Leveraging the Pharmaceutical Opportunity: White Paper

Leveraging the Pharmaceutical Opportunity: White Paper

Pharmaceutical industry is one of the key industries for any country. We shall be focusing on both important streams of the Indian pharmaceutical industry namely;

1. API
2. Formulations

We are glad to roll out a detailed white paper on the Indian Active Pharmaceutical Ingredient (API) industry. Sharing a glimpse of the white paper!

The Global Active Pharmaceutical Ingredient (API) Market is predicted to have a relative CAGR of 4.93% during the forecast period (2019-2023), as per a research. The APIs have been recognized as an asset for multiple pharmaceutical brands owing to the effectiveness of the products. 

Rapid urbanization and growing healthcare awareness have affected the increasing healthcare expenditure, and this has been a global trend. Branded generic drugs are relishing a higher adoption rate, and the case is the same for the speciality medicines. Among the other factors, rising contraction of chronic diseases such as cardiovascular diseases, diabetes, obesity and others have given a lift to the need for APIs in the market. Global Active Pharmaceutical Ingredient (API) Market has seen a relentless growth in volumes and value, mirroring the growth drivers for the overall pharmaceutical industry.

However, everything is not easy enough for the Indian markets. With plenty of opportunities, several challenges come along. Though this year has seen a significant impact of supply disruptions from the conventional supplier base i.e China and India, impacting either API availability or economics. The lack of supply or higher prices of inputs has led to the escalation in API prices, affecting the cost of finished drug in majority of the cases.

The market is also getting pushed by the intense need for commercialization of drugs that would curtail the cost and increasing expenditure in research and development and can turn out to be a boon for the global API market. Patent expiry of various biological drugs can open the market beyond APIs.

However, getting skilled professionals in this segment is difficult and thus it is hampering the production. The medicines are also not instantly accessible in developing countries and are failing to delve into the opportunities given by the developing countries.

By manufacturing process, the market is segmented into captive manufacturing and contract manufacturing. The captive manufacturing segment is anticipated to dominate the market. Once a stronghold of Europe, this market is now gently shifting towards the Asia Pacific (APAC). Low manufacturing cost and high demand for generic drugs are going to boost the APAC market.

To survive into one of the most promising sectors of today’s economy, one must tap into the areas of improvement to grab the opportunities with both the hands to stay profitable. Enhancing performance at an active pharmaceutical ingredient manufacturing plant entails a unified and futuristic approach that contains framework to boost operations management, inventory management, quality control, overall equipment effectiveness improvement, maintenance factor improvement, changeover time reduction, cleaning time reduction, yield improvement and assurance.

We have worked with clients from the API industry, where we have helped the client in organization transformation through:

• Cleaning time reduction
• OEE improvement of machines
• Breakdown reduction
• Yield improvement
• Cost reduction through various continual improvement initiatives

 

To mention, we have worked with one of the worlds leading API manufacturer, where we helped them save more than INR 7 Crore through continual improvement initiatives drive. This drive was based on the 4 Ms – Man, Material, Machine and Method. We also helped the client in quality management and quality control, lead time reduction for the batch released and productivity improvement in quality department.

While the market for active pharmaceutical ingredients (APIs) has been exceedingly profitable, it faces crucial challenges as well. Escalating regulatory forces, the firmer bargaining power of purchasers, rocketing costs, low-cost competition from Asian suppliers, slowdown in drug approvals, and drug failures are forming challenges for research-driven pharmaceutical organizations, contract manufacturers and generic drug firms. These changes necessitate more than just compliance with specifications. Process understanding and robust continual improvement framework is the key to moving from counteractive actions to more efficient incessant improvements.

Achieving manufacturing excellence necessitates process understanding. The biotech /pharmaceutical manufacturing industry tends to focus too much on what one thinks, and regulators want to see, rather than what one needs to do to improve the process. All this should lead towards improvement in the practices to reduce costs, wastage, rework, and improving the quality, productivity, profitability to be into one of the fastest-growing sectors of the Indian economy.

This whitepaper attempts to address the mentioned issues along with its proven solutions. It covers 10 pointers for advanced Pharmaceutical Operational Excellence journey, which is need of the hour today! These 10 points can decide the future of Operational Excellence at your Pharmaceutical Manufacturing Operations. Contact us at [email protected] to get your copy today.

Written & Compiled By Faber Manasi Chandak