Ulcerative Colitis Therapeutics Market

Market Overview

The global ulcerative colitis therapeutics market size was valued at USD 8.12 billion in 2022. It is estimated to reach USD 16.76 billion by 2031, growing at a CAGR of 8.57% during the forecast period (2023–2031). The global ulcerative colitis therapeutics industry is largely boosted by the surging incidence of ulcerative colitis globally, especially in developed economies. Similarly, there has been an increase in research aimed at creating new treatments for ulcerative colitis, and the market is anticipated to grow if these treatments are approved.

Ulcerative colitis is among the two most common forms of inflammatory bowel disease, a chronic inflammatory disease of the gastrointestinal tract, the other being Crohn's disease. The clinical signs of ulcerative colitis, an idiopathic, chronic inflammatory disorder of the colonic mucosa, are diarrhea, abdominal pain, and hematochezia. Several variables, including diet, lifestyle, age, genetics, environmental factors, microbiome, and abnormal immune reactions, can increase the risk of ulcerative colitis. The severity of ulcerative colitis symptoms can range from modest to severe. Bloody diarrhea, abdominal cramping, fatigue and weakness, general illness, loss of appetite and weight, and anemia are common symptoms. Individuals with ulcerative colitis may experience disorders affecting other body regions, including the eyes, skin, and joints.

Market Dynamics

Market Drivers

Surging Prevalence of Ulcerative Colitis

The prevalence of ulcerative colitis is surging worldwide. For instance, there were approximately 2,234,259 new cases of ulcerative colitis in 2020 globally. Industrialized countries have the highest incidence rate of ulcerative colitis. For instance, an estimated 910,000 patients were diagnosed with ulcerative colitis in the US in 2018.

In addition, there is a high incidence rate of ulcerative colitis in emerging economies, such as Japan, according to the World Gastroenterology Organization (WGO). Emerging economies will show a high growth in the incidence rate of ulcerative colitis due to changing diet and lifestyle patterns. There is also a high mortality rate in developing nations due to improper detection at the early stages of the disease. Thus, the growing prevalence of ulcerative colitis is boosting the global ulcerative colitis therapeutics market opportunties.

Increasing Research Activities and Approvals of Drugs

Increasing research activities is the major driver for the global market. For instance, in June 2021, Takeda Pharmaceutical Company Limited, a Japanese multinational pharmaceutical company, initiated a phase III clinical study to evaluate the efficacy and safety of intravenous (IV) Vedolizumab in Japanese patients with moderate to severe ulcerative colitis. It is anticipated that the trial will conclude in September 2024.

The growing approval of the drugs further facilitates the market's expansion. For instance, in 2022, the US FDA approved filgotinib for patients with moderate-severe ulcerative colitis. Similarly, in 2022, the US FDA approved upadacitinib for adult patients with severe ulcerative colitis. Thus, the aspects above are anticipated to stimulate market expansion over the forecast period.

Market Restraint

Frequent Patent Expiration

Most clinical trials to find a treatment for ulcerative colitis have been terminated, which is expected to hinder the market growth for ulcerative colitis therapeutics over the forecast period. For instance, Takeda Pharmaceutical Company Limited terminated its clinical trial for ontamalimab (Phase III) in 2021. The drug was being evaluated for the treatment of ulcerative colitis. Due to the sponsor's decision to discontinue the SHP647 (ontamalimab) clinical trial development program for IBD (inflammatory bowel diseases), the trial was terminated.

Market Opportunities

Strategic Initiatives by Key Players

The increasing participation of key players in product development is anticipated to propel market growth. For instance, Janssen Global Services, LLC demonstrated new safety and effectiveness data from a Phase III trial of Tremyfa (guselkumab) in adults with moderately to severely active ulcerative colitis (UC) in May 2023. Future market expansion is anticipated to be stimulated by the current emphasis of market participants on developing new drugs for treatment.

Key players are also interested in mergers and acquisitions to improve their market share. For instance, Pfizer, an American multinational pharmaceutical and biotechnology company, acquired Arena Pharmaceuticals, an American biopharmaceutical corporation, in March 2022. With this acquisition, the company aimed to connect the outstanding pipeline and history of Arena Pharmaceuticals to Pfizer's Immunology and swelling healing domain, thereby facilitating the development of additional motives to transform the lives of patients with immuno-inflammatory disease. Thus, such developments are expected to create opportunities for market growth.

Regional Analysis

Based on region, the global ulcerative colitis therapeutics market is bifurcated into North America, Europe, and Asia-Pacific.

North America's ulcerative colitis therapeutics market share is expected to expand significantly over the forecast period. This is due to the existence of prominent participants, the surging prevalence of ulcerative colitis in the region, and the continued funding for developing innovative solutions for treating ulcerative colitis. Market participants' emphasis on research activities also contributes to the expansion of the market. For instance, Teva Pharmaceutical Industries initiated a phase II clinical trial to determine the effectiveness and safety of TEV-48574 for Ulcerative Colitis in August 2022. Therefore, the new research studies contribute to expanding companies' product lines, which is anticipated to expedite regional market growth over the forecast period.

In addition, regulatory approvals from agencies such as the Food and Drug Administration of the United States, Health Canada, and others drive market growth. In May 2021, the FDA approved Bristol Myers Squibb's Zeposia (ozanimod) to treat adults with moderate to severe active ulcerative colitis (UC) in the US. As a result of the factors above, the demand for various ulcerative colitis treatment products in the region is anticipated to increase, fostering market growth over the forecast period.

