FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices. Food and Drug Administration (FDA) and World Health Organization (WHO) are providing the guidelines regarding the risk associated with medical device to ensure patient's safety and to check effectiveness of the devices.

The article cited AMA's "Global Insulin Pen Market Study" explored CAGR of 10.9%. According to the report, Reusable insulin pens i.e. replaceable cartridge is one of the primary growth factors for the market. Easy to carry as portable and available in compact size is also expected to contribute significantly to the Insulin Pen market. Overall, Hospital applications of Insulin Pen, and the growing awareness of them, is what makes this segment of the industry important to its overall growth.

New technologies and major shifts in the industry will be game-changing factors that all players have to react now in order to maintain strong positions in the future. As many industry experts agree that significant changes are ahead. AMA’s Analyst on the Global Insulin Pen market identified that the demand is rising in many different parts of the world as "Increasing arrival of diabetes in various age groups ". Furthermore, some recent industry insights like "On 13th April 2021, BioCorp and Roche Diabetes Care France announced the launch of the Mallya smart insulin pen device in France. Developed by BioCorp, Mallya is an intelligent sensor for insulin injection pens that has CE mark approval in Europe. The platform is compatible with any disposable insulin pen. It enables reliable monitoring for doses selected for injection and it offers patients with diabetes better compliance with their treatment, according to the companies." which is constantly making the industry very dynamic.

The report provides an in-depth analysis and forecast about the industry covering the following key features:
o Industry outlook including current and future market trends, drivers, restraints, and emerging technologies
o Analyses the Global Insulin Pen market according to Type, Application, and regions
o Analyzes the top 10 players in terms of market reach, business strategy, and business focus
o Provides stakeholders’ insights and key drivers & trends of the market

**The market is valued based on weighted average selling price (WASP) and includes any applicable taxes on manufacturers. All currency conversions used in the creation of this report have been calculated using constant annual average 2023 currency rates.

Market Size Estimation
In market engineering method, both top-down and bottom-up approaches have been used, along with various data triangulation process, to predict and validate the market size of the Insulin Pen market and other related sub-markets covered in the study.

o Key & emerging players in the market have been observed through secondary research.
o The industry’s supply chain and overall market size, in terms of value, have been derived through primary and secondary research processes.
o All percentage shares, splits, and breakdowns have been determined using secondary sources and verified through primary sources.

Data Triangulation
The overall Insulin Pen market size is calculated using market estimation process, the Insulin Pen market was further split into various segments and sub-segments. To complete the overall market engineering and arriving at the exact statistics for all segments and sub-segments, the market breakdown and data triangulation procedures have been utilized, wherever applicable. The data have been triangulated by studying various influencing factors and trends identified from both demand and supply sides of various applications involved in the study. Along with this, the Global Insulin Pen market size has been validated using both top-down and bottom-up approaches.