P&S Intelligence Archivi - World Wide Trends

30 gennaio 2024

Enhancing Quality and Safety in Biopharmaceutical Manufacturing with Bioprocess Validation

Maintaining high-quality standards is crucial throughout the bioproduct manufacturing process. This involves eliminating contaminants and impurities from chromatographic media, which can consist of viruses, nucleic acids, endotoxins, cell membranes, aggregates, culture media components, proteins, ligands, product alterations, process chemicals, and inactive microbes.

To ensure the effectiveness of equipment and methods used in manufacturing processes, rigorous scientific validation exercises with thorough documentation are necessary. The FDA’s General Principles of Process Validation guidelines require documented evidence at all stages of bioprocess validation studies to provide a high level of confidence in the intended product quality for consumers.

Bioprocess validation is an integrated process that adheres to FDA, EMA, and other national and international regulations and standards. It aims to verify procedures and ensure compliance with current Good Manufacturing Practices (cGMP). Extensive documentation is required by national and international guidelines to confirm that the process follows standard procedures.

To improve production many drug manufacturers are turning to third-party service providers. The use of disposable technologies during medication development further reduces production costs. Single-use bioreactors have increased process adaptability and significantly reduced the risk of cross-contamination. These advancements benefit the bioprocess validation sector by shortening commercialization timelines and ensuring product reliability.

The COVID-19 pandemic has also had a significant impact on bioprocess validation. The demand for validation services increased during the pandemic as validation became necessary at all stages of drug development to monitor accuracy, safety, and efficiency. Extensive testing and manufacturing of vaccines drove the need for process validation.

Increasing Focus on Extractables/Leachables Testing Services

Bioprocess validation services include extractables/leachables testing, bioprocess residual testing, viral clearance testing, and filtration and fermentation systems testing. Extractables/leachables testing dominates this service segment due to the rising risk of product adulteration and the presence of regulatory guidelines. Prominent guidelines in this area include those from the FDA and current good manufacturing practice guidelines.

Rising Utilization of Filter Elements

Bioprocess validation products encompass filter elements, media containers and bags, freezing and thawing process bags, mixing systems, and bioreactor transfer systems. The usage of filter elements is expected to significantly increase, primarily driven by their essential role in various bioprocessing techniques to ensure the efficacy and safety of biopharmaceutical products at each production step.

The use of bioreactors for manufacturing vaccines, medicines, and other pharmaceutical components is also on the rise. Bioreactors are widely employed in healthcare research for converting in-vitro 2D culture models and suspensions into the 3D form, replicating the natural physiological state at the site.

Growing Importance of Biopharmaceuticals

The increasing prevalence of chronic diseases is driving the demand for biopharmaceuticals, leading to the rapid adoption of bioprocess validation services across the healthcare sector. Infectious diseases, cancer, and neurological disorders are becoming more prevalent, highlighting the significance of biopharmaceuticals.

Many biopharmaceuticals used to treat neurodegenerative disorders are directly administered into the brain, which is not feasible with conventional synthetic agents. Furthermore, advancements in bio-based drugs have resulted in higher survival rates for cancer patients, hepatitis cures, improved arthritis management, and transformed treatment options for various diseases. The rising incidence of such diseases drives the growth in biopharmaceutical use, thereby boosting the development of the bioprocess validation sector.

The bioprocess validation sector in Asia is advancing significantly due to increased government support for pharmaceutical research and development, a growing elderly population, and a rising trend of outsourcing in the region. Moreover, the global bioprocess validation industry is projected to reach a value of USD 835 million by the end of this decade.

28 novembre 2023

Biologics CDMO Secondary Packaging Industry Will Grow Fastest in Asia-Pacific

The biologics CDMO secondary packaging market will touch USD 3,622.6 million by 2030, powering at a rate of 8.7% by the end of this decade. This growth is credited to the snowballing drug production, the increasing pharma industry, and the growing prevalence of numerous diseases, such as chronic ailments, infectious ailments, and genetic diseases.

