Disease - Modifying Agents Market

Disease - Modifying Agents Market Outlook 2025 to 2035

The Disease-Modifying Agents Market is expected to grow from USD 6.2 billion in 2025 to USD 11.6 billion by 2035, at a CAGR of 6.5%. Increasing prevalence of chronic inflammatory and autoimmune conditions, particularly rheumatoid arthritis and multiple sclerosis, is driving market demand. Oral therapies dominate due to improved patient adherence and expanding indications. The U.S. and Germany remain leading markets backed by biologic development and favorable reimbursement.

Metric	Value
Disease - Modifying Agents Market Estimated Value in (2025 E)	USD 6.2 billion
Disease - Modifying Agents Market Forecast Value in (2035 F)	USD 11.6 billion
Forecast CAGR (2025 to 2035)	6.5%

In the struggle to slow the progression of disease in many inflammatory conditions such as rheumatoid arthritis, psoriasis, and psoriatic arthritis, the disease-modifying agent class, including treatments such as anti-TNF agents and immunomodulators, the market is experiencing significant growth. There are 15 FDA-approved non-biologics and biologics disease-modifying agents competing in the market today with an estimated 18 biosimilars or standard agents currently testing.

Anti-TNF agents have consistently worked to treat the signs and symptoms of diseases such as rheumatoid arthritis, psoriasis, psoriatic arthritis, multiple sclerosis, and Crohn's disease, preventing the progression of each disease. However, the landscape has changed with the introduction of disease-modifying agents. There are several new disease-modifying drugs in the pipeline, all of which will offer important options for patients with these diseases promoting the disease-modifying agents market in the forecasted period.

Countries	CAGR
U.S.	7.1%
Germany	6.6%
China	6.2%
Japan	5.8%

What are the factors boosting the growth of the Disease-Modifying Agents Market?

Currently, disease-modifying agents are widely used for relapsing forms of multiple sclerosis and the treatment of rheumatoid arthritis. In a 2019 study by the National MS Society, it was estimated that about one million people were living with multiple sclerosis in the United States. Disease-modifying agents for multiple sclerosis patients include clinically isolated patients / high-risk patients at clinics, relapsing patients, ongoing high school patients who are experiencing relapses, and patients who continue to relapse. Disease-modifying agents reduce the number of relapses/less severe relapses that the patient may experience and reduce the severity of the relapses of patient. There are a variety of drugs approved by the NHS in the UK. Each drug offers a different combination of benefits and risks. So far, 20 FDA-approved treatments are indicated for several types of multiple sclerosis and vary in the route of administration (oral, self-administered, intravenous), efficacy, safety, and tolerance. Recurrence of multiple sclerosis is the most common course of the disease, and this pattern affects 97% of people with the disease before the age of 18. Between 2006 and 2015, Disease-modifying agents accounted for 45% of multiple sclerosis visits. Although injections remain the most prescribed disease-modifying agents (78%), the use of oral disease-modifying agents increased (from 11% in 2010-2011 to 40% in 2014-2015) and that injectable disease-modifying agents decreased (from -96% in 2006- 2007 to 52% in 2014-2015).

Worldwide, the annual incidence of rheumatoid arthritis is about three cases per 10,000 people, and the prevalence rate is about 1%, increasing in age and reaching between the ages of 35 and 50. Almost one-third (30.6%) of all adults who are obese also have arthritis. Disease-modifying antirheumatic agents have been shown to treat many inflammatory arthritides including rheumatoid arthritis as well as the treatment of other joint tissue diseases and other cancers. Disease-modifying antirheumatic agents work to suppress the body's overactive immune and/or inflammatory systems thus reducing the after-effects of the disease. These treatment regimens will give rise to the disease-modifying agents market.

Also, disease-modifying agents are expected to be useful for a few rare diseases such as Huntington's disease. However, the drugs are currently under clinical trials.

What are the Key Challenges that may restrain the growth of the Disease-Modifying Agents Market?

