The APAC market size for biologics safety testing is expected to grow at a CAGR of 16.20% from 2022 to 2027, The market size is expected to be worth USD 1.72 billion by 2027 from USD 0.81 billion in 2022.
Biologic safety testing is used for clinical trials and drug development. Biologic safety testing is used during clinical trials of drug development. This test ensures that all biological materials in the drug's development process are safe and free of contaminants. In this drug development, these details must be included for the advancement of the product and result at every stage.
Y-O-Y growth in the biologics and biosimilar markets is boosting the biologics safety testing market in the Asia-Pacific. Humans use biologics and biosimilar drugs to treat diabetes, cancer, kidney disease, and autoimmune diseases. Biological safety testing is done on biosimilar medications to know the safety quality of the drug. India is one of the leading manufacturers of biologics. Biologics are used for patients suffering from rheumatologic diseases, inflammatory bowel disease, malignant conditions, dermatological conditions, and other connective tissue disorders. Most biosimilars that have been approved for use include monoclonal antibodies and vaccinations. Vaccines improve human and animal health by preventing the spread of infectious diseases. India has approved several biosimilars for use in treating various conditions. This test is used for these biosimilar products, which drives the market forward.
Y-O-Y rise in the incidence of chronic diseases and the growth in the aging population are further promoting the growth rate of the biologics safety testing market in this region. Treatment of older patients is a challenging situation with chronic immune-mediated diseases. An increase in age results in several risk factors for comorbidities such as cardiovascular disease1, diabetes2, and cancer. Using any medication in older age may have other side effects which complicate life. Thus, the safety of biological therapy in older patients will increase their lifespan.
However, strict government approvals, lack of skilled professionals for drug development, issues in approvals of biosimilar medicine, and the high cost of drug development are some of the factors hampering the market growth in this region.
This research report on the APAC biologics safety testing market has been segmented and sub-segmented into the following categories.
By Products & Services:
By Test Type:
By Application:
By End-User:
By Country:
Geographically, the APAC region is anticipated to be the fastest growing regional market in the global market during the forecast period.
In the APAC region, the Indian market is growing at a significant growth rate. A large number of Indian biopharmaceutical companies are working on the production of biosimilars. The approval process for similar biologics in India is strict and requires more data than other generic drugs. Indian companies are following multiple steps for the manufacturing of the drug. India is the second largest supplier of vaccines in the world. Biologic drugs have shown more excellent clinical benefits as compared to standard drugs. In India, almost 60 biological agents have received approval, and nearly half of them are related to biologics. Due to decreased manufacturing and development costs, biosimilars are around half as expensive as standard drugs in India.
On the other hand, the Japanese market is estimated to register a healthy CAGR during the forecast period. Many biosimilar products have been developed to treat diseases in Japan. Japanese regulatory authority has followed some of the rules for developing biosimilar products. Japan has published some guidelines to ensure biosimilar or biologic products' quality, safety, and efficacy. These guidelines specify that biosimilar products must possess unique characteristics such as structural complexity, the presence of several functional domain sites, and particular bioactivity. The Japanese Biological Safety Association aims to improve and develop biosafety in Japan. Several training programs have been conducted through professionals to enhance the quality of the drug. The Japanese government encourages the introduction of special treatment for patients who choose to self-inject biosimilar medications.
The Chinese market is a promising region in the Asia-Pacific. In China, registration of biological products is essential. Based on the natural product that has been developed, classification is performed. In addition, a Chinese legal entity must submit a drug registration application for clinical trials. In 2020, China National Medical Product Administration published new regulations on the registration of biologics. As a result, based on all these factors, biologics safety testing has significant growth in this region.
KEY MARKET PLAYERS:
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. are some of the key players operating in the APAC biologics safety testing market.
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