Boxes were the largest category in the industry, with about USD 1 billion revenue, in 2021, and they will continue dominations in the years as well.

Boxes are designed explicitly for the transport of biological products, such as frozen and controlled ambient biologics. They also provide the perfect balance between temperature control and payloads.

North America had the largest revenue share, more than 40%, in the biologics CDMO secondary packaging market. This is because of the increasing outsourcing of drug research and development and production activities by major biopharma players.

Numerous companies wish to team up with competent packing providers providing non-conventional packing solutions and have the vital capabilities to formulate exclusive packing designs in a time and cost-effective manner.

Instead, the APAC will have the fastest growth in the years to come. This growth has a lot to do with the increasing prevalence of chronic ailments, the growing emphasis of businesses on contract manufacturing, and key players are keenly interested in facility developments in the Asia Pacific region.

Furthermore, the growth of the European region will be moderate in nature in the years to come. This can be mainly as a result of the increasing requirement for biologic products, for instance vaccines, driving the research and development spending of the pharma companies.

Due to the increased production of drugs all over the world, the demand for biologics CDMO secondary packaging is on the rise, and this trend will continue in the years to come as well.

24 novembre 2023

Here are 7 Superfoods for Optimal Skin Health

When it comes to achieving glowing and radiant skin, people often rely on expensive skincare products and beauty treatments. However, what many people tend to overlook is the significant impact of their diet on skin health.

The saying “you are what you eat” holds for our skin as well. Consuming a balanced diet that includes skin health foods can work wonders for maintaining a clear, youthful, and vibrant complexion.

Let’s explore seven superfoods that can contribute to optimal skin health, providing essential nutrients and promoting a natural, healthy glow.

Avocado

Known for its high content of healthy fats, avocados are a powerhouse of skin-friendly nutrients. They are packed with monounsaturated fats that help keep the skin moisturized and flexible, reducing the appearance of fine lines and wrinkles.

Additionally, avocados contain vitamins E and C, which act as potent antioxidants, protecting the skin from oxidative damage caused by free radicals.

Sweet Potatoes

Rich in beta-carotene, sweet potatoes are a skin-friendly food that can give your skin a healthy glow. Beta-carotene is converted to vitamin A in the body, which is essential for skin cell turnover and repair. Regular consumption of sweet potatoes can help prevent dry, flaky skin and promote a smoother texture.

Green Tea

Green tea is not only a soothing beverage but also a potent skin health booster. It contains catechins, which have anti-inflammatory and antioxidant properties that can help reduce redness and inflammation. Additionally, green tea can help protect the skin from damage caused by sun exposure and pollution.

Greek Yogurt

Greek yogurt is a great source of probiotics, which play a vital role in promoting a healthy gut. A balanced gut microbiome can positively impact skin health by reducing inflammation and preventing skin conditions like acne and eczema.

Dark Chocolate

Indulging in moderate amounts of dark chocolate (with high cocoa content) can be beneficial for your skin. Dark chocolate is rich in flavonoids, which can enhance blood flow to the skin, improve hydration, and protect against sun damage. Additionally, the antioxidants in dark chocolate can help combat free radicals, promoting a more youthful appearance.

Nuts and Seeds

Almonds, walnuts, chia seeds, and flaxseeds are excellent sources of healthy fats, antioxidants, and vitamins that benefit the skin. Vitamin E in nuts and seeds helps protect the skin from UV damage, while their omega-3 fatty acids maintain skin elasticity and hydration.

Salmon

Salmon is an excellent source of omega-3 fatty acids, which are essential for maintaining skin health. These healthy fats help to keep the skin hydrated and reduce inflammation, promoting a clear and radiant complexion. Omega-3s also support the skin’s natural barrier, which protects against environmental pollutants and irritants.

Additionally, the consumption of fatty fish and walnuts is very high due to the high presence of fatty acids, these acids have numerous benefits, which is why they are now being increasingly utilized in the skincare and beauty industry.