However, the disease modifying agents market still faces major challenges. Few factors could impede the growth of the disease modifying agents market such as drug recalls by the FDA and EMA. Also, the rising cost of multiple sclerosis disease-modifying agents can adversely affect the market globally. The prices of multiple sclerosis disease-modifying agents, among the most expensive drugs in all fields of the disease, have skyrocketed in recent decades. The US health care system spent $ 18.8 billion on multiple sclerosis disease-modifying agents in 2018 - the seventh highest in the general medical category. Consolidated spending on disease-modifying agents has increased due to both increasing prices and the introduction of new disease-modifying agents. According to the study, the price list has more than doubled between 2010 and 2017, and many multiple sclerosis patients in the U.S. now pay thousands of dollars a year out of pocket to get the treatment they need. Prices for self-injectable multiple sclerosis disease-modifying agents have risen sharply between 2006 and 2016. This has resulted in a 7.2-fold increase in outpatient expenditure.

Besides, exclusions and cost-related insurance company limits often create significant barriers to accessing patients.

Competitive Landscape

Key players such as

• Biogen Inc.
• Merck KGaA
• Elan Pharma India Pvt Ltd.
• Fresenius Kabi
• Pfizer Inc
• Teva Pharmaceutical Industries Ltd.
• Hospira, Inc.
• Accord Healthcare Inc
• Nordic Group Bv
• Antares Pharma, Inc.
• Sanofi Aventis
• Pharmascience Inc
• Ascend Laboratories Ltd
• Novartis International AG
• Strides Pharma Science Limited
• and others are actively involved in offering Disease-Modifying Agents.

How Increasing clinical trials to Augment Disease-Modifying Agents Market Growth?

In the market landscape, there are a lot of unmet needs for many diseases like Alzheimer’s, Parkinson’s, and other neurodegenerative diseases which require disease-modifying agents to slow down the onset or progression of the diseases. Several clinical trials of disease-modifying agents are being carried out globally for various diseases.

For Alzheimer’s disease, despite a growing number of well-reported clinical trials, failure of late-stage clinical trials, the introduction of disease-modifying therapy over the next five years is expected. There are many and ongoing efforts to develop therapeutic modalities for underlying pathophysiological changes in Alzheimer’s disease and other neurodegenerative disorders. By 2020, there are 121 agents in clinical trials for Alzheimer’s disease treatment, of which 97 agents are disease-modifying, targeted at the onset of disease or progression. Compared to the 2019 pipeline, there is an increase in the number of mutation agents. Of total 97, 17 (59%) disease modification agents were used in Phase 3, 55 potential disease modification agents in the Phase 2 trial, and 25 disease modification agents tested in Phase 1.

• A phase 3 study of isradipine as a disease-modifying agent in patients with early Parkinson's disease is being carried out by STEADY-PD III, funded by NINDS. In September 2020, Prothena Corporation plc (NASDAQ: PRTA), announced the results of the Phase 2 PASADENA study of prasinezumab. Prasinezumab is the first anti-inflammatory, anti-alpha-synuclein antibody to show efficacy in patients with early Parkinson's disease. In the study, prasinezumab significantly reduced motor performance by 35% compared with placebo in one year and delayed the time to make a meaningful clinical increase in motor continuity for more than one year
• A phase 3 Studies of Lorecivivint (SM04690), is being carried out as a potential disease-modifying knee osteoarthritis drug
• A randomized phase 2 trial of Zoledronic Acid on knee osteoarthritis in Australia (ZAP study, zoledronic acid for knee pain) showed efficacy at six months of Zoledronic Acid in reducing bone marrow lesions in knee osteoarthritis with MRI.

What are the Key Opportunities for the Disease-Modifying Agents Market?

Despite many challenges, there is still room for improvement, and there are still needs that have not been met. Since anti-TNFs are extremely effective treatments, the market is particularly competitive with disease-modifying agents as new entrants. There has been a tremendous increase in the use of disease-modifying agents as the first-line drug. In the first disease-modifying anti-rheumatic agents used in a rheumatoid arthritis patient, there was an increase in methotrexate, use over time from 39.8% to 52.1% in the past decade. The increased use of methotrexate as a first-line agent is consistent with it becoming an anchor for the treatment of rheumatoid arthritis.

