This guide provides you with the overall market size and trends, key drivers, opportunities and challenges, key suppliers in the category and how to improve strategic supplier partnerships.
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The pharmaceutical and biotech industries heavily rely on APIs (Active Pharmaceutical Ingredients) for the development and production of drugs and therapies. APIs are the chemical substances responsible for the therapeutic effect of a pharmaceutical product. They are crucial components that provide the desired pharmacological activity.
The API market encompasses a wide range of chemical compounds that serve as active ingredients in pharmaceutical formulations. These compounds are crucial for delivering the desired therapeutic effect to patients. In this chapter, we provide an overview of the main product categories of APIs, highlighting their unique characteristics and applications.
APIs can be categorized based on various factors such as their chemical structure, therapeutic class, and mode of action. The following are some of the common product categories of APIs:
1. Small Molecule APIs: Small molecule APIs are organic compounds with a low molecular weight. They are chemically synthesized and account for a significant portion of the API market. These APIs are typically well-defined, stable, and have a high level of purity. Small molecule APIs are widely used in various therapeutic areas, including cardiovascular diseases, infectious diseases, oncology, and central nervous system disorders.
2. Biologic APIs: Biologic APIs, also known as large molecule APIs, are complex molecules derived from living organisms or manufactured through biotechnological processes. They include proteins, peptides, antibodies, and nucleic acids. Biologic APIs exhibit high specificity and are used in advanced therapies such as monoclonal antibodies, recombinant proteins, and gene therapies. They require specialized manufacturing processes and stringent quality control measures.
3. Synthetic APIs: Synthetic APIs are chemically synthesized compounds that are manufactured through organic synthesis. These APIs are created by assembling and modifying chemical structures using various reactions and techniques. Synthetic APIs offer advantages such as scalability, cost-effectiveness, and consistent quality. They are widely used in the pharmaceutical industry and have applications in diverse therapeutic areas.
4. Natural Product APIs: Natural product APIs are derived from natural sources such as plants, animals, or microorganisms. These APIs are obtained through extraction or isolation processes from natural materials. Natural product APIs have a long history of use in traditional medicine and continue to be valuable sources of therapeutic compounds. They often possess complex chemical structures and exhibit diverse pharmacological activities.
The global active pharmaceutical ingredient is forecast to reach $216.4 billion by , growing at a CAGR of 8.2% from to .
Contract developers and manufacturers of active pharmaceutical ingredients (APIs) are now playing an even more fundamental role in contemporary drug development strategies.
A report by analyst firm visiongain forecasts that the overallpharmaceutical contract manufacturing market is growing fast, achieving revenues of $84.0 billion by at a compound annual growth rate of 6.4% from . The market, says visiongain analysts, is expected to continue to grow from to as more pharmaceutical companies strategically outsource manufacturing services.*
With the growing reliance on contract services and a fragmented landscape creating plenty of choice, it is more critical than ever to pick the right CDMO.
Where API strategy and procurement tactics intersect
Because most product plans are unique, choosing a small molecule API and drug substance manufacturer that can provide excellent quality, while routinely demonstrating supply reliability over a drug&#;s entire lifecycle, is worth a concerted effort. Finding a &#;perfect&#; partner to marry your drug strategy can be as challenging as it is critical to market success.
Critical qualities and attributes of strategic small molecule API partners
Pharma&#;s drug developers are increasingly sourcing APIs from CDMOs. These intellectual property owners have to evaluate a number of critical aspects in making their choice for such a strategic partnership, including the overall program&#;s financial viability. More and more current drug strategies hinge on the partner&#;s technical and operational capabilities and their experience synthesising the target compound in question. Most procurement professionals understand these competing priorities despite extreme pressure from their organizations to closely control program costs.
That&#;s why when selecting a partner to develop and manufacture small molecule APIs and meet strategic business interests, the decision to choose a supplier must be weighted appropriately among all the critical, strategic attributes a &#;perfect&#; API partner should have.
