Global Pharmaceutical Excipients Market

The Global Pharmaceutical Excipients Market is growing at a high CAGR because of the increasing prevalence of various acute and chronic diseases. Pharmaceutical excipients involve everything in a drug except the active pharmaceutical ingredients. These molecules don't possess medicinal properties and are ultimately used to enhance the drug's physiological absorption. Pharmaceutical excipients are inert, allowing the drug molecule to apply to patients in the right form. Traditionally pharmaceutical excipients were simple molecules, but technological innovation and increasing demand for novel drug delivery systems enhanced the pharmaceutical excipient's complexity. Pharmaceutical excipients promote the patient's drug acceptability and boost the drug's stability and bioavailability. However, the high production cost may act as a huge restraining factor for the global pharmaceutical excipients market.

The Global Pharmaceutical Excipients Market was worth US$ 7,468.78 million in 2021 and is expected to increase at a CAGR of 6.3% in 2022-2029 to reach US$12,199.90 million.

Global Pharmaceutical Excipients Market Segmentation-

Impact of COVID-19-

The COVID-19 pandemic has presented not only challenges but also several opportunities. Supply chain disruptions of medical services and essential medical supplies were prominent in 2020, especially due to travel and trade restrictions all over the globe. In addition, to prevent the rapid spread of COVID-19 globally. This resulted in a moderate impact on specific segments of the market.

Drivers, Restraints, Opportunities, and Challenges of the Global Pharmaceutical Excipients Market-

Drivers-

Rise in generic drug production and uses

According to the U.S. Food and Drug Administration (U.S. Food and Drug Administration). FDA) and the National Center for Biotechnology Information (NCBI), the generic drug is a drug that has been created to look like an approved brand-name drug that is available in dosage form, with safety, strength, route of administration, quality, and performance. After the drug's patent expires, the cost savings associated with the conventional use of the drug are not immediately apparent. Generic drugs, like brand-name drugs, require competition in the generic drug market before reducing costs; two to three years after the loss of exclusivity, the price of a generic drug is usually 60-70% lower than that of a brand-name drug. Since India is one of the countries with the highest per capita spending, these generic drugs will save a lot of money that can be used for other health problems. Nationally, the use of generic drugs has increased significantly in recent years. The fact that cheap substitutes for branded drugs are a major reason likely to spur the growth of the pharmaceutical industry. The generic drug industry in the near future.

For instance,

According to Quintiles and IMS Health, Inc. (IQVIA) in 2020, the growing use of cheap alternative generic in pharmaceutical markets is a leading contributor to the rise of the market for generic drugs. This is both in terms of growth and share. Moreover, branded generics in emerging markets are also likely to contribute as a key driver to growth for the overall generic market

In the United States, 9 out of 10 prescriptions filled are for generic drugs. Increasing the availability of generic drugs helps to create competition in the marketplace, which then helps to make treatment more affordable and increases access to healthcare for more patients

Thus, increasing demand for generic drugs and rising production are propelling the global pharmaceutical excipients market growth. Also, the cost of generic drugs is less, which increases the use of generic drugs.

Surge in demand for excipients–

Pharmaceutical excipients are substances in pharmaceutical dosage forms not for direct therapeutic use but to facilitate the manufacture, protection, support, or improvement of stability, bioavailability, or patient acceptability. With the increase in the development of the global pharmaceutical industry, excipients also have a light part. Recently, there has been an increasing demand for generic drugs, which has led to an increase in the excipients demand. In addition, there has been a sharp increase in cases of chronic diseases.

Excipients are inert substances, other than pharmaceutically active drugs, introduced into the manufacturing process or included in the dosage form of pharmaceutical products. Excipients are widely used in drug formulations to add bulk to solid formulations, provide long-term stability, and facilitate drug absorption. Furthermore, it also improves the product's overall safety or functional properties during use or storage.

Thus, wide uses of excipients in drug formulation and applications of excipients in chronic disease treatment are surging demand for excipients in the global pharmaceutical excipients market.