Moreover, these skin health foods are consumed by both adults and elderly people, however, because of the larger population of adults than that of elderly people around the world, these foods are mostly consumed by adults.

Incorporating these skin-boosting foods into your diet, along with a good skincare routine, proper hydration, and sufficient sleep, can contribute to achieving radiant, beautiful skin that glows from within.

Moreover, with the surging R&D spending by a large number of local and foreign businesses producing functional foods and the rising knowledge of the health benefits of functional foods across Asian countries, the need for skin health foods is increasing, and it will reach a value of USD 3,438.9 million by the end of this decade.

2 novembre 2023

3D Bioprinting – Industry Development and Forecast Report 2030

The 3D bioprinting market will power at a rate of 19.4% in the future, to reach USD 5,873 million by 2030. Living organs can be printed in 3D by layering living cells, which is the reason why bio engineering is progressively significant to human society.

With the growing requirement for bio-engineered organs, investigators have made key progressions in this tech.

Hence, the expansion of 3D biomaterials and bioprinters, their use in the pharma and cosmetics industries, and the surge in private and public financing for bioprinting research actions are persuading the industry positively.

Doctors make use of additive manufacturing for the creation of new bones and organs, and it is a major innovation in healthcare. Also, this allows the printing of prosthetic limbs for replacing missing limbs.

Additionally, as compared to the traditional process, which needs a long time and a donor, 3D bioprinting allows the transplantation to be done at a much faster pace.

The requirement for indispensable body parts for transplantation is enormously high globally. For making the things worse, there is an enormous gap amid the supply and requirement of tissues and organs. Numerous organs, for example the kidneys, lungs, heart, pancreas, liver, and intestines, are desired for transplantation.

Likewise, the requirement for heart valves, corneas, skin, blood vessels, and bones for transplantation is somewhat high. Rates of organ donation are still, while the requirement for tissues and organs is growing.

The inaccessibility of such parts for transplantation has brought about an increase in count of patients on the transplantation waiting list, a main anxiety for healthcare organization and providers.

Download free sample copy of this report: https://www.psmarketresearch.com/market-analysis/3d-bioprinting-market/report-sample

North America held about 40% share in the recent past, because of the tech-progressions, growing R&D activities and improving healthcare infra. Other than that, the increasing expenditure on healthcare, growing elderly population, and growing prevalence of chronic ailments, is powering the requirement for this tech, particularly in the pharma sector.

APAC 3D bioprinting market will grow the fastest, chiefly due to the fact that its large base of consumers, increasing R&D in this field, and support of the government and tax breaks.

Researchers from China have brought about major progressions in this tech, for instance the liquid-inliquid printing process, in which liquid polymers are combined for forming a steady membrane.

They state that the subsequent liquid developments can hold their shape for about 240 hours, before the combining commences. They printed numerous difficult shapes with the use of this novel method, which has also opened the way for tissue printing from living cells.

The high requirement for tissues and organ transplants all over the world has a lot to do with the increasing demand for 3D bioprinting process.

28 luglio 2023

Benign Prostatic Hyperplasia Treatment Industry Growth and Forecast Report 2023-2030

The benign prostatic hyperplasia treatment market will reach USD 18,837.7 million in 2030, with a CAGR of 5.2% in the years to come. The increasing occurrence of BPH, surging preference for minimally invasive surgeries, and growing investments, funds, and grants for conducting research on novel treatments are the protruding contributors to the development.

The larger share, around 85%, was held by drugs. This is because of the growing requirement for alpha-blockers as these medicines relax the muscle of the prostate and bladder neck, enabling urine flowing more easily.

Amongst the diverse types of drugs, alpha-blockers have been extensively used for treating the disease recently. Their increasing usage and the abundance of medicines under expansion present potential prospects for the industry.

Home healthcare settings had the larger share, and they will record the higher rate, over 5%, in the years to come, as a result of the growing patient count prescribed drugs over surgical treatment.

North America dominated the BPH treatment market with 41% share, as stated by a market research firm, P&S Intelligence. The increasing occurrence of the problem is powering the acceptance of cutting-edge treatments, for example, prostatic stenting, laser therapy, and UroLift therapy, thereby powering the development of the industry in the region.

