compared to 22 in 2016.

Increasing R&D spending and improved healthcare facilities are expected to boost revenue. Pharma Research and Manufacturers of America (PhRMA) estimates that US pharmaceutical companies spent roughly 83 billion dollars on research and development in 2010. This should lead to a gradual increase in market expansion during the forecast period.


Companies playing a vital role in the North American biologics safety testing market profiled in this report are Charles River Laboratories International Inc., Merck KGaA, Lonza Group Ltd., Sartorius AG, SGS S.A., Thermo Fisher Scientific Inc., Pace Analytical Services Inc., WuXi AppTec, and Cytovance Biologics Inc.

Please wait. . . . Your request is being processed

Related Reports

Access the study in MULTIPLE FORMATS
Purchase options starting from $ 2000

Didn’t find what you’re looking for?

Need something within your budget?


Call us on: +1 888 702 9696 (U.S Toll Free)

Write to us:

Click for Request Sample