Technological advancements in multifunctional excipients-

Multifunctional excipients are a class of excipients that includes pre-processed and co-processed excipients that provide added functionalities to the formulation. The enhanced functionality includes flow ability, compressibility, particle size distribution, shape, and porosity among others.

The recent interest in demanding manufacturing processes and the focus on alternative delivery systems has led to increased demand for a range of specialty excipients collectively known as multifunctional excipients

For instance,

Ludipress, which is a co-processed product containing lactose, Kollidon, and Kollidon-CL, serves the role of DC diluent with binder and disintegrant properties

Advantose FS 95, manufactured by SPI Pharma, is also considered to be a multifunctional excipient that provides good flow, high compressibility, and taste masking among other additional advantages

Avicel CE-15, which FMC Corp. manufactures, is another multifunctional excipient that provides advantages such as less grittiness and a creamier mouth feel

Star Lac, manufactured by Roquette, severe the pharmaceutical industry by giving advantages such as good flow with disintegration functionality which is ideal for ODTs

These instances mentioned above are of the multifunctional excipient used in pharmaceutical formulations. With the advancement of tablet manufacturing, the demand for excipients with improved functionalities, mainly in flow and compression properties, has increased. The growth of multifunctional excipients in the market is a major factor expected to act as the driver for market growth.

Rising focus on orphan drugs-

An orphan drug is a pharmaceutical product that treats a rare condition or disease. The development of orphan drugs has been financially incentivized through US law via the Orphan Drug Act of 1983. Pharmaceutical compounding of orphan active ingredients can offer cost-effective treatment to patients when no other drug product is available for a rare disease or during drug product shortages.

For instance,

L-arginine, sodium benzoate, sodium phenylbutyrate, L-carnitine, chenodesoxycholic acid, primaquine phosphate, pyridoxal phosphate) are some of the ingredients that are used in the orphan drugs

The mean orphan drug cost per patient of the top 100 US orphan drugs was almost 4.5 times greater than the non-orphan drug cost in 2018

The demand for orphan drugs has increased significantly owing to the surge in the prevalence of rare diseases. In addition, a rise in awareness among the populace regarding rare diseases, an increase in R&D investment, and drug development drive the market growth of the excipient that is used in orphan drugs and is expected to act as a driver for the market.

Opportunities-

Strategic initiatives by market players-

The rise in the pharmaceutical excipients market increases the need for strategic business ideas. It includes a partnership, business expansion, and other development. The rising demand for pharmaceuticals is significantly increasing the demand for pharmaceutical excipients, and to cope with this demand, companies are building new manufacturing sites, among other strategic initiatives.

For instance,

In September 2022, Roquette Frères acquired India-based excipient manufacturer Crest Cellulose. The acquisition resulted in the expansion of pharmaceutical excipients in the Europe and Asia-Pacific market and the creation of a global network of pharmaceutical innovation centers and application development facilities

In May 2021, Evonik Industries AG settled a new facility to cope with the increasing demand for the excipient. Resomer bioresorbable polymers are the company's products in parenteral and implantable medical devices. The site was successfully investigated by the U.S. FDA and EMA and had the most advanced equipment for this polymer manufacturing

In August 2021, Croda International Plc entered a strategic partnership with SiSaf Ltd. The arrangement involves using and developing SiSaf's patented bio-courier, ProSilic, a novel drug delivery technology. This sustainable technology uses biodegradable silicon particles to improve stability, solubility, and, ultimately, the performance of a wide range of active ingredients across many delivery systems

In April 2021, DFE Pharma launched BioHale sucrose in Germany. The launch resulted in the addition of a new pharmaceutical excipient in the portfolio and offered exceptional market purity and low endotoxin excipient to be used in the formulation

In April 2019, The Lubrizol Corporation launched carbopol style 2.0 polymer pharmaceutical excipients. The launch resulted in a rise in product sales and a rise in market growth in North America and Europe

These strategic initiatives, such as product launches, acquisitions, agreements, and business expansion by the major market player, will boost the pharmaceutical excipients market growth and are expected to act as an opportunity for the global pharmaceutical excipients market.