APAC will grow the fastest in the years to come, at a rate of 6.4%. The improving standards of living, increasing per capita income and spending ability, snowballing burden of urological disease, and increasing investment in the healthcare for boosting the progress.

Furthermore, the increasing aging male population, together with a boom in the occurrence of obesity and diabetes, will power the prevalence of BPH and other lower urinary tract conditions.

China, India and Japan together have a large aging male population, requiring regular medical assistance, being extremely susceptible to chronic ailments as a result of its low immunity.

Therefore, patients with an irregular growth of the prostate are needed to be treated, to prevent urethra blockage and decrease the related cancer risk.

The increasing elderly male population is the main reason for the growing demand for BPH treatment all over the world.

27 luglio 2023

North America Is Dominating Professional Acne Treatment Industry

The global professional acne treatment market is experiencing growth and is projected to reach USD 13,124.5 million by 2030. This development can be credited to the increasing occurrence of acne, rising per-capita income in emerging and emerging nations, growing healthcare expenditure, and the rising count of research events.

In recent years, Inflammatory acne had the largest industry share, on the basis of acne type. This is mainly because of the instant need for better-quality treatment as it is normally painful.

Additionally, the generally accessible salicylic acid and benzoyl-peroxide-based over-the-counter items are not completely effective on inflammatory spots. Then, branded and common medications are provided by key medicinal businesses, on prescription, for inflammatory spots.

In the coming few years, the devices category is projected to experience faster development in the professional acne treatment industry, on the basis of treatment type. This can be ascribed to the increasing acceptance of light-based and laser acne treatments, largely in advanced countries, credited to the side effects of medications.

On the basis of professional type, in recent years, the dermatologist’s category is projected to dominate the professional acne treatment industry. This is mainly because of the growing count of expert dermatologists treating skin illnesses, like acne. Moreover, patients choose dermatologists due to their wide expertise and experience in dealing with the issue.

In recent years, North America led the industry, mainly because of the increasing occurrence of acne, growing knowledge of afresh developed medications, the huge pipeline of medications, and high per-capita income in the continent.

Furthermore, the continent is marked by the existence of protuberant dermatology medication producers, including Pfizer Inc., Johnson & Johnson, and Bausch Health Companies Inc., who offer several classes of medications to the North American populace.

Several pharmaceutical businesses are introducing new products, which have become a key trend in the industry for expert acne treatment items. For example, in 2020, Cassiopea SpA got the U.S. Food and Drug Administration (FDA) sanction for Winlevi, a clascoterone-founded cream made for the cure of acne in patients 13 years and elder.

Furthermore, AnnJi Pharmaceutical Co. Ltd. is involved in the growth of AJ101, which is an up-to-date cream formulation for the cure of acne vulgaris. The active element in AJ101 is a new androgen receptor degradation enhancer, which efficiently reduces the level of activity.

Individuals are concentrating on improving their looks by actively spending on a wide-ranging skincare regimen for scars, acne, and other skin issues. There are numerous treatment choices obtainable, such as systemic agents, topical therapies, lasers, physical modalities, and photodynamic therapy.

Hence, the increasing occurrence of acne, rising per-capita income in emerged and emerging nations, growing healthcare expenditure, and the rising count of research events are the major factors propelling the professional acne treatment market.

12 luglio 2023

What Are Two Ways Stomas Are Created and How to Care for Them?

A stoma is an opening in your abdomen that permits waste to remove from your body, rather than going via your digestive system. They’re utilized when part of your bladder or bowels either requires to heal or be detached.

To make a stoma, your surgeon will pull part of your large or small intestine onto the surface of your skin and stitch it onto an opening in your abdomen. The intestine ends and drains waste into an ostomy appliance, which is a bag attached to your stoma. Stomas are generally red, round, and moist, and they measure about 1 or 3 inches wide.