Besides, Alzheimer's disease is becoming a rising threat globally with a rising treatment burden over the population and government. Alzheimer's disease is a progressive neurodegenerative disease currently producing dementia in the US population of 5.8 million and this number will rise to 13.5 million by 2050. Alzheimer's disease dementia is expected to have a devastating impact on the world by the year 2050 affecting 131 million population. The cost of Alzheimer's disease is fast - rising from $ 1 trillion worldwide by 2018 to $ 2 trillion by 2030. Methods of prevention, delay start, delay progress, and improvement of Alzheimer's disease symptoms are urgently needed. This unmet need of the disease will provide a shining opportunity to launch a disease-modifying agent.

Disease modification is not the same as "cure" or prevent descent; disease modification refers to a permanent change in a disease that will delay the onset of symptoms or a slow progression in patients with symptoms. A 5-year delay in Alzheimer's disease could be equivalent to reducing the total number of people affected by 50%. If treatment is achieved by 2025 the annual savings in the US economy by 2050 is expected to be $ 369 billion.

There are no effective disease-modifying agents developed for use with progressive forms of multiple sclerosis. Also, no current agents are cures. The treatment available requires parental management and, especially over time, injection problems become a growing problem for many patients. This urgent need of the time will give provide an opportunity window for oral disease-modifying agents for multiple sclerosis complying with patient ease of use.

Disease-modifying agents are also effective for osteoarthritis, however, the agents are still under the clinical trial phase. Therefore, there is an urgent need for a disease-modifying osteoarthritis drug. The combination of direct medical costs, pain, and suffering, and loss of productivity at work raise osteoarthritis into a major social and economic problem in health systems, economics, and poor patients.

What strategies are the Key Players adopting for expanding globally in the Disease-Modifying Agents Market?

The disease-modifying agents market is set to change in the coming years, attributable to the rising awareness of the better and more effective, and patient-compliant treatment available in the market. Key players are continuously investing in clinical trials of disease-modifying agents for various diseases/disorders. Also, the large players are actively undergoing acquisition and strategic collaboration to expand the availability and expansion of the disease-modifying agents market globally.

Why is the U.S. a Big Market for Disease-Modifying Agents?

In the U.S., the medical care framework is well known for its use and progressed foundation. The state of care facilities and hospitals is governed by regulatory rules and insurance policies. The regulatory bodies and the U.S. government are adopting various cost-effective plans to reduce their healthcare burden. Increasing acceptance of novel and cost-effective treatments is likely to drive disease-modifying agents demand in the country. The prevalence of rheumatoid arthritis is approximately 0.5 to 1 percent in developed countries and 0.6 percent in the U.S. population. In the US, osteoarthritis affects 30% of people about one in two people who are expected to develop osteoarthritis of the knee primarily due to an aging population and an increasing prevalence of obesity. More than 40,000 procedures of the knee and hip replacement have been passed since 2013. Conventional treatment for osteoarthritis, in particular, is symptomatic and expensive. As the geriatric population is rising in the U.S. the disease-modifying agents market will propel in the region.

Moreover, the presence of major players in the country and the presence of a majority of clinical trials in the region are likely to boost the regional market. The U.S. is the most dominating country in the global disease-modifying agents market and is expected to continue during the forecast period.

How is the Disease-Modifying Agents Market of Europe flourishing?

The European medical services framework has a developing medical services framework, with a multi-payer system that is to a great extent funded by the government. It is the second most successful healthcare system after the U.S in the world. One in three postmenopausal women has osteoporosis in Europe. In Western Europe, rheumatoid arthritis prevalence is 346.8/100,000. However, the incidence rates are in Western Europe 20.4/100,000. According to a 2010 European study, the average annual cost of medical, non-medical, and indirect (work productivity loss-related) was higher in patients with systemic sclerosis than in rheumatoid arthritis and/or psoriatic arthritis patients. The significant-high population in Europe with a considerably rising need for better treatment will give significant growth to the disease-modifying agents market. With the presence of many key players, growth in the European countries creates a huge opportunity for the disease-modifying agents market to grow.

What are the restraints for the growth of the Disease-Modifying Agents Market in Asia-MEA?