Here are six critical, strategic attributes to consider right up front when choosing a small molecule API partner:
1. Reliable supply chain
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Great access to a well-executed quality supply chain is an essential attribute of any strategically important supplier. How well one&#;s API supplier manages its own raw material supply chain is a leading indicator. Any disruptions to your supplier&#;s supply chain and your API delivery may be delayed. Pfizer CentreOne, being embedded within Pfizer has direct access to one of the industry&#;s most developed, secure and reliable supply chains in the industry
2. Robust, relevant process expertise and experience
Drug development routes are getting more complicated and the APIs in high therapeutic demand are getting harder to make. Robust process development is paramount, but it has to be matched to deep science and process engineering acumen. This clearly extends to troubleshooting and refining synthesis to find new or better production and cost economies, as well as creating those more robust and effective processes that increase quality and reliability.
3. Knowledgeable in how to accelerate your product&#;s pace to market
Pharma understands that the more directly and succinctly a drug developer can manage a drug&#;s critical timelines on the way to market, the more successful the product will be financially, both in the near and far term.
Early, intensive synthesis analysis is one good way potential partners can add value. Pfizer CentreOne for example, was presented recently with a synthesis that was unsafe to reproduce even under the strictest of lab conditions and controls.
Within a very intensive timeframe, Pfizer chemists and process engineers were able to define a much more stable, scale-able chemistry to reliably make the high-value therapeutics being developed by the company
4. Great quality systems, operational excellence and the staff to back it up
Achieving critical quality attributes (CQAs) with consistency and transparency is certainly a prerequisite for any strategic supply relationship. But for pharma, it&#;s a fundamental requirement and a key performance indicator when assessing the potential for long-term reliability and quality when choosing a strategic API supplier.
For APIs of every kind, one common CQA denominator is the ability of your API developer and manufacturer to effectively, cost efficiently control contaminants or impurities during all primary and intermediary processing steps.
Another KPI is controlling and manipulating an API&#;s physical properties effectively is another KPI. A CDMO partner with the staff, technology and experience to evaluate and address your API&#;s physical properties for therapeutic action and other goals is intrinsically strategic. A supplier that can accurately engineer drug substance attributes to meet drug formulation and drug product (DP) targets early in a small molecule API program can often yield efficiencies to leverage later in the journey to market.
Lastly, when combined with a robust and repeatable process, &#;small molecule&#; API becomes &#;commercial-ready&#; API with a validated process well-proven and ready to go the distance over the drug product&#;s intended life-cycle.
5. An extremely conscious approach to sustainable industrial process
Thinking environmentally? Suppliers that can provide more stable, less volatile chemistries and efficient batching are more efficient. Those with experience optimizing processing methods that reduce or recycle intermediates and other hazardous by-products, are worth considering very carefully.
CDMOs that put an emphasis on delivering cleaner chemistries that reduce their impact on the environment through best-practice operations and technical mastery are better able to deliver project economies. With literally hundreds of CDMO partners to choose from, those that live core sustainability principles of re-use, recycle and reduce, are likely to be both great environmental stewards and the most cost-efficient processors.
6. A singular focus on continuous improvement, flexibility and intelligent collaboration
Processing API batch after batch, month after month, year-after-year may, over time, introduces complacencies and issues related to status-quo in process, operations and technology. If your chosen small molecule API manufacturer is not continuously focused on continuous process improvement, they may not be the perfect partner for strategic drug supply.
CDMOs with experience and vision will likely be able to bring an intelligent, collaborative approach to partnering and the insight needed to innovate solutions. Part of this comes from the talent and resourcefulness of the people who make your API and how they leverage the resources and technologies to assure the best outcomes of every batch. These attributes support creating an environment that is responsive, agile and more capable of performing over the long run.
Whatever your product&#;s market agenda might be, drug owner and drug maker often have to build a common base of knowledge and do it in a timely and prescribed manner. Better drugs begin with a better, smarter collaboration and the sooner both parties can achieve a true and transparent meeting of the minds, the better.
A strategic API partner will always be seeking ways to innovate and improve your compound or product&#;s value as part of the deal, and do it with the dedication of a partner, not a supplier.
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