Numerous individuals use the terms “ostomy” and “stoma” interchangeably, but they do have a little different meaning:

An ostomy denotes the real opening in your abdomen.

A stoma denotes the end of the intestine that’s stitched into the ostomy.

Ostomies can be temporary and permanent. If you have an organ that is enduringly damaged, you’ll likely require a permanent one. However, if part of your intestine just requires to heal for a while, you may have a temporary ostomy.

The stoma care market is experiencing growth and is projected to reach USD 3,882.1 million by 2030.

What are the different types?

There are numerous kinds of stoma, reliant on the process utilized to create them:

Colostomy- A stoma is made with part of your colon, also called your large intestine, to avoid your rectum. In some cases, you may have the minor part of your colon removed, directing to a permanent stoma. A colostomy can also be impermanent if your colon is just required to heal. You may require a colostomy if you have rectal or colon cancer, a colon wound, or a blockage in your colon.

Urostomy- Your medic will make a bag using your small intestine. They’ll attach your ureters to this bag so that urine can gutter outside of your body without passing via your bladder. You may require a urostomy if your bladder is unhealthy or injured.

What kind of care is involved?

Your ostomy appliance comprises a bag that your stoma pipes into. Liable on the kind of bag you have, you’ll require to change it every four to seven days. When you change the bag, clean the skin around your stoma with mild warm water and let it dry totally. You don’t require to utilize soap, but if you do, make sure it’s very light and odorless, While the bag is detached, look for any signs of blood, irritation, or variations in the size and color of your stoma.

Colostomy surgery is leading the industry, based on surgery-type segmentation. This can be ascribed to the increasing occurrence of colon cancer and the growing number of colostomy methods.

For example, as per the United Ostomy Associations of America, around 100,000 ostomy operations are done in the U.S. annually.

Hence, the rising aging populace, the mounting board population of people suffering from inflammatory bowel illnesses and bladder and colorectal cancers, improved technology, the growing number of stoma and ostomy operations of the intestine, and fascinating reimbursement systems in developed countries are the major factors driving the market.

29 giugno 2023

Why Is Diagnostic Imaging System Usage Rising in Cardiology Departments?

According to the International Diabetes Federation (IDF) Diabetes Atlas Ninth edition 2019, approximately 700 million people within the age group of 20–79 years will be living with diabetes by 2045. The report also says that around 374 million people are at an increased risk of developing type 2 diabetes. Furthermore, the World Health Organization (WHO) states that cancer caused around 10 million deaths in 2020. The WHO also forecasts that by 2030, cardiovascular diseases (CVDs) related deaths will rise over 23.6 million. The increasing incidence of such chronic diseases is augmenting the need for diagnostic imaging systems.

As these diseases are highly prevalent among the elderly population, the booming geriatric population will fuel the diagnostic imaging systems market at a CAGR of 5.8% during 2020–2030. The market was valued at $38.9 billion in 2019 and it is projected to reach a revenue of $70.0 billion by 2030. As per the World Population Ageing 2019 report published by the United Nations (UN), the population of people aged 65 years or above will grow to 1.5 billion by 2050. Old people require extensive care, as they are highly susceptible to chronic illnesses, owing to their low immunity levels.

Owing to the burgeoning need for diagnostic imaging systems, companies such as Shenzhen Mindray Bio-Medical Electronics Co. Ltd., General Electric Company, Samsung Electronics Co. Ltd., Canon Inc., Esaote S.p.A., Siemens AG, Analogic Corporation, Carestream Health Inc., and FUJIFILM Holdings Corporation are focusing on introducing advanced products that provide high-quality imaging in healthcare units and quick and accurate results to patients. For instance, in December 2019, Shenzhen Mindray Bio-Medical Electronics Co. Ltd. introduced a comprehensive and dedicated solution to ultrasound imaging— DC-90 with X-Insight. This system assists in improving the diagnostic capabilities and enhancing the clinical workflow.