Rising demand for ease of use

As the market focus drives toward the production of orally deliverable dosage forms, there is a constant struggle to develop appropriate formulations of new molecules that allow oral administration and simultaneously ensure the drug has optimal bioavailability in patients. To overcome this, pharmaceutical excipient manufacturers are developing easier products and reducing development time and cost.

For instance,

ABITEC Corporation, a manufacturer of specialty lipids, has developed a new versatile excipient for oral dose application. CAPMUL GDB EP/NF is a highly-reproducible solid lipid excipient that offers good flow and uniform particle size distribution for use in multiple formulations, including tablets, hard gels, soft gels, solid lipid nanoparticles, nano-structured lipids, granulations, multi-particulates, extrudates, congealing, and liquids. These new products will ease pharmaceutical manufacturing and act as an opportunity for the market

Evonik Industries AG launched a new resomer precise platform of a custom functional polymeric excipient which will enable pharmaceutical companies to control the release profile of the parenteral formulation

In March 2022, Ashland launched Benecel XR and XRF HPMC, an oral pharmaceutical excipient. The launch increased the supply and production capacity and market growth in North America and Europe region, rise in customers, and rise sales

This new launch in the oral pharmaceutical excipients market is enhancing the efficiency of pharmaceutical excipients and increasing the ease of using pharmaceutical excipients. This factor is expected to act as an opportunity for market growth in the forecast period

Rising disposable income -

Rising disposable income is expected to boost medication spending, significantly increasing excipient purchasing and supply demand. In 2019, Americans had per capita disposable income of USD 45,579 and it has been reported that the total disposable personal income. Healthcare spending is also increasing in the U.S. region.

For instance,

In 2020 Indian pharmaceutical industry is growing by 7 to 8 percent a year, according to the Indian Pharmaceutical Alliance, while rating agency ICRA expects growth of 11 to 13 % This is supported by a rising middle class whose disposable income keeps growing rapidly

In 2020, the National Health Expenditure in the U.S. grew 9.7% to USD 4.1 trillion in 2020, or USD 12,530 per person, and accounted for 19.7% of the Gross Domestic Product (GDP)

In 2019, Indian consumers were spending nearly 1 percent of their total income on drugs and pharmaceuticals, which is expected to reach USD 33 annually

In 2017, the healthcare expenditure per person was reported to be USD 10,739, and in 2018, it reached USD 11,172 per person

This signifies that as disposable income rises, people are focusing more on their health and spending a lot on treatment options available for pharmaceutical excipients. Thus, the rising disposable income acts as an opportunity to grow the global pharmaceutical excipients market.

Increasing demand for alternative routes of delivery/dosage forms –

With the increasing economic burden due to the rise in prevalence of many diseases, the demand for alternate therapy and dosage form is taking place. As a result of the amplified level of interest in biopharmaceuticals, the industry has paid increased attention to developing parenteral products. Several trends are driving excipient demand, such as solubility and bioavailability challenges, as well as the desire to increase the lifecycle of a drug, improve manufacturing efficiency and address the growing bioequivalence market.

The development of new treatments for chronic diseases increased access to medication through generic drug production, and increased research and development spending is the major factor for which the alternative routes are a boost.

For instance,

Alternate routes of administration, such as intranasal, inhalation, buccal, sublingual, and transdermal approaches for the delivery of drug candidates to systemic molecular targets, are in great demand due to the increasing trend of self-administration. The novel techniques are also increasing the demand for the newer pharmaceutical excipients

The advancement in the drug delivery system and alternative dosage formulation and route of administration is expected to increase the demand for the new excipient. It will act as an opportunity for market growth.

