The Rise of Cell and Gene Therapy CROs

Over 500 cell and gene therapy candidates are being investigated in different stages of clinical development across various geographies. In fact, in the past five years alone, more than 1,000 clinical trials, that are currently active, were initiated to evaluate the potential of these therapies across multiple therapeutic indications. Due to several development challenges, such

Real World Evidence: Unearthing the Gold Mine

Estimates suggest that each prescription drug requires an average of about 10 years and over USD 2.5 billion in working capital before it gets commercialized. In order to gain regulatory approval and establish standards for the safety and efficacy of these products, randomized clinical trials (RCTs) are conducted; these account for a staggering 40% of

The Rise of Medical Device CROs

According to the World Bank, more than 50,000 different types of medical devices are currently being used every day in health care facilities worldwide.  In 2018, the global medical devices market is estimated to reach a net worth of approximately USD 450 billion. However, a relatively larger proportion of device developers lack the required internal

Pre-Sterilized / Ready-to-Use (RTU) Primary Packaging: Current Market Landscape and Future Growth Opportunities

The use of ready-to-use (RTU), or pre-sterilized / pre-treated, container-closure systems have emerged as a promising alternative to conventional primary packaging, adding significant value to streamline pharmaceutical fill / finish operations. These packaging components eliminate multiple steps in the overall fill / finish process (mainly washing, sterilizing and preparing containers), thereby, helping improve operational efficiencies

Cold Chain Logistics for Healthcare: Emerging Opportunities in Cell Therapies, Vaccines and Human Organs

Presently, a wide variety of pharmaceutical products, such as biologics, vaccines, human organs for transplantation and certain conventional pharmacological interventions as well, are temperature sensitive and require freezing / cryogenic holding temperatures. In fact, over 95% of all approved biologics and 90% of all vaccines are cold chain dependent.  Stakeholders in this segment have designed

Extractables and Leachables Testing: Emerging Opportunities for Service Providers

During drug product manufacturing and fill / finish, it is important to consider not only the impurity profiles of the drugs, but also identify potential sources of contamination in the containers / packaging material used. due to high variability in the type of impurities (organic (volatile, non-volatile or semi- volatile compounds) or inorganic (metals or

ADC Manufacturing: Current Landscape, Growth Opportunities and Future Market Outlook

Antibody drug conjugates (ADCs) are one of the most popular classes of targeted therapeutic agents and have captured the attention of both large and small pharmaceutical companies, and academic / research institutions across the world. Owing to the fact that these novel conjugates are highly potent toxic molecules, their manufacturing requires elaborate technical capabilities, along

Neurostimulation Devices: Competitive Landscape, Market Evolution and Opportunity Areas

Extensive research in the field of neurostimulation has demonstrated the potential of this technique in providing therapeutic relief to a number of patients, who have developed resistance to conventional medication. Since the introduction of the first neurostimulation therapy in 1960s, their numerous observed benefits, such as reversible and minimally invasive nature of the procedures (to

Antibody Discovery: The Rise of Services and Platform Providers

Owing to several beneficial features, such as high specificity, and a favorable safety profile, antibody based pharmacological interventions, with 79 molecules approved till date and over 200 molecules in the preclinical / discovery stages, presently represent the largest class of biologics. The discovery of antibodies is a long, arduous and cost intensive process. As a

Non-Opioids Chronic Pain Management Drugs and Devices: Future Roadmap to USD 10 Billion+ Opportunity

Owing to the rapid onset of their medicinal effect, which offers immediate relief with high efficacy, opioids are still considered to be one of the most widely used pharmacological interventions for the management of moderate to severe forms of pain. However, these drugs are known to induce a euphoric state upon intake, often causing patients