The pharmaceutical industry has long recognized the critical role
excipients or inactive ingredients play in drug formulation and delivery.
Excipients can comprise up to 90 percent of a medicine's total
ingredients and serve crucial functions as binders, disintegrants, coatings, preservatives, colors, and flavorings.
According to recent market research, the pharmaceutical excipients
market was valued at US$ 9.27 billion in 2023. It is growing at a compound
annual growth rate (CAGR) of 7.03 percent and is projected to reach US$ 18.48 billion by 2032.
The main factors driving market growth is an increased demand for
multifunctional excipients, coupled with the expanding use of generic
medications. The development in the biologics sector and advancements in
nanotechnology are also contributing significantly to market growth.
Major excipient providers include BASF, Evonik, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, Roquette Frères, DuPont, Croda International, Seqens, Boai NKY Pharmaceuticals, PMC Isochem, Minakem, Kewpie Corporation, Ashland Global, SPI Pharma, Pfanstiehl, Nanjing Well Pharmaceutical, ICE Pharma, Anhui Ribobay
Pharmaceutical and Nippon Fine Chemical.
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WHO, India’s CDSCO tighten regulations; new GMP guidelines implemented to curb contamination
Last year, the World Health Organization (WHO) issued a health
alert linking at least 300 child deaths in the Gambia, Uzbekistan,
and Indonesia to the ingestion of contaminated cough syrups containing
unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG).
In response to the tragic events, the WHO released two draft appendices to its guideline on good manufacturing practices (GMPs) for excipients this year. Manufacturers are now required to use suitable risk assessment tools to identify and mitigate potential hazards.
Since India-made cough syrups had been linked to the deaths, India’s drug regulator — Central Drugs Standard Control Organization (CDSCO) — took steps to prevent contamination, and advised drugmakers to only use pharmaceutical-grade excipients from approved sources.
Furthermore, the Indian Health Ministry proposed amendments to the
Drugs and Cosmetics Rules,
1945 to include details of excipients on drug labels. While listing
all excipients on every strip of medicine may be challenging, the ministry
suggested mentioning those causing hypersensitivity on the label. Applicants now
mandatorily need to submit evidence of stability and safety of excipients.
These regulatory developments have significant implications for
excipient manufacturers and pharmaceutical companies worldwide. Leading
pharmaceutical excipient firms like Gangwal Healthcare, Sigachi Industries, and Nitika Pharmaceuticals are well-positioned to meet
these heightened quality and safety standards, given their long-standing
commitment to producing high-quality, compliant excipients.
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Roquette buys IFF’s pharma unit for US$ 2.85 bn; Evonik opens new spray-drying facility in Darmstadt
In a significant industry move, France-based Roquette entered into an agreement to acquire IFF's pharma solutions business in a deal valued at US$ 2.85 billion. This acquisition is set to rebalance family-owned Roquette’s portfolio around health and nutrition. The deal is expected to accelerate Roquette’s growth and significantly strengthen its presence in the excipients market.
Evonik has opened a new facility for drying aqueous dispersions of its Eudragit polymers at its site in Darmstadt, Germany. The facility will help Evonik meet increasing demand from drugmakers for its oral drug delivery solutions. The plant uses green energy solutions.
The company has also partnered University of Mainz to commercialize a new class of polyethylene glycols (PEG) lipids for nucleic acid delivery. Evonik’s Health Care business has been growing its nucleic acid drug and vaccine delivery portfolio.
Germany’s Johannes Gutenberg University of Mainz was the first to develop randomized polyethylene glycols (rPEGs). This collaboration aims to expand Evonik’s toolbox of technologies for nucleic acid-based medicines, offering an improved immunogenicity profile for lipid nanoparticle carriers used in mRNA vaccines and therapeutics.
Asahi Kasei made significant strides in addressing a pressing industry concern that emerged in 2018 when potentially carcinogenic nitrosamine impurities were detected in several pharmaceuticals.
Guided by regional authorities, such as the European Medicines Agency and the US Food and Drug Administration, the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of these impurities.
In response to this challenge, Asahi Kasei developed its Ceolus microcrystalline cellulose with extremely low nitrite
levels. The Japanese company achieved nitrite concentrations of 0.1 micrograms
per gram or less, which is equivalent to 0.1 parts per million (ppm). The
company also started full commercial operation of its second manufacturing
facility for Ceolus in Japan, enhancing supply capacity and stability.
JRS Pharma and Gujarat Microwax opened
a state-of-the-art cotton-based croscarmellose
sodium plant in Mehsana, Gujarat (India). This facility aims to produce
high-quality excipients that meet global standards, potentially reducing
India's dependency on imports and boosting its presence in the global excipient
market. The Indian excipient industry accounts for less than 1 percent of the
global market share.
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Seqens to advance innovative
polymer; biologics, personalized medicine create demand for specialized
excipients
Recent industry collaborations highlight the ongoing innovation in novel excipients. France’s Seqens, with over 20 years of
polymer development experience, was chosen by Pleryon Therapeutics to advance
its leading osteoarthritis
candidate – an innovative GMP polymer. This collaboration leverages Seqens’ newly expanded and modernized cGMP plant in Aramon, France, demonstrating the industry’s commitment to investing in advanced manufacturing capabilities for novel excipients.
The rise of biologics and personalized medicine has created a
demand for specialized excipients capable of stabilizing complex molecules and
enabling targeted drug delivery. Roquette’s launch of Lycagel Flex, a hydroxypropyl
pemix for nutraceutical and pharmaceutical softgel capsules, exemplifies this trend. Built on Roquette’s market-first Lycagel pea
starch technology, this plant-based alternative to gelatin offers manufacturers the flexibility to customize formulations for a range of production and end-user needs. The innovative pea starch foundation also underscores the industry’s move towards sustainable bio-based excipients.
The trend towards patient-centric drug development has also
influenced excipient innovation. Excipients that can improve palatability, ease
of swallowing, or enable novel dosage forms (such as orally disintegrating
tablets) are in high demand. For example, IFF brought a super
disintegrant Ac-Di-Sol, that supports faster disintegration and drug
dissolution in oral disintegrating tablets, improving patient experience.
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Our view
The heightened regulatory scrutiny on excipients due to product
contamination incidents has created a high risk perception and uncertainty around the regulatory acceptance of novel excipients. That said, novel excipients are central to the development of new drug modalities and therapies.
Going forward, sustainability will also become an increasingly important factor in excipient selection and development. As the industry innovates towards biologics, personalized therapies, and patient-centric formulations, the role of high-quality, multifunctional excipients will only grow more vital in ensuring drug stability, bioavailability, and patient compliance.
Companies that can navigate the complex regulatory landscape, invest in R&D, and offer high-quality, multifunctional excipients will be well-positioned to succeed in this evolving market.
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