Restraints-

Increasing Regulatory Stringency Regarding the Approval of Drugs and Excipients -

Generic drug approval rules are largely the same worldwide, with little difference in developing countries. This is because it is not required to undergo bioequivalence (BE) study in this part of the world to obtain generic drug approval. Governments must ensure consistent quality of all generic drugs, medical experts say. Only then will doctors be happy and confident in prescribing generic drugs. A major reason for physicians' (and even patients') lack of confidence in generic drugs has been the lack of strict regulatory requirements regarding the number of generic drugs and the number of impurities allowed.

Controlling the manufacture and distribution of excipients is now considered a top priority by regulators and drug manufacturers, as mixing excipients has resulted in adverse patient events. Furthermore, with the emergence of new excipients and delivery systems, better control of the quality and supply of pharmaceutical excipients has become increasingly important in the context of in vivo activity. Recognizing the important role of excipients in pharmaceutical dosage forms requires excipient suppliers to meet the quality requirements of the pharmaceutical industry. The pharmaceutical industry, in general, must work to ensure the product's safety. The integrity of use or storage in the supply chain.

High Production Cost –

High prescription drug prices threaten the health budget and limit the financial resources available to other areas that need public investment. In countries without universal health care, the high cost of prescription drugs poses an additional threat to unsustainable costs per patient. About 25% of Americans struggle to get prescription drugs because of the high out-of-pocket costs. Pharmaceutical companies cite high drug prices as an important factor in supporting innovation.

In India, excipient manufacturers have raised alarm over the rising prices of major excipients by 30% to 50%, which has badly impacted the pharma industry. Major excipients, such as lactose, hydroxypropyl methylcellulose (HPMC), microcrystalline cellulose (MCC), and polyvinylpyrrolidone (PVP) among others, are majorly imported from China.

For instance,

According to National Center for Biotechnology Information (NCBI). Typical costs of excipients used in tablets and the typical proportion of the Finished Pharmaceutical Product (FPP) made up by each excipient were combined, and excipients were assumed to represent 50% of the total tablet weight. This yielded an estimated average excipient cost of US$2.63 per kilogram of Finished Pharmaceutical Product (FPP)

Thus, the high cost of prescription drugs puts pressure on the system, leading to bad-quality drugs. As production costs increase, demand for that drug becomes less, which will restrain the market growth.

Challenges-

Associated side effects

Adverse effects due to pharmaceutical excipients in drug formulations are generally uncommon, but the potential for toxicity is increased at high mg per kg doses, especially in neonates and infants. Methyl and Propyl para-hydroxybenzoate (Parabens), Benzyl Alcohol, Sodium Benzoate, Benzoic Acid, and Propylene Glycol, among others, are some of the common pharmaceutical excipients that have reported side effects.

Lactose is the major excipient used in many formulations. Still, almost 75% of the population is lactose intolerant; hence is the major factor in restraining this excipient from being used in the formulation. Instead of this, it is used in 45 % of all formulations, causing an increase in the side-effect associated with it

The side effects associated with the consumption of pharmaceutical excipients are due to the use of clearly toxic substances (e.g., diethylene glycol). The side effects of diethylene glycol are low birthweight neonates, patients with large surface area burns, and patients with a history of asthma or contact dermatitis)

Overdose in pharmaceutical excipient causes occurred when unusually large doses of a drug containing a preservative were used [chlorbutol in morphine, ethanol in glyceryl trinitrate (nitroglycerin)]

Pharmaceutical excipients are not always the inert substances that we presume. They are intolerant to an individual or, if not properly screened, can cause chemical changes in the drug, causing the side-effect. This can affect the demand for the excipient and is expected to act as a challenge for the global pharmaceutical excipients market.

Safety consideration of pharmaceutical excipients in storage and transportation –

Medicines or pharma products, such as pharmaceutical excipients, are usually transported in a refrigerated or insulated truck. These trucks undergo routine inspections to ensure they are in satisfactory condition and keep inventory at the correct temperature. The ICH and CGMP guidelines must be followed for the proper storage and transportation of the excipient.

