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The Pharmaceutical Traceability Market is Anticipated to Witness High Growth Owing to Increasing Regulations for Drug Security

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ashwinicmi
The Pharmaceutical Traceability Market is Anticipated to Witness High Growth Owing to Increasing Regulations for Drug Security

The pharmaceutical traceability market involves tracking drugs from the point of manufacturing to the point of dispensing. Traceability equipment helps verify the authenticity of drugs and identify counterfeits. Barcode printers, labeling and serialization machines, and verification equipment are widely used. The need for traceability has grown due to rising instances of counterfeit drugs and stringent regulations. The EU Falsified Medicines Directive requires unique identification codes on drug packs. Similarly, the U.S. Drug Supply Chain Security Act mandates tracing pharmaceuticals using serialization.

The Global pharmaceutical traceability market is estimated to be valued at US$ 4.96 Bn in 2024 and is expected to exhibit a CAGR of 9.5% over the forecast period 2024 to 2030.

Key Takeaways

Key players: Key players operating in the Pharmaceutical Traceability Market Size include M&R Printing Equipment, MHM Siebdruckmaschinen GmbH, Lawson Screen & Digital Products, Sakurai USA, SPS TechnoScreen GmbH, ATMA Champ Ent. Corp., Systematic Automation, DECO TECHnology Group, TOSH (Italy), and Thieme GmbH & Co. KG.

Key opportunities: The market provides opportunities for players dealing with serialization and aggregation equipment, used to bundle drugs together and assign unique identifiers. Cloud-based track and trace solutions are also gaining attention to monitor pharmaceuticals across international borders.

Global Expansion: Major manufacturers are expanding globally to cater to the growing demand for traceability from companies operating worldwide. For example, some players have set up production sites and local offices in Europe, Asia, and North America to serve local customers better.

Market drivers: Stringent regulations mandating drug traceability from manufacturing to the consumer are a key driver for this market. Regulations ensure quality and limit counterfeiting activities. Authentication technology advances are also fueling the adoption of track and trace solutions.

Market restraints: High costs of traceability equipment and ongoing upgrades could challenge smaller pharmaceutical firms. Additionally, the lack of a globally harmonized framework for drug traceability remains a hurdle to cross-border trades. This restrains full implementation and scope for global connectivity solutions.


Segment Analysis

The Pharmaceutical Traceability Market can be segmented based on several product types such as serialization solutions, aggregation solutions, and tracking, tracing, and reporting solutions. The serialization solutions segment currently dominates the market due to stricter serialization regulations and deadlines introduced by various regulatory bodies globally to uniquely identify pharmaceutical products and combat counterfeiting. These solutions offer serialization at the unit or carton level to help organizations comply with regulations.

Global Analysis

Regionally, North America holds the major share in the Pharmaceutical Traceability Market due to stringent regulations enforced by the FDA in the region. The FDA requires all pharmaceutical manufacturers in the US to implement product serialization at the unit level by November 2023. However, the market in Asia Pacific is expected to grow at the highest CAGR during the forecast period due to the growing generics market and implementation of track and trace systems by developing countries such as India and China. Key players in the market focus on geographic expansion opportunities across Asia Pacific and Latin America to strengthen their global presence.

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