The pharmaceutical traceability market involves a variety of products such as software solutions, printing and labelling solutions, verification solutions, and serialization solutions that facilitate efficient tracing of pharmaceutical products throughout the complex supply chain. These solutions help track pharmaceutical products, verify authenticity, and detect potential threats like counterfeits. They provide visibility into global supply networks and enable compliance with regulations mandating traceability to ensure patient safety. 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 2031.
Key Takeaways
Key players operating in the pharmaceutical traceability market 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. Serialization solutions are increasingly being adopted to comply with regulations and secure supply chains. The Asia Pacific region is expected to witness significant growth in the market owing to rising healthcare spending and increasing regulatory focus on traceability in major countries like India and China. Manufacturers are focusing on global expansion through partnerships and acquisitions to consolidate their presence across key markets.
Market Drivers
Stringent regulations mandating traceability of pharmaceutical products right from production to the patient are a major driver for the Pharmaceutical Traceability Market Growth. National and regional regulatory bodies worldwide are introducing laws to uniquely identify packages and curb problems related to copyright drugs. For instance, the U.S. Drug Supply Chain Security Act (DSCSA) mandates serialization of pharmaceuticals. Compliance with such regulations is boosting adoption of traceability solutions.
PEST Analysis
Political: Regulations governing pharmaceutical manufacturing and distribution are becoming stricter in many countries to ensure drug safety and authenticity. Strict traceability compliance is necessary to stay in business.
Economic: The rising cost of healthcare and increasing incidence of copyright drugs is driving pharmaceutical companies to invest in track and trace solutions to achieve supply chain visibility and cost savings over the long run.
Social: Patients and consumers want assurance that the drugs they take are genuine and safe. Traceability provides drug pedigree information which enhances confidence in pharmaceutical products.
Technological: Blockchain, RFID, 2D barcoding and other automated identification technologies are being adopted by pharmaceutical manufacturers and distributors to enable item-level traceability across the supply chain in real-time. Advanced traceability platforms also utilize analytics for inventory management and recall procedures.
Geographically, North America accounts for the largest share of the pharmaceutical traceability market currently, driven by stringent regulatory mandates and presence of global pharmaceutical leaders based in the US and copyright. However, with new serialization and traceability laws coming into effect in major markets like the European Union and China, the Asia Pacific region is expected to witness the fastest market growth during the forecast period, as traceability solutions deployment gathers pace in emerging pharma manufacturing hubs.
The European region is also anticipated to experience substantial growth. Requirements under the EU Falsified Medicines Directive have prompted drug makers in Europe to pursue robust traceability compliance over the next few years. Additionally, technology adoption is relatively higher in Western European countries compared to other parts of the world.
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Ravina Pandya, Content Writer, has a strong foothold in the market research industry. She specializes in writing well-researched articles from different industries, including food and beverages, information and technology, healthcare, chemical and materials, etc. (https://www.linkedin.com/in/ravina-pandya-1a3984191)