APIs and Excipients

CMOs expand capacity and capabilities in high-potency manufacturing to meet strong demand for cytotoxic and other potent drugs.

The year 2007 was slow for approvals for new molecular entities and overall pharmaceutical industry growth. Big Pharma seeks relief in a growing biologics portfolio.

Antibody drug conjugates offer a niche opportunity in drug development and contract manufacturing.

Chemocatalytic and biocatalytic routes show promise for more efficient syntheses of select active ingredients.

Moderate growth is projected for the global excipients market. Excipient producers target blends and new grades for improving functionality and performance.

The European Union's REACH initiative has the potential to affect the flow of chemicals into the pharmaceutical suppy chain.

Contract manufacturers expand capabilities in aseptic processing, clinical-trial materials supply, and cytotoxic manufacturing.

Researchers and process chemists share approaches in synthesis of active ingredients and pharmaceutical intermediates.

A surge in capacity in contract microbial and mammalian cell-culture is underway to meet rising production needs for biopharmaceuticals.

The permeation of drugs through the skin is compromised by the presence of polar functional groups such as thiols, alcohols, phenols, imides or amides. By transiently masking these polar functional groups as prodrugs the permeability of drugs containing these functional groups through the skin can be improved.

Market demand for cytotoxic drugs is leading CMOs to expand their API manufacturing and formulation services.

Orally disintegrating tablets (ODTs) continue to attract attention as an alternative to conventional oral dosage forms.

Researchers forward approaches for catalytic hydroformylation, asymmetric hydrogenation, and biocatalysis to achieve enantioselectivity.

A spate of drugs are scheduled to come off patent, offering vast potential and competition.

Catalytic routes to producing atorvastatin and sitagliptin are recent advancements.

Nanotechnology is emerging as a tool for resolving challenges in delivering poorly water soluble and highly potent drugs.

The pharmaceutical majors build their capabilities in peptide technology, and contract manufacturers expand to meet growing demand for bulk peptides.

China creates a potential outlet for specialty excipients as its pharmaceutical market grows.

The pharmaceutical supply chain lengthens as generic drug manufacturers build production platforms offshore and CMOs position in India and China to meet demand for lower-cost production.

As custom manufacturers gather for InformexUSA this month, strategies in asymmetric synthesis and catalysis prevail.

In 2007, the global pharmaceutical market is expected to grow moderately while biologics, generic drugs, and specialty-initiated drugs are projected to increase at double-digit rates. These trends for finished pharmaceuticals are reflected in the global market for active pharmaceutical ingredients (APIs), where the merchant generic API market is expected to see strong demand. On a production basis, India and China are forecast to raise their shares of the global generic API market against industry strongholds Italy and Spain. Meanwhile, the United States is expected to hold its its position as the leading producer of biotechnology-based APIs in an area traditionally dominated by captive production. And biogenerics or biosimilars gradually reshape the market.

AstraZeneca's purchase of Cambridge Antibody Technology and Merck's acquisitions of GlycoFi and Abmaxis are the latest efforts by pharmaceutical majors to build critical mass in biologics capabilities.

As custom manufacturers and pharmaceutical ingredient suppliers gather for CPhI Worldwide in Paris, Oct. 3–Oct. 5, industry observers point to a mixed outlook for pharmaceutical custom synthesis. While industry performance for 2006 is better than 2005, the critical question remains the improvement in drug output. The slow rate of approvals of new molecular entities (NMEs) continues in 2006 as Big Pharma seeks to build pipelines of active pharmaceutical ingredients (APIs) through acquisitions, including capabilities in biologics.

Potent-compound awareness training for operators is important to understand why the containment and controls are in place.

Combinatorial catalysis in asymmetric synthesis and asymmetric biaryl Suzuki coupling highlight recent advances in chiral chemistry. Plus the marriage of green and chiral chemistry.

Select large custom manufacturers expand capacity, private equity firms buy companies in transition, and players from India and China build their positions.

CMOs account for 20–30% of biopharm production. Big Pharma also is filling the biologics supply chain.

Indian suppliers of active pharmaceutical ingredients and dosage formulations expand in India, the United States, and Europe.

New biocatalytic and chemocatalytic routes to chiral intermediates and developments in simulated-moving-bed and supercritical-fluid chromatography for resolving racemic mixtures.

Facing still-sluggish market conditions and a changing world order in fine chemicals, the large Western custom manufacturers are responding by building their toolboxes in specialized technologies in chiral chemistry, catalysis, and biosciences and by adjusting their manufacturing networks via streamlining or investment in Asia.