Active Pharmaceutical Ingredients Market Overview
According to a new study by Infiniti Research, the active pharmaceutical ingredients market is projected to achieve profitable growth through 2022, owing to the growing importance of generics and increasing uptake of biopharmaceuticals. Also, the rising market demand for anti-infectives, diabetes, and pain killer drugs are projected to contribute to the active pharma ingredients market growth. On the flip side, increasing penetration of counterfeit drugs, tightening regulations, rising manufacturing costs, and intensifying competition are increasing challenges for active pharmaceutical ingredient manufacturers. As such, active pharma ingredients manufacturing firms are in the need to create complex APIs that find use in novel formulations. In addition to this, active pharmaceutical ingredients manufacturers are in the need to improve efficiency and quality, while balancing costs.
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Business Challenges Faced
The client is an active pharmaceutical ingredients manufacturer based out of France. Owing to the increase of high safety standards and scrutiny by the FDA (food and drug administration authority), the rate of new chemical entities declined rapidly. This delayed drug launches for the client. Also, with R&D and certification processes becoming longer and more complicated, the client faced difficulties in getting approval for their new drugs. As such, the company witnessed a steady decline in its sales rate for two consecutive years. They wanted to overcome these pressures and cover-up for the lost sales. To do so, they wanted to thoroughly analyze the market landscape and identify investment opportunities. They chose to partner with Infiniti Research to leverage their expertise in offering market landscape analysis.
By leveraging Infiniti’s market landscape analysis, the active pharmaceutical ingredients manufacturer wanted to address other challenges including:
- Controlling the repacking and relabeling of active pharma ingredients
- Procuring non-WHO GMP (Good Manufacturing Practice) or stringent regulatory policy (SRA) approved pharmaceutical ingredients
- Tackling the rising raw material prices and environmental costs
- Understanding key market penetration success factors
- Uncovering regulatory issues that may serve as a potential challenge
- Assessing competing technology providers
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Our Integrated Approach
Infiniti proposed a market landscape analysis solution constituting 2 key components:
1.Personalized or precision market outlook, segment outlook, and competitive landscape analysis
2.Regulatory, compliance, and political insights into the active pharma ingredients market
As a part of the market landscape assessment, a detailed secondary research was conducted. This involved gathering insights from industry reports, publications, discussion boards, journals, magazines, news, and other open sources. Also, our primary research involved conducting 120-130 semi-structured telephone interviews with research specialists, analysts, and other market stakeholders.
The next phase involved mapping and prioritization of technologies and opportunity identification. This involved an in-depth analysis of qualified opportunities to deduce the optimal set of opportunities that are most attractive and best fit the client’s strategic imperative. Also, a detailed addressable market analysis of each down-selected best-fit opportunity in terms of market attractiveness, competitive factors and end-user preferences was conducted.
With Infiniti’s market landscape analysis, the active pharmaceutical element manufacturer was able to thoroughly analyze the industry with respect to market metrics and forecast its growth. Also, the client was able to gather insights on the regulatory and competitive environment in the active pharmaceutical element industry. The experts helped the client to identify competing technology providers. The experts also provided the active pharmaceutical ingredients manufacturer with comprehensive profiles of each technology providers. This helped the client to partner with best technology providers and save huge on operating budgets.
In addition to this, the experts helped the active pharmaceutical element manufacturer to identify challenges associated with obtaining drug approvals from the FDA. This further helped the client to take strategic initiatives to get drug approvals faster.
Also, the experts provided the client with comprehensive insights into packaging implications in the new API guidance. This helped the active pharmaceutical ingredients manufacturer to select the right packaging materials for their drugs and subsequently reduce instances of repacking and relabeling of active pharma ingredients.
By keeping pace with market uncertainties and rapidly changing prices of raw materials, the client was able to adopt contingency plans accordingly. Also, by uncovering regulatory issues that may serve as a potential challenge, the client was able to adopt strategic initiatives to address them.
Infiniti’s market landscape analysis engagement helped the active pharmaceutical ingredients manufacturer to gain 13% market share in its new drug category within one year, generating $4.8 million in savings.