In India, neuro epidemiological studies show that the prevalence of multiple sclerosis has doubled in the last three decades (1.33 vs. 3 / 100,000 cases). Multiple sclerosis -hospital admissions have almost doubled in the last decade (1.58% vs. 2.54%). While multiple sclerosis may not be adequately treated, its symptoms can be treated with existing pharmacotherapy. However, multiple sclerosis treatments specialize in biologics, often more expensive - in patients and even in high-income countries. India, being a low-income country, has few patients who can afford the most expensive out-of-pocket medicine. The availability of poor insurance, the lack of affordable medication, and the evolving health care system are some of the factors contributing to the access and availability of multiple sclerosis patients in India. Currently, India is a low insurance market. About 15% of people have some cover and the other 85% payout of pocket.

Along with India other low economic countries in the Middle East and Africa regions face the same hindrance in adopting disease-modifying agents in respect to better treatment. Therefore, future research should look at cost-effectiveness and treatment equity for patients.

What is the Impact of the Pandemic on the Growth of the Disease-Modifying Agents Market?

The emergence of COVID-19 has brought the world to a halt. The health crisis has phenomenally affected organizations across all ventures. The pandemic has shaken several industries with the complete lockdown imposed after its outbreak. The economies and industries were hampered by the mass spread of the disease, which led to a recession because of the closing down of the offices, production lines, and market. The clinical trials of the disease-modifying agents were affected, subsequently affecting the disease-modifying agents market. Besides, the progression of patients in the hospitals and clinics has likewise declined, resulting in a decline in treatment rates.

The global focus of R&D has shifted to the development of the COVID-19 vaccine, as a result, much of the research and investment funding has been shifted to the development of the COVID-19 vaccine only. However, the demand for disease-causing agents is expected to be met from the current entry in the growth sector, with economic and market restarting.

The report covers exhaustive analysis on

• Disease-Modifying Agents Market Segments
• Disease-Modifying Agents Market Dynamics
• Historical Actual Market Size, 2016 - 2020
• Disease-Modifying Agents market Size & Forecast 2021 to 2031
• Market Current Trends/Issues/Challenges
• Competition & Companies involved
• Market Drivers and Restraints

Regional analysis includes

• North America
• Europe
• South Asia
• East Asia
• Oceania
• Middle East & Africa

Report Highlights

• Shifting Industry dynamics
• In-depth market segmentation
• Historical, current, and projected industry size Recent industry trends
• Key Competition landscape
• Strategies for key players and product offerings
• Potential and niche segments/regions exhibiting promising growth
• A neutral perspective towards market performance

Key Segments of Disease-Modifying Agents Market Covered in the Report

• Based on drug class, the global Disease-Modifying Agents market has been segmented as

  • Interferon Beta-1α/β
  • Natalizumab
  • Mitoxantrone
  • Glatiramer Acetate
  • Fingolimod
  • Dimethyl Fumarate
  • Ocrelizumab
  • Teriflunomide
  • Ciclosporin
  • Cyclophosphamide
  • Hydroxychloroquine
  • Leflunomide
  • Methotrexate
  • Mycophenolate
  • Sulfasalazine
  • Others

• Based on Indication, the global Disease-Modifying Agents market has been segmented as

  • Multiple Sclerosis
  • Rheumatoid Arthritis
  • Psoriatic Arthritis
  • Ankylosing Spondylitis
  • Systemic Sclerosis
  • Cancer
  • Others

• Based on Route of Administration, the global Disease-Modifying Agents market has been segmented as

  • Oral
  • Infusion
  • Subcutaneous
  • Intravenous

• Based on therapy type, the global Disease-Modifying Agents market has been segmented as

  • Monotherapy
  • Combination Therapy

• Based on distribution channel, the global Disease-Modifying Agents market has been segmented as

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
  • Others

• Based on region, the global Disease-Modifying Agents market has been segmented as

  • North America
  • Latin America
  • Europe
  • South Asia
  • East Asia
  • Oceania
  • Middle East & Africa

NOTE - All statements of fact, opinion, or analysis expressed in reports are those of the respective analysts. They do not necessarily reflect formal positions or views of the company.