Report

The sterility testing market is expected to register a CAGR of 8.5% during the forecast period.

As the COVID-19 pandemic started, most pharmaceutical and biotechnological companies started focusing on their research and development for the identification of leads that can diagnose and treat the SARS-CoV-2 infection. The surge in COVID-19 cases forced the major players and research institutions to look beyond conventional medicine or therapies and led to huge investment in the research and development activities by private and government entities across the world. These activities significantly boosted the sterility testing market. The severity and high infection rate of the infection generated demand in the biologics manufacturing sector for sterility testing products, which is expected to fuel the growth of the studied market over the forecast period.

The major factor driving the growth of the sterility testing market is the increasing research and development in the field of life sciences, coupled with huge public and private funding in the sector. For example, as per the Union Budget for the year 2021-2022, the Indian Ministry of Science and Technology allocated a budget of INR 35 billion, a 25% hike from the 2020-21 budget, for the Department of Biotechnology (DBT) of India, mainly for biotechnology research and development and industrial and entrepreneurship development in the country which will boost the studied market.

The other factor contributing to the growth of the sterility testing market is the increasing number of drug approvals and new drug launches over the year. For instance, according to the April 2021 report from the Congressional Budget Office on "Research and Development in Pharmaceutical Industry, between 2010 and 2019, there was a 60% increase in the number of new drugs for sales in the United States. In 2021, the Food and Drug Administration (FDA) approved a total of 50 new drugs in the country. Additionally, the new product launches and developments in the sterility testing market by the key market players and strategic collaborations, mergers, and acquisitions will also drive the growth of the studied market. For instance, Reading Scientific Services Ltd launched a fast, responsive, and flexible sterility testing service for pharmaceutical and medical device companies in November 2019.

Furthermore, certain potential safety concerns that are associated with the products, which generally arise from the manufacturing processes and complex biological and structural characteristics of the products, and the rising demand for sterilized products globally are among other factors expected to boost the market over the forecast period.

Stringent regulatory policies and frameworks of different countries around the world are expected to impede the growth of the sterility testing market over the forecast period.

Sterility Testing Market Trends

The Pharmaceutical and Biological Manufacturing Segment is Expected to Grow Over the Forecast Period

Sterility testing is carried out at all levels of manufacturing pharmaceutical and biological products to minimize the risk of product contamination. The high growth of pharmaceutical and biological industries will considerably boost the overall use of sterility testing, leading to the high demand for sterility testing products and solutions, which may boost the growth of the market over the forecast period.

In the manufacturing process of any pharmaceutical or biological product, sterility testing is carried out for raw materials, finished products, and even before releasing the final product to ensure the absence of microorganisms as per the mandated regulations of the regulatory authority or institutions. As the demand for pharmaceutical and medical products for different health conditions is increasing, the frequency of sterility testing in the industries is also increasing, which is expected to boost the market.

Also, the increasing investments in research and development and growing approvals from the regulatory bodies for drugs and other biologics are surging the launch of new drugs and several products, which is expected to fuel the market in the coming years. For instance, as per the report of the European Federation of Pharmaceutical Industries and Associations, The Pharmaceutical Industry in Figures Key Data 2021, the pharmaceutical industry invested more than EUR 37,700 million in 2019, which increased to EUR 39,000 million in 2020 in R&D in Europe.

Therefore, these increasing research and development activities and expenditures in the segment are expected to propel the market growth over the forecast period.

North America Dominates the Market, and It is Expected to Follow the Same Trend During the Forecast Period

North America holds a major share in the sterility testing market, and it is expected to show a similar trend over the forecast period, mainly due to the growing research and innovations in the biotechnology and pharmaceutical industries in the region, the increasing investment in research and development activities in life sciences and medical technology, and favorable government initiatives.

For instance, according to the government of Canada, Industrial research and development, 2019 (actual), 2020 (preliminary), and 2021 (intentions) report, in 2019, Canadian businesses spent a record high of USD 21.7 billion on in-house R&D, which was a 3.8% increase over the spending in 2018. The pharmaceutical industry profile of the Canadian government shows that from 2011 to 2020, pharmaceutical exports and imports between Canada and the rest of the world increased by 143% and 58%, respectively.

In the North American region, the United States holds the largest market for sterility testing, and it is expected to dominate over the forecast period as well. The high share of the United States in the sterility testing market is attributed to the presence of several global pharmaceutical and biopharmaceutical companies and huge funding for research and development by the government and private entities in the country.

For instance, as per the April 2021 report from the Congressional Budget Office on "Research and Development in Pharmaceutical Industry", the pharmaceutical industry's expenditure on research and development was USD 83 billion in 2019, and if this amount is adjusted for inflation, then it is about 10 times of what the industry spent per year in the 1980s. Also, the high-end research activities in the academics and research institutes may further drive the growth of the sterility testing market in the country over the forecast period.

These increasing R&D expenditure for pharmaceutical development in the countries of the North American region is expected to boost the market over the forecast period.

Sterility Testing Market Competitor Analysis

The sterility testing market is moderately competitive and consists of several major players. With growing opportunities in the biopharmaceutical segment, other new players are also expected to enter the market. Some of the major players in the market are BioMerieux, Charles River Laboratories Inc., Merck KGaA, Sartorius AG, SGS SA, Sotera Health LLC, and Thermo Fisher Scientific, among many others.

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