Currently, diagnostic imaging systems manufacturers are focusing on producing X-ray imaging systems, owing to the extensive use of these systems in various medical application areas, such as dentistry, orthopedics, and cardiology. Whereas, in the coming years, manufacturers will be selling nuclear imaging systems at a rapid pace, due to the surging cases of cancer. These systems are being increasingly adopted for cancer staging and treatment. Additionally, manufacturers are also involved in the production of ultrasound systems, computed tomography (CT) scanners, and magnetic resonance imaging (MRI) systems.

Different types of diagnostic imaging systems are used in application areas such as cardiology, obstetrics/gynecology (OB/GYN), oncology, ophthalmology, neurology, dentistry, urology, and orthopedics. In the coming years, these systems will be mostly used in the field of cardiology, owing to the high prevalence of CVDs worldwide. According to the WHO, CVDs account for over 17.9 million deaths every year, globally. The surging cases of CVDs can be owed to the risk factors such as diabetes, hypertension, obesity, and smoking.

According to P&S Intelligence, North America dominated the diagnostic imaging systems market in the recent past, due to the surging incidence of chronic disorders and soaring healthcare expenditure in the region. Moreover, the presence of a large number of modern diagnostic centers and hospitals also augmented the use of such systems in North America. Whereas, Asia-Pacific is expected to adopt these systems at the highest rate in the foreseeable future. This can be ascribed to the rising prevalence of chronic ailments and the booming number of diagnostic imaging centers across the region.

Thus, the escalating cases of chronic diseases and booming geriatric population will augment the need for diagnostic imaging systems in the coming years.

20 giugno 2023

Battling and Defeating Cancer With Immunotherapy Drugs

It is quite common to find people suffering from cancer. Cancer was once considered untreatable, but it is not the case with all the developments going on in medical science.

Cancer has everything to do with putting bad impact of the body, that’s why the body is not able to recognize the cancer cells and fight with them. In this blog, there will be information about immunotherapy, which is a particularly recent treatment for cancer.

Immunotherapy utilizes the immune system of a person for battling cancer. It usually has fewer side effects than a chemotherapy treatment.

Immunotherapy is done on the basis of immune cells that have the potential of recognizing and killing cancer cells can be produced in the labs and given to patients for the treatment of cancer. Several immunotherapy drugs have got the approval by the FDA or are in the process of clinical trials for determining their efficiency in treating various cancers.

Preparing Immune System To Fight Cancer

Immunotherapies makes use of different methods for battling with cancer cells. There are generally three types of Immunotherapies:

Checkpoint inhibitors- It is that process, which disturbs the system of cancer cell signals dodging the immune system into thinking they’re healthy, exposing them, and get them attacked by the immune system

Cytokines- cytokines helping in regulating and directing the immune system are formulated in a lab and injected into the body in larger dose than that, which are produced naturally in the human body.

Cancer vaccines- These are vaccines which reduce the risk of cancer by launching an open attack on the cancer causing viruses, or might help in the treatment of cancers by motivating the immune system for attacking cancer cells in a precise body part.

Immunotherapy might be put to use alone or in combination with other cancer treatments, for example surgery, chemotherapy, radiation and targeted therapy.

Immunotherapy Vs Chemotherapy

Both immunotherapy and chemotherapy are usually employed treatments of cancer using drugs put a halt or slow the rate of growth of cancerous cells. Though, while chemotherapy drugs attack quickly producing cells all over the body, immunotherapy activates the immune system’s capability to recognize and attack the cells causing cancer.

What are the Benefits of Immunotherapy

Immunotherapies are less common than chemotherapy as a cancer treatment. But these therapies are a treatment option for various cancers.

Immunotherapies can be more comprehensive and less noxious than other treatments used for treating cancer, as they harness the body power to attack the cancer cells rather than inserting chemicals into the body.

Immunotherapies are an active area of research in cancer therapy, and many of the new treatments are waiting to be approved for use for the treatment of cancer.

Due to the increasing prevalence of Chronic diseases around the world, the demand for immunotherapy drugs will further increase in the years to come, and will reach a value of USD 210,752 million by the end of this decade.