A wide range of pharmaceutical excipients is used in the pharmaceutical industry, making it challenging for warehouse professionals to properly maintain all the pharmaceutical excipients as a different type of storage temperature and storage material is needed.

For instance;

Room temperature, cool storage conditions, and cold storage conditions, among others, are some of the temperatures in which the storage is needed to be done. To minimize the degradation of pharmaceutical excipients, proper storage needs to be performed

Due to the global pandemic outbreak in 2020, the global supply chain gets disrupted, which caused the delay in transportation across the globe. The excipient's storage and transportation face challenges that can lead to production delays and a net loss of income.

The supply chain of the excipient is the major factor for the streamlined manufacturing of formulation and preventing the excipient spoilage during the special transport packaging, and transport vehicle with adequate temperature conditions is needed to maintain.

The excipient is the major ingredient in any formulation whose safety during storage and transportation should be properly monitored, which requires extra investment in the proper storage. Hence the safety consideration during storage and transportation is expected to act as a challenge for the global pharmaceutical excipients market

Lack of novel pharmaceutical excipients -

The continued growth is largely driven by the increasing demand for pharmaceutical products to serve an aging population and improve healthcare worldwide. Despite the positive outlook, the industry itself faces a variety of challenges in meeting the expectation of regulators,

Despite the need for innovative pharmaceutical excipients, developing a novel pharmaceutical excipient can be risky for excipient producers. In general, new pharmaceutical excipients can be developed through two pathways: modification of a known excipient as a derivative or successor or creation of a new chemical entity without a base structure.

For instance,

The novel excipient takes six to seven years from structure screening and optimization to pilot scale-up and toxicological testing/production scale-up for Drug Master File (DMF) submission. This lengthy, costly development process presents a major hurdle for excipient innovation

For oral drug excipients that can mitigate challenges associated with poor aqueous solubility and permeability can enable drug development for these otherwise potentially undevelopable candidates

The lack of an independent approval pathway for all of these novel excipients creates significant challenges for drug formulators. The formulation of the novel excipient is a time taking and costly process impacting the growth of this market as the pharmaceutical excipients market lacks an innovative product for drug development and is expected to act as a challenge for the global pharmaceutical excipients market growth in the forecast period.

Future opportunities of the Global Pharmaceutical Excipients Market in India-

The development of the pharmaceutical sector depends on many factors, but the Make in India movement can be the prime point for the market's growth. While the Make in India initiative is directionally right, its impact on improving access to affordable quality healthcare depends on how it is framed, developed, and implemented over the next few months or years. Collaborating with leaders and manufacturers (national/international) to bring innovations, promote local ideas, and make India a global station for the healthcare and medical devices manufacturing market.

Companies should also invest in R&D to bring cost-effective products and services for lower and rural people. Being a country of billions of people, India is the market with large production and consumption.

Players covered-

List of pharmaceutical excipients manufacturers-

More than 240 companies screened for this market based on their types according to the segments. The top player in the market are Evonik, Dow, Croda International Plc, Roquette Frères., The Lubrizol Corporation and BASF SE among others.

BASF SE -

BASF SE is an international supplier of various products and services in Chemicals, Materials, Industrial Solutions, Surface Technologies, Nutrition & Care, Agricultural Solutions others based in Mannheim, Germany. The company clocked total revenue of USD 92,758.00 Million. The company deals in seven segments- Chemicals, Materials, Industrial Solutions, Surface Technologies, Nutrition & Care, Agricultural Solutions, and Others.

Headquartered in Mannheim, Germany, they have representatives across various global locations and large infrastructure in the region, including R&D centers, manufacturing sites, distribution centers, and commercial offices.

Over the past ten years, BASF SE has transformed to reshape its portfolio and become a focused pharmaceutical company. As a result, they are active in highly attractive segments that offer significant potential for growth and margin expansion.

2021 was a good year for BASF SE as its business and financial performances went high due to its focus on execution, quality and supply challenges, and a complex operating model.

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