In Europe, the ulcerative colitis market holds the second-largest market share. The market for ulcerative colitis in the United Kingdom grew fastest in Europe, while Germany held the largest market share. There is a surge in the number of products approved by the European region's government, thereby driving market growth. For instance, in November 2021, Bristol-Myers Squibb received approval from the European Commission to market Zeposia (ozanimod) to treat adults with moderately to severely active ulcerative colitis (UC) who have had a lost response, inadequate response, or are intolerant to either conventional therapy or a biologic agent.

The Asia-Pacific market for ulcerative colitis will rapidly expand due to factors such as rising awareness about the treatment, changing lifestyles that will increase prevalence and incidence rate, and the introduction of new drugs. Some companies will lose their patents on ulcerative drugs in the coming years, such as Humira (adalimumab) in 2016 and Remicade in 2018. This might restrain the market growth. However, some pharmaceutical companies have introduced biosimilar drugs to the ulcerative colitis market. For instance, in 2016, Torrent Pharmaceuticals of India introduced a biosimilar drug under Adfra to compete with Humira. Humira is the brand name for AbbVie Inc.'s adalimumab medication. Such developments are expected to expedite the market growth in the region.

Segmental Analysis

The global ulcerative colitis therapeutics market is segmented by drug class, gender type, and disease type.

Based on drug class, the global ulcerative colitis therapeutics market is bifurcated into TNF-alpha inhibitors, 5-aminosalicylates, corticosteroids, and others. 

The TNF-alpha inhibitors process segment dominates the global market and is expected to exhibit a CAGR of 8.35% over the forecast period. Tumor necrosis factor (TNF) is fundamental to the pathogenesis of several inflammatory diseases, including ulcerative colitis (UC), rheumatoid arthritis (RA), and Crohn's disease, among others. TNF is predominantly produced intracellularly by activated macrophages. After proteolysis, the precursor TNF is converted to soluble TNF by the TNF-converting enzyme. This soluble TNF oligomerizes to form the biologically active TNF homotrimer. In addition, TNF-alpha and TNF-beta are two closely related forms of the cytokine TNF. Both TNFs exert their effects by binding to the TNF receptors I and II (TNFRI and TNFRII), which are present in virtually all cell types (except erythrocytes).

Corticosteroids, also referred to as steroids, are an anti-inflammatory drug. They are recommended for a variety of ailments. They are synthetic hormones that the adrenal glands normally produce (2 small glands on top of the kidneys). Corticosteroids are primarily employed to decrease inflammation and suppress the immune system. They treat conditions like asthma, allergic rhinitis and hay fever, COPD, painful and inflamed joints, muscles and tendons, inflammatory bowel disease (IBD), Crohn's disease, ulcerative colitis, etc.

Based on gender type, the global ulcerative colitis therapeutics market is divided into men and women. 

The men's segment is the largest revenue contributor to the market and is expected to exhibit a CAGR of 8.76% throughout the forecast period. More men than women acquire ulcerative colitis. Although the average age of onset for IBD is between 15 and 35, more men than women are diagnosed with ulcerative colitis in their 50s and 60s. In addition to the effects of UC on the colon, it can also contribute unexpectedly to erectile dysfunction (ED) in men. IBD, including UC and Crohn's disease, is associated with a high prevalence of ED in males. All men with UC or Crohn's should be routinely screened for erectile dysfunction.

Symptoms and complications of ulcerative colitis in women may differ from those in men. Women can experience menstrual problems, as well as anemia and osteoporosis. The symptoms of ulcerative colitis tend to exacerbate during flare-ups or periods. With a few exceptions, ulcerative colitis does not affect a woman's fertility but may increase the risk of pregnancy complications. Women thinking about getting pregnant can manage their ulcerative colitis and reduce inflammation and symptoms by working with their gastroenterologist before getting pregnant.

Based on disease type, the global ulcerative colitis therapeutics market growth is segmented into total colitis, left-sided colitis, and proctitis. 

The total colitis segment owns the highest market share and is estimated to exhibit a CAGR of 8.36% during the forecast period. The inflammation of the entire colon is known as total ulcerative colitis. Total ulcerative colitis is also called pancolitis. Pancolitis can also be caused by infections, such as C. difficile, or inflammatory diseases, such as rheumatoid arthritis (RA). The key participants also invest in R&D to develop novel therapeutics in this segment. For instance, in December 2020, Cristcot LLC initiated a Phase III clinical trial to evaluate the safety and efficacy of hydrocortisone acetate 90 mg suppository administered with the Sephure applicator for the treatment of ulcerative colitis of the rectum in patients with total ulcerative colitis. Therefore, such trials are driving the segment growth.

Left-sided colitis is a subtype of ulcerative colitis. This ulcerative colitis features ongoing inflammation that starts at the rectum and progresses to the splenic flexure, a bend in the colon next to the spleen. Proctosigmoiditis, which impacts the rectum and the lower portion of the colon directly above the rectum and is known as the sigmoid colon, is another symptom of left-sided colitis. The condition of left-sided colitis is chronic. After receiving a diagnosis, patients will typically experience symptoms for the remainder of their lives. It cannot be cured without surgery, but treatment can alleviate symptoms. Various treatment options are available, but the treatment and management will differ from case to case.

Recent Developments

• September 2023- The FDA approved the subcutaneous administration of Entyvio by Takeda Pharmaceuticals for maintenance therapy in adult patients with moderate-to-severe ulcerative colitis following IV administration of the biologic for induction therapy.
• October 2023- Velsipity™ (etrasimod) was authorized to treat moderately to severely active ulcerative colitis in adults by the Food and Drug Administration (FDA).